Name: meta-analysis of the effectiveness and safety of shugan jieyu capsules for the treatment of insomnia
Uploaded: 2023-02-17T12:30:00
Description: Watch this Scientific Journal Video about Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia at JoVE.com

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 t...

<ol>
	<li>Burman, D. Sleep disorders: Insomnia. Fp Essentials. 460, 22-28 (2017).</li>
	<li>Guo, L. Improving the quality of people&#39;s sleep should become a &#34;livelihood project&#34;. Xiaokang. 488 (5), 28-31 (2022).</li>
	<li>Ebben, M. R., Narizhnaya. M. Cognitive and behavioral treatment options for insomnia. Mount Sinai Journal of Medicine. 79 (4), 512-523 (2012).</li>
	<li>Sun, Y. K., et al. Effects of sedative-hypnotic pharmacotherapy on cognitive function in patients with insomnia. Chinese Journal of Neuropsychiatric Disorders. 43 (11), 701-704 (2017).</li>
	<li>Chapoutot, M. et al. Cognitive behavioral therapy and acceptance and commitment therapy for the discontinuation of long-term benzodiazepine use in insomnia and anxiety disorders. International Journal of Environmental Research and Public Health. 18 (19), 10222 (2017).</li>
	<li>Atkin, T., Comai., S., Gobbi. G. Drugs for insomnia beyond benzodiazepines: Pharmacology, clinical applications, and discovery. Pharmacological Reviews. 70 (2), 197-245 (2018).</li>
	<li>Singh, A., Zhao. K. Treatment of insomnia with traditional Chinese herbal medicine. International Review of Neurobiology. 135, 97-115 (2017).</li>
	<li>Weidong, W., Tao, L., Xue, Z., Xueyu, L. V. Clininal practice guidelines of insomnia disorder. World Journal of Sleep Medicine. 3 (2), 65-79 (2016).</li>
	<li>Xu, X. W., Lv, W., Xiao, P. Q., Sun, Q., Liu, F. L. Overview of theoretical and clinical research on insomnia with Chinese medicine. World Journal of Sleep Medicine. 6 (7), 1001-1008 (2019).</li>
	<li>Hou, J. J., Lu, Y., Lv, Y., Yang, Q. Y., Xue, R. W. Clinical research progress of Chinese medicine for insomnia. Shaanxi Journal of Traditional Chinese Medicine. 40 (2), 270-272 (2019).</li>
	<li>Liang, J. H., Guan, B. H., Wu, L. M., Wang, B., Gu, W. X. Clinical research progress of traditional Chinese medicine in treating insomnia. Chinese Medicine Modern Distance Education of China. 20 (16), 198-201 (2022).</li>
	<li>Yu, Q. M., Chen, W. Y., Wang, Q., Li, M., Research progress of Chinese herbal medicines commonly used in the treatment of insomnia in Chinese medicine. Acta Chinese Medicine and Pharmacology. 50 (3), 102-107 (2022).</li>
	<li>Zhao, Q., Li, J. C., Huang, T., He, Q., Li, Y. P. Research progress of the classic prescription Tianwang Buxin Dan in the treatment of insomnia. China Pharmacy. 33 (18), 2295-2298, 2304 (2022).</li>
	<li>Expert panel of the Chinese Academy of Traditional Chinese Medicine, Psychosomatic Medicine Branch. Expert consensus on the clinical application of Shu liver relief capsules for mild to moderate depressive disorders. Journal of Beijing University of Traditional Chinese Medicine. 44 (11), 969-977 (2021).</li>
	<li>Sun, S. B. et al. A review of studies on the improvement of sleep function by Schisandra chinensis, Acanthopanax spp. and Ziziphi jujubae. Medical Food Therapy and Health. 19 (05), 196-198 (2021).</li>
	<li>Liu, H., Dai, Q. M., Zhong, L. L., Li, J. Advances in the mechanism of antidepressant effects of Guan Ye Lian Qiao. Journal of Liaoning University of Traditional Chinese Medicine. 23 (07), 40-44 (2021).</li>
	<li>Lv, Y., et al. Overview of clinical research on the treatment of depression with Shuhelian Jieyu capsule. Journal of Shanxi College of Traditional Chinese Medicin.e. 19 (5), 74-77 (2018).</li>
	<li>Liu, H. D. et al. Exploring potential mechanism of ciwujia tablets for insomnia by UPLC-Q-TOF-MS/MS, network pharmacology, and experimental validation. Frontiers in Pharmacology. 13, 990996 (2022).</li>
	<li>Zhou L., Wang, M. N., Zhu, X., Cheng, H. M., Wang, Y. X. Active ingredients, pharmacological actions, and clinical applications of Acanthopanax senticosus in the central nervous system. Journal of Hunan University of Chinese Medicine. 38 (8), 961-964 (2018).</li>
	<li>Kumar, V. et al. Hypericum perforatum: Nature&#39;s mood stabilizer. Indian Journal of Experimental Biology. 38 (11), 1077-1085 (2000).</li>
	<li>Dang, J. J. et al. Study on the evidence of chronic insomnia. Chinese Journal of Basic Chinese Medicine. 28 (9), 1547-1550 (2022).</li>
	<li>Zhou, J. B., Yu, Z. J., Mai, S. Z., Lu, X. X., Liang, M. M. A randomized controlled trial of ShuMian capsule and ShuLiver relief capsule in the treatment of primary insomnia with liver qi stagnation evidence. China Medical Innovation. 16 (19), 120-123 (2019).</li>
