Effect and placebo effect of acupressure (P6) on nausea and vomiting after outpatient gynaecological surgery. Effectiveness of an antihistamine-decongestant combination for young children with the common cold: a randomized, controlled clinical trial. Reminiscence interviews as stress management interventions for older patients undergoing surgery. A multiple-component treatment approach to smoking reduction. THE EFFECT OF IMIPRAMINE ON ENURESIS. A controlled study to assess the clinical efficacy of totally self-administered systematic desensitization. The hypotensive effect of a single daily dose of labetalol: a preliminary study. Electroacupuncture analgesia for colonoscopy. a prospective, randomized, placebo-controlled study. Lidocaine patch: double-blind controlled study of a new treatment method for post-herpetic neuralgia. Placebo effect and adaptation to noninvasive monitoring of BP. Demonstration by placebo response in asthma by means of exercise testing. Topical treatment of venous microangiopathy in patients with venous ulceration with Essaven gel--a placebo-controlled, randomized study. Acupuncture for the management of primary dysmenorrhea. [Venous leg ulcers: no improvement of wound healing with 685-nm low level laser therapy. Randomised, placebo-controlled, double-blind study]. Insertion of intradermal needles into painful points provides analgesia for intractable abdominal scar pain. Potentiation of placebo analgesia by proglumide. Specific and nonspecific factors in the effectiveness of a behavioral approach to the treatment of marital discord. Control of postoperative pain by transcutaneous electrical nerve stimulation after thoracic operations. A randomized, placebo-controlled trial of exercise therapy in patients with acute low back pain. Comparison of topical anaesthesia methods for venous cannulation in adults. A randomized controlled trial of fentanyl for abortion pain. Does gum chewing ameliorate postoperative ileus? Results of a prospective, randomized, placebo-controlled trial. Increasing Latino adolescents' adherence to treatment for latent tuberculosis infection: a controlled trial. Meprobamate and chlorpromazine in psychotherapy. Some effects on anxiety and hostility of outpatients. Skin temperature biofeedback for Raynaud's disease: a double-blind study. A placebo controlled double blind trial to evaluate the effectiveness of pulsed short wave therapy for osteoarthritic hip and knee pain. Oral antioxidant therapy for marginal dry eye. Relaxation training and attention placebo in the treatment of severe insomnia. CONTROLLED STUDY OF PSYCHIATRIC OUTPATIENT TREATMENT. Randomized study of vaginal chlorhexidine disinfection during labor to prevent vertical transmission of group B streptococci. Zolpidem reduces postoperative pain, fatigue, and narcotic consumption following knee arthroscopy: a prospective randomized placebo-controlled double-blinded study. A large randomized placebo controlled study of auricular acupuncture for alcohol dependence. P6 acupressure may relieve nausea and vomiting after gynecological surgery: an effectiveness study in 410 women. The impact of acupuncture and craniosacral therapy interventions on clinical outcomes in adults with asthma. Local application of sustained-release delivery system of chlorhexidine in Down's syndrome population. Paradoxical intention and insomnia: an experimental investigation. A controlled study of minimal-contact thermal biofeedback treatment in children with migraine. Treatment effectiveness of hypnosis and behaviour therapy in smoking cessation: a methodological refinement. Repeated measurements of non-invasive ambulatory blood pressure: distinction between reproducibility and the proper effect of placebo. Acute pain in a clinical setting: effects of cognitive-behavioural skills training. Social functioning in children with ADHD treated with long-term methylphenidate and multimodal psychosocial treatment. A randomized controlled trial of transurethral microwave thermotherapy. The effect of high and low frequency electroacupuncture in pain after lower abdominal surgery. Cognitive-behavior therapy with adult patients with epilepsy: a controlled outcome study. Training children to cope with dental treatment. EMDR for panic disorder with agoraphobia: comparison with waiting list and credible attention-placebo control conditions. Withdrawal of perphenazine in chronic schizophrenia. Efficacy of maintenance use of anticholinergic agents. Is transcutaneous electrical nerve stimulation an effective analgesia during colonoscopy? Cognitive behavioral psychotherapy for depression following stroke: a randomized controlled trial. Effect of acupressure on nausea and vomiting during pregnancy. A randomized, placebo-controlled, pilot study. Cognitive-behavioral and patient education interventions in cardiac catheterization procedures: the Palo Alto Medical Psychology Project. Use of transcutaneous electrical nerve stimulation for postoperative pain. A behavioral treatment program as a therapy in the control of primary hypertension. Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial. Acupressure for chemotherapy-induced nausea and vomiting: a randomized clinical trial. Role playing and incentives in the modification of the social interaction of chronic psychiatric patients. [Can acupuncture prevent cystitis in women?]. Treatment of chronic schizophrenia with promazine hydrochloride. Methylphenidate and attributions in boys with attention-deficit hyperactivity disorder. Single-needle acupuncture alleviates gag reflex during transesophageal echocardiography: a blinded, randomized, controlled pilot trial. Management of depression in rheumatoid arthritis: a combined pharmacologic and cognitive-behavioral approach. The efficacy and safety of 50 mg penicillin G potassium troches for recurrent aphthous ulcers. TENS for children's procedural pain. Effects of multiple sessions of true and placebo heart rate biofeedback training on the heart rates and anxiety levels of anxious patients during and following treatment. A clinical evaluation of depressives found in a rural survey in India. Effects of a remedial program on visual-motor perception in spina bifida children. Anxiety, relaxation and anaesthesia for day-case surgery. Iron supplementation for acute blood loss anemia after coronary artery bypass surgery: a randomized, placebo-controlled study. Comparison of no medication, placebo, and hyoscyamine for reducing pain during a barium enema. Genital herpetic infection in men and women: clinical course and effect of topical application of adenine arabinoside. Placebo-controlled evaluation of abbreviated progressive muscle relaxation and of relaxation combined with cognitive therapy in the treatment of tension headache. Evaluation of a treatment approach combining nicotine gum with self-guided behavioral treatments for smoking relapse prevention. Randomised controlled trial of intensive cognitive behaviour therapy for patients with chronic schizophrenia. Influence of hospitalization and placebo therapy on blood pressure and sympathetic function in essential hypertension. Physiotherapy-based rehabilitation following disc herniation operation: results of a randomized clinical trial. Both EMLA and placebo cream reduced pain during extracorporeal piezoelectric shock wave lithotripsy with the Piezolith 2300. Transcutaneous electrical nerve stimulator for procedural pain associated with intravenous needlesticks. Acupuncture in patients with chronic low back pain: a randomized controlled trial. Stress management training for hypertensives: cognitive and physiological effects. The effect of therapeutic touch on behavioral symptoms of persons with dementia. Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Interaction of personality and treatment conditions associated with success in a smoking control program. Acupuncture treatment of chronic low-back pain -- a randomized, blinded, placebo-controlled trial with 9-month follow-up. Three-year outcomes for maintenance therapies in recurrent depression. [Comparative study of the action of various treatments and placebos on painful gastro-duodenal ulcer crises]. Home intervention in the treatment of asthma among inner-city children. Anti-inflammatory effects of ultrasound therapy: evidence for a major placebo effect. Self-help for bulimia nervosa: a randomized controlled trial. Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation. Evaluation of TENS during screening flexible sigmoidoscopy. A controlled comparative investigation of psychological treatments for chronic sleep-onset insomnia. Disulfiram implantation: a trial using placebo implants and two types of controls. Reduction of postoperative pain and swelling by ultrasound treatment: a placebo effect. General practice consultations: is there any point in being positive? The effects of reserpine on schizophrenic patients. Self-administered aversive stimulation with hallucinating hospitalized schizophrenics. Possible thermogenesis with dexfenfluramine. A controlled trial of 'Senokot' in faecal soiling treated by behavioural methods. Ethyl vinyl chloride vapocoolant spray fails to decrease pain associated with intravenous cannulation in children. Acustimulation wrist bands are not effective for the control of chemotherapy-induced nausea in women with breast cancer. Rapid initiation of repigmentation in vitiligo with Dead Sea climatotherapy in combination with pseudocatalase (PC-KUS). Project LIFE: a partnership to increase physical activity in elders with multiple chronic illnesses. Trachea-noise biofeedback in asthma: a comparison of the effect of trachea-noise biofeedback, a bronchodilator, and no treatment on the rate of recovery from exercise- and eucapnic hyperventilation-induced asthma. Home based exercise programme for knee pain and knee osteoarthritis: randomised controlled trial. Expectancy, false galvanic skin response feedback, and systematic desensitization in the modification of phobic behavior. Initiation of zinc treatment for acute childhood diarrhoea and risk for vomiting or regurgitation: a randomized, double-blind, placebo-controlled trial. Efficacy of laser-acupuncture in the prevention of exercise-induced asthma. The treatment of tranquilizer dependence by propranolol. Use of a blood glucose monitoring manual to enhance monitoring adherence in adults with diabetes: a randomized controlled trial. Effects of pinaverium bromide in the premedication of endoscopic retrograde cholangio-pancreatography and on motor activity of the sphincter of Oddi. The use of nicotine chewing gum as an aid to stopping smoking. Examination of the effectiveness of various treatment techniques for reducing tension. Placebo and naloxone can alter post-surgical pain by separate mechanisms. Effects of stress management on clinical outcomes in rheumatoid arthritis. Inducing placebo respiratory depressant responses in humans via opioid receptors. A self-control behavior therapy program for depression. The effect of a cognitive behavioral intervention on oral hygiene. Effect of TENS on pain, medications, and pulmonary function following coronary artery bypass graft surgery. Does acupuncture improve the orthopedic management of chronic low back pain--a randomized, blinded, controlled trial with 3 months follow up. Influence of sensory suggestibility on treatment outcome in headache patients. Efficacy of P6 acupressure in the treatment of nausea and vomiting during pregnancy. Behavioural versus cognitive social-skills training with intellectually-handicapped adults. Acustimulation of the Neiguan point during gastroscopy: its effects on nausea and retching. The effect of chiropractic care on jet lag of Finnish junior elite athletes. A controlled study of reserpine on chronically disturbed patients. Acupressure and fatigue in patients with end-stage renal disease-a randomized controlled trial. Acupuncture in patients with tension-type headache: randomised controlled trial. Acupressure and quality of sleep in patients with end-stage renal disease--a randomized controlled trial. Auricular acupuncture for dental anxiety: a randomized controlled trial. Is routinely given conscious sedation of benefit during colonoscopy? Evaluation of specific and non-specific effects in homeopathy: feasibility study for a randomised trial. Pain evaluation during carbon dioxide laser vaporization for cervical intraepithelial neoplasia: a randomized trial. Physiologic observations in a controlled clinical trial of the antiemetic effectiveness of 5, 10, and 15 mg of delta 9-tetrahydrocannabinol in cancer chemotherapy. Ophthalmologic implications. Randomized controlled trials on treatment by homeopaths and self-treatment with homeopathic medicines: design and protocol. Segmental noxious versus innocuous electrical stimulation for chronic pain relief and the effect of fading sensation during treatment. A controlled evaluation of thermal biofeedback and thermal biofeedback combined with cognitive therapy in the treatment of vascular headache. Acupuncture for diagnostic fiberoptic bronchoscopy: a prospective, randomized, placebo-controlled study. Effect of the intensity of transcutaneous acupoint electrical stimulation on the postoperative analgesic requirement. Prevention of breast pain and milk secretion with bromocriptine after second-trimester abortion. Cognitive-educational treatment of fibromyalgia: a randomized clinical trial. I. Clinical effects. The antitussive effect of placebo treatment on cough associated with acute upper respiratory infection. Psychosocial treatment for recurrent genital herpes. House dust mite allergen reduction and allergy at 4 yr: follow up of the PIAMA-study. Oral transmucosal fentanyl citrate for premedication in adults. Evaluation of Simulated Presence: a personalized approach to enhance well-being in persons with Alzheimer's disease. Effectiveness of naltrexone in a community treatment program. Acustimulation wristbands for the relief of chemotherapy-induced nausea. The effects of psychological preparation on pain and recovery after minor gynaecological surgery: a preliminary report. Functional electrical stimulation improves motor recovery of the lower extremity and walking ability of subjects with first acute stroke: a randomized placebo-controlled trial. Clinical hypnosis in the alleviation of procedure-related pain in pediatric oncology patients. Effect of low sodium diet or potassium supplementation on adolescent blood pressure. The effects of applied tension on symptoms in French-speaking blood donors: a randomized trial. The influence of a placebo, body position and medication on motion sickness. Reducing reactions to blood donation with applied muscle tension: a randomized controlled trial. The effects of relaxation response training on menopausal symptoms. Nicotine replacement to reduce cigarette consumption in smokers who are unwilling to quit: a randomized trial. Effects of pill-giving on maintenance of placebo response in patients with chronic mild depression. Acupuncture as an adjunct to exercise based physiotherapy for osteoarthritis of the knee: randomised controlled trial. Controlled comparison of progressive relaxation, stimulus control, and paradoxical intention therapies for insomnia. The Trager approach in the treatment of chronic headache: a pilot study. Bright light treatment decreases depression in institutionalized older adults: a placebo-controlled crossover study. Effects of chiropractic treatment on blood pressure and anxiety: a randomized, controlled trial. Transcutaneous electrical nerve stimulation following appendicectomy: the placebo effect. Electroacupuncture for control of myeloablative chemotherapy-induced emesis: A randomized controlled trial. Randomised trial of analgesic effects of sucrose, glucose, and pacifiers in term neonates. Acupuncture and knee osteoarthritis: a three-armed randomized trial. Randomized controlled trial of calcaneal taping, sham taping, and plantar fascia stretching for the short-term management of plantar heel pain. Chiropractic adjustive manipulation on subjects with acute low back pain: visual analog pain scores and plasma beta-endorphin levels. Acupuncture for patients with migraine: a randomized controlled trial. Randomised, placebo controlled trial of nebulised furosemide for breathlessness in patients with cancer. Prehospital analgesia with acupressure in victims of minor trauma: a prospective, randomized, double-blinded trial. Sedation, topical pharyngeal anesthesia and cardiorespiratory safety during gastroscopy. The Fasting Hyperglycaemia Study: III. Randomized controlled trial of sulfonylurea therapy in subjects with increased but not diabetic fasting plasma glucose. Assessment of efficacy of transcutaneous electrical nerve stimulation for pain management during office-based flexible cystoscopy. An investigation of the placebo effect and age-related factors in the report of needle pain from venipuncture in children. [Evaluation of 2 homeopathic products on the resumption of transit after digestive surgery. A multicenter controlled trial]. Efficacy of intranasal midazolam in facilitating suturing of lacerations in preschool children in the emergency department. Treatment of hypertension with biofeedback and relaxation techniques. Acupuncture and bronchial asthma: a long-term randomized study of the effects of real versus sham acupuncture compared to controls in patients with bronchial asthma. Monoamine metabolite and catecholamine measurements in cerebrospinal fluid in determining the quality of the pre-operative night's sleep. Static magnetic fields for treatment of fibromyalgia: a randomized controlled trial. Prophylactic penicillin: effect on posttreatment symptoms following root canal treatment of asymptomatic periapical pathosis. Use of single session hypnosis for smoking cessation. Two-week topical treatment with Essaven gel in patients with diabetic microangiopathy--a placebo-controlled, randomized study. [Protocol of cervical maturation by acupuncture]. A dyadic remediation program for care recipients with dementia. Changes in cardiovascular risk factors by combined pharmacological and nonpharmacological strategies: the main results of the CELL Study. A comparison of progressive relaxation and autogenic training as treatments for insomnia. Effect of guar gum on body weight and serum lipids in hypercholesterolemic females. Meditation training and essential hypertension: a methodological study. Treatment of carpal tunnel syndrome with vitamin B6: a double-blind study. Evaluation of postoperative bupivacaine infusion for pain management after anterior cruciate ligament reconstruction. Do pelvic floor exercises really improve orgasmic potential? Preoperative administration of prostaglandin to avoid dilatation-induced damage in first-trimester pregnancy terminations.
Acupuncture and acupressure have previously been reported to possess antiemetic effect. We wanted to investigate the "true" and placebo effect of acupressure in prevention of postoperative nausea and vomiting (PONV).
                Sixty women undergoing outpatient minor gynaecological surgery were entered into a double-blind and randomised study. One group received acupressure with bilateral stimulation of P6 (A), a second group received bilateral placebo stimulation (P) and a third group received no acupressure wrist band and served as a reference group (R). PONV was evaluated as number of patients with complete response (no PONV), nausea only or vomiting. In addition, the need for rescue antiemetic medication and nausea after 24 h was registered.
                Complete response was obtained in 11, 11 and 9 patients in groups, A, P and R, respectively. Nine, 7 and 6 patients had nausea before discharge home, and 1, 1 and 8 patients were nauseated (8 vs 1 patient: P < 0.05) 24 h after operation in A, P and R groups, respectively. When compared to placebo acupressure (2 patients vomited and 5 needed rescue), significantly (P < 0.05) fewer needed rescue antiemetic medication after acupressure at P6 (no vomiting or rescue medication). When compared to the observation group (5 vomited and 4 needed rescue antiemetics), significantly fewer vomited after acupressure (P < 0.05)
                In patients undergoing brief gynaecological surgery, placebo effect of acupressure decreased nausea after 24 h but vomiting and need of rescue antiemetics was reduced only by acupressure with the correct P6 point stimulation. We tested the hypothesis that antihistamine-decongestant combinations cause no clinically significant relief of the symptoms of upper respiratory tract infections in young children by randomly assigning 96 children to one of three treatment groups: antihistamine-decongestant, placebo, and no treatment. There were no differences among the three study groups in the proportion of children considered "better" overall by the parent 48 hours after the initial assessment (drug, 67%; placebo, 71%; no treatment, 57%; p = 0.53). There were no differences among groups in individual or composite symptom score changes. Two thirds of parents whose children were eligible for the drug trial believed that their child needed medicine for cold symptoms. In the proportion of parents believing that their child needed medicine, there was no difference between those who consented to participate and those who refused. Parents who wanted medicine at the initial visit reported more improvement at follow-up, regardless of whether the child received drug, placebo, or no treatment. We conclude that there is no clinically significant improvement in symptoms of upper respiratory tract infection, including no significant placebo effect, in young children for whom an antihistamine-decongestant is prescribed. A standard reminiscence interview and one that focused on successfully met challenges reduced state anxiety and enhanced coping self-efficacy when measured against both attention-placebo and no-intervention control groups in a sample of 104 elderly male patients facing surgery. Age-peer interviewers did not elicit significantly greater overall reductions in state anxiety or increases in coping self-efficacy scores than younger interviewers (nonpeers), but did produce significantly higher coping self-efficacy scores than nonpeers when administering the challenge reminiscence interview. nan nan nan We analyzed the efficacy of a single daily dose of labetalol (300 mg) administered at 9 a.m. in six inpatients suffering from medium-severe hypertension. The study was conducted on 3 consecutive days, during which the patients were on labetalol, placebo, and non-treatment (control) according to a trial design of the Latin square type, balanced for residual effects. The hypotensive effect of labetalol manifests itself between hours 1 and 2 after administration of the drug. The systolic and diastolic blood pressure values always proved lower after labetalol as compared to placebo and non-treatment (control) as well as to the average of the latter two values (placebo + control) divided by 2. No side effects were detected. A study was undertaken to compare the effectiveness of acupuncture in reducing patient's discomfort and anxiety during colonoscopy with a standard sedation protocol.
                Thirty patients scheduled to undergo colonoscopy were randomly assigned to receive acupuncture, sham, or no acupuncture. A verbal rating scale was used to measure patient's pain when the endoscope reached four scheduled positions. Midazolam was administered at baseline and again anytime patients complained of "severe" pain. The amount of midazolam administered was recorded. A verbal rating scale was used to assess patient's satisfaction with the level of sedation achieved.
                Pain level was lower, although not significantly, in the acupuncture group. Midazolam boluses were required in three patients with acupuncture (30%), eight in the sham group (80%), and nine in the control group (90%) (p = 0.01). Six patients in the acupuncture group (60%) reported optimum acceptance of colonoscopy compared with only one in the sham group (10%) and none in the control group (0%) (p = 0.016). Satisfaction scores, assessed 24-72 h after colonoscopy, were extremely high (median score 90 of 100) in the three groups.
                Acupuncture may decrease the demand for sedative drugs during colonoscopy by reducing discomfort and anxiety of the patient and the well-known adverse effects of pharmacologic sedation. Post-herpetic neuralgia (PHN) is a common and often intractable neuropathic pain syndrome predominantly affecting the elderly. Topical local anesthetics have shown promise in both uncontrolled and controlled studies. Thirty-five subjects with established PHN affecting the torso or extremities completed a four-session, random order, double-blind, vehicle-controlled study of the analgesic effects of topically applied 5% lidocaine in the form of a non-woven polyethylene adhesive patch. All subjects had allodynia on examination. Up to 3 patches, covering a maximum of 420 cm2, were applied to cover the area of greatest pain as fully as possible. Lidocaine containing patches were applied in two of the four 12-h-long sessions, in one session vehicle patches were applied, and one session was a no-treatment observation session. Lidocaine containing patches significantly reduced pain intensity at all time points 30 min to 12 h compared to no-treatment observation, and at all time points 4--12 h compared to vehicle patches. Lidocaine patches were superior to both no-treatment observation and vehicle patches in averaged category pain relief scores. The highest blood lidocaine level measured was 0.1 micrograms/ml, indicating minimal systemic absorption of lidocaine. Patch application was without systemic side effect and well tolerated when applied on allodynic skin for 12 h. This study demonstrates that topical 5% lidocaine in patch form is easy to use and relieves post-herpetic neuralgia. Three 24 h ambulatory monitorings of BP were performed at two-week intervals in 21 untreated hypertensives (mean age 38 +/- 10 yrs, 13 males and 9 females). After the first baseline monitoring, the patients were randomised, according to a cross-over design, to one of the following sequences: no therapy to placebo or placebo to no therapy. At the end of each period, noninvasive ambulatory monitoring was performed. Mean +/- SE 24 h systolic (SBP) and diastolic (DBP) pressures recorded at the first monitoring were 129.2 +/- 3.5 mmHg and 81.7 +/- 2.3 mmHg respectively. At the second and third monitorings, mean 24 h BP differences versus baseline levels were -2.9 +/- 1.8 and -4.7 +/- 1.7 mmHg for SBP, and -2.0 +/- 1.1 and -2.7 +/- 1.5 mmHg for DBP. Both SBP and DBP differences at repeated monitorings were significant by analysis of variance (P less than 0.05). No significant effects on BP of treatment sequence or of placebo administration were found. Analysis of covariance showed a significant relationship between initial 24 h BP and subsequent mean 24 h BP differences (SBP: beta = -0.260, DBP: beta = -0.124). ANOVA performed on waking and sleeping BP separately showed the observed differences to be significant only during waking hours. Regression analysis showed that the decrease in 24 h BP at repeated monitorings was significantly related to the extent of 'white coat'-induced BP increase only for DBP (P = 0.022). For both 24 h SBP and DBP, however, a negative correlation between the alarm reaction to the presence of the physician and 24 h BP decrease at repeated monitorings was observed. It is concluded that noninvasive ambulatory monitoring is subject to adaptative phenomena but not to placebo effect. Factors influencing the defence reactions to manual measurements and to ambulatory monitoring might be partly different. nan The involvement of the microcirculation in chronic venous insufficiency (CVI), due to venous hypertension, causes venous hypertensive microangiopathy (VHM) and ulceration. VHM is characterized by enlarged, convoluted capillaries; microvascular thrombosis; obliteration of some capillaries; increase in flux, permeability, and edema and altered microlymphatics. PO2 is decreased and CO2 increased. Capillary exchanges are altered and nutritional alterations eventually lead to venous ulcers. Edema is associated with increased capillary pressure, reduced clearance, and increased exchange surface of capillaries, which become tortuous and glomerular-like. The aim of this randomized, placebo-controlled study was to evaluate local treatment with Essaven gel (EG) in subjects with venous microangiopathy and ulcers. Measurements of laser Doppler flux, PO2, and PCO2 in standardized conditions showed positive changes (a significant decrease of the abnormally increased flux and CO2 while PO2 increased) in the EG treatment group. Changes in the placebo and control group were more limited (changes in the placebo group were mainly associated with skin manipulation when placebo-EG was applied). In conclusion, Essaven gel, in comparison with placebo, acutely improves the microcirculation in VHM even with a single acute application. The effectiveness of acupuncture in managing the pain of primary dysmenorrhea was investigated in a randomized and controlled prospective clinical study. Forty-three women were followed for one year in one of four groups: the Real Acupuncture group was given appropriate acupuncture and the Placebo Acupuncture group was given random point acupuncture on a weekly basis for three menstrual cycles; the Standard Control group was followed without medical or acupuncture intervention; the Visitation Control group had monthly nonacupuncture visits with the project physician for three cycles. In the Real Acupuncture group, 10 of 11 (90.9%) women showed improvement; in the Placebo Acupuncture group, 4 of 11 (36.4%); in the Standard Control group, 2 of 11 (18.2%); and in the Visitation Control group 1 of 10 (10%). There was a 41% reduction of analgesic medication used by the women in the Real Acupuncture group after their treatment series, and no change or increased use of medication seen in the other groups. Venous leg ulcers (ulcera crurum venosa) are frequently seen in elderly patients. It has been suggested that low level laser irradiation has a biostimulative and wound healing effect; however, this has not yet been clinically verified by controlled studies.
                The difference in size reduction of leg ulcers with and without low level laser or placebo laser treatment was measured in 44 patients randomised into two treatment groups (685-nm low level laser and placebo laser) or a control group which served to quantify the effect of laser application. All patients received standardized wound care.
