Abstract Background Chaihu Guizhi Ganjiang Decoction combined with Wendan Decoction (CGGWD) is used clinically to treat liver depression and spleen deficiency-related premature ejaculation (PE), while clinical evidence and safety are still limited. Aim To assess the safety and efficacy of the Traditional Chinese Medicine (TCM) formula, CGGWD, in comparison with dapoxetine for PE. Methods This retrospective study included male PE patients with liver depression and spleen deficiency treated at a prominent academic medical center (November 2021-March 2025). Patients completed a 4-week regimen, with sexual function and systemic symptoms evaluated before and after treatment. Outcomes Outcomes were determined based on assessment of intravaginal ejaculatory latency time (IELT), Premature Ejaculation Diagnostic Tool (PEDT), Traditional Chinese Medicine Quality of Life Evaluation Scale (CQ-11D), Global Rating of Sexual Satisfaction (GRISS), and Clinical General Impression of Change (CGIC). Results A total of 226 patients were enrolled in the study, including 165 in the CGGWD group and 61 in the dapoxetine group. After 4 weeks of treatment, the dapoxetine group showed an increase in IELT from 1.5 to 3.0 min, a decrease in PEDT scores from 13 to 9, and a reduction in GRISS scores from 37 to 28 (all P .05), with a CGIC score of 2. In the CGGWD group, IELT increased from 1.5 to 3.5 min, PEDT scores decreased from 12 to 9.5, and GRISS scores dropped from 36 to 26.5 (all P .05), also yielding a CGIC score of 2. No significant differences were observed between the 2 groups regarding changes in IELT, PEDT, GRISS, or overall clinical impression (P = .978, .567, .883, and .993, respectively). However, regarding the CQ-11D score, the dapoxetine group remained stable at 24 points, whereas the CGGWD group decreased significantly from 24 to 19 points (P .05). Furthermore, the incidence of adverse events was significantly lower in the CGGWD group compared to the dapoxetine group (7 cases vs. 29 cases, P .05). Clinical Implications The TCM formulation, CGGWD, demonstrates both safety and efficacy in the management of PE. Strengths and Limitations This study offers the initial clinical validation of CGGWD for PE but is limited by population selection constraints, potential information bias, and unobserved confounding factors. Conclusion For Chinese men with liver depression and spleen deficiency PE, CGGWD matches dapoxetine in efficacy but offers superior safety and systemic symptom relief, serving as a safe, effective alternative.
Sun et al. (Wed,) studied this question.