Literature Characteristics of Clinical Studies on Dose-Response Relationship of Traditional Chinese Medicine

Article type
Authors
Ren S1, Xia R2
1Qi-huang Chinese Medicine School, Beijing University Of Chinese Medicine, Beijing, China
2Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China
Abstract
Objective To summarize the literature characteristics of clinical studies on dose-response relationship of traditional Chinese medicine, to provide reference for the design of clinical studies in this field. Method PubMed, Embase, Web of Science, Cochrane Library and 4 Chinese databases were searched from inception to May 2023 to obtain clinical studies on dose-response relationship of traditional Chinese medicine. After independently screening and data extraction by two reviewers, quantitative analysis was used to describe include studies. Result A total of 354 clinical studies were included, involving 23085 participants (sample size ranging from 3 to 1194). Most trials conducted in China papers (n=331), other countries include Japan, USA, UK, German, Switzerland, Thailand, and South Korea. The most studied disease was cerebral infarction (n=39), followed by dysmenorrhea (n=17), knee osteoarthritis (n=16), peripheral facial paralysis (n=12), diabetes (n=9), and allergic rhinitis (n=8). The intervention measures mainly focused on Chinese herbal medicine (n=131; 78 patent medicine and 53 decoction), acupuncture(n=85), and moxibustion(n=70). For Chinese herbal medicine, dose was differentiated by adjusting overall dosage(n=103), individual herbal ingredients dosage (n=21), course of treatment (n=4) and daily medication frequency (n=2). For acupuncture, dose was mainly differentiated by adjusting acupuncture manipulation (n=47), the method of needle insertio n(n=14), frequency of acupuncture (14), needle retaining time (n=9), number of acupoints(n=7), and acupuncture treatment course (n=8). For moxibustion, dose was mainly differentiated by adjusting time of moxibustion (n=37), number of moxa cone (n=25), moxibustion frequency (n=8), moxibustion treatment course (n=3). 298 clinical trials reported statistically differences between groups at different doses, among which 161 trials showed that the high-dose group had better effects than the low or moderate dose group. Conclusion The number of clinical trial on dose-response relationships in the field of traditional Chinese medicine is limited, although there are many types of diseases and interventions involved.