Placebo setting in trials of traditional Chinese medicine nursing techniques: a systematic critical review(1)

传统中医护理技术试验中的安慰剂设置:系统性批判性评价(1)

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Abstract

BACKGROUND: In the clinical research field of Traditional Chinese Medicine (TCM) nursing techniques, there are an increasing number of randomized controlled trial (RCTs) involving placebo control settings, but the quality of literature reports remains unclear. This paper aims to assess the reporting quality of placebo-controlled RCTs focusing on TCM nursing techniques. METHODS: A comprehensive search was conducted on PubMed, Web of Science, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), WanFang Database, Chongqing Weipu (VIP), and China Biology Medicine (CBM) from inception to December 3, 2023. The search included RCTs with a placebo control group related to clinical studies on TCM nursing techniques. The Consolidated Standards for Reporting of Trials (CONSORT) and Template for Intervention Description and Replication-Placebo (TIDieR-Placebo) criteria were employed to assess the standardization of literature reporting. RESULTS: A total of 39 papers were included, covering 15 TCM nursing techniques with a placebo control group designed for the treatment. Common placebo controls included “fake application of real points,“"real application of fake points,” and changes in the medium. The CONSORT evaluation revealed reporting rates of less than 20% for entries 3b, 6b, 11b, 12b, 14b, 16, 17b, and 18. In the TIDieR-Placebo evaluation, the reporting rates of entries 5, 6, 7, 9, 10, 11, and 13 were all below 20%. CONCLUSIONS: The current literature reporting quality of RCTs incorporating placebo control groups in clinical research on TCM nursing techniques is generally suboptimal. Researchers are advised to conscientiously use CONSORT and TIDieR-Placebo guidelines to enhance the reporting standards of research, fostering greater standardization in clinical research on TCM nursing. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12906-025-05125-0.

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