	<li>Li, L., Zhao, Q. L. Clinical observation on the treatment of post-stroke depression with Shuhelian Xieyu capsule. Chinese Journal of Practical Neurological Disorders. 14 (9), 18-20 (2011).</li>
	<li>Xiao, J., Wang, C. J., Kong, X. F., Wang, L., Ping, H. K. Observation on the efficacy of combining liver detoxification capsule with western medicine in the treatment of perimenopausal insomnia. Journal of Modern Traditional Chinese and Western Medicine. 26 (23), 2584-2586 (2017).</li>
	<li>Xu, X. Q., Zheng, Y. Q., Xu, Q. W., Cai, Q. J. Efficacy of Shuhelian Xieyu capsule combined with risperidone in the treatment of schizophrenia with insomnia in the elderly and the effect on patients&#39; sleep quality and cognitive ability. World Journal of Sleep Medicine. 8 (6), 997-998 (2021).</li>
	<li>Zhang, Z. C., Li, S., Chen, Y., Liu, H., Zhang, Z. Progresson traditional Chinese medicine in the treatment of insomnia. Guangming Journal of Chinese Medicine. 37 (15), 2740-2743 (2022).</li>
	<li>Ni, X. et al. Traditional use of Chinese herbal medicine for insomnia and priorities setting of future clinical research. Journal of Alternative and Complementary Medicine. 25 (1), 8-15 (2019).</li>
	<li>Zhang, H., Liu, P., Wu, X., Zhang, Y., Cong, D. Effectiveness of Chinese herbal medicine for patients with primary insomnia: A PRISMA-compliant meta-analysis. Medicine. 98 (24), e15967 (2019).</li>
	<li>Patterson, P. D., et al. Evidence-based guidelines for fatigue risk management in EMS: Formulating research questions and selecting outcomes. Prehospital Emergency Care. 21 (2), 149-156 (2017).</li>
	<li>Gao, H. Diagnostic criteria for chronic insomnia disorder in the International Classification of Sleep Disorders (3rd edition). World Journal of Sleep Medicine. 5 (5), 555-557 (2018).</li>
	<li>Alprazolam is initially effective in the treatment of insomnia. InPharma. 610 (1), 9 (1987).</li>
	<li>Yin, Y., et al. Low-dose atypical antipsychotic risperidone improves the 5-year outcome in Alzheimer&#39;s disease patients with sleep disturbances. Pharmacology. 96 (3-4) 155-162 (2015).</li>
	<li>Post,&#160;G. L. et al. Estazolam treatment of insomnia in generalized anxiety disorder: A placebo-controlled study. Journal of Clinical Psychopharmacology. 11 (4), 249-253 (1991).</li>
	<li>Takaki, M. Aripiprazole as monotherapy at bedtime was effective for treatment of two cases of obsessive-compulsive disorder and insomnia. American Psychiatric Publishing. 26 (3), E64 (2014).</li>
	<li>Dolev, Z. Case series of perimenopausal women with insomnia treated with mirtazapine followed by prolonged-release melatonin add-on and monotherapy. Archives of Women&#39;s Mental Health. 14 (3), 269-273 (2011).</li>
	<li>Guthrie, K. A. et al. Effects of pharmacologic and nonpharmacologic interventions on insomnia symptoms and self-reported sleep quality in women with hot flashes: A pooled analysis of individual participant data from four MsFLASH trials. Sleep. 41 (1), zsx190 (2018).</li>
	<li>Huo, S. et al. Effects of eszopiclone on sleep quality and cognitive function in elderly patients with Alzheimer&#39;s disease and sleep disorder: A randomized controlled trial. Brain and Behavior. 12 (2), e2488 (2022).</li>
	<li>Teaima, M. et al. Construction of sublingual trilaminated Eszopiclone fast dissolving film for the treatment of Insomnia: Formulation, characterization and in vivo clinical comparative pharmacokinetic study in healthy human subjects. PLoS One. 17 (6), e0266019 (2022).</li>
	<li>Satterlee, W. G., Faries, D. The effects of fluoxetine on symptoms of insomnia in depressed patients. Psychopharmacology Bulletin. 31 (2), 227-237 (1995).</li>
	<li>Lu, T. Y., Li, Y., Xia, P., Zhang, G. Q., Wu, D. R. Reliability and validity analysis of the Pittsburgh Sleep Quality Index. Chongqing Medicine. (3), 260-263 (2014).</li>
	<li>Diagnostic efficacy criteria for Chinese medicine illnesses by the State Administration of Traditional Chinese Medicine.31.-32. Nanjing University Press. Nanjing (1994).</li>
	<li>State Administration of Traditional Chinese Medicine. Guiding principles for clinical research of new Chinese medicines. Beijing: China Pharmaceutical Science and Technology Press. 135-139 (2002).</li>
	<li>Buysse, D. J., Reynolds, C. F. 3rd, Monk, T. H., Berman, S. R., Kupfer, D. J. The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research. Psychiatry Research. 28 (2), 193-213 (1989).</li>
	<li>Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. PLoS Medicine. 6 (7), e1000097 (2010).</li>
	<li>Higgins, J. P. T., Alterman, D. G., Sterne J. A. C. Chapter 8: Assessing risk of bias in included studies. In Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0., edited by Higgins, J. P. T., Green, S. The Cochrane Collaboration. London, UK (2011).</li>
