Needle acupuncture in chronic poststroke leg spasticity. Validating a New Non-Penetrating Sham Acupuncture Device: Two Randomised Controlled Trials Patient characteristics for outpatient acupuncture in Beijing, China. The effect of real and sham acupuncture on thermal sensation and thermal pain thresholds. Effect of acupuncture compared with placebo-acupuncture at P6 as additional antiemetic prophylaxis in high-dose chemotherapy and autologous peripheral blood stem cell transplantation: a randomized controlled single-blind trial. Acupuncture in patients with osteoarthritis of the knee: a randomised trial Effectiveness of Acupuncture as Adjunctive Therapy in Osteoarthritis of the Knee Acupuncture in patients with tension-type headache: randomised controlled trial Electrical impedance along connective tissue planes associated with acupuncture meridians Patient reports of adverse events associated with acupuncture treatment: a prospective national survey Do certain countries produce only positive results? A systematic review of controlled trials. Survey of Adverse Events following Acupuncture (Safa): A Prospective Study of 32,000 Consultations Effects of acupuncture on heart rate variability in normal subjects under fatigue and non-fatigue state Acupuncture for patients with migraine: a randomized controlled trial. Psychophysical outcomes from a randomized pilot study of manual, electro, and sham acupuncture treatment on experimentally induced thermal pain. Functional MRI in healthy subjects during acupuncture: different effects of needle rotation in real and false acupoints Is Acupuncture Analgesia an Expectancy Effect? Needle Acupuncture in Tension-Type Headache: A Randomized, Placebo-Controlled Study Review of randomised controlled trials of traditional Chinese medicine Laser acupuncture induced specific cerebral cortical and subcortical activations in humans Increased placebo analgesia over time in irritable bowel syndrome (IBS) patients is associated with desire and expectation but not endogenous opioid mechanisms Acupuncture compared to placebo‐acupuncture for postoperative nausea and vomiting prophylaxis: A randomised placebo‐controlled patient and observer blind trial Introducing a placebo needle into acupuncture research The placebo needle, is it a valid and convincing placebo for use in acupuncture trials? A randomised, single-blind, cross-over pilot trial An internal standard for verifying the accuracy of serious adverse event reporting: the example of an acupuncture study of 190,924 patients. Role of the Needling per se in Acupuncture as Prophylaxis for Menstrually Related Migraine: A Randomized Placebo-Controlled Study Acupuncture in the treatment of alcohol withdrawal symptoms: a randomized, placebo‐controlled inpatient study A controlled trial of placebo versus real acupuncture. Placebo and Opioid Analgesia-- Imaging a Shared Neuronal Network Randomised clinical trial comparing the effects of acupuncture and a newly designed placebo needle in rotator cuff tendinitis
OBJECTIVE To determine whether needle acupuncture may be useful in the reduction of leg spasticity in a chronic state . DESIGN Single-blind , r and omized , placebo-controlled trial . SETTING Neurologic outpatient department of a medical school in Germany . PARTICIPANTS Twenty-five patients ( 14 women ) suffering from chronic poststroke leg spasticity with pes equinovarus deformity ( Modified Ashworth Scale [ MAS ] score , > /=1 ) , aged 38 to 77 years ( mean + /- st and ard deviation , 58.5+/-10.4 y ) , were enrolled in the study . The mean time from stroke to inclusion in the study was approximately 5 years ( mean , 65.4+/-48.3 mo ; range , 7 - 180 mo ) . INTERVENTIONS Participants were r and omly assigned to placebo treatment ( n=12 ) by using a specially design ed placebo needling procedure , or verum treatment ( n=13 ) . MAIN OUTCOME MEASURES MAS score of the affected ankle , pain ( visual analog scale ) , and walking speed . RESULTS There was no demonstrated beneficial clinical effects from verum acupuncture . After 4 weeks of treatment , mean MAS score was 3.3+/-0.9 in the placebo group versus 3.3+/-1.1 in the verum group . The neurophysiologic measure of H-reflex indicated a significant increase of spinal motoneuron excitability after verum acupuncture ( H-response/M-response ratio : placebo,.39+/-.19 ; verum,.68+/-.41 ; P<.05 ) . CONCLUSIONS This effect might be explained by afferent input of A delta and C fibers to the spinal motoneuron . The results from our study indicate that needle acupuncture may not be helpful to patients with chronic poststroke spasticity . However , there was neurophysiologic evidence for specific acupuncture effects on a spinal ( segmental ) level involving nociceptive reflex mechanisms For clinical trials of acupuncture , it would be desirable to have a sham procedure that is indistinguishable from the real treatment , yet inactive . A sham needle has been design ed which telescopes instead of penetrating the skin . The Park Sham Device involves an improved method of supporting the sham needle and requires validation . The objective of these studies was to test whether the sham procedure using the new device was 1 ) indistinguishable from the same procedure using real needles in acupuncture naïve subjects , and 2 ) inactive , where the specific needle sensation ( de qi ) is taken as a surrogate measure of activity . The studies were design ed as subject and assessor blind , r and omised controlled trials . Study 1 ) included 58 patients enrolled in a clinical trial of acupuncture for acute stroke . Study 2 ) included 63 healthy , acupuncture naïve , adult volunteers . The interventions used were real or sham acupuncture using the Park Sham Device . Study 1 ) was set in a district general hospital , and study 2 ) in a university laboratory . The outcome measure in study 1 ) was the form of treatment that patients believed they had received . In study 2 ) the outcome measure was experience of de qi , as judged by three acupuncture experts . No patient in either group ( study 1 ) believed he or she had been treated with the sham needle . In 40 volunteers ( study 2 ) for whom experts achieved consensus , the relative risk of experiencing de qi with real acupuncture to that with sham acupuncture was 15.38 ( 95 % CI 2.26 to 104.86 ) . The inter-rater reliability of all 13 experts ( study 2 ) , calculated from their judgements on 10 subjects selected by r and omisation , was 0.52 ( 95 % CI 0.19 to 0.61 ) . In conclusion , the results suggest that the procedure using the new device is indistinguishable from the same procedure using real needles in acupuncture naïve subjects , and is inactive , where the specific needle sensation ( de qi ) is taken as a surrogate measure of activity . It is therefore a valid control for acupuncture trials . The findings also lend support to the existence of de qi , a major concept underlying traditional Chinese acupuncture OBJECTIVES This study quantifies and compares patient characteristics in  outpatient acupuncture .  