This work was supported by the National Nature Foundation of China (grant number 82004504) and the Chinese Medicine Administration of Sichuan Province (grant number 2021MS199).

1. Software installation
<ol>
	<li>RevMan software installation
	<ol>
		<li>Go to RevMan&#39;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.</li>
		<li>Double-click to run the exe file: Next &#62; Select the appropriate installation path &#62; Next &#62; Finish.</li>
	</ol>
	</li>
	<li>EndNote software installation
	<ol>
		<li>Go to EndNote&#39;s official website (see Table of Materials) to download the installation package compatible with the computer&#39;s version as a ZIP file.</li>
		<li>Decompress the ZIP file within a local folder. Double-click to start the installer.</li>
		<li>Configure the installation options: Next &#62; Welcome to Endnote X9 &#62; I would like a 30-day free trail &#62; Next &#62; I accept the license agreement &#62; Next &#62; Typical &#62; Next &#62; Finish.</li>
	</ol>
	</li>
</ol>
2. Literature search and screening
<ol>
	<li>Create the retrieval strategy. Determine the search terms according to the inclusion and exclusion criteria. The details of the retrieval strategy for this study are provided in Supplementary File 1.</li>
	<li>Perform a literature search through various databases (common databases: Pubmed, CBM, Web of Science, CNKI, Cochrane Library, VIP, Embase, and Wan fang; see Table of Materials). Take PubMed as an example:
	<ol>
		<li>Go to the PubMed database website.</li>
		<li>Enter the retrieval strategy based on the Pubmed search rules. 
		NOTE: In this study, the query might be (&#34;insomnia&#34; OR &#34;restlessness&#34; OR &#34;sleeplessness&#34; OR &#34;wakefulness&#34; OR &#34;inability to sleep&#34;) AND (&#34;Medicine, Chinese Traditional&#34; OR &#34;Traditional Chinese Medicine&#34; OR &#34;Zhong Yi Xue&#34; OR &#34;Chinese Traditional Medicine&#34; OR &#34;Chinese patent medicine&#34; OR &#34;Shugan Jieyu Capsules&#34;). In this query, the operator &#34;AND&#34; indicates that the studies must have all the keywords, the operator &#34;OR&#34; indicates that the studies must have at least one of the keywords, and the parentheses indicate the order of these logical operations. The literature search time for this study was up to February 21, 2022 (Supplementary Figure 1A).</li>
		<li>Download all the retrieved literature: Save &#62; PubMed &#62; Create file (Supplementary Figure 1B).</li>
	</ol>
	</li>
	<li>Perform the literature screening. 
	NOTE: Take Pubmed as an example using Endnote.
	<ol>
		<li>Import the retrieved literature: File &#62; Import &#62; Options &#62; Import Options &#62; PubMed (NLM) &#62; Import (Supplementary Figure 2A).</li>
		<li>Create inclusion and exclusion groups: My Groups &#62; Create group set or Create group. For example, the exclusion groups contain inappropriate interventions, inappropriate patients, duplication of literature, etc. (Supplementary Figure 2B).</li>
		<li>Remove the duplicates: All References &#62; References &#62; Find Duplicates &#62; Cancel. Then, all the duplicate literature is selected. Drag all the selected documents to the left side of the &#34;Trash&#34; to exclude them. After automatically eliminating the duplicate literature, manually check again to eliminate any duplicate literature (Supplementary Figure 2C).</li>
		<li>For literature screening, firstly, read the titles and abstracts of the studies to delete any that do not meet the inclusion criteria, and then further read the full texts to determine whether each study is included.</li>
	</ol>
	</li>
	<li>Consider performing a manual search of the referenced works in the selected studies to increase the search&#39;s exhaustiveness.</li>
	<li>Consider reaching out to the corresponding authors of the literature to request any missing or unclear data to maximize study inclusion and avoid uncertainty in the data collection. 
	NOTE: The literature search and screening must be performed by two or more independent researchers. Final decisions should be made after discussion, or a third researcher must judge in the case of disagreement.</li>
	<li>Use Microsoft Word to create a PRISMA flowchart44 documenting the number of studies retrieved or excluded for each reason (Supplementary File 2).</li>
</ol>
3. Data extraction
<ol>
	<li>Create an Excel extraction spreadsheet containing a list of specific information to be extracted for each literature. For example, this information could include the first author, year of publication, sample size (experimental group/control group), gender, patient age, intervention, duration of treatment, and medication use in the experimental and control groups.</li>
