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      Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups

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          Abstract

          Objectives To study the analgesic effect of acupuncture and placebo acupuncture and to explore whether the type of the placebo acupuncture is associated with the estimated effect of acupuncture.

          Design Systematic review and meta-analysis of three armed randomised clinical trials.

          Data sources Cochrane Library, Medline, Embase, Biological Abstracts, and PsycLIT.

          Data extraction and analysis Standardised mean differences from each trial were used to estimate the effect of acupuncture and placebo acupuncture. The different types of placebo acupuncture were ranked from 1 to 5 according to assessment of the possibility of a physiological effect, and this ranking was meta-regressed with the effect of acupuncture.

          Data synthesis Thirteen trials (3025 patients) involving a variety of pain conditions were eligible. The allocation of patients was adequately concealed in eight trials. The clinicians managing the acupuncture and placebo acupuncture treatments were not blinded in any of the trials. One clearly outlying trial (70 patients) was excluded. A small difference was found between acupuncture and placebo acupuncture: standardised mean difference −0.17 (95% confidence interval −0.26 to −0.08), corresponding to 4 mm (2 mm to 6 mm) on a 100 mm visual analogue scale. No statistically significant heterogeneity was present (P=0.10, I 2=36%). A moderate difference was found between placebo acupuncture and no acupuncture: standardised mean difference −0.42 (−0.60 to −0.23). However, considerable heterogeneity (P<0.001, I 2=66%) was also found, as large trials reported both small and large effects of placebo. No association was detected between the type of placebo acupuncture and the effect of acupuncture (P=0.60).

          Conclusions A small analgesic effect of acupuncture was found, which seems to lack clinical relevance and cannot be clearly distinguished from bias. Whether needling at acupuncture points, or at any site, reduces pain independently of the psychological impact of the treatment ritual is unclear.

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          Most cited references15

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          Introducing a placebo needle into acupuncture research.

          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. 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. 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. The placebo needle is sufficiently credible to be used in investigations of the effects of acupuncture.
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            Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial.

            Evidence on the efficacy of acupuncture for reducing the pain and dysfunction of osteoarthritis is equivocal. To determine whether acupuncture provides greater pain relief and improved function compared with sham acupuncture or education in patients with osteoarthritis of the knee. Randomized, controlled trial. Two outpatient clinics (an integrative medicine facility and a rheumatology facility) located in academic teaching hospitals and 1 clinical trials facility. 570 patients with osteoarthritis of the knee (mean age [+/-SD], 65.5 +/- 8.4 years). 23 true acupuncture sessions over 26 weeks. Controls received 6 two-hour sessions over 12 weeks or 23 sham acupuncture sessions over 26 weeks. Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores at 8 and 26 weeks. Secondary outcomes were patient global assessment, 6-minute walk distance, and physical health scores of the 36-Item Short-Form Health Survey (SF-36). Participants in the true acupuncture group experienced greater improvement in WOMAC function scores than the sham acupuncture group at 8 weeks (mean difference, -2.9 [95% CI, -5.0 to -0.8]; P = 0.01) but not in WOMAC pain score (mean difference, -0.5 [CI, -1.2 to 0.2]; P = 0.18) or the patient global assessment (mean difference, 0.16 [CI, -0.02 to 0.34]; P > 0.2). At 26 weeks, the true acupuncture group experienced significantly greater improvement than the sham group in the WOMAC function score (mean difference, -2.5 [CI, -4.7 to -0.4]; P = 0.01), WOMAC pain score (mean difference, -0.87 [CI, -1.58 to -0.16];P = 0.003), and patient global assessment (mean difference, 0.26 [CI, 0.07 to 0.45]; P = 0.02). At 26 weeks, 43% of the participants in the education group and 25% in each of the true and sham acupuncture groups were not available for analysis. Acupuncture seems to provide improvement in function and pain relief as an adjunctive therapy for osteoarthritis of the knee when compared with credible sham acupuncture and education control groups.
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              Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial.

              Our aim was to assess the efficacy of a part-standardised verum acupuncture procedure, in accordance with the rules of traditional Chinese medicine, compared with that of part-standardised sham acupuncture and standard migraine prophylaxis with beta blockers, calcium-channel blockers, or antiepileptic drugs in the reduction of migraine days 26 weeks after the start of treatment. This study was a prospective, randomised, multicentre, double-blind, parallel-group, controlled, clinical trial, undertaken between April 2002 and July 2005. Patients who had two to six migraine attacks per month were randomly assigned verum acupuncture (n=313), sham acupuncture (n=339), or standard therapy (n=308). Patients received ten sessions of acupuncture treatment in 6 weeks or continuous prophylaxis with drugs. Primary outcome was the difference in migraine days between 4 weeks before randomisation and weeks 23-26 after randomisation. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN52683557. Of 1295 patients screened, 960 were randomly assigned to a treatment group. Immediately after randomisation, 125 patients (106 from the standard group) withdrew their consent to study participation. 794 patients were analysed in the intention-to-treat popoulation and 443 in the per-protocol population. The primary outcome showed a mean reduction of 2 .3 days (95% CI 1.9-2.7) in the verum acupuncture group, 1.5 days (1.1-2.0) in the sham acupuncture group, and 2.1 days (1.5-2.7) in the standard therapy group. These differences were statistically significant compared with baseline (p<0.0001), but not across the treatment groups (p=0.09). The proportion of responders, defined as patients with a reduction of migraine days by at least 50%, 26 weeks after randomisation, was 47% in the verum group, 39% in the sham acupuncture group, and 40% in the standard group (p=0.133). Treatment outcomes for migraine do not differ between patients treated with sham acupuncture, verum acupuncture, or standard therapy.
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                Author and article information

                Contributors
                Role: physician
                Role: director
                Role: senior researcher
                Journal
                BMJ
                bmj
                BMJ : British Medical Journal
                BMJ Publishing Group Ltd.
                0959-8138
                1468-5833
                2009
                2009
                27 January 2009
                : a3115
                Affiliations
                [1 ]Nordic Cochrane Centre, Rigshospitalet, Department 3343, Blegdamsvej 9, DK-2100 Copenhagen, Denmark
                Author notes
                Correspondence to: A Hróbjartsson  ah@ 123456cochrane.dk
                Article
                madm574145
                10.1136/bmj.a3115
                2769056
                19174438
                1d72bf33-8f90-4317-be59-eb8a120dcba8
                © Madsen et al 2009

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 20 October 2008
                Categories
                Research
                Pain (neurology)
                Pain (palliative care)
                Pain (anaesthesia)
                Complementary medicine
                Drugs: musculoskeletal and joint diseases
                Internet

                Medicine
                Medicine

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