Article type
Abstract
"Background: Chinese patent medicine (CPM) is formulated using Chinese herbal medicines as raw materials according to prescribed methods and preparation process. It represents one of the most commonly used complementary and alternative therapy for insomnia in China. Dozens of CPMs have been applied in clinical settings in treating primary insomnia and ample evidences have proved the efficacy and safety of various CPMs.
Objective: We aimed to use the network meta-analysis method to simultaneously compare the efficacy and safety of Chinese patent medicines for primary insomnia.
Methods: We systematically searched eight databases from their inception to July 2022. of relevant randomized controlled trials (RCTs) were eligible if they compared one CPM or one CPM plus Western drug with another CPM or with Western drug/placebo in adults with primary insomnia. Two reviewers independently performed literature screening, data extraction, and risk of bias assessment. Frequentist network meta-analysis was conducted using the ‘netmeta’ package in R software.
Results: A total of 109 RCTs were included, that involved 11,488 patients with 54.26% female and the median age of 47.97 years. Forty-five CPMs were assessed. Compared with both placebo and Benzodiazepine drugs, Shugan Jieyu capsules, Shenqi Wuweizi tablets, and Tianmeng oral liquid/capsules combined with Benzodiazepine drugs could significantly improve sleep quality. Compared with Benzodiazepine drugs, both Shenqi Wuweizi tablets and Anshen Bunao liquid/granules could significantly prolong subjective total sleep sleep and reduce sleep onset latency. In terms of safety, all CPMs showed insignificant difference or lower risk of experiencing gastrointestinal events and dizziness events compared with western drugs or placebo.
Conclusion: This meta-analysis demonstrated the efficacy and safety of CPMs for primary insomnia, especially several CPMs such as Shugan Jieyu capsules, Shenqi Wuweizi tablets and Tianmeng oral liquid have showed their potential benefits. However, the present conclusions were based on low quality trials. Well-designed trials including rigorous method and patient-important outcomes are needed to verify the results.
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Objective: We aimed to use the network meta-analysis method to simultaneously compare the efficacy and safety of Chinese patent medicines for primary insomnia.
Methods: We systematically searched eight databases from their inception to July 2022. of relevant randomized controlled trials (RCTs) were eligible if they compared one CPM or one CPM plus Western drug with another CPM or with Western drug/placebo in adults with primary insomnia. Two reviewers independently performed literature screening, data extraction, and risk of bias assessment. Frequentist network meta-analysis was conducted using the ‘netmeta’ package in R software.
Results: A total of 109 RCTs were included, that involved 11,488 patients with 54.26% female and the median age of 47.97 years. Forty-five CPMs were assessed. Compared with both placebo and Benzodiazepine drugs, Shugan Jieyu capsules, Shenqi Wuweizi tablets, and Tianmeng oral liquid/capsules combined with Benzodiazepine drugs could significantly improve sleep quality. Compared with Benzodiazepine drugs, both Shenqi Wuweizi tablets and Anshen Bunao liquid/granules could significantly prolong subjective total sleep sleep and reduce sleep onset latency. In terms of safety, all CPMs showed insignificant difference or lower risk of experiencing gastrointestinal events and dizziness events compared with western drugs or placebo.
Conclusion: This meta-analysis demonstrated the efficacy and safety of CPMs for primary insomnia, especially several CPMs such as Shugan Jieyu capsules, Shenqi Wuweizi tablets and Tianmeng oral liquid have showed their potential benefits. However, the present conclusions were based on low quality trials. Well-designed trials including rigorous method and patient-important outcomes are needed to verify the results.
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