Comparison of Tamsulosin Plus Serenoa Repens with Tamsulosin in the Treatment of Benign Prostatic Hyperplasia in Korean Men: 1-Year Randomized Open Label Study

Introduction: In Korea, increasing attention has recently been given to the use of phytotherapeutic agents to alleviate the symptoms of BPH. Serenoa repens has been shown to have an equivalent efficacy to Finasteride or Tamsulosin in the treatment of BPH in previous studies. The present study was designed to compare the efficacy and safety of Serenoa repens plus tamsulosin with tamsulosin only over 12 months in men with LUTS secondary to BPH. Materials and Methods: One hundred forty men with symptomatic BPH (IPSS ≥10) were recruited in our hospital for a 12-month, open-label, randomized trial. Patients were randomly assigned to either tamsulosin 0.2 mg/day plus Serenoa repens 320 mg/day (n = 60) or tamsulosin 0.2 mg/day only (n = 60). Prostate volume and PSA were measured at baseline and at end-point, whereas total IPSS, and its storage and voiding subscores, LUTS-related QoL, Qmax, and PVR were evaluated at baseline and later every 6 months. Results: Total 103 patients were finally available: 50 in the TAM + SR group and 53 in the TAM group. At 12 months, total IPSS decreased by 5.8 with TAM + SR and 5.5 with TAM (p = 0.693); the storage symptoms improved significantly more with TAM + SR (-1.7 vs. -0.8 with TAM, p = 0.024). This benefit with regard to storage symptom in the TAM + SR group lasts at 12 months (-1.9 vs. -0.9, p = 0.024). The changes of voiding subscore, LUTS-related QoL, Qmax, PVR, PSA, and prostate volume showed no significant differences between the TAM + SR and TAM groups. During the treatment period, 8 patients (16.9%) with TAM and 10 (20%) with TAM + SR had drug-related adverse reactions, which included ejaculatory disorders, postural hypotension, dizziness, headache, gastro-intestinal disorders, rhinitis, fatigue and asthenia. Conclusions: The combination treatment of Serenoa repens and tamsulosin was shown to be more effective than tamsulosin monotherapy in reducing storage symptoms in BPH patients after 6 months and up to 12 months of treatment.