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Randomized, double-blind, placebo-controlled crossover study in men with prostate cancer and rising PSA: effectiveness of a dietary supplement.
Plain-language guide to PMID 16263208 (2005): double-blind randomized controlled trial in 49 patients.
Key Facts
- PMID
- 16263208
- Journal
- European urology
- Year
- 2005
- Study type
- Randomized Controlled Trial
- Authors
- Schröder FH et al. (8 authors)
- DOI
- 10.1016/j.eururo.2005.08.005
What This Study Did, in Plain Language
What Was Tested
Researchers studied the intervention named in the title in this randomized controlled trial publication.
Who Took Part
The abstract describes 49 patients taking part.
PubMed indexes the participants as adults, middle-aged adults and older adults, men only.
49 patients with a history of prostate cancer and rising PSA levels after radical prostatectomy (n = 34) or radiotherapy (n = 15) participated in a randomised, double-blind, placebo-controlled crossover study of a dietary supplement.
Treatment periods of 10 weeks were separated by a 4-week washout period.
How the Study Was Run
The researchers set it up as a randomized, double-blind, placebo-controlled and crossover study.
Random assignment meant chance, not the researchers, decided who got the intervention named in the title and who got the comparison, which limits bias.
As a double-blind study, the assignments were hidden from both participants and investigators until the end.
A placebo (an inactive look-alike) gave the intervention group a baseline to be compared against.
Each person switched between the intervention named in the title and the comparison at some point, usually with a gap in between.
Ethical approval of the protocol was obtained.
The supplement consisted of soy, isoflavones, lycopene, silymarin and antioxidants as main ingredients.
Analyses according to intention to treat (ITT) and per protocol (PP) were carried out.
What Was Measured
Topics PubMed links to this paper include Age Distribution, Biomarkers, Tumor, Brachytherapy, Dietary Supplements, Disease Progression, Incidence and Neoplasm Recurrence, Local.
What This Means in Plain Language
The paper is a randomized, double-blind and placebo-controlled study in 49 patients.
The abstract goes on to report its results in about 8 sentences; this page does not restate them, so read the paper for the findings and their limits.
The publication is from 2005 (European urology), a journal based in Switzerland.
More context: all human trials.
Related Pages
Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.