Zhang Zeyu,Huang Yongqing,Qi Yumei,Du Wenzhi,Bai Shuying,Clinical efficacy of the traditional Mongolian medicine Zadi-5 pills combined with escitalopram oxalate in the treatment of first-episode depression[J].SICHUAN MENTAL HEALTH,2026,(3):199-205
Clinical efficacy of the traditional Mongolian medicine Zadi-5 pills combined with escitalopram oxalate in the treatment of first-episode depression
DOI:10.11886/scjsws20251105001
English keywords:Zadi-5 pills  Escitalopram oxalate  First-episode depression
Fund projects:内蒙古自治区卫生健康科技计划项目(项目名称:蒙药匝迪5味丸联合草酸艾司西酞普兰治疗抑郁症的临床疗效研究,项目编号:202202107)
Author NameAffiliationPostcode
Zhang Zeyu 1School of Mental Health, Inner Mongolia Medical University, Hohhot 010030, China 010030
Huang Yongqing* 1School of Mental Health, Inner Mongolia Medical University, Hohhot 010030, China
2Inner Mongolia Autonomous Region Mental Health Center (the Third Hospital of Inner Mongolia Autonomous Region, Mental Health Center of Inner Mongolia Autonomous Region), Hohhot 010010, China 
010010
Qi Yumei 2Inner Mongolia Autonomous Region Mental Health Center (the Third Hospital of Inner Mongolia Autonomous Region, Mental Health Center of Inner Mongolia Autonomous Region), Hohhot 010010, China 010010
Du Wenzhi 1School of Mental Health, Inner Mongolia Medical University, Hohhot 010030, China
2Inner Mongolia Autonomous Region Mental Health Center (the Third Hospital of Inner Mongolia Autonomous Region, Mental Health Center of Inner Mongolia Autonomous Region), Hohhot 010010, China 
010010
Bai Shuying 2Inner Mongolia Autonomous Region Mental Health Center (the Third Hospital of Inner Mongolia Autonomous Region, Mental Health Center of Inner Mongolia Autonomous Region), Hohhot 010010, China 010010
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English abstract:
      Background The global prevalence of depressive disorders is high, with a significant treatment gap remaining. Escitalopram oxalate, as a commonly used antidepressant in clinical practice, has a single target and is prone to cause adverse reactions such as gastrointestinal discomfort. The traditional Mongolian medicine Zadi-5 pills has a multi-target anti-depression mechanism and unique advantages such as improving the intestinal flora. However, there is currently a lack of randomized controlled trial evidence for the combined treatment of first-episode depression, along with insufficient research on its metabolic safety and potential drug interactions.Objective To explore the efficacy and safety of Zadi-5 pills combined with escitalopram oxalate in the treatment of the first-episode depression, so as to provide references for Mongolian medicine in depression management.Methods A randomized controlled trial was conducted. A total of 103 patients with first-episode depression who were treated in the outpatient or inpatient departments of the Inner Mongolia Autonomous Region Mental Health Center from January 2023 to December 2024 and met the diagnostic criteria for depressive episode as defined in International Classification of Diseases, tenth edition (ICD-10) were included. Random numbers were generated using the RAND function in Excel software, and the patients were divided into the study group (n=52) and the control group (n=51). Both groups received escitalopram oxalate treatment, starting from 5 mg/d and gradually increasing to 20 mg/d. The study group additionally received Zadi-5 pills, 13 pills per day. The treatment duration for both groups was 6 weeks. Before treatment and at the 2nd, 4th, and 6th weeks of treatment, the severity of depressive symptoms was evaluated using the Hamilton Depression Scale-24 item (HAMD-24). At these time points, blood was collected on an empty stomach at 7∶00 for the detection of liver function (aspartate aminotransferase, alanine aminotransferase), triglycerides, and the blood concentration of escitalopram oxalate.Results A total of 100 patients completed the study, with 50 cases in the study group and the control group. The results of the repeated measures ANOVA showed that the interaction effect between group and time in the HAMD-24 score was statistically significant (F interaction= 18.070, P<0.01). At the end of the 4th and 6th weeks of treatment, the HAMD-24 score of the study group was lower than those of the control group (P<0.05). At each time point after treatment, the reduction rate of the HAMD-24 score in the study group was higher than those of the control group, and the differences were all statistically significant (P<0.05). The interaction effect between the triglyceride level groups and time was statistically significant (Finteraction=3.381, P<0.05).After treatment, the triglyceride levels in the study group showed a downward trend, while those in the control group showed an upward trend. There was no statistically significant interaction effect between the groups and time for liver function (aspartate aminotransferase and alanine aminotransferase) and the blood concentration of escitalopram oxalate (P>0.05).Conclusion Compared with escitalopram oxalate treatment alone, the combination of Zadi-5 pills and escitalopram oxalate is more effective in treating the first-episode depression, without increasing the risk of liver damage. The combined medication may have a potential beneficial effect on lipid metabolism. [Funded by Inner Mongolia Autonomous Region Health Science and Technology Planning Project (number, 202202107)]
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