	<li>Guyatt, G. H. et al. GRADE: An emerging consensus on rating quality of evidence and strength of recommendations. The British Medical Journal. 336 (7650), 924-926 (2008).</li>
	<li>Lewis, S., Clarke, M. Forest plots: Trying to see the wood and the trees. The British Medical Journal. 322 (7300), 1479-1480 (2001).</li>
	<li>Lu, F., Lan, Y., Wang, Y., Zhou, Y. Observation of the efficacy of combining dexzopiclone with Shuhebeijiao capsule on patients with post-stroke depression with insomnia. World Journal of Sleep Medicine. 8 (09), 1495-1497 (2021).</li>
	<li>Bao, S. H., Guo, T., Zhang, K., Yuan, Z. L., Tang, L. Efficacy and mechanism of action of Shuhelian Xiezhu capsule combined with escitalopram in the treatment of depression with insomnia in the elderly. Journal of Modern Traditional Chinese and Western Medicine. 29 (30), 3385-3389 (2020).</li>
	<li>Gao, C., Zhang, J. H. Effects of combining liver detoxification capsule with western medicine on sleep and cognition in patients with liver depression and qi stagnation type insomnia. World Traditional Chinese Medicine. 13 (05), 1127-1130 (2018).</li>
	<li>Xie, N., Zhang, J. C., Wang, C. J., Liu, Y. C., Wang, L. Effect of liver detoxification treatment on the psychological and BDNF effects of perimenopausal sleep disorder (anxiety-depression type). Journal of Liaoning University of Traditional Chinese Medicine. 19 (10), 135-138 (2017).</li>
	<li>Wang, J., Hu, Y. L. Efficacy of combined Chinese and Western medicine in the treatment of insomnia in depressive disorders. Liaoning Journal of Traditional Chinese Medicine. 42 (06), 1275-1277 (2015).</li>
	<li>Lv, X., Guo, S. S. Clinical study on the treatment of post-stroke sleep disorder with Shuhelian Xieyu capsule combined with dexzopiclone. Journal of Integrated Cardiovascular and Cerebrovascular Diseases of Chinese and Western Medicine. 14 (13), 1543-1544+1568 (2016).</li>
	<li>Guo, C. H., He, X. Q., He, X. Y. Clinical observation on the treatment of insomnia in depressive disorder by combining Shuhelian Xiezhu capsule with mirtazapine. Ningxia Medical Journal. 42 (2), 179-181 (2020).</li>
	<li>Li, X. B., Wang, A. H. Analysis of the effects of combining liver detoxification capsule with western medicine on patients&#39; sleep and cognition in treating liver-depression and qi-stagnation type insomnia. Medical Theory and Practice. 32(11), 1675-1676 (2019).</li>
	<li>Chen, J., Huang, H. Y., Zhou, W. D., Liu, Q. J. Effects of liver detoxification capsule on sleep index and mental status of patients with schizophrenia combined with chronic insomnia. International Journal of Psychiatry. 44 (06), 1038-1040+1044 (2017).</li>
	<li>Zhang, M. X., Wang, L. N., Wang, X. J., Sun, Q. Q., Wang, C. H. Efficacy and safety observation of fluoxetine combined with Shuhelian Xiezhu capsule in the treatment of depression with insomnia. Journal of Xinxiang Medical College. 33 (06), 489-491, 496 (2016).</li>
	<li>Wen, X. Clinical efficacy and safety of liver detoxification capsule for schizophrenia with chronic insomnia. Journal of Clinical Rational Drug Use. 13 (12), 67-68 (2020).</li>
	<li>Chen, J. B., Jia, X. N., Quan, W., Zhang, X. H. A clinical study on the efficacy of Shuhelian Xiezhu capsule combined with escitalopram oxalate on anxiety and depression status in depressed patients. International Journal of Psychiatry., 44 (4), 635-637 (2017).</li>
	<li>Jia, J. M., Wang, H. T., Wang, Z. Q., Song, J., Zhao, S. H. Advances in the pharmacological activity of Acanthopanax spinosus. China Modern Traditional Chinese Medicine. 12 (2), 7-10+18 (2010).</li>
	<li>Huang, W., Teng, H. Y., Mao, Y. Y. Efficacy of combining liver detoxification capsule with eszopiclone in the treatment of post-stroke sleep disorder. Journal of Integrative Cardiovascular and Cerebrovascular Diseases. 16 (8), 1105-1107 (2018).</li>
	<li>Shi, M. L. et al. Meta-analysis of the effectiveness and safety of proprietary Chinese medicines in the treatment of insomnia. Chinese Journal of Traditional Chinese Medicine. 46 (20), 5403-5417 (2021).</li>
	<li>Wang, C. et al. Efficacy and safety of Shumian capsules in treating insomnia: A systematic review and meta-analysis. Medicine. 100 (50), e28194 (2021).</li>
	<li>Wang, D. et al. Discussing on the research of heterogeneity in meta-analysis.Chinese Journal of Evidence-Based Medicine. 9 (10), 1115-1118 (2009).</li>
	<li>Wang, Y. Z., Wang, J., Huang, Q. The use of subgroup analysis in drug clinical trials. Chinese Journal of Clinical Pharmacology. 28 (6), 477-480 (2012).</li>
</ol>

