Efficacy and Safety of Taizi Shenyue Capsules in the Treatment of Mild to Moderate Depression
Abstract
Methods: The study subjects were randomly assigned to an experimental group, a positive drug group, and a placebo group, with a treatment
duration of 8 weeks. The primary measure of efficacy was the reduction in Hamilton Depression Scale-17 items (HAMD-17) scores at the
treatment endpoint; safety evaluation indicators included laboratory tests, electrocardiogram examinations, vital signs, and incidence of adverse events. Results: A total of 601 patients with depression meeting the inclusion criteria were enrolled. There was a statistically significant
difference in score reduction among the three groups at the treatment endpoint (P < 0.0001), with the experimental group showing better results than the placebo group (P < 0.0001), and the experimental group was at least as good as the positive drug group (P = 0.7354 > 0.05). The
rates of adverse events during treatment were 9.27%, 15.97%, and 10.83% for the three groups, respectively, with no statistically significant
difference between groups (P > 0.05). Conclusion: Taizi Shenyue Capsules proved to be both safe and effective for treating mild to moderate
depression.
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DOI: http://dx.doi.org/10.70711/pmr.v2i8.8275
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