Medicina Alternativa e Integrativa

A Clinical Trial for Traditional Chinese Medicine Following Guidelines of Good Clinical Practice

Abstract

King-Fai Cheng and Ping-Chung Leung

This paper described the establishment of a Protocol for the clinical trial, using a traditional herbal formula, for the treatment of Menopausal symptoms among women after menopause. Generally, the traditional practitioners would prefer sticking to their classical practice of a dynamic day to day choice of treatment, according to patients’ “pattern” of physiological state. However, in the standard hospital setting of limited resources, the traditional way of dynamic treatment, according to patient responses and the subsequent comprehensive analysis of variable data would not be possible. As a result, we decided to design a standard protocol following the requirements of Good Clinical Practice. Our experiences demonstrated that it is feasible to perform a well-designed Traditional Chinese Medicine (TCM) clinical trial although there were many challenges such as placebo preparation, outcome determination and batchto- batch consistency of TCM medication.