Strengthening the quality of clinical trials of acupuncture: a guideline protocol

Acupuncture has been accepted in many Western countries and clinical trials have been increasing recently. However, the problems of insufficient and low-quality evidence remain, and substantially hinder the development of acupuncture clinical trials. We therefore aim to develop a guideline to strengthen the quality of acupuncture clinical trials, in accordance with WHO handbook for guideline development and the Reporting Items for practice Guidelines in HealThcare. The guideline will help to improve the quality of acupuncture clinical trials.

We will search for studies on the quality of acupuncture clinical trials using PubMed, EMBASE, Web of Science, China National Knowledge Infrastructure, Wanfang Data, China Science and Technology Journal Database, The Cochrane Library, the WHO and Health Technology Assessment websites, and other sources. We will also check reference lists and contact experts in the field. We will systematically evaluate the quality of acupuncture clinical trials, and extract and summarise the quality problems and countermeasures of such trials. We will also systematically review clinical trial quality control manuals and systems and formulate research questions on quality control in acupuncture clinical trials. Finally, we will develop the guideline and establish a comprehensive quality control system to ensure high quality acupuncture clinical trials. We will also evaluate the guideline and will update the guideline to reflect new scientific evidence.

Ethics committee approval and informed consent are not required for developing guideline because only published data will be used, however, we will interview the patients, the ethics committee approval has been got from West China Hospital of Sichuan Unversity (Number: 2021-1188). We will publish all manuscripts arising from this research and present the findings at conferences.

IPGRP-2021CN093.