Abstract

A growing number of randomized controlled trials (RCTs) have explored the significance of adjusting constitution for preventive treatment of disease in traditional Chinese medicine (TCM). In this study, we sought to comprehensively analyze the characteristics of these RCTs.All RCTs related to constitutional adjustment and preventive treatment of disease were included in the study. Literature was screened searching seven databases, including Pubmed, Web of Science, Embase, SinoMed, CNKI, Chongqing VIP, and Wangfang Database, from inception to December 2018. Data pertaining to bibliometrics, participants, and interventions were extracted and analyzed.Two hundred and forty papers were published between 2007 and 2018, involving 240 RCTs with 55 977 total participants. Sample size in these RCTs ranged from 30 to 7800. Among them, 59 RCTs addressed disease prevention prior to onset involving 11 healthy states of participants, mainly for general health or sub-health population (40.68%) using health care and non-drug therapy. In control the development of existing disease (n = 174), 59 diseases were involved. Based on the number of RCTs and sample sizes, diseases including type 2 diabetes mellitus, primary hypertension, nonalcoholic fatty liver disease, and hyperlipoproteinemia accounted for 51.15% of the total patients studied. Drug therapy as an intervention was frequently used. In preventing recurrence after recovery (n = 7), over 4 kinds of health status in participants were involved. Drug therapy combined with health care was mostly used. Most RCTs reported positive outcomes, with only one reporting negative findings (1/240).The number of RCTs of constitutional adjustment on preventive treatment of disease has gradually increased since 2012. Participants and intervention measures from the above-mentioned types of RCTs exhibit their own characteristics. Future systematic reviews or meta-analyses on constitutional adjustment for preventive treatment of disease are warranted.

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