Pomi-T vs Pom Juice

[Teufelshunde]

I take 1 cup of Pom Juice most days based on the study attached. Doesn't taste great but I mix it with 1/2 c of Beet Juice. All organic. I have seen some talk about using the supplement Pomi-t. When I read the studies, too my non-scientific brain, it certainly looks like Pom Juice is the better of the two. However, not sure what all the P values mean, etc. I was hoping some of the science greats in the group can give me insight as to what shows better based on these. Trying to keep the BCR away if possible. Any help is appreciated. See below.

POMI-T

Methods

The researchers recruited 203 men aged 53 to 89 years with prostate cancer proven by biopsy. 59% of the men had not yet undergone any treatment and were being followed closely with periodic PSA tests (Active surveillance), while 41% had already had a radical intervention (radiotherapy or surgery and radiotherapy) but had relapsed with significantly climbing PSA levels. Men were randomly assigned to receive either the twice-daily oral capsule containing a blend of purified, polyphenol-rich whole foods, or a similar-looking placebo for 6 months. At baseline, there were no significant differences between the two groups. Neither the doctors supervising the trial, the men involved or statisticians analysing the data knew which men were taking a placebo or the Pomi-T.

Results

Percentage rise in PSA: The median percentage change in PSA for patients in the Pomi-T group was a rise of 14.7% (95% CI 3.4%-36.7%), compared to a rise of 78.5% (95% confidence interval 48.1% -115.5%) for patients in the placebo group. The median PSA increased at a significantly slower rate in the Pomi-T group compared to men taking a placebo (difference of 63.8% ANCOVA, p=0.0008).

Percentage of men having a stable or a lower PSA at the end of the study: At trial completion, the number of men with a stable PSA or a lower PSA was 61 (46%) in the Pomi-T group, compared to 9 (14%) in the placebo group. This difference was statistically significant (Chi-squared value with 1 degree of freedom = 19.58, p=0.000010).

Percentage of men in whom Pomi-T prevented a change in management: 114 (92.6%) men in the Pomi-T group continued surveillance or WW at the end of their involvement in the study, as opposed 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 either the Pomi-T or placebo group between any of the pre-determined subgroups (BMI, Gleason grade, age or treatment category). There were no significant differences at the beginning or end of the study between the subgroups for measures of cholesterol, blood pressure, serum glucose or C-reactive protein.

Conclusions

In this study, it was shown that men taking the whole food supplement (Pomi-T) had a significantly lower median percentage rise in PSA compared to men taking a placebo (P<0.0001). The difference in percentage rise in PSA between these groups from the start to end of the study was large (63.8%), and as the patient characteristics 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 contemplating nutritional supplements after prostate cancer. Future trials will look at continuing the intervention for longer and include men with different stages of the disease.

POMEGRANITE JUICE

Purpose: Phytochemicals in plants may have cancer preventive benefits through antioxidation and via gene-nutrient interactions. We sought to determine the effects of pomegranate juice (a major source of antioxidants) consumption on prostate-specific antigen (PSA) progression in men with a rising PSA following primary therapy.

Experimental design: A phase II, Simon two-stage clinical trial for men with rising PSA after surgery or radiotherapy was conducted. Eligible patients had a detectable PSA > 0.2 and < 5 ng/mL and Gleason score < or = 7. Patients were treated with 8 ounces of pomegranate juice daily (Wonderful variety, 570 mg total polyphenol gallic acid equivalents) until disease progression. Clinical end points included safety and effect on serum PSA, serum-induced proliferation and apoptosis of LNCaP cells, serum lipid peroxidation, and serum nitric oxide levels.

Results: The study was fully accrued after efficacy criteria were met. There were no serious adverse events reported and the treatment was well tolerated. Mean PSA doubling time significantly increased with treatment from a mean of 15 months at baseline to 54 months posttreatment (P < 0.001). In vitro assays comparing pretreatment and posttreatment patient serum on the growth of LNCaP showed a 12% decrease in cell proliferation and a 17% increase in apoptosis (P = 0.0048 and 0.0004, respectively), a 23% increase in serum nitric oxide (P = 0.0085), and significant (P < 0.02) reductions in oxidative state and sensitivity to oxidation of serum lipids after versus before pomegranate juice consumption.

Conclusions: We report the first clinical trial of pomegranate juice in patients with prostate cancer. The statistically significant prolongation of PSA doubling time, coupled with corresponding laboratory effects on prostate cancer in vitro cell proliferation and apoptosis as well as oxidative stress, warrant further testing in a placebo-controlled study.

