PNE Ironman athlete

[Celeste]

The burden of proof lies with the practioners making the claims not the people questioning the treatment as we saw in the UK libel case.

Quite right. This bears repeating.

[ezer]

I must say that there is a mystery that puzzles me when I compare papers from different doctors.
Some doctors always seem to find massive fibrosis that prevent the pudendal nerve from gliding (Filler) while other doctors do not see see that problem and instead in the majority of cases find the pudendal nerve squeezed at the ligaments claw (Antolak, Ansell etc...). I think Dr.Antolak reports 90% of the problems at the ligaments.
So it seems that if effectively the fibrosis is the main source of pain, Dr.Andrew and his ESWT, cold laser, and ART technique could be interesting. However if Dr.Antolak is correct and the ligaments are the culprit, ESWT will not work.

[Celeste]

I think it's also possible that not all scar tissue is created equal. I think some of it may bind more tightly than others, and this could explain why sometimes you can see it, but it doesn't cause any pain problems.

I think this because for a solid 40 years pre-delivery, I had the same grown-together ligaments, but never any pain or other problems. I think the nerve had just enough room inside that mess...until it became swollen from the pressure of childbirth, and then it no longer had enough space to recover, and stayed painful.

I think there are a lot of pieces to the puzzle, for sure.

[Pelvis Stressly]

Maybe it's best to let this thread die (I know a lot of time has passed), but I did still want to respond to some points (am finally getting caught up on my post-trip emails/PMs backlog!). Here goes...

The debate is about the validity of the case study to show ART as an effective treatment for PNE.

No, that's not what I've been debating here. All I said from the beginning of this thread is that this article shouldn't be laughed-off in a knee-jerk fashion. I would never claim that a study involving one patient demonstrates any indisputable conclusions (even one published in a peer-reviewed, medical journal, which this is...not a homeopathic journal, as you described it). That said, I still think this is an interesting, relevant result, worthy of being filed away at the back of the brain at the very least, for possible future reference (when/if more data comes to light).

my question would be then why have they still not got around to performing a controlled study?

Probably the same reasons there are barely any similar studies around re. the surgery (aside from the one you linked + a handful of others...even after decades of these surgeries being performed!)...lack of patients (this is a relatively rare condition), expense & time involved w. conducting such a study, etc. Those may not be valid excuses, but unfortunately they're the reality (hence all of us being forced to rely on so much anecdotal evidence).

Some doctors always seem to find massive fibrosis that prevent the pudendal nerve from gliding (Filler, Dellon etc...) while other doctors do not see see that problem and instead in the majority of cases find the pudendal nerve squeezed at the ligaments claw (Antolak, Ansell etc...). I think Dr.Antolak reports 90% of the problems at the ligaments.

I brought this up w. Dr. Andrew when I went to see him & he explained it's not so cut & dry re. fibrosis vs. ligament entrapment. For the latter, it's often not enough to just say, 'the nerve is entrapped by one or both ligaments'. He said even if this is the case, it's often due to fibrosis within the ligament that's really 'gluing' the nerve to it....as everything in the area becomes compromised due to the neuropathy, the ligament can harden, which is specifically how it 'entraps' the nerve (in other words, it's not a normal, healthy ligament compressing the nerve). That's why he feels they're also getting success w. their protocol on patients w. problems at the ligamental level...because the ART & shockwave treatments can soften up a chronically hardened ligament (thus easing pressure on the nerve) as easily as they can isolated scar tissue.

Sorry for delayed response!
PS.

[Charlie]

All I said from the beginning of this thread is that this article shouldn't be laughed-off in a knee-jerk fashion. I would never claim that a study involving one patient demonstrates any indisputable conclusions (even one published in a peer-reviewed, medical journal, which this is...not a homeopathic journal, as you described it). That said, I still think this is an interesting, relevant result, worthy of being filed away at the back of the brain at the very least, for possible future reference (when/if more data comes to light).

I don't think 'Peer reviewed ' carries much weight. There are homeopathic peer reviewed journals as well. http://www.homeopathyusa.org/journal/. When an article is submitted to a peer reviewed journal, the editors send it out to other scholars in the same field (the author's peers) to get their opinion on the quality of the scholarship. In reality they are rarely checked or scrutinized before publishing. The majority of articles in even the top peer reviewed journals are refuted within a few years. I would still maintain that this is really just an anecdotal story.

my question would be then why have they still not got around to performing a controlled study?

Probably the same reasons there are barely any similar studies around re. the surgery (aside from the one you linked + a handful of others...even after decades of these surgeries being performed!)...lack of patients (this is a relatively rare condition), expense & time involved w. conducting such a study, etc. Those may not be valid excuses, but unfortunately they're the reality (hence all of us being forced to rely on so much anecdotal evidence).

I do agree with you here. There is not a lot of evidence for other treatments for this condition. I think there are only 2 controlled studies for the two main treatments discussed on this board. One for myofascial PT on IC patients which showed it was no better than a regular massage. Then you have the Nantes study which did show an improvement for surgery patients but it was a small study. So basically I completely agree with you when you point out there is not much evidence for the other treatments. In that respect I think Art could be worth a try. Good luck with it.