SETTING / DESIGN Prospect i ve primary source evidence was gathered at two prominent outpatient acupuncture clinics in Beijing , China ( n = 563 , n = 233 ) . RESULTS The most common condition was Bell 's palsy , which represented 20.6 % and 25.3 % of total cases at the two clinics , respectively . The second most common condition was cerebrovascular accident ( CVA ) rehabilitation . These treatments represented 11.9 % and 12.0 % of treatments at the two clinics , respectively . Other trends at the clinics included the following : ( 1 ) neurologic complaints predominated ; ( 2 ) doctors see a large number of patients per day ; ( 3 ) the majority of patients overall were female ; while ( 4 ) the majority of patients treated for CVAs rehabilitation were male . As cultural and socioeconomic differences in perceptions of acupuncture exist between peoples of different countries , this study also compared patient  main complaints in China to available data on  acupuncture patients seen in other parts of China , Germany , the United Kingdom , Australia , and the United States . Except for the German clinic data , Western clinic acupuncturists saw more musculoskeletal complaints compared to China , where neurologic complaints predominated . Another significant difference between Asian and Western clinics was the number of patients seen per hour . While acupuncturists were reported to see 1.2 patients per hour in U. S. clinics , acupuncturists at the two Beijing , China , clinics saw 7.0 and 10.4 patients per hour , respectively . CONCLUSION The main complaints seen in acupuncture  outpatient clinics throughout the world likely result from a combination of inherent disease prevalence as well as patients ' attitudes toward what acupuncture can treat successfully OBJECTIVE To compare the effect of real and sham acupuncture and a control intervention on thermal sensation and thermal pain thresholds . DESIGN Single-blind , r and omized controlled , repeated- measures trial . SETTING Laboratory . PARTICIPANTS Eighteen acupuncture-naive , healthy subjects with no history of upper-limb pathology or acupuncture contraindications . INTERVENTION Subjects were r and omly assigned ( blind card allocation ) to 1 of 6 possible orders of application of the interventions , which consisted of 25 minutes each of control , real , and sham acupuncture . MAIN OUTCOME MEASURES Thermal sensation and thermal pain thresholds measured with a thermal sensory analyzer before and after each intervention . RESULTS There were increases in cold and hot pain and cold sensation thresholds with real acupuncture . The level of increase did not differ significantly from the changes that occurred with sham acupuncture and control interventions . CONCLUSIONS Although we observed a trend toward a decreased sensitivity to thermal pain and thermal sensation with real acupuncture , this trend did not differ significantly from the changes with control or sham interventions . Therefore , no support was provided for analgesic or placebo effects of acupuncture . The trend , combined with the relatively low power of the inferential tests applied does , however , suggest that further research is merited PURPOSE The purpose is to investigate an additional antiemetic effect to ondansetron with needle acupuncture at P6 compared with nonskin-penetrating placebo acupuncture in patients undergoing high-dose chemotherapy and autologous peripheral blood stem cell transplantation . EXPERIMENTAL DESIGN Eighty patients who were admitted to hospital for high-dose chemotherapy and autologous peripheral blood stem cell transplantation were included into a r and omized placebo-controlled single-blind trial . The patients were r and omized to receive acupuncture ( n = 41 ) or noninvasive placebo acupuncture ( n = 39 ) at the acupuncture point P6 30 min before first application of high-dose chemotherapy and the day after . All patients received 8 mg ondansetron/day i.v . as basic antiemetic prophylaxis . The main outcome measure was the rate of patients who either had at least one episode of vomiting or required any additional antiemetic drugs on the first 2 days of chemotherapy . RESULTS The main outcome measure showed no significant difference ( P = 0.82 ) : 61 % failure in the acupuncture group and 64 % in the placebo acupuncture group ( 95 % confidence interval of 3 % difference : -18.1 and 24.3 % ) . Comparing nausea , episodes of vomiting or retching and number of additionally required antiemetic drugs did not provide any discrepancy with the main result . CONCLUSIONS This study suggests that in combination with ondansetron i.v . , invasive needle acupuncture at P6 compared with nonskin-penetrating placebo acupuncture has no additional effect for the prevention of acute nausea and vomiting in high-dose chemotherapy BACKGROUND 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 . METHODS Patients with chronic osteoarthritis of the knee ( Kellgren grade < or = 2 ) were r and omly 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 st and ard question naires 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 . RESULTS 294 patients were enrolled from March 6 , 2002 , to January 17 , 2003 ; eight patients were lost to follow-up after r and omisation , 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 ) . INTERPRETATION 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 Context Previous studies of acupuncture for osteoarthritis have had conflicting results . This may have occurred because most studies have included small sample s , a limited number of treatment sessions , or other limitations . Contribution This r and omized , controlled trial compared 24 acupuncture sessions over 26 weeks with sham acupuncture or arthritis education in 570 patients with osteoarthritis of the knee .  