Objectives: In spite of its historical use, published data about phytotherapic products is characterized by the absence of well conducted studies, leading to conflictive and indefinite results about efficiency and safety of theses drugs. In that sense, we have analyzed the results of a combination of Pygeum africanum and stinging nettle (Urtica dioica) extracts in patients with benign prostatic hyperplasia (BPH), based in a double-blind, randomized, placebo-controlled protocol.

Materials and methods: We have selected, according to inclusion and exclusion criteria, only patients with >or=50 years, presenting urinary symptoms assessed by the International Prostatic Symptoms Score (IPSS), with minimum score of 12, and Quality of Life (QoL) index of at least 3 points, rectal examination consistent with BPH, and maximum urinary flow rate (Q(max)) between 5 and 15 mL/s. Phytotherapic and placebo groups were formed by 27 and 22 patients, respectively. The major variables analyzed during the study were IPSS variation, Q(max), and side effects. Reduction of >or=30% and >or=50% in IPSS were the parameters used to define a clinically significant response (CSR). We have also analyzed >or=30% and >or=50% Q(max) increases.

Results: After six months of treatment we did not observe significant differences in clinical improvement potential between the phytotherapic combination and placebo groups. Percent IPSS drop of 21.6% in the phytotherapic group was similar to 19.7% obtained in the placebo group (p=0.928). Neither we observed any difference (p=0.530) for QoL improvement between phytotherapic (9.26%) and placebo (5.98%) groups. The alterations of Q(max) followed the trend line observed in clinical data, with no significant difference (p=0.463) in Q(max) increasing percent between phytotherapic (17.2%) and placebo (13.3%) groups. The CSR evaluation of clinical and urodynamic data was also similar between the groups.

Conclusion: The combination of 25mg Pygeum africanum and 300mg stinging nettle extracts produced clinical and urodynamic effects similar to placebo in a group of HBP patients.