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

This protocol shows the entire meta-analysis process, including literature search and screening, data extraction, risk of bias assessment, quality of evidence, and meta-analysis. Meta-analysis is a research method for a systematic, comprehensive evaluation and quantitative analysis of multiple, independent research results within the same purpose, solving the problem of inconsistency among multiple research results. Go to the PubMed database, enter the retrieval strategy by inputting the query as insomnia.

Click and, then enter Chinese traditional medicine. To download the retrieved literature, click save from the format dropdown menu, select PubMed, and then click create file. To perform literature screening, import the retrieved files by selecting file, and then import.

From the import options dropdown menu, select PubMed NLM, and click import. After creating a PRISMA flow chart using Microsoft Word, create an Excel spreadsheet containing information to be extracted for each literature. To produce quality evaluation charts, open the RevMan software.

Select file, click on new, and then next. To choose an appropriate type of systematic evaluation, select intervention review, click next, and fill in the title. Then select next, full review, and finally, finish.

To add the included literature, go to studies and references. Click references to studies, then included studies, and from the popup menu, select add study. Enter the study ID and press finish.

To enter the quality evaluation results, choose tables, select characteristics of studies, followed by characteristics of included studies. Click on figure, followed by add figure. Then select the risk of bias graph and click on next.

Finally, click on finish to generate a graph. To generate a summary, select risk of bias summary, click next and then finish. For the meta-analysis, go to data and analysis, click add comparison, enter the name of the comparison and select finish.

To add the outcome indicators, click on outcome or subgroup and choose add outcome. Select dichotomous or continuous for variables, click next to enter the name of the outcome, and then select finish. In the text of review window, select add study data.

Select the literature and click finish. To create forest plots, enter the extracted data, select FE or RE and click forest plot. The methodological quality assessment results of the 14 studies are used.

Five trials reported specific randomization methods and were assessed as low risk, while one trial was judged as high risk. For the primary outcome, nine studies including 866 patients, reported a total clinical effectiveness rate of 94%where the effectiveness rate was higher in the experimental group relative to the control. For the secondary outcome, eight studies, including 717 patients, demonstrated adverse events.

The adverse reaction rate was 13%in the experimental group. Three of the four studies that reported sleep duration showed significantly improved sleep duration in the experimental group. The experimental groups also showed reduced night awakening, nightmares, daytime sleepiness, and low energy.

After systematic review and meta-analysis, clinical practice guidelines for traditional Chinese medicine treatment of insomnia can be created using the formulation method of clinical practice guidelines. This study provides a complete description of the development process and operational steps of the systematic review and meta-analysis, which will serve as a reference for future researchers to conduct similar studies.