Pentoxifylline Study

[newguy]

Your right, pentox can slowly heal you over time, longer than six months, I noticed this, and yes your right, once you get off of it, you slowly get worse.  However for the first year off pentox I did not get worse, then a 8 day stint of drinking everyday with a bunch of co-workers who hit the bar everyday from 5pm-1am whilte away at a work related training seemed to fire up my peyronies or get it started again, or just inflame it if it was already getting worse.

Once you stop the pentox you will get worse again, but at  a slow rate, so slow you won't notice it for months upon months. Alcohol makes you get worse even faster as alcohol causes liver fibrosis and severly dehydrates you.

In some cases peyronie's sadly does appear to progress over a period of years. I would think that for these men pentox will be very useful since it appeared to be successful at stabilising conditions in this study. In many men though, the condition becomes stable after a certain period of time, so I certainly wouldn't suggest that long term pentox is for all men. It's best to take it on a case by case basis really. If a person does notice a worsening of their condition when they stop taking it, it is probably something that's useful for them to continue taking.

[Skjaldborg]

I plan on staying on pentox for at least another 6 months. After that, I may taper off the dosage to 2 pentox pills per day down from 3. Perhaps Dr. Lue will refill for longer, I'm not sure as of now.

As for "inflammatory foods" and alcohol, there's no evidence that they affect Peyronie's. There is evidence that in excess, white sugar, flour, bacon and beer will make you fat. Therefore, I eat healthy, exercise and enjoy beer in moderation. I have had this for almost 9 months now and have noticed no worsening and actually have had some improvement due to pentox (less pain, smaller lumps/nodules). So booze hasn't caused me any problems.

Also, alcoholism causes liver fibrosis, moderate drinking does not.

If you don't drink, great. If you drink too much, quit. If you have a healthy lifestyle that includes alcohol, keep enjoying in moderation. I think we tend to obsess about one cause or another with disease because it's so stressful and of course, currently has no cure. Personally, I choose to keep living my life as I see fit. I don't want Peyronie's to control every aspect of my life unless I have good evidence to the contrary. My 2 cents.

-Skjald

[ComeBacKid]

In the case of those with long term progression, with or without pain, it begs the question, what impact does pentox really have. It may be the case for instance that the condition can improve at six months, but if the pentox is stopped, it will gradually get worse again. There is already a "rebound effect" noted in some conditions treated by pentox, in people with conditions that are not known to progress, so it could be doubly important to take pentox for much longer than 6-12 months for those with long term peyronie's progression.

On a more positive note, if peyronie's in some men can slowly worsen over the years, perhaps with pentox use it can gradually improve over a period of years too, rather than only months.

Newguy,

Your right, pentox can slowly heal you over time, longer than six months, I noticed this, and yes your right, once you get off of it, you slowly get worse.  However for the first year off pentox I did not get worse, then a 8 day stint of drinking everyday with a bunch of co-workers who hit the bar everyday from 5pm-1am whilte away at a work related training seemed to fire up my peyronies or get it started again, or just inflame it if it was already getting worse.

Once you stop the pentox you will get worse again, but at  a slow rate, so slow you won't notice it for months upon months. Alcohol makes you get worse even faster as alcohol causes liver fibrosis and severly dehydrates you.

Knowing these two things, stay on pentox as long as possible, years, and avoid alcohol at all costs, I avoid even a glass, I don't even drink it anymore at all, maybe one glass of wine per year at my current rate.

Comebackid

[George999]

I really think that all of these "classifications" are artificial.  They seem to be hand offs from earlier days when Peyronie's was something rare and mysterious and when doctors tended to try to define it without any real substance to work with.  Now they are learning more about it, but they are holding on to the lore of the past.  Somehow medicine tends to be that way.  For doctors there is perceived safety in doing it the way it has always been done without regard to whether there is any evidence to support it.  But they cling tenaciously to what they "know" is true.  I think a part of this has to do with liability issues.  If they are challenged, there is safety in numbers.  After all, 99% of the medical community CAN'T be wrong.

