"This difference is statistically significant."
This study involved > 200 men in a randomized, double-blind, controlled, Phase II clinical trial. All patients received either an oral capsule containing the food supplement twice a day or they received an identical placebo. Here are the early trial results:
- 203 men diagnosed with localized prostate cancer were enrolled into the trial.
- The average age of the patients was 74 years.
- 59 percent were being managed with active surveillance.
- 41 percent were being managed with watchful waiting (progressive PSA relapse following previous radical interventions).
- The patients were randomized into two groups (to receive either the food supplement or the placebo).
- The groups were statistically balanced in terms of Gleason grade, body mass index (BMI), treatment category, and fasting cholesterol.
- Men in the food supplement group were younger (average age 71.8 years) than men in the placebo group (average age 76.4 years).
- Four men withdrew from the study after randomization.
- The average (median) change in PSA levels of men in the two groups at 6 months was:
- +14.7 percent for the men receiving the food supplement
- +78.5 percent for the men receiving the placebo
- This difference is statistically significant.
- At 6 months, stable or lower PSA levels were observed in
- 46 percent of men receiving the food supplement
- 14 percent of the men receiving the placebo.
- This difference is statistically significant.
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