The effect of a polyphenol rich food supplement (Pomi-T) intake for women’s cancer survivors on arthralgia, mood and hot flushes.
A pilot real World evaluationLink 

Yanagisawa Y et al (2021). J Nurs Women’s Health 5: 168.
DOI: 10.29011/2577-1450.100068

Depart of Internal Medicine Bedford Hospital;
The Primrose Lifestyle Research Unit, Bedford Hospital;
College of Liberal Arts, International Christian University, Tokyo;
School of Maths & Stats, Business School City, University of London.
Cambridge University NHS Hospitals:
Department of Biological and Exercise Science Bedfordshire University. 

 



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Summary of trial


Background and rationale:
Late toxicities such as arthritis, low mood, nail changes and hot flushes are common after breast, other women’s cancers and after menopause in general [1-4].  As well as causing discomfort impacting quality of life, persistent arthralgia can  compromise the effectiveness of adjuvant therapies by reducing compliance to hormone treatment  [5]. Discontinuation rates of hormone therapies such as tamoxifen and aromatase inhibitors have been recognised  in up to 30% of women suffering from arthralgia and stiffness [3, 4,5, 6]. Poor adherence to AI therapy has also been associated with worse disease-free and overall survival from breast cancer [7]. In addition, arthritis can significantly  impact patients ability to exercise, which  can lead to an exacerbation of further  symptoms and complications  associated with  cancer [8-9]. In particular, regular exercise can mitigate  the risks of weight gain, hot flushes, fatigue, peripheral neuropathy, erectile function, arthritis itself and osteoporosis, as well as improve  mood and sleep patterns [6, 8, 10-11]. Restricted mobility may have even more sinister consequences for patients, as cohort studies have consistently linked a reduced relapse rate and improved survival benefit amongst those able to be physically active after several different types of cancer, including breast cancer [8, 12-16].

Epidemiology studies have linked higher intake of polyphenol-rich foods with better gut health mood and less arthritis. Lab studies show these foods reduce intra-articular inflammation and oxidative stress,  allowing greater mobility although, up until now, clinically relevant, intervention studies in humans have been lacking. A whole food nutritional supplement can be a convenient way to boost intake of polyphenol-rich foods and ensure sustained  intake throughout the day [1, 39-43]. For this study the OTC supplement Pomi-T was selected given that  it has demonstrated a high safety profile in a randomised trial in which participants also reported improvements in joint discomfort [1, 43]. Pomi-T also contains no phytoestrogenic polyphenols, which may potentially would have beena concern post breast cancer.

How was the study conducted:
This was an open label evaluation of a polyphenol-rich whole food supplement (Pomi-T) supplied to volunteer members of a Japanese Women’s Cancer Support Group, Tokyo. Joint discomfort, mobility, mood and hot flushes were recorded at baseline and after 2 months Pomi-T using validated peer reviewed questionnaires. 38 of 44 (87%) completed pre and post forms (average age 48, range 26-62 years).

pomi-t womenThe 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.

Arthritis: Reassuringly these confer with suggested improvement in joint pains in the original Pomi-T study involving men. This pilot study has provided sufficient encouragement and justification to proceed to a confirmatory robust double-blind, randomised control trial. In the mean time Pomi-T is certainly a practical, safe, natural, dietary option for individuals with these troublesome symptoms.

Further research:
The next trial will also evaluated whether improving mood and alleviating joint discomfort will allow and motivate more men and women to exercise in comfort, more frequently – which will reap even greater short and long term health benefits.

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Table.1 Positive comments women made during this real World evaluation

1: The stiffness in my fingers in the morning seemed to be abated. Normally there is pain in my knee joints which makes climbing stairs a trial but this helped to the extent that I did not feel much pain and could get up the stairs easier. This supplement helped my hay fever symptoms, I did not need to take any associated medicine. I had a general uplift in my feelings and physical situation.

2:  I had the feeling that my symptoms of hay fever were reduced.

