Descriptions of sham acupuncture in randomised controlled trials: a critical review of the literature

Abstract

Background Sham acupuncture is usually used to assess the specific effects of acupuncture. However, the reporting quality of sham acupuncture remains unclear despite its critical importance in understanding and analyzing the effects of acupuncture. This paper presents a literature review aimed at assessing the quality of reporting of sham acupuncture in randomized controlled trials (RCTs) based on STRICTA 2010 and TIDieR-Placebo. Methods Three electronic English-language databases (PubMed, MEDLINE and Embase) were searched from inception to March 7, 2022, and RCTs of sham acupuncture were identified. The reporting quality of sham acupuncture was assessed in accordance with the items recommended in STRICTA 2010 and TIDieR-Placebo. The reporting quality of other items related to sham acupuncture apart from items from these two checklists was also captured to further assess the reporting quality of sham acupuncture. Results A total of 609 eligible studies were included. For all of the items recommended in STRICTA 2010 and TIDieR-Placebo, 100% of the studies reported a brief name that described the sham acupuncture, 93.9% studies reported the needle type, and 90.0% reported the names of the points used. Other items for which the reporting rates were above 50% included the number, frequency and duration of treatment sessions; needle retention time; and number of needle insertions per subject per session. Overall, 49.4% of the studies revealed the rationale why sham acupuncture was chosen, 39.7% of the studies involving insertion processes reported the depth of insertion, and 37.9% of the studies reported the needle manufacturer. Other items for which the reporting rates were below 30% included practitioner-related information, response sought, evaluation of blinding, intervention mode and environment, assisting tools, and the extent to which the treatment was varied. The items “Modifications”, “How well (planned)” and “How well (actual)” were not reported in any of the analyzed studies. Conclusions The overall reporting quality of sham acupuncture in RCTs was suboptimal. Although STRICTA 2010 and TIDieR-Placebo could be beneficial for describing sham acupuncture, neither can offer recommendations specifically for sham acupuncture. There is thus an urgent need to develop specialized guidelines for reporting sham acupuncture in clinical trials.

Effect and safety of electroacupuncture on weight loss in obese patients with pre-diabetes: study protocol of a randomised controlled trial

“…Interestingly, the non-acupoint shallow puncture produced even less placebo response than non-penetration acupuncture. 33 …”

“…Interestingly, the non-acupoint shallow puncture produced even less placebo response than nonpenetration acupuncture. 33 This trial aims to address two key technical issues, namely the application of the SA treatment and patients' compliance. To ensure the appropriate administration of SA, all acupuncturists will receive extensive training before the commencement of the trial.…”

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“…The accidental inclusion of active components in a placebo treatment capable of triggering specific effects has been identified as a significant problem in placebo-controlled trials and is more common than had been previously thought [13][14][15]. The inadequate description of sham acupuncture techniques [16] and the lack of pre-clinical studies demonstrating the lack of specific effects with sham needling techniques [5] continue to plague this field, creating difficulties in interpreting the results from both clinical trials and systematic reviews when sham acupuncture is used as a control treatment [5].…”

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