Clinical research of traditional chinese medicine needs to develop its own system of core outcome sets.

Li Zhang,Jing Chen,Jiaying Wang,Junhua Zhang,Wei Mu,Hongcai Shang,Dongmei Xing

doi:10.1155/2013/202703

Abstract

Currently, quality issues concerning clinical research of traditional Chinese medicine (TCM) have come into the spotlight. It has been recognized that poorly-devised research methodology largely restricted the development of clinical research in TCM. The choice of appropriate outcome measurements is key to the success of clinical research; however, the current procedure for outcomes selection in clinical research of TCM is problematic due to the underdevelopment of clinical methodology. Under this circumstance, we propose the introduction to the concept of Core Outcome Set (COS) and discuss the feasibility of developing a COS system that caters for clinical studies in TCM, in the hope that the outcome evaluation system could be up to international standards.

Highlights

Clinical effectiveness is important for traditional Chinese medicine (TCM), but for all medical systems
There is a growing recognition that more attention has been paid to enhance the quality in clinical research of TCM [3, 4]
Consensus on regarding what constitute a good design has been reached by most scholars, except some characteristics of TCM which have unique difficulties, including placebo making, sham control of acupuncture, tailoring treatment principle, and diagnostic system

Summary

Introduction

Clinical effectiveness is important for traditional Chinese medicine (TCM), but for all medical systems. Due to the many existing methodological defects of TCM trials, the efficacy of TCM remains controversial [1, 2]. All these issues have created a bottleneck in the development of TCM. There is a growing recognition that more attention has been paid to enhance the quality in clinical research of TCM [3, 4] In this decade, a new discipline, clinical evaluation of TCM, has formed into being and its development has been supported by the Chinese Major Science and Technology Projects. There have been several achievements, for instance, the construction and implementation of the central randomization system, the application of the clinical data management system, the introduction of ethical review and trial registration, the promotion of the Consolidated Standards of Reporting Trials (CONSORT) statement, and the standardization of the data processing and analysis techniques

Problems with Outcome Measures in Clinical Trials of TCM

Why COSs in Clinical Trials of TCM Are Established?

Findings

The Feasibility of Establishing COS in Clinical Trials of TCM