Placebo acupuncture as a form of ritual touch healing: A neurophenomenological model What Makes Patients with Fibromyalgia Feel Better? Correlations Between Patient Global Impression of Improvement and Changes in Clinical Symptoms and Function: A Pooled Analysis of 4 Randomized Placebo-controlled Trials of Duloxetine Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. A Prospective Survey of Adverse Events and Treatment Reactions following 34,000 Consultations with Professional Acupuncturists Improvement in fibromyalgia symptoms with acupuncture: results of a randomized controlled trial. Comparison of clinical and evoked pain measures in fibromyalgia. Electroacupuncture in fibromyalgia: results of a controlled trial. Are acupoints specific for diseases? A systematic review of the randomized controlled trials with sham acupuncture controls Acupuncture analgesia for temporal summation of experimental pain: a randomised controlled study. Effects of acupuncture to treat fibromyalgia: A preliminary randomised controlled trial [Combination of acupuncture, cupping and medicine for treatment of fibromyalgia syndrome: a multi-central randomized controlled trial]. Description and validation of a noninvasive placebo acupuncture procedure. Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on μ-opioid receptors (MORs) Patient reports of adverse events associated with acupuncture treatment: a prospective national survey Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol A randomized controlled trial of acupuncture added to usual treatment for fibromyalgia. Survey of Adverse Events following Acupuncture (Safa): A Prospective Study of 32,000 Consultations A Randomized Clinical Trial of Acupuncture Compared with Sham Acupuncture in Fibromyalgia Standards for Reporting Interventions in Controlled Trials of Acupuncture: The Stricta Recommendations The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain Treatment of fibromyalgia with formula acupuncture: investigation of needle placement, needle stimulation, and treatment frequency. Standards for reporting interventions in controlled trials of acupuncture: The STRICTA recommendations. STandards for Reporting Interventions in Controlled Trails of Acupuncture. [Clinical study on combination of acupuncture, cupping and medicine for treatment of fibromyalgia syndrome]. Peripheral effects of needle stimulation (acupuncture) on skin and muscle blood flow in fibromyalgia. [Clinical study on treatment of fibromyalgia syndrome with penetration needling at the back].
Evidence that placebo acupuncture is an effective treatment for  chronic pain  presents a puzzle : how do placebo needles appearing to patients to penetrate the body , but instead sitting on the skin 's surface in the manner of a tactile stimulus , evoke a healing response ? Previous accounts of ritual touch healing in which patients often described enhanced touch sensations ( including warmth , tingling or flowing sensations ) suggest an embodied healing mechanism . In this qualitative study , we asked a subset of patients in a singleblind r and omized trial in irritable bowel syndrome to describe their treatment experiences while undergoing placebo treament . Analysis focused on patients ' unprompted descriptions of any enhanced touch sensations ( e.g. , warmth , tingling ) and any significance patients assigned to the sensations . We found in 5/6 cases , patients associated sensations including " warmth " and " tingling " with treatment efficacy . The conclusion offers a " neurophenomenological " account of the placebo effect by considering dynamic effects of attentional filtering on early sensory cortices , possibly underlying the phenomenology of placebo acupuncture Objective . To investigate the relationship between changes in clinical rating scale items and endpoint Patient Global Impression of Improvement ( PGI-I ) . Methods . Data were pooled from 4 r and omized , double-blind , placebo-controlled studies of duloxetine in patients with fibromyalgia ( FM ) . Variables included in the analyses were those that assessed symptoms in FM domains of pain , fatigue , sleep , cognitive difficulties , emotional well-being , physical function , and impact on daily living . The association of endpoint PGI-I with changes from baseline in individual variables was assessed using Pearson product-moment correlations ( r ) . Stepwise linear regression was used to identify those variables for which changes from baseline were statistically significant independent predictors of the endpoint PGI-I ratings . Results . Changes in pain variables and interference of symptoms with the ability to work were highly correlated ( r ≥ 0.5 or r ≤ −0.5 ) with endpoint PGI-I. Moderate correlation with endpoint PGI-I ( 0.30 ≤ r < 0.5 or −0.5 < r ≤ −0.30 ) included changes in variables that assessed physical functioning , depression , anxiety , fatigue , and several variables related to impact on daily living . Independent predictor variables of endpoint PGI-I identified by stepwise linear regression included assessment s for pain , physical function , vitality , anxiety , social function , and tender point thresholds . Conclusion . In addition to pain reduction , what makes patients with FM feel better may include improvement in fatigue , physical functioning , mood , and impact on daily living . An assessment of these domains may be important in clinical trials of FM and in the management of patients with FM OBJECTIVE Fibromyalgia syndrome ( FMS ) is characterized by widespread musculoskeletal pain and lowered pain threshold . Other prominent symptoms include disordered sleep and fatigue . FMS affects an estimated 2 % of the population , predominantly women . This trial was design ed to evaluate the efficacy and safety of pregabalin , a novel alpha(2)-delta lig and , for treatment of symptoms associated with FMS . METHODS This multicenter , double-blind , 8-week , r and omized clinical trial compared the effects of placebo with those of 150 , 300 , and 450 mg/day pregabalin on pain , sleep , fatigue , and health-related quality of life in 529 patients with FMS . The primary outcome variable was the comparison of end point mean pain scores , derived from daily diary ratings of pain intensity , between each of the pregabalin treatment groups and the placebo group . RESULTS Pregabalin at 450 mg/day significantly reduced the average severity of pain in the primary analysis compared with placebo ( -0.93 on a 0 - 10 scale ) ( P < /= 0.001 ) , and significantly more patients in this group had > /=50 % improvement in pain at the end point ( 29 % , versus 13 % in the placebo group ; P = 0.003 ) . Pregabalin at 300 and 450 mg/day was associated with significant improvements in sleep quality , fatigue , and global measures of change .  