Syndrome pattern and its application in parallel randomized controlled trials

Abstract

Syndrome pattern (SP) is a core concept of Chinese medicine (CM) and is used to diagnose and treat patients based on an overall analysis of symptoms and signs. This study aimed to systematically review randomized controlled trials (RCTs) using the SP concept and to demonstrate how the SP concept could be applied to the study design of parallel RCTs, considering a gold standard of clinical research. After conducting a brief systematic review by way of a PubMed search, we analyzed how the SP concept was applied to the design of RCT in a CM herbal medicine trial. We then formulated possible research questions, applied the SP concept to answer the research questions, and suggested possible RCT designs to be used for conducting future trials. Fourteen RCTs were included in our systematic review, and three key points of the SP concept were formulated for the design of parallel RCTs: the time point of SP diagnosis between before and after randomization; the relationship between the international classification of diseases (ICD) and SP for the inclusion of target population; and the proper diagnostic method of SP. In this study, we formulated three possible research questions and then suggested perspectives for five possible RCT models arrived at using SP concepts. Future trials applying SP concept to RCTs should overcome the shortcomings of past SP trials, moving CM forward from experience-based to evidence-based medicine.

Pulse Waveform Analysis of Chinese Pulse Images and Its Association with Disability in Hypertension

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Are meta-analyses of Chinese herbal medicine trials trustworthy and clinically applicable? A cross-sectional study

“…CHM is often prescribed as a formulae consisting of multiple herbs, and the effect of different formulae on the same disease is often assessed in multiple trials. In trials where Chinese medicine diagnostic theory is taken into account, CHM are prescribed to patients in an individualized manner (Shin et al, 2013). In addition, the dosage form and route of delivery of CHM intervention may differ.…”

Tianma Gouteng Yin as Adjunctive Treatment for Essential Hypertension: A Systematic Review of Randomized Controlled Trials

“…All diagnostic and therapeutic methods in TCM are based on the differentiation of TCM syndrome, and this concept has been used for thousands of years in China [108]. Clinical trials based on TCM zheng classification may lead to more valid conclusions about Chinese herbal formula [109–114]. In our review, TGY combined with antihypertensive drugs appeared to be more effective than antihypertensive drugs alone for LYHS and LKYDS in EH.…”