ABSTRACT
@#Standardization is the universal language of the world, and standardization of traditional Chinese medicine (TCM) is essential for its communication in China and globally. However, the principles and methods of TCM acupuncture standardization have been unclear and inadequate in the early stages. Based on an investigative approach to understanding the current status, identifying problems, and finding solutions, our team has established basic principles of TCM acupuncture that embody Chinese wisdom, evaluated the international strategic environment systematically, proposed the principle of “importance of harmony and exercise of impartiality”, and established basic working principles. A series of methods for TCM acupuncture standard development and evaluation have been constructed, including general standards for the revision of TCM acupuncture standards, the first TCM acupuncture clinical research management specification, a shared full chain technology platform, a data center, and an evaluation research base for TCM acupuncture clinical research. Evaluation criteria for ancient literature and expert experience, a recommendation method for the “three main and three auxiliaries” TCM guideline for prevention were established, and quantifiable assessment methods of TCM standard applicability were proposed. These findings provide methodological guidance for TCM acupuncture standardization.
ABSTRACT
@#Objective To evaluate the efficacy and safety of Huanglian Wendan Decoction (黄连温胆汤, HLWDD) alone or combined with western medicine in treating insomnia caused by phlegm-heat internal disturbance in recent 10 years. Methods The randomized controlled trials of HLWDD alone or combined with western medicine in treating insomnia caused by phlegm-heat internal disturbance from January 1, 2012 to April 1, 2022 were searched in China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), Wanfang Database, China BioMedical Literature Database (CBM), PubMed, Web of Science, Embase, and Cochrane Library databases. After being screening, the included literature was analyzed to evaluate the effective rate, Pittsburgh Sleep Quality Index (PSQI) score, traditional Chinese medicine (TCM) syndrome score, and adverse reactions of HLWDD on insomnia caused by phlegm-heat internal disturbance. The subgroup analyzed the effect of HLWDD after different treatment courses, and compared the therapeutic effects of HLWDD alone and HLWDD combined with western medicine. Results Twenty-seven randomized controlled trials were finally included, with a total of 2 395 patients. The results of the meta-analysis showed that the curative effect of HLWDD alone or combined with the western medicine group was better than that of the western medicine group [RR = 1.14, 95% CI (1.06, 1.22), P = 0.000]. The PSQI score [SMD = – 0.31, 95% CI (– 0.42, – 0.20), P = 0.000], TCM syndrome score [SMD = – 0.40, 95% CI (– 0.67, – 0.12), P = 0.005], and adverse reaction rate [RR = 0.21, 95% CI (0.15, 0.29), P = 0.000] of HLWDD alone or combined with western medicine group were significantly reduced compared with the western medicine group. The subgroup’s analysis showed that the curative effect of HLWDD alone or combined with western medicine group of 4 weeks treatment course was better than that of the western medicine group [RR = 1.14, 95% CI (1.03, 1.26), P < 0.05]. The TCM syndrome score of HLWDD alone or combined with the western medicine group of 4 weeks treatment course decreased more obviously than that of the western medicine group [SMD = – 0.60, 95% CI (– 0.96, – 0.25), P < 0.05]. There were no significant differences between HLWDD alone or combined with western medicine group and western medicine group with different treatment courses based on PSQI score and adverse reaction rate. Based on the effective rate, the comparison between the HLWDD alone group and the western medicine group [RR = 1.09, 95% CI (1.00, – 1.20) P < 0.05], and between the HLWDD combined with western medicine group and the western medicine group [RR = 1.15, 95% CI (1.03, 1.29), P < 0.05] was the same. PSQI score [SMD = – 0.44, 95% CI (– 0.59, – 0.30), P < 0.05] and TCM syndrome score [SMD = – 1.10, 95% CI (– 1.59, – 0.61), P < 0.05] of HLWDD combined with western medicine group were significantly lower than those of the western medicine group. There were no significant differences of adverse reaction rate between HLWDD alone group [RR = 0.08, 95% CI (0.04, 0.17), P < 0.05] and HLWDD combined with western medicine group [RR = 0.36, 95% CI (0.24, 0.53), P < 0.05]. Conclusion HLWDD alone or combined with western medicine is an effective treatment for insomnia caused by phlegm-heat internal disturbance, which has a high effective rate, significantly reduced PSQI score and TCM syndrome score, and favorable safety. The best course of treatment is 4 weeks.