Author(s)

Yuanyuan Zheng ¹, Guosheng Ren ¹, Tian Jin ¹, Zhitao Wang ¹

Affiliation(s)

¹ Jilin Neuropsychiatric Hospital, Siping, Jilin, 136000, China

Corresponding Author

Zhitao Wang

ABSTRACT

We evaluated the efficacy and patient-reported tolerability of adding Jiuwei Zhenxin Granules to trazodone in patients with depression and heart-spleen deficiency syndrome. Of 82 patients screened, 60 completed the study and were randomized to trazodone alone (n=30) or trazodone plus Jiuwei Zhenxin Granules (n=30) for 8 weeks. The primary outcome was the between-group difference in the 17-item Hamilton Depression Rating Scale (HAMD-17) score at week 8. Secondary outcomes included HAMA-14, the traditional Chinese medicine syndrome score (TCMDS), Pittsburgh Sleep Quality Index (PSQI), therapeutic grade, and patient-reported adverse events. At week 8, the HAMD-17 score was lower with combination therapy (6.93±2.57 vs 11.90±2.95; t=6.948; P<0.001). HAMA-14, TCMDS, and PSQI scores were also lower at weeks 4 and 8, and time-by-group interactions were significant for all scales (all P<0.001). Therapeutic-grade distribution favored combination therapy (U=144.5; Z=-5.056; P<0.001), with 43.3% of patients meeting the recovery criterion. No serious drug-related event was reported. Adding Jiuwei Zhenxin Granules to trazodone improved depressive and anxiety symptoms, TCM syndromes, and sleep quality, with good patient-reported tolerability.

KEYWORDS

Depression; Heart-spleen deficiency syndrome; Jiuwei zhenxin granules; Trazodone; Randomized controlled study

CITE THIS PAPER

Yuanyuan Zheng, Guosheng Ren, Tian Jin, Zhitao Wang. Efficacy and Safety of Jiuwei Zhenxin Granules Combined with Trazodone for Depression with Heart-Spleen Deficiency Syndrome: A Randomized Controlled Study. MEDS Chinese Medicine (2026). Vol. 8, No. 1, 139-144. DOI: http://dx.doi.org/10.23977/medcm.2026.080116.

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