                The aim of the study was to compare the effectiveness of low level laser irradiation with that of a placebo "light source". The size of the ulcers was planimetrically measured at baseline (day 1), at the end of therapy (day 28) and 2 months later (day 90). The difference in wound size was evaluated.
                There were no statistically significant differences in reduction of wound size between the three groups, thus suggesting that low level laser light does not have any stimulatory effect on wound healing in ulcera crurum venosa. Conventional treatments are often ineffective for patients having painful abdominal scars. There are painful points in and around scar tissue. We tested the hypothesis that insertion of intradermal needles into these painful points reduces scar pain.
                Patients with abdominal scar pain with painful points that is not relieved by conventional treatments were allocated to a treatment group (n = 23), a sham-treatment group (n = 23), or a control group (n = 24). In the treatment group, intradermal needles were inserted into painful points detected by a pressure threshold meter (pain < or = 2.5 kg/cm(2)). In the sham-treatment group, the same needles were inserted into nonpainful points. The needles were kept in place for 24 hours. This process was repeated 20 times over a 4-week period. Responses were evaluated before and at the end of treatment, and 4 and 26 weeks after the treatment. Continuous and lancinating pain was evaluated on a 10-cm visual analog scale. We measured the area of pain and the pressure required to initiate painful-point pain. All patients took diclofenac as needed and completed a diary of daily diclofenac consumption.
                Patients in the treatment group showed a marked reduction in all pain parameters (>70%). In contrast, analgesia was minimal in the other groups. The decreases in the pain threshold pressure correlated with the decreases in continuous and lancinating pain (r =.57 and r =.63, respectively).
                Our data suggest that insertion of intradermal needles into painful points is a remarkably effective treatment for intractable abdominal scar pain. Analgesia presumably results from inactivation of painful points, through a yet to be elucidated mechanism. nan nan Transcutaneous electrical nerve stimulation (TENS) has been used extensively to control postoperative pain, but its effects are controversial. This is probably due to the different types of operations performed and, therefore, to the varying intensity of postoperative pain. Here we present an extensive study with TENS in 324 patients who underwent different types of thoracic surgical procedures: posterolateral thoracotomy, muscle-sparing thoracotomy, costotomy, sternotomy, and video-assisted thoracoscopy.
                Each patient cohort was randomly subdivided into three treatment groups: TENS, placebo TENS and control. The effectiveness of TENS was assessed by two factors: the time from the beginning of treatment to the request for further analgesia and the total medication intake during the first 12 hours after operation.
                Whereas posterolateral thoracotomy produced severe pain, muscle-sparing thoracotomy, costotomy, and sternotomy caused moderate pain, and video-assisted thoracoscopy caused only mild pain. The TENS treatment was not effective in the posterolateral thoracotomy group, but it was useful as an adjunct to other medications in the muscle-sparing thoracotomy, costotomy, and sternotomy groups. In contrast, representing the only pain control treatment with no adjunct drugs, it was very effective in patients having video-assisted thoracoscopy.
                These findings show that TENS is useful after thoracic surgical procedures only when postoperative pain is mild to moderate; it is uneffective for severe pain. To assess the efficacy of exercise therapy for acute low back pain, a randomized, placebo-controlled trial was performed in 40 Dutch general practices. Patients received either exercise instruction with advice for daily life by a physiotherapist; placebo ultrasound therapy by a physiotherapist; or usual care by the general practitioner. All patients received analgesic agents and information on low back pain before randomization. Four hundred seventy-three patients were included. No differences in number of recurrences, functional health status, or medical care usage could be found among the three groups. In the exercise group, duration of recurrences was shorter and patients were less tired during the first 3 months than in the usual care group, but no differences were found between the exercise and placebo groups. It was concluded that exercise therapy for patients with acute low back pain has no advantage over usual care from the general practitioner. A prospective, randomized clinical trial was performed in order to assess the efficacy and side-effects of commonly used topical anaesthesia methods in adults receiving peripheral venous cannulation. The study was double-blinded to the degree that the methodologies allowed. One hundred and fifty healthy adults undergoing elective surgery were allocated at random to five groups: EMLA cream, ethyl chloride spray, intracutaneous infiltration with 2% lidocaine, placebo cream and no treatment. Venipuncture was performed with a 18G cannula on the dorsal side of the hand. Puncture pain and pain caused by the topical treatment itself were measured using a visual analogue scale (VAS, range: 0-100 mm). Haemodynamic response, difficulties in performing the puncture and side-effects were recorded. All analgesic techniques were well tolerated. Haemodynamic response and degree of puncture difficulty showed no differences among the groups. Puncture pain (median mrnVAS) following infiltration (1.0) and EMLA (10.0) was significantly lower than no treatment (30.0) or placebo (30.0). The benefit of local infiltration was altered by injection pain (11.5). Spray did not significantly lower puncture pain (26.5) and, in addition, was associated with discomfort (10.5). In adults, EMLA cream significantly reduces puncture pain and represents an acceptable alternate method for topical anaesthesia in venous cannulation. Local lidocaine infiltration is impaired by applicational pain, whereas spraying the puncture site with ethyl chloride has no analgesic benefit. Our aim was to find out whether intravenous fentanyl was effective in reducing the pain of first-trimester abortion.
                This randomized controlled trial included 825 women attending a nonhospital abortion facility. Some women chose standard care. Women who did not choose standard care were randomly assigned to receive either 50 to 100 microg of fentanyl, a placebo, or no intervention. With SAS software and a mixed effects analysis of variance model with covariates, we compared mean pain scores of the fentanyl and placebo groups to detect a difference of at least 1 point on an 11-point pain scale.
                The mean pain score of the fentanyl group was 1.0 point less than that of the placebo group (95% confidence interval, 3.7-4.3) and 0.9 point less than that of the observational group (95% confidence interval, 4.7-5.1). This pain reduction was statistically significant, but the women who were studied wanted a 2-point reduction from fentanyl.
                Fentanyl, when compared with the placebo, reduced abortion pain by 1.0 point on an 11-point scale. This reduction was of questionable clinical significance and was less than desired by the women included in the study. A preliminary report has been interpreted to suggest that gum chewing reduces duration of postcolectomy ileus.
                We rigorously tested this hypothesis in a prospective, randomized, placebo-controlled study. Patients undergoing open colectomy (n = 66) were randomized to receive 1 of 3 postoperative regimens beginning on postoperative day 1: sips (control, n = 21); sips and accupressure wrist bracelet (placebo, n = 23); and sips and gum chewing (treatment, n = 22). Patients were unaware of which regimen constituted placebo or treatment; end points were assessed by blinded investigators. Power was set a priori at 85% to detect a 0.75-day difference in time to first postoperative passage of flatus between placebo and treatment groups. Groups were compared using the log-rank test.
                Groups were equivalent with respect to demographic and surgical characteristics. Median times to first postoperative passage of flatus were as follows: sips, 67 hours; bracelet and sips, 72 hours; gum and sips, 60 hours (p = 0.384). There were no significant differences in time to passage of first bowel movement, time until patients were ready for discharge, or time until actual discharge among the three groups. Inpatient and 30-day followup demonstrated no difference in frequency or distribution of postoperative complications.
                In contrast to findings of a preliminary study, our clinical trial suggests that gum chewing, although safe, does not reduce duration of postcolectomy ileus. We sought to determine the efficacy of coaching Latino adolescents with latent tuberculosis infection to adhere to isoniazid treatment.
                Participants (n = 286) were randomly assigned to adherence coaching, attention control, or usual care groups. Adherence was measured via interviews and validated with urine assays.
                Coaching resulted in significant increases in adherence compared with attention and usual care groups. Bicultural adolescents were more likely to be adherent than those most or least acculturated. Age and risk behavior were negatively related to adherence.
                Coaching can increase Latino adolescents' adherence to treatment for latent tuberculosis infection and should contribute to tuberculosis control for adolescents at high risk of contracting the disease. nan The lack of control procedures inherent in most of the experiments conducted to assess the effectiveness of skin temperature biofeedback in the treatment of Raynaud's disease renders the results inconclusive. In this study, control groups and a double-blind approach are adopted. Thirty-six patients, carefully screened for a diagnosis of primary Raynaud's disease, were assigned to a skin temperature increase group (N = 12), to an EMG relaxation control group (N = 12), or to a notreatment control group (N = 12). All patients kept records of their symptoms for the duration of the study. Each subject in the two training groups received 20 sessions, the last 2 conducted under cold stress. data analysis according to original group assignment, as well as following regrouping of subjects according to several learning criteria, showed that while all patients reported a marked decrease in the number of vasospastic attacks, no significant differences were found among the three groups on the clinical measures used to assess symptomatic relief. The general improvement reported must therefore be attributed to nonspecific factors. The aim of this study was to investigate the effectiveness of pulsed short wave (PSW) in the relief of pain in osteoarthritis of the hip and knee. Ninety-two patients, mean age 63 years, (34 men and 58 women) were randomly allocated to one of three groups: (1) Active PSW, using the dosage found in a pilot study to be non-significantly most effective, (2) Placebo PSW, (3) No treatment control group. Nine sessions of treatment were provided over a 3-week period, each application lasting for 15 min. The machine was modified by the manufacturers so that the therapist was able to administer the treatment and carry out assessments without being aware of the treatment allocation. Outcome measures included sensory and affective pain diary reports averaged over days and weeks, self-reported benefit and the General Health Questionnaire. Analysis of variance with repeated measures over time was used to find out if the active treatment had a specific effect, incremental to the placebo effect. There were no significant differences between the active and placebo groups over time. According to the pain diary reports, both active and placebo groups tended to improve slightly during treatment, but worsened after its withdrawal. Patients who were given the placebo application tended to report more benefit than those who had the active treatment, although this did not quite reach statistical significance (P < 0.06). Patients who were not on a waiting list for surgery did significantly better over time than those who were (P < 0.03). There were no significant differences between the groups over time for the other outcome variables. Any treatment effect on this patient population appears to have been largely placebo-mediated. No evidence was found therefore for the specific effectiveness of PSW for treatment of osteoarthritic hip or knee pain. To assess the efficacy of an orally administered antioxidant dietary supplement for managing marginal dry eye.
                A prospective, randomised, placebo controlled trial with cross-over.
                Eye Clinic, Department of Vision Sciences, Glasgow Caledonian University.
                Forty marginal dry eye sufferers composed of 30 females and 10 males (median age 53 y; range 38-69 y).
                Baseline assessments were made of tear volume sufficiency (thread test), tear quality (stability), ocular surface status (conjunctival impression cytology) and dry eye symptoms (questionnaire). Each subject was administered courses of active treatment, placebo and no treatment, in random order for 1 month each and results compared to baseline.
                Tear stability and ocular surface status were significantly improved following active treatment (P<0.05). No changes from baseline were detected following administration of placebo and no treatment (P>0.05). Absolute increase in tear stability correlated with absolute change in goblet cell population density. Tear volume was not improved following any treatment period and dry eye symptom responses were subject to placebo effect.
                Oral antioxidants improved both tear stability and conjunctival health, although it is not yet understood whether increased ocular surface health mediates increased tear stability or vice versa.
                This study was supported by a PhD scholarship funded by the Department of Vision Sciences, Glasgow Caledonian University, Scotland. Antioxidant supplements and placebos were kindly donated by Vitabiotics. nan nan To evaluate the effect of vaginal disinfection with chlorhexidine gel during labor on vertical transmission of group B streptococcus, as a method to prevent vertical transmission and subsequent neonatal early onset group B streptococcal disease.
                A prospective study with randomization of 1020 parturients to one of three groups as soon as labor started. In all parturients, anus, introitus and cervix were cultured semiquantitatively. Two groups were treated double-blindly with 10 ml of either a 0.3% chlorhexidine gel or a placebo gel, applicated around the portio and into the fornices. If labor still continued, a second application was given after 10 h. The third group received no treatment. Ear, pharynx and umbilicus of all newborns were also cultured semiquantitatively.
                Nine hundred and eighty one women were evaluated. The overall incidence of group B streptococcal carriership was 19.4%. Vertical transmission was 52.4% in the chlorhexidine group, 71.4% in the placebo group and 66.7% in the control group (P = 0.069). When testing the transmission rates for the chlorhexidine versus the combined placebo plus control group (69.3%), the difference was 16.9% (P = 0.026).
                Vaginal disinfection with a chlorhexidine gel during labor modestly reduces group B streptococcal vertical transmission. Because the method is cheap, simple and safe, it should be considered for routine use. Our results indicate that it may reduce the incidence of early onset group B streptococcal sepsis by 2-32%. Sixty-eight patients undergoing outpatient knee arthroscopy for treatment of meniscal tears or loose bodies were divided into three treatment groups (zolpidem [24 patients], control [24 patients], and placebo [20 patients]). All groups received postoperative hydrocodone and ibuprofen. Patients in the zolpidem group received a single dose of zolpidem tartrate for the first seven postoperative nights. Patients in the placebo group received a gelatin capsule similar in appearance to zolpidem and patients in the control group received only hydrocodone and ibuprofen. Patients in the control group demonstrated significantly worse mean daily postoperative pain and more daily postoperative fatigue on visual analog scales when compared with the zolpidem group (P=.03 and P=.04, respectively). Patients in the placebo group had worse daily postoperative pain and more daily postoperative fatigue when compared to the zolpidem group, although these differences did not reach statistical significance (P=.15, power=0.6; and P=.27, power=0.48, respectively). Patients in the control group consumed significantly higher quantities of hydrocodone/acetaminophen postoperatively (P=.04) than patients in the zolpidem group. Finally, patients in the placebo group consumed higher quantities of hydrocodone/acetaminophen than the zolpidem group although the difference did not reach statistical significance (P=.4; power=0.15). Power was calculated for each insignificant relationship based on observed effect and sample sizes and variances. This study demonstrates that sleep and fatigue may be an important factor in the effective pain management following knee arthroscopy. Future postoperative treatment regimens should address sleep and fatigue to maximize analgesic effects in these patients. We report clinical data on the efficacy of acupuncture for alcohol dependence. 503 patients whose primary substance of abuse was alcohol participated in this randomized, single blind, placebo controlled trial. Patients were assigned to either specific acupuncture, nonspecific acupuncture, symptom based acupuncture or convention treatment alone. Alcohol use was assessed, along with depression, anxiety, functional status, and preference for therapy. This article will focus on results pertaining to alcohol use. Significant improvement was shown on nearly all measures. There were few differences associated with treatment assignment and there were no treatment differences on alcohol use measures, although 49% of subjects reported acupuncture reduced their desire for alcohol. The placebo and preference for treatment measures did not materially effect the results. Generally, acupuncture was not found to make a significant contribution over and above that achieved by conventional treatment alone in reduction of alcohol use.
                Copyright 2002 Elsevier Science Inc. To investigate the effect of sensory stimulation of the P6 point on postoperative nausea and vomiting (PONV) after gynecological surgery in the everyday clinical setting (effectiveness study).
                Four hundred and ten women undergoing general anesthesia for elective gynecological surgery were included in a prospective, consecutive, randomized, multicentre, placebo-controlled, double-blind clinical trial with a reference group. One group was given bilateral P6 acupressure (n = 135), a second group similar pressure on bilateral non-acupressure points (n = 139), and a third group (n = 136) served as reference group. Nausea (scale 0-6), vomiting, pain, and satisfaction with the treatment were recorded. Primary outcome was complete response, i.e., no nausea, vomiting or rescue medication for 24 hr. Results were analyzed by applying logistic regression with indicators of treatments, type of operation and risk score for PONV as explanatory variables.
                Complete response was more frequent in the P6 acupressure group than in the reference group (P = 0.0194) Conversely, the incidence of PONV was 46% in the reference group, 38% after pressure on a non-acupoint and 33% after P6 acupressure. The decrease from 46% to 33% was statistically significant. When considering vaginal cases separately, the decrease in PONV was from 36% to 20% (P = 0.0168). The corresponding decrease from 59% to 55% in the laparoscopic surgery group was not statistically significant.
                P6 acupressure is a non-invasive method that may have a place as prophylactic antiemetic therapy during gynecological surgery. Synergy has been proposed between modalities operating at different levels of action. Acupuncture and craniosacral therapy are two very different modalities for which synergy has been proposed. This study sought to test for such synergy and to determine if complementary therapies would improve pulmonary function and quality of life for people suffering from asthma, as well as reducing anxiety, depression, and medication usage.
                Subjects were randomly assignment to one of five groups: acupuncture, craniosacral therapy, acupuncture and craniosacral, attention control, and waiting list control.
                Subjects received 12 sessions of equal length with pretreatment and posttreatment assessment of pulmonary function, asthma quality of life, depression, and anxiety. Medication use was also assessed.
                Synergy was not demonstrated. When treatment was compared with the control group, statistically treatment was significantly better than the control group in improving asthma quality of life, whereas reducing medication use with pulmonary function test results remained the same. However, the combination of acupuncture and craniosacral treatment was not superior to each therapy alone. In fact, although all active patients received 12 treatment sessions, those who received all treatments from one practitioner had statistically significant reductions in anxiety when compared with those receiving the same number of treatments from multiple practitioners. No effects on depression were found.
                Acupuncture and/or craniosacral therapy are potentially useful adjuncts to the conventional care of adults with asthma, but the combination of the two does not provide additional benefit over each therapy alone. The effect of local applications of sustained-release delivery polymer containing chlorhexidine as an adjunct to mechanical plaque removal was studied in institutionalized children with Down's syndrome. Thirty children, ages 8-13, participated in the study. Clinical parameters (P1I, GI, papillary bleeding) were recorded and bacterial samples from selected permanent teeth were collected and processed before and following treatment. Following the registration of clinical findings and collection of plaque, all children had their teeth scaled and polished and were randomized into three treatment groups of ten subjects each: Subjects in group I had their teeth coated with ethyl cellulose containing chlorhexidine; those in group II had their teeth coated with placebo polymer and those in group III received no further treatment. Individual oral hygiene habits were not interfered with. The application of the solutions to the respective groups was done every 3 days for 21 days. Chlorhexidine treatment significantly reduced the PLI, GI total aerobic counts and S. viridans counts compared to no treatment. The placebo group showed similar effects to that of the chlorhexidine-treated group except for the total aerobic counts which were not affected. The results suggest that the use of chlorhexidine in a sustained-release dosage form applied to the tooth surfaces may prove useful in the control of plaque and its sequela in children with Down's syndrome. nan To evaluate the effectiveness of handwarming biofeedback (HWB) and stress management training in comparison to attention (handcooling, HCB) and wait-list control groups. Thermal biofeedback has been used in many pediatric migraine treatment studies and has demonstrated a consistent therapeutic effect. No published studies to date have compared this treatment modality with credible attention control using biofeedback technology.
                Thirty-six children and adolescents (mean age: 12.8 years), as well as the mothers and fathers of these children enrolled in the study, were randomly assigned to the three groups. Thirty-four children completed treatment. Both treatment groups received four sessions of biofeedback training and a portable biofeedback device for home practice. Ratings of treatment credibility showed that the children rated the two treatments as equally credible. Assessment included anxiety and depression questionnaires for the children and both of their parents.
                Children who had been assigned to the HWB group were more likely to achieve clinical improvement in migraine after treatment than the children in the HCB group. Treatment gains were maintained up to 6 months after treatment. Home practice data reflected a general increase in temperature in the HWB group and a decrease in temperature for the HCB group.
                The results of this study confirm the findings of earlier pediatric migraine biofeedback treatment studies and also provide support for the specific effect of treatments including stress management and HWB. Future studies with larger sample sizes will aid in delineating the appropriateness of HCB as a control treatment. Studies in smoking cessation have generally failed to adequately control for active treatment effects and have assumed that measures of smoking behaviour (i.e., estimated smoking rate, self-monitoring and chemical analysis) are equally reliable measures. Sixty smokers were randomly assigned to one of four different smoking cessation treatment groups: hypnosis, focussed smoking, attention placebo and a waiting list control. Subjects were asked to estimate and monitor their own smoking behaviour. Blood samples were also taken for thiocyanate analysis before treatment. Smoking rates were similarly measured directly, at 3 months and 6 months after treatment. The results indicate that the three measures of smoking behaviour were all highly correlated. No significant differences were found between treatments, directly after treatment or at the 3- and 6-month follow-ups. These results suggest that active treatment effects may not be responsible for behavioural change in a smoking cessation program. The implications of these findings are discussed. OBJECTIVE: To determine whether non-invasive ambulatory blood pressure is more reproducible and less affected by the placebo treatment than are clinic blood pressure measurements. METHOD: Thirty-four essential hypertensive outpatients were randomly allocated after a 4-week preselection period in two groups in a cross-over study design. One group received placebo for 4 weeks while the other formed the control group (reproducibility), then the treatments were exchanged for another 4 weeks. Clinic and ambulatory blood pressures were measured at three different times for each patient, namely bnefore the random allocation to groups and at the end of each period, using a mercury sphygmomanometer and 24 h non-invasive ambulatory blood pressure monitoring. RESULTS: Administration of placebo was accompanied by a significant reduction in systolic and diastolic clinic blood pressures (by 3.4+/-13 and 3.6+/-8 mmHg, respectively), but not in 24 h, daytime and night-time blood pressures. Circadian hourly blood pressure and heart rate curves were virtually superimposable. In the 13 placebo responder patients selected on the basis of clinic blood pressure, placebo decreased the clinic blood pressure and also reduced systolic and diastolic ambulatory blood pressures, mainly during the day period (by 5.2+/-6.2 and 4.89+/-7.8 mmHg, respectively). This effect is specific and related to the placebo administration because repetition of the measurements without any treatment showed no significant difference. To characterize at baseline the placebo responder patients, comparison with the non-placebo responders showed lower baseline values of ambulatory systolic blood pressure recorded during 24 h daytime and night-time in the placebo responder group. CONCLUSION: The 24 h ambulatory blood pressure average is not affected by placebo in the present group of patients but that a placebo effect occurs mainly during the daytime in patients who decreased their clinic blood pressure under placebo (placebo responders); the placebo-induced reduction in blood pressure is related to a specific effect of placebo and is independent from any alerting reaction or reproducibility hypothesis. This study clearly indicates the necessity of including placebo and ambulatory blood pressure monitoring in the therapeutic and pharmacological trials of antihypertensive drugs. nan To test that methylphenidate combined with intensive multimodal psychosocial intervention, which includes social skills training, significantly enhances social functioning in children with attention-deficit/hyperactivity disorder (ADHD) compared with methylphenidate alone and methylphenidate plus nonspecific psychosocial treatment (attention control).
                One hundred three children with ADHD (ages 7-9), free of conduct and learning disorders, who responded to short-term methylphenidate were randomized for 2 years to receive (1) methylphenidate alone, (2) methylphenidate plus multimodal psychosocial treatment that included social skills training, or (3) methylphenidate plus attention control treatment. Assessments included parent, child, and teacher ratings of social function and direct school observations in gym.
                No advantage was found on any measure of social functioning for the combination treatment over methylphenidate alone or methylphenidate plus attention control. Significant improvement occurred across all treatments and continued over 2 years.
                In young children with ADHD, there is no support for clinic-based social skills training as part of a long-term psychosocial intervention to improve social behavior. Significant benefits from methylphenidate were stable over 2 years.
                Copyright 2004 American Academy of Child and Adolescent Psychiatry To establish the short term clinical and urodynamic effect of transurethral microwave thermotherapy (TUMT) in men with symptomatic uncomplicated benign prostatic hyperplasia (BPH) using a randomized controlled trial comparing the treatment with both 'placebo-like' and untreated control groups.
                The study comprised 120 symptomatic patients with BPH who were candidates for transurethral resection and TUMT. They were randomized to one of three groups: group 1 underwent a standard TUMT, group 2 underwent a simulated treatment identical to group 1 but with no emission of microwaves and group 3 received no treatment. The treatment of the first two groups was 'double-blind' and the heat experienced by the patients during treatment was simulated in both. Patients were assessed on entry to the study and 6 months after treatment using an identical protocol to measure the American Urological Association (AUA) symptom score, maximum urinary flow rate (Qmax), post-void residual urine volume (PVR), minimum urethral opening pressure (Pmuo) and maximum detrusor pressure (Pdet max).
                In the untreated group there were no clinically or statistically significant changes in the median AUA symptom score, Qmax, PVR, Pmuo and Pdet max. In group 1 the AUA score changed significantly, from 19 to 9.5, but the Qmax, PVR, Pmuo and Pdet max did not. In group 2, the AUA score also changed significantly, from 17.5 to 9.5, but Qmax, PVR, Pmuo and Pdet max did not.
