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).

Mthods: 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 sawpalmetto, finasteride, and tamsulosin in patients with mild and moderate BPH, beingsafe and well tolerated.

Cite this article as: Mederos RG, Bello MR, Travieso JCF, et al. Comparative study of the efficacy and tolerability of palmex (Roystonea regia lipid extract), saw palmetto, finasteride, and tamsulosin in patients with benign prostatic hyperplasia. Urol Res Pract. 2024;50(5):302-309.