[Jancapper]

cancer.gov/about-cancer/tre...

[Tall_Allen]

There is only one ingredient in Pomi-T that has not been disproven - sulforaphane. I suggest you just use that.

You seem to ignore the randomized controlled trial that proved pomegranate juice was ineffective:

nature.com/articles/pcan201532

[Teufelshunde in reply to Tall_Allen]

Thanks and I took a look at that. My unscientific but logical mind sees a benefit in that study for pom juice but not pom extract. Then I look at the study I posted, and although no placebo group, something good did happen, and even if PSADT results dont fit the RTC model, I see the below which adds evidence of good things, doesnt it? Comparing before and after from the people shows improvement. I also like the increase in NO. WIth organic juice I dont have to worry about bad things. Thanks for your input.

In vitro assays comparing pretreatment and posttreatment patient serum on the growth of LNCaP showed a 12% decrease in cell proliferation and a 17% increase in apoptosis (P = 0.0048 and 0.0004, respectively), a 23% increase in serum nitric oxide (P = 0.0085), and significant (P < 0.02) reductions in oxidative state and sensitivity to oxidation of serum lipids after versus before pomegranate juice consumption.

[Tall_Allen in reply to Teufelshunde]

Unfortunately, logic is useless for making medical decisons. Only empirical evidence is useful. I guess you didn't read the article I provided which proved that PSADT is useless. Lab studies are also useless. You may understand why I say these things if you read this:

prostatecancer.news/2022/07...

[Purple-Bike in reply to Tall_Allen]

The first study you linked to show there is no statistical difference between the three groups, as per the quote below, P>0.05. However, for those like me who are open to having a go at a range of substances for which there is only weak, <0.05 evidence, the juice could be interesting. Doubling time was almost double that of the placebo. Together with data from other studies, pome juice just "might" be effective. Going for a barrage of substances, each with weak evidence and with little downside. might yield a couple or more of them actually providing benefit, IMHO.

From the study linked by TA: One-hundred eighty-three eligible subjects were randomly assigned to the active and placebo groups with a ratio of 2:1 (extract N=102; placebo N=64; juice N=17). The majority of adverse events were of moderate or mild grade. Median PSADT increased from 11.1 months at baseline to 15.6 months in the placebo group (P0.05).

[Purple-Bike in reply to Purple-Bike]

The rest of the quote: Median PSADT increased from 11.1 months at baseline to 15.6 months in the placebo group (P0.05).

[Purple-Bike in reply to Purple-Bike]

For some reason the whole quote didn´t get sent I try again.

One-hundred eighty-three eligible subjects were randomly assigned to the active and placebo groups with a ratio of 2:1 (extract N=102; placebo N=64; juice N=17). The majority of adverse events were of moderate or mild grade. Median PSADT increased from 11.1 months at baseline to 15.6 months in the placebo group (P0.05). Placebo AA patients experienced a 1.8 month change in median PSADT from 10.9 months at baseline to 12.7 months (P=0.22), while extract patients experienced a 12 month change in median PSADT from 13.6 at baseline to 25.6 months (P=0.03).

[Tall_Allen in reply to Purple-Bike]

This gets to why such studies are done. As in the preliminary study (with no control group) or lab studies, the idea is to screen out substances, and find those that merit further study. They are not powered (have sufficient sample size) to detect the degree of benefit, only a yea or nae on whether there is any benefit at all. There was none (you are violating all rules of statistical inference in your analysis). In fact, 90% of small studies like this, even when they do do show a benefit, later show no benefit when tested on a larger sample. You can see why screening is very important - it saves a lot of wasted time and costs.

The Resnicks, who own Pom Wonderful, funded the research, and were very keen to show there was a benefit. I wondered, at the time, why they even bothered doing a study with no control group. I think they were trying to dupe patients (based on these posts, they are still succeeding). The FTC agreed:

The Verdict: POM Wonderful Misled Its Customers, A Blow To Its Billionaire Owners

May 2, 2016

Can pomegranate juice POM Wonderful and POMx supplements treat, prevent or reduce the risk of heart disease, prostate cancer or erectile dysfunction? According to the Federal Trade Commission and a decision by a U.S. federal court, the short answer is no. The slightly longer answer, as decreed by the FTC is this: The company that makes POM cannot state such claims in advertising. On Monday, the U.S. Supreme Court declined to review the court ruling that upheld the FTC decision, which found POM and its owners had misled consumers in advertising their products.