Pregabalin at 450 mg/day improved several domains of health-related quality of life . Dizziness and somnolence were the most frequent adverse events . Rates of discontinuation due to adverse events were similar across all 4 treatment groups . CONCLUSION Pregabalin at 450 mg/day was efficacious for the treatment of FMS , reducing symptoms of pain , disturbed sleep , and fatigue compared with placebo . Pregabalin was well tolerated and improved global measures and health-related quality of life The paper describes the type and frequency of adverse events and transient reactions following consultations with  professional acupuncturists .  In a postal survey , involving 1848 professional acupuncturists , all of whom were members of the British Acupuncture Council and practising in the UK , details of adverse events and transient reactions following treatment were recorded on st and ardised self-report forms . A sample size of 30,000 treatments was sought , and piloting indicated that a four-week period was required . Practitioners also provided information on themselves , including age , sex , length of training and years of practice . A total of 574 practitioners responded , 31 % of the total population . These practitioners reported on  adverse events and transient reactions associated with 34,407 treatments . No serious adverse events were reported , where these were defined as requiring hospital admission , prolonging hospital stays , permanently disabling , or result ing in death ( 95 % CI : 0 to 1.1 per 10,000 treatments ) . A total of 43 significant minor adverse events were reported , a rate of 1.3 per 1,000 treatments ( 95 % CI : 0.9 to 1.7 ) . These included severe nausea and actual fainting ( 12 ) , unexpected , severe and prolonged aggravation of symptoms ( 7 ) , prolonged and unacceptable pain and bruising ( 5 ) and psychological and emotional reactions ( 4 ) . There were three avoidable events : two patients had needles left in by mistake , and one patient had moxa burns to the skin , also caused by practitioner error . The acupuncturists also recorded 10,920 mild transient reactions occurring in 5136 treatments , 15 % ( 95 % CI : 14.6 to 15.3 ) of the 34,407 total . In terms of local reactions , there were reports of mild bruising ( 1.7 % ) , pain ( 1.2 % ) and bleeding ( 0.4 % ) . Practitioners reported that patients experienced an aggravation of existing symptoms after 2.8 % of treatments . The most common mild transient reactions to treatment were feeling relaxed ( 11.9 % ) and feeling energised ( 6.6 % ) . In this prospect i ve survey of 34,407 treatments , practitioners reported no serious adverse events . This conclusion was based on data collected from one in three members of the British Acupuncture Council . Given that the whole membership delivers between one and a half and two million treatments a year , this is important evidence on public health and safety . When compared with medication routinely prescribed in primary care , the results suggest that acupuncture is a relatively safe treatment modality OBJECTIVE To test the hypothesis that acupuncture improves symptoms of fibromyalgia .  PATIENTS AND METHODS We conducted a prospect i ve , partially blinded , controlled , r and omized clinical trial of patients receiving true acupuncture  compared with a control group of patients who received simulated acupuncture . All patients met American College of Rheumatology criteria for fibromyalgia and had tried conservative symptomatic treatments other than acupuncture .  We measured symptoms with the Fibromyalgia Impact Question naire ( FIQ ) and the Multidimensional Pain Inventory at baseline , immediately after treatment , and at 1 month and 7 months after treatment . The trial was conducted from May 28 , 2002 , to August 18 , 2003 . RESULTS Fifty patients participated in the study : 25 in the acupuncture group and 25 in the control group .  Total fibromyalgia symptoms , as measured by the FIQ , were significantly improved in the acupuncture group compared with the control group during the study period ( P = .01 ) . The largest difference in mean FIQ total scores was observed at 1 month ( 42.2 vs 34.8 in the control and acupuncture groups , respectively ; P = .007 ) . Fatigue and anxiety were the most significantly improved symptoms during the follow-up period . However , activity and physical function levels did not change . Acupuncture was well tolerated , with minimal adverse effects . CONCLUSION This study paradigm allows for controlled and blinded clinical trials of acupuncture . We found that acupuncture significantly improved symptoms of fibromyalgia . Symptomatic improvement was not restricted to pain relief and was most significant for fatigue and anxiety UNLABELLED Evoked pain measures such as tender point count and dolorimetry are often used to determine tenderness in studies of fibromyalgia ( FM ) . However , these measures frequently do not improve in clinical trials and are known to be influenced by factors other than pain such as distress and expectancy . The purpose of this investigation was to determine whether evoked pain paradigms that present pressure stimuli in a r and om fashion ( eg , Multiple R and om Staircase [ MRS ] ) would track with clinical pain improvement in patients with FM better than traditional measures . Sixty-five subjects enrolled in a r and omized clinical trial of acupuncture were observed longitudinally .  