Protocol for the reporting assessment of clinical trials with non-pharmacological therapies in Chinese medicine

Abstract

Introduction

Non-pharmacological treatment in Chinese Medicine (NPTCM) plays a crucial and distinct role in clinical practice, and increasingly within randomized controlled trials (RCTs). With the successive publication of Consolidated Standards Of Reporting Trials (CONSORT) extensions for acupuncture, moxibustion, cupping, and Tuina/massage, this study aims to assess the reporting characteristics and quality of published RCTs based on these specific reporting checklists.

Methods

Databases including All EBM Reviews, AMED, Embase, Ovid MEDLINE(R), CNKI, VIP Chinese Medical Journal Database, and Wanfang Data will be searched, with the publication date limited to January 1, 2022 to December 31, 2022. The interventions of interest are RCTs involving acupuncture, moxibustion, cupping or Tuina/massage, with language restricted to Chinese or English. Two reviewers will conduct the screening process with double-checking by the third reviewer. The purpose of data extraction is to summarize the study designs and implementation characteristics of these four types of interventions, and a pre-designed data extraction form will be utilized. For quality assessment, a standard operating procedure (SOP) will be developed, using an assessment form based on the checklist items of the four CONSORT extensions. Each article will be reviewed by two reviewers in a paired back-to-back manner, and Cohen's kappa statistic will be calculated to assess inter-rater agreement. Descriptive statistics will be used to present the quality of reporting. Subgroup comparisons will be conducted regarding different types of interventions, locations and publication languages.

Discussion

This study aims to identify and assess the current reporting characteristics and quality of the above four types of NPTCM interventional trials. Based on the results, it is hoped to provide suggestions for future application or promotion of the CONSORT extensions for NPTCM.