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Auxilium AA4500 Trials Report.
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12/19/2007 03:27
bshatzer 
12/19/2007 03:27
bshatzer 
Re: Auxilium AA4500 Trials Report.

Well darn. I suppose a 93% success rate means there is a 7% failure rate but it's the pits when you end up among the 7%.

No joy today. Despite repeated attempts to break the cord, nothing happened except, perhaps, to add some extra swelling to the finger.

I am, needless to say extremely disappointed. Nothing to do I guess except go back to doing the exercises, wearing the night time splint, and hope something good happens. If not, the protocol calls for a repeat of the whole process in a month.

The attempts to break the cord were extremely painful - which would have been acceptable had they accomplished something.

As they didn't, it seems like a lot of pain for absolutely no gain. While the second set of injections themselves were less uncomfortable than the first time around, the hand, especially the pinkie finger, seems much more swollen and bruised than the last time.

36 hours after the injections and 12 hours after the physical manipulation, it's still quite swollen, discolored and quite uncomfortable and tender. Sufficiently so that I'm skipping the exercises today and I think I'll dispense with the splint tonight. If it follows the same course as last time, things should be considerably better by tomorrow and I can return to the prescribed routine.

Oh well, ever onward and be of good cheer. Even though I'm a bit down right now.

12/19/2007 08:11
wach 

Administrator

12/19/2007 08:11
wach 

Administrator

French data

Randy, while I agree with everything you wrote about collagenase I believe your general statement about "French data" is just too strong. The French not only published papers describing the therapy (e.g. Lermusiaux et al., full text on http://www.dupuytren-online.info/NA_training_literature.html) but there are also papers with well documented statistics, two of them cited on http://www.dupuytren-online.info/NA_side_effects.html. There is always room for improvement and Charles Eaton's data will be important to publish. I am sure he will document them immaculately, present them in a way that the US surgeons accept (he himself being one), and will publish in the right journal. All this will provide more convincing evidence.

But Dr. Eaton will also face the common problem of such studies: his patients come from all over the US and only some of them will return when they facce a recurrence or extension. Those without recurrence will vanish in the dark, others with recurrence might consult other doctors at an increasing number of NA clinics in the US and Canada (http://www.dupuytren-online.info/NA_list_North_America.html). Getting feedback from former patients is difficult and elaborate. They wouldn't travel to FL just for an inspection and their selection might not be representative.

I am wondering whether the surgeons who treat Dupuytren's with classical surgery meet these demanding criteria. E. g. a double blind study wouldn't make any sense. The published data on surgical results vary so widely that you might get suspicious about their quality (at least some of them). Have e.g. a look at the overview of side effects that Keith Denkler presented at ASSH 2006 (http://www.dupuytren-online.info/surgery...s_denkler_2.htm). Nerve damage varies from 0.4 to 36 percent, sympathetic dystrophy from 0 to 19.4 percent. Another example: Surgeons typically report a very high success rate of surgery, yet a recent British audit of concludes "Surgery for Dupuytren's contracture achieved a high rate of full, or almost full, correction in 826 patients (75%) but had a high incidence of post-operative patient-reported complications of 46%." Did you ever see such a complication rate reported by surgeons themselves? Developing reliable statistics in this area is just very difficult.

Wolfgang

Quote:


Eaton told me that even he was surprised at how unscientific the record keeping is in France. It's tends to be very anecdotal and often not specific, such as "We did NA on patient X last week and he was happy with the results." Perhaps it's not *that* bad, but certainly not close to the standards of scrutiny we have in the US. For that reason none of the American CHS were impressed by the French study(s) of safety and effectiveness of NA. ...


12/19/2007 20:01
Randy_H 
12/19/2007 20:01
Randy_H 

The American scientific community

Wolfgang,

Perhaps I was a little too hard on the French, but what I was trying to get across is that fact that their data is completely inadmissible in the US. It will take Eaton, collecting the data in the form acceptable to the American scientific community. This is unfortunate because all Eaton will do is corroborate what we and the French already know: NA is safe and effective. Yes, the French data has been there all along but US CHSs couldn't care less. It was American *patients* that trusted it, took advantage of NA, and bought it to the US. It's was good enough for us, just not our hand surgeons.

