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

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.