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...

Watch this Scientific Journal Video about Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia at JoVE.com

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 ...

meta-analysis-effectiveness-safety-shugan-jieyu-capsules-for

Research

Education

JoVE Core

JoVE Journal

Introduction to Psychology

Medicine

Unit 1

States of Consciousness

SCIENTISTS IN ACTION

Thermal Ablation for the Treatment of Abdominal Tumors

Percutaneous thermal ablation is an emerging treatment option for many tumors of the abdomen not amenable to conventional treatments. During a thermal ablation procedure, a thin applicator is guided into the target tumor under imaging guidance. Energy is then applied to the tissue until temperatures rise to cytotoxic levels (50-60 &deg;C). Various energy sources are available to heat biological tissues, including radiofrequency (RF) electrical current, microwaves, laser light and ultrasonic waves. Of these, RF and microwave ablation are most commonly used worldwide.
During RF ablation, alternating electrical current (~500 kHz) produces resistive heating around the interstitial electrode. Skin surface electrodes (ground pads) are used to complete the electrical circuit. RF ablation has been in use for nearly 20 years, with good results for local tumor control, extended survival and low complication rates1,2. Recent studies suggest RF ablation may be a first-line treatment option for small hepatocellular carcinoma and renal-cell carcinoma3-5. However, RF heating is hampered by local blood flow and high electrical impedance tissues (eg, lung, bone, desiccated or charred tissue)6,7. Microwaves may alleviate some of these problems by producing faster, volumetric heating8-10. To create larger or conformal ablations, multiple microwave antennas can be used simultaneously while RF electrodes require sequential operation, which limits their efficiency. Early experiences with microwave systems suggest efficacy and safety similar to, or better than RF devices11-13.
Alternatively, cryoablation freezes the target tissues to lethal levels (-20 to -40 &deg;C). Percutaneous cryoablation has been shown to be effective against RCC and many metastatic tumors, particularly colorectal cancer, in the liver14-16. Cryoablation may also be associated with less post-procedure pain and faster recovery for some indications17. Cryoablation is often contraindicated for primary liver cancer due to underlying coagulopathy and associated bleeding risks frequently seen in cirrhotic patients. In addition, sudden release of tumor cellular contents when the frozen tissue thaws can lead to a potentially serious condition known as cryoshock 16.
Thermal tumor ablation can be performed at open surgery, laparoscopy or using a percutaneous approach. When performed percutaneously, the ablation procedure relies on imaging for diagnosis, planning, applicator guidance, treatment monitoring and follow-up. Ultrasound is the most popular modality for guidance and treatment monitoring worldwide, but computed tomography (CT) and magnetic resonance imaging (MRI) are commonly used as well. Contrast-enhanced CT or MRI are typically employed for diagnosis and follow-up imaging.

