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Unilateral versus Bilateral Acupuncture on Knee Function in Advanced Osteoarthritis of the Knee – a Prospective Randomised Trial Comparison Between Electro-Acupuncture and Hydrotherapy, Both in Combination With Patient Education and Patient Education Alone, on the Symptomatic Treatment of Osteoarthritis of the Hip
BACKGROUND Glucosamine and chondroitin sulfate are used to treat osteoarthritis . The multicenter , double-blind , placebo- and celecoxib-controlled Glucosamine/chondroitin Arthritis Intervention Trial ( GAIT ) evaluated their efficacy and safety as a treatment for knee pain from osteoarthritis . METHODS We r and omly assigned 1583 patients with symptomatic knee osteoarthritis to receive 1500 mg of glucosamine daily , 1200 mg of chondroitin sulfate daily , both glucosamine and chondroitin sulfate , 200 mg of celecoxib daily , or placebo for 24 weeks . Up to 4000 mg of acetaminophen daily was allowed as rescue analgesia . Assignment was stratified according to the severity of knee pain ( mild [ N=1229 ] vs. moderate to severe [ N=354 ] ) . The primary outcome measure was a 20 percent decrease in knee pain from baseline to week 24 . RESULTS The mean age of the patients was 59 years , and 64 percent were women . Overall , glucosamine and chondroitin sulfate were not significantly better than placebo in reducing knee pain by 20 percent . As compared with the rate of response to placebo ( 60.1 percent ) , the rate of response to glucosamine was 3.9 percentage points higher ( P=0.30 ) , the rate of response to chondroitin sulfate was 5.3 percentage points higher ( P=0.17 ) , and the rate of response to combined treatment was 6.5 percentage points higher ( P=0.09 ) . The rate of response in the celecoxib control group was 10.0 percentage points higher than that in the placebo control group ( P=0.008 ) . For patients with moderate-to-severe pain at baseline , the rate of response was significantly higher with combined therapy than with placebo ( 79.2 percent vs. 54.3 percent , P=0.002 ) . Adverse events were mild , infrequent , and evenly distributed among the groups . CONCLUSIONS Glucosamine and chondroitin sulfate alone or in combination did not reduce pain effectively in the overall group of patients with osteoarthritis of the knee . Exploratory analyses suggest that the combination of glucosamine and chondroitin sulfate may be effective in the subgroup of patients with moderate-to-severe knee pain . ( Clinical Trials.gov number , NCT00032890 . ) OBJECTIVE To assess the efficacy of glucosamine sulfate in knee osteoarthritis ( OA ) . METHODS A 4-center , 6-month , r and omized , double-blind , placebo-controlled glucosamine discontinuation trial was conducted in 137 current users of glucosamine with knee OA who had experienced at least moderate improvement in knee pain after starting glucosamine .  Study medication dosage was equivalent to the dosage of glucosamine taken prior to the study ( maximum 1,500 mg/day ) . Followup continued for 6 months or until disease flare , whichever occurred first . The primary outcome was the proportion of disease flares in the glucosamine and placebo groups using an intent-to-treat analysis . Secondary outcomes included time to disease flare ; analgesic medication use ; severity of disease flare ; and change in pain , stiffness , function and quality of life in the glucosamine and placebo groups . RESULTS Disease flare was seen in 28 ( 42 % ) of 66 placebo patients and 32 ( 45 % ) of 71 glucosamine patients ( difference -3 % ; 95 % confidence interval [ 95 % CI ] -19 , 14 ; P = 0.76 ) . In the Cox regression analysis , after adjustment for sex , study site , and OA radiographic severity , time to disease flare was not significantly different in the glucosamine compared with placebo group ( hazard ratio of flare = 0.8 ; 95 % CI 0.5 , 1.4 ; P = 0.45 ) . At final study visit ,  acetaminophen  was used in 27 % and 21 % of placebo and glucosamine patients , respectively ( P = 0.40 ) , nonsteroidal antiinflammatory drugs were used in 29 % and 30 % ( P = 0.92 ) , and both were used in 20 % and 21 % ( P = 0.84 ) . No differences were found in severity of disease flare or other secondary outcomes between placebo and glucosamine patients . CONCLUSION In patients with knee OA with at least moderate subjective improvement with prior glucosamine use , this study provides no evidence of symptomatic benefit from continued use of glucosamine sulfate OBJECTIVE To determine whether it is possible to specify different score patterns for hip and knee osteoarthritis ( OA ) , and to identify the degree of responsiveness and the validity of the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) factors , which are alternative health dimensions obtained by factor analysis of the WOMAC items . METHODS  WOMAC scales and WOMAC factors  were compared in a prospect i ve setting examining patients with hip and knee OA before and after rehabilitative inpatient intervention ( n = 317 ) . In a partial sample ( n = 103 ) , the validity of the WOMAC factors was determined by a global rating of their activities . RESULTS The WOMAC factor " ascending/descending " was significantly different for hip and knee OA in the health state before therapy ( score in hip 5.09 , in knee 6.59 ; p < 0.001 ) ; this was also true of the effect size after therapy ( hip 0.39 , knee 0.65 ; p = 0.012 ) . The WOMAC scales did not differ for the 2 conditions . The WOMAC factor " ascending/descending " was the most responsive dimension in knee OA ( effect size 0.65 ) , but in hip OA the WOMAC pain scale was most responsive ( effect size 0.55 ) . Most of the WOMAC factors correlated moderately ( r = 0.52 - 0.69 ) with the patient 's self-rating on the validation question naire . CONCLUSION The WOMAC factors are valid measures . Analyzing the WOMAC by the WOMAC factors facilitates and improves the differential relevance and accuracy of the WOMAC for specific conditions such as hip and knee OA Objectives To compare the effect of acupuncture ( manual and electroacupuncture ) with that of a non-penetrating sham ( ‘ placebo ’ needle ) in patients with osteoarthritic knee pain and disability who are blind to the treatment allocation . Methods Acupuncture naive patients with symptomatic and radiological evidence of osteoarthritis of the knee were r and omly allocated to a course of either acupuncture or non-penetrating sham acupuncture using a sheathed ‘ placebo ’ needle system . Acupuncture points for pain and stiffness were selected according to acupuncture theory for treating Bi syndrome . Both manual and electrical stimulation were used . Response was assessed using the WOMAC index for osteoarthritis of the knee , self reported pain scale , the EuroQol score and plasma β-endorphin . The effectiveness of blinding was assessed . Results There were 34 patients in each group . The primary end point was the change in WOMAC pain score after the course of treatment . Comparison between the two treatment groups found a significantly greater improvement with acupuncture ( mean difference 60 , 95 % CI 5 to 116 , P=0.035 ) than with sham . Within the acupuncture group there was a significant improvement in pain ( baseline 294 , mean change 95 , 95 % CI 60 to 130 , P<0.001 ) which was not seen by those who had sham acupuncture ( baseline 261 , mean change 35 , 95 % CI-10 to 80 , P=0.12 ) . Similar effects within group , but not between groups , were seen with the secondary end points of WOMAC stiffness , WOMAC function , and self reported pain . One month after treatment the between group pain difference had been lost ( mean difference 46 ; 95 % CI −9 to 100 , P=0.10 ) although the acupuncture group was still benefiting compared to baseline ( mean difference 59 ; 95 % CI 16 to 102 , P=0.009 ) . The EuroQol score , a generic measure of health related quality of life , was not altered by the treatments . A minority of patients correctly guessed their treatment group ( 41 % in the acupuncture group and 44 % in the control group ) . Plasma β-endorphin levels were not affected by either treatment . Conclusions Acupuncture gives symptomatic improvement for patients with osteoarthritis of the knee , and is significantly superior to non-penetrating sham acupuncture . The study did not confirm earlier reports of release of plasma β-endorphin during acupuncture Background Using an open r and omised controlled study , we examined the effectiveness of manual and electroacupuncture on symptom relief for patients with osteoarthritis of the knee . Methods Patients with symptomatic osteoarthritis of the knee were r and omised to one of three treatment groups . Group A had acupuncture alone , group B had acupuncture but continued on their symptomatic medication , and group C used their symptomatic medication for the first five weeks and then had a course of acupuncture added . Patients receiving acupuncture were treated twice weekly over five weeks . Needles were inserted ( with manual and electrical stimulation ) in acupuncture points for pain and stiffness , selected according to traditional acupuncture theory for treating Bi syndrome . Patients were assessed by a blinded observer before treatment , after five weeks ’ treatment and at one month follow up , using a visual analogue pain scale ( VAS ) and the Western Ontario McMaster ( WOMAC ) question naire for osteoarthritis of the knee . Results The 30 patients in our study were well matched for age , body mass index , disease duration , baseline VAS pain score and baseline WOMAC scores . Repeated measure analyses gave a highly significant improvement in pain ( VAS ) after the courses of acupuncture in groups A ( P=0.012 ) and B ( P=0.001 ) ; there was no change in group C until after the course of acupuncture , when the improvement was significant ( P=0.001 ) . Similarly significant changes were seen with the WOMAC pain and stiffness scores . These benefits were maintained during the one month after the course of acupuncture . Patients ’ rating of global assessment was higher than that of the acupuncturist . Conclusion We conclude that manual and electroacupuncture causes a significant improvement in the symptoms of osteoarthritis  of the knee , either on its own or as an adjunct therapy , with no loss of benefit after one month Clinical and experimental data indicate that most acupuncture clinical results are mediated by the central nervous system , but the specific effects of acupuncture on the human brain remain unclear . Even less is known about its effects on the cerebellum . This fMRI study demonstrated that manual acupuncture at ST 36 ( Stomach 36 , Zusanli ) , a main acupoint on the leg , modulated neural activity at multiple levels of the cerebro-cerebellar and limbic systems . The pattern of hemodynamic response depended on the psychophysical response to needle manipulation . Acupuncture stimulation typically elicited a composite of sensations termed deqi that is related to clinical efficacy according to traditional Chinese medicine . The limbic and paralimbic structures of cortical and subcortical regions in the telencephalon , diencephalon , brainstem and cerebellum demonstrated a concerted attenuation of signal intensity when the subjects experienced deqi . When deqi was mixed with sharp pain , the hemodynamic response was mixed , showing a predominance of signal increases instead . Tactile stimulation as control also elicited a predominance of signal increase in a subset of these regions . The study provides preliminary evidence for an integrated response of the human cerebro-cerebellar and limbic systems to acupuncture stimulation at ST 36 that correlates with the psychophysical response A prospect i ve , controlled clinical trial was undertaken to assess the relative efficacies of physiotherapy and electroacupuncture in the treatment of cervical spondylosis . The results suggested that , while both methods were effective , electroacupuncture produced an earlier symptomatic improvement with increased neck movement , especially in patients with mild degenerative changes of the cervical spine OBJECTIVE The purpose of this study was to investigate the efficacy of acupuncture as an adjunctive therapy to st and ard care for the relief of pain and dysfunction in elderly patients with osteoarthritis ( OA ) of the knee . METHODS Seventy-three patients with symptomatic OA of the