Improving BPH symptoms and sexual dysfunctions with a saw palmetto preparation? Results from a pilot trial Andreas Suter, 1,4 * Reinhard Saller, 2 Eugen Riedi 3 and Michael Heinrich 4 1 Medical Department, A. Vogel Bioforce AG, Roggwil, Switzerland 2 Institute of Natural Medicine, Zurich University Hospital, Zurich, Switzerland 3 Urological practice, Chur, Switzerland 4 School of Pharmacy, University of London, University College London, London, United Kingdom In elderly men, benign prostatic hyperplasia (BPH) is a major risk factor for sexual dysfunctions (SDys). Additionally, the standard treatments for BPH symptoms, alpha blockers and 5-alpha-reductase inhibitors, cause SDys themselves. Preparations from saw palmetto berries are an efficacious and well-tolerated symptomatic treatment for mild to moderate BPH and have traditionally been used to treat SDys. We conducted an open multicentric clinical pilot trial to investigate whether the saw palmetto berry preparation Prostasan W influenced BPH symptoms and SDys. Eighty-two patients participated in the 8-week trial, taking one capsule of 320 mg saw palmetto extract daily. At the end of the treatment, the International Prostate Symptom Score was reduced from 14.4 Æ 4.7 to 6.9 Æ 5.2 (p < 0.0001); SDys measured with the brief Sexual Function Inventory improved from 22.4 Æ 7.2 to 31.4 Æ 9.2 (p < 0.0001), and the Urolife BPH QoL-9 total improved from 162.7 Æ 47.9 to 105.0 Æ 56.3 (p < 0.0001). Investigators’ and patients’ assessments confirmed the good efficacy, and treatment was very well tolerated and accepted by the patients. Correlation analyses confirmed the relationship between improved BPH symptoms and reduced SDys. This was the first trial with saw palmetto to show improvement in BPH symptoms and SDys as well. Copyright © 2012 John Wiley & Sons, Ltd. Keywords: benign prostatic hyperplasia; sexual dysfunctions; clinical trial; saw palmetto; Serenoa repens. INTRODUCTION The prostate is a fibromuscular glandular organ that lies between the urinary bladder and the pelvic floor and surrounds the prostatic urethra (Dixon, 2005). Starting around the age of 40, the prostatic tissue enclosing the urethra starts growing; this nonmalignant growth is known as benign prostate hyperplasia (BPH) (Isaacs and Coffey, 1989). It leads to constriction of the urethra and gives rise to associated lower urinary tract symptoms (LUTS), such as urgency, frequency, noc- turia, incomplete bladder emptying and weak urine stream. LUTS occur in about one third of all men in their 60s and half of men older than 80 (McVary, 2006), even though the histological presence of BPH is observed in more than 90% of men in this age group (Berry et al., 1984). In addition to obstructive and irritative symptoms, BPH also negatively influences sexual functions (Gur et al., 2008). Epidemiological studies show that, along with the general ageing process, BPH-related LUTS are a key factor in development of erectile dysfunctions and ejaculatory disorders (Braun et al., 2003; Boyle et al., 2004), representing a stronger risk factor than diabetes, hypertension, heart disease or hyperlipidemia (Rosen et al., 2003). Overall, there appears to be a clear and clinically significant association between LUTS and various types of sexual dysfunctions in ageing men worldwide. From epidemiological data, Rosen et al. (2005) concluded that, compared with patients without BPH-symptoms, patients with BPH-symptoms were at a 3.7-fold higher risk of developing erectile dysfunction during the 2-year period following the onset of BPH- symptoms. Additionally, the severity of the LUTS symptoms was correlated with more frequent and more severe occurrence of erectile and ejaculatory dysfunctions (Rosen et al., 2005). The main medical treatments for BPH symptoms include alpha blockers such as tamsulosin, doxazosin and alfuzosin (Novara et al., 2006) that provide fast relief of the LUTS symptoms (Kaplan, 2004) or the 5-alpha-reductase-inhibitors finasteride and dutasteride, which lead to symptom relief after 6–9 months and are most favourable in patients with large prostates (Dull et al., 2002). Both treatment options show beneficial effects on the BPH symptoms; however, they also each have a significant negative impact on sexual functions. The main sexual dysfunction reported under alpha blocker therapy is retrograde or abnormal ejaculation, which occurs in 4–18% of patients taking tamsulosin, with rise to 30% during long-term use (Carbone and Hodges, 2003). Studies on 5-alpha-reductase inhibitors report sexual dysfunctions with a frequency of 2.1–38%, with erectile dysfunctions being most prominent, followed by decreased libido and ejaculatory disorders (Erdemir et al., 2008). Sexual dysfunctions are the most often reported adverse events under 5-alpha-reductase- * Correspondence to: Andreas Suter, A. Vogel Bioforce AG, Medical Department, Roggwil, Switzerland. E-mail: A.Suter@bioforce.ch PHYTOTHERAPY RESEARCH Phytother. Res. (2012) Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/ptr.4696 Copyright © 2012 John Wiley & Sons, Ltd. Received 20 November 2011 Revised 15 March 2012 Accepted 16 March 2012