Tang Xing, Wang Chengcheng, Huang Qinwan, Yang Chunxia, Lan Shoujen, Yen Yeayin, Yu Congcong
College of Acupuncture-Moxibustion and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Sub-Health Clinical Detection and Evaluation Laboratory, Sichuan Integrative Medicine Hospital, Chengdu, China.
Sci Rep. 2025 Jul 2;15(1):23111. doi: 10.1038/s41598-025-09113-9.
To evaluate the synergistic effect of the Shugan Jieyu Capsule combined with Escitalopram in the treatment of senile depression. The study protocol has been registered in PROSPERO with registration number CRD42023440270. Eight databases, including PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Network (CNKI), China Biomedical Literature Database (CBM), VIP database, and Wanfang Database, were searched, respectively. Randomized controlled trial (RCTs) of the Shugan Jieyu Capsule combined with Escitalopram in the treatment of senile depression was included. The search time was from the listing of Shugan Jieyu Capsule (2009) to January 1, 2025. Outcome measures included Total effective rate, Hamilton Depression Scale (HAMD) score, Hamilton Anxiety Scale (HAMA) score, serum 5-hydroxytryptamine (5-HT), serum norepinephrine (NE), and Incidence of adverse reactions. The treatment period should be at least 6 weeks. Data extraction and methodological quality evaluation were carried out for the included literature, and statistical analysis was performed using RevMan 5.3 software. Finally, the Grading of Recommendations Assessment, Development and Evaluation (GRADE ) system was used to assess the quality of the evidence. A total of 8 RCTs were included in the study, with a total of 765 patients. The results of this meta-analysis showed that the combination of Shugan Jieyu Capsule and Escitalopram could improve Total effective rate [OR = 4.25, 95%CI(2.53, 7.14), P<0.00001] and reduce HAMD score in terms of clinical symptom indicators [SMD=-1.26, 95%CI(-1.45, -1.08), P<0.00001], and decrease HAMA score [SMD=-0.82, 95%CI(-1.05, -0.59), P<0.00001]. In terms of laboratory indexes, serum 5-HT levels could be increased in the combined group [MD = 31.92, 95%CI(28.34, 35.50), P < 0.00001]. In terms of safety, no serious adverse reactions were observed in both group, and the incidence of adverse reactions was lower in the combined group [OR = 0.62, 95%CI(0.42, 0.92), P = 0.02]. During the treatment period of 12 weeks, Shugan Jieyu Capsule combined with Escitalopram had a good effect in the treatment of senile depression, which could significantly reduce HAMD and HAMA scores of senile depression. In addition, the combined application of the two drugs can help to increase the level of serum 5-HT, without increasing the occurrence of adverse events, and has a good application prospect.
评估疏肝解郁胶囊联合艾司西酞普兰治疗老年抑郁症的协同效应。该研究方案已在国际前瞻性系统评价注册库（PROSPERO）注册，注册号为CRD42023440270。分别检索了8个数据库，包括PubMed、Embase、Cochrane图书馆、Web of Science、中国知网（CNKI）、中国生物医学文献数据库（CBM）、维普数据库和万方数据库。纳入疏肝解郁胶囊联合艾司西酞普兰治疗老年抑郁症的随机对照试验（RCT）。检索时间从疏肝解郁胶囊上市（2009年）至2025年1月1日。观察指标包括总有效率、汉密尔顿抑郁量表（HAMD）评分、汉密尔顿焦虑量表（HAMA）评分、血清5-羟色胺（5-HT）、血清去甲肾上腺素（NE）及不良反应发生率。治疗周期至少6周。对纳入文献进行数据提取和方法学质量评价，并使用RevMan 5.3软件进行统计分析。最后，采用推荐分级的评估、制定与评价（GRADE）系统对证据质量进行评估。本研究共纳入8项RCT，共计765例患者。该Meta分析结果显示，疏肝解郁胶囊联合艾司西酞普兰在临床症状指标方面可提高总有效率[OR = 4.25，95%CI（2.53，
7.14），P < 0.00001]，降低HAMD评分[SMD = -1.26，95%CI（-1.45， -1.08），P < 0.00001]，降低HAMA评分[SMD = -0.82，95%CI（-1.05， -0.59），P < 0.00001]。在实验室指标方面，联合组可提高血清5-HT水平[MD = 31.92，95%CI（28.34，35.50），P < 0.00001]。在安全性方面，两组均未观察到严重不良反应，联合组不良反应发生率更低[OR = 0.62，95%CI（0.42，0.92），P = 0.02]。在12周的治疗期间，疏肝解郁胶囊联合艾司西酞普兰治疗老年抑郁症效果良好，可显著降低老年抑郁症患者的HAMD和HAMA评分。此外，两种药物联合应用有助于提高血清5-HT水平，且不增加不良事件的发生，具有良好的应用前景。