knee were r and omly assigned to treatment ( acupuncture ) or st and ard care ( control ) . Analysis was performed on last score carried forward to account for patients who dropped out before completion . Patients self-scored Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) and Lequesne indices at baseline and at 4 , 8 and 12 weeks . Patients in the control group were offered acupuncture treatment after 12 weeks . The data for these patients are pooled with those from the original acupuncture group for within-group analysis . RESULTS Patients r and omized to acupuncture improved on both WOMAC and Lequesne indices compared to those who received st and ard treatment alone . Significant differences on total WOMAC Scale were seen at 4 and 8 weeks . There appears to be a slight decline in effect at 4 weeks after cessation of treatment ( 12 weeks after first treatment ) . No adverse effects of acupuncture were reported . CONCLUSION These data suggest that acupuncture is an effective and safe adjunctive therapy to conventional care for patients with OA of the knee 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 OBJECTIVE To evaluate the effects of st and ardized western acupuncture and physiotherapy on pain and functional ability in patients with severe osteoarthritic knee pain awaiting knee arthroplasty . METHODS Three-arm , assessor-blind , r and omized controlled trial . PARTICIPANTS 181 patients awaiting knee arthroplasty . INTERVENTIONS acupuncture for 6 weeks ; physiotherapy for 6 weeks ; st and ardized advice . MAIN OUTCOME MEASURES Oxford Knee Score question naire ( OKS ) ( primary ) ; 50 m timed walk , and duration of hospital stay following knee arthroplasty . RESULTS There was no baseline difference between groups . At 7 weeks , there was a 10 % reduction in OKS in the acupuncture group which was a significant difference between the acupuncture and the control group : Mean ( s.d . ) acupuncture 36.8 ( 7.20 ) ; physiotherapy 39.2 ( 8.22 ) ; control 40.3 ( 8.48 ) ( P = 0.0497 ) . These effects were no longer present at 12 weeks . There was a trend ( P = 0.0984 ) towards a shorter in-patient stay of 1 day for the physiotherapy group [ mean 6.50 days ( s.d . 2.0 ) ] compared with the acupuncture group [ mean 7.77 days ( s.d . 3.96 ) ] . CONCLUSIONS We have demonstrated that patients with severe knee osteoarthritis can achieve a short-term reduction in OKS when treated with acupuncture . However , we failed to demonstrate any other clinical ly or statically significant effects between the groups . Both interventions can be delivered effectively in an out-patient group setting at a district general hospital . Further study is needed to evaluate the combined effects of these treatments The purpose of this study was to compare the effectiveness of transcutaneous nerve stimulation ( TENS ) , electroacupuncture ( EA ) , and ice massage with placebo treatment for the treatment of pain . Subjects ( n = 100 ) diagnosed with osteoarthritis ( OA ) of the knee were treated with these modalities . The parameters for evaluating the effectiveness of treatment include pain at rest , stiffness , 50 foot walking time , quadriceps muscle strength , and knee flexion degree . The results showed ( a ) that all three methods could be effective in decreasing not only pain but also the objective parameters in a short period of time ; and ( b ) that the treatment results in TENS , EA and ice massage were superior to placebo Background The present study tests whether a combined treatment of acupuncture and transcutaneous electrical nerve stimulation ( TENS ) is more effective than acupuncture or TENS alone for treating knee osteoarthritis ( OA ) . Methods Thirty-two patients with knee OA were r and omly allocated to four groups . The acupuncture group ( ACP ) received only acupuncture treatment at selected acupoints for knee pain ; the TENS group ( TENS ) received only TENS treatment at pain areas ; the acupuncture and TENS group ( A&T ) received both acupuncture and TENS treatments ; the control group ( CT ) received topical poultice ( only when necessary ) . Each group received specific weekly treatment five times during the study . Outcome measures were pain intensity in a visual analogue scale ( VAS ) and knee function in terms of the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . Results The ACP , TENS and A&T groups reported lower VAS and WOMAC scores than the control group . Significant reduction in pain intensity ( P = 0.039 ) and significant improvement in knee function ( P = 0.008 ) were shown in the A&T group . Conclusion Combined acupuncture and TENS treatment was effective in pain relief and knee function improvement for the sample d patients suffering from knee OA 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 BACKGROUND Acupuncture is widely used by patients with low back pain , although its effectiveness is unclear . We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with chronic low back pain .  METHODS Patients were r and omized to treatment with acupuncture , minimal acupuncture ( superficial needling at nonacupuncture points ) , or a waiting list control . Acupuncture and minimal acupuncture were administered by specialized acupuncture physicians in 30 outpatient centers , and consisted of 12 sessions per patient over 8 weeks . Patients completed st and ardized question naires at baseline and at 8 , 26 , and 52 weeks after r and omization . The primary outcome variable was the change in low back pain intensity from baseline to the end of week 8 , as determined on a visual analog scale ( range , 0 - 100 mm ) . RESULTS A total of 298 patients ( 67.8 % female ; mean + /- SD age , 59 + /- 9 years ) were included . Between baseline and week 8 , pain intensity decreased by a mean + /- SD of 28.7 + /- 30.3 mm in the acupuncture group , 23.6 + /- 31.0 mm in the minimal acupuncture group , and 6.9 + /- 22.0 mm in the waiting list group . The difference for the acupuncture vs minimal acupuncture group was 5.1 mm ( 95 % confidence interval , -3.7 to 13.9 mm ; P = .26 ) , and the difference for the acupuncture vs waiting list group was 21.7 mm ( 95 % confidence interval , 13.9 - 30.0 mm ; P<.001 ) . Also , at 26 ( P=.96 ) and 52 ( P=.61 ) weeks , pain did not differ significantly between the acupuncture and the minimal acupuncture groups . CONCLUSION Acupuncture was more effective in improving pain than no acupuncture treatment in patients with chronic low back pain , whereas there were no significant differences between acupuncture and minimal acupuncture OBJECTIVES To examine the relative effectiveness of electro-acupuncture ( EA ) and transcutaneous electrical nerve stimulation ( TENS ) in alleviating osteoarthritic (OA)-induced knee pain .  DESIGN Single-blinded , r and omized controlled study . SUBJECTS Twenty-four ( 24 ) subjects ( 23 women and 1 man ) , mean age 85 , were recruited from eight subsidized Care & Attention Homes for the elderly . INTERVENTIONS Subjects were r and omly assigned to the EA , TENS , or control groups . Subjects in the EA group ( n = 8) received low-frequency EA ( 2 Hz ) on two acupuncture points ( ST-35 , Dubi and EX-LE-4 , Neixiyan ) of the painful knee for 20 minutes . Subjects in the TENS group ( n = 8) received low-frequency TENS of 2 Hz and pulse width of 200 micros on the same acupuncture points for 20 minutes . In both treatment groups , electrical treatment was carried out for a total of eight sessions in 2 weeks . Eight subjects received osteoarthritic knee care and education only in a control group . All subjects were evaluated before the first treatment , after the last treatment , and at 2-week follow-up periods . RESULTS After eight sessions of treatment , there was significant reduction of knee pain in both EA group and TENS group , as measured by the Numeric Rating Scale ( NRS ) of pain ( p < 0.01 ) . Prolonged analgesic effect was maintained in the EA and the TENS groups at a 2-week follow-up evaluation . The Timed Up- and -Go Test ( TUGT ) score of the EA group was significantly lower than that of the control group ( p < 0.05 ) , but such change was not observed in the TENS group . CONCLUSIONS Both EA and TENS treatments were effective in reducing OA-induced knee pain .  EA had the additional advantage of enhancing the TUGT results as opposed to TENS treatment or no treatment , which did not produce such corollary effect Context  Chronic neck pain  is a common , disabling condition and is difficult to treat . Because traditional therapies , such as physical therapy and nonsteroidal anti-inflammatory drugs , have limited effectiveness and can have adverse effects , many patients seek alternative therapies , such as acupuncture . Contribution This r and omized , controlled trial of acupuncture versus sham transcutaneous electrical stimulation for patients with chronic mechanical neck pain  identified no clinical ly significant benefit of acupuncture over placebo with respect to pain , function , or analgesic use . Implication s Acupuncture did not lead to clinical ly significant improvement in chronic mechanical neck pain when compared with placebo . The Editors Chronic mechanical neck pain can be caused by dysfunction of a variety of structures within the neck ( 1 - 3 ) but specifically excludes systemic problems such as rheumatoid arthritis . It is usually associated with unspecified degenerative changes ( cervical spondylosis ) that include osteoarthritis . Neck pain presents a substantial problem and may be responsible for as many days of work absenteeism as low back pain ( 4 ) . Osteoarthritis is the most common of the chronic diseases and affects most people older than 65 years of age ( 5 ) . It is degenerative and progressive in nature ( 1 - 3 , 6 ) . Because there is no cure for cervical spondylosis , treatment tends to center on symptom relief ( 7 , 8) . If the condition is symptomatic and symptoms are left untreated , this manifests as increasing episodic pain , stiffness , or both , and patients may then experience a spiral of increasing dysfunction ( 9 ) . Two systematic review s of conventional conservative physical therapy suggest that little evidence supports the efficacy of such intervention ( 8 , 10 ) . Nonsteroidal anti-inflammatory drugs , the mainstay of pharmacologic treatment , are associated with a wide spectrum of serious and well-documented adverse reactions ( 5 ) . There has been a huge increase in the use of complementary and alternative medicine in both the United States and the United Kingdom ( 11 , 12 ) . Acupuncture is the most frequently used type of complementary and alternative medicine therapy for the treatment of osteoarthritis ( 13 ) . Despite little sound evidence of efficacy ( 14 ) , approximately 1 million people seek complementary and alternative medicine treatment annually in the United States ( 15 ) . Two systematic review s of acupuncture in neck pain ( 4 , 16 ) suggest that there has been insufficient research in this area and that the published studies are of poor quality . Therefore , we conducted a rigorous evaluation to test whether western-style acupuncture performs better than placebo for treatment of chronic mechanical neck pain . We defined western acupuncture as a conventional diagnosis followed by individualized acupuncture treatment using a combination of prescriptive tender , local , and distal points . This is in contrast to a traditional Chinese approach , which would formulate an individualized diagnosis based on traditional Chinese theories of meridians and energy ( or qi ) . Methods Study Design and Patient Selection We design ed a r and omized , single-blind , placebo-controlled trial using a pragmatic treatment regimen . The study was conducted in the outpatient departments of Southampton General Hospital and Salisbury District Hospital in the United Kingdom . Between 1999 and 2001 , patients were referred by rheumatologists or family physicians or from physiotherapy waiting lists . Appropriate ethical approval was obtained from the Southampton and South West Hampshire Joint Research Ethics Committee . Patients were 18 to 80 years of age , had chronic ( > 2 months ) mechanical neck pain , and had a pain score of more than 30 mm on a visual analogue scale ( VAS ) for 5 of 7 pretreatment days ( possible score on this VAS ranges from 0 to 100 mm ) . We excluded pregnant patients ; those with a history of fracture or surgery