Efficacy and safety of Shugan Jieyu capsule in the treatment of essential hypertension with insomnia, anxiety or depression A protocol for systematic review and meta-analysis

Background: Shugan Jieyu capsule can reduce blood pressure and improve its concomitant symptoms. However, it is not widely used in clinic because of its incomplete understanding of its nature. There are many reports on the clinical trials of Shugan Jieyu capsule in the treatment of essential hypertension with insomnia, anxiety or depression in recent years. However, the lack of systematic review and meta-analysis has not provided effective evidence. As a consequence, we provide a protocol to evaluate the efficacy and safety of Shugan Jieyu capsule (SJC) in the treatment of essential hypertension (EH) with insomnia, anxiety or depression. Methods: The search time range of Cochrane Library, PubMed, excerpt Database (EMBASE), Chinese Biomedical Literature Database (CBM), China National knowledge Infrastructure (CNKI), Chinese Science and Technology Journal Database (VIP), and Wanfang Database (WanFang), was searched by computer from the establishment of the database to December 31, 2020. In the meanwhile, the list of references and related reviews were checked. The data were extracted by 2 evaluators independently, and the literature quality was evaluated according to Cochrane manual 4.2.2. In addition, CochraneRevman5.3 software was used for heterogeneity test, meta-analysis, publication bias analysis and GRADE3.6 evidence quality classification system evaluation related statistical data. Results: This study intends to evaluate the efficacy and safety of SJC in the treatment of EH from many aspects, including changes in blood pressure [systolic blood pressure (SBP), diastolic blood pressure (DBP)], effective rate of blood pressure reduction, improvement rate of concomitant symptoms and adverse reactions. Conclusion: The conclusion of systematic review intends to provide evidence for judging that SJC is an effective intervention for EH patients with insomnia, anxiety and depression. PROSPERO registration number: PROSPERO CRD 42021219704.

Automated summary

This study aims to evaluate the efficacy and safety of Shugan Jieyu capsule in the treatment of essential hypertension with insomnia, anxiety, or depression, including changes in blood pressure, effective rate of blood pressure reduction, improvement rate of concomitant symptoms, and adverse reactions.