Clinical pain was measured on a 101-point numerical rating scale ( NRS ) and the Short Form McGill Pain Question naire ( SF-MPQ ) , whereas evoked pressure sensitivity was assessed via manual tender point count , dolorimetry , and MRS methods . Improvements in clinical pain and evoked pain were assessed irrespective of group assignment . Improvement was seen in clinical pain during the course of the trial as measured by both NRS ( P = .032 ) and SF-MPQ ( P = .001 ) . The MRS was the only evoked pain measure to improve correspondingly with treatment ( MRS , P = .001 ; tender point count and dolorimeter , P > .05 ) . MRS change scores were correlated with changes in NRS pain ratings ( P = .003 ) ; however , this association was not stronger than tender point or dolorimetry correlations with clinical pain improvement ( P > .05 ) . Pain sensitivity as assessed by r and om paradigms was associated with improvements in clinical FM pain . Sophisticated pain testing paradigms might be responsive to change in clinical trials . PERSPECTIVE Trials in fibromyalgia often use both clinical and experimental methods of pain assessment ; however , these two outcomes are often poorly correlated . We explore the relationship between changes in clinical and experimental pain within FM patients .  Pressure pain testing that applies stimuli in a r and om order is associated with improvements in clinical pain , but this association was not stronger than other experimental techniques OBJECTIVE --To determine the efficacy of electroacupuncture in patients with fibromyalgia , a syndrome of unknown origin causing diffuse musculoskeletal pain . DESIGN --Three weeks ' r and omised study with blinded patients and evaluating physician . SETTING --University divisions of physical medicine and rehabilitation and rheumatology , Geneva . PATIENTS --70 patients ( 54 women ) referred to the division for fibromyalgia as defined by the American College of Rheumatology . INTERVENTIONS -- Patients were r and omised to electroacupuncture ( n = 36 ) or a sham procedure ( n = 34 ) by means of an electronic numbers generator . MAIN OUTCOME MEASURES --Pain threshold , number of analgesic tablets used , regional pain score , pain recorded on visual analogue scale , sleep quality , morning stiffness , and patient 's and evaluating physician 's appreciation . RESULTS --Seven of the eight outcome parameters showed a significant improvement in the active treatment group whereas none were improved in the sham treatment group . Differences between the groups were significant for five of the eight outcome measures after treatment . CONCLUSIONS --Electroacupuncture is effective in relieving symptoms of fibromyalgia . Its potential in long term management should now be studied Background The results of many clinical trials and experimental studies regarding acupoint specificity are contradictory . This review aims to investigate whether a difference in efficacy exists between ordinary acupuncture  on specific acupoints and sham acupuncture controls on non-acupoints or on irrelevant acupoints . Methods Data bases including Medline , Embase , AMED and Chinese Biomedical Data base were search ed to identify r and omized controlled trials published between 1998 and 2009 that compared  traditional body acupuncture  on acupoints  with sham acupuncture controls  on irrelevant acupoints or non-acupoints with the same needling depth . The Cochrane Collaboration 's tool for assessing risk of bias was employed to address the quality of the included trials . Results Twelve acupuncture clinical trials with sham acupuncture controls were identified and included in the review . The conditions treated varied . Half of the included trials had positive results on the primary outcomes and demonstrated acupoint specificity . However , among those six trials ( total sample size : 985 ) with low risk of bias , five trials ( sample size : 940 ) showed no statistically significant difference between proper and sham acupuncture treatments . Conclusion This review did not demonstrate the existence of acupoint specificity . Further clinical trials with larger sample sizes , optimal acupuncture treatment protocol s and appropriate sham acupuncture controls are required to resolve this important issue BACKGROUND Temporal summation of pain , a phenomenon of the central nervous system ( CNS ) , represents enhanced painful sensation or reduced pain threshold upon repeated stimulation . This pain model has been used to evaluate the analgesic effect of various medications on the CNS . AIMS The present study aim ed to evaluate the effects and characteristics of analgesia induced by electroacupuncture ( EA ) , manual acupuncture ( MA ) and non-invasive sham-acupuncture ( SA ) in healthy humans on temporal summation of pain . METHODS Thirsty-six pain-free volunteers were r and omised into one of the three groups EA ( 2/100 Hz ) , MA or SA . Acupuncture intervention was on ST36 and ST40 on the dominant leg delivered by an acupuncturist blinded to the outcome assessment . Both subjects and the evaluator were blinded to the treatment allocation . Pain thresholds to a single pulse ( single pain threshold , SPT ) and repeated pulses electrical stimulation ( temporal summation thresholds , TST ) were measured before , 30 min after and 24h after each treatment . RESULTS The baseline values of three groups were comparable . Compared to SA , EA significantly increased both SPT and TST immediately after the treatment on the treatment leg as well as 24h after on both the treatment and non-treatment legs ( ANOVA , p<0.05 ) . MA also increased SPT and TST , but the changes were not significantly different from those induced by SA . CONCLUSION EA induces bilateral , segmentally distributed and prolong analgesia on both SPT and TST , indicating a non- central ly specific effect . This effect needs to be verified with heat or mechanical model and in pain patients Background Acupuncture is often used to treat fibromyalgia ( FM ) , but it remains unclear whether acupuncture is effective . This study aims to evaluate the effects of acupuncture on pain and quality of life ( QoL ) in FM patients . Methods Sixteen patients ( 13 women and 3 men aged 25 - 63 years ) suffering from FM were r and omised into two groups : group A ( n = 8) received five acupuncture treatments after the fifth week and group B received ten acupuncture treatments . Outcome measures used in this study were pain intensity ( visual analogue scale , VAS ) and the fibromyalgia impact question naire ( FIQ ) . Results After the fifth week , pain intensity ( U = 25.0 ; P = 0.022 ) in group B decreased and QoL ( U = 24.5 ; P = 0.026 ) improved compared to group A. Conclusion The present study suggests that acupuncture treatment is effective to relieve pain for FM patients in terms of QoL and FIQ OBJECTIVE To evaluate the clinical effect of combination of acupuncture , cupping and medicine for treatment of fibromyalgia syndrome . METHODS By using multi- central r and omized controlled method , 186 cases were r and omly divided into an acupuncture combined with cupping and western medicine group ( group A ) , an acupuncture combined with cupping group ( group B ) and a western medicine group ( group C ) and treated continuously for 4 weeks . The treatment of acupuncture combined with cupping was produced by acupuncture at five mental points and moving cupping on the Hechelu of the back , once evrey other day , thrice each week , and the western medicine therapy by oral administration of Amitriptyline , once each day . The scores of McGill Pain Question naire ( MPQ ) , the amount of tenderness point and the time of producing effect were compared and the therapeutic effects were assessed with the Hamilton Depression Scale ( HAMD ) . RESULTS The cured and markedly effective rate was 65.0 % ( 39/60 ) in the group A , which was superior to 15.9 % ( 10/63 ) in the group B and 16.1 % ( 9/56 ) in the group C ( both P < 0.001 ) . After treatment , the scores of MPQ and HAMD and the amount of tenderness point all decreased in the three groups , group A being significantly better than group B and group C , and the time of producing effect in the group A was more earlier than those in the group B and the group C. CONCLUSION The therapeutic effect of combination of acupuncture , cupping and medicine on fibromyalgia syndrome is superior to that of the simple acupuncture combined with cupping or the simple medicine OBJECTIVE To evaluate a simulated acupuncture technique for use in r and omized controlled trials assessing the efficacy of acupuncture for low-back pain . SETTING The clinic of an accredited acupuncture college in Seattle , Washington . SUBJECTS Acupuncture-naïve enrollees of Group Health Cooperative who had visited their primary care provider with a complaint of back pain that persisted for at least 3 months . EXPERIMENTAL DESIGN In the first experiment , subjects received six insertions of real needles and six pokes with a toothpick in a guidetube in a two-period crossover design . In the second experiment , subjects were r and omly assigned to receive either a complete treatment with real acupuncture needles or a simulated treatment using a toothpick in a guidetube . OUTCOMES In the first experiment , we compared subjects ' perceptions about which implement was used for each " insertion " while in the second , we compared the perceptions ( e.g. , acupuncturist 's warmth and caring , the reasonableness of acupuncture as a treatment ) and pain relief of those who received an acupuncture treatment using needles to those receiving simulated acupuncture . RESULTS In the first experiment , the toothpick insertions were perceived as slightly more like real needling than the real needling ( mean ratings of 2.8 and 2.1 , respectively ; p = 0.08 ) . In the second experiment , 52 % percent of those receiving the simulated needling versus 65 % of those receiving real acupuncture believed they were " definitely " or " probably " receiving real acupuncture ( p = 0.33 ) . Perceptions of acupuncture  , as measured by a credibility question naire , were similar in the two groups . Those receiving real acupuncture were more likely to report immediate pain relief , and this was the factor most predictive of the subject 's belief about which treatment they had received ( p = 0.02 ) . CONCLUSIONS The simulated acupuncture procedure evaluated in this study represents a reasonable control treatment for acupuncture-naïve individuals in r and omized controlled trials assessing the efficacy of acupuncture for low-back pain Controversy remains regarding the mechanisms of acupuncture analgesia . A prevailing theory , largely unproven in humans , is that it involves the activation of endogenous opioid antinociceptive systems and mu-opioid receptors ( MORs ) . This is also a neurotransmitter system that mediates the effects of placebo-induced analgesia . This overlap in potential mechanisms may explain the lack of differentiation between traditional acupuncture and either non-traditional or sham acupuncture in multiple controlled clinical trials . We compared both short- and long-term effects of traditional Chinese acupuncture ( TA ) versus sham acupuncture ( SA ) treatment on in vivo MOR binding availability in chronic pain patients diagnosed with fibromyalgia ( FM ) . Patients were r and omized to receive either TA or SA treatment over the course of 4 weeks .  