to the neck , cervical congenital abnormality , uncontrolled low back pain , contraindication to acetaminophen , systemic illness ( for example , rheumatoid arthritis ) , or ongoing neck-related litigation or disability cl aims ; and those with current or recent manual neck treatment or steroid use ( oral or local injection ) . Sample Size Previous studies suggested a 50 % to 75 % improvement using  acupuncture  for patients with chronic pain  , compared with 30 % for placebo treatment ( 17 ) . We used these findings as the basis for our power calculation . At 5 % significance and 90 % power , 53 patients were required in each group to detect a 30 % difference in response between active and placebo treatments . Interventions Informed consent was obtained along with a full medical history , neurologic examination , cervical radiography , and laboratory investigations ( full blood count , erythrocyte sedimentation rate , and liver function tests ) . We told patients that we were comparing 2 types of intervention : 1 ) acupuncture with needles and 2 ) treatment with a machine design ed to stimulate acupuncture points through skin electrodes . The patients were informed that the treatment might or might not prove to be effective and that there was a 50 % chance that they would be assigned to a placebo but were not told what the placebo was . Blinding was not broken until 1 year after treatment . One practitioner performed all interventions . Acupuncture We used single-use , sterile , silver-h and le , prepacked needles without guide tubes . Sizes used were 13 mm 0.25 mm , 25 mm 0.25 mm , and 40 mm 0.25 mm . We based point selection on individualized western acupuncture techniques by using a list of points previously reported as being effective in neck pain ( 18 , 19 ) and by reaching a consensus according to our own clinical and teaching practice ( Appendix Table ) . The specific points for each individual were defined at each treatment session , depending on the patient 's pain distribution  and palpation of the neck and thorax to determine ah-shi points , or local tender points , for acupuncture . At least 1 distal point was used . Point location and depth of insertion were as described in traditional texts ( 19 ) . Six points on average , per side if pain was bilateral , were used on each patient , and deqi ( a term used to describe acupuncture needle sensation ) was obtained on each needle . Twenty-minute treatment sessions were given . The patient was checked every 6 or 7 minutes to ascertain whether deqi was still present , and needles were manipulated again if required . Placebo There is considerable debate about the ideal placebo for acupuncture studies ( 20 ) . To enhance the rigor of our study , we chose to use a previously well-vali date d placebo ( 17 , 21 - 23 ) that could not have a specific physiologic effect . The Noma FM-4 electroacupuncture stimulator ( Noma Ltd. , Southampton , United Kingdom ) was used . It has 4 channels , allowing pseudostimulation of up to 8 acupuncture points simultaneously , and emits visual and audio signals . Reusable electrodes ( Body Clock Health Care Ltd. , London , United Kingdom ) were fixed to the surface of the patient 's skin and were connected to the stimulator through decommissioned cables . The cables were severed inside the output plug , so that no current could reach the patient . Examination and point selection were the same as with real acupuncture for each treatment . Point location and treatment variables were changed during subsequent treatment sessions if patients felt they were not progressing . Patients were told that the machine could stimulate acupuncture points through high-frequency , low-intensity stimulation and therefore would not produce any sensation . If patients reported sensation , the therapist adjusted the unit for comfort ( although since this was a sham procedure , such adjustment made no real difference ) . Patients in both groups were instructed to use acetaminophen alone for pain relief and were not given or permitted any other form of treatment , including exercises or stretches , during the study and for 2 months after treatment ended . Patients were treated twice per week for 4 weeks . The therapist had taken an Acupuncture Association of Chartered Physiotherapists accredited course on western acupuncture techniques and had 7 years of experience practicing acupuncture . R and omization R and omization lists for Southampton General Hospital and Salisbury District Hospital were generated by using a computer program , R and omlogue , produced by Southampton University Department of Medical Statistics , Southampton , United Kingdom . Sealed envelopes containing the individual r and omization codes , numbered consecutively with sex and age strata , were then prepared ( sex strata were male and female , and age strata were 18 to 49 years and 50 to 80 years ) Patients were strictly allocated across 4 strata for either of the study hospitals according to the next available envelope number . Data Collection Before r and omization , patients were instructed to use a daily pain diary  ( on a VAS ) to record pain and  acetaminophen  use for 7 consecutive days . After a week , the pain diaries were examined , and if the inclusion criteria ( which were unknown to the patients ) were satisfied , r and omization occurred . Patients completed the various question naires before treatment and at 1 and 8 weeks after treatment . Pain continued to be recorded either weekly or daily throughout treatment and up to 8 weeks after treatment . Additional question naires and pain evaluation were also completed at 6 and 12 months after treatment . Figure 1 shows a flow chart of the trial . Figure 1 . Study flow with outcome assessment s. Outcomes The VAS score for pain 1 week after treatment , recorded daily for 7 consecutive days , was the primary outcome . Pain was recorded on a scale of 0 mm ( indicating no pain ) to 100 mm ( indicating worst pain imaginable ) . A significant outcome for acupuncture was considered to be a 30 % difference in VAS score between groups 5 weeks after r and omization ( 1 week after treatment ) , taking into account baseline pain . Secondary Blinding embodies a rich history spanning over two centuries . Most research ers worldwide underst and blinding terminology , but confusion lurks beyond a general comprehension . Terms such as single blind , double blind , and triple blind mean different things to different people . Moreover , many medical research ers confuse blinding with allocation concealment . Such confusion indicates misunderst and ings of both . The term blinding refers to keeping trial participants , investigators ( usually health-care providers ) , or assessors ( those collecting outcome data ) unaware of the assigned intervention , so that they will not be influenced by that knowledge . Blinding usually reduces differential assessment of outcomes ( information bias ) , but can also improve compliance and retention of trial participants while reducing biased supplemental care or treatment ( sometimes called co-intervention ) . Many investigators and readers naïvely consider a r and omised trial as high quality simply because it is double blind , as if double-blinding is the sine qua non of a r and omised controlled trial . Although double blinding ( blinding investigators , participants , and outcome assessors ) indicates a strong design , trials that are not double blinded should not automatically be deemed inferior . Rather than solely relying on terminology like double blinding , research ers should explicitly state who was blinded , and how . We recommend placing greater credence in results when investigators at least blind outcome assessment s , except with objective outcomes , such as death , which leave little room for bias . If investigators properly report their blinding efforts , readers can judge them . Unfortunately , many articles do not contain proper reporting . If an article cl aims blinding without any accompanying clarification , readers should remain sceptical about its effect on bias reduction Abstract Objective To investigate whether a sham device ( a vali date d sham acupuncture needle ) has a greater placebo effect than an inert pill in patients with persistent arm pain . Design A single blind r and omised controlled trial created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls . Comparison of participants who remained on placebo continued beyond the run-in period to the end of the study . Setting Academic medical centre . Participants 270 adults with arm pain due to repetitive use that had lasted at least three months despite treatment and who scored ≥3 on a 10 point pain scale . Interventions Acupuncture with sham device twice a week for six weeks or placebo pill once a day for eight weeks . Main outcome measures Arm pain measured on a 10 point pain scale . Secondary outcomes were symptoms measured by the Levine symptom severity scale , function measured by Pransky 's upper extremity function scale , and grip strength . Results Pain decreased during the two week placebo run-in period in both the sham device and placebo pill groups , but changes were not different between the groups ( −0.14 , 95 % confidence interval −0.52 to 0.25 , P = 0.49 ) . Changes in severity scores for arm symptoms and grip strength were similar between groups , but arm function improved more in the placebo pill group ( 2.0 , 0.06 to 3.92 , P = 0.04 ) . Longitudinal regression analyses that followed participants throughout the treatment period showed significantly greater downward slopes per week on the 10 point arm pain scale in the sham device group than in the placebo pill group ( −0.33 ( −0.40 to −0.26 ) v −0.15 ( −0.21 to −0.09 ) , P = 0.0001 ) and on the symptom severity scale ( −0.07 ( −0.09 to −0.05 ) v −0.05 ( −0.06 to −0.03 ) , P = 0.02 ) . Differences were not significant , however , on the function scale or for grip strength . Reported adverse effects were different in the two groups . Conclusions The sham device had greater effects than the placebo pill on self reported pain and severity of symptoms over the entire course of treatment but not during the two week placebo run in . Placebo effects seem to be malleable and depend on the behaviours embedded in medical rituals Introduction Use of complementary and alternative medicine ( CAM ) for chronic conditions has increased in recent years . There is little information , however , on CAM use among adults with clinic-confirmed diagnoses , including arthritis , who are treated by primary care physicians . Methods To assess the frequency and types of CAM therapy  used by Hispanic and non-Hispanic white women and men with osteoarthritis , rheumatoid arthritis , or fibromyalgia , we used stratified r and om selection to identify 612 participants aged 18–84 years and seen in university-based primary care clinics . Respondents completed an interviewer-administered survey in English or Spanish . Results Nearly half ( 44.6 % ) of the study population was of Hispanic ethnicity , 71.4 % were women , and 65.0 % had annual incomes of less than $ 25,000 . Most ( 90.2 % ) had ever used CAM for arthritis , and 69.2 % were using  CAM at the time of the interview . Current use was highest for oral supplements ( mainly glucosamine and chondroitin ) ( 34.1 % ) , mind-body therapies ( 29.0 % ) , and herbal topical ointments ( 25.1 % ) . Fewer participants made current use of vitamins and minerals ( 16.6 % ) , herbs taken orally ( 13.6 % ) , a CAM therapist  ( 12.7 % ) ,  CAM movement therapies  ( 10.6 % ) , special diets ( 10.1 % ) , or  copper jewelry  or magnets ( 9.2 % ) . Those with fibromyalgia currently used an average of 3.9  CAM therapies  versus 2.4 for those with rheumatoid arthritis and 2.1 for those with osteoarthritis . Current  CAM  use was significantly associated with being female , being under 55 years of age , and having some college education . Conclusion Hispanic and non-Hispanic white arthritis patients  used CAM  to supplement conventional treatments . Health care providers should be aware of the high use of CAM and incorporate questions about its use into routine assessment s and treatment planning An estimated 40,000 physicians offer acupuncture treatment to patients in Germany . Due to a decision of the German Federal Committee of SHI-accredited Physicians and Health Insurance