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 Urinary Tract Infections: Urinary Tract Conditions: Examining the Evidence on Cranberry and Saw Palmetto 
National Institutes of Health National Center for Complementary and Alternative Medicine ©

Practice Guidelines
The American Urological Association's (AUA) evidence-based guideline on diagnosis and treatment of BPH—last updated in 2006 and currently being updated—recommends:

  • For patients whose symptoms (as measured with a validated instrument such as the AUA Symptom Score Index) are mild or moderate, or who have severe symptoms that are not bothersome or do not interfere with daily activities of living, watchful waiting is preferred.
  • For patients with bothersome moderate-to-severe symptoms, treatment options include watchful waiting and one or more of the following therapies: alpha-adrenergic blockers and 5-alpha-reductase inhibitors, separately or combined; minimally invasive therapies, such as transurethral microwave heat treatments or transurethral needle ablation; and, if earlier interventions have not resolved the problem, surgical treatment.

The AUA also states that phytotherapeutic agents (i.e., plant-derived medications such as saw palmetto) and other dietary supplements cannot be recommended to treat BPH. Despite widespread use, their mechanisms of action, effectiveness, and safety have not been sufficiently documented in high-quality clinical trials.

The 6th International Consultation on New Developments in Prostate Cancer and Prostate Diseases (held in 2005 and including AUA representation) focused on LUTS, including from BPH, in older men. This guideline recommends that only treatments with a strong evidence base for clinical effectiveness be used. With regard to "alternative treatments" (defined as consisting mostly of botanicals and polyene-derived agents), it notes that while progress has been made toward isolating components and identifying possible mechanism(s) of action, it is difficult to compare studies, and further research (including with long-term followup) is needed to draw conclusions.

Systematic Reviews/Meta-Analyses
Findings from systematic reviews of saw palmetto for symptoms of BPH have been mixed, and the topic is an active area of debate. The number of trials available, especially randomized controlled trials (RCTs), is modest. Many earlier trials—in contrast to two more recent, better designed RCTs—have had issues that can affect the validity of findings, such as short duration, small size, and/or not having used standardized outcome measures.

Cochrane Systematic Reviews

  • A 2009 Cochrane review of 30 trials concluded that saw palmetto has little or no efficacy over placebo for treating BPH symptoms, although it appears to be safe. This conclusion changed from two earlier Cochrane reviews. Here, the review noted the availability of two better quality RCTs, one of which was also adequately powered. [The latter refers to the NCCAM-funded trial published in 2006, the largest and most rigorously designed study on this question to date, which found no improvement from saw palmetto, compared with placebo, in urinary symptoms and objective measures related to BPH.] The review found a certain amount of ambiguity in evidence on this topic and called for additional high-quality studies.

Other systematic reviews/meta-analyses include:

  • A 2005 review on 38 studies (mostly on one commercial product), by the Natural Standard Research Collaboration, which concluded in favor of efficacy
  • A 2002 meta-analysis on 17 published studies of a European commercial saw palmetto extract, by the European Institute of Oncology, which found suggestions of effectiveness over placebo on several measures in BPH symptoms.
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