Baclofen: a 2-year observational study of 100 patients just published

[LadyLush]

Baclofen: a 2-year observational study of 100 patients just published

In a nutshell Otter what?

My Friend of course!

[Ne/Neva Eva]

Baclofen: a 2-year observational study of 100 patients just published

hmmmm. This study is confusing. At best. You all know (or some of you do anyway) that I'm a big proponent of getting information about baclofen out to the whole wide world.

ach. Never mind! Let's just say I'm glad there are other studies in the works.

Hope it's a good day/eve/night everybody.

[DonQuixote]

Baclofen: a 2-year observational study of 100 patients just published

Hi Eva

First of all, I am German, my English is poor, and so it is not easy for me to follow in a exactly way all your text or the entire text of the presented study or to express myself as I would to. But just let me say this:

When you study a treatment, the treatment has to be completely accomplished, following the rules of the treatment. If the treatment (Patient) did not follow these rules or the treatment has not been accomplished, then you cannot, at the end, say anything about this single case.

However, the results are wildly better than any other results for any other therapy against alcoholism. Agreed?

DonQuixote

[Ne/Neva Eva]

Baclofen: a 2-year observational study of 100 patients just published

DonQuixote;1447090 wrote:
However, the results are wildly better than any other results for any other therapy against alcoholism. Agreed?

I am a bit disappointed with the paper. It is a good therapy against alcoholism. I wish we had actual research to verify what it is capable of doing, and how to overcome the obstacles. If people can't take the medication because the side effects are too much of a burden (and they are) then it won't work for many people.

Thanks again, Don. Onward!

EDIT: Your English is fine, and it is much better than my German. I really do appreciate you sharing this information with us.

[Colin]

Baclofen: a 2-year observational study of 100 patients just published

Ne/Neva Eva;1447231 wrote: I am a bit disappointed with the paper.

I was very encouraged. Here is my take on the paper:-
[Q1, Q2.... are successive quotes from the paper.]

Q1: A hundred patients with alcohol dependence, resistant to usual treatments, were treated with escalating doses of baclofen (no superior limit).

Q2: Results: While all patients were rated ?at high risk? at baseline, approximately half of them were rated ?at low risk? at 3, 6, 12, and 24 months. The sum of patients who were at ?low risk? and at ?moderate risk? (improved patients) was 84% at 3 months, 70% at 6 months, 63% at 1 year, and 62% at 2 years. The constancy of improvement over the 2-years was remarkable.

Colin: With 100 patients there is no distinction between absolute patient numbers and percentages.
Colin: 84, 70, 63, 62 is a better progression than it might seem because patients were losing contact with the researcher during the period covered.

Q3: Conclusion: Baclofen produces an effortless decrease or suppression of alcohol craving when it is prescribed with no superior limit of dose. Potential limitations in the effectiveness of baclofen include the coexistence of a mental disorder, the concomitant use of other psychotropic drugs, a lack of real motivation in patients to stop drinking, and the impossibility to reach the optimal dose of baclofen because of unbearable side-effects (sometimes possibly related to too sharp a protocol of dose escalation).

Q4: One hundred and thirty-two alcohol-dependent patients (DSM-IV criteria) were consecutively seen between November 2008 and August 2009. Among them, 32 were excluded because they were lost before the third month of follow-up (some of them provided no feedback after the first visit, others stopped taking their medication rapidly, generally arguing they could not bear the adverse effects of baclofen, and some acknowledged that they were not motivated to stop drinking). These patients were not included in the follow-up because the purpose of the study is to evaluate precisely the effects of baclofen, and treatment-observant patients are needed to achieve this objective

Colin: From here on the 32 excluded above are not mentioned.

Q5: As a whole, 24 patients did not use the protocol of dose increase exactly as described above.

Colin: As with all baclofen studies there is very clearly "no suit fits all".

Q6: Results
Patients included 70 men and 30 women, with an average age of 47 (men 48, women 45, p = 0.197).

A hundred patients were followed at 3 months, 97 at 6 months, 92 at 12 months, and 87 at 24 months. Among the 13 lost patients at 24 months, 11 had moved providing no feedback, and two had died (one accidental ingestion of a cleaning product, one false passage ? both unlikely to be related to baclofen treatment). The number of patients who discontinued baclofen for whatever reason came to 25 at 6 months, 51 at 12 months, and 58 at 24 months.

Q7: Ninety-two patients (92%) reported a decrease in their motivation to drink at one time or another during the follow-up. At baseline, all patients belonged to the WHO ?at high risk? category. At 3 months, 50% of the responses were classified as ?at low risk,? 34% ?at medium risk,? and 16% ?at high risk?; at 6 months, the percentages were respectively 52, 18, and 27%, they were 48, 15, and 29% at 1 year, and 50, 12, and 25 at 2 years (percentages refer to the 100 patients included; Table 2). Treatment discontinuation increased over time. At 2 years, 45 patients had stopped their treatment, and this concerned all patients in the ?at high risk? group, 10 out of 12 in the ?at medium risk? group, and 10 (20%) in the ?at low risk? group.

