Dataset Information

Efficacy and safety of herbal medicine (Bailemian capsule) for treating insomnia: Protocol for a systematic review and meta-analysis.

ABSTRACT:

Background

Insomnia has become a universal subhealth disease, affecting more and more modern people's health and quality of life. At present, western medicine is only symptomatic treatment for insomnia. Bailemian Capsule (BLMC) is a proprietary Chinese medicine for treating insomnia. It has been widely used in China, but lacks evidence for evidence-based medicine. At the same time, the clinical efficacy and safety of BLMC are controversial. Therefore, the effectiveness and safety of BLMC in the treatment of insomnia are studied and systematically evaluated in this study. It provides reliable theoretical support for the treatment of insomnia with Traditional Chinese Medicine and the combination of traditional Chinese and Western medicine.

Methods

The information was retrieved from electronic databases, Cochrane, PubMed, EMBASE, SinoMed, China National Knowledge Infrastructure, VIP Data, and WangFang Data. Randomized controlled trials on the BLMC in the treatment of insomnia were conducted. There was no limitation on the literature language. RevMan 5.3 software and STATA 12.0 software were used to perform the meta-analysis.

Results

This review will be to assess the efficacy and safety of BLMC for insomnia.

Conclusion

Our systematic evaluation will provide evidence for the clinical efficacy and safety of BLMC in the treatment of insomnia, and will be published in the form of academic papers in the future to provide new ideas for clinicians in the treatment of insomnia.

SUBMITTER: Tian T

PROVIDER: S-EPMC6358357 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of herbal medicine (Bailemian capsule) for treating insomnia: Protocol for a systematic review and meta-analysis.

Tian Tian T Hua Lian L Wang Jianxin J Guan Jingzhi J

Medicine 20190101 4

<h4>Background</h4>Insomnia has become a universal subhealth disease, affecting more and more modern people's health and quality of life. At present, western medicine is only symptomatic treatment for insomnia. Bailemian Capsule (BLMC) is a proprietary Chinese medicine for treating insomnia. It has been widely used in China, but lacks evidence for evidence-based medicine. At the same time, the clinical efficacy and safety of BLMC are controversial. Therefore, the effectiveness and safety of BLMC ...[more]

PMID: 30681630

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Project description:Introduction: The effectiveness and safety of the Chinese herbal medicine (CHM) Xiao Yao San (XYS) used for treating anxiety disorders are still unknown. Thus, we conducted this systematic review with meta-analysis and trial sequential analysis (TSA) to determine its safety and efficacy. Methods: We searched 12 databases for relevant studies from the inception of each database till 10 August 2023. We selected randomized controlled trials to compare the efficacy and safety of XYS (including XYS only and XYS + anxiolytics) to those of anxiolytics in patients with anxiety. Results: We found 14 trials with 1,256 patients in total that met the requirements for inclusion. We assessed the majority of studies (8 out of 14) as being at high risk of bias; 6 were assessed as having a moderate risk of bias. Three trials compared oral XYS to anxiolytic medication, and 11 trials compared oral XYS plus anxiolytics to anxiolytic treatment alone. The pooled results showed that the efficacy of treatment in the XYS + anxiolytics groups was significantly higher than that of the anxiolytics alone group (RR = 1.19; 95% CI: [1.13, 1.26]; p < 0.00001; I2 = 0) and the adverse event rates in the XYS + anxiolytics groups were significantly lower than those in the anxiolytics alone group (RR = 0.44; 95% CI: [0.28, 0.82]; p = 0.001 < 0.05; I2 = 13). The efficacy of treatment in the XYS alone groups was also significantly higher than that of the anxiolytics alone groups (RR = 5.41; 95% CI: [2.23, 13.11]; p < 0.0001; I2 = 0). However, there was no statistical difference between the adverse events of the XYS alone group and the anxiolytics alone group, although the incidence of adverse events in the XYS alone group was lower than that in the anxiolytics alone group. The results of the TSA confirmed the above findings. Conclusion: The use of XYS combined with anxiolytics for treating anxiety was found to be safe and effective. However, although XYS alone is effective in the treatment of anxiety disorder, more large-scale research is needed to investigate adverse events. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=350358, identifier CRD42022350358.

Project description:Background: In recent years, systematic reviews/meta-analyses (SRs/MAs) of Chinese herbal medicine (CHM) for psoriasis have continuously emerged. Their methods and evidence quality, however, are yet to be evaluated, and whether their conclusions can provide clinicians with reliable evidence is still debatable. Objectives: This overview aims to evaluate the methodological quality, risk of bias, and reporting quality of relevant SRs/MAs, as well as the current evidence of CHM for treating psoriasis. Methods: We searched nine electronic databases from their respective time of establishment to January 20, 2021, as well as the reference lists of the included SRs/MAs, protocol registries, and gray literature. Two reviewers independently used the following: A Measurement Tool to Assess Systematic Reviews (AMSTAR) 2, Risk of Bias in Systematic Reviews (ROBIS), the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA), and Grades of Recommendations, Assessment, Development and Evaluation (GRADE) to evaluate the methodological quality, risk of bias, reporting quality, and evidence quality of the included SRs/MAs. Results: This review included 14 SRs/MAs involving 45 outcomes, of which 12 (85.71%) SRs/MAs had a very low quality evaluated by AMSTAR 2 and 7 (50.00%) SRs/MAs had a high risk of bias assessed by ROBIS. The protocol and registration and funding statements were the major reporting flaws according to the PRISMA checklist. The evaluation with the GRADE system demonstrated no outcome of high-quality evidence, and inconsistent efficacy evaluations were found in this overview. Only 15 (33.33%) outcomes were moderate-quality evidence, supporting the claim that CHM plus Western medicine (WM) was superior to WM. Generally low quality of evidence showed no difference in the incidence of adverse events between the combined therapy and WM. However, the conclusion that CHM was superior to WM cannot be drawn due to the inconsistent results. Conclusion: Despite that CHM has the potential benefit and safety in the adjuvant treatment of psoriasis, the conclusion should be treated with caution because of the generally low quality of methodology and evidence. In the future, high-quality randomized controlled trials (RCTs) should be carried out, and the quality of relevant SRs should also be improved to promote their clinical application.

Dataset Information

Efficacy and safety of herbal medicine (Bailemian capsule) for treating insomnia: Protocol for a systematic review and meta-analysis.

Background

Methods

Results

Conclusion

Publications

Efficacy and safety of herbal medicine (Bailemian capsule) for treating insomnia: Protocol for a systematic review and meta-analysis.

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