Acupuncture led to greater improvements in function but not pain after 8 weeks and in both pain and function after 26 weeks . No adverse effects were associated with acupuncture . Caution s Many participants dropped out of the study , so readers should interpret the findings at 26 weeks with caution . The Editors Osteoarthritis is the most common form of arthritis and is a major cause of morbidity , limitation of activity , and health care utilization , especially in elderly patients ( 1 , 2 ) . Pain and functional limitation are the primary clinical manifestations of osteoarthritis of the knee . Current recommendations for managing osteoarthritis , including guidelines published by the American College of Rheumatology ( 3 ) and European League of Associations of Rheumatology ( 4 ) , focus on relieving pain and stiffness and maintaining or improving physical function as important goals of therapy . No curative therapies exist for osteoarthritis ; thus , both pharmacologic and nonpharmacologic management focus on controlling pain and reducing functional limitation ( 5 ) . Nonpharmacologic therapy , which includes patient education , social support , physical and occupational therapy , aerobic and resistive exercises , and weight loss , is the cornerstone of a multidisciplinary approach to osteoarthritis patient management ( 3 ) . Pharmacologic therapies include nonopioid analgesics ( such as acetaminophen ) , nonsteroidal anti-inflammatory drugs ( NSAIDs ) ( including cyclooxygenase-2 [ COX-2 ] enzyme selective inhibitors ) , topical analgesics ( capsaicin cream ) , opioid analgesics , and intra-articular steroid and hyaluronate injections . Often , these agents are used in combination for additive analgesic efficacy ( 6 ) . Pharmacologic management of osteoarthritis is often ineffective , and agents such as NSAIDs may cause unwanted and dangerous side effects ( 7 , 8) . Complementary and alternative medicine is another approach to treating osteoarthritis ( 9 - 12 ) , particularly in Asian societies ( 13 ) . Many U.S. patients with osteoarthritis also use complementary and alternative medical therapies ( 14 ) . A systematic review of acupuncture and knee osteoarthritis ( 15 ) identified 7 small r and omized , controlled trials published in English . Within the method ologic limitations of the studies , the evidence suggested that acupuncture seemed to alleviate knee pain and function compared with sham acupuncture controls , although 2 trials comparing acupuncture with an active , nonpharmacologic treatment ( physical therapy ) did not indicate such an effect ( 16 , 17 ) . Before conducting our large-scale trial , we completed both a pilot study ( 18 ) and a r and omized , single-blind trial ( 19 ) of the effect of acupuncture on osteoarthritis of the knee . Participants in the uncontrolled pilot study ( n= 12 ) showed statistically significant improvement in both self-reported pain and physical function , as well as performance measures of physical function after 8 weeks of acupuncture treatment and at 12-week follow-up as compared with their baseline ( 18 ) . In our larger r and omized , single-blind trial ( n= 73 ) , which examined the benefit of acupuncture added to st and ard management with NSAIDs , the acupuncture  treatment group experienced statistically significant improvements in self-reported pain and disability scores compared with a st and ard-care control group as late as 4 weeks after the end of treatment ( 19 ) . However , this effect diminished within 18 weeks ( 26 weeks after the beginning of the trial ) after the final acupuncture treatment . Together , however , the previously conducted trials ( both our preliminary studies [ 18 , 19 ] and those referenced in the systematic review [ 15 ] ) have 3 method ologic limitations : lack of credible controls for the placebo effect , inadequate assessment of long-term treatment benefits , and insufficient sample sizes . We tested the hypothesis that an 8-week intensive acupuncture treatment regimen , followed by an 18-week tapering regimen , reduces pain and improves function among patients with knee osteoarthritis as compared with both sham acupuncture and education control groups . Methods Patient Recruitment We recruited patients for this multisite , placebo-controlled trial from March 2000 through December 2003 , primarily through print and radio advertisements . The 3 sites were the Integrative Medicine Clinic of the University of Maryl and School of Medicine , Baltimore , Maryl and ; the Innovative Medical Research Center ( a private research firm ) , Towson , Maryl and ; and the Hospital for Special Surgery , New York City , New York . The institutional review boards of the 3 sites approved the study . We determined the sample size ( n= 570 ) by a power analysis based on our r and omized pilot study ( 19 ) , adjusted by the estimated decrease in effect size result ing from the inclusion of a sham acupuncture group design ed to control for placebo effects . Patients met the following inclusion criteria : age 50 years or older , a diagnosis of osteoarthritis of the knee , radiographic evidence of at least 1 osteophyte at the tibiofemoral joint ( KellgrenLawrence grade 2 ) , moderate or greater clinical ly significant knee pain on most days during the past month , and willingness to be r and omly assigned . Exclusion criteria were the presence of serious medical conditions that precluded participation in study , bleeding disorders that might contraindicate acupuncture , intra-articular corticosteroid or hyaluronate injections ( as well as any knee surgeries or concomitant use of topical capsaicin cream ) during the past 6 months , previous experience with acupuncture , or any planned events ( including total knee replacement ) that would interfere with participation in the study during the following 26 weeks . After a brief telephone screening , patients were scheduled to visit 1 of the 3 participating sites to sign an informed consent statement and undergo a brief rheumatologic examination ( including radiographic examination of affected knees ) by a physician or a nurse practitioner . Because the education course was a group activity , patients were recruited until a cohort of 12 to 21 patients was formed , at which point each cohort at each site was r and omly assigned to 1 of 3 groups by a computer-generated process using r and omly selected blocks of 3 , 6 , and 9 . We assured allocation concealment by using disguised letter codes that were generated and sent to the site coordinators by a central statistical core . We used this procedure to ensure that approximately equal numbers of participants were in each treatment group across the course of the study , to ensure that each cohort would have participants assigned to all 3 treatment groups , and to make the breaking of the group assignment process more difficult . The research assistants who collected assessment s from participants , the participants themselves ( in the true acupuncture and sham acupuncture groups ) , and the statistician were blinded to group assignment . Assessment s were conducted at baseline and 4 , 8 , 14 , and 26 weeks after r and omization . Study Interventions We developed and modified the acupuncture treatment and sham control protocol s from previously reported and vali date d procedures ( 18 - 21 ) . During the trial , 7 acupuncturists were used : 3 at the Integrative Medicine Clinic , 3 at the Innovative Medical Research Center , and 1 at the Hospital for Special Surgery . In general , acupuncturists were assigned to the same participants throughout