Comparative efficacy and safety of Chinese patent medicines for primary insomnia: A systematic review and network meta-analysis of 109 randomized trials.

ETHNOPHARMACOLOGICAL RELEVANCE

Chinese patent medicine (CPM) is formulated using Chinese herbal medicines as raw materials according to prescribed methods and preparation processes. It is one of the most commonly used complementary and alternative therapies for insomnia in China. Dozens of CPMs have been applied in clinical settings to treat primary insomnia, and ample evidence has proven the efficacy and safety of various CPMs.

AIM OF THE STUDY

We aimed to use the network meta-analysis method to simultaneously compare the efficacy and safety of Chinese patent medicines for primary insomnia.

MATERIALS AND METHODS

We systematically searched eight databases from their inception to July 2022. The relevant randomized controlled trials (RCTs) were eligible if they compared one CPM or one CPM plus a 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. We evaluated the certainty of evidence utilizing CINeMA (Confidence in Network Meta-Analysis) framework.

RESULTS

A total of 109 RCTs involved 11,488 patients (54.26% female) with a median age of 47.97 years. Forty-five CPMs were assessed in this study. Compared with placebo and Benzodiazepine drugs, Shugan Jieyu capsules, Shenqi Wuweizi tablets, and Tianmeng oral liquid/capsules combined with Benzodiazepine drugs significantly improved sleep quality. Compared to Benzodiazepine drugs, both Shenqi Wuweizi tablets and Anshen Bunao liquid/granules significantly prolonged subjective total sleep duration and reduced sleep onset latency. Considering safety, all CPMs showed an insignificant difference or lower risk of gastrointestinal and dizziness events compared to Western drugs or placebo. The certainty of evidences was rated as low or very low.

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, which have shown their potential benefits. However, the present conclusions are based on low quality trials. Well-designed trials, including rigorous methods and patient-important outcomes, are required to verify these results.