Study of pomegranate extract shows no effect on PSADT

Thank you for posting the study. Based on past threads, I found it very interesting.

I also found your thoughts on disease genetics interesting .... time to do more reading.

Thanks again.

As I think I mentioned in an earlier post about this, this is actually the second time pomegranate has failed to show a benefit in a randomized clinical trial.

It’s just my opinion, but I think the MnSOD AA genotype subanalysis was a Hail Mary play. This is probably a very rare genotype and it is more than likely that if they had tested other antioxidants, soy isoflavones, smoking cessation, or even just exercise, they may have had similar findings. Pantuck’s lab has been trying to prove pomegranate efficacy since 2006, and when POM Wonderful tried to make claims about their pomegranate juice, they were challenged by the FDA to come up with a placebo-controlled trial. This is the result, unfortunately for them. I had always wondered why they didn’t have placebo controls in their earlier studies — it would have been so easy.

- Allen

Here’s what we know:

First, not every body responds in the same way to various treatments—and in particular here, various chemoprevention agents. (But we knew this well before this study was published.) In general, we point to different individual “genetic makeup” to rationalize this, but the details are not well understood today; we just know that different people respond differently. Stake in the ground.

Second, we know that scientists have described the mechanisms for plant-derived phytochemicals to have cancer prevention benefits. The mechanisms have been demonstrated (by several sets of scientists) both in vitro and in vivo studies showing that pomegranate extracts are capable of inhibiting tumor cell proliferation, migration, invasion, while also inducing apoptosis. Another stake in the ground.


For the first time ever (for pomegranate extract), scientists are making a connection between these two perspectives.

This study demonstrated that not everybody with recurrent PC responds the same to pomegranate extract. The findings also, however, suggested that men with that a specific genotype may represent a group that IS more sensitive to the antiproliferative effects of pomegranate and other antioxidants on PSADT.

Me? I’m a glass half full guy. This is how science progresses. A small step at a time. In the future, we may not only be able to identify which guys have the genes to benefit from antioxidant therapy…but after that we may be able to boost other men who don’t naturally have those genetics so that they too may benefit.

I like these findings. Small step of scientific progress for men with recurrent PC disease.

Add another miracle supplement to the only produces more expensive urine group. I am not surprised.

+1 to Ziggy's remark.

I made this same statement some 5-6 years ago on HW, and was mocked for it, and told my doctor didn't know his stuff. I still stand by the remark and opinion, just another of several ways out there for men to produce expensive urine. Nothing, more, nothing less. Save the money, there are no magic cures.

Newporter said...
Thank you for sharing the pomegranate study. A few comments:

1. I don't understand why the study was biased towards extract and left very few patients on juice? There were 84 patients on placebo, 102 on extract and only 17 on juice. No wonder the results of the juice group is considered statistically non significant. 17 is barely the minimum number for statistical study once one considered attrition.

2. It seemed to be poorly designed: The striation of patient types are just way too diverse so every subgroup did not have sufficient numbers to be statistically significant as each subgroup (e.g. staging) had very few numbers.

3. In a statistically non significant way, the juice group showed a lot of promises: an increase from 12.7 at baseline to 20.3 in the juice group (P=0.004). Unfortunately, since they only had 17 patients to begin and 5 dropped out leaving only 12 patients in the study which by itself cannot form a statistically significant group.

4. For example: An additional analysis was performed in patients who received a minimum of 12 months of blinded treatment to determine whether length of treatment had any additional impact on PSADT. Median PSADT increased 3.5 months in Placebo patients from 12.2 at baseline to 15.7 months (P<0.0001), 18 months from 16.1 at baseline to 34.1 months in juice patients (P=0.05) and 5.6 months from 13.9 at baseline to 19.5 months in Extract patients (P=0.0003). Notice the juice group increased the PSADT from 16.1 months to 34.1 months, very similar to the prior UCLA and Johns Hopkins studies. To a non professional I think there are something in the juice that was not extracted to include in the extracts.

In my non professional opinion, the juice group warrant a further study. However, since it is non proprietary I doubt anyone would support such a study as there is most likely no profit in it.

I was wondering about many of the same things, Newporter, and was about to post such when I saw your post. 1st I was curious about why the 2:1 ratio between extract and placebo. And then I was even more curious about this small item called "juice" which seemed to show a rather impressive increase in doubling time. So why was that chosen to be BY FAR the smallest group to be tested?

I'm always sorry to hear about results like this only because, though I have not yet ever really explored the Pomegranate thingy, would it not surely be nice to find various natural approaches that would help even a little?

However, let the facts fall where they fall, so be it. Still, in all studies, by whoever, bias must be considered. Anti-Pom or anti-natural bias seems unlikely in this case since at least a couple of the folks of(of many) involved in this study were funded by Pom Wonderful. Still, I am convinced that bias often influences studies.

For one example, the recent big news on the network news was the new study that finally proved- SCIENTIFICALLY! - that just as much(actually more) fat is burned with a 2 week low fat diet approach as with a 2 week low carb approach. And apparently pure science- finally!- because the subjects were locked away in a metabolic lab and their food intake strictly controlled and fat loss actually measured. At last we can know the truth! I saw this reported numerous times on TV and several times in other news sources.

I decided to try and find details of the actual study, which required a bit of digging. And sure enough, without going into details here(unless requested) I found that this was about as sorry a study as could have been performed. Since I'm pretty sure that the people who did the study - being science folks and all- understood how a low carb diet is supposed to work, it almost seems as though the study was purposely designed so that the low carb approach had no chance of working. I found 3 or 4 items that disqualified this test from being an actual low carb diet test, i.e. several rules of low carb dieting were clearly broken. Thus, I smelled huge bias. But no matter, the news is out there. "Science" has spoken, and it clearly shows just as much(or more) fat is burned in a 2 week low fat diet as on a 2 week low carb diet. One headline was: "New Study Says Low-Fat Diet Trumps Low-Carb...". IMO, not really. What a good opportunity was missed to get at the truth, either way.