                The untreated control group showed no clinically relevant deterioration or improvement. The standard and simulated TUMT groups showed little clinically relevant improvement in 'objective' variables, while the clinically significant symptom improvement was of a similar magnitude in both groups. In the present study, we examined the effects of preoperative electroacupuncture (EA) at classical bilateral acupuncture points (Zusanli, also known as ST-36) on postoperative pain and opioid-related side effects. One hundred healthy consenting women undergoing lower abdominal surgery were randomly assigned to four treatment regimens: Group I (n=25), control; Group II (n=25), sham-EA (needle insertion without electrical stimulation); Group III (n=25), low-EA (2 Hz of electrical stimulation); and Group IV (n=25), high-EA (100 Hz of electrical stimulation). EA groups received needle insertion with or without electrical stimulation 20 min prior to anesthesia. All patients received patient-controlled analgesia (PCA) of morphine postoperation. Postoperative pain was evaluated by recording (1). the time of the first required analgesic, (2). the number of PCA demands, (3). the total amount of morphine required by PCA, and (4) patients' VAS pain score. We found that the time of first analgesic requested was 10, 18, 28, and 28 min in the control, sham-, low-, and high-EA groups, respectively. During the first 24h, the total amount of morphine required was decreased by 21, 43 and 61% in the sham-, low- and high-EA groups, respectively. The incidence of nausea and dizziness during the first 24h after surgery was significantly reduced in both the low-EA and high-EA groups compared with the control and sham-EA groups. We also found that sham-EA exerts a beneficial effect with respect to its pain relieving quality but not the side effect profiles. Our findings demonstrates that preoperative treatment with low-EA and high-EA can reduce postoperative analgesic requirements and associated side effects in patients undergoing lower abdominal surgery. The present study evaluated the efficacy of group cognitive-behavior therapy for the alleviation of psychosocial problems and reduction of seizures with adult epileptic patients. Twenty-seven outpatients were randomly assigned to one of three groups: Cognitive-Behavior Therapy, Supportive Counseling (attention-placebo control), and Waiting list (no treatment control). The major outcome measures used were: patient's, neurologist's, and therapist's global ratings of psychological adjustment, patient's target complaints and weekly seizure frequency, patient's and neurologist's ratings of seizure control, the Minnesota Multiphasic Personality Inventory, the Washington Psychosocial Seizure Inventory, and the Beck Depression Inventory. No significant differences were found among the three groups on these measures except for therapist's global ratings of psychological adjustment, on which both the Cognitive-Behavior Therapy and Supportive Counseling groups improved significantly after therapy, but the Waiting List control group did not. Overall, little support was found for the efficacy of group cognitive behavior therapy (eight 2-h weekly sessions) for the reduction of psychosocial difficulties or seizures. Implications of the present findings are discussed, with the need for further controlled outcome research stressed. nan In a randomized controlled trial, eye movement desensitization and reprocessing (EMDR) for panic disorder with agoraphobia (PDA) was compared with both waiting list and credible attention-placebo control groups. EMDR was significantly better than waiting list for some outcome measures (questionnaire, diary, and interview measures of severity of anxiety, panic disorder, and agoraphobia) but not for others (panic attack frequency and anxious cognitions). However, low power and, for panic frequency, floor effects may account for these negative results. Differences between EMDR and the attention-placebo control condition were not statistically significant on any measure, and, in this case, the effect sizes were generally small (eta2 = .00-.06), suggesting the poor results for EMDR were not due to lack of power. Because there are established effective treatments such as cognitive-behavior therapy for PDA, these data, unless contradicted by future research, indicate EMDR should not be the first-line treatment for this disorder. nan Twenty-seven long-term psychiatric inpatients maintained on neuroleptics with concomitant antiparkinsonian medication were entered into a study in which anticholinergic medication was gradually withdrawn in a randomized double-blind within-subjects design. The extrapyramidal symptoms of each patient were compared when taking their usual anticholinergic medication, when taking placebo and when taking no antiparkinsonian drug. The relapse rate on no medication was 14%, and if patients relapsed on no medication they also relapsed on placebo. The relapse rate was not significantly different on active medication. Nor were there significant differences in ratings of parkinsonism or dyskinesia. The lack of difference between double-blind and overt withdrawal does not mean that studies that find a much higher relapse rate are necessarily unaffected by nonspecific factors, as significant unblinding may occur in clinical trials. To evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) as analgesia during colonoscopy.
                In a randomised controlled trial, patients undergoing diagnostic colonoscopy were assigned to one of three groups: standard medication only (midazolam); active TENS plus standard medication; or non-functioning TENS and standard medication. Efficacy of TENS was determined using numerical rating scores for pain and the post-procedural evaluation questionnaire.
                Patients undergoing diagnostic colonoscopy in a teaching hospital.
                There was no statistically significant differences between the three groups. However in the active TENS group there was a greater variation in "physical discomfort" and "psychological distress", suggesting TENS may be effective in subgroup of patients. There is inconclusive evidence of the effectiveness of psychological interventions for depression after stroke. We report the results from a randomized controlled trial of cognitive behavioral therapy (CBT).
                Stroke patients admitted to hospital were invited to complete mood questionnaires 1, 3 and 6 months after stroke. Patients who were depressed were invited to take part in a trial and randomly allocated to receive CBT (n=39), an attention placebo intervention (n= 43), or standard care (n=41). Outcome assessments were undertaken at 3 and 6 months after recruitment, on the Beck Depression Inventory, Wakefield Depression Inventory, Extended Activities of Daily Living scale, London Handicap Scale, and a rating of satisfaction with care.
                There were no significant differences between the groups in patients' mood, independence in instrumental activities of daily living, handicap, or satisfaction with care.
                CBT in the treatment of depression following stroke was found to be ineffective in this study. However, because of the small sample size, method of recruitment, and selection criteria, further randomized trials are required. To compare the antiemetic effect of acupressure at the Neiguan point (P6) in a group of healthy women with normal pregnancy and nausea and vomiting during pregnancy (NVP) with a similar group receiving acupressure at a placebo point and another, similar group not receiving any treatment.
                A randomized, placebo-controlled, pilot study involving 60 women.
                It is possible to reduce NVP significantly with acupressure at P6 as compared to acupressure at a placebo point or no treatment at all in healthy women with normal pregnancies. Relief from nausea appeared one day after starting treatment in both the P6 and placebo groups but lasted for only six days in the placebo group. The P6 group, however, experienced significantly less nausea after 14 days as compared to the other two groups.
                This study involved 60 healthy women with normal pregnancy and suffering from NVP. According to the results, in healthy women with normal pregnancy it is possible to reduce NVP significantly at P6 as compared to acupressure at a placebo point and to no treatment. nan This study examined the effects of transcutaneous electrical nerve stimulation (TENS) on incisional pain caused by the procedure of cleaning and packing an abdominal surgical wound. Seventy-five subjects (mean age 56.9 years) were randomly assigned to one of three intervention groups: TENS, placebo-TENS, or no-treatment control. The appropriate experimental treatment was administered during the routine dressing change which took place two mornings after surgery. Using an 11-point, visual analogue pain scale, subjects described pain experienced during the dressing change. Subjects who received TENS reported a significantly lower level of pain after dressing change than did those subjects who received either placebo-TENS or no-treatment. Drug administration variables did not contribute significantly to level of reported pain. In order to assess the effects of a Behavioral Treatment Program in the control of primary hypertension, twenty one unmedicated hypertensives were randomly allocated to three groups: first, a treatment group (BHG) receiving a Behavioral Treatment which included: deep muscle relaxation, peripheral temperature Biofeedback and anxiety management training; second, the placebo attention control group (PHG) and third, a control group of hypertensives too (CHG). Additionally, were compared with seven normotensives subjects (CNG). The post-treatment measures showed a significant reduction (p < 0.001) in systolic and diastolic values only in the (BHG). In a six months follow-up the (BHG) group still showed a significant reduction in the systolic and diastolic BP (p < 0.02; p < 0.01). Moreover individual variations in response to treatment were observed in this group, (BHG). A randomized controlled trial was conducted.
                To determine the efficacy of osteopathic manipulative treatment as a complementary treatment for chronic nonspecific low back pain.
                Osteopathic manipulative treatment may be useful for acute or subacute low back pain. However, its role in chronic low back pain is unclear.
                This trial was conducted in a university-based clinic from 2000 through 2001. Of the 199 subjects who responded to recruitment procedures, 91 met the eligibility criteria. They were randomized, with 82 patients completing the 1-month follow-up evaluation, 71 completing the 3-month evaluation, and 66 completing the 6-month evaluation. The subjects were randomized to osteopathic manipulative treatment, sham manipulation, or a no-intervention control group, and they were allowed to continue their usual care for low back pain. The main outcomes included the SF-36 Health Survey, a 10-cm visual analog scale for overall back pain, the Roland-Morris Disability Questionnaire, lost work or school days because of back pain, and satisfaction with back care.
                As compared with the no-intervention control subjects, the patients who received osteopathic manipulative treatment reported greater improvements in back pain, greater satisfaction with back care throughout the trial, better physical functioning and mental health at 1 month, and fewer cotreatments at 6 months. The subjects who received sham manipulation also reported greater improvements in back pain and physical functioning and greater satisfaction than the no-intervention control subjects. There were no significant benefits with osteopathic manipulative treatment, as compared with sham manipulation.
                Osteopathic manipulative treatment and sham manipulation both appear to provide some benefits when used in addition to usual care for the treatment of chronic nonspecific low back pain. It remains unclear whether the benefits of osteopathic manipulative treatment can be attributed to the manipulative techniques themselves or whether they are related to other aspects of osteopathic manipulative treatment, such as range of motion activities or time spent interacting with patients, which may represent placebo effects. To compare differences in the chemotherapy-induced nausea and vomiting (CINV) among three groups of women (acupressure, placebo acupressure, and usual care) undergoing chemo-therapy for breast cancer.
                A multicenter, longitudinal, randomized clinical trial throughout one cycle of chemotherapy.
                Ten community clinical oncology programs associated with the M.D. Anderson Cancer Center and nine independent sites located throughout the United States.
                160 women who were beginning their second or third cycle of chemotherapy for breast cancer treatment and had moderate nausea intensity scores with their previous cycles.
                Subjects were randomized to one of three groups: acupressure to P6 point (active), acupressure to SI3 point (placebo), or usual care only. Subjects in the acupressure group were taught to apply an acupressure wrist device by research assistants who were unaware of the active acupressure point. All subjects completed a daily log for 21 days containing measures of nausea and vomiting and recording methods (including antiemetics and acupressure) used to control these symptoms.
                Acute and delayed nausea and vomiting.
                No significant differences existed in the demographic, disease, or treatment variables among the treatment groups. No significant differences were found in acute nausea or emesis by treatment group. With delayed nausea and vomiting, the acupressure group had a statistically significant reduction in the amount of vomiting and the intensity of nausea over time when compared with the placebo and usual-care groups. No significant differences were found between the placebo and usual-care groups in delayed nausea or vomiting.
                Acupressure at the P6 point is a value-added technique in addition to pharmaceutical management for women undergoing treatment for breast cancer to reduce the amount and intensity of delayed CINV.
                Acupressure is a safe and effective tool for managing delayed CINV and should be offered to women undergoing chemotherapy for breast cancer. nan 67 adult women with a history of recurrent lower urinary tract infection (UTI) were randomized for acupuncture treatment, sham acupuncture, or no treatment. The incidence rate of UTI over the following six months was noted. In the acupuncture group a total of 85% was free of cystitis during the six-month observational period, as compared to 58% in the sham group (p < 0.05), and 36% in the control group (p < 0.01). Compared to the acupuncture group, twice as many incidents of cytitis occurred in the sham group, and three times as many in the control group (p < 0.05). Acupuncture seems a worthwhile alternative in the prevention of frequently recurring cystitis in women. nan In Experiment 1, 28 attention-deficit hyperactivity disorder (ADHD) boys underwent a double-blind, placebo-controlled medication assessment in a summer day-treatment program. Daily, boys were asked questions to assess their attributions for and evaluations of their behavior. Objective measures showed improved behavior with methylphenidate; however, boys tended to attribute their performance to effort rather than to medication, particularly when medicated. Experiment 2 involved 38 ADHD boys the following summer and replicated the procedures in Experiment 1, with the addition of a no-pill condition and a comparison of attributions for success and failure outcomes. Simply taking a pill (no-pill vs. placebo comparison) did not show significant effects, whereas the results of Experiment 1 were replicated with placebo-methylphenidate comparisons. Across drug conditions a self-enhancing attributional pattern was obtained; the majority of attributions for success were to ability or effort, whereas attributions for failure were to the pill or to counselors. To study the effect of single-needle acupuncture in suppressing gag-reflex in transesophageal echocardiography (TEE).
                Prospective, blinded trial. Settings/locations: Patients with ischemic stroke or transient ischemic attack undergoing TEE because of presumed cardioembolic origin in a specialized stroke unit of the Johann Wolfgang Goethe-University, Frankfurt/Main, Germany. Subjects/Study interventions: Forty-one (41) patients were studied. Patients received single-needle acupuncture with a 0.2 x 13 mm disposable acupuncture needle (Suzhou Medical Appliances, China), 10-mm deep either at Chengjiang (midline between lower lip and chin) or superficially at a sham point (tip of the chin) during TEE or no acupuncture for alleviating gag reflex.
                Severity of gagging was rated on a visual-analogue scale.
                The acupuncture group experienced significantly less gagging than the sham group (p = 0.037) or the nonacupuncture group (p = 0.013).
                Acupuncture of CV24 is an easy to apply and effective method to reduce gag reflex during TEE. To examine the effectiveness of cognitive-behavioral and pharmacologic treatment of depression in rheumatoid arthritis (RA).
                Subjects (n = 54) with confirmed diagnoses of both major depression and RA were randomly assigned to 1 of 3 groups: 1) cognitive-behavioral/pharmacologic group (CB-PHARM), 2) attention-control/pharmacologic group, or 3) pharmacologic control group. Measures of depression, psychosocial status, health status, pain, and disease activity were collected at baseline, posttreatment (10 weeks), 6-month followup, and 15-month followup. Data were analyzed to compare the treatment effectiveness of the groups; data also were aggregated to examine the effects of antidepressive medication over time. Lastly, a no-treatment control group was defined from a cohort of persons who declined participation.
                Baseline comparisons on demographic and dependent measures revealed a need to assess covariates on age and education; baseline scores on dependent measures also were entered as covariates. Analyses of covariance revealed no statistically significant group differences at postintervention, 6-month followup, or 15-month followup, except higher state and trait anxiety scores for the CB-PHARM group at the 15-month followup. In the longitudinal analyses of the effects of antidepressive medication, significant improvement in psychological status and health status were found at posttreatment, 6-month followup, and 15-month followup, but no significant improvements were shown for pain or disease activity. In addition, the comparison of the aggregated pharmacologic group with a no-treatment group revealed a statistically significant benefit for the 3 groups that received the antidepressive medication.
                In persons with RA, cognitive-behavioral approaches to the management of depression were not found to be additive to antidepressant medication alone, but antidepressant intervention was superior to no treatment. To determine both the efficacy and safety of the topical application of 50 mg penicillin G potassium troches (Cankercillin) in the treatment of minor recurrent aphthous stomatitis (RAS).
                The investigation used a phase 2 double-blind, randomized placebo-controlled trial with a no-treatment arm. Subjects with minor aphthous ulcers of duration <48 hours were followed for 1 week. The primary endpoint for efficacy was time (days) to complete ulcer resolution, and the secondary endpoint was time (days) to complete pain relief.
                Thirty-one, 33, and 36 subjects were randomized to the active treatment, placebo, and no-treatment arms, respectively. Baseline findings were heterogeneous across arms. Subjects who received penicillin G treatment had complete ulcer healing and pain relief significantly earlier than those in the placebo and no-treatment arms. No allergic reactions were observed.
                Topical penicillin G, by mechanisms which remain unclear, reduces the time of healing and pain relief of minor aphthous ulcers with minimal safety concerns. Larger phase 3 studies are necessary to confirm these findings. A 3 x 6 factorial design with a double blind and placebo control was employed to investigate the effect of TENS treatment on pain produced by venipuncture. The three treatment groups consisted of TENS, placebo-TENS and control. Subjects were blocked into six 2-year age groups (ages: 5-17 years). During the period of the study, 896 children attending the outpatient laboratory of a general hospital were screened and 514 children completed the study. The data which were collected before venipuncture included expected pain and state anxiety. Following venipuncture, pain intensity was measured with a vertical visual analogue scale (VAS) and pain affect was assessed with McGrath's faces scale. Significant main effects for treatment and age groups were obtained. Pain intensity and affect were lowest for the TENS group and highest for the control group. The pain scores were greatest for lower age groups and lowest for higher age groups. The results of this study support the use of TENS for children's pain and the need for interventions for children's procedural pain. nan Those who were labelled as depressives in a rural survey were randomly divided into a Medicine group (who received antidepressive drug treatment), a Placebo group (who received placebo) and a Natural Process group (who received no treatment). The depth of their depression was assessed by Hamilton's Depressive Rating Scale before the beginning of the trial, on the 14th day and on the 28th day of trial. They were compared with a matched group of healthy controls and again with a matched group of depressives who attended an urban clinic for treatment. The results indicate that the rural depressives who never sought treatment voluntarily were not different from those who sought treatment in clinics, so far as their response to treatment is concerned. Most studies dealing with spina bifida children concentrate on medical or physical factors, largely ignoring any psychosocial and educational consequences. The present study assessed the effect of a remedial program on visual-motor perception in spina bifida children. Thirty-six spina bifida boys and girls (mean age 82.87 months) with a myelomeningocele and an associated hydrocephalus were assigned randomly to either a control, attention-placebo, or experimental group. Following the administration of the Frostig Program for the Development of Visual Perception, the experimental group significantly improved on a global index of visual perception and the five subtests of Frostig's Development Test of Visual Perception; at a maintenance test two months later, all treatment gains (except on the visual spatial perception subtest) were still evident. These results are discussed in terms of the provision of remedial education for spina bifida children, and a possible cognitive mechanism mediating the behavioral change in the experimental group. It is recognized that pre-operative anxiety can have adverse effects on the course and outcome of surgery and there is a considerable amount of research into the influences of interventions for pre-operative anxiety on a number of post-operative variables. However, little attention has been paid to the potential influences of treatments on intra-operative variables, most notably on the facilitation of anaesthesia. The present study examined the impact of a brief relaxation procedure on anaesthesia in comparison to attention-control and no-treatment control procedures. A sample of 21 patients about to undergo anaesthesia for day-case surgery were randomly assigned to one of the three conditions. It was found that the relaxation treatment significantly reduced pre-operative anxiety as measured by the state scale of the State-Trait Anxiety Inventory (Spielberger, 1983). This reduction was reflected in physiological indicators of anxiety. Both the relaxation group and the attention-control group required significantly less time to induce anaesthesia and less of the anaesthetic agent used to maintain anaesthesia. The relaxation group also scored significantly lower than the no-treatment control group on an anaesthetist's rating of difficulty of maintenance of anaesthesia. Whilst the relaxation treatment appeared to have no advantages over the attention-control procedure in terms of anaesthetic requirements, the latter treatment did not reduce anxiety and showed no benefit over the no-treatment control condition in terms of an anaesthetist's rating of difficulty of maintenance of anaesthesia. In addition, following recovery the relaxation subjects reported more favourable perceptions of their treatment than the attention-control subjects. To evaluate the use of oral iron replacement therapy as an effective treatment for acute surgically induced anemia.
                Double-blind, placebo-controlled, randomized clinical trial.
                Perioperative acute care hospital and a surgery clinic for a single cardiothoracic physician group.
                One hundred twenty-eight men and postmenopausal women, 50 years of age or older, admitted for elective coronary artery bypass surgery over a consecutive 8-month period.
                Before surgery: serum iron, serum ferritin, hemoglobin and hematocrit. Six days after surgery: hemoglobin and hematocrit. Mean of 59 days after surgery: serum iron, serum ferritin, hemoglobin and hematocrit.
                Patients were randomized to one of four groups: control group; placebo group; low-dose group, 50 mg elemental iron + 60 mg ascorbic acid in a multi-vitamin daily; and usual-dose group, 200 mg elemental iron daily.
                One hundred twenty-one subjects completed the study: 100 men (82.6%) mean age 64.5 years and 21 women (17.4%), mean age 65.7 years. There were no statistically significant age or gender differences among groups. Statistical analysis revealed, except for side effects, no differences between or among groups for any variable measured during the last two time intervals. The mean hemoglobin and hematocrit of the entire sample at 6 days was 9.5 +/- 1.2 gm/dl and 28% +/- 2.3%, respectively. At a mean of 59 days later these values increased equally for all groups to a mean for the cohort of 13.6 +/- 1 gm/dl for hemoglobin and 40.6% +/- 3 for hematocrit. Serum iron and ferritin were within the normal range. The 200 mg group experienced significantly more side effects (p < 0.01).
                Thus the use of oral iron supplements for the treatment of acute blood loss anemia after uncomplicated coronary artery bypass surgery did not assist in restoring red blood cell mass or help maintain total body iron stores. We carried out a prospective, randomized study to evaluate the usefulness of premedication with an oral anticholinergic for relief of pain during and after a barium enema of the colon.
                Patients were randomized into three groups: no medication, placebo, and sublingual 1-hyoscyamine sulfate. The placebo or hyoscyamine tablet was placed under the tongue 15-30 min before the examination. After the procedure the patients were interviewed. An analog scale (0-10) was used to score the level of pain that the patients experienced during the examination. Forty-eight hours after the examination, the patients returned by mail a survey that used the same scale and asked about delayed pain.
                Data from 110 patients were studied. Sixty-nine patients were women, and 41 were men. They ranged from 24 to 82 years old (mean, 55 years). For the no-medication group (n = 36), the mean pain score was 4.1; for the placebo group (n = 34), 3.8; and for the hyoscyamine group (n = 40), 4.2. No statistically significant difference in pain scores was found between any groups (p = .72). Six patients from each group reported minor side effects. The mean scores from the returned surveys (n = 79) were 3.8 for the no-medication group (n = 26) and placebo group (n = 22) and 3.1 for the hyoscyamine group (n = 31). No statistically significant difference was found between any of these groups (p = .48) or between delayed pain responses and initial pain responses (p = .27).
                Although safe, hyoscyamine seems to provide no benefit over no drug or a placebo when used as a pain premedication for patients undergoing a barium enema. Sixty-three episodes of genital herpetic infection in 55 men and 45 episodes in 42 women were randomly assigned to topical treatment with 3% adenine arabinoside, topical treatment with placebo ointment, or no therapy. In addition, 10 episodes in women who were not randomly assigned to therapy were evaluated and followed. Clinical evaluation and viral cultures were done on day 3, day 8, and weekly thereafter until the lesions had healed. The natural clinical course of genital herpetic infection was defined in patients given placebo or no therapy. Patients with a history of previous genital herpetic infection had significantly less pain, few lesions, and shorter duration of illness and viral shedding than patients who had no history of previous genital infection with Herpesvirus. An unexpected finding was that 87% of women experiencing their first episode of genital herpetic infection had cervical cultures positive for Herpesvirus hominis, whereas only 4% of women with recurrent herpetic infection had a positive cervical culture. Treatment with 3% adenine arabinoside did not influence the course of either primary or recurrent genital infection with Herpesvirus. Sixty-six tension headache patients were randomly assigned to one of four conditions for 8 weeks: (a) progressive muscle relaxation (PMR) alone; (b) PMR plus cognitive therapy (PMR + Cog); (c) pseudomeditation, a credible attention-placebo control; or (d) continued headache monitoring. A comparison of overall headache activity (headache index), derived from a daily headache diary, for 4 weeks before treatment to 4 weeks after treatment, revealed that active treatment (PMR and PMR + Cog) was superior to either control condition. Moreover, level of headache medication consumption decreased significantly for the active treatment groups. Although headache-index comparisons of the two active treatments showed no advantage for adding cognitive therapy to PMR, a measure of clinically significant change showed a trend for PMR + Cog to be superior to PMR alone. 1,218 smokers able to quit smoking for 48 hr were randomly assigned to one of 12 cells in a 4 x 3 fully crossed factorial experiment. A pharmacologic factor contained four levels: nicotine polacrilex (gum) delivered ad lib or on a fixed regimen, placebo gum, and no gum. A self-guided behavioral treatment factor contained three levels: self-selected relapse prevention modules, randomly administered modules, and no modules. Those receiving nicotine gum were more likely to be abstinent at the 2- and 6-month follow-ups. The fixed regimen accounted for most of the effect for gum. There was no effect for the relapse prevention module factor. Men and women showed a differential treatment response. Men who received nicotine gum were more likely to be abstinent at each follow-up (2, 6, and 12 months). No treatment was significantly better among women. We conclude that research on different gum chewing regimens is warranted and that further examination of possible gender differences in response to replacement therapy is needed. To investigate whether intensive cognitive behaviour therapy results in significant improvement in positive psychotic symptoms in patients with chronic schizophrenia.
                Patients with chronic schizophrenia were randomly allocated, stratified according to severity of symptoms and sex, to intensive cognitive behaviour therapy and routine care, supportive counselling and routine care, and routine care alone.
                Adjunct treatments were carried out in outpatient clinics or in the patient's home.
                87 patients with persistent positive symptoms who complied with medication; 72 completed treatment.
                Assessments of positive psychotic symptoms before treatment and 3 months after treatment. Number of patients who showed a 50% or more improvement in symptoms. Exacerbation of symptoms and rates of readmission to hospital.
                Significant improvements were found in the severity (F=5.42, df =2,86; P=0.006) and number (F=4.99, df=2,86; P=0.009) of positive symptoms in those treated with cognitive behaviour therapy. The supportive counselling group showed a non-significant improvement. Significantly more patients treated with cognitive behaviour therapy showed an improvement of 50% or more in their symptoms (chi2=5.18, df=1; P=0.02). Logistic regression indicated that receipt of cognitive behaviour therapy results in almost eight times greater odds (odds ratio 7.88) of showing this improvement. The group receiving routine care alone also experienced more exacerbations and days spent in hospital.
                Cognitive behaviour therapy is a potentially useful adjunct treatment in the management of patients with chronic schizophrenia. The decline in blood pressure (BP) in essential hypertensives following hospitalization may result from: 1) regression toward the mean; 2) reduction of anxiety as patients habituate to a new environment; 3) the placebo effect of medication; and 4) an independent effect of hospitalization itself. A randomized crossover study of 12 essential hypertensives demonstrated a fall in supine blood pressure from 165.0/97.9 +/- 2.3/1.1 mm Hg to 154.3/89.6 +/- 2.7/1.1 mm Hg (p less than 0.005) due to hospitalization. A similar reduction in BP from 164.9/99.5 +/- 8.4/4.1 mm Hg to 151.9/93.4 +/- 4.5/1.9 mm Hg (p less than 0.005) resulted from regression toward the mean and habituation during the study period. Urinary catecholamines fell from 68.7 +/- 5.0 to 55.1 +/- 4.3 micrograms/g creatinine/24 hours (p less than 0.05) due to hospitalization and from 56.1 +/- 5.4 to 49.7 +/- 4.3 micrograms/g creatinine/24 hours (p less than 0.05) with time. Although placebo therapy tended to reduce BP, it failed to do so significantly. When expressed as a percentage of the individual's overall mean, urinary catecholamine excretion fell from 110.5% +/- 3.7% to 89.5% +/- 3.7% (p less than 0.001) during hospitalization and from 105.8% +/- 3.9% to 94.2% +/- 3.9% (p less than 0.05) during the outpatient period. Blood pressure and sympathetic activity rapidly returned to prehospitalization values on discharge. These factors may confound the analysis of drug effects on BP and sympathetic activity in essential hypertensives following admission to hospital. Three-group, randomized, single blinded, controlled trial.