As for the rebound effect, I experienced it really intensely when I quit ALC.  The result was intense pain and the appearance of new curvature.  At this point it has been two weeks since I stopped taking Pentox.  So far, no rebound whatsoever.  No pain and no new deformity.  No evidence of progression at all.  So either I am in that so called "stable" phase or the Vitamin D and Low Dose Naltrexone are covering me.  - George

[newguy]

Tim - We don't appear to have many insights into the ways in which pain (or lack of) can impact different stages of peyronie's disease (at least in people suffering from long term pain). Perhaps that should be the actual emphasis of a future study. It could be split into three groups:

A group of men never experiencing any peyronie's pain at all
A group who suffered short term peyronie's pain
A group with long term peyronie's pain

I suppose the typical route for peyronie's disease (if there is such a thing) involves relatively short term pain, then eventual disease stability. Very little appears to be known about those suffering from very long term pain though, or long term progression (with or without pain). This type of patient even appears to leave Dr Levine and co scratching their head, and saying "i'll operate anyway, despite the pain, because it's probably nerve damage".

In the case of those with long term progression, with or without pain, it begs the question, what impact does pentox really have. It may be the case for instance that the condition can improve at six months, but if the pentox is stopped, it will gradually get worse again. There is already a "rebound effect" noted in some conditions treated by pentox, in people with conditions that are not known to progress, so it could be doubly important to take pentox for much longer than 6-12 months for those with long term peyronie's progression.

On a more positive note, if peyronie's in some men can slowly worsen over the years, perhaps with pentox use it can gradually improve over a period of years too, rather than only months.

[Tim468]

Thanks for finding that cbf.

The weird thing is that this is an artificial definition. "Early" refers to time - yet time is not really part of that definition.

Also, the final stage ("chronic") is defined as painful - yet many men with stable long-standing disease report that the pain has gone away.

These criteria also ignore the effects of long lasting but progressive disease (like I have).

Simply put - this definition is not that exclusive or inclusive for the purposes of a study. I wish they would come up with a better way of classifying this disease!

Tim

[ComeBacKid]

I've seen improvements from pentox and I got on it during year 7 of peyronies.

This study says more of what we've been saying all along, Pentox works well, get on it !!!!!!  The earlier the better, don't WAIT!

Comebackid

[jackp]

CBF

I have had peyronies since 1995. I have never had any pain in my penis from peyronies.

Jackp

[cowboyfood]

Tim,

Here is the study's definition of the "three phases of Peyronies Disease:"

"There are three phases through which the disease processes, i.e. acute, early chronic and chronic [8].

The acute inflammatory or active phase usually lasts 6–18 months and is characterized by permanent spontaneous pain which increases on erection or there is only pain during erection, and palpable and tender plaque, which is iso- or hypoechoic on dynamic Doppler ultrasonography (US).

It is then followed by the early chronic phase characterized by pain during erection; penile curvature with no difficulty with vaginal penetration; palpable hyperechoic plaque(s) with no pain and calcification with a total area of <2 cm2 limited to albuginea; and no arterial involvement and venous leakage on dynamic Doppler US.

The last phase is the chronic or stable phase, characterized by pain during erection; penile curvature affecting vaginal penetration and ED; palpable hyperechoic plaque(s) with no pain, with a total area of >2 cm2, and calcifications; arterial involvement, and venous leakage on dynamic Doppler US [8]"

and, footnote [8] credits:
Biagiotti G, Cavallini G. Acetyl-L-carnitine vs tamoxifen in the oral therapy of Peyronie's disease: a preliminary report. BJU Int 2001; 88: 63–7

Interestingly, ALL participants reported experiencing painful erections before entering the study (if I read it correctly).

