KARLSRUHE, Germany, 8 July 2005.

According to latest research, Dr. Willmar Schwabe Pharmaceuticals’ proprietary saw palmetto and nettle root extract combination is significantly superior to placebo in the treatment of lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). The combination product contains WS® 1473, an extract of saw palmetto berry and WS® 1031, an extract of nettle root and is known in Germany as Prostagutt® forte. The randomised, double-blind, placebo-controlled, multi-centre clinical trial investigated the efficacy and safety of WS® 1473/WS® 1031 versus placebo in 257 patients suffering from moderate to severe LUTS and was recently published online in the World Journal of Urology[1]. (http://www.ncbi.nlm.nih.gov/)

BPH is a non-cancerous condition and is characterised by a regional growth of the prostate that occurs in almost all older men. More than half the men in their sixties, and as many as 90 percent in their seventies and eighties, have some symptoms of BPH.

In the new study, 257 patients were divided into two groups: Following a placebo run-in phase of 2 weeks, the patients either received 2×1 capsule/day of WS® 1473/WS® 1031 or placebo for 24 weeks. After that all patients received WS® 1473/WS® 1031 for an additional 24 weeks. Data for an additional 48 week follow-up period are currently under evaluation and will create a total observation period of 96 weeks.

After 24 weeks patients treated with the drug exhibited a substantially better symptom relief compared to placebo as measured by the international standard rating scale, the I-PSS (6 points versus 4 points; p=0.003). This corresponds to a 35.3% reduction for the WS® 1473/WS® 1031 treated patients and lies within the therapeutic range of alpha-blockers.
Both obstructive and irritative symptoms improved and both patients with moderate or severe symptoms at baseline benefited from this treatment.

Of the patients with initially moderate symptoms, 26.4% in the WS® 1473/WS® 1031 group and 14.6% in the placebo group had only mild symptoms at week 24. In patients with severe symptoms at baseline, more than 4 out of 5 patients treated with the drug improved to moderate or mild LUTS at the end of double-blind treatment.

After completion of the double blind phase all patients received WS® 1473/WS® 1031 for an additional 24 weeks. During this period patients who had received placebo during the first 24 weeks showed marked improvements when now treated with WS® 1473/WS® 1031.

The herbal combination was well tolerated. The average incidence densities were 0.0011 adverse events per day of observation for WS® 1473/WS® 1031 and 0.0014 for placebo.

These results are in line with the findings of previous clinical trials of WS® 1473/WS® 1031 showing significant advantages over placebo[2] and an efficacy comparable to that of finasteride[3].

“This study shows that the combination product of WS® 1473/WS® 1031 significantly reliefs the lower urinary tract symptoms and thus improves the quality of life of elderly men suffering from BPH“ says Prof. N. A. Lopatkin, principal investigator of the study and direcor of the Institute of Urology MH of Russia, Moscow. “With a clear advantage over placebo this drug represents an efficacious and very safe alternative in the treatment of lower urinary tract symptoms.“

Each capsule of the product investigated contains 160 mg of WS® 1473 (saw palmetto special extract) and 120 mg WS® 1031 (nettle root special extract), a unique combination that was previously shown to act synergistically[4]. The drug was developed and is produced by Dr. Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany, the leading research-based phytomedicine company worldwide.

Contact:
Dr. Willmar Schwabe Pharmaceuticals
Willmar-Schwabe-Str. 4
76227 Karlsruhe

Dr. Jochen Muehlhoff
Phone: +49 721 4005 216
Email: jochen.muehlhoff@schwabe.de

[1] Lopatkin N, Sivkov A, Walther C, Schlafke S, Medvedev A, Avdeichuk J, Golubev G, Melnik K, Elenberger N, Engelmann U. Long-term efficacy and safety of a combination of sabal and urtica extract for lower urinary tract symptoms-a placebo-controlled, double-blind, multicenter trial. World J Urol. 2005 Jun 1; [Epub ahead of print].
[2] Metzker H, Kieser M, Hölscher U. Wirksamkeit eines Sabal-Urtica-Kombinationspräparats bei der Behandlung der benignen Prostatahyperplasie (BPH). Urologe 1996 (B 36):292–300.
[3] Sökeland J. Combined sabal and urtica extract compared with finasteride in men with benign prostatic hyperplasia: analysis of prostate volume and therapeutic outcome. Br J Urol 2000 (86):439–442.
[4] Koch E, Biber A: "Pharmacological Effects of Sabal and Urtica Extracts as Basis for a Rational Medication of Benign Prostate Hyperplasia", Urologe 1994 (34/2): 3-8.