The whole food supplement rich in polyphenols Pomi-T® has been shown to have a direct anticancer effect in men with prostate cancer.
Summary of the National Cancer Research Network double-blind randomized placebo-controlled trial.
Robert Thomas 1,2,3 Madeleine Williams
Certification and quality assurance
This trial was approved by the National Ethics Committee, peer-reviewed by the National Cancer Research Institute (NCRI) Complementary Therapies Research Committee, and adopted by the National Cancer Research Network. t35> Financial support was provided by the charity Prostate Action and the Primrose Oncology Research Fund. Received no commercial funding. The randomization process was outsourced and independently audited by an external agency to ensure compliance with European Good Clinical Practice Guidelines. Data were externally audited prior to independent analysis in Cranfield University.
Other information and links about the scientific evaluation:
Financial support was provided by the charity Prostate Action and the Primrose Oncology Research Fund. Received no commercial funding.
The randomization process was outsourced and independently audited by an external agency to ensure compliance with European Good Clinical Practice Guidelines. Data were externally audited prior to independent analysis in Cranfield University.
Foods rich in polyphenols, such as pomegranate, green tea, turmeric, and broccoli, have shown anti-cancer effects in laboratory studies. In humans, observational studies have linked their intake with a lower risk of diseases related to chronic inflammation, including chronic diseases, including cancer. Concentrating these foods into a capsule is a convenient way to increase an individual's intake of polyphenols, but until now clinical studies have not firmly established these health benefits or markers of cancer progression Men with prostate cancer, managed with active surveillance (AS) or watchful waiting for PSA relapse after radical treatments, are an ideal cohort to evaluate a lifestyle intervention as they have a marker useful serum of their disease (the PSA). In addition, the interventions Medical remedies are often not indicated initially in case of relapse. Furthermore, these men seem to have a strong interest in self-help remedies, with reports indicating that 50-70% of men with prostate cancer admit to taking over-the-counter supplements.
Objectives of this study:
To determine whether a polyphenol-rich dietary pill influenced the rate of PSA progression among men treated with active surveillance or watchful waiting versus a placebo.
203 men, aged 53 to 89 years (mean 74 years), with histologically confirmed prostate cancer were evaluated in this double-blind, randomized, placebo-controlled trial. The 59% were being managed with primary active surveillance (SA) or 41% with watchful waiting (WW) with progressive PSA relapse after prior radical interventions. They were randomized to receive one oral capsule twice daily day containing a mixture of pomegranate seeds, green tea, broccoli, and turmeric or an identical placebo for 6 months. The random process produced no statistical difference in Gleason grade, body mass index ( BMI) or treatment category, although the men were slightly older in the placebo group (72 years vs. 76 years). Four men withdrew after randomisation, started androgen therapies, Therefore, they were not included in the evaluation. adistic.
Percentage increase in PSA: the median percentage change in PSA for patients in the Pomi-T group was an increase of 14, 7% (95% CI: 3.4%-36.7%), compared to an increase of 78.5% (95% confidence interval: 48.1%-115.5%) for patients Median PSA increased at a significantly slower rate in the Pomi-T group compared to men taking placebo (63.8% ANCOVA difference, p = 0.0008 ).
Percentage of men who had a stable or lower PSA at the end of the study: At the end of the trial, the number of men with stable or lower PSA was 61 (46%) in the Pomi-T group, compared to 9 (14%) in the placebo group. This difference was statistically significant (Chi-square value with 1 degree of freedom = 19.58, p=0.000010).
Percentage of men in whom Pomi-T prevented a change in management: One hundred fourteen (92.6%) men in the Pomi-T group continued with surveillance or WW at the end of their participation in the study, compared to 38 (74%) in the placebo group. This difference of 18.6% was statistically significant (p=0.01)
Subgroup analysis: there was no significant difference in the median change in PSA from baseline to 6 months in the Pomi-T or placebo group between any of the predetermined subgroups (BMI, Gleason grade, age, or treatment category). There were no significant differences at the beginning or end of the study between subgroups for measures of cholesterol, blood pressure, serum glucose, or C-reactive protein.
Side Effects, Safety and Drug Interaction: Pomi-T was well tolerated and no central nervous system symptoms such as agitation were reported , insomnia, or tremors. None of the men taking warfarin reported unexpected changes in INR or blood pressure while taking ramipril. 12% of the men in the Pomi-T group and 4.6% of men in the placebo group reported positive effects; 24% of men in the Pomi-T group and 34% of men in the placebo group reported adverse events; Gastrointestinal events, considered separately, were reported by 15.5% of men in the Pomi-T group compared with 7.5% of men in the placebo group.
In this study, men taking the complete food supplement (Pomi-T) were shown to have a significantly lower mean percentage increase in PSA compared to men taking a placebo (P<0 .0001). The difference in percent increase in PSA between these groups from the beginning to the end of the study was large (63.8%); and since the characteristics of patients were well balanced and the trial had sufficient numbers to ensure adequate statistical power, the results of this study offer clinically meaningful guidance for men considering nutritional supplementation after prostate cancer. Future Trials they will look at continuing the intervention longer and will include men with different stages of the disease.