Appropriateness of sham or placebo acupuncture for randomized controlled trials of acupuncture for nonspecific low back pain: a systematic review and meta-analysis

Journal of Pain Research, Dec 2017

Appropriateness of sham or placebo acupuncture for randomized controlled trials of acupuncture for nonspecific low back pain: a systematic review and meta-analysis Yan Xiang,1 Jinyuan He,2 Rui Li1 1Department of Teaching, School of Acupuncture and Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China; 2Department of Cardiothoracic Surgery, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China Objectives: To establish whether sham acupuncture (SA) or placebo acupuncture (PA) is more efficacious for reducing low back pain (LBP) than other routine treatments and to discuss whether SA or PA is appropriate for randomized controlled trials of acupuncture for LBP.Methods: Six databases were searched on 31 May 2017. We included only randomized controlled trials of adults with LBP and lower back myofascial pain syndrome. The studies had at least two control arms: a sham-controlled acupuncture arm and a routine care or waiting list arm (people who did not receive acupuncture until the end of treatment). Trials were combined using meta-analysis methods when the data allowed statistical pooling. Pooled effect sizes were calculated by random effects models.Results: This review identified 7 trials (1768 participants); all were included in the meta-analysis. We found statistically significant differences in pain reduction post-intervention between SA or PA and routine care or a waiting list, with a standardized mean difference of −0.36 (95% CI −0.54 to −0.18; I2 statistic=16%; participants=624; studies=6) for the Visual Analog Scale and −0.35 (95% CI −0.49 to −0.20; I2 statistic=0%; participants=736; studies=1) for the Chronic Pain Grade Scale; however, no significant difference was observed between SA or PA and routine care or no treatment for post-intervention function.Conclusion: Compared with routine care or a waiting list, SA or PA was more efficacious for pain relief post-intervention. Concluding that SA or PA is appropriate for acupuncture research would be premature. Guidelines evaluating SA or PA control methods are needed to determine the specific effect of acupuncture over placebo. Keywords: acupuncture, alternative medicine, backaches, pain management, placebos, controlled clinical trial, lumbago

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Appropriateness of sham or placebo acupuncture for randomized controlled trials of acupuncture for nonspecific low back pain: a systematic review and meta-analysis

Journal of Pain Research Appropriateness of sham or placebo acupuncture for randomized controlled trials of acupuncture for nonspecific low back pain: a systematic review and meta-analysis Yan Xiang 1 Jinyuan He 0 Rui Li 1 0 Department of Cardiothoracic Surgery, The Third Affiliated Hospital of Sun Yat-sen University , Guangzhou , China 1 Department of Teaching, School of Acupuncture and Moxibustion and Tuina, Beijing University of Chinese Medicine , Beijing , China 8 1 0 2 - l u J - 2 1 n o 7 0 2 . 6 4 . 9 5 . 7 3 y b / m o c . s s PowerdbyTCPDF(ww.tcpdf.org) O R I G I N A L R E S E A R C H Objectives: To establish whether sham acupuncture (SA) or placebo acupuncture (PA) is more efficacious for reducing low back pain (LBP) than other routine treatments and to discuss whether SA or PA is appropriate for randomized controlled trials of acupuncture for LBP. Methods: Six databases were searched on 31 May 2017. We included only randomized controlled trials of adults with LBP and lower back myofascial pain syndrome. The studies had at least two control arms: a sham-controlled acupuncture arm and a routine care or waiting list arm (people who did not receive acupuncture until the end of treatment). Trials were combined using meta-analysis methods when the data allowed statistical pooling. Pooled effect sizes were calculated by random effects models. Results: This review identified 7 trials (1768 participants); all were included in the meta-analysis. We found statistically significant differences in pain reduction post-intervention between SA or PA and routine care or a waiting list, with a standardized mean difference of −0.36 (95% CI −0.54 to −0.18; I2 statistic=16%; participants=624; studies=6) for the Visual Analog Scale and −0.35 (95% CI −0.49 to −0.20; I2 statistic=0%; participants=736; studies=1) for the Chronic Pain Grade Scale; however, no significant difference was observed between SA or PA and routine care or no treatment for post-intervention function. Conclusion: Compared with routine care or a waiting list, SA or PA was more efficacious for pain relief post-intervention. Concluding that SA or PA is appropriate for acupuncture research would be premature. Guidelines evaluating SA or PA control methods are needed to determine the specific effect of acupuncture over placebo. acupuncture; alternative medicine; backaches; pain management; placebos; con- - open access to scientific and medical research Introduction Nonspecific low back pain (LBP) is among the most common health complaints; it is the leading cause of years lived with disability worldwide and sixth in terms of overall disease burden (disability-adjusted life-years).1 Although LBP is usually a self-limiting and benign disease, a large variety of therapeutic interventions are available to treat it.2 Acupuncture, based on the concepts of traditional Chinese medicine (TCM), is one of the oldest and most popular complementary or alternative treatment methods. Although it is one of the most commonly used interventions to treat LBP, acupuncture has mixed support. Despite a 2005 Cochrane review that reported the existence of some evidence supporting acupuncture for chronic LBP,3 a conclusion supported by another systematic review,4 the National Institute for Health and Care Excellence (NICE) in the UK removed acupuncture from their LBP guidelines in early 2016, citing a lack of evidence to indicate that it was more effective than sham treatment.5 Sham acupuncture (SA), also called placebo acupunc801 ture (PA), performed away from the acupuncture points l-J2u established by TCM or without stimulation and manipula-12 tion to avoid eliciting “De Qi” sensations or using a non7on penetrating technique, is used as control in scientific studies .602 to determine the efficacy of acupuncture.6,7 However, in .549 China, wrist-ankle acupuncture and abdomen acupuncture, .37 both with shallow needling, are the primary treatments for /yb LBP. It might be argued that the superficial or minimal .com acupuncture might stimulate C fibers in the skin to trigger ss some kind of analgesic effect.8,9 Of those sham-controlled rvepe l.yno clinical trials, several of them found no significant differ.doww lsuea eLnBcPe.s10b–1e4tAwseeanreresuallta,ccuopnutrnocvteurrseyapnedrSsiAst/sPrAeginarpdaiinngrwelhieefthfoerr /w no / ttsp rspe acupuncture for LBP works primarily by the placebo effect. : Meanwhile, some investigators argued that using SA/PA as a control is problematic because SA/PA might not meet the criteria of being physiologically inert.15,16 Regardless, no systematic review and meta-analysis to date has addressed whether SA/PA has effects for LBP. We, therefore, performed a systematic review and meta-analysis of acupuncture for the treatment of LBP to determine whether SA/PA was more efficacious in reducing LBP than routine care and to discuss whether SA/PA is appropriate for use in randomized controlled trials (RCTs) of acupuncture for LBP. ohm roF fr d (...truncated)


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Yan Xiang, Jinyuan He, Rui Li. Appropriateness of sham or placebo acupuncture for randomized controlled trials of acupuncture for nonspecific low back pain: a systematic review and meta-analysis, Journal of Pain Research, 2017, pp. 83-94, DOI: 10.2147/JPR.S152743