CF

[newguy]

Thanks for posting the pdf! This will really help to spread the word, and hopefully make more urologists offer pentox instead of 'wait and see, here's vitamin E'

I'd quite like to see a study on men with very long term peyronie's (5 years+) to see if there is any difference in impovement rate. Levine stated that quite often, several years after peyronie's development plaque cannot even be felt (but the shortening/curvature may remain). I wonder if these changes also impact the type of treatments that are useful. The nearest I found to an answer previously was this radiation induced fibrosis study (breast tissue):  http://www.ncbi.nlm.nih.gov/pubmed/16260695  Here it seems to be the case that long standing fibrosis can be helped, but it may take considerably longer to see the maximum benefit. Whether this translates to peyronie's is anyones guess, but to me is does suggest a scenario where if any improvement is seen early on(within 6 months), it's a good idea to stick with it to see if further improvements can be seen.

This stance becomes even more conpelling when we consider evidence from multiple pentox studies (for other conditions) of a 'rebound effect' when treatment is stopped. I'd definitely say that the suggestion of 6 months treatment by many urologists is too short.

[Tim468]

Cross posted in the study folder (hopefully I can remove it there later:

My impressions of this study.

It is well done.

Numbers - adequate for good stats - this is not a 10 patient study.

Stats - well done with adequate controls for multiple comparisons.

Methods - did IIEF to assess erectile function, a good and validated study method. They injected one or two injections of Caverject to induce a firm erection, demonstrated to do a more reproducible erection for the purposes of a study than self measurements or measurements of "natural" erections (a common weakness might be that erections are better if a guy thinks he is better and thus has less stress. The injection removes this potential source of bias).

Results - Modest to very good - not stupendous. Again not a magic silver bullet. I think this reflects the multi-factoral nature of Peyronie's Disease and how one man may be quite different for the "same" disease.

Weakness (I think) - they identify Pentox as helpful for "early chronic Peyronie's Disease". The inclusion criteria are for disease of greater than 12 months. Thus, many would not call this "early", though it might be "early chronic" disease. I think that "early chronic" suggests that there is a "later chronic" form of the disease (how about more than 5 years? More than 2 years? - I dunno). But there is no criteria for cutoff for having had the disease for "too long" - no upper limit. Thus the "early" qualifier seems irrelevant.

Thus, this is mixed news. Treatment in early disease (i.e. as a first line of defense in the first 6 months, say) might yield better results. Speaking selfishly (as someone with chronic disease), this is exactly the kind of result I want to see - someone who is unlikely to have disease that is getting better spontaneously - meaning it was the drug that did it - not random chance. The control group bears out this impression - the very low improvement in the control group is consistent with a stable process that is unlikely to improve spontaneously (as opposed to acute trauma that may heal completely).

Thus, from my standpoint, a 47% improved or no progression result is outstanding. I'd take that any day.

Tim

[UK]

what's the difference between early chronic (referenced in the study) versus just chronic anybody?

[newguy]

I will try to post a Word text version of this in our document/study folder.

Tim

http://www.peyroniesforum.net/index.php/topic,1004.0.html

Thanks so much Tim. Perhaps any comment relating to the study should be conducted here, in order to keep the resource thread as clean and accessible as possible. There's now a significant body of evidence for patients to take to urologists in order to gain access to pentox .

[Tim468]

I will try to post a Word text version of this in our document/study folder.

Tim

[George999]

Agreed. It would be nice to have access to the whole study. I wonder if there's any way of gaining access to it.

Unfortunately, access requires money.  And I don't know whether it can be freely distributed or if it is somehow copyrighted and restricted.  I have asked Tim if he can look into this very question when (if) he can find the time.  - George

[newguy]

Agreed. It would be nice to have access to the whole study. I wonder if there's any way of gaining access to it.

[George999]

Hopefully the Iranian abstract makes it into our resource section.  - George

[newguy]

Any comments from anybody on this study? I think it's positive!

