Objective:

To assess efficacy and safety of Sini San combined with Xiaoxianxiong Tang as add-on therapy for adolescents (12–18 years) with liver qi stagnation and phlegm-heat depression, and to provide preliminary evidence for TCM syndrome-based treatment.

Approach:

Key Findings:

• At 8 weeks, the study group had significantly lower CDRS-R scores (13.02 vs. 21.85, P < 0.001).
• The study group had lower TCM syndrome scores (3.21 vs. 6.98, P < 0.001).
• Higher PedsQL scores were observed in the study group (79.35 vs. 66.89, P < 0.001).
• The clinical effective rate was higher in the study group (90.0% vs. 63.3%, P = 0.010).
• 6.7% of participants reported mild gastrointestinal discomfort, with no serious adverse events.

Interpretation:

Limitations:

• Small sample size.
• Single-center design, limiting generalizability.
• Lack of double-blinding and placebo control.

Conclusion:

Findings are hypothesis-generating and cannot support broad clinical promotion.

Attribution Notice

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