Comparative Study of the Efficacy and Tolerability of Palmex® (Roystonea regia Lipid Extract), Saw Palmetto, Finasteride and Tamsulosin in Patients with Benign Prostatic Hyperplasia.

Objective: Evaluate and compare the efficacy and tolerability of the treatment with Palmex®, saw palmetto, finasteride, or tamsulosin administered for 6 months to patients with benign prostatic hyperplasia (BPH).

Methods: This multicenter, open, prospective, comparative study was conducted in men !40 years with mild and moderate BPH according to the International Prostate Symptoms Score (IPSS) (!1, <19). The study included 200 patients (50 per group) who were randomly allocated to receive Palmex® (320 mg/d), saw palmetto (320 mg/d), finasteride (5 mg/d), or tamsulosin (0.4 mg/d). The primary study outcome was the improvement of the maximum urinary flow (Qmax), while significant decreases in IPSS values, prostate size, and residual post-voiding volume were secondary efficacy variables. Statistical analysis was performed according to Intention to treat.

Results: The demographic baseline characteristics of all the groups were similar. All groups exhibited a significant mean increase in Qmax from baseline to week 24, being 3.8 mL/s (27.7%), 3.6 mL/s (23.1%), 4.2 mL/s (28.6%), and 4.1 mL/s (26.3%) on Palmex®, saw palmetto, finasteride, and tamsulosin, respectively. Likewise, all the treatments significantly reduced the IPSS scores by 74.2% (Palmex®), 74.6% (saw palmetto), 60.3% (finasteride), and 74.2% (tamsulosin), also decreasing the prostate size and the residual post-voiding volume. No significant differences among the groups were found regarding any efficacy variable. The treatments were well tolerated.

Conclusion: Palmex® for 6 months demonstrated to have a comparable efficacy to saw palmetto, finasteride, and tamsulosin in patients with mild and moderate BPH, being safe and well tolerated.