                To test the effectiveness of physiotherapy-based rehabilitation starting 1 week after lumbar disc surgery. In addition, we tried to estimate the contribution of specific effects to the observed outcome (efficacy).
                Physiotherapy-based rehabilitation is usually recommended for patients following lumbar disc surgery. Few and conflicting data exist for the relative effectiveness of this intervention.
                A total of 120 patients following first-time, uncomplicated lumbar disc surgery were randomly assigned to "comprehensive" physiotherapy, "sham" neck massage, or no therapy. Before enrollment, all subjects completed a minimal physiotherapeutic intervention. Physiotherapy was administered by experienced physiotherapists and consisted of 20 sessions per patient over 12 weeks. Masseurs administered "sham massage" to the neck. The amount of treatment time was equal to that of physiotherapy. The main outcome measure was the Low Back Pain Rating Score (LBPRS) at 6 and 12 weeks, and 1.5 years after randomization. Secondary parameters were patients' overall satisfaction with treatment outcome and socioeconomic and psychologic measures.
                At the end of therapy (12 weeks), the LBPRS revealed a significantly better improvement in the physiotherapy group than in the untreated group. LBPRS outcome, however, did not significantly differ between physiotherapy and "sham" therapy. There was a tendency toward significance between the sham therapy and no therapy. Within the 1.5-year follow-up, LBP rating scales remained significantly improved compared with baseline, but there were no significant outcome differences. No statistically significant between-group differences were found for the secondary outcome parameters.
                As compared with no therapy, physiotherapy following first-time disc herniation operation is effective in the short-term. Because of the limited benefits of physiotherapy relative to "sham" therapy, it is open to question whether this treatment acts primarily physiologically in patients following first-time lumbar disc surgery, but psychological factors may contribute substantially to the benefits observed. The objectives were to determine whether a eutectic mixture of local anesthetic (EMLA) or placebo cream reduces pain during extracorporeal piezoelectric shock wave lithotripsy (EPSWL), and to determine which of the components of the application (i.e., the occlusive dressing, the cream, or the local anesthetic) contributes to analgesia.
                A randomized, double blind, crossover study (part 1) was performed in 12 patients who were scheduled for EPSWL procedures on an ambulatory basis who received the first treatment without any intervention and who had verbal pain scores of 70 or more (on a 0-to- 100 scale). For the next two treatments at 2-week intervals, patients were randomly assigned to receive either 10 g EMLA or 10 g placebo cream and then crossed over to receive the other. The cream and occlusive dressing were left in place and immersed in water throughout the procedure. Verbal numeric pain score was assessed at 5 min after receiving the maximal tolerable intensity of shock wave and at the end of the procedure. The study continued (part 2) in 202 ambulatory patients; 125 men and 77 women, American Society of Anesthesiologists physical status I and II, subjected to EPSWL were randomly allocated into five groups who received (1) nothing on the skin (control), (2) plastic occlusive dressing, (3) placebo cream and plastic occlusive dressing, (4) EMLA cream and plastic occlusive dressing, (5) EMLA cream and plastic occlusive dressing for 60 min to achieve cutaneous anesthesia, which was removed before EPSWL. Pain score was evaluated 10 min into the procedure and at the end of the procedure.
                Both parts of the study showed that patients who received either EMLA or placebo cream with dressing throughout the procedure experienced less pain and tolerated higher energy levels compared with the control. Patients who received only pre-EPSWL cutaneous anesthesia of EMLA and who received only the occlusive dressing did not have a reduction in pain score.
                EMLA and placebo creams under occlusive dressing reduced pain during EPSWL. The presence of the cream itself as a coupling medium contributed to analgesia. This may be a useful, simple, safe, and economical adjuvant technique to reduce pain during immersion EPSWL. Venipuncture continues to be considered a painful and unpleasant experience for those receiving medical treatment. A prospective study investigating whether the application of a transcutaneous electrical nerve stimulator (TENS) decreases the complaints of pain and unpleasantness with i.v. needle insertion was conducted using a group of 71 subjects who were double-blinded and randomized to one of three groups: TENS, placebo-TENS, and control. This article gives an overview of this research and describes its findings. Acupuncture is widely used by patients with low back pain, although its effectiveness is unclear. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with chronic low back pain.
                Patients were randomized to treatment with acupuncture, minimal acupuncture (superficial needling at nonacupuncture points), or a waiting list control. Acupuncture and minimal acupuncture were administered by specialized acupuncture physicians in 30 outpatient centers, and consisted of 12 sessions per patient over 8 weeks. Patients completed standardized questionnaires at baseline and at 8, 26, and 52 weeks after randomization. The primary outcome variable was the change in low back pain intensity from baseline to the end of week 8, as determined on a visual analog scale (range, 0-100 mm).
                A total of 298 patients (67.8% female; mean +/- SD age, 59 +/- 9 years) were included. Between baseline and week 8, pain intensity decreased by a mean +/- SD of 28.7 +/- 30.3 mm in the acupuncture group, 23.6 +/- 31.0 mm in the minimal acupuncture group, and 6.9 +/- 22.0 mm in the waiting list group. The difference for the acupuncture vs minimal acupuncture group was 5.1 mm (95% confidence interval, -3.7 to 13.9 mm; P = .26), and the difference for the acupuncture vs waiting list group was 21.7 mm (95% confidence interval, 13.9-30.0 mm; P<.001). Also, at 26 (P=.96) and 52 (P=.61) weeks, pain did not differ significantly between the acupuncture and the minimal acupuncture groups.
                Acupuncture was more effective in improving pain than no acupuncture treatment in patients with chronic low back pain, whereas there were no significant differences between acupuncture and minimal acupuncture. The contribution of training procedures designed to alter individuals' psychological responses to stressful life stimuli to the reduction of blood-pressure levels of hypertensives was evaluated. The treatment consisted of a set of coping skill-building experiences. Forty-one black males, mildly to moderately hypertensive and under medical supervision in an outpatient cardiovascular unit of a veterans' hospital, participated. Subjects were randomly assigned to one of three groups: Cognitive Self-Management Training (CSM), Attention Placebo Control, and Current Clinic Conditions Control. The dependent measures were the State Anxiety Scale, Trait Anxiety Scale, Coping Strategic Inventory, systolic blood pressure, and diastolic blood pressure. Subjects in the CSM group reported significant increases in the use of cognitive coping strategies in their lives and demonstrated significant decreases in measured levels of state anxiety and systolic blood pressure. Promising reductions of diastolic blood pressure ratings were obtained as well. Approximately 80% of nursing home residents who suffer from Alzheimer's disease and related dementia develop behavioral symptoms of dementia. Given the deleterious side effects of pharmacologic therapy in this population there is an urgent need for clinical trials of nonpharmacologic interventions.
                To examine the effect of therapeutic touch on the frequency and intensity of behavioral symptoms of dementia.
                A randomized, double-blind, three-group experimental study: experimental (therapeutic touch), placebo (placebo therapeutic touch), and control (usual care). Fifty-seven residents, aged 67 to 93 years, exhibiting behavioral symptoms of dementia, were randomized to one of the three groups within each of three Special Care Units within three Long-Term Care facilities in a western Canadian province. Behavioral observation was completed every 20 minutes from 8:00AM to 6:00PM for three days pre-intervention and for three days post-intervention by trained observers who were blind to group assignment. The intervention consisted of therapeutic touch given twice daily for 5-7 minutes for three days between 10:00AM and 11:30PM and between 3:00PM and 4:30PM (N = 57). The main outcome variable was overall behavioral symptoms of dementia, consisting of six categories of behaviors: manual manipulation (restlessness), escape restraints, searching and wandering, tapping and banging, pacing and walking, and vocalization.
                Analysis of variance (ANOVA) (F = 3.331, P = .033) and the Kruskal-Wallis test (chi2 = 6.661, P = .036) indicated a significant difference in overall behavioral symptoms of dementia, manual manipulation and vocalization when the experimental group was compared to the placebo and control groups. The experimental (significant) was more effective in decreasing behavioral symptoms of dementia than usual care, while the placebo group indicated a decreasing trend in behavioral symptoms of dementia compared to usual care.
                Therapeutic touch offers a nonpharmacological, clinically relevant modality that could be used to decrease behavioral symptoms of dementia, specifically manual manipulation (restlessness) and vocalization, two prevalent behaviors. Acupuncture is widely used by patients with chronic pain although there is little evidence of its effectiveness. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with osteoarthritis of the knee.
                Patients with chronic osteoarthritis of the knee (Kellgren grade < or =2) were randomly assigned to acupuncture (n=150), minimal acupuncture (superficial needling at non-acupuncture points; n=76), or a waiting list control (n=74). Specialised physicians, in 28 outpatient centres, administered acupuncture and minimal acupuncture in 12 sessions over 8 weeks. Patients completed standard questionnaires at baseline and after 8 weeks, 26 weeks, and 52 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index at the end of week 8 (adjusted for baseline score). All main analyses were by intention to treat.
                294 patients were enrolled from March 6, 2002, to January 17, 2003; eight patients were lost to follow-up after randomisation, but were included in the final analysis. The mean baseline-adjusted WOMAC index at week 8 was 26.9 (SE 1.4) in the acupuncture group, 35.8 (1.9) in the minimal acupuncture group, and 49.6 (2.0) in the waiting list group (treatment difference acupuncture vs minimal acupuncture -8.8, [95% CI -13.5 to -4.2], p=0.0002; acupuncture vs waiting list -22.7 [-27.5 to -17.9], p<0.0001). After 52 weeks the difference between the acupuncture and minimal acupuncture groups was no longer significant (p=0.08).
                After 8 weeks of treatment, pain and joint function are improved more with acupuncture than with minimal acupuncture or no acupuncture in patients with osteoarthritis of the knee. However, this benefit decreases over time. nan There is some evidence for the efficacy of acupuncture in chronic low-back pain (LBP), but it remains unclear whether acupuncture is superior to placebo. In a randomized, blinded, placebo-controlled trial, we evaluated the effect of traditional acupuncture in chronic LBP. A total of 131 consecutive out-patients of the Department of Orthopaedics, University Goettingen, Germany, (age=48.1 years, 58.5% female, duration of pain: 9.6 years) with non-radiating LBP for at least 6 months and a normal neurological examination were randomized to one of three groups over 12 weeks. Each group received active physiotherapy over 12 weeks. The control group (n=46) received no further treatment, the acupuncture group (n=40) received 20 sessions of traditional acupuncture and the sham-acupuncture group (n=45) 20 sessions of minimal acupuncture. Changes from baseline to the end of treatment and to 9-month follow-up were assessed in pain intensity and in pain disability, and secondary in psychological distress and in spine flexion, compared by intervention groups. Acupuncture was superior to the control condition (physiotherapy) regarding pain intensity (P=0.000), pain disability (P=0.000), and psychological distress (P=0.020) at the end of treatment. Compared to sham-acupuncture, acupuncture reduced psychological distress (P=0.040) only. At 9-month follow-up, the superiority of acupuncture compared to the control condition became less and acupuncture was not different to sham-acupuncture. We found a significant improvement by traditional acupuncture in chronic LBP compared to routine care (physiotherapy) but not compared to sham-acupuncture. The trial demonstrated a placebo effect of traditional acupuncture in chronic LBP. We conducted a randomized 3-year maintenance trial in 128 patients with recurrent depression who had responded to combined short-term and continuation treatment with imipramine hydrochloride and interpersonal psychotherapy. A five-cell design was used to determine whether a maintenance form of interpersonal psychotherapy alone or in combination with medication could play a significant role in the prevention of recurrence. A second question was whether maintaining antidepressant medication at the dosage used to treat the acute episode rather than decreasing to a "maintenance" dosage would provide prophylaxis superior to that observed in earlier trials in which a maintenance dosage strategy was employed. Survival analysis demonstrated a highly significant prophylactic effect for active imipramine hydrochloride maintained at an average dose of 200 mg and a modest prophylactic effect for monthly interpersonal psychotherapy. We conclude that active imipramine hydrochloride maintained at an average dose of 200 mg is an effective means of preventing recurrence and that monthly interpersonal psychotherapy serves to lengthen the time between episodes in patients not receiving active medication. nan In Atlanta, as in other major urban areas of the United States, asthma is a leading cause of school absenteeism, emergency department use, and hospitalization. Recent guidelines for asthma management recommend reducing exposure to relevant allergens, but neither the feasibility nor the efficacy of this form of treatment has been established for children living in poverty.
                We sought to investigate allergen avoidance as a treatment for asthma among inner-city children.
                One hundred four children with asthma living in the city of Atlanta were enrolled into a controlled trial of avoidance without being skin tested. The children were randomized to an active avoidance group, a placebo avoidance group, and a second control group for which no house visits occurred until the end of the first year. Avoidance included bed and pillow covers, hot washing of bedding, and cockroach bait. Eighty-five children completed the study, and the outcome was measured as unscheduled clinic visits, emergency department visits, and hospitalization for asthma, as well as changes in mite and cockroach allergen levels.
                There was a significant decrease in acute visits for asthma among children whose homes were visited (P < .001). However, there was no significant difference between the active and placebo homes either in the effect on asthma visits or in allergen concentrations. When the children with mite allergy were considered separately, there was a significant correlation between decreased mite allergen and change in acute visits (P < .01). The avoidance measures for cockroach allergen appeared to be ineffective, and the changes observed did not correlate with changes in visits.
                Applying allergen avoidance as a treatment for asthma among children living in poverty is difficult because of multiple sensitivities and problems applying the protocols in this environment. The current results demonstrate that home visiting positively influences the management of asthma among families living in poverty. Furthermore, the results for children with mite allergy strongly suggest that decreasing relevant allergen exposure should be an objective of treatment in this population. The value of therapeutic ultrasound (US) for reducing inflammation was tested in a double-blind controlled study in 150 patients following surgical removal of impacted lower third molars. Facial swelling, trismus, pain and serum C-reactive protein (CRP) were significantly reduced in the US-treated groups and in a placebo group ('mock' US) compared with an untreated control group. The majority of the anti-inflammatory activity was attributable to the placebo effect, and the highest intensity of US (1.5 W.cm-2) was consistently less beneficial than the lower intensities (0.1 and 0.5 W.cm-2) and the mock US. The authors examined the effectiveness of unguided self-help as a first step in the treatment of bulimia nervosa.
                A total of 85 women with bulimia nervosa who were on a waiting list for treatment at a hospital-based clinic participated. The patients were randomly assigned to receive one of two self-help manuals or to a waiting list control condition for 8 weeks. One of the self-help manuals addressed the specific symptoms of bulimia nervosa (cognitive behavior self-help), while the other focused on self-assertion skills (nonspecific self-help).
                Twenty patients (23.5%) dropped out of the study. The data were analyzed with intention-to-treat analysis. Although the group-by-time interaction for binge eating and purging was not statistically significant, simple effects showed that there was a significant reduction in symptom frequency in both self-help conditions at posttreatment but not in the waiting list condition. There were no statistically significant changes in levels of dietary restraint, eating concerns, concerns about shape and weight, or general psychopathology. A greater proportion of patients in the cognitive behavior self-help (53.6%) and nonspecific self-help (50.0%) conditions reported at least a 50% reduction in binge eating or purging at posttreatment, compared with the waiting list condition (31.0%). A lower baseline knowledge about eating disorders, more problems with intimacy, and higher compulsivity scores predicted a better response.
                The findings suggest that a subgroup of patients with bulimia nervosa may benefit from unguided self-help as a first step in their treatment. Cognitive behavior self-help and nonspecific self-help had equivalent effects. Conventional dentoalveolar osseous reconstruction often involves the use of grafting materials with or without barrier membranes. The purpose of this study was to evaluate the efficacy of bone induction for the placement of dental implants by two concentrations of recombinant human bone morphogenetic protein-2 (rhBMP-2) delivered on a bioabsorbable collagen sponge (ACS) compared to placebo (ACS alone) and no treatment in a human buccal wall defect model following tooth extraction.
                Eighty patients requiring local alveolar ridge augmentation for buccal wall defects (> or =50% buccal bone loss of the extraction socket) of the maxillary teeth (bicuspids forward) immediately following tooth extraction were enrolled. Two sequential cohorts of 40 patients each were randomized in a double-masked manner to receive 0.75 mg/ml or 1.50 mg/ml rhBMP-2/ACS, placebo (ACS alone), or no treatment in a 2:1:1 ratio. Efficacy was assessed by evaluating the amount of bone induction, the adequacy of the alveolar bone volume to support an endosseous dental implant, and the need for a secondary augmentation.
                Assessment of the alveolar bone indicated that patients treated with 1.50 mg/ml rhBMP-2/ACS had significantly greater bone augmentation compared to controls (P < or =0.05). The adequacy of bone for the placement of a dental implant was approximately twice as great in the rhBMP-2/ACS groups compared to no treatment or placebo. In addition, bone density and histology revealed no differences between newly induced and native bone.
                The data from this randomized, masked, placebo-controlled multicenter clinical study demonstrated that the novel combination of rhBMP-2 and a commonly utilized collagen sponge had a striking effect on de novo osseous formation for the placement of dental implants. The expectation of pain is a statistically significant factor negatively affecting patient compliance with current screening flexible sigmoidoscopy recommendations. Numerous pain reduction modalities have been studied with limited success. Transcutaneous electrical nerve stimulation (TENS) has been used to treat pain of various origins. The purpose of this pilot study was to determine the efficacy of TENS in reducing discomfort experienced during screening flexible sigmoidoscopy.A double-blind study was conducted in which 90 subjects were randomized to receive TENS, sham TENS, or control (standard care). The same pulse frequency and intensity were used for all subjects in the TENS group. Subjects completed preprocedural and postprocedural questionnaires, and the endoscopist completed a postprocedural questionnaire. A slight, but statistically insignificant (p =.526) reduction in the mean pain score reported by the TENS group was noted when compared with the sham TENS and control groups (2.00, 2.27, and 2.23 respectively). In light of the fact that only one pulse frequency and intensity of the TENS intervention were used in this study, further study with this safe and cost-effective modality is warranted. A sample of physician-referred chronic insomniacs was randomly allocated to either progressive relaxation, stimulus control, paradoxical intention, placebo or no treatment conditions. Treatment process and outcome were investigated in terms of mean and standard deviation (night to night variability) measures of sleep pattern and sleep quality. Only active treatments were associated with significant improvement, but the nature of treatment gains varied. In particular, stimulus control improved sleep pattern, whereas relaxation affected perception of sleep quality. All improvements were maintained at 17 month follow-up. Results are discussed with reference to previous research and guidelines are given for clinical practice. Both disulfiram and placebo implant patients abstained longer and had more intense disulfiram-ethanol reactions than did two control groups. Ultrasound (US) therapy is used to reduce pain and inflammation and to accelerate healing after soft tissue injury. However, there is little objective evidence of its effectiveness and the mechanisms which may cause these effects are unknown. In a placebo-controlled double-blind clinical trial we examined the contribution of placebo and massage effects in ultrasound therapy following bilateral surgical extraction of lower third molars. Four to 6 h after surgery the patients (25 per group) received either no therapy, US (0.1 W/cm2), 'mock' US with massage, 'mock' US without massage, or 'self-massage' with a dummy applicator. Facial swelling, trismus, serum C-reactive protein, serum cortisol, pain and anxiety were measured 24 h postoperatively. The results showed that the beneficial analgesic and anti-inflammatory effects of US therapy were placebo-mediated, with maximum effect in the placebo ('mock' US) group without circular massaging with the applicator). Self-massage by the patient produced no significant effect. This placebo action was independent of changes in serum cortisol or patient anxiety state. US therapy can significantly reduce postoperative morbidity, but by placebo-mediated mechanisms which are unrelated to the US itself. A group of 200 patients who presented in general practice with symptoms but no abnormal physical signs and in whom no definite diagnosis was made were randomly selected for one of four consultations: a consultation conducted in a "positive manner," with and without treatment, and a consultation conducted in a "non-positive manner," called a negative consultation, with and without treatment. Two weeks after consultation there was a significant difference in patient satisfaction between the positive and negative groups but not between the treated and untreated groups. Similarly, 64% of those receiving a positive consultation got better, compared with 39% of those who received a negative consultation (p = 0.001) and 53% of those treated got better compared with 50% of those not treated (p = 0.5). nan nan Fifty obese patients with a body mass index greater than 25 kg/m2 were randomized into 3 groups: control (C = 19), placebo (P = 18) and dexfenfluramine (D = 18). A behavioral modification program which included eating habits, exercise, attitudes, social relationships and six steps to lifetime weight control was taught every week. All patients strictly followed the food manual and recorded their behavior, physical activity and food intake every day through 12 weeks. Placebo and dexfenfluramine 30 mg/day were given in a double blind placebo controlled study. The results showed that all 3 groups had significant decreases in rest times and increased activity times (p < 0.05) and significant reductions of the average total daily energy, carbohydrate and fat intake (p < 0.05). They all lost weight. Mean +/- SEM cumulative weight loss was 8.3 +/- 0.7 kg in group D, 3.3 +/- 1 kg, in group P and 2.9 +/- 0.7 kg, in group C. The mean additional weight loss of 5 kg, and 5.4 kg seen with dexfenfluramine being highly significant (p < 0.001) from group P and C most likely due to increased thermogenesis. Significant (p < 0.05) and gradual reduction of biceps, triceps skinfold and per cent body fat were constantly observed only in the dexfenfluramine group. There were no significant differences among the 3 groups regarding blood pressure, heart rate, hematologic, lipids and biochemical profiles. A double-blind randomly controlled trial of one particular laxative, Senokot, used in moderate dosage, was carried out on a group of 40 children with severe and persistent soiling and often with a history of faecal retention. Significant improvement occurred following three months of outpatient treatment using a behavioural approach and either Senokot, placebo or no medication. However, there was no evidence either during the trial or subsequently when Senokot was employed to supplement behavioural treatment in every child who continued with therapy that this laxative contributed in any way to relieving the problem in this group of cases. The purpose of the study was to determine the effect of ethyl vinyl chloride vapocoolant spray on pain reported by children undergoing intravenous cannulation. A randomized, double-blinded, placebo-controlled trial was conducted on eligible children between the ages of 9 and 18 years seen in a pediatric emergency department and requiring intravenous cannulation. Informed consent was obtained, and children were randomized to receive ethyl vinyl chloride spray, isopropyl alcohol spray, or no spray (control group). Patient demographics and information pertaining to each intravenous cannulation were recorded. Children indicated the degree of pain associated with intravenous cannulation on a 100-mm visual analog scale (VAS) compared to a baseline pain score of "zero." Statistical analysis was performed by using Stata version 7. One hundred twenty-seven subjects were enrolled: 37 received ethyl vinyl chloride vapocoolant spray, 48 received isopropyl alcohol spray (placebo), and 42 received no pretreatment. Mean VAS scores for pain experienced during cannulation were 34, 33, and 31 mL for each group, respectively. Ethyl vinyl chloride vapocoolant spray failed to measurably reduce pain associated with intravenous cannulation when compared to those pretreated with isopropyl alcohol spray or receiving no intervention. This experiment examined the efficacy of an acustimulation wrist band for the relief of chemotherapy-induced nausea using a randomized three-arm clinical trial (active acustimulation, sham acustimulation, and no acustimulation) in 96 women with breast cancer who experienced nausea at their first chemotherapy treatment. Five outcomes related to wrist band efficacy (acute nausea, delayed nausea, vomiting, QOL, and total amount of antiemetic medication used) were examined. The five outcomes were examined separately using analysis of covariance controlling for age and severity of past nausea. There were no significant differences in any of these study measures among the three treatment conditions (P>0.1 for all). Study results do not support the hypothesis that acustimulation bands are efficacious as an adjunct to pharmacological antiemetics for control of chemotherapy-related nausea in female breast cancer patients. Low catalase levels and cellular vacuolation in the epidermis of patients with vitiligo support major oxidative stress in this compartment. There is now in vivo evidence for increased epidermal hydrogen peroxide (H(2)O(2)) accumulation in this patient group by utilizing noninvasive Fourier Transform Raman spectroscopy (FT Raman). Epidermal H(2)O(2) can be removed with a topical application of narrow band UVB activated pseudocatalase cream (PC-KUS). (Mn/EDTA-bicarbonate complex, patent No. EPO 58471 1 A), yielding initiation of repigmentation. Dead Sea climatotherapy is another successful treatment modality for vitiligo, but the mode of action has escaped definition so far.
                Epidermal hydrogen peroxide (H(2)O(2)) was assessed in vivo before and after 21 days treatment at the Dead Sea using noninvasive Fourier-Transform Raman spectroscopy. The effectiveness of repigmentation was followed in 59 patients with vitiligo by comparing Dead Sea climatotherapy alone with the combination of Dead Sea climatotherapy/pseudocatalase cream (PC-KUS) as well as Dead Sea climatotherapy/placebo cream. Clinical repigmentation was documented by standardized black/white photography using non-UV coated bulbs as flashlight and by color photography.
