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Open Access Study protocol

Use of comparative effectiveness research for similar Chinese patent medicine for angina pectoris of coronary heart disease: a new approach based on patient-important outcomes

Hongbo Cao12*, Jingbo Zhai1, Wei Mu12, Xiang Lei1, Hongxia Cao3, Chunxiang Liu1 and Hongcai Shang12*

Author Affiliations

1 88, Yuquan road, Tianjin Institute of Clinical Evaluation, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China

2 312, Anshanxidao road,Center for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China

3 518, Anxi roadGansu Hospital of Traditional Chinese Medicine, Lanzhou 730050, China

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Trials 2014, 15:84  doi:10.1186/1745-6215-15-84

Published: 19 March 2014

Abstract

Background

The practice of traditional Chinese medicine (TCM) has a profound history in many Asian countries. TCM syndrome is a set of characteristic physical signs and symptoms shared by a group of patients. Syndrome diagnosis and treatment assignment according to the identified TCM syndrome is a long-held practice of Chinese medicine. Owing to its distinctive way of interpreting illness and administering care, medical practitioners not well educated in TCM theories and practices are generally incapable of giving out prescriptions for Chinese patent drugs. Currently, the existence of a multitude of Chinese patent drugs marked with largely identical indications is further complicating this situation.

Methods

In this multicenter, randomized, controlled, double-blind, double-dummy clinical trial, in which we will use the comparative effectiveness research method, we will compare the efficacy of two commonly used Chinese patent medicines for angina patients diagnosed with qi deficiency and blood stasis syndrome. A total of 160 patients will be recruited and randomly assigned to receive either (1) QiShenYiQi dripping pills, Tongxinluo placebo and routine medication or (2) Tongxinluo capsules, QiShenYiQi placebo and routine medication. These treatment regimens will be carried out for 4 weeks, followed by a 10-day washout period and a 4-week crossover phase in which the treatments in the two patient groups will be exchanged. Patients will be allowed to choose symptoms that matter most to them and will be grouped accordingly. Patient-reported outcomes such as the Seattle Angina Questionnaire score and the 15-point Likert scale score will be measured and reported. The minimally clinical important difference will be calculated and used for efficacy assessment, and correspondence analysis will be performed to identify the best indications for each drug.

Discussion

The goal of the study is to establish a methodology for the precise identification of the characteristic indications for which a Chinese patent drug is most effective. The findings of this study will inform the practicality of the proposed evaluation method.

Trial registration

Chinese clinical trials register Chi CTRTTRCC13003732

Keywords:
Angina pectoris; Chinese patent medicine; Comparative effectiveness research; Patient-important outcomes