A thermal tumor ablation procedure is described. The entire procedure is detailed, including pretreatment planning and imaging studies, anesthesia, adjuvant techniques to facilitate a percutaneous approach, imaging guidance of the ablation device to the tumor, thermal treatment, post-treatment care and follow-up.

Percutaneous thermal ablation is an emerging treatment option for many tumors of the abdomen not amenable to conventional treatments. During a thermal ...

The Measurement and Treatment of Suppression in Amblyopia

Amblyopia, a developmental disorder of the visual cortex, is one of the leading causes of visual dysfunction in the working age population. Current estimates put the prevalence of amblyopia at approximately 1-3%1-3, the majority of cases being monocular2. Amblyopia is most frequently caused by ocular misalignment (strabismus), blur induced by unequal refractive error (anisometropia), and in some cases by form deprivation.
Although amblyopia is initially caused by abnormal visual input in infancy, once established, the visual deficit often remains when normal visual input has been restored using surgery and/or refractive correction. This is because amblyopia is the result of abnormal visual cortex development rather than a problem with the amblyopic eye itself4,5 . Amblyopia is characterized by both monocular and binocular deficits6,7 which include impaired visual acuity and poor or absent stereopsis respectively. The visual dysfunction in amblyopia is often associated with a strong suppression of the inputs from the amblyopic eye under binocular viewing conditions8. Recent work has indicated that suppression may play a central role in both the monocular and binocular deficits associated with amblyopia9,10 .
Current clinical tests for suppression tend to verify the presence or absence of suppression rather than giving a quantitative measurement of the degree of suppression. Here we describe a technique for measuring amblyopic suppression with a compact, portable device11,12 . The device consists of a laptop computer connected to a pair of virtual reality goggles. The novelty of the technique lies in the way we present visual stimuli to measure suppression. Stimuli are shown to the amblyopic eye at high contrast while the contrast of the stimuli shown to the non-amblyopic eye are varied. Patients perform a simple signal/noise task that allows for a precise measurement of the strength of excitatory binocular interactions. The contrast offset at which neither eye has a performance advantage is a measure of the "balance point" and is a direct measure of suppression. This technique has been validated psychophysically both in control13,14 and patient6,9,11 populations.
In addition to measuring suppression this technique also forms the basis of a novel form of treatment to decrease suppression over time and improve binocular and often monocular function in adult patients with amblyopia12,15,16 . This new treatment approach can be deployed either on the goggle system described above or on a specially modified iPod touch device15.

Amblyopia is a developmental disorder of the visual cortex that is often accompanied by strong suppression of one eye. We present a new technique for measuring and treating interocular suppression in patients with amblyopia that can be deployed using virtual reality goggles or a portable iPod Touch device.

Amblyopia, a developmental disorder of the visual cortex, is one of the leading causes of visual dysfunction in the working age population. Current ...

The Goeckerman Regimen for the Treatment of Moderate to Severe Psoriasis

Psoriasis is a chronic, immune-mediated inflammatory skin disease affecting approximately 2-3% of the population. The Goeckerman regimen consists of exposure to ultraviolet B (UVB) light and application of crude coal tar (CCT). Goeckerman therapy is extremely effective and relatively safe for the treatment of psoriasis and for improving a patient's quality of life. In the following article, we present our protocol for the Goeckerman therapy that is utilized specifically at the University of California, San Francisco. This protocol details the preparation of supplies, administration of phototherapy and application of topical tar. This protocol also describes how to assess the patient daily, monitor for adverse effects (including pruritus and burning), and adjust the treatment based on the patient's response. Though it is one of the oldest therapies available for psoriasis, there is an absence of any published videos demonstrating the process in detail. The video is beneficial for healthcare providers who want to administer the therapy, for trainees who want to learn more about the process, and for prospective patients who want to undergo treatment for their cutaneous disease.