the 26-week treatment schedule , except for vacation conflicts and staff turnover , and provided approximately the same proportions of true versus sham procedures . All acupuncturists were state-licensed and had at least 2 years of clinical experience . The study 's principal acupuncturist trained and supervised the acupuncturists in performing true or sham procedures and avoiding interactions that could inadvertently communicate group assignment . True Acupuncture The true acupuncture  ( experimental ) group underwent 26 weeks of gradually tapering treatment according to the following schedule : 8 weeks of 2 treatments per week followed by 2 weeks of 1 treatment per week , 4 weeks of 1 treatment every other week , and 12 weeks of 1 treatment per month . We based the acupuncture point selection s on Traditional Chinese Medicine meridian theory to treat knee joint pain , known as the Bi syndrome . These points consisted of 5 local points ( Yanglinquan [ gall bladder meridian point 34 ] , Yinlinquan [ spleen meridian point 9 ] , Zhusanli [ stomach meridian point 36 ] , Dubi [ stomach meridian point 35 ] , and extra point Xiyan ) and 4 distal points ( Kunlun [ urinarybladder , meridian point 60 ] , Xuanzhong [ gall bladder meridian point 39 ] , Sanyinjiao [ spleen meridian point 6 ] , and Taixi [ kidney meridian point 3 ] ) on meridians that traverse the area of pain ( 22 , 23 ) . The same points were treated for each affected leg . If both knees were affected , 9 needles were inserted in each leg . ( The outcome measures were not specifically targeted to whether the patient had osteoarthritis in 1 or both knees , and we observed no differential effects on the basis of the number of knees treated . ) The acupuncturists inserted 1.5-inch ( for local points ) and 1-inch ( for distal points ) 32-gauge ( 0.25-mm diameter ) acupuncture needles to a conventional depth of approximately 0.3 to 1.0 inch , depending on point location . All participants in the treatment group achieved the De-Qi sensation , a local sensation of heaviness , numbness , soreness , or paresthesia that accompanies the insertion and manipulation of needles during acupuncture , at these 9 points . Acupuncturists applied electrical Abstract Objective To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache . Design Three armed r and omised controlled multicentre trial . Setting 28 outpatient centres in Germany . Participants 270 patients ( 74 % women , mean age 43 ( SD 13 ) years ) with episodic or chronic tension-type headache . Interventions 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 . Main outcome measure Difference in numbers of days with headache between the four weeks before r and omisation and weeks 9 - 12 after r and omisation , as recorded by participants in headache diaries . Results 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 . Conclusions 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 . Trial registration number IS RCT N9737659 Background Acupuncture points and meridians are commonly believed to possess unique electrical properties . The experimental support for this cl aim is limited given the technical and method ological shortcomings of prior studies . Recent studies indicate a correspondence between acupuncture meridians and connective tissue planes . We hypothesized that segments of acupuncture meridians that are associated with loose connective tissue planes ( between muscles or between muscle and bone ) visible by ultrasound have greater electrical conductance ( less electrical impedance ) than non-meridian , parallel control segments . Methods We used a four-electrode method to measure the electrical impedance along segments of the Pericardium and Spleen meridians and corresponding parallel control segments in 23 human subjects . Meridian segments were determined by palpation and proportional measurements . Connective tissue planes underlying those segments were imaged with an ultrasound scanner . Along each meridian segment , four gold-plated needles were inserted along a straight line and used as electrodes . A parallel series of four control needles were placed 0.8 cm medial to the meridian needles . For each set of four needles , a 3.3 kHz alternating ( AC ) constant amplitude current was introduced at three different amplitudes ( 20 , 40 , and 80 μAmps ) to the outer two needles , while the voltage was measured between the inner two needles . Tissue impedance between the two inner needles was calculated based on Ohm 's law ( ratio of voltage to current intensity ) . Results At the Pericardium location , mean tissue impedance was significantly lower at meridian segments ( 70.4 ± 5.7 Ω ) compared with control segments ( 75.0 ± 5.9 Ω ) ( p = 0.0003 ) . At the Spleen location , mean impedance for meridian ( 67.8 ± 6.8 Ω ) and control segments ( 68.5 ± 7.5 Ω ) were not significantly different ( p = 0.70 ) . Conclusion Tissue impedance was on average lower along the Pericardium meridian , but not along the Spleen meridian , compared with their respective controls . Ultrasound imaging of meridian and control segments suggested that contact of the needle with connective tissue may explain the decrease in electrical impedance noted at the Pericardium meridian . Further studies are needed to determine whether tissue impedance is lower in ( 1 ) connective tissue in general compared with muscle and ( 2 ) meridian-associated vs. non meridian-associated connective tissue Objective : The primary aim was to establish from  acupuncture patients the type and frequency of adverse events they experienced and attributed to their treatment . Secondary aims included the measurement of patient reported adverse consequences arising from advice received about conventional/prescribed medication or from delayed conventional diagnosis and treatment . Methods : Postal survey of prospect ively identified acupuncture patients . One in three members of the British Acupuncture Council ( n = 638 ) invited consecutive patients to participate in the survey . Participating patients gave baseline data and consented to direct follow up by the research ers at 3 months . A structured question naire was used to collect data on perceived adverse events . Results : 9408 patients gave baseline information and consent and 6348 ( 67 % ) completed 3 month question naires . Responders were not dissimilar to non-responders for all known characteristics . 682 patients reported at least one adverse event over 3 months , a rate of 107 per 1000 patients ( 95 % CI 100 to 115 ) . Three patients reported a serious adverse event . The most common events reported were severe tiredness and exhaustion , pain at the site of needling , and headache .  Patients receiving acupuncture treatment  that was not funded by the NHS and patients not in contact with a GP or hospital specialist were less likely to report adverse events ( odds ratios 0.59 and 0.66 , respectively ) . 