Background: Insomnia is one of the most common sleep problems, which can impact physical and mental quality of life, resulting in a heavy social and economic burden. Xiaoyao san, a Chinese Herbal Medicine product, has been widely used as an alternative to recommended treatments for insomnia, but still lack of evidence of evidence-based medicine, which the clinical efficacy and its safety are questioned. Accordingly, we provide a protocol to evaluate the efficacy and safety of Xiaoyao san to update the search and evaluation for the best available and security treatment for insomnia.
Methods: This review systematic and comprehensive retrieves of 8 related databases at home and abroad. Only randomized controlled trials (RCTs) of Xiaoyao san on Insomnia published in English and Chinese will be included. The quality of the included trials including randomization, allocation concealment, blinding, withdrawal, and loss of follow-up which was evaluated using internationally accepted evaluation criteria. And then systematically comprehensive analysis of the efficacy.
Results: This review will be to assess the efficacy and safety of Xiaoyao san for insomnia.
Conclusion: This systematic review will provide strong evidence for the effectiveness and safety of Xiaoyao san in the treatment of insomnia.
Prospero registration number: CRD42019127326.