The Supreme Court's decision not to hear the case is a big blow to Stewart and Lynda Resnick, the billionaire couple behind Pom Wonderful. Their Wonderful Company also sells Fiji Water, branded pistachios and almonds, and more. It has poured millions of dollars into researching the potential health effects of its 100% pomegranate juice and pills since launching POM Wonderful in 2002. Stewart Resnick, who survived prostate cancer several years ago, drinks 8 ounces of POM Wonderful and takes a pomegranate pill every day. In a Forbes Magazine feature published in November, Stewart told Forbes how he hasn’t had a cold in a decade. Last summer, the 77 -year-old cycled about 40 miles a day across Italy during a nine-day bike trip. Stewart told Forbes in the fall that the company was expecting to soon release positive results from human trials.

Steven Clark, vice president of corporate communications for The Wonderful Company, said in a statement Monday afternoon that POM Wonderful is committed to "honest, transparent communication with consumers everywhere," pointing to the fact that the FTC questioned just 36 of the company's about 600 ads. "We continue to stand behind our efforts to publicly convey valuable information about the health benefits of POM, as well as the $40 million in peer-reviewed, scientific research we’ve conducted regarding the power of this amazing fresh fruit," he said.

Some history: The FTC filed a complaint in 2010 that the Resnicks’ POM Wonderful had used deceptive advertising when marketing the antioxidant-rich drink as being able to treat, prevent or reduce the risk of heart disease, prostate cancer and erectile dysfunction. In 2012 a federal judge agreed that some of the ads were misleading. In 2013 FTC commissioners denied the Resnicks’ appeal. In January, the Court of Appeals for the District of Columbia Circuit also affirmed the FTC's decision. In October the Resnicks asked the Supreme Court to take the case.

The FTC cease and desist order requires POM’s "future disease treatment and prevention claims to be supported by at least one randomized, well-controlled human clinical trial, and other health benefit claims to be supported by competent and reliable scientific evidence," according to a statement from the FTC.

FTC Chairwoman Edith Ramirez lauded the Supreme Court's decision in a statement issued on Monday. “I am pleased that the POM Wonderful case has been brought to a successful conclusion,” Ramirez said. “The outcome of this case makes clear that companies like POM making serious health claims about food and nutritional supplement products must have rigorous scientific evidence to back them up. Consumers deserve no less.”

Forbes estimates that Stewart and Lynda are worth a combined $4.2 billion.

...

[Purple-Bike in reply to Tall_Allen]

This is a damning account of the owners of Pom Juice and funders of the research.

Right, the randomized placebo-controlled trial did not show statistically significant difference in the increase in PSADT between pomi juice and controls, and so there is no rationale to carry on into larger trials.

That said, don´t you think a case be made for someone who is willing to take the limited chance that the non-statistically significant increase in PSADT for pomi juice compared to placebo might actually be a real benefit? Basing this decision, together with other admittedly not strong evidence, on the small chance of getting a huge payoff in preventing recurrence of this terrible disease.

[Tall_Allen in reply to Purple-Bike]

No. That is NOT what the statistics show. It doesn't show there is a small benefit, it shows no benefit. It is a common misinterpretation of p values. A p>0.5 means that the null hypothesis is accepted. The null hypothesis is that there is no effect of pomegranate juice on prostate cancer. That means that the observed change in PSADT would have been observed if the null hypothesis is true. Pomegranate juice has no effect on prostate cancer. It is just a way for the Resnicks to make more money by duping patients.

If you believe based on your intuition that the data are wrong, then you are practicing pseudoscience.

[Purple-Bike in reply to Tall_Allen]

I get it. P = 0.049 can mean weak evidence, but P = 0.051 means the null hypothesis is accepted. In my layman´s mind the difference between the two is not huge and I happen to have just made a reply on another study, with P=0.051 calling it "weak evidence" but thanks to you added "science says no evidence".

In the Resnick study, p may have been much higher than 0.05. Scientifically there is no difference in both the null hypothesis is accepted.

[Tall_Allen in reply to Purple-Bike]

Even p=0.05 is probably too high. Many top statisticians think it should be set a factor of 10 lower to 0.005. Remember, the goal is to have find drugs/supplements that will reproduce what the patients can expect.

nature.com/articles/s41562-...