	<li>Ensure that two reviewers independently conduct the data extraction and make the final decision after discussion or after a judgment by a third researcher when there is disagreement.</li>
	<li>Summarize the outcome indicators that reflect the effectiveness and safety of the treatment of insomnia with Shugan Jieyu capsules in the two groups. Extract the sample size and composition ratio for the outcome indicators of dichotomous variables; however, extract the mean and standard deviation for continuous variables. 
	&#8203;NOTE: When two or more included studies mention the same outcome index, extract the specific data of that outcome index. For example, this could include the total clinical effectiveness rate, PSQI score, adverse effects, etc.</li>
</ol>
4. Risk of bias assessment and quality of evidence
<ol>
	<li>Use the Cochrane Risk Assessment Manual45 to evaluate the risk of bias (RoB) of the included literature.
	<ol>
		<li>Divide the evaluation grades into unclear, low, and high risk based on seven aspects: random sequence generation, blinding of participants and personnel, allocation concealment, incomplete outcome data, blinding of outcome assessment, selective reporting45, and other biases (other biases refer to the potential risk of bias in the included studies, such as in relation to the age of the participants, co-interventions, etc.).</li>
	</ol>
	</li>
	<li>Produce quality evaluation charts.
	<ol>
		<li>Create a new file. Open the RevMan software: File &#62; New &#62; Next, and then select an appropriate type of systematic evaluation: systematic evaluation &#62; Intervention review &#62; fill in the title &#62; Next &#62; Full review &#62; Finish (Supplementary Figure 3A).</li>
		<li>Add the included literature: Studies and references &#62; References to studies &#62; Included studies &#62; Add Study (Supplementary Figure 3B). Enter the study ID (e.g., Xiao Juan 2017)24.</li>
		<li>Enter the quality evaluation results: Tables &#62; Characteristics of studies &#62; Characteristics of included studies. Select the literature to be evaluated, and enter the evaluation result and basis for each item (Supplementary Figure 3C). 
		NOTE: If the RoB is &#34;Unclear risk&#34;, enter &#34;Unclear risk&#34; in the text box after it; otherwise, it cannot be displayed in the quality evaluation chart.</li>
		<li>Create a graph of the RoB: Figures &#62; Add Figure &#62; Risk of bias graph or Risk of bias summary &#62; Save (Supplementary Figure 4A).</li>
	</ol>
	</li>
	<li>Use the GRADE guidelines46 to assess the quality of evidence, and generate a summary sheet in which the results of each study included in the meta-analysis are classified based on evidence quality. 
	NOTE: The overall quality is downgraded according to five factors (risk of bias, indirectness, imprecision, inconsistency, and publication bias) and upgraded according to three factors (large effect size, negative bias, and dose-effect relationships). The GRADE guidelines classify the quality of evidence as high, medium, low, and very low, reflecting the degree of confidence that the effect estimates are correct.</li>
	<li>Ensure that two reviewers independently assess the risk of bias and quality of the evidence and that disagreements are resolved by discussion or by an adjudicator.</li>
</ol>
5. Meta-analysis
<ol>
	<li>Start the meta-analysis by using RevMan software: Data and analyses &#62; Add Comparison, then add a comparison and enter the name of the control group &#62; Finish.</li>
	<li>Add the outcome indicators: Add Outcome &#62; select the variable type (&#34;Dichotomous&#34; for dichotomous variables; &#34;Continuous&#34; for continuous variables) &#62; Next, and then enter the outcome indicators (e.g., &#34;Total clinical effectiveness&#34;, &#34;PSQI overall score&#34;) &#62; Finish (Supplementary Figure 4B).</li>
	<li>Add the study data: Add Study Data, then select the literature &#62; Finish (Supplementary Figure 5A).</li>
	<li>Create forest plots47: Enter the extracted data &#62; FE or RE &#62; Forest Plot&#160;(Supplementary Figure 5B). 
	NOTE: Due to the non-homogeneity of the population and intervention, random effect models were used to combine all the effect sizes in this study.</li>
</ol>

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The authors have no conflicts of interest to declare.