Positron emission tomography ( PET ) with (11)C-carfentanil was performed once during the first treatment session and then repeated a month later following the eighth treatment . Acupuncture therapy evoked short-term increases in MOR binding potential , in multiple pain and sensory processing regions including the cingulate ( dorsal and subgenual ) , insula , cau date , thalamus , and amygdala . Acupuncture therapy also evoked long-term increases in MOR binding potential in some of the same structures including the cingulate ( dorsal and perigenual ) , cau date , and amygdala . These short- and long-term effects were absent in the sham group where small reductions were observed , an effect more consistent with previous placebo PET studies . Long-term increases in MOR BP following TA were also associated with greater reductions in clinical pain . These findings suggest that divergent MOR processes may mediate clinical ly relevant analgesic effects for acupuncture and sham acupuncture 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 Background Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory . Studies of an acupuncture-based approach , despite its broad acceptance among patients and healthcare staff , have not produced sufficient evidence of its effectiveness in treating this syndrome . The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia , with respect to reducing their pain and level of incapacity , and improving their quality of life . Methods / design R and omized controlled multicentre study , with 156 out patients , aged over 17 years , diagnosed with fibromyalgia according to American College of Rheumatology criteria , either alone or associated with severe depression , according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders . The participants will be r and omly assigned to receive either " True acupuncture " or " Sham acupuncture " . They will be evaluated using a specific measurement system , constituted of the Fibromyalgia Impact Question naire and the Hamilton rating scale for depression . Also taken into consideration will be the clinical and subjective pain intensity , the patient 's family structure and relationships , psychological aspects , quality of life , the duration of previous temporary disability , the consumption of antidepressant , analgesic and anti-inflammatory medication  , and the potential effect of factors considered to be predictors of a poor prognosis . All these aspects will be examined by question naires and other suitably-vali date d instruments . The results obtained will be analysed at 10 weeks , and 6 and 12 months from the start of treatment . Discussion This trial will utilize high quality trial method ologies in accordance with CONSORT guidelines . It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression . Trial registration IS RCT N trial number IS RCT N60217348 ( 19 October 2010 Background The Vaccine Assessment using Linked Data ( VALiD ) trial compared opt-in and opt-out parental consent for a population -based childhood vaccine safety surveillance program using data linkage . A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent . This paper describes the rationale for the trial and provides an overview of the design and methods . Methods / Design Single-centre , single-blind , r and omised controlled trial ( RCT ) stratified by firstborn status . Mothers who gave birth at one tertiary South Australian hospital were r and omised at six weeks post-partum to receive an opt-in or opt-out reply form , along with information explaining data linkage . The primary outcome at 10 weeks post-partum was parental participation in each arm , as indicated by the respective return or non-return of a reply form ( or via telephone or email response ) . A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form , and attitudes and knowledge about data linkage , vaccine safety , consent preferences and vaccination practice s. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period . Analysis has not yet been undertaken . The participation rate and selection bias for each method of consent will be compared when the data are analysed . Discussion The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour , and socioeconomic factors . The limitations to generalisability are discussed . Trial registration Australian New Zeal and Clinical Trials Registry OBJECTIVE To evaluate the effectiveness of acupuncture for fibromyalgia . METHODS Fifty-eight women with fibromyalgia were allocated r and omly to receive either acupuncture together with tricyclic antidepressants and exercise ( n=34 ) , or tricyclic antidepressants and exercise only ( n=24 ) . Patients rated their pain on a visual analogue scale . A blinded assessor evaluated both the mean pressure pain threshold value over all 18 fibromyalgia points and quality of life using SF-36 . RESULTS At the end of 20 sessions , patients who received acupuncture were significantly better than the control group in all measures of pain and in 5 of the SF-36 subscales . After 6 months , the acupuncture group was significantly better than the control group in numbers of tender points , mean pressure pain threshold at the 18 tender points and 3 subscales of SF-36 . After one year , the acupuncture group showed significance in one subscale of the SF-36 ; at 2 years there were no significant differences in any outcome measures . CONCLUSION Addition of acupuncture to usual treatments for fibromyalgia may be beneficial for pain and quality of life for 3 months after the end of treatment . Future research is needed to evaluate the specific effects of acupuncture for fibromyalgia 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 Context A substantial number of patients use acupuncture to treat the symptoms of fibromyalgia , but previous r and omized trials of this intervention are inconclusive , in part because of control groups that did not permit adequate blinding of the patients . Contribution This study r and omly assigned 100 patients with fibromyalgia to 12 weeks of either true acupuncture treatment or one of 3 types of sham acupuncture . No differences in pain were identified between acupuncture and sham acupuncture . Caution s The study had too few patients to detect small differences between the groups . Patients could use other fibromyalgia therapies , so this study evaluates acupuncture as adjunctive treatment . The Editors Fibromyalgia is a condition of unknown cause that is characterized by chronic , diffuse pain and tenderness to palpation at specific musculoskeletal sites ( 1 ) . It is the second most common rheumatologic condition after osteoarthritis , afflicting 2 % to 4 % of the U.S. population ( 2 ) . Most r and omized , controlled trials of allopathic interventions have not demonstrated sustained benefit , and use of complementary and alternative medicine for fibromyalgia is common ( 3 ) . For example , 60 % to 90 % of patients with fibromyalgia report using 1 or more complementary or alternative treatments ( 4 , 