%0 Journal Article
%T A traditional Chinese medicine versus Western combination therapy in the treatment of rheumatoid arthritis: two-stage study protocol for a randomized controlled trial
%A Chi Zhang
%A Miao Jiang
%A Aiping Lu
%J Trials
%D 2011
%I BioMed Central
%R 10.1186/1745-6215-12-137
%X This is a two-stage multi-center trial of Chinese herbal medicine for the management of rheumatoid arthritis. The stage one trial is an open-label trial and aims to explore what groups of Chinese medicine information (such as symptoms) correlates with better efficacy, and the stage two trial is a randomized, controlled, double-blind, double-dummy clinical trial that incorporates the efficacy-related information identified in the stage-one trial into the inclusion criteria.The indication of a Chinese herbal formula is a specific Chinese medicine pattern and not a single disease and stratifying a disease into several patterns with a group of symptoms is a feasible procedure in clinical trials. This study is the first to investigate whether this approach in the design of Chinese herbal medicine trials can improve responses.ChiCTR-TRC-10000989Clinical trials are mainly aimed at showing the efficacy and safety of a therapy after initial indications are determined in preclinical studies, but the results obtained from a clinical trial have become less important in identifying the specific indications of a therapy. At present, "-omics"-based pharmacology contributes to individualized medicine, which attempts to find more specific indications for therapies by identifying biomarkers [1]. Similarly, Chinese medicine (CM) generally prescribes therapies based on the identification of CM patterns in the patient by analyzing the symptoms and characteristics [2].All medicines should be rigorously tested [3,4], and the WHO Traditional Medicine Strategy suggests that clinical trials should be performed to establish the efficacy of CM [5]. Randomized clinical trials are useful to evaluate the efficacy of single drugs or combination therapy in a biomedical context [6]. However, they have distinct limitations when applied to CM because CM treatments focus on CM pattern classification [7]. Thus, alternative strategies, based on the CM concept, must be developed for the evaluation of CM e
%U http://www.trialsjournal.com/content/12/1/137