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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). 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.-
link to Pomi-T website.
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:
Methodology
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.
Conclusions: In this cohort of men with prostate cancer managed with AS or WW this study demonstrated 6 months of Pomi-T demonstrated highly statistically significant short term favourable effect on the percentage rise in PSA compared to placebo. It was well tolerated without any significant adverse effects or concomitant drug interactions and resulted in significantly more men remaining on AS or WW avoiding the toxicities and expense of medical interventions. No change in testosterone levels occurred in men taking Pomi-T and disease seen on MRI correlated with PSA dynamics.
The PSA - MRI correlation study
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
The Tokyo Women's study The effect of a boosting phytochemical rich foods for women’s cancer survivors on arthralgia, mood and hot flushes. Yanagisawa Y et al (2021). J Nurs Women’s Health 5: 168. DOI: 10.29011/2577-1450.100068 Background
and rationale:
How
was the study conducted: The
Pomi-T supplement consisted of a vegan capsule containing 150mg whole
pomegranate fruit powder (Punica granatum) ; 30mg ground green tea leaf
(Camellia sinensis) of 5:1 extract (equivalent to 150mg of whole leaf); 150mg
whole ground turmeric; 150mg whole ground broccoli florets (brassica oleracea).
The Swiss manufacturers (Helsinn Integrative) are adherent to good
manufacturing practice guidelines and perform in-house analysis for
authenticity and purity from heavy metals and pesticides on each batch. It was
supplied free to the women volunteers by the Japanese distributor PT Plus
(Higashi Kanamachi 5-48-28, Katsushika-ku, Tokyo 125-0041, Japan). Results: There was a statistically significant improvement in mean mood scores
was 1.9 (19.96-18.06), with a paired T-test of p=0.01. Mean reduction in
hot flush score was 6.68 (38.41-31.71), with a two tailed sign test of p=
0.016. Mean reduction in joint pain, stiffness and immobility was 3.84
(25.21-21.37), with a two tailed sign test of p=0.011. In practical terms this
represented about a 10% improvement in symptoms. Positive comments from
individuals (Table.1) were received from 30 of 38 (79%) women and included an
unexpected reduction in hay fever symptoms in 8 (21%) of women. Conclusion: This open labelled study demonstrated that symptomatic women with
breast and other had a statistically significant reduction in arthralgia, hot
flushes and improved mood after consuming two capsules of Pomi-T per day.
This evaluation did not formally measure hay fever symptoms, and the
comments from the participants were spontaneous. This was not completely
unexpected, as polyphenols have previously been investigated for their
anti-allergic effect in models and in human clinical trials [97, 98]. This
evaluation took place in late spring in Japan, just before the “Cherry
Blossom” season which is associated with a higher pollen count. It
would be interesting to repeat this evaluation focusing specifically on the
effect of Pomi-T in individuals who suffer from hay fever over a similar
time period using designated formal measures of allergy symptom severity. Read more on the Pomi-T website
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Green
Tea, rich in epigallocatechin gallate, blocks ornithine decarboxylase
resulting in reduced proliferation, angiogenesis and de-differentiation in
cancer cell lines. A meta-analysis of 5000 women showed that regular consumption
had reduced breast cancer recurrence. Phase 2 studies have demonstrated reduced
PSA in prostate cancer [Mclarty, Ogunleye Porrini, Liao].
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. 
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.
Late
toxicities such as
Epidemiology
studies have linked higher intake of polyphenol-rich foods with better