[peaches]

My two penneth for what it's worth....

He either never had PNE or the symptoms are just in the early stages. As we know this condition can come and go to start with and that's the dangerous bit because you think you are better. I would say to him if I met him 'PLEASE cut out the cycling for your own good' , but he probably wouldn't listen. If he is in the early stages of nerve damage, it will come back to bite him if he's not careful. Find some other form of exercise whilst there is still time.

Cheers
Peaches

[Pelvis Stressly]

I don't think 'Peer reviewed ' carries much weight. There are homeopathic peer reviewed journals as well

Well, I agree that 'peer reviewed' doesn't necessarily = 'guaranteed error free', but it's still obviously better for an article to be peer reviewed than not. And I'm not really sure what point the fact that peer reviewed homeopathic journals exist makes, given that that's not where this article comes from (refer back to p.4 of this thread, where I explained how chiropractors, at least in Canada, based on the amount of education required, are considered full medical doctors).

I would still maintain that this is really just an anecdotal story.

Anecdotal stories aren't subjected to the following (or any) criteria. This is the submission policy from the Journal of the Canadian Chiropractic Association (where the article was published)...

"Articles of a highly speculative nature, which are not adequately supported by the literature, or by usual methods of research may not be accepted for publication.

Papers submitted to the JCCA are reviewed by members of an editorial board and/or other referees. Referees with special qualifications in the subject matter presented are consulted, and decisions are made with due consideration of their evaluations.

All statistical techniques must be identified and, when appropriate, referenced. Levels of statistical significance must be stated. All individuals responsible for statistical evaluation must be identified.

Authors are expected to disclose any commercial associations that might pose a conflict of interest in connection with the submitted article. All funding sources supporting the work should be acknowledged in a footnote on the title page. All affiliations with or financial involvement in any organization or entity with a direct financial interest in the subject matter or materials of the research discussed (eg, employment, consultancies, stock ownership or other equity interest, patent-licensing arrangements) should be cited in the cover letter."

I think there are only 2 controlled studies for the two main treatments discussed on this board.

My understanding is that a 'controlled' study includes the use of a placebo (or 'control') on some of the study participants, correct? That said, I'm not sure how one would administer an ART 'placebo', as it's quite a vigorous treatment (surely patients receiving the placebo would know they weren't getting the real deal?). And for that matter, how does one come up w. a placebo for surgery?! (in the case of the 'controlled' Nantes study you mention)

[Charlie]

And I'm not really sure what point the fact that peer reviewed homeopathic journals exist makes, given that that's not where this article comes from (refer back to p.4 of this thread,

I mentioned the peer reviewed homepathic journal as you said this in your previous post

. I would never claim that a study involving one patient demonstrates any indisputable conclusions (even one published in a peer-reviewed, medical journal, which this is...not a homeopathic journal, as you described it).

Well, I agree that 'peer reviewed' doesn't necessarily = 'guaranteed error free', but it's still obviously better for an article to be peer reviewed than not

Peer reviewed articles can often be completely wrong and sometimes even outright fraud . I really don't think it means much at all. I would be much more inclined to go on a success story of someone I personally knew than a case study in a peer reviewed journal. Do you really believe that the Journal of the Canadian Chiropractic Association did all those checks that you mentioned? I personally doubt it. Here is an interesting article discussing scientific studies.

http://moreintelligentlife.com/content/ ... ts-science

Most laymen probably assume that the 350-year-old institution of “peer review”, which acts as a gatekeeper to publication in scientific journals, involves some attempt to check the articles that see the light of day. In fact they are rarely checked for accuracy, and, as a study for the Fraser Institute, a Canadian think-tank, reported last year, “the data and computational methods are so seldom disclosed that post-publication verification is equally rare.” Journals will usually consider only articles that present positive and striking results, and scientists need constantly to publish in order to keep their careers alive.

I accept that article could well be biased itself.

If we were to rely on peer reviewed articles we should all go to see Dr Filler who has a 87% good to excellent outcomes for his PNE surgery. This is actually based on a group of patients and not a case study and has been published and peer reviewed by neuro surgeons. Yet the paradox to this is that it seems impossible to find a Filler success story. I realize that you are not defending the practice of Peer review and can see that you have not tried to do this but my point is I don't think it means much that this case study has been peer reviewed and published. With this being a solitary case study it is not credible evidence for the efficacy of ART for PNE. My reaction when people say something is 'Peer Reviewed' is to say 'so what?'.

I think what we really need to do when assessing evidence is look at how the study has been designed. Was it blinded? How did they judge success? what treatment did the control group have, how long were patients tracked? etc, etc

I accept your point that there is not much evidence for other treatments and am in complete agreement with you on that. Your right when you say that we don't have much to go on other than anecdotal stories, it is a poor state of affairs. I am not trying to be unfairly critical of ART but I am trying to present the counter argument to it. As I said I really hope it works for you and if it does I will be honest and say I would be tempted to try it myself.