                This study on 59 patients who had vitiligo for an average time of 17 years (range 3-53 years) confirmed in vivo H(2)O(2) accumulation in mM concentrations in the epidermis of untreated patients. Furthermore, we demonstrated a pseudocatalase activity after 15 min of Dead Sea bathing, but the decrease of epidermal H(2)O(2) levels was significantly less compared to narrowband UVB activated pseudocatalase cream (PC-KUS). Initiation of repigmentation was already observed between day 10 and day 16 after a combination of Dead Sea climatotherapy/pseudocatalase cream compared to conventional pseudocatalase monotherapy (8-14 weeks) and Dead Sea climatotherapy alone (5-6 weeks).
                The results of this study show a significantly faster initiation of repigmentation in vitiligo after a combination of short-term climatotherapy (21 days) at the Dead Sea in combination with a pseudocatalase cream (PC-KUS) compared to either conventional climatotherapy at the Dead Sea alone or with placebo cream in combination with climatotherapy. This combined therapy is significantly faster in repigmentation than narrowband UVB activated pseudocatalase cream (PC-KUS) treatment alone. The results of this study support the necessity of epidermal H2O2 removal as well as the influence of solar UV-light in the successful treatment of vitiligo. The authors describe a medical center-based randomized trial aimed at determining the feasibility and effectiveness of partnering patients and primary-care providers with an exercise health counselor. Study participants included 165 veterans age 70 years and older. The primary end point was change in physical activity at 3 and 6 months comparing patients receiving high-intensity physical activity counseling, attention control counseling, and usual care after receiving standardized clinic-based counseling. We noted a significant Group x Time interaction (p = .041) for physical activity frequency and a similar effect for caloric expenditure (p = .054). Participants receiving high-intensity counseling and usual care increased physical activity over the short term, but those with usual care returned to baseline by the end of the study. The intervention was well received by practitioners and patients. We conclude that partnering primary-care providers with specialized exercise counselors for age- and health-appropriate physical activity counseling is effective. We review some of the evidence that supports the existence of psychosomatic triggers to bronchospasm in asthmatics, and hypothesize that it may also be possible to consciously reverse bronchospasm using trachea-noise biofeedback. We precipitated significant levels of bronchospasm in 16 asthmatics using exercise or eucapnic-hyperventilation challenges on five occasions, and administered four different treatments and a no-treatment control. The treatments were trachea-noise biofeedback (TNBF), wrong-information TNBF, an inhaled adrenergic bronchodilator, and a placebo inhaler, all given double blind. Half of the subjects had 3 training days in the use of the TNBF device before study. Our results show that TNBF, in the trained subjects only, is associated with a detectable, but not statistically significant, increase in the rate of recovery from bronchospasm over that found with no treatment. We conclude that, although asthmatics seem to have a strong ability to consciously induce bronchospasm, conscious reversal of a full asthma attack using TNBF is limited. Despite contrary conclusions by other investigators, we believe that this study demonstrated little TNBF-assisted recovery from bronchospasm. We suggest that this is because its effect may be inhibited by humoral mechanisms that sustain the attack, but we believe further work is required to support this. To determine whether a home based exercise programme can improve outcomes in patients with knee pain.
                Pragmatic, factorial randomised controlled trial of two years' duration.
                Two general practices in Nottingham.
                786 men and women aged >/=45 years with self reported knee pain. Interventions: Participants were randomised to four groups to receive exercise therapy, monthly telephone contact, exercise therapy plus telephone contact, or no intervention. Patients in the no intervention and combined exercise and telephone groups were randomised to receive or not receive a placebo health food tablet.
                Primary outcome was self reported score for knee pain on the Western Ontario and McMaster universities (WOMAC) osteoarthritis index at two years. Secondary outcomes included knee specific physical function and stiffness (scored on WOMAC index), general physical function (scored on SF-36 questionnaire), psychological outlook (scored on hospital anxiety and depression scale), and isometric muscle strength.
                600 (76.3%) participants completed the study. At 24 months, highly significant reductions in knee pain were apparent for the pooled exercise groups compared with the non-exercise groups (mean difference -0.82, 95% confidence interval -1.3 to -0.3). Similar improvements were observed at 6, 12, and 18 months. Regular telephone contact alone did not reduce pain. The reduction in pain was greater the closer patients adhered to the exercise plan.
                A simple home based exercise programme can significantly reduce knee pain. The lack of improvement in patients who received only telephone contact suggests that improvements are not just due to psychosocial effects because of contact with the therapist. nan The childhood diarrhoea-management guidelines of the World Health Organization/United Nations Children's Fund (WHO/UNICEF) now include zinc treatment, 20 mg per day for 10 days. To determine if a dispersible zinc sulphate tablet formulation is associated with increased risk of vomiting or regurgitation following the initial, first treatment dose, a double-blind, placebo-controlled randomized clinical trial was carried out in the Dhaka hospital of ICDDR,B: Centre for Health and Population Research (n=800) and in an adjacent NGO outpatient clinic (n=800). Children were randomized to one of three groups: no treatment, placebo, or zinc sulphate tablet (20 mg). They were then observed for 60 minutes, and all vomiting or regurgitation episodes were recorded. When compared with placebo, zinc treatment resulted in an attributable risk increase of 14% for vomiting and 5.2% for regurgitation. The median time to vomiting among those receiving zinc was 9.6 minutes and was limited to one episode in 91.2% of the cases. Overall, the proportion of 60-minute post-treatment vomiting attributable to zinc, placebo, and the illness episode was estimated to be 40%, 26%, and 34% respectively. The dispersible zinc sulphate tablet formulation at a dose of 20 mg is associated with increased risks of vomiting and regurgitation. Both are transient side-effects. Many asthmatic patients are reluctant to follow the medication schedule prescribed for them and turn to alternative treatment methods. The results of this study indicate that one such method, laser acupuncture, does not prevent exercise-induced asthma. Forty four subjects were treated for benzodiazepine dependence. The withdrawal programme lasted for 10 weeks and included regular group support sessions. Patients were also treated with either propranolol, placebo or "no pill" under double blind conditions. Twenty three patients complied with the full treatment regimen and completed the trial. The outcome of treatment was moderately successful, with 8 out of the 23 patients stopping their tranquilizers and a further 11 achieving a reduction of 50% or more of their original benzodiazepine dose. Tranquilizer dependence is a difficult condition to treat, but preliminary results suggest that propranolol is helpful in reducing the symptoms of benzodiazepine withdrawal. Frequent blood glucose (BG) monitoring is a critical component of diabetes management, yet many barriers exist to consistent monitoring.
                In this randomized controlled trial, we sought to determine if an educational manual, the Blood Sugar Monitoring Owner's Manual (BGMOM), could increase adherence to BG monitoring by helping patients form realistic expectations and responses to BG monitoring results. The 199 participants were recruited from a multidisciplinary diabetes clinic and had high-risk diabetes (hemoglobin A(1C) >or=8.0%); 35% had type 1 diabetes mellitus. Participants were randomized to 1 of 3 groups: BGMOM intervention (BGM+), attention control (BG meter only [MT]), or standard care (SC). The BGM+ and MT groups received BG meters and meter education; the BGM+ group also received BGMOM booklets. The SC group received usual care. Data gathered during 6 months of follow-up included BG monitoring frequency and hemoglobin A(1C) measurement.
                Monitoring frequency increased significantly in the BGM+ group (1.9 +/- 1.3 to 2.8 +/- 1.5 times daily, P<.001) but only slightly in the MT group (1.7 +/- 1.3 to 2.0 +/- 1.3 times daily). The BGM+ group experienced the greatest improvement in hemoglobin A(1C) level (BGM+: -0.13 +/- 1.28; MT: -0.04 +/- 1.31; SC: 0.04 +/- 1.10). Further, a higher percentage of those in the BGM+ group (61%) improved their glycemic control compared with the other groups (44%; P = .05). Finally, the BGM+ group displayed the most knowledge about the definition of hemoglobin A(1C) (P = .04) and reported the least amount of negative affect about out-of-range BG monitoring results (P = .03).
                As an adjunct to standard diabetes education and support, a manual such as the BGMOM can help optimize BG monitoring and glycemic control. A double-blind study was carried out in 18 patients with biliary and pancreatic disease to assess the use of pinaverium bromide in premedication for endoscopic retrograde cholangio-pancreatography and its effects on motor activity of the sphincter of Oddi. Patients were divided at random into three groups. One group received 100 mg pinaverium bromide twice daily for 3 days before and then 100 mg 1 hour before the examination, the second group received placebo, and the third had no medication. All patients received 10 to 20 mg diazepam intravenously 10 minutes before endoscopy. Assessments were made of the transit time of various endoscopic phases and patients' tolerance of the procedure. The effects of treatment on the sphincter of Oddi were estimated by means of endoscopic manometry. The results showed that pinaverium bromide allowed transit time reduction in endoscopic procedure, a greater tolerance on the part of the patient and marked reduction in the amplitude and duration of the phasic activity of the sphincter. Two hundred and ten subjects entered a trial to test the use of a chewing gum containing nicotine as an aid to stopping smoking. They were divided into three groups: nicotine chewing gum, placebo chewing gum, and control. The trial was double blind between the two chewing gum groups. After 1 month the percentage of confirmed non-smokers in the nicotine gum group was 34%, in placebo chewing gum group 37% and the control group 24%. By 6 months most of the non-smokers had relapsed, but the nicotine gum group (23%) was more successful than the placebo (5% or the control group (14%). The effectiveness of various tension-reducing techniques was investigated. Sixty-three subjects were randomly assigned to four treatment groups (EMG feedback, finger temperature feedback, EMG plus finger temperature feedback, autogenic training), a placebo control group, and a waiting-list control group. Physiological as well as a variety of cognitive measures were used to monitor changes in tension. The results showed no significant difference in effectiveness between the six groups. On virtually all cognitive measures there were significant decreases in tension, but not on the physiological measures. The decreases in tension on the cognitive measures were interpreted to be the results of non-specific (placebo) effects. These non-specific effects were not short-term, but did persist for at least three months after completion of treatment. The discovery of an endogenous opioid-mediated analgesic system has led to the search for its physiological roles and how it might be activated in natural conditions. Environmental and surgical stress and certain forms of transcutaneous electrical stimulation or acupuncture appear to activate this system. Several studies also suggest that this opioid system mediates placebo analgesia. Placebo reduces post-surgical pain in comparison with no treatment, and this analgesia is apparently reversed by the opioid antagonist, naloxone. However, these studies did not indicate whether naloxone and placebo exert their effects by common or by separate mechanisms. By administering hidden infusions of naloxone (in subjects unaware that the medication was being given) separate from the administration of a placebo, we were able to assess the effects of these two treatments independently. We report here evidence that placebo analgesia can occur after blockade of opioid mechanisms by naloxone and that naloxone can produce hyperalgesia independent of the placebo effect. The combined action of these effects is sufficient to explain the reversal of placebo analgesia by naloxone. To examine the effects of stress-management training on clinical outcomes in persons with rheumatoid arthritis (RA).
                Patients with RA (n = 141) were randomly assigned to 1 of 3 groups: a stress management group, an attention control group, or a standard care control group. The stress management and the attention control groups received a 10-week intervention followed by an additional 15-month maintenance phase.
                The stress management group showed statistically significant improvements on measures of helplessness, self-efficacy, coping, pain, and health status. Selected beneficial effects were still detectable at the 15-month followup evaluation.
                The data indicated that stress management interventions are capable of producing important clinical benefits for persons with RA. Several lines of evidence indicate that placebos produce analgesia through the activation of endogenous opioid systems. Recently, we showed that placebos may also produce respiratory depressant responses, a typical side-effect of narcotics, when a subject had a prior experience of respiratory depression in the course of narcotic treatment. In the present study, we report that the placebo respiratory depression can be induced after repeated administrations of the partial opioid agonist buprenorphine. The placebo respiratory depressant effect that resulted from the buprenorphine conditioning was completely blocked by a dose of 10 mg of naloxone, indicating that it was mediated by endogenous opioids. These findings show that placebos act, via the activation of opioid receptors, not only on pain mechanisms but on the respiratory centres as well, thus mimicking a typical side-effect of narcotics. In addition, the experimental procedure we used did not produce any expectation of respiratory depression and, similarly, the subjects did not notice any sign of respiratory discomfort. Thus, the placebo respiratory depression elicited in the present study cannot be explained on the basis of cognitive or motivational mechanisms. Rather, it appears to be a sequence effect due to learning, thus suggesting a conditioning mechanism mediated by endogenous opioids. nan Several medical areas that require patient compliance have successfully used psychological interventions emphasizing cognitive behavioral components. However, there are no published reports on the effect of cognitive behavioral interventions on oral hygiene in adults using an experimental design. For this study, 100 male veterans age 21-65 years were randomly assigned to 4 groups (cognitive behavioral, education, attention control, and control); to compare the effectiveness of these interventions on oral hygiene, a 5-week pre-test-post-test design was utilized. The dependent variables were self-report of brushing and flossing behavior and dental plaque levels utilizing the plaque index. After the interventions, there was only one significant difference between the control and the experimental groups for brushing frequency. There were no significant differences among the experimental groups for this intervention. The self-report of flossing frequency significantly increased in all 3 treatment groups, but there were no significant differences between these groups. In addition, plaque levels decreased significantly in all 3 experimental groups. Plaque levels in the cognitive behavioral group were significantly lower than those of the educational group. It was not possible to determine whether the greater plaque reduction in the cognitive-behavioral group could be attributed to the nature of the intervention or to the extra time spent with patients in the cognitive behavioral group. The efficacy of transcutaneous electrical nerve stimulation (TENS) as an adjunct to narcotic medications for the management of postoperative pain was assessed in a prospective, randomized, controlled study of patients following coronary artery bypass graft (CABG) surgery with the right or left internal thoracic artery (ITA). Forty-five male patients (mean age, 57 +/- 6 years) were randomly assigned to (1) TENS, (2) placebo TENS, or (3) control treatments (n = 15 each), following extubation and during the 24- to 72-h postoperative period. Two-way analysis of variance tests indicated no significant differences among treatment groups for (1) pain with cough, (2) narcotic medication intake, (3) FVC, (4) FEV1, and (5) PEFR (p > 0.05). However, pain at rest reported by the TENS group was significantly lower than that reported by the control group (treatment main effect; p < 0.04), although no significant differences were observed between the TENS and placebo or between the placebo and control groups (p > 0.05). All six criterion measures were characterized by significant changes over time for the entire group (n = 45; time main effect; p < 0.01), as follows: pain and medication intake were similar on days 1 and 2, but were significantly less on day 3, and pulmonary functions were significantly lower than preoperatively on day 1, decreased further on day 2, and despite an improvement on day 3, remained significantly lower than preoperative values (p < 0.01). This study suggests that the addition of TENS, applied continuously during the immediate postoperative period following CABG with ITA, may not be advantageous in pain management or the prevention of pulmonary dysfunction. This prospective, randomised controlled trial, with three parallel groups, patient and observer blinded for verum and sham acupuncture and a follow up of 3 months raises the question: "Does a combination of acupuncture and conservative orthopedic treatment improve conservative orthopedic treatment in chronic low back pain (LBP). 186 in-patients of a LBP rehabilitation center with a history of LBP >or=6 weeks, VAS >or=50mm, and no pending compensation claims, were selected; for the three random group 4 weeks of treatment was applied. 174 patients met the protocol criteria and reported after treatment, 124 reported after 3 months follow up. Patients were assorted 4 strata: chronic LBP, <or=0.5 years, 0.5-2 years, 2-5 years, >or=5 years. Analysis was by intention to treat. Group 1 (Verum+COT) received 12 treatments of verum acupuncture and conservative orthopedic treatment (COT). Group 2 (Sham+COT) received 12 treatments of non-specific needling and COT. Group 3 (nil+COT) received COT alone. Verum- and Sham acupuncture were blinded against patient and examiner. The primary endpoints were pain reduction >or=50% on VAS 3 months after the end of the treatment protocol. Secondary endpoints were pain reduction >or=50% on VAS and treatment efficacy on a four-point box scale directly after the end of the treatment protocol and treatment efficacy after 3 months. In the whole sample a pain relief of >or=50% on VAS was reported directly after the end of treatment protocol: Verum+COT 65% (95%CI 51-77%), Sham+COT 34% (95%ci 22-49%), nil+COT 43% (95%ci 29-58%) - results are significant for Verum+COT over Sham+COT (P<or=0.02). The results after 3 months are: Verum+COT 77% (95%ci 62-88%), Sham+COT 29% (95%ci 16-46%), nil+Cot 14% (95%ci 4-30%) - effects are significant for Verum+COT over Sham+COT (P<or=0.001) and for Verum+COT over nil+COT (P<0.001). No difference was found in the mobility of the patients nor in the intake of NSAID diclofenac. Our conclusion is that acupuncture can be an important supplement of conservative orthopedic treatment in the management of chronic LBP. In 45 headache patients the relationship between sensory suggestibility and three measures of treatment effect--ratings on (1) intensity of headaches; (2) efficacy of drugs, and (3) physician's competence--was investigated in a double-blind long-term crossover study. Subjects scoring high on sensory suggestibility clearly showed more relief of headaches upon the analgesic as well as upon the placebo. The physician's competence was rated higher by high-suggestible patients, whereas ratings on drug efficacy were low in all patients. The seemingly controversial behavior of high-suggestible patients was interpreted as a call for continuation of the physician's efforts in spite of the relief the patients already achieved. Our purpose was to investigate the efficacy of P6 acupressure in reducing or relieving symptoms of nausea with or without vomiting and retching during pregnancy.
                Symptomatic pregnant volunteers (n=161) participated in a 7-day community-based clinical trial. All participants were assigned to one of three groups (i.e., P6 acupressure, placebo [acupressure bands inappropriately placed], or control) on the basis of a process of blocked randomization. Data were analyzed by error bar charts and analysis of variance of difference scores.
                Of 161 women, 149 (92.5%) completed the protocol. Irrespective of group assignment, participants reported significant decreases in nausea (p<0.0009) and vomiting or retching (p<0.0009). However, there was no differential treatment effect as a result of acupressure.
                There was no apparent medical benefit from the use of P6 acupressure. Our findings differ from other recently published studies that did not include a control group. nan Gastroscopic procedure causes nausea and retching in many patients. Recently, alternative methods have been employed in an effort to reduce these symptoms. The Neiguan point (P6) is an acupuncture point that has been used for approximately 3,000 years to overcome gastric symptoms including nausea and retching. The aim of this study was to investigate the effects of the stimulation of the P6 acupoint on swallowing, nausea and retching during the gastroscopic procedure.
                Three hundred and twenty-seven patients who visited the gastroenterology unit for dyspeptic complaints were included in the study. A portable transcutaneous electrical nerve stimulation device (Reliefband; Maven Lab, Yuba City, CA) was used for acustimulation. The device was attached 15 minutes before the endoscopic procedure and no sedation was applied. The device was turned on in 78 patients (Group 1). The device was attached but not turned on in another 79 patients (Group 2). In Group 3, the device was attached to the Sham point (n: 79). In Group 4 the procedure was performed with no attachments (n: 77). Fourteen patients dropped out of the study because esophagogastroduodenoscopy could not be completed due to patient intolerance or to obstruction in the upper gastrointestinal tract. After the procedure, each patient's opinion about the severity of nausea and retching was measured on a visual analogue scale. Distress in swallowing and the impression of the endoscopist during the procedure were scored from 1 to 4. Patients were queried regarding their willingness to undergo re-endoscopy.
                Groups were compared regarding their distress in swallowing the endoscope, nausea and retching, the impression of the endoscopist during the procedure and their acceptance of re-endoscopy. Groups 1, 2, 3 and 4 were compared using the chi-square test, and no significant difference was observed between the groups (p>0.05).
                Acustimulation of the Neiguan (P6) acupoint does not relieve patients of the nausea observed during gastroscopy, and its application does not facilitate the procedure. To determine the effect of chiropractic care on jet lag in Finnish junior elite athletes.
                Fifteen Finnish junior elite athletes.
                Through use of a table of random numbers, each athlete was assigned by sex to one of 3 groups: chiropractic adjustment, sham adjustment, or control. As needed, the chiropractic adjustment group athletes (n = 5) were adjusted on a daily basis by licensed chiropractors using a toggle/recoil procedure. The sham adjustment group athletes (n = 5) received sham adjustments on a daily basis by licensed chiropractors. The control group athletes (n = 5) were not adjusted or sham-adjusted but participated in all test protocols. Sleep, jet lag, chiropractic, and mood data (the last acquired through use of the Profile of Mood States) were collected on a daily basis for 18 consecutive days.
                Repeated-measures analyses of variance (3 x 2) of total mood disturbance scores and heart rate variables indicated that there were no significant (.05 level) between-group differences. Sleep data were analyzed through use of a 3 x 2, repeated-measures multivariate analysis of variance. Pillai's trace indicated that there were no between-group differences. Self-assessment of jet lag by participants after traveling to Georgia and after returning to Finland showed no between-group differences.
                It was concluded that chiropractic care did not reduce the effects of jet lag. nan The purpose of the study is to investigate the effectiveness of acupressure on fatigue in patients with end-stage renal-disease (ESRD). The study was a randomized control trial; qualified patients were randomly assigned into acupressure group, sham group or control group. A total of 106 participants were included in the study. The measures included the revised Piper Fatigue Scale (PFS), VAS of Fatigue, the Pittsburgh Sleep Quality Index and the Beck Depression Inventory. Data of fatigue measures were collected at pretreatment and a week following treatment. Sleep quality and depression were collected during post-test only. The statistical methods included the descriptive statistics, one-way ANOVA, ANCOVA, and repeated-measures ANOVA. ANCOVA that adjusted for differences in baseline fatigue scores (PFS), post-test of depression and sleep quality, result was significant, F(2,100)=3.99, p=0.02. Post-hoc tests revealed that patients in the acupressure group were significantly having lower scores of fatigue than patients in the control group. ANCOVA results also significant for VAS of Fatigue among groups, F(2,100)=5.63, p=0.003. Comparisons indicated that there were significant differences between the acupressure group and the control group (p=0.01) and between the sham group and control group (p=0.003). Predialysis fatigue was assessed routinely by using a rating of 0-10. Repeated-measures ANOVA results demonstrate the group main effect was significant in the perceived fatigue (F(2,88)=19.46, p<0.001). Follow-up tests indicated there were significant differences between the acupressure group and the control group (p<0.001) and between the sham group and control group (p<0.001). The study provided an alternative method for health care providers to managing ESRD patients with fatigue. To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache.
                Three armed randomised controlled multicentre trial.
                28 outpatient centres in Germany.
                270 patients (74% women, mean age 43 (SD 13) years) with episodic or chronic tension-type headache.
                Acupuncture, minimal acupuncture (superficial needling at non-acupuncture points), or waiting list control. Acupuncture and minimal acupuncture were administered by specialised physicians and consisted of 12 sessions per patient over eight weeks.
                Difference in numbers of days with headache between the four weeks before randomisation and weeks 9-12 after randomisation, as recorded by participants in headache diaries.
                The number of days with headache decreased by 7.2 (SD 6.5) days in the acupuncture group compared with 6.6 (SD 6.0) days in the minimal acupuncture group and 1.5 (SD 3.7) days in the waiting list group (difference: acupuncture v minimal acupuncture, 0.6 days, 95% confidence interval -1.5 to 2.6 days, P = 0.58; acupuncture v waiting list, 5.7 days, 3.9 to 7.5 days, P < 0.001). The proportion of responders (at least 50% reduction in days with headache) was 46% in the acupuncture group, 35% in the minimal acupuncture group, and 4% in the waiting list group.
                The acupuncture intervention investigated in this trial was more effective than no treatment but not significantly more effective than minimal acupuncture for the treatment of tension-type headache.
                ISRCTN9737659. The purpose of the study is to test the effectiveness of acupressure on sleep quality of end-stage renal disease patients. The study was a randomized controlled trial; qualified patients in the dialysis centers of four major hospitals were randomly assigned into an acupressure group, a sham acupressure group, and a control group. A total of 98 participants were included in the study. The main outcomes measured were the Pittsburgh sleep quality index (PSQI) and the sleep log. Data were collected at pretreatment and following treatment. Primary statistical analysis was by means of Analysis of Covariance, the Kruskal-Wallis Test and repeated measure ANOVA. The results indicated that PSQI scores of the acupressure group have a significantly greater improvement (p < 0.01) than the control group. However, there were no differences between the acupressure group and the sham group or the sham group and the control group (p > 0.05). Subscales of PSQI were further analyzed. Results demonstrated significant differences between the acupressure group and the control group in subjective sleep quality (p = 0.009), sleep duration (p = 0.004), habitual sleep efficiency (p = 0.001), and sleep sufficiency (p = 0.004). Significant differences in the subscale of subjective sleep quality (p = 0.003) between the sham acupressure group and the control group were also observed. Sleep log data showed that the acupressure group significantly decreased awake time and improved quality of sleep over time more than the control group (p < 0.01). The improvement could be seen as soon as the acupoints massage was implemented, and it was maintained through the post intervention.
                Copyright 2002 Elsevier Science Ltd. Auricular acupuncture can be an effective treatment for acute anxiety, but there is a lack of direct comparisons of acupuncture to proven standard drug treatments. In this study we compared the efficacy of auricular acupuncture with intranasal midazolam, placebo acupuncture, and no treatment for reducing dental anxiety. Patients having dental extractions (n = 67) were randomized to (i) auricular acupuncture, (ii) placebo acupuncture, and (iii) intranasal midazolam and compared with a no treatment group. Anxiety was assessed before the interventions, at 30 min, and after the dental extraction. Physiological variables were assessed continuously. With the no treatment group as control, the auricular acupuncture group, and the midazolam group were significantly less anxious at 30 min as compared with patients in the placebo acupuncture group (Spielberger Stait-Trait Anxiety Inventory X1, P = 0.012 and <0.001, respectively). In addition, patient compliance assessed by the dentist was significantly improved if auricular acupuncture or application of intranasal midazolam had been performed (P = 0.032 and 0.049, respectively). In conclusion, both, auricular acupuncture and intranasal midazolam were similarly effective for the treatment of dental anxiety. Sedative drugs are generally given to patients undergoing colonoscopy. However, the benefit of routinely administered conscious sedation for colonoscopy has not been studied in adequately controlled trials.
