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Placebo Devices as Effective Control Methods in Acupuncture Clinical Trials: A Systematic Review.

ABSTRACT: While the use of acupuncture has been recognised by the World Health Organisation, its efficacy for many of the common clinical conditions is still undergoing validation through randomised controlled trials (RCTs). A credible placebo control for such RCTs to enable meaningful evaluation of its efficacy is to be established. While several non-penetrating acupuncture placebo devices, namely the Streitberger, the Park and the Takakura Devices, have been developed and used in RCTs, their suitability as inert placebo controls needs to be rigorously determined. This article systematically reviews these devices as placebo interventions. Electronic searches were conducted on four English and two Chinese databases from their inceptions to July 2014; hand searches of relevant references were also conducted. RCTs, in English or Chinese language, comparing acupuncture with one of the aforementioned devices as the control intervention on human participants with any clinical condition and evaluating clinically related outcomes were included. Thirty-six studies were included for qualitative analysis while 14 were in the meta-analysis. The meta-analysis does not support the notion of either the Streitberger or the Park Device being inert control interventions while none of the studies involving the Takakura Device was included in the meta-analysis. Sixteen studies reported the occurrence of adverse events, with no significant difference between verum and placebo acupuncture. Author-reported blinding credibility showed that participant blinding was successful in most cases; however, when blinding index was calculated, only one study, which utilised the Park Device, seemed to have an ideal blinding scenario. Although the blinding index could not be calculated for the Takakura Device, it was the only device reported to enable practitioner blinding. There are limitations with each of the placebo devices and more rigorous studies are needed to further evaluate their effects and blinding credibility.

SUBMITTER: Zhang CS

PROVIDER: S-EPMC4633221 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Placebo Devices as Effective Control Methods in Acupuncture Clinical Trials: A Systematic Review.

Zhang Claire Shuiqing CS Tan Hsiewe Ying HY Zhang George Shengxi GS Zhang Anthony Lin AL Xue Charlie Changli CC Xie Yi Min YM

PloS one 20151104 11

While the use of acupuncture has been recognised by the World Health Organisation, its efficacy for many of the common clinical conditions is still undergoing validation through randomised controlled trials (RCTs). A credible placebo control for such RCTs to enable meaningful evaluation of its efficacy is to be established. While several non-penetrating acupuncture placebo devices, namely the Streitberger, the Park and the Takakura Devices, have been developed and used in RCTs, their suitability ...[more]

PMID: 26536619

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Project description:Background Allergic rhinitis (AR) is a common symptomatic, inflammatory, and immunological disorder of nasal mucosa. Multiple clinical trials and systematic reviews have implicated acupuncture methods as potentially effective treatment strategies for AR, however, considering the great burden of AR, it is crucial to explore the most recent clinical evidence supporting acupuncture in AR. Besides, the methodologies reported in previous studies as well as those commonly applied during clinical practices greatly vary. Herein, we conducted network meta-analysis to compare the effectiveness of diverse acupuncture methods for AR treatment. Methods We conducted a literature search for relevant reports published from inception to 1 July 2020 in several scientific databases, including PubMed, Embase, Cochrane library, Web of Science, CNKI, WF, VIP, CBM, AMED as well as related registration platforms. Primary outcomes as reported in the identified studies were assessed using nasal symptoms. All Meta-analyses were performed with RevMan, ADDIS, and STATA software. To ensure consistency among our reviewers, the intra-class correlation coefficient was used. Results Exactly 39 studies with 3433 participants were covered in this meta-analysis. The meta-analysis demonstrated that all acupuncture types were superior to sham acupuncture in terms of total nasal symptom score and rhinoconjunctivitis quality of life questionnaire. Moxibustion was recommended as the most effective intervention as it reduced nasal symptoms in 6 treatments. On the other hand, manual acupuncture plus conventional medicine was recommended as the most effective intervention in improving the quality of life in 9 treatments. Notably, moxibustion was recommended as the most effective intervention that changed the content of IgE in 9 treatments. Moreover, adverse events of these interventions were acceptable. Conclusion Our findings revealed that all acupuncture methods are effective and safe for AR. Moreover, either moxibustion or manual acupuncture plus conventional medicine are potentially the most effective treatment strategies for AR. Based on these findings, it is evident that acupuncture therapy is not inferior to pharmacologic therapy. Therefore, for AR patients who are either unresponsive to conventional medicine or are intolerant to adverse events, acupuncture therapy should be administered. However, the quality of these included trials was mainly ranked as moderate quality, we recommend additional well-designed RCTs with larger sample sizes to validate these findings.

Project description:BackgroundPrimary trigeminal neuralgia (PTN) is a clinical refractory disorder characterized by excruciating pain that severely impacts the quality of life. Several studies have shown that acupuncture can improve PTN pain. However, the comparative efficacy and safety of acupuncture are unknown. Herein, a systematic review was conducted to compare the efficacy and safety of various acupuncture methods for PTN treatment.MethodsRelevant randomized controlled trials (RCTs) published up to 1 August 2021 were obtained from PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science Core Collection, Chinese National Knowledge Infrastructure, Chinese Biomedical Literature Database, CQVIP Database, Wanfang Database, Allied and Alternative Medicine Database, and related registration platforms. Two authors independently selected the studies and obtained data. Cochrane Handbook was used to assess the methodological quality. We put the pain relief as the primary outcome and the response rate and adverse events as the secondary outcomes. Review Manager v5.3, ADDIS v1.16.8, and STATA v15.0 software were used for data analysis. The intraclass correlation coefficient was used to assess the consistency of the two investigators.ResultsA total of 58 RCTs with 4,126 participants were obtained. The meta-analysis indicated that five acupuncture methods were superior to conventional medicine (carbamazepine) in pain reduction intensity and response rate. Meanwhile, electronic acupuncture plus manual acupuncture was the most effective therapy since it reduced pain intensity in 11 methods and improved the response rate in 10 interventions. Moreover, six interventions had acceptable adverse events, and none of the included studies reported severe adverse events. However, most pieces of evidence were ranked as critically low.ConclusionThese findings show that acupuncture methods can be effective and safe for PTN. Moreover, electronic acupuncture plus manual acupuncture maybe the best acupuncture treatment for PTN and should be administered to PTN patients. However, additional well-designed and high-quality RCTs should be conducted to verify the above findings in the future. The systematic review is registered with CRD42020221456.

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Placebo Devices as Effective Control Methods in Acupuncture Clinical Trials: A Systematic Review.

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Placebo Devices as Effective Control Methods in Acupuncture Clinical Trials: A Systematic Review.

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