5 ) , and 22 % of these patients have tried acupuncture ( 6 ) . Despite skepticism in western cultures , the literature suggests that acupuncture may alleviate chronic pain ( 7 ) . R and omized , controlled trials of acupuncture face many method ologic challenges , including the identification of appropriate treatment and control groups , blinding of study participants , and the inability to blind practitioners ( 8) . Needle placement and the extent to which needle insertion and stimulation is necessary are also controversial ( 7 - 9 ) . In the only rigorous r and omized , controlled trial of acupuncture for fibromyalgia , 7 of 8 outcome measures significantly improved after 3 weeks of treatment with electroacupuncture ( 10 ) . However , because blinding was not assessed and electroacupuncture involves perceptible current , these promising results could reflect a lack of blinding to treatment condition . Moreover , the study followed patients only during treatment . Because fibromyalgia is a chronic condition , longer-term outcomes should be examined . To address these method ologic problems , we performed a r and omized , controlled trial of acupuncture to treat fibromyalgia that included 3 sham acupuncture treatments to account for the effects of needle insertion and placement . The adequacy of participant blinding was carefully evaluated . We sought to determine whether directed acupuncture that is design ed to treat fibromyalgia relieves pain better than does sham acupuncture in adults with fibromyalgia . On the basis of the scant literature and our clinical experience , we hypothesized a priori that directed acupuncture would result in the greatest clinical improvement . Methods Participants Participants were recruited from the greater Seattle , Washington , metropolitan area between January 2001 and September 2002 . Recruitment strategies included dissemination of information on the study through newspapers , television , advertisements , signs posted at university-affiliated hospitals , and letters to local fibromyalgia support groups and health care providers with large caseloads of patients with fibromyalgia . Potential participants were told that they had an equal chance of being assigned to 1 of 4 acupuncture interventions , none of which have been proven but 1 of which was believed to have the most potential to improve the symptoms of fibromyalgia . The institutional review boards at the participating institutions approved the study , and participants provided written informed consent . Eligible participants were English-speaking adults 18 years of age or older in whom fibromyalgia was diagnosed by a physician and who had a prer and omization global pain score of 4 or greater on a visual analogue scale ( 0 = no pain , 10 = worst pain ever ) . Participants agreed to undergo r and omization and kept use of any fibromyalgia-related pharmacologic and nonpharmacologic therapies constant throughout the study . At the baseline evaluation before r and omization , a research coordinator trained in tender-point examination confirmed the diagnosis of fibromyalgia by using the 1990 criteria of the American College of Rheumatology ( 1 ) . Participants were excluded if they reported other pain-related medical conditions or potential contraindications to acupuncture treatment ( such as bleeding disorders or severe needle phobia ) , were pregnant or breastfeeding , used narcotics ( which could blunt the effects of acupuncture ) , were involved in litigation related to fibromyalgia ( which might reduce their incentive for improvement ) , or had previously received acupuncture ( to maximize blinding ) . R and omization Procedure A research coordinator screened and enrolled participants at an academic research center . After participants completed a baseline evaluation , another research coordinator who was uninvolved with data collection r and omly assigned them to 1 of 4 treatment groups by using a computer-generated , blocked r and om-allocation sequence with a block size of 4 . This research coordinator informed the acupuncture clinic of the treatment assignment . Intervention Eight U.S.-trained and licensed acupuncturists with a median of 10 years of experience ( range , 4 to 18 years ) provided study treatments in their private offices . One investigator trained the acupuncturists in the study procedures to increase their comfort with delivering all 4 treatments and monitored compliance with the protocol throughout the study . Participants were assigned an acupuncturist according to geographic convenience and schedule availability , and every effort was made to have them treated by the same acupuncturist for the entire 12 weeks . The primary acupuncturist was defined as the practitioner from whom a participant received the most treatments . In all groups , participants were asked to attend treatment sessions twice weekly for 12 weeks ( 24 treatments ) . We considered participants who attended 80 % or more ( 19 of 24 ) of acupuncture appointments to have completed a full course of treatment . Outcome measures were collected at regularly scheduled time points from participants who discontinued treatment . Participants received directed acupuncture design ed to treat fibromyalgia according to the practice of Traditional Chinese Medicine or 1 of 3 sham acupuncture treatments . One sham intervention , a control for acupoint specificity , involved acupuncture typically used to treat irregular menses or early menses due to Blood Heat ( an unrelated condition ) according to Traditional Chinese Medicine . Another sham intervention , which was also a control for acupoint specificity , used body locations not recognized as true acupoints or meridians for needling ( sham needling ) . The third sham treatment , a control for needle insertion , consisted of noninsertive simulated acupuncture at the same acupoints used in directed acupuncture ( simulated acupuncture ) . This technique , in which a toothpick in a needle guide-tube is used to mimic needle insertion and withdrawal , has been shown to be indistinguishable from true acupuncture in acupuncture-nave patients with