But the bigger point is: why? Why would these science types, while going to all this trouble and expense to do this study, and bring in 19 participants to live in the “metabolic ward”, then structure the low carb end of the study so that several low carb rules were not followed, guaranteeing poor results? What would be the reason for that? Some form of bias is all that I can come up with.

Back OT: NOT that I am suggesting such a thing for this POM study, even though I admit I am curious about the item that showed the best results, "juice", being dwarfed in number of participants compared to extract and placebo, and why placebo is approx. 1/2 extract in N? (is that right? Am I reading all that wrong?) If correct, that does raise a red flag for me, but it could well be just something I don't understand about how these studies are structured. Curious though. But I am saying that all studies have to be watched for bias, or at least I will try to do that even if others find it unimportant.

In the meantime, too bad about the POM, my bias towards things natural that might help health makes me wish it had been the opposite! I am biased! Beware of any studies that I am involved in!

Somebody said...
Results:

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).....................Median PSADT increased from 11.1 months at baseline to 15.6 months in the placebo group (P<0.001) compared with an increase from 12.9 months at baseline to 14.5 months in the extract group (P=0.13) and an increase from 12.7 at baseline to 20.3 in the juice group (P=0.004).........

Post Edited (BillyBob@388) : 8/18/2015 7:52:00 AM (GMT-6)

Fairwind said...
So I wonder where this leaves "Pomi-T", a popular supplement containing 4 "cancer fighters" specifically aimed at Prostate Cancer..

This product SEEMS to have proven itself in two studies conducted by reputable organizations..

Other studies conducted by John-Hopkins supported the effectiveness of Pomegranate juice and supplements...

Is it possible that if you fund one of these studies (as POM Wonderful did) that you are almost certain to get the results you were hoping for?

meetinglibrary.asco.org/content/72101-104

But as you see here, Fairwind, there is always another study. But the OT's study, being a randomized, double-blind, placebo-controlled study, is supposedly superior to the others. Still, as you may see from a couple of previous posts including mine, a couple of questions about this study have been raised. And if nothing else, it is small. With the element that did far and away the best, i.e. juice, had an N that was not small, but tiny. So once again, we may need another study, even if many are convinced by the results of this study.

I do not understand why there are so many studies about which questions can be raised. Why not just make them so ironclad that questions can not be raised? Assuming you truly want to know the answer in the 1st place?

Another question I have about this study(don't shoot me, I may not understand the science/research rules and I am just asking and seeking info):

Somebody said...
an increase from 12.7 at baseline to 20.3 in the juice group (P=0.004). However, none of these changes were statistically significant

My new question is: why is that statistically insignificant? It sounds pretty significant to me. How many of you would like to increase your doubling time from say 13 months to 21, or about 62%, maybe even without being cut, radiated or hormone blocked with all of the glorious SEs? (or even just in addition to treatments?) I guess it all depends on what your definition of is, oops I mean significant, is. But why is this insignificant? Is it because the N is so small? If so, why is the N so small (17 out of 183) to start with? There may well be (probably are) good scientific reasons, I just don't know what they are.

EDIT: BTW, I just noticed that the % increase in doubling time was very close(55% vs 62%) in the study linked by you and the study linked in the OT's results for juice. Just a coincidence?

Post Edited (BillyBob@388) : 8/18/2015 10:16:27 AM (GMT-6)

Statistically significant and meaningfully significant are two different things. Statistically significant only gets at the odds that a finding is "real" (as opposed to a fluke, meaning, by chance the small number of people in this sample were atypical and you can't project from their results to the larger group -- if you repeated the study, would you get the same result?).

If you knew a guy who tried something and it worked for him, you'd be happy for him, you might even try what he tried, but you wouldn't count on it working for you. If you knew 1,000 guys tried something and it worked for every one of them, you'd feel pretty certain it'd work for you too. Same finding, different base size. Your gut has statistical sense too!

So you're right, that change is great and we'd all take it if we could get it. It's just cursed by its small base size.

I missed this in the study, but did the correlate the effects of POM in conjunction with a large intake of beer?

That would be about the only way you'd get me to drink the stuff...

Am I allowed to say "Sur --prise.. Surprise". Read that with a Gomer Pyle accent.

Years of infighting here about the miracles of Pom. Members left, member offended.

I still drink the juice (OJ is out due to bladder irritation), but am on a downward spiral that proves, in my case, that it might, maybe, in a magic show, sort of slow things down, but it is not a silver bullet.

And, as some of us have experienced, reduction of PSA--or lengthening of doubling time--may or may not have anything to do with the presence or absence of cancer. A risk here is reinforcing the perception that PSA is a cancer test, which as we all know, it is not.

142 said...
Am I allowed to say "Sur --prise.. Surprise". Read that with a Gomer Pyle accent.

Years of infighting here about the miracles of Pom. Members left, member offended.

I still drink the juice (OJ is out due to bladder irritation), but am on a downward spiral that proves, in my case, that it might, maybe, in a magic show, sort of slow things down, but it is not a silver bullet.

Never tried any Pom myself. I'm not sure why, I must not have seen enough studies that looked promising to me. We probably won't ever get any big studies on anything that is not being patented by a pharm, but it would be nice to see(at least for me) a follow up study on the juice that was in this test. I'm still trying to figure out why the juice was not the major component looked at to compare to placebo? Isn't juice what most people take? Or maybe not, I don't know.

Whatever, though I have never done so, I have often considered adding Pom juice to my diet. I'll probably hold off on that after this study, especially since I have heard it does not taste good.