Effects of the combination of red yeast rice-containing commercial Chinese polyherbal preparation with statins for dyslipidemia: a systematic review and meta-analysis.

Background: Significant challenges are associated with the pharmacological management of dyslipidemia, an important risk factor for cardiovascular disease. Limited reliable evidence exists regarding the efficacy of red yeast rice (RYR)-containing commercial Chinese polyherbal preparation (CCPP), despite their widespread use in China. Purpose: We aimed to investigate the efficacy of RYR-containing CCPPs combined with statins in treating dyslipidemia. Methods: Eight databases were searched for relevant randomized controlled trials (RCTs) from database inception date to November 2023. Outcome measures, including low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglyceride (TG), clinical efficacy, and adverse reactions, were assessed. The Cochrane Handbook for Systematic Reviews of Interventions was used for quality evaluation, and the meta-analysis was conducted using RevMan 5.3 and Stata 15.1. Results: Thirty-three studies involving 4,098 participants were included. The combination of RYR-containing CCPP, such as Xuezhikang (XZK), Zhibitai (ZBTAI), or Zhibituo (ZBTUO) with statins had a significant effect on the increase in clinical efficacy [RR:1.16, 95%CI (1.13, 1.19), p < 0.00001]. In addition, they also improved blood lipid profile parameters by increasing HDL-C levels [MD:0.21, 95%CI(0.17, 0.25), p < 0.00001], and decreasing TC [MD: 0.60, 95%CI(-0.76, -0.45), p < 0.00001], TG [MD: 0.33, 95%CI(-0.39, -0.26), p < 0.00001] and LDL-C levels [MD: 0.45, 95%CI(-0.54, -0.36), p < 0.00001]. No significant adverse reactions was observed in the RYR-containing CCPPs. Notably, ZBTAI and XZK significantly reduced the incidence of gastrointestinal disturbances and muscular adverse reactions. However, subgroup analyses suggested that the type of CCPPs, dose, and treatment duration might affect the efficacy of RYR-containing CCPPs. Conclusion: RYR-containing CCPPs combined with statins appears to improve lipid profiles and clinical efficacy in patients with dyslipidemia. However, due to the poor quality of the included studies, and some studied showing negative findings was unpublished. The results should be interpreted with caution until further confirmation by well-designed RCTs. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=487402, identifier CRD42023487402.

Efficacy and safety of Chinese patent medicines for tension-type headache: Systematic review and network meta-analysis.

Objective: The high incidence of Tension-type headache (TTH) has led to significant social and economic challenges. Given the widespread use of Chinese patent medicines (CPM) for TTH patients, this study aim to evaluate the efficacy of different CPMs in treating TTH by network meta-analysis. Methods: Eight databases were conducted to identify CPMs-related randomized controlled trials (RCTs) from database inception date to August 2023. The primary outcome was clinical efficiency rate. The secondary outcomes were numerical rating scale (NRS), frequency of headache, duration of headache, hamilton anxiety scale (HAMA), hamilton depression Scale (HAMD) and adverse reactions. ROB 2.0 were used for quality evaluation. Stata 15.1 and R 3.5.3 software were used for Bayesian network meta-analysis. Results: A total of forty-one RCTs were included, involving 3,996 patients and 8 CPMs. The network meta-analysis revealed that Shugan Jieyu capsule plus western medicine (WM) was the best choice of CPM for improving clinical efficiency rate [vs. WM: relative risk (RR) = 7.31, 95 % confidence interval (CI): (1.65, 56.71)]. Yangxue Qingnao granule plus WM was superior to other therapeutic combinations in reducing duration of headache [vs. WM: MD = 1.05, 95%CI(0.74, 1.40)]. Jieyu pill plus WM might have best effect in reducing HAMD [vs. WM: MD = 7.15, 95%CI(-3.77, 18.14)], HAMA scores [vs. WM: MD = -7.41, 95%CI(-13.39, -1.42)], and NRS scores [vs. WM: mean difference (MD) = 2.01, 95%CI(1.47, 2.55)]. In terms of the frequency of headache, although Yangxue Qingnao granule plus WM and Toutong-ning capsule plus WM performed best, the optimal CPMs in reducing the frequency of headache remain to be further explored. Furthermore, due to the limited safety evidence available, reliable safety conclusions could not be drawn. Conclusion: CPM can effectively improve headache symptoms, clinical efficiency, and quality of life in patients with TTH. However, research with high quality and large sample sizes is needed for further investigation due to the limitations of this study.

[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.

Effectiveness of Shuxuening injection in coronary heart disease: a systematic review and meta-analysis.

Background: Coronary heart disease (CHD) poses a serious threat to public health, and the current medical management still faces significant challenges. Reliable evidence on the efficacy of Shuxuening injection (SXNI) in CHD is still lacking, even though it is widely used in China. Purpose: To evaluate the efficacy of SXNI combination therapy in treating CHD. Methods: A systematic search of eight databases was conducted to identify relevant randomized controlled trials (RCTs) from the inception of each database until June 2023. ROB 2.0, RevMan 5.4, and Stata 15.1 were used for quality evaluation and data analysis. The Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach was used to evaluate the quality of evidence. Results: A total of 3,779 participants from 39 studies were included. The results showed SXNI combination therapy increased the clinical efficacy and decreased the frequency and duration of angina. Furthermore, SXNI combination therapy improved cardiac function of patients by decreasing LVEDD, and increased CI, CO, and LVEF. It also improved blood lipid profiles by increasing HDL, decreasing TC, TG, and LDL. The thrombosis factors of patients were also improved by decreasing FIB, PV, HCT, and HS. Moreover, SXNI combination therapy was superior to the conventional treatment in improving CRP levels, increasing ECG efficacy and BNP. However, due to the limited safety information, reliable safety conclusions could not be drawn. Furthermore, the levels of evidence ranged from very low to moderate due to publication bias and heterogeneity. Conclusion: SXNI can effectively improve angina symptoms, clinical efficacy, cardiac function, blood lipid indicators, and thrombosis factors of patients with CHD. However, more multi-center and large-sample studies are needed to confirm the conclusions due to the limitations of this study. Registration https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=399606; Identifier: CRD42023433292.

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.