back pain ( 9 ) . Simulated acupuncture more closely duplicates the needle insertion experience than do techniques using placebo needles that require placing adhesive or plastic foam on the skin ( 11 , 12 ) . Acupoints and sham points ( Appendix Figure ) were chosen by a study acupuncturist with 15 years of experience in treating fibromyalgia and were approved by 3 other senior acupuncturists . In all groups that underwent needle insertion , needles were retained at st and ard depths ( 13 ) for 30 minutes at each acupoint . Disposable Chinese , Japanese , or Korean needles ( 34 to 40 gauge ) were used , depending on the practitioner 's preference . In the simulated acupuncture group , participants remained on the table for 30 minutes after simulated insertion and then underwent simulated needle withdrawal . Efforts were made to imitate the sounds of opening needle packs and needle disposal . Acupuncturists were not blinded to the treatments they delivered . To maximize participant blinding , we included only acupuncture-nave persons who could not compare their treatment with previous experiences with acupuncture , limited contact among study participants , restricted conversation between acupuncturists and participants , and blindfolded participants during treatment . All research personnel who collected or analyzed data were unaware of treatment group . At the end of 12 weeks , we collected data to assess the adequacy of blinding . Outcome Measures Demographic measures collected at the baseline evaluation included age , sex , race , education , marital status , and duration of pain and diagnosis of fibromyalgia . Participants also listed the types of therapies they had previously tried for their pain . We grouped this information into manual therapies ( physical , ergonometric , chiropractic , or massage therapy ) , mental health therapies ( psychotherapy or cognitive behavioral therapy ) , dietary changes , or other therapies ( nerve blocks , hypnosis , or biofeedback ) . Outcome measures were collected at baseline ; after 1 , 4 , 8 , and 12 weeks of acupuncture treatment ; and 3 and 6 months after completion of treatment ( weeks 24 and 36 ) . The primary outcome was subjective pain , as measured by a st and ard 10-cm visual analogue scale ( 0 = no pain , 10 = worst pain ever ) . Other outcomes measured by using a visual analogue scale were intensity of fatigue ( 0 = none , 10 = worst ever ) , sleep quality ( 0 = worst ever , 10 = best ever ) , and overall well-being ( 0 = worst ever , 10 = best ever ) . We assessed physical and mental functioning by using the Medical Outcomes Study 36-item Short-Form Health Survey ( 14 ) , which has high reliability and validity in many patient groups , including Acupuncture treatment and control group interventions in parallel-group r and omised trials of acupuncture are not always precisely reported . In an attempt to improve st and ards , an international group of experienced acupuncturists and research ers devised a set of recommendations , design ating them STRICTA : ST and ards for Reporting Interventions in Controlled Trials of Acupuncture . In a further consensus-building round , the editors of several journals helped redraft the recommendations . These follow the Consoli date d St and ards for Reporting Trials ( CONSORT ) format , acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies . Participating journal editors are publishing the STRICTA recommendations and requesting prospect i ve authors to adhere to them when preparing reports for publication . Other journals are invited to adopt these recommendations . The intended outcome is that interventions in controlled trials of acupuncture  will be more adequately reported , thereby facilitating an improvement in critical appraisal , analysis and replication of trials Abstract In a pooled analysis of four r and omized controlled trials of acupuncture in patients with migraine , tension‐type headache , chronic low back pain , and osteoarthritis of the knee we investigated the influence of expectations on clinical outcome . The 864 patients included in the analysis received either 12 sessions of  acupuncture or minimal ( i.e. sham ) acupuncture ( superficial needling of non‐acupuncture points ) over an 8 week period . Patients were asked at baseline whether they considered acupuncture to be an effective therapy in general and what they personally expected from the treatment . After three acupuncture sessions patients were asked how confident they were that they would benefit from the treatment strategy they were receiving . Patients were classified as responders if the respective main outcome measure improved by at least fifty percent . Both univariate and multivariate analyses adjusted for potential confounders ( such as condition , intervention group , age , sex , duration of complaints , etc . ) consistently showed a significant influence of attitudes and expectations on outcome . After completion of treatment , the odds ratio for response between patients considering acupuncture an effective or highly effective therapy and patients who were more sceptical was 1.67 ( 95 % confidence interval 1.20–2.32 ) . For personal expectations and confidence after the third session , odds ratios were 2.03 ( 1.26–3.26 ) and 2.35 ( 1.68–3.30 ) , respectively . Results from the 6‐month follow‐up were similar . In conclusion , in our trials a significant association was shown between better improvement and higher outcome expectations OBJECTIVES The objective of this study was to investigate whether typical acupuncture methods such as needle placement , needle stimulation , and treatment frequency were important factors in fibromyalgia symptom improvement . DESIGN / SETTING S/SUBJECTS : A single-site , single-blind , r and omized trial of 114 participants diagnosed with fibromyalgia for at least 1 year was performed . INTERVENTION Participants were r and omized to one of four treatment groups : ( 1 ) T/S needles placed in traditional sites with manual needle stimulation ( n = 29 ) : ( 2 ) T/0 traditional needle location without stimulation ( n = 30 ) ; ( 3 ) N/S needles