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&#160;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...

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 behavior therapy, aim to modify the behaviors that contribute to sleep difficulties. Sedative-hypnotic drugs, which act quickly to induce sleep, are also commonly used to treat insomnia4. However, these drugs can have toxic side effects, including respiratory depression, hypotension, and excessive sedation. The prolonged usage of these drugs can lead to dependence, resulting in significant harm and burden to the patients and their families5,6,7. In traditional Chinese medicine (TCM), insomnia is referred to as &#34;no sleep&#34; or &#34;sleeplessness&#34; and is believed to result from deficiencies in organs such as the liver, kidneys, spleen, and heart, as well as dysfunction of the heart and mind8. In the history of traditional Chinese medicine, several experts have described the mechanisms underlying insomnia; specifically, insomnia is thought to occur due to disorder of the function of the internal organs, the loss of harmony between the qi and blood, and the disorder of yin and yang, which lead to a loss of nourishment or the disturbance of the heart and mind. The basic pathological alternation of insomnia is the loss of yang and yin9. Utilizing the active ingredients of TCM and following the principles of TCM compounding for complex conditions, research10,11,12,13 has shown that TCM plays a critical role in preventing and treating insomnia. One example of a TCM treatment for insomnia is the Shugan Jieyu capsule14, which comprises Hypericumperforatum L15,16 and Acanthopanax senticosus17.
Acanthopanax senticosus18,19, a traditional Chinese herb, has been used for tonifying the middle qi and kidney and calming the mind. It has been found to effectively improve symptoms such as insomnia, excessive dreaming, and neurasthenia. Hypericum perforatum20, another traditional Chinese herb, has demonstrated antidepressant properties, with its active components potentially possessing similar antidepressant effects to tricyclic antidepressants (TCAS) and selective serotonin reuptake inhibitors (SSRIs), but with better tolerability. The combination of Hypericum perforatum and Acanthopanax senticosus has been found to regulate neurotransmitters, improve neuronal synaptic plasticity, and clinically relieve insomnia caused by mental illness; indeed, it improves the sleep quality and cognitive function of patients with liver-depression type insomnia21,22. Syndrome differentiation is a unique characteristic of TCM. The Shugan Jieyu capsule containing Hypericum perforatum and Acanthopanax senticosus is formulated to treat insomnia caused by stagnation of liver qi. It has been reported to be effective in improving the condition and safety of patients21,22. Combining these two herbs has been proven to relieve depression, calm the mind, soothe the liver, and strengthen the spleen23,24,25. However, there currently needs to be more conclusive evidence regarding the clinical effectiveness and safety of Shugan Jieyu capsules in treating insomnia.
There are various forms of Chinese herbal medicine for treating insomnia, including decoction, patent medicine, plaster, and auricular point sticking26. Previous research has examined the effect of traditional Chinese herbs on insomnia using meta-analyses. It has been found that traditional Chinese herbs significantly improve the symptoms of patients with primary insomnia, are superior to placebo, and have promising potential for research and development27,28. This study aims to evaluate the clinical effectiveness and safety of the Shugan Jieyu capsule in treating insomnia through a systematic evaluation and meta-analysis in order to provide clinical evidence and guidance for using these capsules.
The inclusion criteria for this study were defined using the population, intervention or exposure, comparison, outcome(s) (PICO) framework29. The inclusion criteria for this study were as follows: (1) randomized controlled trials (RCTs) or semi-RCTs that enrolled patients diagnosed with insomnia30; (2) studies in which the experimental group received Western medicine in combination with Shugan Jieyu capsules, while the control group received Western medicine alone (Western medicines include alprazolam tablets31, risperidone32, estazolam tablets33, aripiprazole orally disintegrating tablets34, mirtazapine35, escitalopram oxalate tablets36, eszopiclone tablets37, zopiclone tablets38, and fluoxetine dispersible tablets39); (3) studies published in Chinese or English; (4) studies in which the primary outcomes were the overall clinical effectiveness and the Pittsburgh Sleep Quality Index (PSQI)40. According to the &#34;Diagnostic Effectiveness Criteria for Chinese Medicine Evidence&#34;41 and the &#34;Guidelines for Clinical Research on New Chinese Medicines&#34;42, effective clinical outcomes are defined as patients being clinically documented as cured or showing efficacious results. The secondary outcomes identified include sleep latency, sleep duration, nighttime awakening, nightmares with excessive dreaming, daytime sleepiness, lack of energy, and sleep quality, all evaluated by the PSQI scale and the frequency of adverse events. Among these outcome measures, sleep latency, sleep duration, nighttime awakening, nightmares, daytime sleepiness, lack of energy, and sleep quality are all evaluated using the PSQI scale43.
The exclusion criteria were defined according to the PICO framework. The exclusion criteria for this study were as follows: (1) studies unrelated to insomnia; (2) duplicate published research; (3) non-randomized controlled trials; (4) non-clinical patient studies, such as preclinical and animal model studies; and (5) case reports, comments, conferences, reviews, and dissertations.