Psoriasis is a chronic, immune-mediated inflammatory skin disease. The Goeckerman regimen, formulated for the treatment of psoriasis, consists of exposure to ultraviolet B (UVB) light and application of crude coal tar (CCT). The following protocol is for the administration of Goeckerman therapy for the treatment of moderate-to-severe psoriasis.

Psoriasis is a  chronic, immune-mediated inflammatory skin disease affecting approximately 2-3%  of the population. The Goeckerman regimen consists of ...

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo

Due to the high level of heterogeneity and mutations inherent in human cancers, single agent therapies, or combination regimens which target the same pathway, are likely to fail. Emphasis must be placed upon the inhibition of pathways that are responsible for intrinsic and/or adaptive resistance to therapy. An active field of investigation is the development and testing of DNA repair inhibitors that promote the action of, and prevent resistance to, commonly used chemotherapy and radiotherapy. We used a novel protocol to evaluate the effectiveness of BRCA2 inhibition as a means to sensitize tumor cells to the DNA damaging drug cisplatin. Tumor cell metabolism (acidification and respiration) was monitored in real-time for a period of 72 hr to delineate treatment effectiveness on a minute by minute basis. In combination, we performed an assessment of metastatic frequency using a chicken embryo chorioallantoic membrane (CAM) model of extravasation and invasion. This protocol addresses some of the weaknesses of commonly used in vitro and in vivo methods to evaluate novel cancer therapy regimens. It can be used in addition to common methods such as cell proliferation assays, cell death assays, and in vivo murine xenograft studies, to more closely discriminate amongst candidate targets and agents, and select only the most promising candidates for further development.

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo

Here, real-time monitoring of tumor cell metabolism, combined with an in vivo chicken embryo chorio-allantoic membrane (CAM) model of metastasis, are used to evaluate novel anti-cancer targets/agents for their ability to sensitize tumor cells to DNA damaging chemotherapeutics.

Due to the high level of heterogeneity and mutations inherent in human cancers, single agent therapies, or combination regimens which target the same ...

Detection of Disease-associated &#945;-synuclein by Enhanced ELISA in the Brain of Transgenic Mice Overexpressing Human A53T Mutated &#945;-synuclein

In addition to established methods like Western blot, new methods are needed to quickly and easily quantify disease-associated &#945;-synuclein (&#945;SD) in experimental models of synucleopathies. A transgenic mouse line (M83) over-expressing the human A53T &#945;S and spontaneously developing a dramatic clinical phenotype between eight and 22 months of age, characterized by symptoms including weight loss, prostration, and severe motor impairment, was used in this study. For molecular analyses of &#945;SD (disease-associated &#945;S) in these mice, an ELISA was designed to specifically quantify &#945;SD in sick mice. Analysis of the central nervous system in this mouse model showed the presence of &#945;SD mainly in the caudal brain regions and the spinal cord. There were no differences in &#945;SD distribution between different experimental conditions leading to clinical disease, i.e., in uninoculated and normally aging transgenic mice and in mice inoculated with brain extracts from sick mice. The specific detection of &#945;SD immunoreactivity using an antibody against Ser129 phosphorylated &#945;S by ELISA essentially correlated with that obtained by Western blot and immunohistochemistry. Unexpectedly, similar results were observed with several other antibodies against the C-terminal part of &#945;S. The propagation of &#945;SD, suggesting the involvement of a &#8220;prion-like&#8221; mechanism, can thus be easily monitored and quantified in this mouse model using an ELISA approach.

An ELISA offering a novel quantitative approach is described. It specifically detects disease-associated &#945;-synuclein (&#945;SD) in a transgenic mouse model (M83) of synucleinopathy using several antibodies against either the Ser129 phosphorylated &#945;S form or the C-terminal part of the protein.

In addition to established methods like Western blot, new methods are needed to quickly and easily quantify disease-associated &#945;-synuclein (&#945;SD) ...

Network Analysis of Foramen Ovale Electrode Recordings in Drug-resistant Temporal Lobe Epilepsy Patients

Approximately 30% of epilepsy patients are refractory to antiepileptic drugs. In these cases, surgery is the only alternative to eliminate/control seizures. However, a significant minority of patients continues to exhibit post-operative seizures, even in those cases in which the suspected source of seizures has been correctly localized and resected. The protocol presented here combines a clinical procedure routinely employed during the pre-operative evaluation of temporal lobe epilepsy (TLE) patients with a novel technique for network analysis. The method allows for the evaluation of the temporal evolution of mesial network parameters. The bilateral insertion of foramen ovale electrodes (FOE) into the ambient cistern simultaneously records electrocortical activity at several mesial areas in the temporal lobe. Furthermore, network methodology applied to the recorded time series tracks the temporal evolution of the mesial networks both interictally and during the seizures. In this way, the presented protocol offers a unique way to visualize and quantify measures that considers the relationships between several mesial areas instead of a single area.

