Comparative efficacy of Huatan Jieyu formula versus paroxetine for the treatment of generalized anxiety disorder

Generalized anxiety disorder (GAD) is commonly accompanied by depressive symptoms, sleep disturbance, and somatic symptom burden, which may influence treatment selection and real-world outcomes. This retrospective cohort study evaluated the comparative effectiveness and tolerability of Huatan Jieyu Formula (HTJYF) versus paroxetine in adults with GAD treated at a single institution between September 2023 and December 2024. Eligible patients received an 8-week course of HTJYF (n = 38) or paroxetine (n = 40). Anxiety severity was assessed using the Hamilton Anxiety Rating Scale (HAMA) and the Generalized Anxiety Disorder 7-item scale (GAD-7). Secondary measures included the 17-item Hamilton Depression Rating Scale, Pittsburgh Sleep Quality Index, and Patient Health Questionnaire-15. Baseline characteristics were broadly comparable between groups. Both treatments were associated with significant within-group reductions in HAMA and GAD-7 scores from baseline to week 8 (all P < .001), while between-group differences in anxiety improvement were not statistically significant (HAMA change: 1.21 points, 95% confidence interval − 0.45 to 2.87, P = .151; GAD-7 change: 0.90 points, 95% confidence interval − 0.26 to 2.06, P = .125). Improvements in depressive symptoms and somatic symptom burden were similar between groups, whereas sleep quality improved slightly more with HTJYF (Pittsburgh Sleep Quality Index ΔΔ = 0.90, P = .045). Treatment-emergent adverse events occurred at comparable rates (35.0% vs 28.9%, P = .567). No serious adverse events were observed. Because of the retrospective, nonrandomized design and modest sample size, these findings should be interpreted as hypothesis-generating associations rather than evidence of causal superiority, equivalence, or noninferiority.