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.
Subject(s)
Humans , Randomized Controlled Trials as Topic , Research Design , Syndrome , Treatment OutcomeABSTRACT
<p><b>OBJECTIVE</b>Red ginseng (RG, Panax ginseng C.A. Meyer) is one of the widely used herbs for treating type 2 diabetes mellitus (DM). However, no systematic review of the effectiveness of RG for type 2 DM is available. This systematic review aimed to evaluate the current evidence for the effectiveness of RG in patients with type 2 DM.</p><p><b>METHODS</b>Electronic searches of 14 electronic databases were conducted without language restrictions. All randomized clinical trials (RCTs) with RG as a treatment for type 2 DM were considered for inclusion. Their methodological quality was assessed using the Cochrane criteria.</p><p><b>RESULTS</b>Four RCTs met our inclusion criteria. Their methodological quality was variable. Three of the RCTs compared the effectiveness of RG with placebo. The meta-analysis of these data failed to favor RG over placebo for fasting plasma glucose (FPG) [n =76, weighted mean difference (WMD): -0.43 mmol/L; 95% confidence interval (CI): -1.16 to 0.30, =0.25] and fasting plasma insulin (FPI) (n =76, WMD: -8.43 pmol/L; 95% CI: -19.54 to 2.68, P =0.14) for 12 weeks of treatment. One RCT compared the effects of RG with no treatment. The results did not suggest favorable effects of RG on FPG, hemoglobin A(1c) (HbA(1c)) or 2-h blood glucose after a meal (PP2h).</p><p><b>CONCLUSIONS</b>The evidence for the effectiveness of RG in controlling glucose in type 2 DM is not convincing. Few included studies with various treatment regimens prohibit definitive conclusions. More rigorous studies are needed to clarify the effects of RG on this condition.</p>