Trial reportComplementary therapies in medicine2008
A detailed safety assessment of a saw palmetto extract.
Trial report in Complementary therapies in medicine, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Complementary medicine use by men with prostate cancer: a systematic review of prevalence studies.Prostate cancer and prostatic diseases · 2011Pooled it
- Interactions between herbal medicines and prescribed drugs: an updated systematic review.Drugs · 2009Pooled it
- Serenoa repens (saw palmetto): a systematic review of adverse events.Drug safety · 2009Pooled it
- Efficacy and Safety ofNutrients · 2026Trial
- Trial
- Safety and toxicity of saw palmetto in the CAMUS trial.The Journal of urology · 2013Trial
- Trial
- Randomized double-blind controlled clinical trials with herbal preparations of Serenoa repens fruits in treatment of lower urinary tract symptoms : An overview.Wiener medizinische Wochenschrift (1946) · 2017Article
- [S2e guideline of the German urologists: Conservative and pharmacologic treatment of benign prostatic hyperplasia].Der Urologe. Ausg. A · 2016Article
- Serenoa repens extract in the treatment of benign prostatic hyperplasia.Therapeutic advances in urology · 2011Article
- Complementary and alternative medicine use by otolaryngology patients: a paradigm for practitioners in all surgical specialties.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2010Article
- Acute liver damage due to Serenoa repens: a case report.British journal of clinical pharmacology · 2010Article
- [Treatment of LUTS in BPS. When and when not to administer pills?].Der Urologe. Ausg. A · 2009Review
- IsAmerican journal of men's healthArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundSaw palmetto is commonly used by men for lower-urinary tract symptoms. Despite its widespread use, very little is known about the potential toxicity of this dietary supplement.
methodsThe Saw palmetto for Treatment of Enlarged Prostates (STEP) study was a randomized clinical trial performed among 225 men with moderate-to-severe symptoms of benign prostatic hyperplasia, comparing a standardized extract of the saw palmetto berry (160 mg twice daily) with a placebo over a 1-year period. As part of this study, detailed data were collected on serious and non-serious adverse events, sexual functioning, and laboratory tests of blood and urine. Between-group differences were assessed with mixed-effects regression models.
resultsThere were no significant differences observed between the saw palmetto and placebo-allocated participants in the risk of suffering at least one serious adverse event (5.4% vs. 9.7%, respectively; p=0.31) or non-serious symptomatic adverse event (34.8% vs. 30.1%, p=0.48). There were few significant between-group differences in sexual functioning or for most laboratory analyses, with only small differences observed in changes over time in total bilirubin (p=0.001), potassium (p=0.03), and the incidence of glycosuria (0% in the saw palmetto group vs. 3.7% in the placebo group, p=0.05).
conclusionsDespite careful assessment, no evidence for serious toxicity of saw palmetto was observed in this clinical trial. Given the sample size and length of this study, however, these data do not rule out potential rare adverse effects associated with the use of saw palmetto.
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Registered trials
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