inserted in nontraditional locations that were not thought to be acupuncture sites , with stimulation ( n = 28 ) ; and ( 4 ) N/0 nontraditional needle location without stimulation ( n = 2 7 ) . All groups received treatment once weekly , followed by twice weekly , and finally three times weekly , for a total of 18 treatments . Each increase in frequency was separated by a 2-week washout period . OUTCOME MEASURES Pain was assessed by a numerical rating scale , fatigue by the Multi-dimensional Fatigue Inventory , and physical function by the Short Form-36 . RESULTS Overall pain improvement was noted with 25%-35 % of subjects having a clinical ly significant decrease in pain ; however this was not dependent upon " correct " needle stimulation ( t = 1.03 ; p = 0.307 ) or location ( t = 0.76 ; p = 0.450 ) . An overall dose effect of treatment was observed , with three sessions weekly providing more analgesia than sessions once weekly ( t = 2.10 ; p = 0.039 ) . Among treatment responders , improvements in pain , fatigue , and physical function were highly codependent ( all p < or = 0.002 ) . CONCLUSIONS Although needle insertion led to analgesia and improvement in other somatic symptoms , correct needle location and stimulation were not crucial Acupuncture treatment and control group interventions in parallel-group r and omised trials of acupuncture are not always precisely reported . In an attempt to improve st and ards , an international group of experienced acupuncturists and research ers devised a set of recommendations , design ating them STRICTA : ST and ards for Reporting Interventions in Controlled Trials of Acupuncture . In a further consensus-building round , the editors of several journals helped redraft the recommendations . These follow the Consoli date d St and ards for Reporting Trials ( CONSORT ) format , acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies . Participating journal editors are publishing the STRICTA recommendations and requesting prospect i ve authors to adhere to them when preparing reports for publication . Other journals are invited to adopt these recommendations . The intended outcome is that interventions in controlled trials of acupuncture  will be more adequately reported , thereby facilitating an improvement in critical appraisal , analysis and replication of trials OBJECTIVE To observe the therapeutic effect of acupuncture at five mental points and moving cupping on the Hechelu of the back on fibromyalgia syndrome ( FS ) . METHODS Sixty-six cases who conformed to the criteria were r and omly divided into the treatment group treated with acupuncture at five mental points , moving cupping on the Hechelu of the back and amitriptyline , and the control group treated with amitriptyline . Clinical therapeutic effects were assessed with McGill Pain Question naire ( MPQ ) and HAMD depression scale . RESULTS The therapeutic effect of the treatment group was better than that of the control group with a significant difference between the two groups ( P < 0.01 ) . CONCLUSION Combination of acupuncture with cupping therapy is an effective therapy for fibromyalgia syndrome Acupuncture has become a widely used treatment modality in various musculoskeletal pain conditions . Acupuncture is also shown to enhance blood flow and recovery in surgical flaps . The mechanisms behind the effect on blood flow were suggested to rely on vasoactive substances , such as calcitonin gene-related peptide , released from nociceptors by the needle stimulation . In a previous study on healthy subjects , one needle stimulation into the anterior tibial muscle was shown to increase both skin and muscle blood flow . The aim of this study was to examine the effect of needle stimulation on local blood flow in the anterior tibial muscle and overlying skin in patients suffering from a widespread chronic pain condition . Fifteen patients with fibromyalgia ( FM ) participated in the study . Two modes of needling , deep muscle stimulation and subcutaneous needle insertion were performed at the upper anterior aspect of the tibia , i.e. , in an area without focal pathology or ongoing pain in these patients . Blood flow changes were assessed non-invasively by photoplethysmography ( PPG ) . The results of the present study were partly similar to those earlier found at a corresponding site in healthy female subjects , i.e. , deep muscle stimulation result ed in larger increase in skin blood flow ( mean ( SE ) ) : 62.4 % ( 13.0 ) and muscle blood flow : 93.1 % ( 18.6 ) , compared to baseline , than did subcutaneous insertion ( mean ( SE ) skin blood flow increase : 26.4 % ( 6.2 ) ; muscle blood flow increase : 46.1 % ( 10.2 ) ) . However , in FM patients subcutaneous needle insertion was followed by a significant increase in both skin and muscle blood flow , in contrast to findings in healthy subjects where no significant blood flow increase was found following the subcutaneous needling . The different results of subcutaneous needling between the groups ( skin blood flow : p=0.008 ; muscle blood flow : p=0.027 ) may be related to a greater sensitivity to pain and other somatosensory input in FM OBJECTIVE To compare therapeutic effects of penetration needling at the back and western medicine on fibromyalgia syndrome ( FS ) . METHODS Thirty-eight cases were r and omly divided into the observation group treated with penetration needling at the first and second lines of The Bladder Meridian of Foot-Taiyang and Governor Vessel , and the control group treated mainly with oral administration of amitriptyline , 19 cases in each group . RESULTS There were significant differences in the cured-markedly effective rate and the results of follow-up for 6 months for the cured-markedly effective cases between the observation group and the control group ( all P < 0.01 ) . CONCLUSION Penetration needling therapy in the therapeutic effect on fibromyalgia syndrome is better than the medical treatment
BACKGROUND One in five fibromyalgia sufferers use acupuncture treatment within two years of diagnosis .
OBJECTIVES To examine the benefits and safety of acupuncture treatment for fibromyalgia .