199 ( 3 % ) of responding patients reported receiving advice about conventional/prescribed medication , six of whom reported adverse consequences after taking the advice . Two patients reported  delayed conventional treatment .  Conclusion : Patients report a range of adverse events but these do not prevent most patients seeking further acupuncture . This large scale survey supports existing evidence that acupuncture is a relatively safe intervention when practised by regulated practitioners OBJECTIVE To determine whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture  was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than  acupuncture  that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture  trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffective . CONCLUSIONS Some countries publish unusually high proportions of positive results . Publication bias is a possible explanation . Research ers undertaking systematic review s should consider carefully how to manage data from these countries Acupuncture is increasingly used , so it is important to establish whether its benefits outweigh its risks . Numerous case reports of adverse events show that acupuncture is not free of risk , but accurate data from prospect i ve investigations is scarce . A prospect i ve survey was undertaken using intensive event monitoring . Forms were developed for reporting minor events each month and significant events as they occurred . The sample size was calculated to identify any adverse events that occurred more frequently than once in 10,000 consultations . Acupuncturists were recruited from two professional organisations in the UK . Seventy-eight acupuncturists , all doctors or physiotherapists , reported a total of 2178 events occurring in 31,822 consultations , an incidence of 684 per 10,000 consultations . The most common minor adverse events were bleeding , needling pain , and aggravation of symptoms ; aggravation was followed by resolution of symptoms in 70 % of cases . There were 43 significant minor adverse events reported , a rate of 14 per 10,000 , of which 13 ( 30 % ) interfered with daily activities . One patient suffered a seizure ( probably reflex anoxic ) during acupuncture , but no adverse event was classified as serious . Avoidable events included forgotten patients , needles left in patients , cellulitis and moxa burns . In conclusion , the incidence of adverse events following acupuncture performed by doctors and physiotherapists can be classified as minimal ; some avoidable events do occur . Acupuncture seems , in skilled h and s , one of the safer forms of medical intervention The objective of this study was to assess the effects of acupuncture applied at Hegu ( LI 4 ) points and Neiguan ( PC6 ) points on heart rate variability ( HRV ) in normal subjects under fatigue and non-fatigue states using power spectral analysis . Twenty-nine normal male subjects were r and omly divided into three groups . Subjects in Group A and Group B performed a simulated driving task for 3 h and acupuncture needles were then inserted perpendicularly into the LI 4 points in the middle of the dorsal thenar muscle and PC 6 points situated between the tendons of the palmaris longus and carpi radialis muscles for 15 min for Group A but inserted subcutaneously to the acupuncture points for Group B as a control . Acupuncture needles were directly inserted perpendicularly into the LI 4 points and PC 6 points for 15 min for Group C. Stimulations of the acupuncture points induced a significant decrease in heart rate ( HR ) , HRV total power ( TP ) , low frequency ( LF ) power and ratio of low frequency to high frequency ( LF/HF ) , and a significant increase in the HF power in normalized units ( NU ) during the post stimulation period in fatigue state ( P<0.05 ) . Stimulation of acupuncture points result ed in a significant increase both in the LF power and HF power in absolute units ( AU ) ( P<0.05 ) but no significant change in NU was found during the post stimulation period in non-fatigue state . It was concluded that the modulating effect of acupuncture on heart rate variability not only depended on the points of stimulation such as acupuncture or non-acupuncture points but also on the functional state of the subject , namely whether the subjects are in a state of fatigue or not CONTEXT Acupuncture is widely used to prevent migraine attacks , but the available evidence of its benefit is scarce . OBJECTIVE To investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine . DESIGN , SETTING , AND PATIENTS Three-group , r and omized , 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 . INTERVENTIONS 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 r and omization and from week 21 to 24 after r and omization . MAIN OUTCOME MEASURES Difference in headache days of moderate or severe intensity between the 4 weeks before and weeks 9 to 12 after r and omization . RESULTS 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 . CONCLUSION Acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were more effective than a waiting list control UNLABELLED In this pilot study comparing the analgesic effects of three acupuncture modes -- manual , electro , and placebo ( with Streitberger placebo needles)--in a cohort of healthy subjects , we found that verum acupuncture treatment , but not placebo , lowered pain ratings in response to calibrated noxious thermal stimuli . This finding was mainly the result of highly significant analgesia in 5 of the 11 subjects who completed the 5-session study . Of the 5 responders , 2 responded only to electroacupuncture and 3 only to manual acupuncture , suggesting that acupuncture 's analgesic effects on experimental pain may be dependent on both subject and mode . We developed a simple quantitative assessment tool , the  Subjective Acupuncture Sensation Scale ( SASS ) , comprised of 9 descriptors and an anxiety measure to study the relationship between the deqi sensation induced by acupuncture and the putative therapeutic effects of acupuncture . The SASS results confirm that the deqi sensation is complex , with all subjects rating multiple descriptors during each mode . We found significant correlations of analgesia with SASS ratings of numbness and soreness , but not with ratings of stabbing , throbbing , tingling , burning , heaviness , fullness , or aching . This suggests that attributes of the deqi sensation may be useful clinical indicators of effective treatment . PERSPECTIVE The results of this study indicate the existence of both individual subject and acupuncture mode variability in the analgesic effects of acupuncture . This suggests that switching acupuncture mode may be a treatment option