P=0.5092 in the Pantuk/Resnick trial, which was not even close. But perhaps you will find this trial more convincing (p=0.83)

jcancer.org/v04p0597.htm

[Purple-Bike in reply to Tall_Allen]

The first paper illustrates that sharpening p to 0.005 will mean a much lower rate of false positives, which have become common. It proposes that p between 0.05 and 0.005 be labelled "suggestive", rather than significant. It restricts the recommended sharpening to claims of discovery of new effects, not for confirmatory or contradictory replications of existing claims.

This seems most reasonable. I may still be interested in trials with higher p numbers, but will be aware of their strong limitations.

There may be other papers with other results, but the second paper is a phase 2b RCT and makes clear that in this study there is no effect from pomegranate juice, at least in the short term. One´s gut feeling obviously says the same thing as the absurdly high p number, 0.83.

"PSA progression within the first four weeks was observed in 41% in the control group compared to 38% in the pomegranate group (p=0.83). There were no responses with PSA decline >50% in either group, but 1 patient in the placebo group and 3 patients in the pomegranate group showed a decline ≥30% (Table 2A). In the second period of the study, when all patients consumed 250 ml of PJ, PSA progression was observed at a rate of 24% in the former placebo group and 29% in those patients that had been given 500 ml PJ in the first period (group B), (p=0.63, Table 2A)".

[Irun]

since advanced diagnosis 8 years ago I have been having both pomegranate juice and initially Pomi-T (plus match green tea, cumin and broccoli ) daily . I took the view that they are all good for you in general and there was a bit of anecdotal evidence that they may help my situation.

I only took 1 Pomi-T as I was also having all the constituent parts in natural form .

Pomi -T has risen in price considerably and I then discovered Pro Phenol , has exactly the same ingredients as Pomi-T plus cloves and peppermint which again in my view do no harm but Pro Phenol is half the price of Pomi-T .

Until there is evidence that the above is bad for me I will carry on with what I do but write this more as a money saver for others (I have no involvement in Pro Phenol apart from buying it off Amazon and taking it btw)

[Teufelshunde in reply to Irun]

Makes sense. I guess I already take BROQ (sulforaphane), curcumin, EGCG so juice looking more like the correct choice for me.

[brilliant17 in reply to Teufelshunde]

Thanks for sharing. How do I consume sulforaphane by itself? Is this a liquid or a pill? And can someone clarify for me the acronym EGCG? Thank you in advance.

[Teufelshunde in reply to brilliant17]

A pill. Go to broq.life or Amazon and search BROQ. EGCG is basically a green tea extract. Google EGCG for more.

[tn12 in reply to brilliant17]

You can grow broccoli sprouts yourself and avoid the unknown in pill form.

[Teufelshunde in reply to tn12]

Actually it is exactly the opposite. Broq was tested in a clinical trial and the results speak for themselves. Have seen no study on sprouts and no data on dosage that would equate to what worked in the study, but maybe that info is out there.

[tn12 in reply to Teufelshunde]

Study on sprouts? That's where the sulforaphane is from. These are preservatives and gums and best to be avoided. What's better than eating organic real broccoli sprouts?

Broq

[Teufelshunde in reply to tn12]

I guess that would be ok if you know how many sprouts equals 60mg of pure sulforaphane and not all the precursors to the actual sulforaphane.

[tn12 in reply to Teufelshunde]

It's 100g-140g of sprouts for 60mg of sulforaphane, according to Dr Rhonda Patrick.

brainflow.co/2021/11/08/rho...

[Teufelshunde in reply to tn12]

I think it is great if someone wants to grow and eat 1/2 of her jars every day. For my lifestyle, growing and doing that is not going to happen so I take the broq. Problem with most sulforaphane supplements is they have so little acutal sulforaphane and if you are going to take sulforaphane, take enought to get the study results.

[tn12 in reply to Teufelshunde]

Yes I agree, my husband eats 100g a day. He mixes the sprouts in San Marzano tomatoes! The price is worth it. I calculated my organic seeds I get are $40/kg and makes about $550 worth of store bought sprouts.

[Teufelshunde in reply to tn12]

Good. One of the few items that works per studies.

[pd63]

Not being negative but better to stick to tried and tested, could get distracted from proven benefits

[Teufelshunde in reply to pd63]

Not sure what your reply means. Help.

[allie2020]

I had RP over four years ago and have taken one Pomi-T daily since then. I also drink organic pomegranate juice , eat the seeds, and try to ingest quite a bit of the three other ingredients reasonably often. They are all healthy.