Finally they are beginning to discover what many of us around here already knew.  - George

Yes, I think it's now very hard for urologists to deny patients pentox - or at least it should be. Some are stubborn, but this study really compliments Dr Lues observations and the existing and well known pentox case study. I'd like to see a PAV cocktail study sometime in the future, as it's not beyond the realms of possibility that it provides additional benefits. 

[George999]

Any comments from anybody on this study? I think it's positive!

Finally they are beginning to discover what many of us around here already knew.  - George

[newguy]

Any comments from anybody on this study? I think it's positive!

[newguy]

Its hard to measure curvature, seems like my curve is never exactly the same in every erection, throw in some people have a twist at the base(which seems even worse) and throw in that sometimes people just get a semi-erection or have venous leakage and dont get "filled up," and this will always be a challenge to measure.  I guess a uniform way could be taken to attempt to measure it. 

Comebackid

Difficult but not impossible, if a slight margin of area is accounted for. I assume that they would induce a rigid erection and not measure a semi etc. Measurements of curvature is relevant to area's of research (studies of oral treatments, mechanical methods, xiaflex etc) and surgery, so it's something that we have to appreciate, even if it is imperfect.

[ComeBacKid]

Its hard to measure curvature, seems like my curve is never exactly the same in every erection, throw in some people have a twist at the base(which seems even worse) and throw in that sometimes people just get a semi-erection or have venous leakage and dont get "filled up," and this will always be a challenge to measure.  I guess a uniform way could be taken to attempt to measure it. 

Comebackid

[newguy]

A double-blind placebo-controlled study of the efficacy and safety of pentoxifylline in early chronic Peyronie's disease.

OBJECTIVE To analyse the safety and efficacy of pentoxifylline sustained-release (PTX-SR) treatment in patients with early chronic Peyronie's disease (Peyronies Disease). PATIENTS AND METHODS In all, 228 patients with a mean (sd) age of 51 (9) years who had early chronic Peyronies Disease were randomized to receive 400 mg PTX-SR (Apo-Pentoxifylline, Apotex Inc., Toronto, Canada) twice daily (group 1, 114) or similar regimen of placebo (group 2, 114) for 6 months. A medical history was taken and the men had a complete physical examination. The following variables were assessed before and after therapy: penile curvature and penile artery spectral traces (end-diastolic velocity, EDV, peak systolic velocity, PSV, and resistivity index, RI, of the right and left cavernous arteries assessed with dynamic penile duplex ultrasonography), plaque characteristics (assessed by penile X-ray and penile ultrasonography), pain (assessed by visual analogue scale), erectile function (assessed by the International Index of Erectile Function, IIEF questionnaire), treatment satisfaction (assessed by Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire), and side-effects. Patient perception of penile curvature and plaque size, and mean weekly intercourse attempts were also assessed. RESULTS Overall, 36.9% of patients who received PTX-SR reported a positive response, vs only 4.5% in the placebo group. Of patients in PTX-SR group, 12 (11%) had disease progression, vs 46 (42%) in placebo group (P = 0.01). Improvement in penile curvature (P = 0.01), and plaque volume (P = 0.001) was significantly greater in patients treated with PTX-SR than placebo. The increase in IIEF total score was significantly higher in the PTX-SR group (P = 0.02). Mean PSV changes after therapy compared to baseline were statistically significant between PTX-SR (right, +11.4%, left, +11.7%) and placebo-treated (+0.2% and -4.2%, respectively) patients (both P = 0.04). CONCLUSIONS PTX-R was moderately effective in reducing penile curvature and plaque volume in patients with early chronic Peyronies Disease. Further studies with different treatment regimens are needed to better elucidate the beneficial effects of PTX-SR in Peyronies Disease.

- http://www.ncbi.nlm.nih.gov/pubmed/19863517

I haven't been around so much of late, so sorry if this has already been posted. It's good news cfrom where I'm standing, especially in relation to acting against disease progression and should be added to the evidence that people take to urologists when wishing to obtain pentox. It's a shame there isn't more info relating to the actual changes in curvature in percentage terms.