                We randomly assigned 180 patients scheduled for diagnostic colonoscopy into 3 groups: (1) sedation with intravenous midazolam (midazolam group); (2) sedation with intravenous saline (placebo group); and (3) no intravenous cannula (control group). The endoscopist assessed the procedure immediately after the examination. The patients completed a questionnaire before leaving the endoscopy unit. Another questionnaire was sent to the patients 2 weeks after the examination. Answers were mainly given on a 100 mm visual analog scale.
                Shortly after the procedure, the patients in the midazolam group rated the examination less difficult than those in the placebo group (30 vs. 40 mm; p < 0.05; visual analog scale, 0 to 100 mm: 0 = not at all, 100 = extremely). However, no significant difference was found between midazolam and control groups (30 vs. 36 mm, respectively). Otherwise, there were no differences between the three groups with respect to the patients' or endoscopists' assessments or the examination time.
                Routinely administered sedation does not markedly increase patient tolerance or make colonoscopy technically easier. To determine the feasibility, in terms of acceptability to patients, physicians and other staff; data return and statistical power of a study to elucidate the relative contributions of specific and non-specific effects in homeopathic treatment of dermatitis.
                Randomised, controlled 4-arm trial, 2 arms double-blind.
                Outpatient clinic, Royal London Homoeopathic Hospital.
                Seventy-five adult patients with dermatitis.
                Patients were randomly allocated to: 'fast track' open verum homeopathy, 'fast track' double-blind verum homeopathy, 'fast track' double-blind placebo homeopathy or waiting list control.
                One hundred millimeter visual analogue scale of overall symptom severity; 10 point digital scores of sleep, itching, skin condition; weekly 5-point Likert scale of topical steroid use; Dermatology Life Quality Index at entry and completion.
                Recruitment was below target, but the study was acceptable to staff and feasible. Blinded patients were more likely to withdraw (P=0.021, chi2 test). After correction for baseline differences and multiple comparisons, no outcome measure showed statistically significant between group differences. Blindness appeared to have a negative effect, but this was confounded by differential withdrawal.
                A definitive trial of this design is unlikely to discriminate the relative contributions of the non-specific and specific effects to the outcome of homeopathic treatment of dermatitis, because of patient preference issues. 63 pts affected by CIN of various degrees were randomly divided into 3 groups in order to evaluate the pain experienced during laser vaporization of the lesion. All pts were premenopausal and ages ranged between 19 and 39 years. 21 pts received Naproxene Sodium (550 mg) 30 minutes before surgery; 21 pts received placebo and 21 pts received no drug. Laser vaporization was performed with a Coherent System 451 CO2 laser with a power setting of 28 W/cm2 and a spot size of 1.8 mm. The severity of pain was assessed by means of a Visual Analogue Scale. The mean VAS value was 19 for the group treated with Naproxene Sodium; the mean VAS value was 20 for the placebo group and 23 for the group which received no pre-operative drug. Analysis of data from the 3 groups showed no statistically significant difference. Analgesia or anaesthesia before laser surgery for CIN is not a necessity. One hundred twenty patients about to receive their first treatment with potentially nauseant cancer chemotherapy were randomized to one of six antiemetic treatments: (1) no treatment; (2) placebo; (3) prochlorperazine (PCPZ), 10 mg; (4) delta 9-tetrahydrocannabinol (THC), 5 mg; (5) THC, 10 mg; (6) THC, 15 mg. Four doses of each medication were given orally at 4-hour intervals starting 2 hours before chemotherapy. A study nurse was responsible for both objective (nurse) and subjective (patient) symptom questionnaires. Serum levels were obtained at intervals for cross-reacting cannabinoids. Physiologic measurements including intraocular pressure (IOP), blood pressure, and pulmonary function were also recorded. In summary, the patients were remarkably free of adverse physiologic effects. All intraocular pressures before and after treatment were within the normal range, although a surprising statistically significant increase in IOP occurred in the group receiving 5 mg THC. BACKGROUND AND OBJECTIVE: This study investigates (1) whether treatment by homeopaths is more efficacious than self-selected conventional health care and (2) whether self-treatment with self-selected homeopathic medicines is more efficacious than placebo in preventing childhood upper respiratory tract infections (URTIs). DESIGN: A four-arm randomized controlled trial involving two independent investigations, one open and pragmatic (evaluating the effect of treatment by homeopaths including homeopathic medicines) and one double-blinded (evaluating the effect of self-treatment with homeopathic medicine). PATIENTS: The planned sample size is 420 children below the age of 10, recruited by a postal invitation to all children diagnosed with URTIs when attending a casualty department in Trondheim, Norway. INTERVENTIONS: The children are randomly assigned to receive either (1) self-selected homeopathic medicine or placebo (270 patients), (2) treatment by one of four different homeopaths who could prescribe any homeopathic medicine (75 patients), or (3) waiting list control using self-selected conventional health care (75 patients). MAIN OUTCOME MEASURE: Total URTI symptom scores from patients' diary over 12 weeks. PLAN: The results of these two studies (available at the end of 2004) have the potential to provide information about the efficacy of treatment by homeopaths independently from the efficacy of homeopathic medicines in children with URTIs. It is not clear whether segmental innocuous stimulation has a stronger analgesic effect than segmental noxious stimulation for chronic pain and whether the fading of current sensation during treatment interferes with the analgesic effect, as suggested by the gate control theory. Electrical stimulation (by way of Interferential Current) applied at the pain area (segmental) was administered to 4 groups of patients with osteoarthritis (OA) knee pain. Two groups were administered with noxious stimulation (30% above pain threshold) and two with innocuous stimulation (30% below pain threshold). In each group half of the patients received a fixed current intensity while the other half raised the intensity continuously during treatment whenever fading of sensation was perceived. Group 5 and 6 received sham stimulation and no treatment, respectively. The outcome measures were: chronic pain intensity, morning stiffness, range of motion (ROM), pain threshold and % pain reduction. Both noxious and innocuous stimulation significantly decreased chronic pain (P<0.001) and morning stiffness (P<0.01) and significantly increased pain threshold (P<0.001) and ROM (P<0.001) compared with the control groups. Nevertheless, noxious stimulation decreased pain intensity (P<0.05) and increased pain threshold (P<0.001) significantly more than innocuous stimulation. No differences in treatment outcomes were found between adjusted and unadjusted stimulation. (a) Interferential current is very effective for chronic OA knee pain, (b) segmental noxious stimulation produces a stronger analgesic effect than segmental innocuous stimulation, (c) the fading of sensation during treatment, does not decrease the analgesic effect. Possible mechanisms explaining the findings are discussed. One-hundred-sixteen patients suffering from vascular headache (migraine or combined migraine and tension) were, after 4 weeks of pretreatment baseline headache monitoring, randomly assigned to one of four conditions: (a) thermal biofeedback with adjunctive relaxation training (TBF); (b) TBF plus cognitive therapy; (c) pseudomediation as an ostensible attention-placebo control; or (d) headache monitoring. The first three groups received 16 individual sessions over 8 weeks, while the fourth group continued to monitor headaches. All groups then monitored headaches for a 4-week posttreatment baseline. Analyses revealed that all treated groups improved significantly more than the headache monitoring group with no significant differences among the three treated groups. On a measure of clinically significant improvement, the two TBF groups had slightly higher (51%) degree of improvement than the meditation group (37.5%). It is argued that the attention-placebo control became an active relaxation condition. Patients usually fear fiberoptic bronchoscopy (FBS) and they report a low level of satisfaction after this examination. We evaluated the efficacy of acupuncture in decreasing patient anxiety before diagnostic FBS and in improving tolerance to the examination. In a prospective double-blind study, we enrolled 48 patients scheduled to undergo diagnostic FBS. Patients were randomly assigned to one of three groups. Group A (16 patients): standard FBS, with airway topic anesthesia; Group B (16 patients): standard FBS, with airway topic anesthesia and acupuncture treatment; Group C (16 patients): standard FBS, with airway topic anesthesia and sham acupuncture. EKG, non-invasive arterial pressure, and pulse oximetry were monitored on a routine basis. We evaluated patient anxiety before and after acupuncture and, at the end of FBS, the discomfort suffered during the examination by a 100-mm Visual Analog Scale (VAS). Patient satisfaction in Group A was 50% worse than in Group B (p = 0.04). We observed a strong, even if not statistically significant, tendency toward a lower pre-FBS anxiety in Group B. Patients in group C had values very close to those recorded in group A. We observed no adverse event and no differences in cardio-respiratory parameters in these three groups; in particular, we did not observe a respiratory depression in Group B. Acupuncture seems an effective resource for a Thoracic Endoscopic Room to improve patient tolerance to FBS. Given the inherent side effects associated with both opioid and nonopioid analgesic drugs, a nonpharmacologic therapy that could decrease the need for analgesic medication would be valuable. We designed a sham-controlled study to assess the effect of the intensity of transcutaneous acupoint electrical stimulation (TAES) on postoperative patient-controlled analgesia (PCA) requirement for hydromorphone (HM), the incidence of opioid-related side effects, and the recovery profile after lower abdominal surgery. One hundred one healthy consenting women undergoing lower abdominal procedures with a standardized general anesthetic technique were randomly assigned to one of four postoperative analgesic treatment regimens: Group I (n = 26) PCA only; Group II (n = 25), PCA + sham-TAES (no electrical stimulation); Group III (n = 25), PCA + low-TAES (4-5 mA of electrical stimulation); Group IV (n = 25), PCA + high-TAES (9-12 mA of electrical stimulation). The PCA device was programmed to deliver HM, 0.2-0.4 mg intravenously boluses "on demand," with a minimum lockout interval of 10 min. The TAES skin electrodes were placed at the Hegu acupoint on the nondominant hand and on both sides of the surgical incision. The TAES frequency was set in the dense-and-disperse mode, alternating at 2 Hz and 100 Hz every 3 s, with stimulation of the hand and incision alternated every 6 s. The patients in Groups II-IV were instructed to use TAES every 2 h for 30 min while awake. After discontinuation of PCA, oral pain medications were administered on demand. The postoperative PCA-HM requirement, pain scores, opioid-related side effects, and requirements for antiemetic and antipruritic medication were recorded. High-TAES decreased the HM requirement by 65% and reduced the duration of PCA therapy, as well as the incidence of nausea, dizziness, and pruritus. Low-TAES produced a 34% decrease in the HM requirement compared with only 23% in the "sham" TAES group. We conclude that high-TAES produced a significant decrease in the PCA opioid requirement and opioid-related side effects after low intraabdominal surgery. Within 24 hours after abortion, 62 patients with a mean gestational age of 19 weeks, who had either induced (n = 50) or spontaneous (n = 12) abortions were randomly allocated to three groups: Group 1, bromocriptine 2.5 mg twice daily for 2 weeks; Group 2, placebo tablets 1 tablet twice daily for 2 weeks; Group 3, no treatment. Fifty-two patients completed the study (bromocriptine n = 18, placebo n = 18 and no treatment n = 16). Placebo had no apparent influence on breast symptoms. In both the placebo group and the untreated group, breast pain and milk secretion peaked on days 3 to 7, and milk secretion often continued for 3 weeks. Only 3/34 (9%) of untreated and placebo treated patients were free of breast symptoms. Compared with placebo, bromocriptine caused a significant reduction in the objective assessment score of breast tenderness (p less than 0.05) and milk secretion (p less than 0.01), in serum prolactin (PRL) (p less than 0.001) and in the subjective assessment score of breast pain (p less than 0.01) and milk secretion (p less than 0.01). Alleviation of breast pain and prevention of milk secretion appears to be indicated after second-trimester abortion, and treatment with bromocriptine is efficacious. This randomized controlled clinical trial evaluates the effectiveness of outpatient group cognitive/educational treatment for patients with the fibromyalgia (FM) syndrome. We hypothesized that the combination of group education with cognitive treatment aimed at developing pain coping skills would be more effective than group education alone.
                131 patients with FM were randomly assigned to 3 conditions: an experimental condition, which was the combined cognitive/educational intervention (ECO); an attention control condition consisting of group education plus group discussion (EDI); and a waiting list control (WLC). For the treatment conditions ECO and EDI, assessments were made 2 weeks before treatment, at start of treatment, at post-treatment, and at 6 and 12 mo followup. WLC patients received only 3 assessments.
                There were no pretreatment differences between the groups, or between dropouts and patients who remained in the study. At post-treatment, and compared with the WLC, the ECO patients improved in knowledge about FM (p = 0.007) and pain coping (p < 0.001). EDI patients improved on pain coping (p = 0.005) and pain control (p = 0.002). EDI patients reported significantly less fear than ECO patients (p = 0.005). There were no other differential effects between ECO and EDI at post-treatment or 6 mo or 12 mo followup. Based on the reliability of change index for clinical significance, the relative short term success rates are 6.4 and 18.4% for ECO and EDI, respectively.
                The surplus value of a highly structured, 12 session group cognitive treatment added to group education cannot be supported by our study. In EDI, fear reduction might have enhanced pain coping and pain control, while poor compliance, the difficulty of homework assignments, and lack of individual support may have limited the effectiveness of ECO. The objective of this study was to determine the effects of a placebo treatment on cough in patients with cough associated with acute upper respiratory tract infection (URTI).
                Patients with dry or slightly productive cough associated with a history of URTI were recruited. Cough frequency (CF) over 15 minutes was recorded by means of a microphone connected to a pen recorder. Cough suppression time (CST) was recorded when patients were instructed by means of a red light to try not to cough. Patients received either a single dose of vitamin E (placebo treatment) or no treatment. CF and CST were recorded before and 15 minutes after treatment.
                Twenty-seven patients were randomized to placebo treatment and 27 to the no-treatment group (mean age 22.6 years). The median difference between post- and pretreatment CF was -3 in the no-treatment group and -18 in the placebo group (p = .0003). There was a significant increase in CST in the placebo group compared with no treatment (p = .027).
                The results demonstrate that placebo treatment has significant antitussive activity. This placebo effect may be related to generation of central neurotransmitters such as endogenous opioids. nan Exposure to high allergen levels in early life is a risk factor for the development of allergy. We previously reported limited effects of mite allergen impermeable mattress covers in the prevention and incidence of asthma and mite allergy (PIAMA) cohort at the age of 1 and 2 yr. We now present the results of follow-up at 4 yr objectives. To examine the effects of early reduction of house dust mite (HDM) allergen exposure by means of mattress covers on the incidence of allergy and asthma symptoms in the PIAMA birth cohort at the age of 4 yr. High-risk children (allergic mother) were prenatally recruited and randomly allocated to three groups; receiving mite allergen impermeable mattress covers (n = 416), placebo covers (n = 394) or no intervention (n = 472). At 4 yr of age, atopy was assessed by questionnaire; specific Immunoglobulin E (IgE) to inhalant and food allergens was measured in serum. Dust samples collected from the children's mattresses were analysed for mite allergens. Dermatophagoides farinae1 allergen (Der f 1) levels in dust were reduced in the active group. However, Dermatophagoides pteronissinus 1 (Der p 1) levels, sensitization and atopic symptoms were similar in all groups. We found no effect of mite allergen impermeable mattress covers on sensitization and atopy at 4 yr. Moreover, the allergen reducing effects of the covers had disappeared for one of the two mite allergens that were measured. This study was designed to assess the efficacy of oral transmucosal fentanyl citrate (OTFC) for premedication in an adult population and to determine its effects on anxiety, sedation, gastric volume, and gastric fluid acidity. The fentanyl citrate is incorporated in a lozenge mounted on a handle (oralet). The effects of OTFC, placebo oralet, and no premedication were compared in a prospective, double-blind study on 90 adult ASA physical status I and II patients undergoing same-day admission surgery. Patients were randomly assigned to one of three groups: OTFC group (n = 30), placebo group (n = 30), and control group (n = 30). Arterial blood pressure, heart rate, respiratory frequency, and oxygen saturation determined by pulse oximetry were recorded before any premedication was given, and then every 10 min until the patient was taken to the operating room. Baseline anxiety and sedation levels were assessed to ensure group similarity immediately before premedication was given and at the more anxiety-provoking phase upon entering the operating room. Anxiety levels were rated using the Spielberger State-Trait Anxiety Inventory short form and sedation levels were assessed with the Ramsay scale. Side effects, as reported by the patients, were also recorded. Gastric contents were aspirated via an orogastric tube after induction of anesthesia and were measured for volume and pH. No significant differences were found among the three groups in mean arterial pressure, heart rate, or respiratory frequency. Initial oxygen saturation levels in all groups decreased after 30 min but not less than 96% except for one patient in the OTFC group, who decreased to 88%. On entering the operating room, the OTFC group demonstrated significantly higher levels of anxiolysis than the control group, but no significant differences were seen between the OTFC and the placebo groups or the placebo and control groups. Mean gastric volumes (OTFC, 29 mL; placebo, 26 mL; control, 24 mL) and pH (OTFC, 2.0; placebo, 1.8; control, 2.1) were similar in all groups. There were no significant differences among the groups in levels of sedation achieved. Mild dizziness or light-headedness was the most commonly reported side effect in 23% of the OTFC group. In the OTFC group, 71.4% like the premedicant effect as compared to 46.4% of the placebo group. Most of the groups found the oralet method of premedicant delivery very acceptable. This study demonstrates that the OTFC oralet is an effective anxiolytic in adults. It has minimal side effects and is prepared in an acceptable format. There was no measurable increase in gastric contents or acidity in the oralet groups, compared to those patients who were given nothing by mouth. To evaluate the efficacy of Simulated Presence, a personalized approach to enhance well-being among nursing home residents with Alzheimer's disease and related dementia's (ADRD).
                Latin-Square, double blinded, 3-factor design with restrictive randomization of three treatments (the study intervention, a placebo audio tape of a person reading the newspaper, and usual care). The three factors were treatment, time, and facility type.
                Nine nursing homes in Eastern Massachusetts and Southern New Hampshire.
                Fifty-four subjects with documented ADRD who were aged 50 years or older, medically stable, had resided in their current nursing home for at least 3 months, and who had no planned discharge. All subjects had a history of agitated or withdrawn behaviors.
                The purpose of Simulated Presence is to provide a personalized intervention for persons with moderate to severe cognitive impairment. Through a unique testing process, some of the best loved memories of the ADRD person's lifetime are identified and then those memories are introduced to the patient in the format of a telephone conversation using a continuous play audio tape system. The intervention may be used for extended periods of time because each repetition is viewed as a fresh, live telephone call as a result of the short-term memory deficit of the person with ADRD.
                Direct observations of outcomes included using a newly developed scale, the Scale for the Observation of Agitation in Persons with Dementia, an agitation visual analog scale, the Positive Affect Rating Scale (mood and "interest"), a withdrawal visual analog scale, and facial diagrams of mood. Reported measures included daily staff observation logs of responses to interventions offered, and weekly staff surveys using the short-form Cohen-Mansfield Agitation Inventory and the Multidimensional Observation Scale for Elderly Subjects (mood and "interest"). Severity of dementia was assessed by the Mini-Mental State Exam, the Test for Severe Impairment, the Bedford Alzheimer's Nursing Scale, and the ADL Self-Performance Scale.
                Chi-square analysis of direct observations, using facial diagrams, revealed that Simulated Presence was equivalent to usual care (P = .141) and superior to placebo for producing a happy facial expression (P = .001). A positive effect was also documented in nursing staff observation logs using Analysis of Variance techniques (ANOVA) for subjects during Simulated Presence phases compared with the placebo phases (P < .001) and usual care phases (P < .001). According to ANOVA analyses of "interest" from weekly surveys, Simulated Presence was superior to both usual care (P = .001) and placebo (P = .008). We were unable to find evidence of significant differences (P < .05) among interventions for other direct observations and weekly reports of overall agitation or mood aspects of withdrawal. Subjects accepted the intervention most of the time, except for five subjects who refused it more than 50% of the time.
                This study provided evidence that Simulated Presence can be effective in enhancing well-being and decreasing problem behaviors in the nursing home setting as a substitute for or complement to usual care. In several large, well-designed, randomized, double-blind studies, the opiate antagonist naltrexone demonstrated efficacy in the treatment of alcohol dependence. Specifically, when combined with certain psychosocial therapies, naltrexone reduces the number of drinking days, heavy drinking, and time to relapse to alcohol use in alcohol-dependent individuals. Whether this efficacy can be generalized to individuals who have alcohol use disorders and present for treatment at front-line community treatment programs has not been well established.
                A total of 145 patients who presented for treatment at a rural community substance abuse treatment center were randomized to receive naltrexone 50 mg daily plus usual program treatment (n = 54), placebo plus usual treatment (n = 43), or usual treatment alone (n = 48) for 12 week. A total of 133 participants had at least one follow-up visit. Primary outcome measures included percent days drinking, average drinks per drinking day, average drinks per day, heavy drinking days (four or more for women and six or more for men), and time to first heavy drinking day. Secondary measures included changes in serum biological markers (alkaline phosphatase, alanine transaminase, aspartate transaminase, and gamma-glutamyltransferase), craving, and psychosocial functioning.
                In the intention-to-treat analysis, there were no between-group differences for any of the primary drinking outcomes at 12 weeks. In post hoc exploratory analyses, the entire sample of participants was divided into two new groups: (1) people who drank during the 2 weeks before the start of medication (entry drinkers) and (2) people who did not drink during this interval (entry abstainers). Entry abstainers were at an advantage at study entry in that they were significantly more likely to have an inpatient hospitalization immediately before entry into outpatient treatment. Mixed-model analysis of variance revealed a main effect for entry group at the 12-week treatment endpoint on the primary outcome measures of percent days drinking, average drinks per drinking day, average drinks per day, heavy drinking days, and time to first heavy drinking day. Participants in any of the randomized groups who were entry abstainers had significantly better improvement on all of the primary outcome measures. The abstainer groups that were randomized to placebo and usual treatment had significantly better outcomes than the entry drinkers in those perspective groups. However, for the naltrexone-treated group, entry drinkers and entry abstainers had similar improvement in drinking-related outcomes.
                These data suggest that naltrexone may offer particular benefit to patients who continue to drink during the early stages of the trial as compared with those who have achieved abstinence before treatment entry. Substantial evidence suggests that acupuncture-point stimulation may be effective in controlling side effects of chemotherapy.
                To examine the efficacy of an acustimulation wristband for the relief of chemotherapy-induced nausea.
                Randomized clinical trial using a 3-level crossover design.
                Three outpatient oncology clinics in the northeastern United States.
                Twenty-five women and 2 men who experienced moderate or more severe nausea following their first chemotherapy treatment.
                We compared active acustimulation of the Pericardium 6 (PC-6) point on the ventral surface of the wrist with sham acustimulation (a corresponding point on the posterior surface of the wrist). A control group received no acustimulation.
                Severity of nausea and quantity of antiemetic medication used.
                No statistically significant differences in average severity of nausea were observed between the 3 interventions. However, the data showed a difference close to statistical significance in the severity of delayed nausea reported during active acustimulation compared to no acustimulation (P <.06). In addition, patients took fewer antinausea pills during the active-acustimulation cycle of this experiment compared to the no-acustimulation phase (P < .05).
                Findings on the efficacy of an acustimulation band for the control of chemotherapy-induced nausea are positive but not conclusive. These findings provide ample justification for further study of acustimulation in clinical oncology. Investigated the effects of psychologically preparing patients for minor gynaecological surgery. A total of 59 women who were undergoing elective laparoscopy were assigned randomly to three experimental conditions: Preparation, in which an informative preoperative interview was conducted; placebo, in which a reassuring preoperative interview was held; and control, in which no contact was made prior to surgery. The women were assessed postoperatively in terms of pain, anxiety and attitudes and required to complete a follow-up questionnaire that followed a 3-week interval, which assessed subjective report of recovery rate. The results showed similar levels of pain report for all groups, although significantly fewer prepared patients requested postoperative analgesia. No differences in pain reports emerged at follow-up, although there was a tread for prepared patients to report a more rapid return to full health. The results are considered in the context of explanatory models that have been proposed to account for the effects of psychological preparation. The effectiveness of functional electrical stimulation (FES) has been investigated in chronic hemiplegia. The present study examines whether FES, given during acute stroke, was more effective in promoting motor recovery of the lower extremity and walking ability than standard rehabilitation alone.
                Forty-six subjects, 70.9+/-8.0 years old and 9.2+/-4.1 days after stroke, were assigned randomly to 1 of 3 groups receiving standard rehabilitation with FES or placebo stimulation or alone (control). FES was applied 30 minutes and placebo stimulation 60 minutes, 5 days per week for 3 weeks. Outcome measurements included composite spasticity score, maximum isometric voluntary contraction of ankle dorsi-flexors and planter-flexors, and walking ability. They were recorded before treatment, weekly during the 3-week treatment, and at week 8 after stroke.
                No significant differences were found in the baseline measurements. After 3 weeks of treatment, there was a significant reduction in the percentage of composite spasticity score, and a significant improvement in the ankle dorsiflexion torque, accompanied by an increase in agonist electromyogram and a reduction in electromyogram cocontraction ratio in the FES group, when compared with the other 2 groups (P<0.05). All subjects in the FES group were able to walk after treatment, and 84.6% of them returned home, in comparison with the placebo (53.3%) and control (46.2%, P<0.05) groups.