12/20/2007 06:47
wach 

Administrator

12/20/2007 06:47
wach 

Administrator

scientific community

Randy, I believe that one of the obstacles, maybe even the biggest one, is that NA wasn't in the books when the surgeons went to university. Another confirmation of the statement that any new theory takes 25 years to get accepted because the old generation of scientists needs to move out of business first ... I believe that this was first stated for physical theories but it seems to hold for medicine as well. Fortunately some doctors and many patients are more flexible (and wiser) than that.

Wolfgang

12/20/2007 18:15
Randy_H 
12/20/2007 18:15
Randy_H 

Flexable Fingers

More flexible? Not really Wolfgang. NA has been around for 30 years, so we are *five* years late already :-)

But let us watch and see just how *fast* Collegenase will be strongly embraced by US CHSs. Once approved it will quickly become the entry level procedure of choice (even with all the screaming that reportedly goes on when patients have their fingers pulled straight. Their marketing doesn't mention that part. :-)

12/28/2007 19:59
bshatzer 
12/28/2007 19:59
bshatzer 
Re: Auxilium AA4500 Trials Report.

Seven day check up following the second injection and "procedure" - delayed somewhat because of the Xmas holidays so it was more like a ten-day check up.

There's been considerable progress - the little finger PIP joint has gone from 60 degrees before starting the trial to 50 degrees after the first series of injections and procedure to 30 degrees now following the second set of injections and procedure. Still not there yet but the results are more encouraging now. I could probably live with the current extent of contracture even if there were no further improvement.

The finger was MUCH sorer and more tender following this set of injections than the first time and there's still some quite prominent swelling and discoloration including a particularly nasty looking red scabby thing on the outside of the PIP knuckle. And if I whack the thing just right, it's a definite "owie". The doctor seemed to think it no big deal however.

Third and final set of injections scheduled for the middle of next month. Hopefully there'll be some further improvement in the interim and the third time will be a charm. In the meantime, it's back to the exercises and the night time split.




01/05/2008 05:14
bshatzer 
01/05/2008 05:14
bshatzer 
Re: Auxilium AA4500 Trials Report.

It's now a bit more than two weeks after the second set of injections and the "procedure".

There's been some improvement in the angle of the joint though not a lot. But the finger looks really ugly. Still somewhat swollen, still somewhat discolored and bits of skin flaking off at the injection sites.

And, while the finger joint is a bit straighter, after taking off the hand splint in the morning, I can't make a fist - the finger just doesn't want to contract. It loosens up during the day but first thing in the morning, it's almost "reverse dupuytren. Rather than contracting involuntarily, the darn thing doesn't want to contract at all.

Still, the overall improvement is there. While I'm not looking forward to the third (and final) set of injections and the following "procedure", it's generally been worth it even if the joint ultimately falls short of complete straigtening .

01/05/2008 22:26
GPM 
01/05/2008 22:26
GPM 
Re: Auxilium AA4500 Trials Report.

Wow, it really sounds like you've had a tough go of it. I wonder how many others have had injections directly into the finger as opposed to the palm. Since my starting contraction (25%) was so much less I only needed the one injection to reach zero degrees. I still wear the hand splint most nights and have stiffness when I remove it in the morning. Generally within a few minutes it subsides. Good luck with your final injection. It will be interesting to hear what the doctor tries next.

01/08/2008 16:37
jocond 
01/08/2008 16:37
jocond 
Re: Auxilium AA4500 Trials Report.

bshatzer,

Hey, What city do you live in and what city are you participating in the trials at? I'm currently doing mine in State College, PA. I live about an hour away from there.

Thanks,

Joe Conrad

01/08/2008 20:24
Wanker 
01/08/2008 20:24
Wanker 
Re: Auxilium AA4500 Trials Report.

I had the needle by Dr. Eaton three years ago. My finger is still straight. I had very little pain. I actually enjoyed chatting with Dr. Eaton while he worked on my little bent finger. I am concerned about the pain and trouble told by the Auxilium AA4500 patients. I am sure I would prefer the "French Neddle" should I have a bent finger again.

I add that I email a picture of my finger to Dr. Eaton every 3 months. I hope many of his patients do the same.

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improvement   probably   injections   recurrence   degrees   Auxilium   collagenase   patients   dupuytren-online   because   Collegenase   Surgery   fingers   Wolfgang   swelling   straight   contraction   injection   procedure   treatment