Funds , acupuncture treatment for chronic low back pain , headache and osteoarthritic pain may be reimbursed from 2000 onwards if patients and physicians participate in specific scientifically evaluated model projects of the Statutory Health Insurance Funds . Currently , three separate acupuncture programmes are offered by different Statutory Health Insurance Funds . The scientific evaluation of all these programmes includes both r and omised trials ( comparing acupuncture to no treatment , sham acupuncture or st and ard treatment in 300 to several thous and s of patients ) and large cohort studies . Details of the three programmes will be presented in the following chapters Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture . There is a lack of large multi-centre acupuncture trials . The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of  chronic pain caused by gonarthrosis up to now . Methods 900 patients will be r and omised to three treatment arms . One group receives verum acupuncture , the second sham acupuncture , and the third conservative st and ard therapy . The trial protocol is described with eligibility criteria , detailed information on the treatment definition , blinding , endpoints , safety evaluation , statistical methods , sample size determination , monitoring , legal aspects , and the current status of the trial . Discussion A critical discussion is given regarding the considerations about st and ardisation of the acupuncture treatment , the choice of the control group , and the blinding of patients and observers [ The cure for the  headache ] was a kind of leaf , which required to be accompanied by a charm , and if a person would repeat the charm at the same time that he used the cure , he would be made whole ; but that without the charm the leaf would be of no avail . Socrates , according to Plato ( 1 ) There is a renewed interest in placebos and the placebo effecton their reality , their ethics , their place in medicine , or not , both in and out of the clinic and academy . The U.S. National Institutes of Health recently sponsored a large conference called Science of the Placebo ( 2 ) . At least five serious books on the subject ( 3 - 7 ) plus a book of poetry ( 8) and a novel (9)each titled Placebo Effecthave been published since 1997 . In the past 10 years , the National Library of Medicine has annually listed an average of 3972 scholarly papers with the keywords placebo , placebos  , or placebo effect , with a low of 3362 papers in 1992 and a high of 4814 in 2000 . During the fall of 2000 , a discussion of the effect of new drag free suits , which might give an edge to Olympic swimmers , appeared in US News and World Report : [S]wimming officials are n't convinced this is anything more than the placebo effect . Swimmers excel because they think they 've got an edge ( 10 ) . One widely reported study , which concluded that placebos were powerless ( 11 ) , or represented the Wizard of Oz ( 12 ) , occasioned a blizzard of criticism ( 13 - 26 ) and some support ( 27 ) . It 's in the papers ( 28 , 29 ) . It 's in the air . Yet the most recent serious attempt to try logically to define the placebo effect failed utterly ( 30 ) . Given the ways people have gone about it , this seems unsurprising . Arthur K. Shapiro , MD , who spent much of his career as a psychiatrist study ing the placebo effect , recently wrote : A placebo is a substance or procedure that is objective ly without specific activity for the condition being treated The placebo effect is the therapeutic effect produced by a placebo . ( 31 ) If we replace the word placebo in the second sentence with its definition from the first , we get : The placebo effect is the therapeutic effect produced by [ things ] objective ly without specific activity for the condition being treated . This makes no sense whatsoever . Indeed , it flies in the face of the obvious . The one thing of which we can be absolutely certain is that placebos do not cause placebo effects . Placebos are inert and do n't cause anything . Moreover , people frequently exp and the concept of the placebo effect very broadly to include just about every conceivable sort of beneficial biological , social , or human interaction that does n't involve some drug well-known to the pharmacopoeia . A narrower form of this expansion includes identifying natural history or regression to the mean ( as we might observe them in a r and omized , controlled trial ) as part of the placebo effect . But natural history and regression occur not only in the control group . Nothing in the theory of regression to the mean ( 31 ) hints that when people are selected for being extreme on some measure ( blood pressure or cholesterol , for example ) , they are immune to regression if they receive active treatment . Such recipients are as likely ( or unlikely ) to move toward homeostasis as are control group patients . So , regression to the mean is in no meaningful way a placebo effect . Ernst and Resch ( 32 ) took an important step in trying to clarify this situation by differentiating the true from the perceived placebo effect . But true placebo effect has n't really caught on as a viable concept . The concept of the placebo effect has been exp and ed much more broadly than this . Some attribute the effects of various alternative medical systems , such as homeopathy ( 33 ) or chiropractic ( 34 ) , to the placebo effect . Others have described studies that show the positive effects of enhanced communication , such as Egbert 's ( 35 ) , as the placebo response without the placebo ( 7 ) . No wonder things are confusing . Meaning and Medicine We suggest thinking about this issue in a new way . A group of medical students was asked to participate in a study of two new drugs , one a tranquilizer and the other a stimulant [ 36 ] . Each student was given a packet containing either one or two blue or red tablets ; the tablets were inert . The students ' responses to a question naire indicated that 1 ) the red tablets acted as stimulants while the blue ones acted as depressants and 2 ) two tablets had more effect than one . The students were not responding to the inertness of the tablets . Moreover , these responses can not be easily accounted for by natural history , regression to the mean , or physician enthusiasm [ presumably the experimenters were as enthusiastic about the reds as the blues ] . Instead , they can be explained by the meanings in the experiment : 1 ) Red means up , hot , danger , while blue means down , cool , quiet and 2 ) two means more than one . These effects of color ( 37 - 40 ) and number ( 41 , 42 ) have been widely replicated . In a British study , 835 women who regularly used analgesics for headache were r and omly assigned to one of four groups ( 43 ) . One group received aspirin labeled with a widely advertised br and name ( one of the most popular analgesics in the United Kingdom that had been widely available for many years and supported by extensive advertising ) . The other groups received the same aspirin in a plain package , placebo marked with the same widely advertised br and name , or unmarked placebo . In this study , br and ed aspirin worked better than unbr and ed aspirin , which worked better than br and ed placebo , which worked better than unbr and ed placebo . Among 435 headaches reported by br and ed placebo users , 64 % were reported as improved 1 hour after pill administration compared with only 45 % of the 410 headaches reported as improved among the unbr and ed placebo users . Aspirin relieves headaches , but so does the knowledge that the pills you are taking are good ones . In a study of the benefits of aerobic exercise , two groups participated in a 10-week exercise program . One group was told that the exercise would enhance their aerobic capacity , while the other group was told that the exercise would enhance aerobic capacity and psychological well-being . Both groups improved their aerobic capacity , but only the second group improved in psychological well-being ( actually self-esteem ) . The research ers called this strong evidence that exercise may enhance psychological well-being via a strong placebo effect ( 44 ) . In the red versus blue pill study , we can correctly ( if not very helpfully ) classify the responses of the students as placebo effects because they did indeed receive inert tablets ; it seems clear , however , that they responded not to the pills but to their colors . In the second study , the presence of the br and name enhanced the effect of both the inert and the active drug . It does n't seem reasonable to classify the br and name effect as a placebo effect because no placebos are necessarily involved . Meanwhile , calling the consequences of authoritative instruction to the exercisers a placebo effect could come only from someone who believes that words do not affect the world , someone who has never been told I love you or who has never read the review s of a rejected grant proposal . It seems reasonable to label all these effects ( except , of course , of the aspirin and the exercise ) as meaning responses , a term that seeks , among other things , to recall Dr. Herbert Benson 's relaxation response ( 45 ) . Ironically , although placebos clearly can not do anything themselves , their meaning can . We define the meaning response as the physiologic or psychological effects of meaning in the origins or treatment of illness ; meaning responses elicited after the use of inert or sham treatment can be called the placebo effect when they are desirable and the nocebo effect ( 46 ) when they are undesirable . This is obviously a complex notion with several terms that would be challenging to unpack ( desirable , effect , meaning , treatment , illness)an exercise that can not be carried out here . Note that this definition excludes several elements that are usually included in our underst and ing of the placebo effect , such as natural history , regression , experimenter or subject bias , and error in measurement or reporting . Note as well that the definition is not phrased in terms of nonspecific effects ; although many elements of the meaning response or placebo effect may seem nonspecific , they are often quite specific in principle after they are understood . Meaning Permeates Medical Treatment Insofar as medicine is meaningful , it can affect patients , and it can affect the outcome of treatment ( 47 - 49 ) . Most elements of medicine are meaningful , even if practitioners do not intend them to be so . The physician 's costume ( the white coat with stethoscope hanging out of the pocket ) ( 50 ) , manner ( enthusiastic or not ) , style ( therapeutic or experimental ) , and language ( 51 ) are all meaningful and can be shown to affect the outcome ; indeed , we argue that both diagnosis ( 52 ) and prognosis ( 53 ) can be important forms of treatment . Many studies can be cited to document aspects of the therapeutic quality of the practitioner 's manner ( 54 ) . In one , a strong message of the effect of a drug ( an inert capsule ) substantially reduced the patients ' report of the pain of m and ibular block injection compared with the pain after a weak message . Patients who received the weak message reported less pain than a group that received no placebos and no message at all ( 55 ) . In another study , 200 patients with symptoms but no abnormal physical signs were r and omly assigned to a positive or a negative consultation . In a survey of patients 2 weeks later , 64 % of patients in the positive consultation group said they were all better , while only 39 % of those who had negative consultations thought they were better ( 56 ) . Although there is strong evidence for such physician effects , little evidence shows that patient effects are very important . A mass of research in the Acupuncture is becoming a common technique within the physiotherapy profession as a treatment modality for pain relief ; however , few r and omised controlled trials have been undertaken to assess the effectiveness of acupuncture , particularly in the treatment of osteoarthritis ( OA ) of the hip . Therefore , a r and omised trial to compare the effectiveness of acupuncture with advice and exercises on the symptomatic treatment of OA of the hip was carried out . Thirty-two patients awaiting a total hip arthroplasty were r and omly allocated to either the experimental group , ( A ) , to have six sessions of acupuncture each lasting up to 25 minutes , or the control group , ( B ) , to be given advice and exercises for their hip over a six week period . Group A consisted of three men and 13 women , and group B consisted of four men and eight women . The average age in group A was 66 years and in group B it was 68 years . Patients were assessed for pain and functional ability , using a modified version of the WOMAC question naire , pre-treatment , immediately post-treatment and at eight weeks post-treatment . The pre-treatment WOMAC scores in the two groups were similar ( p=0.85 ) . There was a significant improvement in group A ( decrease in WOMAC score ) immediately post-treatment ( p=0.002 ) and this was maintained at the eight-week follow-up ( p=0.03 ) . There were no significant changes in group B. When the changes in WOMAC scores were compared between groups , a significantly greater improvement was found between pre-treatment and immediately post-treatment in group A , compared with group B ( p=0.02 ) . The changes between pre-treatment and the eight-week follow-up also showed a significant improvement in group A compared with group B ( p=0.03 ) . In conclusion , this trial supports the hypothesis that acupuncture is more effective than advice and exercises in the symptomatic treatment of OA of the hip Background The purpose of this study was to compare the efficacy of electroacupuncture ( EA ) , diclofenac and their combination in symptomatic treatment of osteoarthritis ( OA ) of the knee . Methods This study was a r and omized , single-blind , placebo controlled trial . The 193 out- patients with OA of the knee were r and omized into four groups : placebo , diclofenac , EA and combined ( diclofenac plus EA ) . Paracetamol tablets were prescribed as a rescue analgesic during the study . The patients were evaluated after a run-in period of one week ( week 0 ) and again at the end of the study ( week 4 ) . The clinical assessment s included the amount of paracetamol taken/week , visual analog scale ( VAS ) , Western Ontario and McMaster Universities ( WOMAC ) OA Index , Lequesne 's functional index , 50 feet-walk time , and the orthopedist 's and patient 's opinion of change . Results One hundred and eighty six patients completed the study . The improvement of symptoms ( reduction in mean changes ) in most outcome parameters was greatest in the EA group . The proportions of responders and patients with an overall opinion of " much better " were also greatest in the EA group . The improvement in VAS was significantly different between the EA and placebo group as well as the EA and diclofenac group . The improvement in Lequesne 's functional index also differed significantly between the EA and placebo group . In addition , there was a significant improvement in WOMAC pain index between the combined and placebo group . Conclusion EA is significantly more effective than placebo and diclofenac in the symptomatic treatment of OA of the knee in some circumstances . However , the combination of EA and diclofenac treatment was no more effective than EA treatment alone Forty-four patients with chronic cervical osteoarthritis took part in this study . Patients were treated with acupuncture , sham-acupuncture , diazepam or placebo-diazepam in r and omized order . Pain was rated on visual analogue scales before , during , and after treatment . Two scales were separately used to rate the intensity ( sensory component ) and the unpleasantness ( affective component ) of pain . The results analyzed from these trials show that diazepam , placebo-diazepam , acupuncture and sham-acupuncture have a more pronounced effect on the affective than on the sensory component of pain .  Acupuncture was significantly more effective than placebo-diazepam ( p less than 0.05 ) , but not significantly more effective than diazepam or sham-acupuncture OBJECTIVE The purpose of this study was to determine whether acupuncture was more effective than sham acupuncture in the reduction of pain in persons with osteoarthritis ( OA ) of the knee . METHODS Forty subjects ( 20 men , 20 women ) with radiographic evidence of OA of the knee were stratified by gender and r and omly assigned to either the experimental ( real acupuncture ) or control ( sham acupuncture ) groups . Subjects were treated three times per week for 3 weeks and evaluated at three test sessions . Outcome measures were : 1 ) the Pain Rating Index of the McGill Pain Question naire , 2 ) the Western Ontario and McMaster Universities ( WOMAC ) Osteoarthritis Index , and 3 ) pain threshold at four sites at the knee . RESULTS The analyses of variance showed that both real and sham acupuncture significantly reduced pain , stiffness , and physical disability in the OA knee , but that there were no significant differences between groups . CONCLUSIONS Acupuncture is not more effective than sham acupuncture in the treatment of OA pain Both specific and non-specific factors may play a role in acupuncture therapy for pain . We explored the cerebral consequences of needling and expectation with real acupuncture , placebo acupuncture and skin-prick , using a single-blind , r and omized crossover design with 14 patients suffering from painful osteoarthritis , who were scanned with positron emission tomography ( PET ) .  The three interventions , all of which were sub-optimal acupuncture treatment , did not modify the patient 's pain . The insula ipsilateral to the site of needling was activated to a greater extent during real acupuncture than during the placebo intervention . Real acupuncture and placebo ( with the same expectation of effect as real acupuncture ) caused greater activation than skin prick ( no expectation of a therapeutic effect ) in the right dorsolateral prefrontal cortex , anterior cingulate cortex , and midbrain . These results suggest that real acupuncture has a specific physiological effect and that patients ' expectation and belief regarding a potentially beneficial treatment modulate activity in component areas of the reward system Background : We report on the study design and protocol s of two r and omized controlled trials ( Acupuncture R and omized Trials = ART ) that investigate the efficacy of acupuncture in the treatment of chronic low back pain and osteoarthritis of the knee , respectively . Objective : To investigate whether acupuncture is more efficacious than ( a ) no treatment or ( b ) minimal acupuncture in the treatment of low back pain and osteoarthritis . Design : Two r and omized , controlled , multicenter trials with three treatment arms and a total follow-up time of 52 weeks . Setting : 30 practitioners and outpatient units in Germany specialized in acupuncture treatment . Patients : 300 patients will be included in each study . In the low back pain trial , patients will be included according to clinical diagnosis . In the osteoarthritis pain trial , patients will be included according to the American College of Rheumatology criteria . Interventions : Patients are r and omly assigned to receive either ( 1 ) semi-st and ardized acupuncture ( 150 patients ) , ( 2 ) minimal acupuncture at non-acupuncture points ( 75 patients ) , or ( 3 ) no treatment for two months followed by semi-st and ardized acupuncture ( 75 patients , waiting list control ) . Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks . Main Outcome Measure : The main outcome measure is the difference between baseline and the end of the 8-week treatment period in the following parameters : pain intensity as measured by a visual analogue scale ( VAS ; 0–100 mm ) in the low back pain trial and by the Western Ontario and McMaster Universities Osteoarthritis Score ( WOMAC ) in the osteoarthritis trial . Outlook : The results of these two studies ( available in 2004 ) will provide health care providers and policy makers with the information needed to make scientifically sound assessment s of acupuncture therapy A single-blind , r and omised , placebo-controlled trial of superficial acupuncture in the treatment of low back pain was carried out by comparing 8 patients treated by acupuncture with 9 patients treated by placebo .  In all five measures of efficacy chosen for study the acupuncture group achieved better responses than the placebo group ; four of the five inter-group differences were statistically significant . In addition , an overall mean for all five measures combined showed significant superiority of acupuncture over placebo Purpose : Acupuncture treatment of patients waiting for arthroplasty surgery . Methods : 29 patients with a total of 42 osteoarthritic knees were r and omized to two groups . Group A was treated while Group B served as a no‐treatment control group . After 9 weeks Group B was treated too . Analgesic consumption , pain and objective measurements were registered . All objective measures were done by investigators who were “ blinded ” as to Group A & B. In the second part of the study 17 patients ( 26 knees ) continued with treatments once a month . Registration of analgesic consumption , pain and objective measurements continued . Total study period 49 weeks . Results : Comparing Group A to B there was a significant reduction in pain , analgesic consumption and in most objective measures . In Group A + B combined there was an 80 % subjective improvement , and a significantly increased knee range movement – an increase mainly in the worst knees . Results were significantly better in those who had not been ill for a long time . In the second part of the study , it was shown that it was possible to maintain the improvements . Conclusions : Acupuncture can ease the discomfort while waiting for an operation and perhaps even serve as an alternative to surgery . Seven patients have responded so well that at present they do not want an operation . ( USD 9000 saved per operation ) Within the context of a double blind r and omized controlled parallel trial of 2 nonsteroidal antiinflammatory drugs , we vali date d WOMAC , a new multidimensional , self-administered health status instrument for patients with osteoarthritis of the hip or knee . The pain , stiffness and physical function subscales fulfil conventional criteria for face , content and construct validity , reliability , responsiveness and relative efficiency . WOMAC is a disease-specific purpose built high performance instrument for evaluative research in osteoarthritis clinical trials Severe acetaminophen hepatotoxicity frequently leads to acute liver failure ( ALF ) . We determined the incidence , risk factors , and outcomes of acetaminophen-induced ALF at 22 tertiary care centers in the United States . Detailed prospect i ve data were gathered on 662 consecutive patients over a 6-year period fulfilling st and ard criteria for ALF ( coagulopathy and encephalopathy ) , from which 275 ( 42 % ) were determined to result from acetaminophen liver injury . The annual percentage of acetaminophen-related ALF rose during the study from 28 % in 1998 to 51 % in 2003 . Median dose ingested was 24 g ( equivalent to 48 extra-strength tablets ) . Unintentional overdoses accounted for 131 ( 48 % ) cases , intentional ( suicide attempts ) 122 ( 44 % ) , and 22 ( 8 % ) were of unknown intent . In the unintentional group , 38 % took two or more acetaminophen preparations simultaneously , and 63 % used narcotic-containing compounds . Eighty-one percent of unintentional patients reported taking acetaminophen and /or other analgesics for acute or chronic pain syndromes . Overall , 178 subjects ( 65 % ) survived , 74 ( 27 % ) died without transplantation , and 23 subjects ( 8 % ) underwent liver transplantation ; 71 % were alive at 3 weeks . Transplant-free survival rate and rate of liver transplantation were similar between intentional and unintentional groups . In conclusion , acetaminophen hepatotoxicity far exceeds other causes of acute liver failure in the United States . Susceptible patients have concomitant depression , chronic pain , alcohol or narcotic use , and /or take several preparations simultaneously . Education of patients , physicians , and pharmacies to limit high-risk use setting s is recommended Context Although many patients use glucosamine to treat osteoarthritis , available studies have reported inconsistent effects of glucosamine on symptoms and joint changes . In addition , previous studies have more often included