                Fifteen sessions of FES, applied to subjects with acute stroke plus standard rehabilitation, improved their motor and walking ability to the degree that more subjects were able to return to home. This prospective controlled trial investigated the efficacy of a manual-based clinical hypnosis intervention in alleviating pain in 80 pediatric cancer patients (6-16 years of age) undergoing regular lumbar punctures. Patients were randomly assigned to 1 of 4 groups: direct hypnosis with standard medical treatment, indirect hypnosis with standard medical treatment, attention control with standard medical treatment, and standard medical treatment alone. Patients in the hypnosis groups reported less pain and anxiety and were rated as demonstrating less behavioral distress than those in the control groups. Direct and indirect suggestions were equally effective, and the level of hypnotizability was significantly associated with treatment benefit in the hypnosis groups. Therapeutic benefit degraded when patients were switched to self-hypnosis. The study indicates that hypnosis is effective in preparing pediatric oncology patients for lumbar puncture, but the presence of the therapist may be critical. The roots of essential hypertension extend back into the first two decades of life, suggesting that effective intervention during those years may lead to a reduction in the incidence of adult hypertension. Decreasing the dietary sodium/potassium ratio offers a potentially effective approach to blood pressure reduction. This study tested the feasibility of 3-year sodium reduction or potassium supplementation in adolescents and the effect of these interventions on the rate of rise of blood pressure during adolescence. After 19,452 5th to 8th grade students were screened, 210 from the upper 15 percentiles of blood pressure distribution (105 boys, 105 girls) were randomly assigned to one of three groups: low sodium diet (70 mmol sodium intake per day), potassium chloride supplementation (normal diet plus 1 mmol/kg potassium chloride per day), or placebo (normal diet plus placebo capsule). Capsules for the potassium chloride and placebo groups were administered in a double blind protocol. Blood pressure was measured every 3 months for 3 years. The effect of the intervention was determined by comparing the rate of rise (slope) of blood pressure among the groups using a random-coefficient growth curve model. The boys groups and the girls placebo group had similar positive blood pressure slopes that were significantly different from zero. The girls low sodium group had a slightly negative slope (significantly lower than the slope of the girls placebo group), and the girls potassium group had a slightly positive slope. Both of these slopes were not significantly different from zero and were significantly lower than the slopes of the respective boys groups.(ABSTRACT TRUNCATED AT 250 WORDS) Blood-donation-related symptoms such as dizziness and weakness discourage people from participating in this important health-related activity. Four hundred sixty-seven young adult, French-speaking blood donors were randomly assigned to (a) a condition in which they learned a possible preventive technique called applied tension and were asked to practice it from the time they got on the donation chair until they were just about to get up, (b) a placebo condition in which they learned applied tension and were asked to practice it from the time they got on the chair until the insertion of the donation needle, or (c) a no-treatment control condition. Donors assigned to the treatment condition reported significantly fewer blood-donation-related symptoms than did donors assigned to the other conditions and rated their likelihood of returning to give blood again as greater than did those in the no treatment condition. Among donors whose chairs were not reclined, participants in the treatment condition had significantly smaller heart rate reactions to blood donation than did those in the other conditions.
                2006 APA, all rights reserved nan Unpleasant blood donation-related symptoms may discourage otherwise healthy, altruistic individuals from becoming repeat donors. This study examined a behavioral technique called applied muscle tension (AMT) that might reduce reactions.
                A total of 605 donors at mobile clinics were assigned to either an AMT treatment condition, a no-treatment control condition, or a placebo control condition. AMT involves repeated tensing of major muscles and was taught using an instructional video. Participants in the placebo control group watched the same video but were told to practice the technique only from the time they got on the donation chair until insertion of the needle, without being told that reactions are unlikely during this period.
                There were no differences between men assigned to the three conditions. Women donors assigned to the AMT condition reported significantly fewer donation-related symptoms, required less chair reclining for reactions, and were more likely to produce a full unit of blood than women in both the no-treatment and placebo control conditions. Women in the AMT condition also said they would be more likely to recommend it to a friend who was going to give blood, but there were no significant effects of AMT on the rated probability of giving blood again or blood pressure change.
                Although it was not universally effective and the mechanisms of its effects are unclear, AMT is a simple behavioral technique that may be useful in reducing reactions to blood donation. The specific aim of this study was to investigate the efficacy of elicitation of the relaxation response for the treatment of menopausal hot flashes and concurrent psychological symptoms. The volunteer sample consisted of 33 women, between the ages of 44 and 66 years, who were in general good health, with a minimum of 6 months without a menstrual period, experiencing at least five hot flashes per 24-h, and not using hormone replacement therapy. The setting was an outpatient clinic in a tertiary care teaching hospital. The interventions used were relaxation response training and an attention-control group and a daily symptom diary measuring both the frequency and intensity of hot flashes, the Spielberger State-Trait Anxiety Inventory (STAI), and the Profile of Mood Scale (POMS) were the measures used. This was a randomized, controlled, prospective study. Subjects were randomly assigned to one of three groups (relaxation response, reading, or control) for the 10-week study. The first 3 weeks of baseline measurement of frequency and intensity of hot flash symptoms, and the preintervention psychological scores were compared with the final 3 weeks measurement of frequency and intensity and the postintervention psychological scores for symptomatic improvement. The relaxation response group demonstrated significant reductions in hot flash intensity (p < 0.05), tension-anxiety (p < 0.05) and depression (p < 0.05). The reading group demonstrated significant reductions in trait-anxiety (p < 0.05) and confusion-bewilderment (p < 0.05). There were no significant changes for the control group. Daily elicitation of the relaxation response leads to significant reductions in hot flash intensity and the concurrent psychological symptoms of tension-anxiety and depression. The objective of this study was to assess whether nicotine replacement therapy, administered in a real-life situation, could reduce cigarette consumption in smokers who were not prepared to quit smoking. Daily smokers of more than 20 cigarettes per day who had no intention to quit smoking in the next 6 months were recruited from the general population and randomly assigned to either a 6-month treatment of nicotine (choice among a 15-mg nicotine patch, a 4-mg nicotine gum, a 10-mg nicotine inhaler, or a combination of these, N = 265), matching placebo products (N = 269), or no intervention (N = 389). Products were sent to participants by mail. Education was limited to a booklet. Of 923 participants, 879 (95%) were followed up after 6 months. Mean baseline consumption was 30 cigarettes per day in all groups. At 6 months, cigarette consumption decreased by a median of 10 cigarettes per day in the nicotine group, 7.5 in the placebo group, and 2.5 among controls ( < 0.04 for all pair-wise comparisons). Smoking cessation rates were low (2%-4%) and did not differ significantly between groups. Quit attempts were less frequent among controls (21%) than among the nicotine (28%, = 0.04) and placebo (27%, = 0.08) subjects. In conclusion, nicotine replacement therapy helped smokers reduce their cigarette consumption and maintain this reduction over 6 months, but a large part of this reduction was attributable to a placebo effect. Nicotine treatment for smoking reduction had no detectable impact on smoking cessation. Fifty outpatients with mild, chronic, mood-reactive depression whose mood improved markedly after a 10-day single-blind placebo trial were randomly assigned in a double-blind design either to have their placebo medication discontinued or to have it maintained for an additional 6 weeks. Half of the patients in each condition relapsed within 6 weeks, indicating that pill-taking itself does not influence maintenance of placebo response. Placebo response was more likely to be maintained in patients who were currently married. At the end of 3 months, the overall relapse rate was 58%. The authors raise questions about the utility of the initial 10-day placebo washout in antidepressant clinical trials, and they discuss limits on the generalizability of their findings. To investigate the benefit of adding acupuncture to a course of advice and exercise delivered by physiotherapists for pain reduction in patients with osteoarthritis of the knee.
                Multicentre, randomised controlled trial.
                37 physiotherapy centres accepting primary care patients referred from general practitioners in the Midlands, United Kingdom.
                352 adults aged 50 or more with a clinical diagnosis of knee osteoarthritis.
                Advice and exercise (n=116), advice and exercise plus true acupuncture (n=117), and advice and exercise plus non-penetrating acupuncture (n=119).
                The primary outcome was change in scores on the Western Ontario and McMaster Universities osteoarthritis index pain subscale at six months. Secondary outcomes included function, pain intensity, and unpleasantness of pain at two weeks, six weeks, six months, and 12 months.
                Follow-up rate at six months was 94%. The mean (SD) baseline pain score was 9.2 (3.8). At six months mean reductions in pain were 2.28 (3.8) for advice and exercise, 2.32 (3.6) for advice and exercise plus true acupuncture, and 2.53 (4.2) for advice and exercise plus non-penetrating acupuncture. Mean differences in change scores between advice and exercise alone and each acupuncture group were 0.08 (95% confidence interval -1.0 to 0.9) for advice and exercise plus true acupuncture and 0.25 (-0.8 to 1.3) for advice and exercise plus non-penetrating acupuncture. Similar non-significant differences were seen at other follow-up points. Compared with advice and exercise alone there were small, statistically significant improvements in pain intensity and unpleasantness at two and six weeks for true acupuncture and at all follow-up points for non-penetrating acupuncture.
                The addition of acupuncture to a course of advice and exercise for osteoarthritis of the knee delivered by physiotherapists provided no additional improvement in pain scores. Small benefits in pain intensity and unpleasantness were observed in both acupuncture groups, making it unlikely that this was due to acupuncture needling effects.
                Current Controlled Trials ISRCTN88597683 [controlled-trials.com] . nan Although the traditional treatment of headache has been pharmacological, there have been many attempts to treat headaches with other methods with mixed levels of success.
                To obtain preliminary data on the efficacy of the Trager approach in the treatment of chronic headache.
                Small-scale randomized controlled clinical trial.
                University-based clinic.
                Thirty-three volunteers with a self-reported history of chronic headache with at least one headache per week for at least 6 months.
                Medication only control group, medication and attention control group, and medication and Trager treatment group.
                Self-reported frequency, duration, and intensity of headache, medication usage and headache quality of life (HQOL) obtained at baseline and after a 6-week treatment period.
                Analyses of variance demonstrated significant improvement in HQOL for the Trager and attention control groups, and reduction in medication usage for the Trager group (P < 0.05). Within-group analyses revealed that participants randomized to Trager demonstrated a significant decrease in the frequency of headaches (P = 0.045), improvement in HQOL (P = 0.045), and a 44% decrease in medication usage (P = 0.03). Participants randomized to the attention control group demonstrated a significant improvement in HQOL (P = 0.035) and a 19% decrease in medication usage (P = 0.15). Participants randomized to the no-treatment control group revealed a significant increase in headache duration (P = 0.025) and intensity (P = 0.025), and a declination in HQOL (P = 0.035).
                The Trager approach decreased headache frequency and medication usage. Trager and physician attention improved HQOL. A larger, multi-site study is recommended. An important parallel exists between patients with seasonal affective disorder and institutionalized older adults. Many older patients, as a result of global physical decline and immobility, are confined to their rooms, experiencing little natural sunlight. Thus, institutionalized older adults are at risk for chronic light deprivation. Testing the hypothesis that chronic light deprivation might be responsible, at least in part, for some depression among institutionalized older adults, the aim of this study was to investigate the efficacy of morning bright light treatment on depression among older adults residing in a long-term care facility.
                In a placebo controlled, crossover design, participants (N = 10, six women and four men; M age = 83.8) received each of the following: (i) 1 week (5 days) of 10,000 lux (therapeutic dose); (ii) 1 week (5 days) of 300 lux (placebo); or 1 week of no treatment (control). Each week of light treatment was 5 consecutive days, 30 minutes daily, with a wash-out period consisting of 1 week between conditions.
                Geriatric Depression Scale (GDS) scores at baseline during all treatment conditions were positively correlated (r = .81, p < .01) with months of institutionalization, where participants with higher GDS scores experienced more time institutionalized. Scores on the GDS remained unchanged during the placebo and control conditions, but depression scores decreased significantly during the 10,000 lux treatment (pretest GDS M = 15 vs posttest GDS M = 11, p < .01). After the 10,000 lux treatment, 50% of the participants no longer scored in the depressed range. Improvement during the 10,000 lux condition was positively correlated (r = .62, p < .05) to baseline GDS scores, where participants with higher GDS scores experienced greater improvement following the 10,000 lux treatment.
                The results of the present study suggest that bright light treatment may be effective among institutionalized older adults, providing nonpharmacological intervention in the treatment of depression. Furthermore, the length of institutionalization may play an important role in determining the efficacy of bright light treatment for older adults in the nursing-home setting. This study examined the effects of chiropractic adjustments of the thoracic spine (T1-T5) on blood pressure and state anxiety in 21 patients with elevated blood pressure. Subjects were randomly assigned to one of three treatment conditions: active treatment, placebo treatment, or no treatment control. The adjustments were performed by a mechanical chiropractic adjusting device. Dependent measures obtained pre- and post-treatment included systolic and diastolic blood pressure, and state anxiety. Results indicated that systolic and diastolic blood pressure decreased significantly in the active treatment condition, whereas no significant changes occurred in the placebo and control conditions. State anxiety significantly decreased in the active and control conditions. Results provide support for the hypothesis that blood pressure is reduced following chiropractic treatment. Further study is needed to examine the long-term effects of chiropractic treatment on blood pressure. A controlled trial was undertaken to compare the efficacy of transcutaneous electrical nerve stimulation (TENS) with standard intramuscular opiate analgesia in the management of postoperative pain following appendicectomy. Consecutive patients undergoing emergency appendicectomy were randomised into control, sham TENS and active TENS groups. There was a significant decrease in pain severity and analgesic intake in both active and sham TENS groups when compared with the control group (P less than 0.01). No difference was demonstrated in pain severity between active and sham TENS groups but the active TENS group required slightly less analgesia. These results suggest that the major benefit of TENS in the postappendicectomy patient is due to its 'placebo effect' and its use in this situation cannot be recommended. High-dose chemotherapy poses considerable challenges to emesis management. Although prior studies suggest that acupuncture may reduce nausea and emesis, it is unclear whether such benefit comes from the nonspecific effects of attention and clinician-patient interaction.
                To compare the effectiveness of electroacupuncture vs minimal needling and mock electrical stimulation or antiemetic medications alone in controlling emesis among patients undergoing a highly emetogenic chemotherapy regimen.
                Three-arm, parallel-group, randomized controlled trial conducted from March 1996 to December 1997, with a 5-day study period and a 9-day follow-up.
                Oncology center at a university medical center.
                One hundred four women (mean age, 46 years) with high-risk breast cancer.
                Patients were randomly assigned to receive low-frequency electroacupuncture at classic antiemetic acupuncture points once daily for 5 days (n = 37); minimal needling at control points with mock electrostimulation on the same schedule (n = 33); or no adjunct needling (n = 34). All patients received concurrent triple antiemetic pharmacotherapy and high-dose chemotherapy (cyclophosphamide, cisplatin, and carmustine).
                Total number of emesis episodes occurring during the 5-day study period and the proportion of emesis-free days, compared among the 3 groups.
                The number of emesis episodes occurring during the 5 days was lower for patients receiving electroacupuncture compared with those receiving minimal needling or pharmacotherapy alone (median number of episodes, 5, 10, and 15, respectively; P<.001). The electroacupuncture group had fewer episodes of emesis than the minimal needling group (P<.001), whereas the minimal needling group had fewer episodes of emesis than the antiemetic pharmacotherapy alone group (P =.01). The differences among groups were not significant during the 9-day follow-up period (P =.18).
                In this study of patients with breast cancer receiving high-dose chemotherapy, adjunct electroacupuncture was more effective in controlling emesis than minimal needling or antiemetic pharmacotherapy alone, although the observed effect had limited duration. JAMA. 2000;284:2755-2761. To assess and compare the analgesic effects of orally administered glucose and sucrose and pacifiers. To determine the synergistic analgesic effect of sucrose and pacifiers.
                Randomised prospective study with validated behavioural acute pain rating scale.
                Maternity ward.
                150 term newborns undergoing venepuncture randomly assigned to one of six treatment groups: no treatment; placebo (2 ml sterile water); 2 ml 30% glucose; 2 ml 30% sucrose; a pacifier; and 2 ml 30% sucrose followed by a pacifier.
                Median (interquartile) pain scores during venepuncture were 7 (5-10) for no treatment; 7 (6-10) for placebo (sterile water); 5 (3-7) for 30% glucose; 5 (2-8) for 30% sucrose; 2 (1-4) for pacifier; and 1 (1-2) for 30% sucrose plus pacifier. Mann-Whitney U test P values for comparisons of 30% glucose, 30% sucrose, pacifier, and 30% sucrose plus pacifier versus placebo (sterile water) were 0.005, 0.01, <0.0001, and <0.0001, respectively. Differences between group median pain scores for these comparisons were 2 (95% confidence interval 1 to 4), 2 (0 to 4), 5 (4 to 7), and 6 (5 to 8), respectively. P values for comparisons of 30% glucose, 30% sucrose, and 30% sucrose plus pacifier versus pacifier were 0.0001, 0.001, and 0.06, respectively. Differences between group medians for these comparisons were 3 (2 to 5), 3 (1 to 5), and 1 (0 to 2), respectively.
                The analgesic effects of concentrated sucrose and glucose and pacifiers are clinically apparent in newborns, pacifiers being more effective than sweet solutions. The association of sucrose and pacifier showed a trend towards lower scores compared with pacifiers alone. These simple and safe interventions should be widely used for minor procedures in neonates. Despite the popularity of acupuncture, evidence of its efficacy for reducing pain remains equivocal.
                To assess the efficacy and safety of traditional Chinese acupuncture (TCA) compared with sham acupuncture (needling at defined nonacupuncture points) and conservative therapy in patients with chronic pain due to osteoarthritis of the knee.
                Randomized, controlled trial.
                315 primary care practices staffed by 320 practitioners with at least 2 years' experience in acupuncture.
                1007 patients who had had chronic pain for at least 6 months due to osteoarthritis of the knee (American College of Rheumatology [ACR] criteria and Kellgren-Lawrence score of 2 or 3). Interventions: Up to 6 physiotherapy sessions and as-needed anti-inflammatory drugs plus 10 sessions of TCA, 10 sessions of sham acupuncture, or 10 physician visits within 6 weeks. Patients could request up to 5 additional sessions or visits if the initial treatment was viewed as being partially successful.
                Success rate, as defined by at least 36% improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 26 weeks. Additional end points were WOMAC score and global patient assessment.
                Success rates were 53.1% for TCA, 51.0% for sham acupuncture, and 29.1% for conservative therapy. Acupuncture groups had higher success rates than conservative therapy groups (relative risk for TCA compared with conservative therapy, 1.75 [95% CI, 1.43 to 2.13]; relative risk for sham acupuncture compared with conservative therapy, 1.73 [CI, 1.42 to 2.11]). There was no difference between TCA and sham acupuncture (relative risk, 1.01 [CI, 0.87 to 1.17]).
                There was no blinding between acupuncture and traditional therapy and no monitoring of acupuncture compliance with study protocol. In general, practitioner-patient contacts were less intense in the conservative therapy group than in the TCA and sham acupuncture groups.
                Compared with physiotherapy and as-needed anti-inflammatory drugs, addition of either TCA or sham acupuncture led to greater improvement in WOMAC score at 26 weeks. No statistically significant difference was observed between TCA and sham acupuncture, suggesting that the observed differences could be due to placebo effects, differences in intensity of provider contact, or a physiologic effect of needling regardless of whether it is done according to TCA principles. Prospective, experimental, randomized, single-factor, pretest/posttest design.
                To examine the effects of a calcaneal and Achilles-tendon-taping technique, utilizing only 4 pieces of tape and not involving the medial arch, on the symptoms of plantar heel pain.
                Plantar fasciitis is one of the most common causes of heel and foot pain. Physical therapists have applied many techniques in an attempt to relieve the symptoms of plantar heel pain, including various taping methods for which there is little existing evidence.
                Subjects (n=41) were randomly assigned into 4 groups: (1) stretching of the plantar fascia, (2) calcaneal taping, (3) control (no treatment), and (4) sham taping. A visual analog scale (VAS) for pain and a patient-specific functional scale (PSFS) for functional activities were measured pretreatment and after 1 week of treatment (posttreatment).
                A significant difference was found posttreatment among the groups for the VAS (P < .001). Specifically, significant differences were found between stretching and calcaneal taping (mean + SD, 4.6 +/- 0.7 versus 2.7 +/- 1.8; P = .006), stretching and control (mean +/- SD, 4.6 +/- 0.7 versus 6.2 +/- 1.0; P = .026), calcaneal taping and control (mean +/- SD, 2.7 +/- 1.8 versus 6.2 +/- 1.0; P < .001), and calcaneal taping and sham taping (mean +/- SD, 2.7 +/- 1.8 versus 6.0 +/- 0.9; P < .001). No significant difference among groups was found for posttreatment PSFS (P = .078).
                Calcaneal taping was shown to be a more effective tool for the relief of plantar heel pain than stretching, sham taping, or no treatment. The purpose of this study was to evaluate pain scores and plasma beta-endorphin levels following a single spinal adjustive manipulation in subjects with acute low back pain. Eighteen subjects were randomly assigned to either a control group, which received no treatment; a sham group, which received only light physical contact (touch); or an experimental group, which received an adjustive manipulation at a specific lumbar segment. Following a standard protocol, all subjects were administered visual analog pain scales and venous blood was drawn 5 min prior to, 5 min after, and 30 min after intervention. Analysis of the pain scores indicated that there was a slight, but significant, reduction of pain in the experimental group, but no similar reduction in the control or sham groups. Furthermore, this reduction of pain in the experimental group was not accompanied any significant change in the plasma beta-endorphin concentration. Acupuncture is widely used to prevent migraine attacks, but the available evidence of its benefit is scarce.
                To investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine.
                Three-group, randomized, controlled trial (April 2002-January 2003) involving 302 patients (88% women), mean (SD) age of 43 (11) years, with migraine headaches, based on International Headache Society criteria. Patients were treated at 18 outpatient centers in Germany.
                Acupuncture, sham acupuncture, or waiting list control. Acupuncture and sham acupuncture were administered by specialized physicians and consisted of 12 sessions per patient over 8 weeks. Patients completed headache diaries from 4 weeks before to 12 weeks after randomization and from week 21 to 24 after randomization.
                Difference in headache days of moderate or severe intensity between the 4 weeks before and weeks 9 to 12 after randomization.
                Between baseline and weeks 9 to 12, the mean (SD) number of days with headache of moderate or severe intensity decreased by 2.2 (2.7) days from a baseline of 5.2 (2.5) days in the acupuncture group compared with a decrease to 2.2 (2.7) days from a baseline of 5.0 (2.4) days in the sham acupuncture group, and by 0.8 (2.0) days from a baseline if 5.4 (3.0) days in the waiting list group. No difference was detected between the acupuncture and the sham acupuncture groups (0.0 days, 95% confidence interval, -0.7 to 0.7 days; P = .96) while there was a difference between the acupuncture group compared with the waiting list group (1.4 days; 95% confidence interval; 0.8-2.1 days; P<.001). The proportion of responders (reduction in headache days by at least 50%) was 51% in the acupuncture group, 53% in the sham acupuncture group, and 15% in the waiting list group.
                Acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were more effective than a waiting list control. Breathlessness is a common and difficult symptom to treat in patients with cancer. Case reports suggest that nebulised furosemide can relieve breathlessness in such patients but few data are available.
                Patients with primary or secondary lung cancer and a Dyspnoea Exertion Scale score of >or=3 were recruited. Following familiarisation, patients received either nebulised furosemide 40 mg or nebulised 0.9% saline under double blind conditions or no treatment, in random order on 3 consecutive days. Patients undertook number reading and arm exercise tests to assess breathlessness and its impact, and were asked to report subjective benefit and any preference between nebulised treatments.
                15 patients took part. There were no differences between furosemide, saline and no treatment in the outcomes of the number reading test (eg, mean number read per breath was 6.7, 6.4 and 6.7, respectively) or arm exercise test (eg, mean Borg score at maximum equivalent workload was 2.3, 2.5 and 2.7, respectively). No adverse effects were reported, although there was a small fall in forced expiratory volume in 1 s and forced vital capacity following saline. Six patients considered that their breathlessness improved with nebulised treatment, three preferring saline, one furosemide and two reporting they were of equal benefit.
                Our findings do not support a beneficial effect from nebulised furosemide in patients with cancer related breathlessness. Listed on the National Research Register (N0170118249) and the UK Clinical Research Network Portfolio Database (1428). Untreated pain during the transportation of patients after minor trauma is a common problem in emergency medicine. Because paramedics usually are not allowed to perform invasive procedures or to give drugs for pain treatment, a noninvasive, nondrug-based method would be helpful. Acupressure is a traditional Chinese treatment for pain that is based on pain relief followed by a short mechanical stimulation of specific points. Consequently, we tested the hypothesis that effective pain therapy is possible by paramedics who are trained in acupressure. In a double-blinded trial we included 60 trauma patients. We randomly assigned them into three groups ("true points," "sham-points," and "no acupressure"). An independent observer, blinded to the treatment assignment, recorded vital variables and visual analog scales for pain and anxiety before and after treatment. At the end of transport, we asked for ratings of overall satisfaction. For statistical evaluation, one-way analysis of variance and the Scheffé F test were used. P < 0.05 was considered statistically significant. Morphometric and demographic data and potential confounding factors such as age, sex, pain, anxiety, blood pressure, and heart rate before treatment did not differ among the groups. At the end of transport we found significantly less pain, anxiety, and heart rate and a greater satisfaction in the "true points" groups (P < 0.01). Our results show that acupressure is an effective and simple-to-learn treatment of pain in emergency trauma care and leads to an improvement of the quality of care in emergency transport. We suggest that this technique is easy to learn and risk free and may improve paramedic-based rescue systems.