This protocol describes a procedure to track the evolution of mesial network measures in temporal lobe epilepsy (TLE) patients. It is based on the combination of intracranial recordings with a novel numerical technique for data analysis. Specifically, we present a protocol for network analyses of foramen ovale recordings.

Approximately 30% of epilepsy patients are refractory to antiepileptic drugs. In these cases, surgery is the only alternative to eliminate/control ...

Laparoscopy-endoscopy Cooperative Surgery for the Treatment of Gastric Gastrointestinal Stromal Tumors

In view of the shortcomings of endoscopic or laparoscopic surgeries alone in the treatment of gastric gastrointestinal stromal tumors (G-GISTs), this approach makes an innovative improvement in the treatment of G-GISTs that are less than 5 cm in size. Laparoscopy-endoscopy cooperative surgery (LECS) is used to combine endoscopic and laparoscopic surgeries, fully realizing their respective advantages and avoiding their drawbacks. The main steps are as follows. First, gastroscopy and laparoscopy are combined to confirm the location and boundary of the tumor. Tumor resection is carried out laparoscopically, guided by a gastroscope. The specimen is removed orally and the gastric wound closed laparoscopically. Then, gastroscopy and laparoscopy are combined to determine whether there is wound bleeding, if the suture is satisfactory, and if the gastric cavity is deformed.
LECS has natural advantages in the treatment of G-GISTs that are less than 5 cm in size. The accurate estimation of tumor location and boundary greatly improves the complete resection rate of tumors. The risk of tumor rupture is substantially reduced, and the long-term prognosis of patients is significantly improved. The process allows for accurate resection of the tumor, maximum preservation of normal gastric tissue and organ function, and avoids postoperative gastric deformation. The patient's postoperative rehabilitation is greatly accelerated, and oral feeding can resume on the day of the operation. The specimen is taken out through the mouth to avoid the need for an extended abdominal incision. This greatly reduces the patient's postoperative pain and scarring. The method greatly shortens the postoperative hospital stay (i.e., discharge is possible on the day after the operation), increasing the turnover of hospital beds.

Laparoscopy-endoscopy cooperative surgery is appropriate for the treatment of gastric gastrointestinal stromal tumors less than 5 cm in size. It can achieve the respective advantages of endoscopic and laparoscopic surgeries while avoiding their drawbacks.

In view of the shortcomings of endoscopic or laparoscopic surgeries alone in the treatment of gastric gastrointestinal stromal tumors (G-GISTs), this ...

Laser-Induced Action Potential-Like Measurements of Cardiomyocytes on Microelectrode Arrays for Increased Predictivity of Safety Pharmacology

Life-threatening drug-induced cardiac arrhythmia is often preceded by prolonged cardiac action potentials (AP), commonly accompanied by small proarrhythmic membrane potential fluctuations. The shape and time course of the repolarizing fraction of the AP can be pivotal for the presence or absence of arrhythmia.
Microelectrode arrays (MEA) allow easy access to cardiotoxic compound effects via extracellular field potentials (FP). Although a powerful and well-established tool in research and cardiac safety pharmacology, the FP waveform does not allow to infer the original AP shape due to the extracellular recording principle and the resulting intrinsic alternating current (AC) filtering.
A novel device, described here, can repetitively open the membrane of cardiomyocytes cultivated on top of the MEA electrodes at multiple cultivation time points, using a highly focused nanosecond laser beam. The laser poration results in transforming the electrophysiological signal from FP to intracellular-like APs (laser-induced AP, liAP) and enables the recording of transcellular voltage deflections. This intracellular access allows a better description of the AP shape and a better and more sensitive classification of proarrhythmic potentials than regular MEA recordings. This system is a revolutionary extension to the existing electrophysiological methods, permitting accurate evaluation of cardiotoxic effect with all advantages of MEA-based recordings (easy, acute, and chronic experiments, signal propagation analysis, etc.).

The combination of laser poration and microelectrode arrays (MEA) allows action potential-like recordings of cultivated primary and stem cell-derived cardiomyocytes. The waveform shape provides superior insight into test compounds' mode of action than standard recordings. It links patch-clamp and MEA readout to further optimize cardio safety research in the future.