for unresponsive patients The cerebral activation pattern due to acupuncture is not completely understood . Although the effect of acupuncture on cerebral haemodynamics has been studied , no previous report has focused on different puncture and stimulation methods . We used functional MRI ( fMRI ) in 15 healthy subjects to investigate cortical activation during stimulation of two real acupoints ( Liv3 and G40 ) and one sham point , needled in a r and om and , for the subjects , blinded order employing rotating and non-rotating methods , using a blocked paradigm on a 1.5 tesla imager . Compared to the non-rotating stimulation method , during rotating stimulation of the real acupoints , we observed an increase in activation in both secondary somatosensory cortical areas , frontal areas , the right side of the thalamus and the left side of the cerebellum ; no such effects of the needling technique were seen while stimulating the sham point . The observation that rotating the needle strengthened the effects of acupuncture only at real acupoints suggests that , as cl aim ed in Chinese traditional medicine , stimulation of these acupoints has a specific effect on cortical neuronal activity , absent with sham acupoints . These specific cerebral activation patterns might explain the therapeutic effects of acupuncture in certain subjects This purpose of this article is to contrast the analgesic efficacy of acupuncture following dental surgery with the analgesic effects based on the expectation of benefit in two independently conducted placebo-controlled trials evaluating acupuncture as an adjunctive therapy for dental surgery . Both trials used pain following dental surgery as the outcome variable , and both included a blinding check to ascertain patients ’ beliefs regarding which treatment they were receiving . Although no statistically significant analgesic effect was observed between the acupuncture and placebo groups , participants in both experiments who believed they received real acupuncture  reported significantly less pain than patients who believed that they received a placebo . Patients ’ beliefs regarding the receipt of acupuncture bore a stronger relationship to pain than any specific action possessed by acupuncture . These results also support the importance of both employing credible controls for the placebo effect in clinical trials and evaluating the credibility of those controls A study with needle acupuncture was performed in tension-type headache employing a new placebo acupuncture method .  Sixty-nine patients ( mean age 48.1 years , sd = 14.1 ) fulfilling the International Headache Society criteria for tension-type headache were r and omly assigned to verum or placebo condition . No significant differences between placebo and verum with respect to visual analogue scale and frequency of headache attacks could be observed immediately , 6 weeks and 5 months after the end of treatment . There was a significant but weak improvement in quality of life parameters ( clinical global impressions , Nottingham Health Profile ) after verum treatment . In decision tree analyses , the changes in clinical global impressions and headache frequency depended significantly on primary headache frequency with a limit value of 24.5 days headache per month . High values in the von Zerssen Depression Score result ed in high mean visual analogue scale values Many r and omised controlled trials have been conducted in China to evaluate the effectiveness of traditional Chinese medicine , but much of the information is inaccessible to Western doctors . We estimated the total number of r and omised controlled trials published in China and identified problems in applying such methodology to the evaluation of traditional Chinese medicine , which would serve as preparatory work for systematic review and dissemination of the r and omised evidence for such medicine . We r and omly selected 28 journals using stratified sampling from a total of 100 Chinese journals of traditional Chinese medicine ( 4 national , 10 university , 10 provincial or regional , and 4 specialist journals ) . After special training , eight fifth year medical students ( working in pairs ) h and search ed all the issues of the journals published before 1 January 1997 to identify r and omised controlled trials . Discrepancies were settled by one of the principal investigators ( S-YZ ) . Data on method ological quality of r and omised controlled trials were extracted from 414 full length articles As recent studies demonstrated , acupuncture can elicit activity in specific brain areas . This study aims to explore further the central effect using  laser acupuncture .  We investigated the cerebral effects of  laser acupuncture at both acupoints GB43 with functional magnetic resonance imaging ( fMRI ) . As a control condition the laser was mounted at the same acupoints but without application of laser stimulation . The group results showed significant brain activations within the thalamus , nucleus subthalamicus , nucleus ruber , the brainstem , and the Brodmann areas 40 and 22 for the acupuncture condition . No significant brain activations were observed within the placebo condition . The activations we observed were laser acupuncture-specific and predominantly ipsilateral . This supports the assumption that acupuncture is mediated by meridians , since meridians do not cross to the other side . Furthermore , we could show that laser acupuncture allows one to design a pure placebo condition & NA ; A study was conducted to determine whether changes in expected pain levels , desire for pain relief , or anxiety contribute to an increase in placebo analgesia over time as well as to determine whether placebo analgesic effects of IBS patients are related to endogenous opioid mechanisms . Twenty‐six women with IBS were exposed to rectal stimulation ( 35 or 55 mmHg for 30 s ) and tested under natural history ( NH ) , rectal placebo ( RP ) and rectal lidocaine ( RL ) conditions . During all conditions , 16 patients were given saline intravenously ( to test for a placebo effect ) and 10 patients were given naloxone intravenously ( to test naloxone antagonism of the placebo effect ) on a double blind basis . Patients rated expected pain level , desire for pain relief and anxiety at 2 and 22 min after the onset of NH , RP , and RL conditions and they rated actual pain intensity at 5‐min intervals for 40 min . There was a large and significant placebo effect ( P<0.001 ) that increased over time . Ratings of expected pain levels , desire for pain relief and anxiety decreased over time and contributed to more variance in placebo and lidocaine responses during the last half of the session . These changes suggest that a reduction in negative emotions may be central to placebo effects . There was no significant difference between psychological mediators ( desire , expectation , anxiety ) or the placebo effect in the saline and naloxone groups , indicating that neither the psychological mediators nor the placebo analgesic effect were associated with endogenous opioids in this clinical ly related paradigm This r and omised , placebo‐controlled , patient and observer blinded trial was conducted to determine whether acupuncture at the acupuncture point P6 is effective in preventing postoperative nausea and vomiting ( PONV ) compared to placebo acupuncture .  