                We tested, in a double-blinded manner, the hypothesis that acupressure could be an effective pain therapy in minor-trauma patients. Our results show that acupressure is an effective and simple-to-learn treatment of pain in emergency medical care and can improve the quality of care. In a prospective, double-blind study, we examined the effects of routine sedation and pharyngeal anesthesia on cardiorespiratory parameters during gastroscopy.
                Intravenous sedation and topical pharyngeal anesthesia are used to alleviate the discomfort during upper gastrointestinal endoscopy. Cardiorespiratory changes during gastroscopy are common.
                Two hundred fifty two consecutive outpatients undergoing gastroscopy were assigned into 4 groups: (1) sedation with intravenous midazolam and placebo throat spray (midazolam group), (2) placebo sedation and pharyngeal anesthesia with lidocaine throat spray (lidocaine group), (3) placebo sedation and placebo throat spray (placebo group), and (4) no intravenous cannula nor throat spray (control group). Arterial oxygen saturation (SaO2), systolic and diastolic blood pressure and continuous electrocardiogram were recorded before, during, and after the endoscopic procedure.
                Gastroscopy increased heart rate in all study groups. Premedication with intravenous midazolam or lidocaine spray alleviated this rise (P<0.001, repeated measures analysis of variance) and decreased the incidence of tachycardia. Similarly, sedation with midazolam or topical pharyngeal anesthesia decreased the rise in systolic blood pressure (P<0.001). Midazolam produced lower SaO2 values during gastroscopy compared with lidocaine, placebo or control groups (P<0.001). However, episodes of desaturation (SaO2 </=92) were no more common in the midazolam group than in other groups.
                Premedication with midazolam alleviated the rise in heart rate and systolic blood pressure but induced a statistically significant decrease in arterial oxygen saturation. However, gastroscopy proved to be a safe procedure both with and without sedation. Self-referred subjects (N = 227) thought to be at increased risk of developing diabetes who had fasting plasma glucose (FPG) values in the range of 5.5 to 7.7 mmol.L-1 on two consecutive occasions 2 weeks apart were randomized to sulfonylurea therapy (gliclazide, < or = 160 mg.d-1) or to a control group allocated either to double-blind placebo or to no tablets. Subjects were randomly allocated also to reinforced or basic healthy-living advice in a factorial design. A total of 201 subjects have been evaluated for 1 year in three English and two French hospital outpatient centers. Those allocated to sulfonylurea had a significant (P < .001) reduction in median FPG compared with the control group (6.0 mmol.L-1 to 5.6 mmol.L-1, P < .001, v 6.0 mmol.L-1 to 6.0 mmol.L-1, NS). Median hemoglobin A1c (HbA1c) also improved (P < .0002; 5.8% to 5.6%, P < .001, v 5.7% to 5.6%, NS), as did mean beta-cell function (62% to 70%, P < .01, v 62% to 61%, NS). Mean body weight was unchanged in subjects allocated to sulfonylurea (81.7 kg to 82.4 kg, NS), but decreased in the control group (81.6 kg to 80.4 kg, P < .01). More subjects in the sulfonylurea group versus the control group reported one or more minor symptoms of hypoglycemia over 1 year (50% v 24%, P < .0001). Only two subjects reported major hypoglycemic episodes requiring assistance, both of whom were taking sulfonylurea. Insulin sensitivity did not change between groups. Sulfonylurea therapy with gliclazide improved glycemic control and beta-cell function significantly in subjects with increased but not diabetic FPG levels. The study is being extended to determine whether sulfonylurea therapy prevents progression to non-insulin-dependent diabetes mellitus (NIDDM). To evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) for its effectiveness in eliminating or minimizing discomfort during office-based flexible cystoscopy.
                A total of 148 patients were prospectively randomized into one of three groups: flexible cystoscopy with no analgesics, a placebo TENS, or an activated TENS. The patient data collected included patient parameters, number of previous flexible cystoscopies, visual analog pain scores during and after the procedure, surgeon's difficulty rating of procedure, and International Prostate Symptom Score before and 24 hours after the procedure.
                No statistically significant difference was found among the three groups regarding patient parameters. The visual analog pain scores were similar before and after the procedure. At 30 seconds, the mean visual analog scale score for the control group, placebo group, and TENS study group was 3.73, 3.65, and 3.52, respectively (control versus placebo, control versus active, and placebo versus active: P = 0.97, 0.29, and 0.53, respectively). At 1 and 5 minutes, the corresponding scores were 3.44, 4.37, and 3.50 (P = 0.88, P = 0.99, and P = 0.99) and 0.86, 1.23, and 0.88 (P = 0.97, P = 0.35, and P = 0.56), respectively. The surgeon's mean difficulty rating for the control procedures was 1.08 and for the placebo group was 2.30 (P = 0.02).
                All patients undergoing flexible cystoscopy in the office setting experienced discomfort. The TENS device provided no significant benefit for pain. The trend toward greater pain scores in the control group could be attributed to the greater degree of difficulty. To examine the potential role for a placebo cream in reducing reported needle pain severity in children, and the impact of age-related factors on pain self-report, a convenience sample of 117 children scheduled for venipuncture were randomly assigned to one of three treatments: (a) placebo cream with the suggestion that it might help reduce needle pain, (b) placebo cream with no indication as to the cream's purpose, and (c) no cream (control group). In allocation to treatment, children were stratified by age group, (3-7, 8-11, 12-17 years). They rated their needle pain severity (both predicted and reported) using the Faces Pain Scale, and rated their anxiety about the procedure using the Children's Anxiety and Pain Scale. Children in the cream groups were also asked whether they thought the cream had helped. Using video-tapes, an independent observer, blind to the placebo manipulation, rated each child's reaction to the needle. For the two groups receiving cream, 83% of those children told it might help stated that they believed it did, as compared with only 33% of children who received the cream but were told nothing of its purpose. These beliefs, however, were not reflected in self-report ratings of pain which showed no statistically significant treatment effect. Similarly, children who gave higher preprocedural anxiety ratings were no more likely to report less pain as a result of receiving the cream. There was, however, a treatment effect on the observer's ratings: children receiving cream plus suggestion were assigned significantly lower ratings of pain-related behaviour than those children who received the cream alone. While venipuncture was associated with only mild levels of pain, younger children, irrespective of treatment group, did report more pain than older children. Hierarchical regression analysis indicated that 60% of the variance in self-reported pain severity scores could be accounted for by how much the child thought the needle would hurt, how anxious the child was about receiving the needle, gender (higher pain ratings associated with girls), and estimated body surface area (higher pain ratings associated with smaller bodies). We conclude that the efficacy of placebo treatments for needle pain in children may depend on the suggestion of a possible benefit rather than upon treatment application per se. The effects of two homeopathic preparations, Opium and Raphanus, given in dilutions of 10(30) (15 HC) and 10(10) (5 HC) respectively, on the resumption of intestinal peristalsis after operations on the digestive tract were evaluated in a controlled, double-blind therapeutic trial involving patients from 12 hospitals. The patients were allocated at random into 4 groups of 150 each: 1 untreated group and 3 groups who received either Opium and Raphanus, or Opium and the placebo of Raphanus or the placebos of the two products. The results were assessed on the time elapsed between closure of the abdominal wall and the first faeces and (accessorily) the first bowel sounds and passing of flatus per rectum. Pre-operative and operative features were similar in all 4 groups. There was no significant difference in the effects of treatment between the groups, even when such predictive factors as type and duration of surgery and age were taken into account. It is concluded that the trial failed to demonstrate any effect of Opium or Raphanus on the resumption of intestinal peristalsis after digestive tract surgery. Nor did it confirm the activity of ultra-molecular dilutions claimed for this type of drugs. Sedating children safely and effectively for minor laceration repair is a well-recognized clinical problem. A randomized, double-blind, and controlled study was conducted to evaluate the efficacy of intranasal midazolam for reducing stress during the suturing of lacerations in preschool children. Fifty-nine children with simple lacerations that required suturing were randomly assigned to one of three groups. Group 1 received intranasal midazolam, 0.4 mg/kg, prior to suturing. Group 2 received an equivalent volume of normal saline intranasally prior to suturing as a placebo. Group 3 was the control group and received no intervention prior to suturing. Heart rate, respiratory rate, blood pressure, and pulse oximetry were monitored at 5-minute intervals throughout the procedure. Subjective variables were also measured at 5-minute intervals and included a cry score, a motion score, and a struggle score. Parent satisfaction was measured via a short telephone interview the following day. There were no significant differences in outcome between the placebo group and the control group. Their results were pooled and compared with the results for the midazolam group. The midazolam group showed significant reductions for mean heart rate, maximum heart rate, and maximum systolic blood pressure when compared with the placebo/control group. Scores for two of the three subjective variables, cry and struggle, were significantly reduced for the midazolam group. The papoose board was considered unnecessary in retrospect for more than half of patients in the midazolam group compared with only one fifth of patients in the placebo/control group.(ABSTRACT TRUNCATED AT 250 WORDS) The present study describes a 16-week trial of the use of a combination of biofeedback and relaxation techniques for the treatment of hypertension. Twenty-two hypertensive patients were randomly allocated to one of three groups: (1) diastolic blood pressure feedback, electromyographic feedback, and verbal relaxation; (2) sham blood pressure feedback; and (3) no treatment. For the 14 patients completing active treatment during an initial or crossover period, the average changes in blood pressure as measured outside the laboratory were minimal (0/-1 and +1/0 mm Hg, supine and standing, respectively). Average blood pressure reduction in the laboratory was no greater with active than with sham blood pressure feedback (-3/-2 vs. -5/-2 mm Hg). One subject, however, after showing no change in blood pressure during sham feedback, achieved pronounced and prolonged improvement following active treatment. Overall results do not support the usefulness of these techniques as primary therapy in most hypertensives. Acupuncture has traditionally been used in China in the treatment of bronchial asthma and is being increasingly applied in Western countries. Although there are many published studies on acupuncture and asthma, few meet the scientific criteria necessary to prove the effectiveness of acupuncture.
                To examine the short- and long-term effects of real versus sham or no acupuncture in patients with bronchial asthma.
                Randomized partially blinded study with three parallel groups.
                Sixty-six (66) patients of both genders (mean age, 39 years) with mild-to-moderate persistent bronchial asthma.
                After 2 weeks of run-in, the patients with asthma were randomized to receive either real (23 patients) or sham acupuncture (23 patients) or no acupuncture (20 patients). Two acupuncture periods (each 4 weeks) within the first 4 months were followed by a 6-month observation.
                Primary outcome was the change of peak expiratory flow (PEF) variability at the end of the two treatment periods. Secondary outcomes were changes in forced expiratory volume in 1 second (FEV1), airway responsiveness, symptoms of asthma, the use of asthma drugs, and patients' well-being. Moreover, the effect of the intervention on eosinophils and eosinophil cationic protein (ECP) in blood and sputum was assessed.
                PEF variability decreased in all groups. In a subgroup of patients whose asthma medication remained fairly unchanged, PEF variability decreased significantly after needling of real as well as sham points at month 4 and 5 compared to controls (p < or = 0.005). However, there was no difference in the decrease of PEF variability between patients who had the blinded treatment with real or sham acupuncture. Most of the other functional and clinical variables did not differ from those obtained in controls. Eosinophils and ECP in blood and sputum decreased in all groups, but the only significant differences were found in blood eosinophil count at 4 months between sham acupuncture and the control group (p < 0.05) and at 10 months between real and sham acupuncture (p < 0.05) suggesting a possible effect on eosinophilic inflammation.
                In view of the fact that the effects after real and sham acupuncture compared to controls who had no needling at all were small, in all likelihood clinically irrelevant, our data do not seem to support the use of acupuncture in the management of pharmacologically well-treated patients with mild-to-moderate persistent asthma. Temazepam 20 mg (n = 18), midazolam 15 mg (n = 14), placebo (n = 15) or no medication (n = 20) were given orally as pre-operative hypnotic in healthy patients operated on under spinal analgesia. The quality of the pre-operative night's sleep assessed subjectively was significantly better in patients receiving temazepam (P = < 0.05) and midazolam (P = < 0.05) compared with those receiving no drug. The concentrations of cortisol and monoamine neurotransmitters or their metabolites in cerebrospinal fluid were of no value in monitoring the quality of the pre-operative night's sleep. To test effectiveness of static magnetic fields of two different configurations, produced by magnetic sleep pads, as adjunctive therapies in decreasing patient pain perception and improving functional status in individuals with fibromyalgia.
                Randomized, placebo-controlled, 6-month trial conducted from November 1997 through December 1998.
                Adults who met the 1990 American College of Rheumatology criteria for fibromyalgia were recruited through clinical referral and media announcements and evaluated at a university-based clinic.
                Subjects in Functional Pad A group used a pad for 6 months that provided whole-body exposure to a low, uniform static magnetic field of negative polarity. Subjects in the Functional Pad B group used a pad for 6 months that exposed them to a low static magnetic field that varied spatially and in polarity. Subjects in two Sham groups used pads that were identical in appearance and texture to the functional pads but contained inactive magnets; these groups were combined for analysis. Subjects in the Usual Care group continued with their established treatment regimens.
                Primary outcomes were the change scores at 6 months in the following measures: functional status (Fibromyalgia Impact Questionnaire), pain intensity ratings, tender point count, and a tender point pain intensity score.
                There was a significant difference among groups in pain intensity ratings (p = 0.03), with Functional Pad A group showing the greatest reduction from baseline at 6 months. All four groups showed a decline in number of tender points, but differences among the groups were not significant (p = 0.72). The functional pad groups showed the largest decline in total tender point pain intensity, but overall differences were not significant (p = 0.25). Improvement in functional status was greatest in the functional pad groups, but differences among groups were not significant (p = 0.23).
                Although the functional pad groups showed improvements in functional status, pain intensity level, tender point count, and tender point intensity after 6 months of treatment, with the exception of pain intensity level these improvements did not differ significantly from changes in the Sham group or in the Usual Care group. It has been reported that administration of prophylactic penicillin may prevent flare-ups or other undesirable posttreatment sequelae following root canal treatment. To test this hypothesis in a prospective study, 80 patients with a diagnosis of pulp necrosis and chronic apical periodontitis were divided into three groups: group A (prophylactic penicillin, AHA recommendation), group B (placebo, same regimen), and group C (no medication). Medications and evaluations were double-blinded. Patients reported their posttreatment events including incidence of flare-ups, incidence and severity of pain/swelling, and occurrence of adverse side effects. Differences in the three groups were determined statistically using chi-square tests. The outcome showed no significant difference (p = 0.68) among the three groups. That is, administration/nonadministration of penicillin prophylactically was unrelated to posttreatment signs and symptoms following canal preparation. Incidence of flare-ups was very low (1 of 80). Occurrence of pain in the mild-moderate levels was fairly high (approximately 70% overall), but was primarily in the mild category. Overall incidence of side effects was also very low (2 of 80). Severe levels of pain/swelling and flare-up incidence were low with no difference between administration or nonadministration of antibiotics. Based on our data, using penicillin (a potentially dangerous drug) prophylactically to control posttreatment symptoms is not recommended in cases of pulp necrosis and asymptomatic periapical pathosis. Twenty of sixty volunteers for smoking cessation were assigned to single-session hypnosis, 20 to a placebo control condition, and 20 to a no-treatment control condition. The single-session hypnosis group smoked significantly less cigarettes and were significantly more abstinent than a placebo control group and a no treatment control group at posttest, and 4-week, 12-week, 24-week and 48-week follow-ups. The involvement of the microcirculation in diabetic microangiopathy (DM) causes of severe incapacitation and ulceration. DM is characterized by a diffuse increase in flux, reduction in venoarteriolar response, associated with increased permeability resulting in edema and altered function of microlymphatics. In DM, skin PO2 is decreased and CO2 increased. In this condition capillary exchanges are altered and nutritional alterations eventually lead to skin lesions and ulcers. The aim of this randomized, placebo-controlled study was to evaluate the effect of local (foot) treatment with Essaven gel (EG) in 35 subjects with DM and neuropathy and localized, small (< 0.5 cm in maximum diameter) ulcers treated for 2 weeks. Measurements of laser Doppler (LDF) flux, PO2, and PCO2 in standardized conditions showed positive microcirculatory changes (a significant decrease of the abnormally increased flux and CO2 while PO2 increased) in the active EG group. Changes in the control group were not significant. In the placebo group variations were limited (mainly associated with skin manipulation and gel application). In conclusion, local treatment for 2 weeks with standardized application of EG acutely improves the microcirculation in subjects with DM and small ulceration. Protocol was carried out on 98 patients who were divided into three groups selected as (one control group, two "placebo" group, and three treated with acupuncture). This protocol showed that it was possible to improve cervical maturation if acupuncture sessions were carried out at the beginning of the 9th month. The Bishop scores in the three groups after 10 days interval show that there was a significant progression of 2.61 points in the group treated with acupuncture as against only 0.89 and 1.08 in the placebo and control groups. A cognitive remediation intervention was tested for its effect on functional outcomes of older care recipients with the diagnosis of dementia of the Alzheimer's type. The 78 community-dwelling care recipients were assessed on cognitive and behavioral functioning and randomly assigned to one of three conditions. Care recipients were expected to benefit most from active cognitive stimulation training as compared to placebo (passive) activity or wait-list control conditions. Following each weekly instruction session, the intervention was executed in the home by the family caregiver. Care recipients in the experimental group improved in cognitive and behavioral performance with treatment, but returned to former level of functioning by the 9th month. In contrast, the control group declined, while the placebo group remained static on these variables. These findings support the viability of remediation interventions in dementia despite the trajectory of cognitive decline. The objectives of the Cost Effectiveness of Lipid Lowering (CELL) study were twofold: (i) to evaluate the effect on overall cardiovascular risk of two types of health care advice ("usual' and "intensive') given in primary care, with or without pharmacological medication, with the target being to attain a moderate decrease in cholesterol; (ii) to evaluate the ritual of daily medication on compliance with the health care advice.
                A prospective, double-blind, randomized, controlled trial of 18 months' duration.
                The study was carried out in 32 health centres (out of a total of approximately 850) in Sweden.
                In all, 681 subjects, aged 30-59 years, were randomized. They had at least two cardiovascular risk factors in addition to moderate primary hyperlipidaemia (total cholesterol of at least 6.50 mmol L-1 on three occasions measured by Reflotron triglycerides less than 4.0 mmol L-1 and an LDL:HDL cholesterol ratio of more than 4.0). Most (87%) of the subjects were males; 626 subjects (92%) completed the 18-month follow-up.
                Half the subjects were randomized to 'intensive advice' given in group sessions led by doctors and nurses in primary care. The other half received 'usual advice'. In each of the two advice groups, one-third received an active lipid-lowering drug (pravastatin), one-third placebo, and one-third no drug at all. The tablets were titrated to achieve a 15% reduction in cholesterol.
                Changes in the overall Framingham risk score, and the development of adverse events in each group.
                The change in Framingham risk score was significantly reduced only in subjects taking lipid-lowering medication (together with intensive advice -0.13; 95% CI-0.20, -0.06, and together with usual advice -0.16; 95% CI -0.23, -0.09). The other subjects receiving intensive advice tended to fare better than those on usual advice. Lifestyle was not influenced significantly over the study period. The ritual of daily medication did not affect the outcome.
                As expected, lipid-lowering medication reduced serum cholesterol as well as overall cardiovascular risk in subjects with several risk factors for cardiovascular disease. There was no additive effect of intensive advice to these subjects. However, there was a meagre but significant effect of intensive advice in subjects not receiving active lipid-lowering drugs. One explanation for this difference may be that those on active lipid-lowering medication who had substantial drops in cholesterol might have felt less inclined to change their lifestyle compared with those on other treatment regimens who had less successful drops in cholesterol. There was no benefit from the ritual of taking daily medication. nan The effect of guar gum (15 g/day) on serum lipids and body weight of middle-aged hypercholesterolemic females was studied in a double-blind controlled trial. No consistent changes were observed in serum cholesterol, triglycerides or HDL cholesterol in patients taking guar gum, placebo or no medication at all. A highly significant decrease in body weight (62.9 +/- 2.1 vs. 60.4 +/- 2.2 kg, p < 0.0005, paired comparison) was seen in subjects receiving guar gum, whereas body weight remained constant in the other two groups. It is concluded that the daily ingestion of 15 g of guar gum results in a permanent weight loss, but does not influence serum lipids in females with hypercholesterolemia. Meditation training appears to be a promising psychological approach to the control of hypertension. However, most studies to date have had serious deficiencies. This study attempted to correct many of these deficiencies. Forty-one unmedicated hypertensives referred by general practitioners were randomly allocated to three groups. The treatment group (SRELAX) underwent training procedures based on Transcendental Meditation; a placebo control group (NSRELAX) underwent identical training but withou a mantra. Both procedures were compared with a no-treatment control group. The results showed modest reductions in blood pressure in both SRELAX and NSRELAX groups, compared with the no-treatment controls, with diastolic percentage reductions reaching significance (p < 0.05). There was considerable subject variation in response, with overall a mean decline i diastolic blood presure of 8-10% on 3-month follow-up. Possible indicators to predict the response of subjects are considered and reasons for the similarity in the effectiveness of the SRELAX and NSRELAX conditions are discussed. We undertook a randomized, double-blind, placebo-controlled study to investigate the therapeutic effect of vitamin B6 on carpal tunnel syndrome. After ten weeks in the study, ten of 15 patients improved (this included patients given placebo and those given no treatment). Vitamin B6 seems to have no advantage over conservative therapy for carpal tunnel syndrome. This study also suggests that repeat electrodiagnostic testing is no more useful than clinical symptoms in deciding on surgical intervention after unsuccessful conservative therapy. Postoperative pain control has received increasing attention by health care providers in the new millennium. In fact, pain was called the "sixth vital sign" by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) in 2001. The continued challenge of effective, safe analgesia in the outpatient setting has promoted the use of various devices designed to deliver local anesthetic directly to the surgical site. We endeavored to evaluate the efficacy of one such device currently in use.
                Prospective, randomized, placebo-controlled, double-blinded study.
                In this study, 49 consecutive patients were prospectively enrolled and randomly assigned to 1 of 3 groups after anterior cruciate ligament (ACL) reconstruction. Patients and investigators were blinded to group assignment. Group 1 (control group) received no catheter. Group 2 (placebo group) received an infusion catheter filled with saline. Group 3 (experimental group) received the same catheter filled with 0.25% bupivacaine solution. All patients received an ipsilateral femoral nerve block with 30 mL 0.25% bupivacaine and 20 mL 0.25% bupivacaine intra-articular injection. Patients recorded narcotic consumption and pain levels on visual analogue scales twice a day for 4 days after surgery. The catheters were removed on day 4 and physical therapy performance was recorded. The patients were then asked to continue to record pain ratings and medication consumption for an additional 4 days after catheter removal. All patients underwent bone-patellar tendon-bone ACL reconstruction by the senior author (P.D.F.). Seven patients were excluded from the study for ineffective femoral nerve block or catheter disconnection or occlusion. Narcotic consumption and the maximum, minimum, and median pain ratings were analyzed by analysis of variance.
                Median pain ratings show lower pain levels (P <.03) for both catheter groups versus the control group. No significant differences were found between the catheter groups for the median pain ratings, but lower maximum pain ratings were seen in the bupivacaine group compared with both placebo and no-catheter control subjects. Postoperative narcotic consumption was also lower in both catheter groups versus control subjects (P <.03). Physical therapy data revealed no difference in range of motion on postoperative day 4. More patients were able to perform straight leg raises during the first therapy session in both the saline placebo catheter group (70%) and bupivacaine group (72%) compared with the control group (50%).
                The data suggest some element of placebo benefit at median pain ratings but a protective effect of the bupivacaine at maximum pain levels. Women with orgasmic difficulties are commonly taught pubococcygeal (PC) muscle exercises which, practiced regularly, are said to have both specific and nonspecific beneficial effects on sexual enjoyment. The hypothesis tested was that women practicing these exercises over a 12-week period, would be more likely to become orgasmic than women practicing relaxation exercises, or than women in an attention-control group. Forty-six women were allocated to one of three groups, PC exercise, relaxation or control. PC muscle tone was measured and questionnaires about sexual response were completed over a 12-week period with a 6-month follow-up assessment. Results indicated that there was no difference in orgasmic outcome for the three groups during the experimental period. This was taken to imply that PC exercises are not of specific value for women with normal muscle tone. It remains possible that women with poor muscle tone are helped by the exercises and further research is considered necessary in this area. A prospective, randomized, controlled study was carried out to investigate the dilating and softening effect on the cervix of prostaglandin F2-alpha gel administered intracervically and of prostaglandin E2 tablets administered orally. A total of 581 patients were included in the study: 149 received 2.5 mg prostaglandin F2-alpha in gel form intracervically, 150 received 1 mg prostaglandin E2 in tablet form orally, 138 were given placebo gel and 144 no medication at all. In the group given prostaglandin F2-alpha gel intracervically, success was achieved in 85.8% of patients and partial success in 8.8%. In the group given prostaglandin E2 tablets orally, the results were successful in 29.4% and partially successful in 40.6%. The incidence of side effects in the group given prostaglandin F2-alpha gel was rather high - 53%. The results show that prostaglandin can bring about a certain softening of the cervix, but side effects cannot be ruled out. Nevertheless, priming of the cervix is to be recommended in young primigravidas.
We did not find that placebo interventions have important clinical effects in general. However, in certain settings placebo interventions can influence patient-reported outcomes, especially pain and nausea, though it is difficult to distinguish patient-reported effects of placebo from biased reporting. The effect on pain varied, even among trials with low risk of bias, from negligible to clinically important. Variations in the effect of placebo were partly explained by variations in how trials were conducted and how patients were informed.