Here is the Nantes study listed below. It is not very impressive and does not exactly have me booking my ticket to France. Having said that I do know a person that has been cured by the French surgery. For the myofascial PT study they compared it with regular massage. Myofascial PT did not have a significantly greater effect on pain scores than a regular massage. Perhaps Art could compare itself with Myofascial PT, that would be an interesting study.

http://www.ncbi.nlm.nih.gov/pubmed?term ... controlled

[Pelvis Stressly]

I mentioned the peer reviewed homepathic journal as you said this in your previous post

Pelvis Stressly wrote:
. I would never claim that a study involving one patient demonstrates any indisputable conclusions (even one published in a peer-reviewed, medical journal, which this is...not a homeopathic journal, as you described it).

All I said re. homeopathic journals (as you quoted above) was that this article didn't come from one, so I'm not sure how they're relevant to the discussion (peer-reviewed or otherwise).

Peer reviewed articles can often be completely wrong and sometimes even outright fraud.

Agreed. But that doesn't mean publishers should do away w. the practice altogether (in theory, it still means more rigorously scrutinized articles than ones that haven't been peer-reviewed).
We have laws prohibiting murder. But murders still happen. Does that mean we get rid of those laws?

Do you really believe that the Journal of the Canadian Chiropractic Association did all those checks that you mentioned? I personally doubt it.

I have no evidence-based reasons to doubt it. As you said earlier in the thread, 'the burden of proof lies on those making the claims'. If you're claiming this journal doesn't follow its stated editorial guidelines, you need to back that up w. some tangible proof.

And I'm not sure how 'controlled' the Nantes study really was to be honest. Again, my understanding is that in a true 'controlled' study, the control group isn't aware they're being given a placebo (so as not to affect their feedback...which is what the results of this study were based on). Obviously in the case of the Nantes study however, the patients who didn't get the surgery were clearly aware of that fact! So not sure how truly 'controlled' it really was.

And same for the Myofascial PT study actually. I can't find your link for it at the moment, but did it include internal trigger point release (which is a key part of pelvic floor PT)? Because believe me, there's no way of passing that off as 'regular massage'!! So again, not sure how truly 'controlled' that study could have been (assuming it did include the internal work).
And really same would go for any study involving ART I would think...it's very specific & also intense, so I think it would be hard to provide a convincing alternative as a placebo.

[Charlie]

All I said re. homeopathic journals (as you quoted above) was that this article didn't come from one, so I'm not sure how they're relevant to the discussion (peer-reviewed or otherwise).

I guess what I am saying is that homeopathy has peer reviewed articles so therefore the stamp of Peer Review does not really mean much.

I have no evidence-based reasons to doubt it. As you said earlier in the thread, 'the burden of proof lies on those making the claims'. If you're claiming this journal doesn't follow its stated editorial guidelines, you need to back that up w. some tangible proof.

I see where your coming from but I am questioning the validity of the source making the claim.

And I'm not sure how 'controlled' the Nantes study really was to be honest. Again, my understanding is that in a true 'controlled' study, the control group isn't aware they're being given a placebo (so as not to affect their feedback...which is what the results of this study were based on). Obviously in the case of the Nantes study however, the patients who didn't get the surgery were clearly aware of that fact! So not sure how truly 'controlled' it really was.

And same for the Myofascial PT study actually. I can't find your link for it at the moment, but did it include internal trigger point release (which is a key part of pelvic floor PT)? Because believe me, there's no way of passing that off as 'regular massage'!! So again, not sure how truly 'controlled' that study could have been (assuming it did include the internal work).
And really same would go for any study involving ART I would think...it's very specific & also intense, so I think it would be hard to provide a convincing alternative as a placebo.

I believe ideally in a randomized controlled trial the patients should not be aware of the treatment they are receiving. When the patients are not aware of the treatment they are receiving this is called a blinded study. For the reasons you have explained that is not always feasible.

When there is no blinding I am not sure if a study can still be called a controlled trial. I am no expert. The French clearly think so as they have entitled theirs a controlled trial and there is no mention of blinding being successful. The title of the study is Decompression and transposition of the pudendal nerve in pudendal neuralgia: a randomized controlled trial and long-term evaluation. On Wikipedia it only says that Controlled trials 'may' be blinded. Like I say I though I am not sure and I think when blinding is unsuccessful they may just be called Randomized trials and as you say not 'controlled' trials. So basically I think you are correct when you say they are not 'controlled' trials' rather just randomized trials. Patients have just been assigned randomly to each group. Either way I think it is great there have been attempts at studies for these treatments which have featured control groups.

Ideally randomized controlled trials should additionally be double blinded or triple blinded.

Interestingly in the PT study blinding was attempted but it failed as patients guessed they were getting the sham treatment. Not surprising but they did try.

Anyway best of luck with the ART and it is nice to debate with you. I mean none of this personally. I am in the same boat as you and just trying to get better, as we all are.

This is a good video on blinding in medical studies.

http://www.youtube.com/watch?v=aSP2OMiFxhg