Effects of a Saw Palmetto Herbal Blend in Men With Symptomatic Benign Prostatic Hyperplasia

Abstract

Purpose: We tested the effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia (BPH) via a randomized, placebo controlled trial.Materials and Methods: We randomized 44 men 45 to 80 years old with symptomatic BPH into a trial of a saw palmetto herbal blend versus placebo. End points included routine clinical measures (symptom score, uroflowmetry and post-void residual urine volume), blood chemistry studies (prostate specific antigen, sex hormones and multiphasic analysis), prostate volumetrics by magnetic resonance imaging, and prostate biopsy for zonal tissue morphometry and semiquantitative histology studies.Results: Saw palmetto herbal blend and placebo groups had improved clinical parameters with a slight advantage in the saw palmetto group (not statistically significant). Neither prostate specific antigen nor prostate volume changed from baseline. Prostate epithelial contraction was noted, especially in the transition zone, where percent epithelium decreased from 17.8% at baseline to 10.7% after 6 months of saw palmetto herbal blend (p Ͻ0.01). Histological studies showed that the percent of atrophic glands increased from 25.2% to 40.9% after treatment with saw palmetto herbal blend (p Ͻ0.01). The mechanism of action appeared to be nonhormonal but it was not identified by tissue studies of apoptosis, cellular proliferation, angiogenesis, growth factors or androgen receptor expression. We noted no adverse effects of saw palmetto herbal blend. When the study was no longer blinded, 41 men elected to continue therapy in an open label extension.Conclusions: Saw palmetto herbal blend appears to be a safe, highly desirable option for men with moderately symptomatic BPH. The secondary outcome measures of clinical effect in our study were only slightly better for saw palmetto herbal blend than placebo (not statistically significant). However, saw palmetto herbal blend therapy was associated with epithelial contraction, especially in the transition zone (p Ͻ0.01), indicating a possible mechanism of action underlying the clinical significance detected in other studies.

Randomized, double-blind, placebo-controlled trial of saw palmetto in men with lower urinary tract symptoms

“…A number of placebo-controlled trials have been published concerning the use of saw palmetto in men with LUTS. [5][6][7][8][9] Many of these studies have suggested significant subjective and objective improvement in patients with benign prostatic hyperplasia. 5,6 However, most of these trials were limited by several factors, including small patient numbers, brief study intervals of 1 to 3 months, and/or the absence of standardized testing instruments, such as symptom scores.…”

“…5,6 However, most of these trials were limited by several factors, including small patient numbers, brief study intervals of 1 to 3 months, and/or the absence of standardized testing instruments, such as symptom scores. [5][6][7][8][9] In addition, several investigators have used meta-analyses of saw palmetto and have concluded that this alternative agent is beneficial in men with LUTS. 10,11 Despite the results of these studies, many physicians remain skeptical about the benefits of saw palmetto, and it has been suggested that any improvement in symptoms was largely induced by a placebo effect.…”

Risks and benefits of commonly used herbal medicines in Mexico

“…In one study, taking a combination product (PRO 160/120, Willmar Schwabe GmbH, Germany) containing a specific extract of stinging nettle (WS 1031) 120 mg plus a specific extract of saw palmetto (WS 1473) 160 mg twice daily for 24 weeks seemed to significantly improve urinary tract symptoms in men with BPH (Lopatkin et al, 2005). In another trial, an herbal product containing stinging nettle root extract 80 mg, saw palmetto lipoidal extract 106 mg, pumpkin seed oil extract 160 mg, lemon bioflavonoid extract 33 mg, and vitamin A (100% as beta-carotene) 190 IU taken three times daily for 6 months did not significantly improve symptoms of BPH (Marks et al, 2000). Nettle seems to have an anti-proliferative effect on prostatic epithelial and stromal cells, which could be a potential mechanism of action in patients with BPH (Durak et al, 2004).…”

The safe usage of herbal medicines: counterindications, cross-reactivity and toxicity

“…Similarly, Serenoa serrulata (saw palmetto) competes with dihydrotestosterone for binding to receptors. 85 This competitive inhibition of dihydrotestosterone function affects all levels of the hormones action. As dihydrotestosterone function is particularly important during male development, saw palmetto intake should be avoided during childhood and adolescence.…”