Efficacy of Jiaotai Gujing Formula combined with psychosexual therapy for premature ejaculation: a randomized controlled trial

Background: Premature ejaculation (PE) is a prevalent male sexual dysfunction with significant psychological and relational impacts. While selective serotonin reuptake inhibitors are commonly used as first-line treatments, their adverse effects and limited efficacy necessitate alternative approaches. Traditional Chinese medicine, particularly Jiaotai Gujing Formula (JGF), has shown promise in preclinical studies, but its combined effect with psychosexual therapy remains underexplored. Methods: This randomized controlled trial enrolled 120 PE patients, allocated equally to a treatment group (JGF plus psychosexual therapy) and a control group (JGF alone). Psychosexual therapy included structured counseling and assessments of anxiety and depression. Primary outcomes were measured by intravaginal ejaculatory latency time (IELT), with secondary outcomes including Hamilton Anxiety (HAM-A) and Hamilton Depression (HAM-D) scales, Chinese Medicine Symptom Score (CMSS), and Clinical Global Impression (CGI). Results: Of 110 completers (56 in the treatment group, 54 in the control group), the treatment group demonstrated superior outcomes. IELT increased significantly in both groups (211.11 ± 103.22 vs. 174.74 ± 86.82 seconds, p < 0.05), with a greater improvement observed in the treatment group (p < 0.05). HAM-A and HAM-D scores decreased more markedly in the treatment group (7.70 ± 3.25 and 6.45 ± 1.92, respectively) than in the control group (9.89 ± 3.94 and 8.59 ± 4.47, p < 0.05). After treatment, the CMSS of both groups was significantly lower than that at baseline (p < 0.05). However, there were no significant differences between the two groups in CGI scores. Safety profiles were favorable, with no severe adverse events reported. Conclusions: JGF combined with psychosexual therapy significantly prolongs IELT and alleviates psychosomatic symptoms in PE patients, offering a safe and effective integrative treatment. Clinical Trial Registration: This study was registered in ITMCTR (registration number: ITMCTR2024000718) and can be accessed at http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=238e5723-9556-422b-ac9f-0c8c41ecdc0b.