Saw Palmetto

• Benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS): Large, high-quality randomized trials and Cochrane reviews generally find little to no clinically meaningful benefit versus placebo for overall urinary symptom scores, nocturia, or urinary flow (evidence: moderate, largely negative). Some meta-analyses focusing on standardized hexanic/liposterolic extracts report small improvements; clinical significance remains uncertain and results are inconsistent (evidence: moderate, mixed).
• Adjunct use with alpha-1 blockers (e.g., tamsulosin): Some small trials suggest additive symptom relief when combined, but data are limited and heterogenous (evidence: emerging).
• Androgenetic alopecia (male pattern hair loss): Small, low-quality studies (some randomized/pilot) suggest modest benefits in hair density or stabilization in a subset of users; overall evidence is preliminary and mixed (evidence: emerging).
• Chronic prostatitis/chronic pelvic pain syndrome: Limited, small studies (often in combination formulas) suggest possible symptom improvement; high-quality data are lacking (evidence: emerging).
• Mechanistic/biomarkers: In vitro and small clinical studies show 5-alpha-reductase inhibition and anti-inflammatory effects, but translation to consistent clinical benefit is uncertain (evidence: emerging).

Generally well tolerated in clinical trials, with overall adverse event rates similar to placebo. Common (usually mild): gastrointestinal upset (nausea, abdominal discomfort, diarrhea or constipation), headache, dizziness, fatigue. Less common: decreased libido or erectile dysfunction (rates typically low and near placebo in RCTs), mild elevations in blood pressure or blood glucose have been sporadically reported. Rare but serious: liver injury (idiosyncratic hepatitis), acute pancreatitis, significant bleeding (especially with concomitant anticoagulants/antiplatelets), severe allergic reactions. Most serious events are based on case reports. Dose-related: higher doses (e.g., up to 960 mg/day studied) did not show clear increases in side effects vs standard doses, but GI upset may be more likely at higher intakes. Taking with food may reduce GI symptoms.

Commonly used ranges in studies: 160 mg twice daily or 320 mg once daily of a liposterolic/hexanic extract standardized to approximately 80–95% fatty acids and sterols (e.g., Permixon/HESr). Some trials have used escalating doses up to 960 mg/day without added benefit. Optimal dosage likely varies by individual and formulation; different extraction methods (hexanic, ethanolic, supercritical CO2) are not interchangeable. Always consider product standardization and consult a clinician for individualized guidance.

• Pregnancy and breastfeeding: Avoid; potential hormonal activity and lack of safety data.
• Children and adolescents: Not recommended due to limited safety data and potential hormonal effects.
• Bleeding disorders or active bleeding: Avoid/caution due to possible antiplatelet effects; stop at least 2 weeks before surgery or invasive dental procedures.
• Concomitant use of anticoagulants/antiplatelets/NSAIDs: Increased bleeding risk; medical supervision recommended.
• Hormone-sensitive conditions or therapies (e.g., use of 5-alpha-reductase inhibitors, testosterone therapy, certain prostate/breast conditions): Potential hormonal interactions; consult a clinician.
• History of liver disease or pancreatitis: Use caution due to rare case reports of hepatotoxicity and pancreatitis; discontinue if jaundice, dark urine, severe abdominal pain, or unexplained fatigue occur.
• Allergy to Arecaceae (palm) family plants: Potential cross-reactivity.
• PSA testing: Most studies suggest minimal effect on PSA, but inform your clinician you are using saw palmetto to aid interpretation.