Efficacy and mechanism of Shugan Jieyu combined with sertraline in alcohol-dependent patients with depression: A randomized clinical study

doi:10.5498/wjp.v15.i12.111801

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World Journal of Psychiatry

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2220-3206

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Clinical Trials Study

World J Psychiatry. Dec 19, 2025; 15(12): 111801
Published online Dec 19, 2025. doi: 10.5498/wjp.v15.i12.111801

Efficacy and mechanism of Shugan Jieyu combined with sertraline in alcohol-dependent patients with depression: A randomized clinical study

Yan Zhang, Hao-Yu Xing, Juan Yan

Yan Zhang, Juan Yan, Graduate School, Zhejiang Chinese Medical University, Hangzhou 311402, Zhejiang Province, China

Hao-Yu Xing, Department of Medical Engineering, The Affiliated Mental Health Center & Hangzhou Seventh People's Hospital, Zhejiang University School of Medicine, Hangzhou 310013, Zhejiang Province, China

Juan Yan, Quality Control Office, Affiliated Mental Health Center & Hangzhou Seventh People's Hospital, Zhejiang University School of Medicine, Hangzhou 310013, Zhejiang Province, China

Co-first authors: Yan Zhang and Hao-Yu Xing.

Author contributions: Zhang Z and Xing HY contribute equally to this study as co-first authors; Zhang Z was responsible for writing – original draft, conceptualization, conceptualization, data curation, investigation, methodology, resources; Xing HY was responsible for writing – review & editing, formal analysis, project administration, supervision, validation; Yan J was responsible for writing – review & editing, data curation, investigation, supervision; all authors approved the final version of the article.

Institutional review board statement: The study was reviewed and approved by the Ethics Review Committee of Lishui Second People's Hospital (date: December 16, 2021; No: 20211216-03).

Clinical trial registration statement: This study is registered at https://www.chictr.org.cn/bin/project/edit?pid = 282771.

Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.

Conflict-of-interest statement: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.

Data sharing statement: The raw data supporting the conclusions of this study will be made available by the authors, without undue reservation.

Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/

Corresponding author: Juan Yan, MD, Manager, Professor, Graduate School, Zhejiang Chinese Medical University, No. 305 Tianmushan Road, Xihu District, Hangzhou 311402, Zhejiang Province, China. 294162939@qq.com

Received: July 11, 2025
Revised: August 15, 2025
Accepted: October 11, 2025
Published online: December 19, 2025
Processing time: 140 Days and 6.6 Hours

Abstract

BACKGROUND

Proper antidepressant use can improve mood and reduce desire to drink alcohol in alcohol-induced-affective-disorder patients. Shugan Jieyu capsules (SJC) have various impacts on the central nervous system, producing antidepressant effects. Traditional Chinese medicine (including Shugan Jieyu) is highly therapeutic in treating alcohol dependence, with few side-effects. However, research on its combination with Western antidepressants (e.g., sertraline) to improve patients’ depression is insufficient.

AIM

To evaluate the clinical efficacy and safety of SJC combined with sertraline vs sertraline monotherapy in alcohol-dependent patients with comorbid depression.

METHODS

We conducted a randomized, double-blind, placebo-controlled trial. Sixty patients (aged 18-65 years) were randomly assigned to two groups (n = 30 per group). Primary outcome: Hamilton Depression Rating Scale (HAMD)-17 changes over 6 weeks. Benzodiazepines were permitted for severe insomnia.

RESULTS

The HAMD-17 score of the study (vs control) group was lower at treatment weeks 2, 4, and 6 (P < 0.05). Regarding intra-group comparisons, the study group’s HAMD score was significantly lower than that before treatment from week 2 (P < 0.05), while that of the control group was significantly lower than that before treatment from week 4 (P < 0.05). The study and control groups’ total efficacy rates were 90% and 73.3%, respectively, showing a significant difference in efficacy (χ² = 4.812, P = 0.028). No significant difference was observed in adverse reactions’ incidence between the groups at treatment weeks 2, 4, and 6 (P > 0.05).

CONCLUSION

SJC-sertraline combination therapy accelerates depressive symptom relief (by 2 weeks) and improves response rates (+16.7%) in alcohol-dependent patients, without increasing adverse events. Clinical outcomes suggest potential synergistic mechanisms, though no biomarker analyses were performed.

Keywords: Shugan Jieyu capsules; Sertraline; Alcohol dependence; Depression; Efficacy; Mechanism

Core Tip: This study investigates the efficacy and safety of combining Shugan Jieyu capsules (SJC) with sertraline in treating alcohol dependence and comorbid depression. The results show that the combination significantly reduces depression symptoms, with improved outcomes seen as early as 2 weeks. The study group demonstrated a higher total efficacy rate (90%) compared to the control group (73.3%), with no significant difference in adverse reactions between the two groups. These findings suggest that SJC, when used alongside sertraline, offer a promising, safe, and effective treatment option for patients with alcohol-induced depression.