This randomised controlled trial has now completed. The results were announced as a full oral presentation at the world's largest and most prestigious cancer conference ASCO in 2013. The full paper was published in a Nature Journal in 2014. In 2016, a further trial was conducted and published which confirmed the very low progression of PSA in men taking Pomi-T on surveillance but also confirmed that this correlated with underlying control of disease seen on MRI (read second paper).
Further studies involving this supplement are planned in men with more advances prostate cancer, to help urinary symptoms in men with benign disease and help prevent or relieve arthritis in women on hormone therapies. In the mean time the manufacturers who supplied this supplement for this trial have now made it available to the public - link to Pomi-T website.
The supplement used in this trial had the highest practicable quality assurance, including specific test for authenticity, purify and lack of heavy metal or bacterial contamination of the ingredients. In addition, an independent academic body performed mass spectrometry to ensure no unexpected additives were present. The original manufacturers agreed with the clinical trials committee to continue this high quality assurance programme but unfortunately unregulated copies have since appeared on some UK and international websites. If you are interested in taking Pomi-T we recommend you refer to the original regulated website and avoid discount stores which may not adhere to the same quality assurance.
Background to the study
An increasing numbers of published studies have linked polyphenols, the natural plant based phytochemicals found in healthy foods, with a lower risk of chronic illnesses such as dementia, arthritis, skin aging, macular degeneration and more recently cancer [Rezai-Zadeh], [Maclarty]. Women with early breast cancer taking higher than the recommended “5 a day” amount of fruits and vegetable have been found to lower their risk of recurrence risk by one third especially if combined with physically activity [Pierce 2009]. Breast cancer recurrence has been demonstrated to be lower amoung women regularly drinking green tea [Ogunleye 2010] or eating foods rich in dietary lignans [Buck 2011], isoflavones and flavanones [Boyapati 2005]. A full scientific review of the evidence for polyphenols and cancer has been conducted by the trials team and can be downloaded free.
Although the benefits of boosting the diet with polyphenol rich whole food supplements for individuals with cancer have been investigated in small phase II studies, they have rarely been evaluated within an adequately powered Randomised Controlled Trials. For this reason, the UK’s government’s clinical trials design committee decided to set up a national trial to investigate whether there are any anticancer benefits. These committee green tea, broccoli, turmeric and pomegranate of chose these foods as they originate from separate categories (spice, herb, fruit, vegetable), hypothesising that their diverse polyphenol profile would have synergistic action whilst avoid accumulation of one particular phytochemical. Each ingredient has also demonstrated anti-oxidant activity, protecting cells from carcinogenic exposure, as well as direct anti-neoplastic activity within previous laboratory or phase II trials:
Two hundred and three men, aged 53-89 yrs (average 74 yrs), with prostate cancer (95% Gleason 6/7, 5% >7), 59% managed with primary active surveillance or 41% with watchful waiting (WW) with a progressive PSA relapse following previous radical interventions were randomised to receive a Pomi-T or an identical placebo for 6 months. The randomised process produced no statistical difference in baseline characteristics except the placebo group were slightly older which, if anything would be more advantageous to the placebo group. The power calculation and independent statistical analysis took place at Cranfield University and men were recruited from across the UK. Enthusiasm to enter the study was overwhelming. The trials team completed the quota 10 months ahead of schedule (see graph).
Quality assurance: This non commercial academic trial received peer reviewed sponsorship from Prostate Action, was designed by NCRI Complementary Therapies Research Committee, adopted by the UK’s NCRN and independently audited to ensure it adherence to European Good Clinical Practice Guidelines. The manufacturers performed in house analysis to ensure authenticity and purity and a further independent mass spectrometry was performed to confirm purity. Statistical evaluation was independent to the trials unit.
Results: Two men from each group men withdraw before the first 3 month evaluation. of the remaining 199 men, the median rise in PSA in the Pomi-T was 14.7% (95% CI 3.4-36.7%) v 78.5% in the PG (95% CI 48.1-115.5%). This difference of 63.8% was significant (ANCOVA p=0.0008). 18.6% more men stayed off interventions at the end of the trial in the Pomi-T group. There was no significant difference between any of the pre-determined subgroups.
Secondary end points: There was no effect on average serum sex hormone analysis: Testosterone 13.4 nmol/l (nr 9-29) FSH 9.2 iu/l (nr 2-12), LH 7.4 iu/l (nr 2-9) There was no effect on cholesterol, INR or BP amoung men taking warfarin or ramipril. MRI scans, taken routinely as part of their AS protocol, were retrospectively evaluated. 35% had no visual disease, 15% had progressive disease with significant rises in PSA (removed from trial) 50% had visual disease with no progression, no man remaining on Pomi-T had MRI defined progression. There was a 14% difference in urinary symptoms (mainly urgency) and a 6% difference in joint pains although these two endpoint were not predetermined in the statistical plan so need further varification.
Further information on the post trial availability of this nutritional supplement:
Pomi-T® was manufactured in the UK for the study supplied to the trial centres in blank bottles together with an identical placebo pills. The trial centre has no legal or official connection to suppliers of Pomi-T® outside the parameters of this study. The committee of this trial as advised that we signpost where individuals can find more information on Pomi-T® .
Pomi-T® is classed as a food supplement not a drug so it is available over the counter. After the trial was completed and published manufacturing was changed to a Swiss / Italian factory. It is still made from natural purified ingredients, to the highest quality assurance standards and EU compliance regulations. The international distribution rights for Pomi-T are owned Helsinn Integrative Health.
A second evaluation has taken place involving men who have continued to take pomi-t post trial. It specifically addressed the issue of of whether PSA correlated with underlying changes in Cancer size seen on MRI. It involved men followed for up to 2 years on active surveillance.
The results, as shown in the adjacent picture, should a 100% correlation between PSA and underlying disease indicating that the PSA effect on the main Pomi-t trial was unlikely to be just a chemical effect but related to actual prostate cancer itself - read full paper
The trials team has now designed a RCT evaluating a polyphenol rich nail balm with the aim of reducing chemotherapy induced nail damage this trial is underway - read more.
The team has also performed two evidence reviews summarising the evidence for polyphenols and exercise. A further evidence review examining the Biology of exercise has been write with Coventry University and Stacey Kenfield from the University f South California and been published in the British Journal of Sports medicine and is available to read here.
The trials unit are moving on to evaluate the evidence for a polyphenol rich supplement to improve arthritis and exercise levels. In the mean time they have successfully designed and conducted a double blind randomised trial of a polyphenol rich nail balm to stop distressing chemotherapy associated nail damage. This trial known as the polybalm study has been published in ASCO 2017.... read more
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