Previous pentoxifylline study has been retracted (Safarinejad et al. 2010)

[StayStrong2030]

This is my first post... I've been coming back here from time to time since my injury 2 years ago.

I feel the need to post this because it is significant and I don't think it's been posted here yet.

The Safarinejad et al. (2010) study (which found a reduction in curvature and plaque volume in patients treated with pentox vs. control) has been retracted. See here: Retraction statement: A double-blind placebo-controlled study of the efficacy and safety of... - Abstract - Europe PubMed Central

The editors of BJU International retracted the paper "after an independent review found a pattern of inappropriate statistical analysis."  This makes their Coenzyme Q study suspect too.

From what I gather from lit. review, there are no other studies proving that pentox pills work in vivo. Only in vitro studies that find that pentox inhibits elastogen etc. formation in a petri dish. But swallowing a pill and having the pentox diffuse into your bloodstream to attack peyronie's plaques and elastins is far less direct. And it's not proven at all after this retraction.

I've been on pentox since the beginning and I can say that my conditions has not improved much. If anything, plaques have gotten slightly larger. And I notice that the pills don't affect me well, mentally (difficulty concentrating) and physically (earlobes seem to have gotten slightly larger - but this could just be that I've been aging faster).

Interested in your thoughts.

[Mending the Bend]

Very glad I never went on Pentox. My doctor, Mulhall, dismissed it as being ineffective - and some on this board have criticized him for that view. I believe this vindicates him.

[emasculated]

This is interesting. There is also the Lue study which is quite extensive, though it is not randomized, placebo controlled.
I would not conclude anything from this besides that the study is flawed, it does not necessarily imply anything about the effectiveness of Pentox for treatment of Peyronies.
But it is definitely a major setback.  

[nemo]

It's definitely disappointing news, especially considering that the study has been used by our members as support for getting a Urologist to prescribe. I reckon this will be a setback in that regard.

In my own experience, I can't say I've ever seen any benefit from Pentox. I had a flare up in Nov. '13 and immediately got on Pentox. While those initial inflamed nodules definitely reduced in size after about a year, the indentations they caused are still present - but more troubling is that after a full year on Pentox, I developed another new inflamed plaque. So that caused me to question how much good Pentox could be doing if a plaque (in absence of injury) can actually develop while you're taking the drug.

I think the bottom line here is that ANYTHING we put in our mouth is likely to have a minimal impact on our penis (that goes for all the supplements too, at least in my experience), while injectables like Xiaflex, and perhaps PRP, obviously stand to be much more effective.

Nemo

[emasculated]

If this study is not also flawed (which I tend to doubt): Pentoxifylline treatment and penile calcifications in men with Peyronie's disease

then it is hard to believe Pentox does not have an effect on some men's condition.
It is unlikely this would be due to Placebo effect. I have never taken Pentox, but I would guess there is some effect which is probably only much less significant than what the flawed study suggested.

[lonelyboy]

Does anyone really understand statistics? did Safarinejad et al. send their results off to the statisticians to write up and someone got the sums wrong? I would doubt that it is completely made up results.

[Thisismyusername]

I'm not surprised.  In my own experience I did not experience any benefits from pentox at all.  All it did was increase my anxiety and decrease my quality of sleep and make it difficult to think straight for the few months that I was on it.  I do not believe in pentox at all; I know that's an unpopular opinion around here.  I just think that urologists (and doctors in general) really want to publish positive results (i.e. that a drug helps) and it skews the reliability of papers.  Unless something is firmly established I wouldn't trust it.  

In my opinion CoQ10 is almost certainly worthless too.  I don't trust the study at all.  

[mtricher]

When authors submit a paper for publication they have a choice about the approach the use to conduct their analyses. There are many different methods and some methods require specific assumptions that determine whether or not they are appropriate to use.  Just by taking a quick glance at the paper, it looks like the methods they chose were fairly rudimentary (t-tests, chi-square, Mann Whitney U test), which are taught in most first to second level stats class.  It's quite possible the inappropriately applied some of them or drew the wrong conclusions. Without seeing the comments, it's hard to know. Even so, it seems likely that the results could be reanalyzed using appropriate methods and you could still draw conclusions (whatever they may be).

When I showed these types of studies to my doctor to get a Pentox prescription, he pointed out that they all came from second and third tier journals, so we should be cautious in putting a lot of stock in them.  You can't always be sure how well they were peer reviewed.  A good reviewer should be able to identify inappropriate stats.

[StayStrong2030]

Just a follow up:

I forgot to mention that the major benefit I noticed from being on pentox was a softening of the plaques - there was no mistaking that this is what happened when I stayed on it (at least one 400 mg pill every day for a couple weeks). Other members notice this too. It has been proven to de-calcify plaques in the peer-reviewed lit.

So the cons are that pentox does not have any proven direct impact on curvature and plaque size, and it causes dizziness and other symptoms. The big pro is that it softens plaques.

