Abstract
BACKGROUND: Depression is a global disease with high prevalence, recurrence, disability rates. Currently, antidepressant chemical drug therapeutic regimens are the mainstay, but it with low recovery rates. Consequently, traditional Chinese medicine (TCM) emerges as a crucial alternative, with various studies investigating its potential in both standalone and adjunctive treatments for depression. AIMS & OBJECTIVES: To evaluate the efficacy and safety of Shugan Jieyu capsule combined with fluoxetine in the treatment of depression. METHOD: The study was divided into a basic study period (0-8 weeks) and an extended study period (9-24 weeks). The basic study period employed a multicenter, randomized, double-blind, placebo-parallel controlled study, selecting patients with moderate to severe depression and randomly assigning them in a 1:1 ratio, with 80 cases in each group. The extended study period utilized a multicenter, open-label observational study. During the basic study period, the experimental group received oral Fluoxetine (20 mg, qd) and Shuganjieyu capsules (2 capsules, bid), while the control group received Fluoxetine (20 mg, qd) and a Shuganjieyu capsule simulant (2 capsules, bid). The dosing regimen for the extended study period was formulated based on the condition of the subjects after 8 weeks of the basic study period. RESULTS: The change from baseline of HAMD-17 score (-17.8 vs. -15.6, P = 0.012), score reduction rate (81.86% vs. 72. 31, P = 0.006) and remission rate (86.21% vs. 65%, P = 0.008) in the experimental group were superior to those in the control group at 16 weeks. In the CGI-I score, the proportion of patients with improvement (1 point or 2 points) was higher in the experimental group than in the control group (85% vs. 68.25%, P = 0.027) at 12 weeks. At 16 weeks, the DARS total score and factor score in the experimental group were significantly better than those in the control group (total score P = 0.038, hobby factor score P = 0.0337, social activity factor score P = 0.020), and the change of TEPS total score from baseline was better in the experimental group (P = 0.005). The PSQI total score and related factor score were significantly better in the experimental group (total score P = 0.009, sleep quality score P = 0.036, sleep latency score P = 0.013, sleep efficiency score P = 0.031, use of sleeping medication P = 0.006) at 24 weeks. At the same time, the percentage of Q-LES-Q-S in the experimental group was significantly better (P = 0.003). There was no statistical difference in safety analysis between the two groups, but the correlation analysis for adverse events occurring after treatment showed that the proportion of gastrointestinal system adverse events in the experimental group during the basic study period was significantly lower (P = 0.044), and the correlation was significantly lower (P = 0.0499). DISCUSSION & CONCLUSIONS: In this study, the combination of Shuganjieyu capsules and fluoxetine Shugan enhanced the efficacy of depression treatment, and improved depression symptom score, sleep score, anhedonia scale score, pleasurable experience Scale score, and quality of life.