Colin: Apparently Xadrian and a few others might belong to the 20% of "completely in control" baclofentists who can reduce to zero. The 10 of 12 in the ?at medium risk? group are living life at the edge but if they fall off they know what to do - just ask TexasAg.

Q7: http://c431376.r76.cf2.rackcdn.com/3...00103-t002.jpg

[MaryGoRound]

Baclofen: a 2-year observational study of 100 patients just published

I am very, very pleased with this study. I know we all have a different take on it but this is my simplified version.

1. Of all the people remaining in the study at 2 years (87 people), there is a 57.5% success rate (high risk to low risk)

2. In the success group, 80% were still in compliance (taking Bac as suggested)

3. Of the 33% that remained in the high risk group, 100% of them had discontinued treatment

4. Over 90% of all patients in the original group said BAC relived their cavings

I have looked and looked for this kind of success rate for alcoholism and I have never seen such good results. It confirmed what we keep hearing...just keep taking the damn pills!

[DonQuixote]

Baclofen: a 2-year observational study of 100 patients just published

Hi @all

The journals review-policy you can find here.

http://www.frontiersin.org/Addictive_Disorders_and_Behavioral_Dyscontrol/reviewguidelines`

The article itself was reviewed by Giovanni Addolorato, Catholic University of Rome, Italy and Lei Liu, University of Virginia, USA.

DonQuixote

[Hippyman]

Baclofen: a 2-year observational study of 100 patients just published

DonQuixote;1425009 wrote: Hi @all


I don?t think so. The results of two big French clinical studies should come in 2014. But I see serious problems in recruiting the necessary number of participants, so it will be probably in 2015. Then the results have to be published, acknowledged and accepted by the physicians. After that somebody has to run for an application for admission. I fear that all this will take years and years.


Well done, Xadrian! And don?t forget to spread the ?Baclofen prescribing guide? you can find here...

DonQuixote

P.S. Sorry, my English isn?t so good.

Don, Your English is fine and your help is much appreciated by so many of us! Thanks so much!!!

[Ne/Neva Eva]

Baclofen: a 2-year observational study of 100 patients just published

There were only 42 or 55 people that were compliant at the end of the study. (There are two numbers there. One says that 45 people stopped taking bac. The other says that 58 people stopped taking bac.)

The number of patients who discontinued baclofen for whatever reason came to 25 at 6 months, 51 at 12 months, and 58 at 24 months.

and a little later in the paper,

At 2 years, 45 patients had stopped their treatment

, and this concerned all patients in the “at high risk” group, 10 out of 12 in the “at medium risk” group, and 10 (20%) in the “at low risk” group.

The rest of the numbers are off, too.

I did a little bit of due diligence about who reviewed the article, and how articles are reviewed on Frontiers. It's fascinating! But it's also not a peer reviewed journal. And there is no way that this study would or could stand up to any scrutiny at all. There's no scientific method. It's very likely a reflection of the fact that the person who wrote it isn't a researcher or something. And maybe some of the confusion is in the translation.

Addolorato, who has my utmost respect and seems to be a really legitimate guy, has a vested interest in baclofen.
Liu and one other read it. Doesn't mean they approved of or endorsed it.

It's good news. We know that bac works. I know that bac works. But I was disappointed in this article. Still, it is good news. But beware, please of any article anywhere about anything that promises these kind of results. It's bad for people. It's bad for bac. And it's bad for any attempt at finding some sort of legitimacy for alcoholism treatment based on science. In my opinion.

[Ne/Neva Eva]

Baclofen: a 2-year observational study of 100 patients just published

I was very heartened that there was at least a little discussion about side effects! Though Dr. de Beaurepaire insists that they are benign (and I suppose anything that doesn't last/grow is benign) it is a beginning! I feel like this particular topic, when openly discussed by professionals, will really help people. Hopefully it will help identify them, find a cause, or ways to mitigate/lessen them, and definitely improve management of them!

I'm not trying to be negative. I would just like to be pragmatic about all of this.

[Ne/Neva Eva]

Baclofen: a 2-year observational study of 100 patients just published

Colin;1447293 wrote:

Q3: Conclusion: Baclofen produces an effortless decrease or suppression of alcohol craving when it is prescribed with no superior limit of dose. ... a lack of real motivation in patients to stop drinking, and the impossibility to reach the optimal dose of baclofen because of unbearable side-effects (sometimes possibly related to too sharp a protocol of dose escalation).

I think that's a bit ironic. Or at the very least, very funny. It's effortless, unless you don't really try or you can't take gobs of it because the side effects are unbearable.

