[Summary and evaluation of randomized controlled trial on Chinese patent medicine in treatment of diabetic foot ulcer].

This study systematically collected, analyzed, and evaluated randomized controlled trial(RCT) in the treatment of diabetic foot ulcer(DFU). The aim as provide references for future studies and to enhance the application of clinical evidence. The RCT of DFU treated with Chinese Patent Medicine was obtained and analyzed using the AI-Clinical Evidence Database of Chinese Patent Medicine(AICED-CPM). The analysis was supplemented with data from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science. A total of 275 RCTs meeting the requirements were retrieved, with only 7 of them having a sample size of 200 or more. These trials involved 66 different Chinese patent medicine including 25 oral medications, 24 Chinese herbal injections, and 17 external drugs. Among the 33 different intervention/control designs identified, the most common design was Chinese patent medicine + conventional treatment vs conventional treatment(86 cases, 31.27%). Out of the 275 articles included in the literature, 50 did not provide information on the specific course of treatment(18.18%). A total of 10 counting indicators(with a frequency of 426) and 36 measuring indicators(with a frequency of 962) were utilized. The methodological quality of the RCT for the treatment of DFU with Chinese patent medicine was found to be low, with deficiencies in blind methods, other bias factors, study registration, and sample size estimation. There were noticeable shortcomings in the reporting of allocation hiding and implementation bias(blind method application). More studies should prioritize trial registration, program design, and strict quality control during implementation to provide valuable data for clinical practice and serve as a reference for future investigations.

Efficacy and safety of acupuncture on sleep quality for post-stroke insomnia: a systematic review and meta-analysis.

Background: Stroke is the second leading cause of death worldwide, and improving sleep quality in post-stroke insomnia is beneficial to the recovery of stroke. Acupuncture is widely used for the treatment of post-stroke insomnia in China. Therefore, this systematic review and meta-analysis were performed to explore the efficacy and safety of acupuncture for post-stroke insomnia. Methods: Eight databases were searched from their inception to 12 September 2022. Two reviewers independently performed the study screening and data extraction. The outcomes include Pittsburgh Sleep Quality Index (PSQI), objective sleep data measured by polysomnography (PSG), long-term efficacy and adverse events. The quality of the trials was assessed by the Cochrane risk of bias tool 2.0. The RevMan 5.4 and Stata 15.1 were used for data synthesis. Results: Among 3,233 participants from 41 studies were included. Pooled results indicated that acupuncture was superior to control group (CG) in improving PSQI total score (standardized mean difference (SMD) = -1.03, 95% confidence interval (CI): -1.32, -0.74, P < 0.00001), increasing sleep efficiency (SMD = 0.65, 95% CI: 0.37 to 0.92) and total sleep time (SMD = 0.54, 95% CI: 0.22 to 0.86). The favorable results in improving PSQI total score (SMD = 0.65, 95% CI: 0.37 to 0.92), reduced sleep latency (SMD = 1.84, 95% CI: 0.31 to 3.38) and increased total sleep time (SMD = -0.73, 95% CI: -1.15 to -0.31) were also observed in comparisons of acupuncture plus CG vs. CG. As of long-term efficacy and safety, the effects of acupuncture were long-term and robustness, however, due to limited safety information, reliable safety conclusions cannot be drawn. Subgroup analysis showed that acupuncture plus CG was superior to CG for post-infarction patients, but the efficacy of acupuncture alone compared to non-BZDs or other hypnotics needs further research. The GRADE assessment demonstrated that the level of evidence was mostly low or very low given the flaws in the study design and considerable heterogeneity among the included studies. Conclusion: Acupuncture could improve sleep quality, has long-term efficacy and without serious adverse events. However, the findings should be treated with caution owing to the existence of methodological quality issues. More studies with rigorous designs are warranted for validation and explored the safety of acupuncture.

[Network Meta-analysis of efficacy and safety of Chinese patent medicines in treatment of insomnia].

To evaluate the efficacy and safety of Chinese patent medicines in the treatment of insomnia by frequency network Meta-analysis. Randomized controlled trials of Chinese patent medicines for insomnia were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase and Cochrane Library databases from the time of database establishment to October 2020. The quality of the included RCTs was evaluated according to the Cochrane bias risk standard, and the data was analyzed by RevMan 5.3 and Stata/MP 15.1. A total of 11 kinds of Chinese patent medicines in 27 RCTs were included. According to Meta-analysis, in term of the effective rate, Tianmeng Liquid, Zaoren Anshen Capsules, Shumian Capsules, Shensong Yangxin Capsules, Shenqi Wuweizi Tablets, Shugan Jieyu Capsules, Anshen Bunao Liquid and Qiye Anshen Tablets combined with nonbenzodiazepine drugs(NBZDs) were superior to NBZDs alone. In term of the improvement of Pittsburg sleeping quality index(PSQI) score, Tianmeng Liquid, Shumian Capsules, Shensong Yangxin Capsules, Bailemian Capsules, Shenqi Wuweizi Tablets, Shugan Jieyu Capsules, Yangxue Qingnao Granules and Yindan Xinnaotong Capsules combined with NBZDs were superior to NBZDs alone. In terms of the safety, Shumian Capsules, Shensong Yangxin Capsules, Shenqi Wuweizi Tablets and Qiye Anshen Tablets combined with NBZDs were superior to NBZDs alone. In terms of the avoidance of dizziness and headache, Qiye Anshen Tablets combined with NBZDs were superior to NBZDs alone. The results of Network Meta-analysis indicated that in term of the effective rate, top three optimal medication regimens were NBZDs combined with Shugan Jieyu Capsules, combined with Zaoren Anshen Capsules and combined with Shensong Yangxin Capsules in the order from high to low. With the respect of improvement of PSQI score, top three optimal medication regimens were NBZDs combined with Yangxue Qingnao Granules, combined with Tianmeng Liquid and combined with Yindan Xinnaotong Capsules in the order from high to low. In terms of the safety, top three optimal medication regimens were NBZDs combined with Qiye Anshen Tablets, combined with Shensong Yangxin Capsules and combined with Shenqi Wuweizi Tablets in the order from high to low. In terms of the avoidance of dizziness and headache, top three optimal medication regimens were NBZDs combined with Qiye Anshen Tablets, combined with Zaoren Anshen Capsules and combined with Shumian Capsules in the order from high to low. In terms of the avoidance of fatigue, top three optimal medication regimens were NBZDs combined with Shensong Yangxin Capsules, combined with Shumian Capsules and combined with Qiye Anshen Tablets in the order from high to low. In conclusion, Chinese patent medicines combined with NBZDs can effectively alleviate the symptoms of insomnia with a high safety. However, the conclusion of this study needs to be verified by more high-quality studies because of the low methodological quality of the included studies.