Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia

Summary

The presented protocol describes an investigation strategy and systematic review to evaluate the clinical effectiveness and safety of Shugan Jieyu capsules for treating insomnia.

Abstract

A systematic review and meta-analysis were conducted to evaluate the clinical effectiveness and safety of Shugan Jieyu capsules for treating insomnia by searching seven databases up to February 21, 2022. The study was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The quality of the studies was assessed using the risk of bias assessment tool. This article describes in detail how to retrieve and screen the literature. The detailed steps for conducting the meta-analysis are also included in the protocol. Fourteen studies were found to be eligible, including 1,283 insomnia patients (644 with and 639 without Shugan Jieyu capsules at baseline). The meta-analysis showed a better total clinical effectiveness (odds ratio [OR]: 5.71, 95% confidence interval [CI]: 3.56 to 9.15) and a lower Pittsburgh Sleep Quality Index (PSQI) score (mean difference [MD]: −2.95, 95% CI: −4.97 to −0.93) with combined Shugan Jieyu capsules and Western medicine compared to Western medicine alone. The secondary outcomes showed that the Shugan Jieyu capsule group had significantly reduced adverse reactions and improvements in sleep duration, night awakening, nightmares with excessive dreaming, daytime sleepiness, and low energy. Further multicenter randomized trials must be encouraged to provide more concrete evidence on whether Shugan Jieyu capsules are beneficial in routine clinical practice.

Introduction

Insomnia is a sleep disorder characterized by difficulty in falling asleep, difficulty in maintaining sleep, and premature or intermittent waking¹, which can cause discomfort and disrupt daily functioning. According to the China Sleep Study Report (2022), over 300 million Chinese people suffered from sleep disorders in 2021, with a prevalence of insomnia among adults as high as 38.2%².

Western medicine for insomnia treatment typically involves psychological therapies or medication³. Psychotherapies, such as simple insomnia behavior therapy and cognitive insomnia behavio....

Protocol

1. Software installation

1. RevMan software installation
   1. Go to RevMan's official website (see Table of Materials), and according to the configuration of the computer system, select the compatible software version, and download it in the form of an exe file.
   2. Double-click to run the exe file: Next > Select the appropriate installation path > Next > Finish.
2. EndNote software installation
   1. Go to EndNote's official website (see Table of Materials) to download the installation package compatible with the computer's ver....

Results

Search results
A total of 1,117 studies were identified from databases, including 204 in Chinese and 913 in English. After eliminating 392 duplicates, 725 studies remained. After reading the titles and abstracts, 31 studies remained. Eventually, 14 studies were included through reading the full texts. The search process and selection procedure are shown in Figure 1.

Study characteristics
The characteristics of the incl.......

Discussion

In the present study, a comprehensive evaluation of the effectiveness and safety of Shugan Jieyu capsules for treating insomnia was conducted, and the following results were observed. In the experimental group, using Shugan Jieyu capsules in combination with conventional Western medicine improved the overall clinical effectiveness for patients with insomnia and resulted in higher PSQI scores. Additionally, the Shugan Jieyu capsules group showed improvements in clinical outcomes, such as sleep latency, night awakenin.......

Materials

Name	Company	Catalog Number	Comments
Endnote	Clarivate	Free trial version	EndNote is a widely used reference management tool to help you collect, organize, and share your references. Official website: https://endnote.com/downloads
Microsoft Excel	Microsoft	Official Version	Microsoft Excel, a spreadsheet software with an intuitive interface, excellent computing capabilities and charting tools, is one of the most popular data processing software for personal computers.
Microsoft Word	Microsoft	Official Version	Microsoft Word offers a number of easy-to-use document creation tools, as well as a rich set of features for creating complex documents, as well as text formatting or image manipulation.
Revman	Cochrane collaboration	Official Version	Review Manager (RevMan) is the international Cochrane Collaboration's proprietary software for systematic reviewers to produce and maintain Cochrane systematic reviews. Official website: https://training.cochrane.org/online-learning/core-software-cochrane-reviews/revman/revman-5-download/download-and-installation
Database websites
CBM			http://www.sinomed.ac.cn/
CNKI			https://www.cnki.net/
Cochrane Library			https://www.cochranelibrary.com/
Embase			https://www.embase.com/
Pubmed			https://pubmed.ncbi.nlm.nih.gov/
VIP			http://www.cqvip.com/
Wan fang			https://www.wanfangdata.com.cn/
Web of Science			http://www.webofscience.com/