patients with knee than with hip osteoarthritis . Contribution The investigators r and omly assigned 222 patients with hip osteoarthritis to glucosamine , 1500 mg/d , or placebo . After 2 years of treatment , no clinical ly significant effect on pain , function , or joint space narrowing was found . Caution Twenty of the patients in the trial had joint replacement during the study . The Editors The effectiveness of glucosamine sulfate for treating osteoarthritis is controversial . A 2005 systematic review of 20 trials found evidence to be inconclusive ( 1 ) . In the 15 trials comparing glucosamine with placebo , the overall effect on pain favored glucosamine , but 8 of the trials found no effect on pain . More recent trials ( 24 ) have also yielded inconclusive results . In the Netherl and s and other countries , glucosamine is sold as an over-the-counter dietary supplement and is used by many patients , often on the advice of their physicians . Given the prevalent use of glucosamine , definitive evidence about its effectiveness is needed . Some studies suggest that glucosamine may provide greater benefit to patients with less severe radiographic osteoarthritis than to patients with more severe disease ( 5 , 6 ) . Most previous trials have studied only patients with knee osteoarthritis , with the exception of 3 early trials that included patients with other affected joints ( 79 ) . Trials specifically testing glucosamine in patients with hip osteoarthritis have not been available . Although osteoarthritis of the knee is more common than hip osteoarthritis , hip osteoarthritis is common enough to warrant assessment of glucosamine for this condition . To date , only 2 trials have published data on the effects of  glucosamine sulfate on joint structure ( 10 , 11 ) . Some expressed concern about the radiography protocol used in these trials ( 1214 ) , and further study is needed to clarify these findings . To explore some of the uncertainties regarding the effectiveness of glucosamine sulfate , we conducted a 2-year , blinded , r and omized , placebo-controlled trial to evaluate the effect of glucosamine sulfate on the symptomatic and radiographic progression of hip osteoarthritis  in patients recruited from primary care setting s. Methods Study Design In this trial , all outcome assessors , patients , data analysts , and research ers were blinded to group assignment . The Medical Ethics Committee of the Erasmus Medical Center , Rotterdam , the Netherl and s , approved the study design , and patients provided written informed consent . We reported the detailed study protocol in 2005 ( 15 ) and summarize it here . Setting and Participants General practitioners in the Rotterdam area recruited study patients . Patients were eligible for inclusion if they met the American College of Rheumatology clinical criteria for hip osteoarthritis ( 16 ) during a screening examination at the research center . Patients who had undergone or were awaiting hip replacement surgery were not eligible . We excluded patients who had a Kellgren and Lawrence score of 4 ( 17 ) , renal disease , liver disease , diabetes mellitus , or a disabling comorbid condition that would make visits to the research center impossible , as well as patients already receiving glucosamine and those unable to fill out Dutch question naires . We encouraged patients who violated study protocol and those who had total hip arthroplasty during the study to complete data collection to limit the loss to follow-up . R and omization and Intervention Eligible patients were r and omly assigned to receive either 1500 mg of oral glucosamine sulfate ( administered once daily as two 750-mg tablets ) or placebo for 2 years . The glucosamine used in this study was provided by Numico Research BV ( Wageningen , the Netherl and s ) but was manufactured by Nutricia Manufacturing USA ( Greenville , South Carolina ) . It contained 2000 mg of D-glucosamine sulfate 2-potassium chloride , which results in a net content of 1500 mg of glucosamine sulfate per 2 pills . The placebo pills were identical in appearance , smell , and taste . We used a computer-generated , blinded r and omization list provided by an independent research er to r and omly assign patients to glucosamine sulfate or placebo . This list , which was r and omized per block of 6 numbers , stratified patients by radiologic findings ( Kellgren and Lawrence score < 2 vs. 2 ) and by local versus generalized osteoarthritis ; patients received a number in chronological order ( 15 ) . Assignment of patients to the right stratum of the r and om assignment list was done by the main research er , who was blinded to therapy . To evaluate blinding , patients had to indicate in the last question naire to which treatment they thought they were r and omly assigned . Outcomes and Follow-up Primary outcome measures were WOMAC 3.1 ( 5-point Likert format ) pain and function over 24 months and joint space narrowing after 24 months ( 18 , 19 ) . Secondary outcome measures were WOMAC pain , function , and stiffness after 3 , 12 , and 24 months ; overall WOMAC stiffness ; a visual analogue scale ( VAS ) to measure pain in the past week ; and pain medication use . The WOMAC subscales are presented as normalized scores ( 0 to 100 , where 0 equals no symptoms ) . We recorded the use of pain medication ; classified patients as never , occasional , or daily users ; and then determined whether people increased , decreased , or did not change their use of pain medication from baseline . In the case of patients with bilateral hip symptoms , we asked patients to indicate their most affected hip for our analyses of joint space narrowing . For patients who were undecided , we used the hip with the highest Kellgren and Lawrence score or the smallest internal rotation during a physical examination . We used QBone Planner 5.4 ( Medis , Leiden , the Netherl and s ) to measure joint space width on calibrated digital radiographs of the hip joints . We read radiographs from both time points ( baseline and 24 months ) side by side . One research er measured joint space width manually on predefined lateral , superior , axial , and medial sites ( 20 ) . In addition to these 4 points , we visually identified and measured the minimal joint space width on both the baseline and 24-month radiograph . We used the smallest of these 6 measurements as the actual minimum joint space width for analyses . A second observer also measured the joint space width in a r and om subset of 28 study patients , and we found high interobserver agreement ( intraclass correlation coefficient of minimal joint space width , 0.98 ) . We collected data for the primary and secondary outcome measures at different time points throughout the study . At baseline and after 24 months , patients came to the Erasmus Medical Center for radiography and to complete study question naires . Weight-bearing , anteroposterior digital radiography of the pelvis was performed according to a highly st and ardized protocol to allow reliable measurement of joint space narrowing ( 15 ) . At baseline and then every 3 months through month 24 , we asked patients to complete the WOMAC instrument , a VAS for pain in the past week ( score range , 0 to 100 ; 0 equals no pain ) , and a checklist for specific adverse events and to answer questions regarding pain medication and adherence . We mailed the intermediate question naires to the patients for completion at home . A research er visited patients every 6 months to deliver a new supply of study medication and evaluate adherence by using the Brief Medication Question naire ( BMQ ) ( 21 ) and a pill count . The BMQ monitors the amount of days per week that patients have taken their study medication . For overall effect , we considered patients to be adherent if they ingested more than 80 % of the total study medication . Statistical Analysis We used the data from all nine 3-month question naires ( at baseline and 3 , 6 , 9 , 12 , 15 , 18 , 21 , and 24 months ) . We also report outcomes for measurements at 3 , 12 , and 24 months and a mean effect of the therapy over 24 months incorporating all scores . We performed the analyses by using SPSS 11.0.1 ( SPSS , Chicago , Illinois ) and SAS 8.2 ( SAS Institute , Cary , North Carolina ) . We used linear mixed models to analyze the data , assuming that data were missing at r and om . We chose an unstructured covariance structure to model the covariance of repeated measures by patients , because this yielded the lowest Akaike information criterion . Fixed effects were time , time by therapy , and the covariates we adjusted for . For patients who had total hip arthroplasty during the trial , we included observed data before surgery in the analysis and assumed data after surgery to be missing . For patients who were lost to follow-up , we included all observed data in the analysis . We adjusted the WOMAC and VAS pain analyses for body mass index , sex , and agefactors that may have influenced symptoms ( 22 , 23 ) . We also adjusted analyses for pain medication use and Kellgren and Lawrence score . The analyses for joint space narrowing were adjusted for Kellgren and Lawrence score ( 24 ) , age , and sex ( 25 ) . We used ordinal regression analysis to assess the effect of glucosamine sulfate on pain medication use by using data from all patients who completed the study and did not have total hip arthroplasty . We performed additional analyses to assess the effect of adherence on the outcome . To explore the validity of the missing-at-r and om data assumption for patients who underwent total hip arthroplasty during the study , we did sensitivity analyses on the WOMAC pain data . In 5 scenarios , the missing data for patients who underwent total hip arthroplasty were imputed with extreme scores : mean of the 5 best scores for the glucosamine sulfate recipients and that of the 5 worst scores for the placebo recipients ( traditional best case ) ; mean of the best scores for placebo recipients 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 Twenty-five out- patients with chronic neck pain participated in a prospect i ve , r and omized trial of acupuncture versus placebo transcutaneous nerve stimulation . A single-blind , non-cross-over design incorporated several outcome measures in an attempt to determine any particular facet of pain that responded to acupuncture .  No significant difference between the two treatments was found either post-treatment or at follow-up . Whilst the small population studied limits the conclusions that may be drawn , these findings suggest that acupuncture may have no greater effect than that of a powerful placebo Recent reports have highlighted the importance of having good evidence on the safety of acupuncture . 1 2 Sound evidence on the risks associated with acupuncture is , however , scarce.3 Our primary aim , therefore , was to describe the type and frequency of adverse events after acupuncture . A secondary aim was to examine mild transient reactions associated with  acupuncture  , some of which may indicate a positive response to treatment . The study involved a prospect i ve postal audit of treatments undertaken during a four week period in 2000 . All 1848 professional acupuncturists who were members of the British Acupuncture Council and were practising in the United Kingdom were invited to record details of adverse events and mild transient reactions after treatment . St and ardised self report forms were used . Participating practitioners also provided information on themselves , including age , sex , length of training , and years of practice . To have a OBJECTIVE The research ers sought to assess whether the widely used 1994 Cochrane Highly Sensitive Search Strategy ( HSSS ) for r and omized controlled trials ( RCTs ) in MEDLINE could be improved in terms of sensitivity , precision , or parsimony . METHODS A gold st and ard of 1,347 RCT records and a comparison group of 2,400 non-trials were r and omly selected from MEDLINE .  