Commentary

Study designs of randomized controlled trials not based on Chinese medicine theory are improper

Jian Yan¹ , Veronica F Engle² , Yuxin He³ , Yan Jiao⁴ and Weikuan Gu⁴

¹  Molecular Resource Center, University of Tennessee Health Science Center, Memphis, TN 38163, USA

²  Department of Primary Care Nursing and Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN 38163, USA

³  Acupuncture & Chinese Medical Center, Austin, TX 78757, USA

⁴  Department of Orthopedics Surgery, University of Tennessee Health Science Center, Memphis, TN 38163, USA

author email corresponding author email

Chinese Medicine 2009, 4:3doi:10.1186/1749-8546-4-3

Published:	25 February 2009

Abstract

Current biomedical research methods to evaluate the efficacy of Chinese medicine interventions are often conceptually incompatible with the theory and clinical practice of Chinese medicine. In this commentary, we (1) highlight the theory and principles underlying Chinese medicine clinical practice; (2) use ginseng as an example to describe clinical indications in Chinese medicine; (3) propose a framework guided by Chinese medicine theory for the evaluation of study designs in Chinese medicine research; and (4) evaluate 19 randomized, double-blind, placebo-controlled trials of ginseng. Our analysis indicates that all 19 trials with both positive and negative results confirm the specific effects of ginseng indicated by Chinese medicine theory. Study designs guided by Chinese medicine theory are necessary to validate and improve future randomized controlled clinical trials in Chinese medicine.