ArticleClinical trials (London, England)2009
Redesigning a large-scale clinical trial in response to negative external trial results: the CAMUS study of phytotherapy for benign prostatic hyperplasia.
Article in Clinical trials (London, England), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00603304 (Complementary and Alternative Medicine for Urological Symptoms), which is not on this map. Cited by 9 papers.
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
9 citing papers in PubMed, 24 citations in OpenAlex.
- 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
- 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
- Trial
- Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia.Journal of alternative and complementary medicine (New York, N.Y.) · 2011Trial
- Serenoa repens for the treatment of lower urinary tract symptoms due to benign prostatic enlargement.The Cochrane database of systematic reviews · 2023Review
- Determination of the potency of a novel saw palmetto supercritical CO2 extract (SPSE) for 5α-reductase isoform II inhibition using a cell-free in vitro test system.Research and reports in urology · 2016Article
- [Phytotherapy of benign prostate syndrome and prostate cancer: better than placebo].Der Urologe. Ausg. A · 2012Article
- LUTS and sleep disorders: emerging risk factor.Current urology reports · 2012Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 15 institutions in 2 countries.
Funding
Abstract
backgroundBenign prostatic hyperplasia (BPH), a common condition among older men, confers its morbidity through potentially bothersome lower urinary tract symptoms. Treatments for BPH include drugs such as alpha-adrenergic receptor blockers and 5-alpha reductase inhibitors, minimally invasive therapies that use heat to damage or destroy prostate tissue, and surgery including transurethral resection of the prostate. Complementary and alternative medicines are gaining popularity in the US. Two phytotherapies commonly used for BPH are extracts of the fruit of Serenoa repens, the Saw palmetto dwarf palm that grows in the Southeastern US, and extracts of the bark of Pygeum africanum, the African plum tree. PURPOSE: The objective of the Complementary and Alternative Medicines for Urological Symptoms (CAMUS) clinical trial is to determine if phytotherapy is superior to placebo in the treatment of BPH.
methodsCAMUS was originally designed as a 3300-participant, four-arm trial of S. repens, P. africanum, an alpha-adrenergic blocking drug, and placebo with time to clinical progression of BPH, a measure of long-term efficacy, as the primary endpoint. Before enrollment started, a randomized, double-blind, placebo-controlled, single institution clinical trial showed that S. repens at the usual dose did not demonstrate any benefit over placebo with respect to symptom relief at 1 year. Consequently, the focus of CAMUS shifted from evaluating long-term efficacy to determining if any short-term (6-18 months) symptom relief could be achieved with increasing doses of S. repens, the phytotherapy most commonly used in the US for BPH.
resultsResults are anticipated in 2011.
conclusionsTrial design occurs in an environment of continually evolving information. In this case, emerging results from another trial suggested that a study of long-term efficacy was premature, and that an effective dose and preparation of S. repens had to be established before proceeding to a long-term clinical trial.
Indexed as
Identifiers
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.