Female patients ( n = 220 ) scheduled for gynaecological or breast surgery were r and omly assigned to two groups receiving either acupuncture ( n = 109 ) or placebo acupuncture ( n = 111 ) . Each group was stratified for type of surgery and included two subgroups receiving intervention either before or after induction of anaesthesia . The incidence of PONV and /or antiemetic rescue medication within 24 h after surgery was the main outcome measure which showed no statistically significant difference between groups ( 43.7 % acupuncture , 50.9 % placebo , p = 0.27 ) . The differences were more pronounced for patients having gynaecological surgery ( 48.9 % acupuncture , 67.6 % placebo , p = 0.07 ) than for those having breast surgery ( 38.7 % acupuncture , 40.3 % placebo , p = 0.86 ) . The secondary outcome , vomiting , was significantly reduced by acupuncture from 39.6 % to 24.8 % ( p = 0.03 ) . Subgroup analysis showed no difference between applications of acupuncture before compared to after induction of anaesthesia BACKGROUND A problem acupuncture research has to face is the concept of a control group . If , in control groups , non-acupoint needling is done , physiological acupuncture effects are implied . Therefore the effects shown in this group are often close to those shown in the acupuncture group . In other trials , control groups have received obviously different treatments , such as transcutaneous electrical nervous stimulation or TENS-laser treatment ; it is not clear if the effects of acupuncture are due only to the psychological effects of the treatment . METHODS We developed a placebo acupuncture needle , with which it should be possible to simulate an acupuncture procedure without penetrating the skin . In a cross-over experiment with 60 volunteers we tested whether needling with the placebo needle feels any different from real acupuncture . FINDINGS Of 60 volunteers , 54 felt a penetration with acupuncture  ( mean visual analogue scale [ VAS ] 13.4 ; SD 10.58 ) and 47 felt it with placebo ( VAS 8.86 ; SD 10.55 ) , 34 felt a dull pain sensation ( DEQI ) with acupuncture and 13 with placebo . None of the volunteers suspected that the needle may not have penetrated the skin . INTERPRETATION The placebo needle is sufficiently credible to be used in investigations of the effects of acupuncture & NA ; The issue of what constitutes an effective and realistic acupuncture placebo control has been a continuing problem for acupuncture research . In order to provide an effective placebo , the control procedure must be convincing , visible and should mimic , in all respects , apart from a physiological effect , the real active treatment . The ‘ Streitberger ’ needle might fulfil these criteria and this paper reports on a validation study . This was a single‐blind , r and omised , cross‐over pilot study . Patients were drawn from the orthopaedic hip and knee , joint replacement waiting list . Intervention consisted of either 2 weeks of treatment with real acupuncture followed by 2 weeks on placebo , or vice versa . The prime outcome was a needle sensation question naire and there was a range of secondary outcomes . Thirty‐seven patients were r and omised and completed treatment . Groups were well balanced at baseline . No significant differences between groups or needle types were found for any of the sensations measured . Most patients were unable to discriminate between the needles by penetration ; however , nearly 40 % were able to detect a difference in treatment type between needles . No major differences in outcome between real and placebo needling could be found . The fact that nearly 40 % of subjects did not find that the two interventions were similar , however , raises some concerns with regard to the wholesale adoption of this instrument as a st and ard acupuncture placebo . Further work on inter‐tester reliability and st and ardisation of technique is highly recommended before we can be confident about using this needle in further studies BACKGROUND Reporting of all serious adverse events ( SAEs ) is a requirement for regulatory approval of a drug . Can equally rigorous reporting st and ards be expected in studies of non-drug treatments and how can underreporting , if any , be detected and proven ? Using data from our large-scale prospect i ve cohort study of acupuncture on out patients , we examine the use of an internal st and ard , a principle taken from laboratory medicine , to quantify real event rates . METHODS A total of 190,924 patients ( 68.6 % women ) seeking treatment for chronic pain ( headache , low back pain , coxarthrosis or gonarthrosis ) from 12,000 physicians in private practice in Germany were observed during a six-month period ending in May 2002 . Most received ten sessions of body acupuncture . Mean treatment time was six weeks . All practitioners were certified in acupuncture and received written instructions on completing forms for basic patient data and SAE monitoring . They were also informed that payment by insurers would be made only upon return of the completed form . All SAEs occurring between start of the first acupuncture session and end of the last one were to be reported , whether causally related to the treatment or not . Multiple minor adverse events ( AEs ) per single patient were to be reported only once . As the internal st and ard we chose the expected number of deaths , based on the death rate for the German population , adjusted for age , sex distribution and mean observation time of our study patients . RESULTS 45 SAEs and 14,404 AEs were reported ( i.e. 2.4 SAEs and 754 AEs per 10,000 patients ) . The number of reported deaths ( 9 ) was only 5 % of the statistically expected number ( 180 ) . Applying the result ing correction factor of 20 to all reported SAEs , result ed in 900 expected SAEs ( versus 45 reported ) or 47 per 10,000 patients . CONCLUSIONS Without verifying the accuracy of a measurement , results remain speculative . Our internal st and ard for the first time provides a means of verifying the accuracy of the reported SAE rate and correcting it to the statistically expected SAE rate The objectives were to introduce a new method for controlled trials of acupuncture in the field of headache research and