Trial reportJAMA2011
Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial.
Trial report in JAMA, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00603304 (Complementary and Alternative Medicine for Urological Symptoms), which is not on this map. Cited by 53 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Complementary and Alternative Medicine for Urological Symptoms (CAMUS)
Who cites it
53 citing papers in PubMed, 6 syntheses or guidelines pooled it, 160 citations in OpenAlex.
- [Conservative and pharmacological treatment of benign prostatic hyperplasia : The German S2e-guideline 2023-part2].Urologie (Heidelberg, Germany) · 2023Guideline
- Complementary therapies in the control of male lower urinary tract symptoms: A systematic review.Revista latino-americana de enfermagem · 2022Pooled it
- Pooled it
- Serenoa repens for benign prostatic hyperplasia.The Cochrane database of systematic reviews · 2012Pooled it
- Serenoa repens monotherapy for benign prostatic hyperplasia (BPH): an updated Cochrane systematic review.BJU international · 2012Pooled it
- Comparison ofAmerican journal of men's healthPooled it
- Efficacy and Safety ofNutrients · 2026Trial
- Management of Male Lower Urinary Tract Symptoms in a Simulated, Over-the-Counter Setting: An Exploratory Study of Tamsulosin.Drugs & aging · 2019Trial
- Huo-Luo-Xiao-Ling (HLXL)-Dan, a Traditional Chinese Medicine, for patients with osteoarthritis of the knee: a multi-site, randomized, double-blind, placebo-controlled phase II clinical trial.Osteoarthritis and cartilage · 2015Trial
- Fixed-dose combination PRO 160/120 of sabal and urtica extracts improves nocturia in men with LUTS suggestive of BPH: re-evaluation of four controlled clinical studies.World journal of urology · 2014Trial
- Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto.Journal of alternative and complementary medicine (New York, N.Y.) · 2014Trial
- Safety and toxicity of saw palmetto in the CAMUS trial.The Journal of urology · 2013Trial
- Relationships among participant international prostate symptom score, benign prostatic hyperplasia impact index changes and global ratings of change in a trial of phytotherapy in men with lower urinary tract symptoms.The Journal of urology · 2013Trial
- The effect of increasing doses of saw palmetto fruit extract on serum prostate specific antigen: analysis of the CAMUS randomized trial.The Journal of urology · 2013Trial
- Effects ofSexual medicine · 2026Review
- Article
- Pharmacological Approaches in Managing Symptomatic Relief of Benign Prostatic Hyperplasia: A Comprehensive Review.Cureus · 2023Review
- Serenoa repens for the treatment of lower urinary tract symptoms due to benign prostatic enlargement.The Cochrane database of systematic reviews · 2023Review
- Role of Phytotherapy in the Management of BPH: A Summary of the Literature.Journal of clinical medicine · 2023Review
- UPDATE - Canadian Urological Association guideline: Male lower urinary tract symptoms/benign prostatic hyperplasia.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2022Article
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
20 authors at 1 institution in 1 country.
Funding
Abstract
contextSaw palmetto fruit extracts are widely used for treating lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH); however, recent clinical trials have questioned their efficacy, at least at standard doses (320 mg/d).
objectiveTo determine the effect of saw palmetto extract (Serenoa repens, from saw palmetto berries) at up to 3 times the standard dose on lower urinary tract symptoms attributed to BPH. DESIGN, SETTING, AND
participantsA double-blind, multicenter, placebo-controlled randomized trial at 11 North American clinical sites conducted between June 5, 2008, and October 10, 2010, of 369 men aged 45 years or older, with a peak urinary flow rate of at least 4 mL/s, an American Urological Association Symptom Index (AUASI) score of between 8 and 24 at 2 screening visits, and no exclusions.
interventionsOne, 2, and then 3 doses (320 mg/d) of saw palmetto extract or placebo, with dose increases at 24 and 48 weeks.
main outcome measuresDifference in AUASI score between baseline and 72 weeks. Secondary outcomes included measures of urinary bother, nocturia, peak uroflow, postvoid residual volume, prostate-specific antigen level, participants' global assessments, and indices of sexual function, continence, sleep quality, and prostatitis symptoms.
resultsBetween baseline and 72 weeks, mean AUASI scores decreased from 14.42 to 12.22 points (-2.20 points; 95% CI, -3.04 to -1.36) [corrected]with saw palmetto extract and from 14.69 to 11.70 points (-2.99 points; 95% CI, -3.81 to -2.17) with placebo. The group mean difference in AUASI score change from baseline to 72 weeks between the saw palmetto extract and placebo groups was 0.79 points favoring placebo (upper bound of the 1-sided 95% CI most favorable to saw palmetto extract was 1.77 points, 1-sided P = .91). Saw palmetto extract was no more effective than placebo for any secondary outcome. No clearly attributable adverse effects were identified.
conclusionIncreasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo.
trial registrationclinicaltrials.gov Identifier: NCT00603304.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.