Is Saw Palmetto safe?
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Safety of Saw Palmetto: A Comprehensive Review
Introduction to Saw Palmetto Safety
Saw palmetto, derived from the fruit of the American dwarf palm tree, is widely used for treating lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH)1 2 3. Despite its popularity, questions about its safety and potential adverse effects remain. This article synthesizes findings from multiple studies to provide a clear understanding of the safety profile of saw palmetto.
Clinical Trials and Safety Assessments
Randomized Clinical Trials
Several randomized clinical trials have assessed the safety of saw palmetto. The STEP study, involving 225 men over a year, found no significant differences in serious or non-serious adverse events between the saw palmetto and placebo groups1. Similarly, the CAMUS trial, which included 357 participants over 18 months, reported no significant differences in adverse events, vital signs, or laboratory test abnormalities between the saw palmetto and placebo groups, even at doses up to three times the usual clinical dose3.
Long-Term Safety and Tolerability
A systematic review of 40 articles, including randomized controlled trials and case reports, concluded that saw palmetto is generally well-tolerated. The most common adverse events were mild and included abdominal pain, diarrhea, nausea, fatigue, headache, decreased libido, and rhinitis7. Serious adverse events were rare and not conclusively linked to saw palmetto use7.
Comparative Studies with Other Treatments
Saw Palmetto vs. Finasteride
In a study comparing saw palmetto with finasteride for treating chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), saw palmetto was associated with fewer adverse events. The most common side effect in the saw palmetto group was headache, while the finasteride group reported decreased libido4. This suggests that saw palmetto may be a safer alternative for some patients.
Specific Safety Concerns
Drug Interactions and Contraindications
There are no known drug interactions with saw palmetto, making it a safe option for many users9 10. However, it is advised not to use saw palmetto if you have prostate cancer, as its effects on prostate cancer are not well understood9.
Special Populations
Saw palmetto should not be taken by children, and it is crucial to consult a healthcare professional before starting the supplement, especially if you are taking prescription drugs9.
Conclusion
Overall, saw palmetto appears to be a safe and well-tolerated supplement for treating LUTS and BPH. Clinical trials and systematic reviews indicate that adverse events are generally mild and infrequent, with no significant differences compared to placebo. However, as with any supplement, it is essential to consult with a healthcare provider before use, particularly for individuals with specific health conditions or those taking other medications. Further large-scale studies are needed to confirm these findings and explore any potential long-term adverse effects.
Sources and full results
Most relevant research papers on this topic
A detailed safety assessment of a saw palmetto extract.
Saw palmetto showed no evidence of serious toxicity in this clinical trial, but rare adverse effects may still exist.
RCTSaw palmetto for the treatment of men with lower urinary tract symptoms.
Saw palmetto may significantly improve urinary flow rates and symptom scores in men with lower urinary tract symptoms, but large-scale, placebo-controlled trials are needed to confirm its efficacy.
Systematic Review
Highly CitedSafety and toxicity of saw palmetto in the CAMUS trial.
Saw palmetto extract showed no evidence of toxicity at doses up to 3 times the usual clinical dose during an 18-month period.
RCT
Large Human TrialA prospective, 1-year trial using saw palmetto versus finasteride in the treatment of category III prostatitis/chronic pelvic pain syndrome.
Finasteride significantly improves quality of life and pain in men with chronic pelvic pain syndrome, while saw palmetto shows no long-term improvement.
RCTHighly CitedNatural Hair Supplement: Friend or Foe? Saw Palmetto, a Systematic Review in Alopecia
Saw palmetto-containing supplements show potential in improving hair quality, density, and stabilizing disease progression in patients with androgenetic alopecia and telogen effluvium.
Systematic ReviewEffects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia.
Saw palmetto herbal blend is a safe and desirable option for men with moderately symptomatic benign prostatic hyperplasia, but its clinical effect is slightly better than placebo.
RCTHighly CitedSerenoa repens (Saw Palmetto)
Saw palmetto is well-tolerated and not associated with serious adverse events, with most reported mild side effects.
Systematic ReviewSaw palmetto for benign prostatic hyperplasia.
Saw palmetto did not improve symptoms or objective measures of benign prostatic hyperplasia in this study.
RCTHighly CitedChapter 90 – Saw Palmetto (Serenoa repens)
Saw palmetto is safe for most adults, but not for children, and should not be used if you have prostate cancer or if you take prescription drugs.
Saw palmetto for prostate disorders.
Saw palmetto is an effective and well-tolerated herbal treatment for benign prostatic hyperplasia, with potential benefits similar to finasteride and no known drug interactions.
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