to examine the role of needling per se . Women with menstrually related migraine were r and omized to three months of treatment with verum or placebo needles . Three st and ard size casts were moulded to secure the placebo needles in the head . No significant differences were found between the verum group ( n = 15 ) and the placebo group ( n = 13 ) during treatment or follow up three and six months later , either in the attack frequency or in the number of days per month with migraine , headache intensity or drug-use . The casts held the needles exactly in place despite movements of the head , and are vali date d as practical , hygienic and extremely durable . This method is satisfactory for controlled studies of acupuncture in headache . It is possible that the positive results in earlier clinical trials on acupuncture in migraine are attributable to other mechanisms than needling of subcutaneous tissue Thirty‐four alcoholics were treated with acupuncture to the ear and the body in a r and omized single‐blind placebo‐controlled design over 14 days . Orthodox points and placebo needles to orthodox points were used daily for a total of 10 treatments starting on the first day of admission as add‐on therapy to st and ard medication with carbamazepine . The primary outcome was the Clinical Institute Withdrawal Assessment ( CIWA‐Ar‐scale ) assessed on days 1‐6 , 9 and 14 . No initial differences were found regarding sociodemographic data , drinking history and alcohol‐related data , indicating successful r and omization . Longitudinal analysis of the Clinical Institute Withdrawal Assessment ( CIWA‐Ar‐scale ) data showed that patients assigned to acupuncture had a general tendency towards better outcome results and significantly fewer withdrawal symptoms on day 14 ( Wilcoxon‐W=177.500 , Z=‐2.009 , p = 0.045 ) . No significant differences were found in the Beck Depression Inventory ( BDI ) , State‐Trait Anxiety Inventory ( STAI X1 and X2 ) and Eigenschaftswoerterliste ( EWL S60 ) . We conclude that acupuncture as an adjunctive treatment to carbamazepine medication shows promise for the treatment of alcohol withdrawal symptoms . Further investigation of this treatment modality appears to be warranted UNLABELLED We sought to determine whether a novel method of placebo acupuncture can be differentiated by subjects from real acupuncture treatment . A single-blind , r and omized , controlled clinical trial with an independent observer was performed . Forty-nine healthy subjects over the age of 18 years were r and omly assigned to one of 2 experimental groups : 24 subjects received real acupuncture , and 25 subjects received placebo acupuncture . Placebo acupuncture was performed by administering a blunted acupuncture needle through a foam pad at the Large Intestine 4 acupoint . The blunted needle touched but did not penetrate the skin . Real acupuncture was performed by administering an acupuncture needle through a foam pad at the Large Intestine 4 acupoint . The needle pricked and penetrated the skin to a depth of 10 to 20 mm . A simple question naire followed , asking whether the subject believed they received real or placebo acupuncture . Twenty-two ( 88 % ) of the 25 subjects who received placebo acupuncture believed they received real acupuncture . Nineteen ( 79.2 % ) of the 24 subjects who received real acupuncture correctly determined they received real acupuncture . The Fisher exact test showed an insignificant difference between real and placebo acupuncture treatments ( P = .463 ) . Subjects were not able to differentiate between real or placebo acupuncture  , thereby validating this novel method of administering placebo acupuncture as a good control for acupuncture-naive patients . PERSPECTIVE The method of placebo acupuncture herein described is a valid control for acupuncture research involving acupuncture-naive patients It has been suggested that placebo analgesia involves both higher order cognitive networks and endogenous opioid systems . The rostral anterior cingulate cortex ( rACC ) and the brainstem are implicated in opioid analgesia , suggesting a similar role for these structures in placebo analgesia . Using positron emission tomography , we confirmed that both opioid and placebo analgesia are associated with increased activity in the rACC . We also observed a covariation between the activity in the rACC and the brainstem during both opioid and placebo analgesia , but not during the pain-only condition . These findings indicate a related neural mechanism in placebo and opioid analgesia Acupuncture has gained increasing attention in the treatment of  chronic pain .  The lack of a satisfying placebo method has made it impossible to show whether needling is an important part of the method or whether the improvement felt by the patient is due to the therapeutic setting and psychological phenomena . Also , the effectiveness of acupuncture has not been demonstrated sufficiently . We treated 52 sportsmen with rotator cuff tendinitis in a r and omised single-blind clinical trial using a new placebo-needle as control . Patients were treated for 4 weeks . The primary endpoint of the trial was the change in the modified Constant-Murley-score from the baseline . Assessment of the treatment outcome was made by experienced orthopaedists not informed of the treatment allocation . Acupuncture with penetration of the skin was shown to be more effective than a similar therapeutic setting with placebo needling in the treatment of pain . The  acupuncture-group  improved 19.2 Constant-Murley-score points ( SD 16.1 , range from -13 to 50 ) , the  control-group  improved 8.37 points ( SD 14.56 , range from -20 to 41 ) , ( P=0.014 ; C.I. 2.3;19.4 ) . This study showed that needling is an important part of the acupuncture effect in the treatment of  chronic shoulder pain in athletes . No conclusions can be derived from this study concerning the importance of choosing points and the rules of Traditional Chinese Medicine . Using the new placebo method as control for other ailments could improve the evidence of specific  acupuncture effects beyond pain treatment
Even though widely used in today 's clinical practice , acupuncture has remained a controversial subject .
Many review s are currently available but most lack a critical stance and some are overtly promotional .
The aim of this overview is to provide a balanced , critical analysis of the existing evidence .
Some of the original concepts of traditional acupuncture are not supported by good scientific evidence .
Several plausible theories attempt to explain how acupuncture works but none are proved beyond doubt .
The clinical effectiveness of acupuncture continues to attract controversy .
Many controlled clinical trials and numerous systematic review s of these studies have been published .