Terms occurring in at least 1 % of RCT records were identified . Fifty percent of the RCT and comparison group records were r and omly selected , and the ability of the terms to discriminate RCTs from non-trial records was determined using logistic regression . The best performing combinations of terms were tested on the remaining records and in MEDLINE . RESULTS The best discriminating term was " Clinical Trial " ( Publication Type ) . In years where the Cochrane assessment of MEDLINE records had taken place , the strategies identified few additional unindexed records of trials . In years where Cochrane assessment has yet to take place , " R and omized Controlled Trial " ( Publication Type ) proved highly sensitive and precise . Adding six more search terms identified further , unindexed trials at reasonable levels of precision and with sensitivity almost equal to the Cochrane HSSS . CONCLUSIONS Most reports of RCTs in MEDLINE can now be identified easily using " R and omized Controlled Trial " ( Publication Type ) . More sensitive search es can be achieved by a brief strategy , the Centre for Review s and Dissemination/Cochrane Highly Sensitive Search Strategy ( 2005 revision ) Acupuncture is increasingly popular , but it is not free from risk for the patient.1 Safety is best established with prospect i ve surveys . Our aim was to ascertain the incidence of adverse events related to acupuncture treatment , as currently practised in Britain by doctors and physiotherapists . Volunteer acupuncture practitioners were recruited through journals circulated to members of the British Medical Acupuncture Society and the Acupuncture Association of Chartered Physiotherapists ( approximately 2750 members).2 A prospect i ve survey was undertaken using forms for intensive event monitoring that had been piloted previously.3 Minor adverse events were defined as “ any ill-effect , no matter how small , that is unintended and non-therapeutic , even if not unexpected . ” These events were reported every month , along with the total number of consultations . Minor or serious events that were considered to be “ significant”—“unusual , novel , dangerous , significantly inconvenient , or requiring further information”—were reported on separate forms when they occurred . Anonymous reporting was accepted . A sample size of Background There is evidence for the efficacy of acupuncture treatment in knee osteoarthritis , but it remains unclear which acupuncture modes are most effective . We evaluated the effects of trigger point acupuncture on pain and quality of life in knee osteoarthritis patients , compared with acupuncture at st and ard points , and sham acupuncture . Methods Thirty patients ( 27 women , 3 men ; aged 61–82 years ) with non-radiating knee osteoarthritis pain for at least six months and normal neurological examination were r and omised to one of three groups for the study period of 21 weeks . Each group received five acupuncture treatment sessions . The st and ard acupuncture point group ( n=10 ) received treatment at traditional acupuncture points for knee pain ; the trigger point acupuncture group ( n=10 ) received treatment at trigger points ; and the third group ( n=10 ) received sham acupuncture treatment at the trigger points . Outcome measures were pain intensity ( visual analogue scale , VAS ) and WOMAC index ( Western Ontario and McMaster Universities Arthritis Index ) . The groups were compared by the area under the curve method . Results Five patients dropped out of the study because of lack of improvement , and one patient ( in the trigger point acupuncture group ) dropped out because of deterioration of symptoms ; the remaining 24 patients were included in the analysis . After treatment , the trigger point acupuncture group reported less pain intensity on VAS than the st and ard acupuncture or sham treatment group , but both the trigger point acupuncture and st and ard acupuncture groups reported improvement of function of knee . There was a significant reduction in pain intensity between pre-treatment and five weeks after treatment for the trigger point acupuncture ( P<0.01 ) and st and ard acupuncture groups ( P<0.01 ) included in the analysis , but not for the sham treatment group . Group comparison using the area under the curves demonstrated a significant difference only between trigger point acupuncture and sham treatment groups analysed ( P<0.025 for VAS , and P<0.031 for WOMAC ) . Conclusion These results suggest that trigger point acupuncture therapy may be more effective for osteoarthritis of the knee in some elderly patients than st and ard acupuncture therapy We report a prospect i ve controlled trial , comparing acupuncture with no treatment , in patients with advanced osteoarthritis of the knee awaiting total knee replacement .  Knee function was assessed at the beginning of study and at the end of two months , using four parameters : HSS score , time to walk 50 metres , time to climb 20 steps , and degree of pain .  Acupuncture was given at four local points around the knee and at one distal point . The acupuncture group improved in all parameters , whereas the control group deteriorated , a finding that was highly statistically significant ( p<0.0002 ) . Further r and omised-controlled trials with longer follow-up are required to confirm these findings OBJECTIVE To investigate the effectiveness of acupuncture in addition to routine care , compared with routine care alone , in the treatment of patients with chronic pain due to osteoarthritis ( OA ) of the knee or hip . METHODS In a r and omized , controlled trial , patients with chronic pain due to OA of the knee or hip were r and omly allocated to undergo up to 15 sessions of acupuncture in a 3-month period or to a control group receiving no acupuncture . Another group of patients who did not consent to r and omization underwent acupuncture treatment . All patients were allowed to receive usual medical care in addition to the study treatment . Clinical OA severity ( Western Ontario and McMaster Universities Osteoarthritis Index [ WOMAC ] ) and health-related quality of life ( Short Form 36 ) were assessed at baseline and after 3 months and 6 months . RESULTS Of 3,633 patients ( mean + /- SD age 61.8 + /- 10.8 years ; 61 % female ) , 357 were r and omized to the acupuncture group and 355 to the control group , and 2,921 were included in the nonr and omized acupuncture group . At 3 months , the WOMAC had improved by a mean + /- SEM of 17.6 + /- 1.0 in the acupuncture group and 0.9 + /- 1.0 in the control group ( 3-month scores 30.5 + /- 1.0 and 47.3 + /- 1.0 , respectively [ difference in improvement 16.7 + /- 1.4 ; P < 0.001 ] ) . Similarly , quality of life improvements were more pronounced in the acupuncture group versus the control group ( P < 0.001 ) . Treatment success was maintained through 6 months . The changes in outcome in nonr and omized patients were comparable with those in r and omized patients who received acupuncture . CONCLUSION These results indicate that acupuncture plus routine care is associated with marked clinical improvement in patients with chronic OA-associated pain of the knee or hip 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 The aim of this investigation was to determine whether bee venom ( BV ) administered directly into an acupoint was a clinical ly effective and safe method for relieving the pain of patients with knee osteoarthritis ( OA ) as compared to traditional needle acupuncture . We evaluated the efficacy of BV acupuncture using both pain relief scores and computerized infrared thermography ( IRT ) following 4 weeks of BV acupuncture treatment . We observed that a significantly higher proportion of subjects receiving BV acupuncture reported substantial pain relief as compared with those receiving traditional needle acupuncture therapy . Furthermore , the IRT score was significantly improved and paralleled the level of pain relief OBJECTIVE To determine whether demographic , medical history , or arthritis assessment data may influence outcome and rate of decay for patients with osteoarthritis treated with acupuncture .  DESIGN Seventy-three persons with symptomatic osteoarthritis of the knee were recruited for this r and omized controlled trial . Both treatment and crossover control groups received acupuncture treatments twice weekly for 8 weeks . Patients self-scored on the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) and the Lequesne Algofunctional Index at baseline and 4 , 8 , and 12 weeks . Sample size for this outcome analysis was 60 patients at 4 weeks , 58 at 8 weeks , and 52 at 12 weeks . RESULTS Patients ' scores on both indexes improved at 4 , 8 , and 12 weeks . Scores were stable regardless of the baseline severity of the osteoarthritis . Despite some decay in outcomes at week 12 , measures were significantly improved over baseline . With WOMAC scores partitioned into equal quartiles , a strong effect on outcome was apparent at 12 weeks ( 4 weeks after treatment ) related to initial WOMAC scores . The group with the least disability and pain rebounded to original levels to a greater degree than did those who initially were more disabled . The more disabled groups retained the benefits of acupuncture treatment through the 12-week period . CONCLUSION Acupuncture for patients with osteoarthritis of the knee may best be used early in the treatment plan , with a method ical decrease in frequency in treatment once the acute treatment period is completed to avoid a rebound effect . Demographic and medical history data were not mediating variables Participants are often not informed by investigators who conduct r and omised , placebo-controlled acupuncture trials that they may receive a sham acupuncture intervention . Instead , they are told that one or more forms of acupuncture are being compared in the study . This deceptive disclosure practice lacks a compelling method ological rationale and violates the ethical requirement to obtain informed consent . Participants in placebo-controlled acupuncture trials should be provided an accurate disclosure regarding the use of sham acupuncture , consistent with the practice of placebo-controlled drug trials PURPOSE To present the safety and effectiveness results of a prototypical 12-week , double-blind , r and omized placebo-controlled trial of glucosamine among subjects with knee osteoarthritis who were recruited and followed entirely over the Internet . METHODS The study comprised 205 subjects aged 45 years or older with symptomatic knee osteoarthritis who were recruited over the Internet ; eligibility was authenticated through medical record review . Participants were assigned r and omly to 1.5 g/d of glucosamine ( n = 101 ) or placebo ( n = 104 ) , of whom 108 completed the intervention ( 93 in each arm ) . The primary outcome measure was the pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index ( Likert version ) . Additional outcome measures included the physical function and stiffness subscales and overall score of the question naire , and analgesic use . RESULTS There was no difference between treatment and control groups in terms of change in pain score ( 2.0 + /- 3.4 vs. 2.5 + /- 3.8 , P = 0.41 ) , stiffness ( 0.7 + /- 1.6 vs. 0.8 + /- 1.5 , P = 0.52 ) , physical function ( 5.2 + /- 9.5 vs. 4.6 + /- 9.6 , P = 0.49 ) , overall score ( 7.8 + /- 13.1 vs. 7.8 + /- 13.5 , P = 0.81 ) , and analgesic use ( 133 + /- 553 vs. -88 + /- 755 , P = 0.12 ) . Stratification by osteoarthritis severity , glucosamine product , and use of a nonsteroidal anti-inflammatory drug , as well as exclusion of opiate users , did not alter the results . The number and type of adverse events reported was similar between the groups . CONCLUSION Our results suggest that although glucosamine appears to be safe , it is no more effective than placebo in treating the symptoms of knee osteoarthritis OBJECTIVES To examine the efficacy of periosteal stimulation therapy ( PST , osteopuncture ) for the treatment of  chronic pain associated with advanced knee osteoarthritis . DESIGN R and omized , controlled clinical trial . SETTING Outpatient pain clinic . PARTICIPANTS Eighty-eight community-dwelling older adults with moderate knee pain or greater for 3 months or longer and Kellgren-Lawrence ( K-L ) grade 2 through 4 radiographic severity ( 80 % had K-L 4 ) . INTERVENTION Participants were r and omized to receive PST or control PST once a week for 6 weeks . MEASUREMENTS Pain severity and self-reported function ( Western Ontario and McMasters University Osteoarthritis Index ( WOMAC ) ) and physical performance ( Short Physical Performance Battery ( SPPB ) ) were assessed at baseline , after the last PST session ( post ) , and 3 months later ( follow-up ) . Pain severity was also assessed monthly