[MaryGoRound]

Baclofen: a 2-year observational study of 100 patients just published

I think the discrepancies in the numbers is caused by the fact that they lost track of 13 people from the original 100 people used in the baseline. At the end of year 2, only 87 were still part of the study. It is assumed that the 13 people who were no longer being tracked were non-complient.

Interesting point about the the perspective of the author and reviewers. I agree this was not a scientific study (especially in regard to double-blind and control group methodologies) but it was a fascinating observational study.

The other point is that all participants were failures in other rehabilitation programs. These were not people who were using Bac as their first treatment option.

I also liked the fact that they talked about the SEs. Many people found them intolerable but in no case (at least documented in the study) were the SEs life-threatening. Love the word word benign. The point is to keep the SEs in perspective. We know that long term alcohol use has serious negative consequences to health. Insomnia or nausea can feel like hell at the time but it is better than a crippled liver or cancer. I need to keep reminding myself of this point when I lose faith.

[Hippyman]

Baclofen: a 2-year observational study of 100 patients just published

MaryGoRound;1447863 wrote: I am very, very pleased with this study. I know we all have a different take on it but this is my simplified version.

1. Of all the people remaining in the study at 2 years (87 people), there is a 57.5% success rate (high risk to low risk)

2. In the success group, 80% were still in compliance (taking Bac as suggested)

3. Of the 33% that remained in the high risk group, 100% of them had discontinued treatment

4. Over 90% of all patients in the original group said BAC relived their cavings

I have looked and looked for this kind of success rate for alcoholism and I have never seen such good results. It confirmed what we keep hearing...just keep taking the damn pills!

YEP Mary, Great news for sure. I started with the pills but the liquid is less expensive and has had almost no side effects for me. I like the liquid much better but keep taking the bac ...anyway you can get it. 90% said...IT WORKS!!!

[Ne/Neva Eva]

Baclofen: a 2-year observational study of 100 patients just published

MaryGoRound;1448000 wrote:
The other point is that all participants were failures in other rehabilitation programs. These were not people who were using Bac as their first treatment option.
I agree! And that was definitely my situation. Bac was a last resort. I had tried, I thought, everything else. And there was no way and nothing going to stop me even though I was scared and it's weird and even I thought it was crazy to do it. :H

MaryGoRound;1448000 wrote: ...Many people found them intolerable but in no case (at least documented in the study) were the SEs life-threatening.

Yep. Bac'll mess you up, but it won't kill you. :H (Mess you up means...well, what I really want to say is that it will f*ck you up. I'm pretty sure that doesn't need translation. Forgive the vulgarity.)

It is all about perspective, in my opinion. I might have lived a very long life, and thought that I was even sort of content-ish, as a drunk. I know some people like that. But the truth is that my life was lousy, the things I was protecting (my job) or was really scared of (financial insecurity) are SO MUCH BETTER without booze. And I kind of suspected they might be. It was worth a shot, because I was shrinking every year...with every damn drink the real me was getting smaller. Anyway. Back to the point! (Too bad they can't quantify that in a study, huh? If you could find that in a pill, the whole world would want some. Oh. Wait. I did find that in a pill. )
Hang in there Mary. I'm looking forward to your, "Holy Cow It's Happened to ME!" post. :l

[Colin]

Baclofen: a 2-year observational study of 100 patients just published

Humpty Dumpty

Humpty Dumpty | Through the Looking Glass, by Lewis Carroll

Ne/Neva Eva;1447944 wrote: I did a little bit of due diligence about who reviewed the article, and how articles are reviewed on Frontiers. It's fascinating! But it's also not a peer reviewed journal. And there is no way that this study would or could stand up to any scrutiny at all. There's no scientific method. It's very likely a reflection of the fact that the person who wrote it isn't a researcher or something. And maybe some of the confusion is in the translation.

Addolorato, who has my utmost respect and seems to be a really legitimate guy, has a vested interest in baclofen.
Liu and one other read it. Doesn't mean they approved of or endorsed it.

"When I use a word," Humpty Dumpty said in rather a scornful tone, "it means just what I choose it to mean -- neither more nor less."
"The question is," said Alice, "whether you can make words mean so many different things."
"The question is," said Humpty Dumpty, "which is to be master - - that's all."
(Through the Looking Glass, Chapter 6)


If Addolorata and Liu are not peers of de Beaurepaire then I am the Mad Hatter.

"has a vested interest in baclofen. " don't we all?

"Reviewed by:Giovanni Addolorato, Catholic University of Rome, Italy
Lei Liu, University of Virginia, USA" - quoted from the paper in question.

This strongly suggests that they not only read the paper but also reviewed it. I might be wrong in suggesting that this implies they both approved and endorsed. Then again I might be right.

"No scientific method" - WHAT?

Have I forgotten anything? Oh yes.

"person who wrote it isn't a researcher" I would be very surprised if he is not a fully qualified researcher but to give the benefit of the doubt - maybe.