3: The packaging is good and the capsule effective; Felt better in myself. I felt less dropping in my feelings and I did not get irritated as much. Felt less pain in my joints, felt a lightening of may allergy to house dust and a reduction in tendency to hot flushes. Felt less exhausted than normal. In general I was less irritable, and in certain joints I had less pain.

4: The size of the capsule is a little large. There was no change in my occurrence of hot flushes. There seemed to be no change in my general condition whilst taking the supplement.

5: It seemed to help with my shortness of breath. I seemed to have a better general skin condition whilst taking the supplement.

6: I had the feeling that hot flush severity was reduced but it was difficult to judge.

7: I noticed on my morning run that the pain in my legs was reduced.. The capsule is large, the size should be reduced or it should be packed in an easier digestible manner.

8: Whilst taking the supplement I noticed a reduction in the occurrence of hot flushes.

9: During the night I often get hot flushes and it is uncomfortable, I have the feeling that with taking Pomi-t that the symptoms have become somewhat lighter; I had a reduction in feeling stress when I took Pomi-T and a general increase of feel in wellbeing.

10: There was a reduction in hot flushes.; I also felt a reduction in joint pains; Pomi-T helped reduce my anxiety level and increased my feeling of wellbeing.

11: Whilst taking Pomi-t I felt  a decrease  intensity of my hot flushes; Taking Pomi-T, my toilet function became regular and good. I did get any relief from my joint pains and I found the capsule a bit large.

12: I noticed after taking Pomi-T for a few days that I had an alleviation of the tendonitis in both my little fingers, now I they feel almost fully alleviated. I also had some discomfort in my elbow and knee joints but this also seems to have alleviated. I don’t know if it was an effect of the supplement but also my hay fever/ house dust  symptoms this season somewhat alleviated.

13: My hay fever symptoms seemed better and my mood was more stable when I took Pomi-T. There are only good things in Pomi-T so I feel surely in the product. The capsule is large and difficult to swallow, a smaller size is better.

14: At first, I did not notice any benefits but after one month I noticed that the occurrence of hot flushes decreased. When I climb stairs I have pain in my right knee joint but this also seems to have somewhat reduced since taking Pomi-T. It does not seem to have helped my headaches. It does seem to have helped with the sensation of coldness that I used to have in my ankles.

15: After a certain length of time taking Pomi-T I noticed an alleviation in certain joint pains.

16: Two weeks after taking this I had an improvement in my hot flushes but this may have been due to other factors. I felt benefits from the supplement after getting over the hot flush period.

17: During the middle of April, my stomach swelled up and I had discomfort so I stopped taking Pomi-T. After stopping Pomi-T I did notice an increase in the frequency of my hot flushes.

18: I noticed a real decrease in the pain level in my thigh joints. In general, I noticed a decrease in pain in my joints, I was taking certain drugs but the pain lowering seemed significant, I am considering to take Pomi-T.

19: It seemed to help my back pain a little.

20: It seemed to help a little with my hay fever symptoms.

21: In the first month I did not notice any discernible effects but after a month or so I noticed some improvement in the lines and skin condition around my eyes.

22: It seems to help alleviating pain in my wrist and some hay fever symptoms. After stopping Pomi-T I noticed that I had more pain in my joints again.

23: It seemed to alleviate my hot flushes severity.

24: My hay fever this year did not seem so severe.

25: It seemed to help improve my constipation. It seemed to help me be less exhausted.

26: It seemed to help alleviate my hot flush syndrome and my hay fever symptoms.

27: I had an improvement in general feeling. My hot flushes seemed to be much lighter than previously; the numb feeling in my legs also seemed to improve.

28: I seemed to get an improvement in my skin tone.

29: I noticed increased flexibility in my joints, getting up in the morning and when getting up from a chair. I noticed a reduction in the number and severity of hot flushes and an upward swing in attitude and feeling of wellbeing.

30: I noticed during the course of taking the supplement that my normal weak hot flushes did not occur and I also noticed that my discomfort in certain joints did not happened.


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