Life-threatening drug-induced cardiac arrhythmia is often preceded by prolonged cardiac action potentials (AP), commonly accompanied by small ...

Microscopic Cyst Resection for the Treatment of Patients Diagnosed with Epididymal Cyst

Epididymal cysts mostly occur in men aged 20-40 years old. Previous reports have covered concerns about postoperative complexes, including postoperative asoedema, hematoma, sustaining pain, and seminal tract obstruction in patients who have undertaken nonmicroscopic epididymal cyst resection or epididymal resection. Nonmicroscopic epididymal cyst surgery is suggested for patients with childbirth plans as a precaution. The treatment of male epididymal cysts via microtechnology is obviously a beneficial option; we took the lead in carrying out microscopic epididymal exploration and cyst resection surgery in China. From September 2017 to April 2021, 41 young and middle-aged male patients diagnosed with epididymal cysts underwent microtechnology treatment in a program titled &#34;microscopic epididymal exploration and cystectomy&#34;. The postoperative follow-up lasted for 3-50 months. The results confirmed that, as microscopic manipulation largely improved visualization of the subtle tissue structures of the epididymis, the cyst could be clearly dissected apart and completely removed intact under the microscope. Bleeding during the operation was significantly reduced (2-3 mL) and wound drainage was not required. According to follow-up data, microscopic treatment significantly reduced the incidence of postoperative scrotal hematoma, edema, and long-term postoperative pain, thereby promising a higher surgical success rate as well as recurrence prevention. Besides, preliminary experience and reflection suggest that microscopic epididymal exploration and cystectomy provide efficient preservation of the epididymal patency through refined treatment, while a better prognosis can be achieved. We recommend that surgery be carried out before the epididymal cyst develops to 0.8 cm in diameter, for fear that a larger epididymal cyst (&#62;0.9 cm in diameter) could cause the complete destruction of all tubules of the ipsilateral epididymis - a more severe case with damage to the testicular output network.

Here, we present a protocol to treat patients diagnosed with an epididymal cyst using microscopic cyst resection. Based on microscopic manipulation, a largely improved visualization of the subtle tissue structures of the epididymis was obtained, so the cyst could be clearly dissected apart and completely removed intact.

Epididymal cysts mostly occur in men aged 20-40 years old. Previous reports have covered concerns about postoperative complexes, including postoperative ...

Systematic Review and Meta-Analysis on Viral Encephalitis Treatments

The Adjuvant Efficacy of Angong Niuhuang Pill in the Treatment of Viral Encephalitis: A Meta-Analysis of Randomized Controlled Trials

This meta-analysis aims to evaluate the efficacy of Angong Niuhuang Pill (ANP) as an adjuvant therapy in the treatment of viral encephalitis. Seven databases (PubMed, Cochrane Library, Embase, SinoMed, CNKI, VIP and WanFang) were included for literature retrieval from inception to July 2023. Randomized controlled trials comparing ANP plus conventional therapy with conventional therapy alone were eligible. Pooled effect sizes and 95% confidence intervals (CIs) were calculated for evaluating efficacy and safety. Sensitivity analysis and publication bias assessments were performed for analyzing the inconclusiveness of findings. 13 studies involving 1045 cases were included for meta-analysis. Adjuvant treatment with ANP increased the probability of the total effective rate by 17% compared with conventional treatment (Risk ratios (RR) = 1.17, 95%CI [1.08, 1.27]). The disappearance time of clinical syndromes and signs was significantly decreased after adjuvant treatment with ANP, including the time of defervescence (weighted mean difference (WMD) = -1.59, 95%CI [-2.09, -1.09]), the time of consciousness recovery (WMD = -1.79, 95%CI [-2.06, -1.51]), the time of headache disappearance (WMD = -1.51, 95%CI [-1.93, -1.08]), the time of tic disappearance (WMD = -1.88, 95%CI [-2.39, -1.36]). The adjuvant efficacy of ANP for treating viral encephalitis (VE) appears to improve the total effective rate and shorten the disappearance time of clinical syndromes. More high-quality randomized controlled trials (RCTs) are needed to support our findings.

Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment

Here, we present a protocol to analyze the effectiveness and safety of Angong Niuhuang Pill in the treatment of viral encephalitis.

This meta-analysis aims to evaluate the efficacy of Angong Niuhuang Pill (ANP) as an adjuvant therapy in the treatment of viral encephalitis. Seven ...