Introduction: Insomnia is a major public health problem. Due to the side effects of pharmacological therapy, people are seeking to choose complementary and alternative therapies for insomnia disorder. Traditional Chinese herbal bath therapy is an important complementary therapy which combines advantages of Chinese herbs and bathing therapy. This protocol describes the methodology of a systematic review assessing the effectiveness and safety of traditional Chinese herbal bath therapy for insomnia.
Methods and analysis: Reporting of this review will be adherent to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. We will electronically search the following seven databases from inception to January 23, 2020: PubMed, Cochrane database (CENTRAL), EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), VIP Database, and Wanfang Database. Parallel randomized controlled trials evaluating the effectiveness and safety of traditional Chinese herbal bath therapy for insomnia will be included. Study selection, data extraction and assessment of risk of bias will be performed independently by two researchers. The sleep quality will be assessed as the primary outcome. Global symptom improvement, anxiety and depression, and adverse events will be evaluated as secondary outcomes. The Cochrane's risk of bias tool will be utilized for assessing the methodological quality of included studies. Revman software (v.5.3) will be used for data synthesis and statistical analysis. Data will be synthesized by either fixed-effects or random-effects model according to a heterogeneity test. If it is not appropriate for a meta-analysis, a descriptive analysis will be conducted. GRADE system will be used to assess the quality of evidence.
Prospero registration number: CRD42020168507.