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Saw Palmetto and Tamsulosin (Flomax®) Tested for the Treatment of BPH Symptoms
ISSUE:
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27
Reviewed: Hizli F, Uygur MC. A prospective study of the efficacy of Serenoa repens, tamsulosin, and Serenoa repens plus tamsulosin treatment for patients with benign prostate hyperplasia. Int Urol Nephrol. 2007;110(2):305-310.

Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH), a non-malignant enlargement of the prostate, are common in men older than 60 years worldwide. The availability of 5-alpha-reductase inhibitors, alpha-blockers, and phytomedicinal agents (herbal preparations) to treat the symptoms associated with this condition has reduced the need for surgery in these patients. However, the use of many of the conventional pharmaceutical drugs is associated with adverse effects, including postural hypotension (drop in blood pressure due to a change in body position, e.g., standing up) and sexual dysfunction. Thus, increasing attention has focused on the use of phytotherapeutic agents to ameliorate the symptoms associated with BPH.

The objective of this study was to assess the safety and efficacy of saw palmetto (Serenoa repens, Arecaceae) extract (Prostagood®; Dr. Willmar Schwabe GmbH & Co. Arzneimittel, Karlsruhe, Germany) and tamsulosin (Flomax®; Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT), alone or in combination, for the treatment of LUTS secondary to BPH.

Sixty men aged 43–73 years with symptomatic BPH were enrolled between May and November 2005 in this 6-month prospective, open-label, randomized study, the location of which was not identified. The subjects were randomly assigned to 1 of 3 groups (n = 20 per group): 320 mg saw palmetto/day (referred to in this study as the SR group), 0.4 mg tamsulosin/day (TAM group), or 320 mg SR/day + 0.4 mg TAM/day (SR + TAM group). No placebo group was included. The International Prostate Symptom Score (I-PSS), the maximal urinary flow rate (Qmax), prostate volume, prostate-specific antigen (PSA) concentrations, qualityof-life scores, and postvoiding residual volume (PVR) were determined at baseline and at months 2, 4, and 6 of the study.

The I-PSS decreased significantly (P < 0.05) from baseline to 6 months by 6.1, 4.6, and 4.9 points in the SR, TAM, and SR + TAM groups, respectively. Qmax increased significantly (P < 0.05) from baseline to 6 months by 3.2, 3.7, and 4.3 mL/second in the SR, TAM, and SR + TAM groups, respectively; however, the differences between groups were not significant. Prostate volume, PSA concentrations, quality-of-life scores, and PVR decreased in all 3 groups by 6 months, but not significantly in any of the groups. No adverse effects were observed in the SR group, and those that were observed in the 2 other groups (e.g., postural hypotension, dizziness, decrease in libido, dry mouth, and fatigue) were not serious enough to require withdrawal from the study.

Treatment of the urinary symptoms of BPH with saw palmetto extract or tamsulosin alone was equally effective, while treatment with a combination of the herbal extract and the drug conferred no extra benefit. The authors conclude that saw palmetto extract “is a well-tolerated agent that can be used alternatively in the treatment of LUTS due to BPH.”

—Brenda Milot, ELS