It seems to me that the best hope for pentox is to use it in conjunction with VED or traction - I read this somewhere on the forum before. The penis may be "re-molded" better with VED/traction + pentox than with VED/traction alone (because the plaques are softer and more moldable). Maybe after some time, one could stop taking the pentox and continue with VED/traction. As the scar tissue hardens again with no pentox (in my direct experience, it definitely does this) the better form achieved may stay with routine VED/traction.

[kuaka]

It seems to me that the best hope for pentox is to use it in conjunction with VED or traction - I read this somewhere on the forum before.

As an engineer, this makes the most sense.  The purpose of VED and/or traction is to reshape, and reshaping is going to be easier if the hard plaque is softened.  

I am doing everything non prescription that I can before resorting to prescription meds for this, but I will know in a few weeks if I need to go the Pentox or other route in conjunction with my other efforts.

[emasculated]

This is by far not the only paper by Safarinejad which has been retracted:
Urology researcher in Iran has third paper retracted - Retraction Watch at Retraction Watch

[james1947]

Retracted or not, I know that Pentox helped me with many things, also not connected to Peyronies.

James

[NeoV]

It's now up to six retractions according to the website.
Urology researcher in Iran up to six retractions - Retraction Watch at Retraction Watch

I don't know how I missed this post.

While I understand it may not mean much, I am now very worried about CoQ10. A member of this forum DID very recently mention Dr. Levine actually saying that the CoQ10 study was soon being retracted, but I cannot find the post. I figured he was mistaken at the time of reading it.

It's terrifying because the study on CoQ10 is good, perfect. Everything is taken into perfect consideration, and a lot of effort was put into it.
It is the best study we have on any oral treatment, when it comes to details and results, and basically screams at anyone reading it to take the supplement above anything else.

I am really unsure what to make of this. I would like to know why his studies were retracted, and if the CoQ10 one will be retracted as well.  

[skunkworks]

Do we know when the flawed statistical method was brought into play? If it was after results were tabulated then I'll just find the study and work the real results out from the raw data. The retraction info is very sparse.

If it was something to do with the actual measurements taken (not sure how that could possibly be the case) then not much we can do.  

[Jonbinspain]

As with James, I can only speak as I find. I took Pentox for 3 years. It did absolutely nothing to reduce my plaques or their calcification.

As we all should be aware, what works for one guy doesn't necessarily work for another. For me, it just plain didn't work.  

[james1947]

So Pentox helped me indeed on many levels, I can detail if someone is interested.
I had to stop after 18 months because it wreaked havoc in my immune system
Regarding CoQ10, used Ubiquinol for 3 months with no results.
But I clearly remember George (George999) explanation on why and how it helps. George knowledge is huge in many subjects
He is online but not posting long time, hope will chime in in the subject

James

[skunkworks]

Anecdotally, I got on pentox very early after injury and I think it was a big help. I have a personal belief though, that knowing how adenosine works, pentox is going to be most useful in the early stages and usefulness will diminish from then on.  

[Jonbinspain]

Skunkworks;

That coincides with Dr Kuehhas's belief. At my first appointment with him I told him I was taking Pentox. He slowly shook his head and said, "No, too late"  

[rich68]

NeoV - was it this post?
Xiaflex and plaque near urethra - Peyronies Society Forums

[NeoV]

Yes thank you, that post and actually I think one more in which Levine was quoted. I could be mistaken however.

CoQ10 still has reason to suspect it can help Peyronie's however. Even ALCAR, which had a very poorly done study and was even shown later that another form of carnitine had no effect, has interesting science behind it to help with Peyronie's.

Coenzyme Q10 / Uniquinol Studies - Peyronies Society Forums

Acetyl-L-Carnitine Studies - Peyronies Society Forums

While I still believe both supplements should be useful, I'm starting to suspect Citrulline, proanthocyanidins, and other supplements could be more helpful.

I'll still be taking CoQ10 and ALCAR regardless.

[Freemason]

I've been sitting on a 6 month RX for Pentox for months now and haven't taken it yet...Mr Uro said it's harmless and safe...however I just find that hard to believe...I want to believe that this drug will help me but I'm a drug rep and have been on this side for 15 years. Pentox is a heart medication that is primarily prescribed for those with congestive heart failure to increase blood flow. It's a drug that forces your body to increase red blood cell production.  This isn't like taking ibuprofen.

[james1947]

While taking Pentox for 18 months my red blood cells didn't increase and the white blood cells didn't decrease at all even it is stated that is a known side effect. I was hopping for that as my white blood cells are around 20,000 for many years now.
Was monitoring my blood every month while on Pentox with the hope it will help.

James

[basebend]

The other pentox study stands though correct?

Pentoxifylline treatment and penile calcifications in men with Peyronie's disease

[NeoV]

Correct.

And I do think pentox is harmless, since it seems almost no different than caffeine and theobromine. Still, you never know. The same can be said for supplements however, even more so since they are unregulated. It's always hard to make these choices, I've never been able to stay on pentox either granted I was unable to get it in Japan.

[snowydreams]

Didn't this same urologist also do a study on the supposed benefits of pistachios on improving ED?