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      How large are the nonspecific effects of acupuncture? A meta-analysis of randomized controlled trials

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      Author(s): 1 , , 1 , 1 , 1 , 2
      Publication date (Electronic):
      Journal: BMC Medicine
      Publisher: BioMed Central

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          Abstract

          Background

          While several recent large randomized trials found clinically relevant effects of acupuncture over no treatment or routine care, blinded trials comparing acupuncture to sham interventions often reported only minor or no differences. This raises the question whether (sham) acupuncture is associated with particularly potent nonspecific effects. We aimed to investigate the size of nonspecific effects associated with acupuncture interventions.

          Methods

          MEDLINE, Embase, Cochrane Central Register of Controlled Clinical Trials and reference lists were searched up to April 2010 to identify randomized trials of acupuncture for any condition, including both sham and no acupuncture control groups. Data were extracted by one reviewer and verified by a second. Pooled standardized mean differences were calculated using a random effects model with the inverse variance method.

          Results

          Thirty-seven trials with a total of 5754 patients met the inclusion criteria. The included studies varied strongly regarding patients, interventions, outcome measures, methodological quality and effect sizes reported. Among the 32 trials reporting a continuous outcome measure, the random effects standardized mean difference between sham acupuncture and no acupuncture groups was -0.45 (95% confidence interval, -0.57, -0.34; I 2 = 54%; Egger's test for funnel plot asymmetry, P = 0.25). Trials with larger effects of sham over no acupuncture reported smaller effects of acupuncture over sham intervention than trials with smaller nonspecific effects (β = -0.39, P = 0.029).

          Conclusions

          Sham acupuncture interventions are often associated with moderately large nonspecific effects which could make it difficult to detect small additional specific effects. Compared to inert placebo interventions, effects associated with sham acupuncture might be larger, which would have considerable implications for the design and interpretation of clinical trials.

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          Most cited references113

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          Acupuncture in patients with osteoarthritis of the knee: a randomised trial.

          C Witt, B. Brinkhaus, S. Jena … (2015)
          Acupuncture is widely used by patients with chronic pain although there is little evidence of its effectiveness. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with osteoarthritis of the knee. Patients with chronic osteoarthritis of the knee (Kellgren grade < or =2) were randomly assigned to acupuncture (n=150), minimal acupuncture (superficial needling at non-acupuncture points; n=76), or a waiting list control (n=74). Specialised physicians, in 28 outpatient centres, administered acupuncture and minimal acupuncture in 12 sessions over 8 weeks. Patients completed standard questionnaires at baseline and after 8 weeks, 26 weeks, and 52 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index at the end of week 8 (adjusted for baseline score). All main analyses were by intention to treat. 294 patients were enrolled from March 6, 2002, to January 17, 2003; eight patients were lost to follow-up after randomisation, but were included in the final analysis. The mean baseline-adjusted WOMAC index at week 8 was 26.9 (SE 1.4) in the acupuncture group, 35.8 (1.9) in the minimal acupuncture group, and 49.6 (2.0) in the waiting list group (treatment difference acupuncture vs minimal acupuncture -8.8, [95% CI -13.5 to -4.2], p=0.0002; acupuncture vs waiting list -22.7 [-27.5 to -17.9], p<0.0001). After 52 weeks the difference between the acupuncture and minimal acupuncture groups was no longer significant (p=0.08). After 8 weeks of treatment, pain and joint function are improved more with acupuncture than with minimal acupuncture or no acupuncture in patients with osteoarthritis of the knee. However, this benefit decreases over time.
          Article 0 comments Cited 157 times – based on 0 reviews     Review now
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            Acupuncture for patients with migraine: a randomized controlled trial.

            Klaus Linde, Andrea Streng, Susanne Jürgens … (2005)
            Acupuncture is widely used to prevent migraine attacks, but the available evidence of its benefit is scarce. To investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine. Three-group, randomized, controlled trial (April 2002-January 2003) involving 302 patients (88% women), mean (SD) age of 43 (11) years, with migraine headaches, based on International Headache Society criteria. Patients were treated at 18 outpatient centers in Germany. Acupuncture, sham acupuncture, or waiting list control. Acupuncture and sham acupuncture were administered by specialized physicians and consisted of 12 sessions per patient over 8 weeks. Patients completed headache diaries from 4 weeks before to 12 weeks after randomization and from week 21 to 24 after randomization. Difference in headache days of moderate or severe intensity between the 4 weeks before and weeks 9 to 12 after randomization. Between baseline and weeks 9 to 12, the mean (SD) number of days with headache of moderate or severe intensity decreased by 2.2 (2.7) days from a baseline of 5.2 (2.5) days in the acupuncture group compared with a decrease to 2.2 (2.7) days from a baseline of 5.0 (2.4) days in the sham acupuncture group, and by 0.8 (2.0) days from a baseline if 5.4 (3.0) days in the waiting list group. No difference was detected between the acupuncture and the sham acupuncture groups (0.0 days, 95% confidence interval, -0.7 to 0.7 days; P = .96) while there was a difference between the acupuncture group compared with the waiting list group (1.4 days; 95% confidence interval; 0.8-2.1 days; P<.001). The proportion of responders (reduction in headache days by at least 50%) was 51% in the acupuncture group, 53% in the sham acupuncture group, and 15% in the waiting list group. Acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were more effective than a waiting list control.
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              A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain.

              Daniel Cherkin, Karen Sherman, Andrew Avins … (2009)
              Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. A total of 638 adults with chronic mechanical low back pain were randomized to individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland-Morris Disability Questionnaire score; range, 0-23) and symptom bothersomeness (0-10 scale). Outcomes were assessed at baseline and after 8, 26, and 52 weeks. At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P .05). Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture's purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects.
              Article 0 comments Cited 122 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMC Med
                Title: BMC Medicine
                Publisher: BioMed Central
                ISSN (Electronic): 1741-7015
                Publication date Collection: 2010
                Publication date (Electronic): 23 November 2010
                Volume: 8
                Page: 75
                Affiliations
                [1 ]Institute of General Practice, Technische Universität München, Orleansstrasse 47, D-81667 Munich, Germany
                [2 ]Institute of Medical Psychology, Ludwig-Maximilians-University, Goethestrasse 31, D-80336 Munich, Germany
                Article
                Publisher ID: 1741-7015-8-75
                DOI: 10.1186/1741-7015-8-75
                PMC ID: 3001416
                PubMed ID: 21092261
                SO-VID: b4006068-4490-4aa7-bca2-f24af330fbd0
                Copyright © Copyright ©2010 Linde et al; licensee BioMed Central Ltd.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License (<url>http://creativecommons.org/licenses/by/2.0</url>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 17 July 2010
                Date accepted : 23 November 2010
                Categories
                Subject: Research Article

                ScienceOpen disciplines: Medicine
                Data availability:
                ScienceOpen disciplines: Medicine

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