<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td>Endnote</td>
			<td>Clarivate</td>
			<td>Free trial version</td>
			<td>EndNote is a widely used reference management tool to help you collect, organize, and share your references. Official website: https://endnote.com/downloads</td>
		</tr>
		<tr>
			<td>Microsoft Excel</td>
			<td>Microsoft</td>
			<td>Official Version</td>
			<td>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.</td>
		</tr>
		<tr>
			<td>Microsoft Word</td>
			<td>Microsoft</td>
			<td>Official Version</td>
			<td>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.</td>
		</tr>
		<tr>
			<td>Revman</td>
			<td>Cochrane collaboration</td>
			<td>Official Version</td>
			<td>Review Manager (RevMan) is the international Cochrane Collaboration&#39;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</td>
		</tr>
		<tr>
			<td>Database websites</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>CBM</td>
			<td></td>
			<td></td>
			<td>http://www.sinomed.ac.cn/</td>
		</tr>
		<tr>
			<td>CNKI</td>
			<td></td>
			<td></td>
			<td>https://www.cnki.net/</td>
		</tr>
		<tr>
			<td>Cochrane Library</td>
			<td></td>
			<td></td>
			<td>https://www.cochranelibrary.com/</td>
		</tr>
		<tr>
			<td>Embase</td>
			<td></td>
			<td></td>
			<td>https://www.embase.com/</td>
		</tr>
		<tr>
			<td>Pubmed</td>
			<td></td>
			<td></td>
			<td>https://pubmed.ncbi.nlm.nih.gov/</td>
		</tr>
		<tr>
			<td>VIP</td>
			<td></td>
			<td></td>
			<td>http://www.cqvip.com/</td>
		</tr>
		<tr>
			<td>Wan fang</td>
			<td></td>
			<td></td>
			<td>https://www.wanfangdata.com.cn/</td>
		</tr>
		<tr>
			<td>Web of Science</td>
			<td></td>
			<td></td>
			<td>http://www.webofscience.com/</td>
		</tr>
	</tbody>
</table>

meta-analysis of the effectiveness and safety of shugan jieyu capsules for the treatment of insomnia

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]: &#8722;2.95, 95% CI: &#8722;4.97 to &#8722;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.

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...

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

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

A systematic review and meta-analysis were conducted to evaluate the clinical effectiveness and safety of Shugan Jieyu capsules for treating insomnia by ...

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867 Views.  Chengdu University of Traditional Chinese Medicine. The presented protocol describes an investigation strategy and systematic review to evaluate the clinical effectiveness and safety of Shugan Jieyu capsules for treating insomnia.