using the multidimensional pain inventory short form . RESULTS Pain was reduced significantly more in the PST group than in the control PST group at post ( P=.003 ; mean WOMAC pain subscale baseline 9.4 vs 6.4 ) and 1 month later ( P<.001 ) , but by 2 months , pain levels had regressed to pre-intervention levels . The group-by-time interaction for the WOMAC function scale was significant at post ( P=.04 ) but not at follow-up ( P=.63 ) . No significant group differences were found for the SPPB . Neither analgesic use nor global improvement differed between groups . There were four treatment dropouts . CONCLUSION PST affords short-term modest pain reduction for older adults with advanced knee OA . Future research should test the effectiveness of booster treatments in sustaining analgesic benefits and of combining PST with therapeutic exercise in ameliorating disability risk OBJECTIVES This report presents health statistics from the 2002 National Health Interview Survey ( NHIS ) for the civilian noninstitutionalized adult population , classified by sex , age , race and Hispanic origin , education , income , poverty status , health insurance coverage , marital status , place of residence , and region of residence for chronic condition prevalence , health status , functional limitations , health care access and utilization , health behaviors , and human immunodeficiency virus testing . The presentation of percentages and percent distributions in both age-adjusted and unadjusted versions is new this year . SOURCE OF DATA The NHIS is a household , multistage probability sample survey conducted annually by interviewers of the U.S. Census Bureau for the Centers for Disease Control and Prevention 's National Center for Health Statistics . In 2002 , data were collected for 31,044 adults for the Sample Adult question naire . The conditional response rate was 84.4 % , and the final response rate was 74.4 % . The health information for adults in this report was obtained from one r and omly selected adult per family . HIGHLIGHTS In 2002 , 62 % of adults 18 years of age or over reported excellent or very good health . Fifty-nine percent of adults never participated in any type of vigorous leisure-time physical activity  , and 14 % of adults did not have a usual place of health care . Eleven percent of adults had been told by a doctor or health professional that they had heart disease , and 21 % had been told on two or more visits that they had hypertension . Twenty-two percent of all adults were current smokers , and 23 % were former smokers . Based on their body mass index , 35 % of adults were overweight , and 23 % were obese OBJECTIVE To estimate minimal clinical ly important differences ( MCID ) of effects measured by the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) in patients with osteoarthritis ( OA ) of the lower extremities undergoing a comprehensive inpatient rehabilitation intervention . METHODS A prospect i ve cohort study assessed patients ' health by the WOMAC at baseline ( entry into the clinic ) and at the 3 month followup , and by a transition question naire asking about the change of " health in general related to the OA joint " during that time period . The WOMAC section score differences between the " equal " group and the " slightly better " and " slightly worse " groups result ed in the MCID for improvement and for worsening . RESULTS In total 192 patients were followed up . The MCID for improvement ranged from 0.80 to 1.01 points on the continuous WOMAC numerical rating scale from 0 to 10 , reflecting changes of 17 to 22 % of baseline scores . The MCID for worsening conditions ranged from 0.29 ( 6 % ) to 1.03 points ( 22 % ) . In the transition reply subjectively unchanged patients reported a " pessimistic bias " of 0.35 to 0.51 points , except for the stiffness section . Both MCID and pessimistic bias showed regression to the mean and baseline dependency . CONCLUSION The assessment of MCID using the transition method is a heuristic and valid strategy to detect particular rehabilitation effects in patients with OA of the lower extremities with the use of the WOMAC , and it is worth implementing . The size of the MCID and of the systematic bias is comparable to that assessed by other methods and in other therapeutic setting Objective To investigate the benefit of adding acupuncture to a course of advice and exercise delivered by physiotherapists for pain reduction in patients with osteoarthritis of the knee . Design Multicentre , r and omised controlled trial . Setting 37 physiotherapy centres accepting primary care patients referred from general practitioners in the Midl and s , United Kingdom . Participants 352 adults aged 50 or more with a clinical diagnosis of knee osteoarthritis . Interventions Advice and exercise ( n=116 ) , advice and exercise plus true acupuncture ( n=117 ) , and advice and exercise plus non-penetrating acupuncture ( n=119 ) . Main outcome measures The primary outcome was change in scores on the Western Ontario and McMaster Universities osteoarthritis index pain subscale at six months . Secondary outcomes included function , pain intensity , and unpleasantness of pain at two weeks , six weeks , six months , and 12 months . Results Follow-up rate at six months was 94 % . The mean ( SD ) baseline pain score was 9.2 ( 3.8 ) . At six months mean reductions in pain were 2.28 ( 3.8 ) for advice and exercise , 2.32 ( 3.6 ) for advice and exercise plus true acupuncture , and 2.53 ( 4.2 ) for advice and exercise plus non-penetrating acupuncture . Mean differences in change scores between advice and exercise alone and each acupuncture group were 0.08 ( 95 % confidence interval −1.0 to 0.9 ) for advice and exercise plus true acupuncture and 0.25 ( −0.8 to 1.3 ) for advice and exercise plus non-penetrating acupuncture . Similar non-significant differences were seen at other follow-up points . Compared with advice and exercise alone there were small , statistically significant improvements in pain intensity and unpleasantness at two and six weeks for true acupuncture and at all follow-up points for non-penetrating acupuncture . Conclusion The addition of acupuncture to a course of advice and exercise for osteoarthritis of the knee delivered by physiotherapists provided no additional improvement in pain scores . Small benefits in pain intensity and unpleasantness were observed in both acupuncture groups , making it unlikely that this was due to acupuncture needling effects . Trial registration Current Controlled Trials IS RCT N88597683 A comparative study between acupuncture and physical therapy in patients with gonarthrosis is reported . Patients treated with physical therapy showed 4 parameters significantly reduced after a treatment duration of 2 weeks , and 7 out of 10 parameters after 4 weeks of therapy . Acupuncture could better 2 parameters but only after 4 weeks of treatment . Although physical therapy was superior in most of the objective measurements , the subjective judgement by the patients of the efficacy of both treatments found no significant difference . In summary acupuncture is thought to be only an additional form of treatment in gonarthrosis OBJECTIVES The effectiveness of acupuncture treatment  in patients with osteoarthritis of the hip was tested . DESIGN This is a prospect i ve , r and omized , controlled , patient- and investigator-blinded clinical trial . PATIENTS AND SETTING The study was performed at a university department for physical medicine and rehabilitation . Sixty-seven patients were separated into two treatment groups . INTERVENTIONS Group 1 ( treatment ) had traditional needle placement and manipulation , whereas in group 2 ( control ) needles were placed away from classic positions and not manipulated . In both groups needles were placed within the L2 to L5 dermatomes . Outcome parameters were : pain ( VAS ) , functional impairment ( hip score ) , activity in daily life ( ADL ) and overall satisfaction before treatment , and 2 weeks and 2 months after treatment . RESULTS For all parameters there was a significant improvement versus baseline in both groups 2 weeks and 2 months following treatment , but no significant difference between the two treatment groups . CONCLUSIONS We conclude from these results that needle placement in the area of the affected hip is associated with improvement in the symptoms of osteoarthritis . It appears to be less important to follow the rules of traditional acupuncture techniques Thirty patients with cervical spine pain syndromes persisting a mean of 8 years were assigned r and omly into equal treatment and control groups . After 12 weeks , 12 of 15 ( 80 % ) of the treated group felt improved , some dramatically , with a mean 40 % reduction of pain score , 54 % reduction of pain pills , 68 % reduction of pain hours per day and 32 % less limitation of activity . Two of 15 ( 13 % ) of the control group reported slight improvement after 12.8 weeks . The control group had a mean 2 % worsening of the pain score , 10 % reduction in pain pills , no lessening of pain hours and 12 % less limitation of activity We report a prospect i ve r and omised trial of acupuncture given to 44 patients with advanced osteoarthritis ( OA ) of the knee awaiting total knee joint replacement . Patients were r and omly allocated into two groups , group A receiving acupuncture to the most affected knee only and group B receiving acupuncture to both knees . Acupuncture was given to four local points around the knee and one distal point . The local points were Spleen 9 ( Yinlinquan , SP9 ) , Spleen 10 ( Xuehai , SP10 ) , Stomach 34 ( Liangqui , ST34 ) , and Stomach 36 ( Zusanli , ST36 ) . The distal point was Large Intestine 4 ( Hegu , LI4 ) on the first web space of the ipsilateral h and . A blinded observer assessed knee function before starting treatment , and at the end of two and six months . Analysis of the results showed a significant reduction in symptoms in both groups , and this improvement was sustained for six months . There was no statistically significant difference between the groups . In conclusion , unilateral acupuncture is as effective as bilateral acupuncture in increasing function and reducing the pain associated with OA of the knee . This trial is not able to distinguish the specific from the non-specific effects of the treatment Objectives : The aim of the study was to evaluate the therapeutic effect of electro-acupuncture ( EA ) and hydrotherapy , both in combination with patient education or with patient education alone , in the treatment of osteoarthritis in the hip . Methods : Forty-five patients , aged 42–86 years , with radiographic changes consistent with osteoarthritis in the hip , pain related to motion , pain on load , and ache were chosen . They were r and omly allocated to EA , hydrotherapy , both in combination with patient education , or patient education alone . Outcome measures were the disability rating index ( DRI ) , global self-rating index ( GSI ) , and visual analogue scale ( VAS ) . Assessment s were done before the intervention and immediately after the last treatment and 1 , 3 , and 6 months after the last treatment . Results : Pain related to motion and pain on load was reduced up to 3 months after last the treatment in the hydrotherapy group and up to 6 months in the EA group . Ache during the day was significantly improved in both the EA and hydrotherapy group up to 3 months after the last treatment . Ache during the night was reduced in the hydrotherapy group up to 3 months after the last treatment and in the EA group up to 6 months after . Disability in functional activities was improved in EA and hydrotherapy groups up to 6 months after the last treatment . Quality of life was also improved in EA and hydrotherapy groups up to 3 months after the last treatment . There were no changes in the education group alone . Discussion : In conclusion , EA and hydrotherapy , both in combination with patient education , induce long-lasting effects , shown by reduced pain and ache and by increased functional activity and quality of life , as demonstrated by differences in the pre- and post-treatment assessment
BACKGROUND Peripheral joint osteoarthritis is a major cause of pain and functional limitation .
Few treatments are safe and effective .
OBJECTIVES To assess the effects of acupuncture for treating peripheral joint osteoarthritis .