Randomised , placebo - controlled , double - blind clinical trial of & bgr ; - sitosterol in patients with benign prostatic hyperplasia

Purpose: To determine the effects of therapy with Urticadioica for symptomatic relief of lower urinary tract symptoms (LUTS)secondary to benign prostatic hyperplasia (BPH).Material and Methods: A 6-month, double-blind, placebo-controlled,randomized, partial crossover, comparative trial of Urtica dioica withplacebo in 620 patients was conducted. Patients were evaluated usingthe International Prostate Symptom Score (IPSS), the maximum urinaryflow rate (Qmax), postvoid residual urine volume (PVR), Serum Pros-tatic-Specific Antigen (PSA), testosterone levels, and prostate size. Atthe end of the 6-month trial, unblinding revealed that patients who ini-tially received the placebo were switched to Urtica dioica. Both groupscontinued the medication up to 18 months.Results: Five hundred fifty-eight patients (90%) completed the study(287/305, 91% in the Urtica dioica group, and 271/315, 86% in the pla-cebo group). By intention-to-treat analysis, at the end of the 6-month trial,232 (81%) of 287 patients in the Urtica dioica group reported improvedLUTS compared with 43 (16%) of 271 patients in the placebo group (P <0.001). Both IPSS and Qmax showed greater improvement with drugsthan with placebo. The IPSS went from 19.8 down to 11.8 with Urtica Mohammad Reza Safarinejad is Assistant Professor of Urology, Associate Editorof Urology Journal, Department of Urology, Urology Nephrology Research Center,Shaheed Beheshti University of Medical Sciences, Tehran, Iran.Address correspondence to: Mohammad Reza Safarinejad, MD, P.O. Box 19395-1849, Tehran, Iran (E-mail: [email protected]). Journal of Herbal Pharmacotherapy, Vol. 5(4) 2005Available online at http://www.haworthpress.com/web/JHP 2005 by The Haworth Press, Inc. All rights reserved.doi:10.1300/J157v05n04_011 dioica and from 19.2 to 17.7 with placebo (P = 0.002). Peak flow ratesimproved by 3.4 mL/s for placebo recipients and by 8.2 mL/s for treatedpatients (P < 0.05). In Urtica dioica group, PVR decreased from an ini-tial value of 73 to 36 mL (P < 0.05). No appreciable change was seen inthe placebo group. Serum PSA and testosterone levels were unchangedin both groups. A modest decrease in prostate size as measured bytransrectal ultrasonography (TRUS) was seen in Urtica dioica group(from 40.1 cc initially, to 36.3 cc; P < 0.001). There was no change in theprostate volume at the end of study with placebo. At 18-month fol-low-up, only patients who continued therapy, had a favorable treatmentvariables value. No side effects were identified in either group.Conclusion: In the present study, Urtica dioica has beneficial effectsin the treatment of symptomatic BPH. Further clinical trials should beconducted to confirm these results before concluding that Urtica dioicais effective. [Article copies available for a fee from The Haworth Document De-livery Service: 1-800-HAWORTH. E-mail address: com> Website:  2005 by The Haworth Press,Inc. All rights reserved.]