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**Lo0p** · September 17, 2010, 03:10 PM

Here's a Google translation of the full study

Do we have the full study posted here somewhere already?

I've got the full, official original PDF if anybody wants it. It is in French though, but it's the full one and not just the abstract.

**Lo0p** · September 17, 2010, 04:24 PM

Here's a Google translation of the full study

Here's a screenie of the first page:

**wort** · September 17, 2010, 06:09 PM

Here's a Google translation of the full study

Lo0p,

Many thanks!

-wort

**Seethepony** · September 18, 2010, 03:08 AM

Here's a Google translation of the full study

"a series of suicide attempts of 23 consecutive patients with massive doses of baclofen (up to 2.5 grams) was published"

There's a Monty Python sketch in there, I think... (how the hell do you obtain 2.5 grams of a substance that comes in 25mg tablets?! And how desperate do you have to be to think of Bacofen as a way of topping yourself?!)

Google did quite a good job on this translation. I had to translate something from a German kindergarten into English, and an innocent passage about parents volunteering to help with breakfast turned into something about child labour and cannibalism. Worst translation ever! (Luckily, I noticed.)

thanks for posting it, Lo0p.

**Pride before Fall** · September 18, 2010, 10:44 AM

Here's a Google translation of the full study

Guys, I don't want to be a buzz kill, but I assess this stuff for a living, and I feel obligated to comment even if it's potentially unpopular.

This article is of the very poorest quality. There's no way to reproduce it--rule 1 for a clinical study (there isn't even a methods section). There's no control group, no patient demographic or readiness-to change data ("participants read the book so came for treatment" is not RTC--did they adjust for motivation bias?), no selection criteria or exclusions. Were patients screened for conditions contraindicating baclofen treatment (eg, kidney disease)? Did participants have abuse or dependence Were they taking bac (self-medicating) at baseline? Were they taking anything else that could be potentially harmful (barbiturates, benzos)? Did they receive adjunct therapy (participate in group or individual substance-abuse treatment)?

They list one of the criteria for dependence, yet didn't assess severity despite validated screening tools. If they did, where are the data, and whaat effect did severity have on outcomes? Was follow-up at 3 months (Abstract) or sometime "more than 3 months" (Discussion)?

Here where it says about ref 14: "A series of suicide attempts of 23 consecutive patients with massive
doses of baclofen (up to 2.5 grams) was published. Among them, some just needed to be observed or treated in intensive care. Not a single death has occurred and all patients left the hospital without sequelae [14]."

Here are the results from the actual ref. 14 (there's no evidence presented that all the ODs were suicide attempts, either): "Doses greater than 200 mg were predictive of patients developing delirium, coma and seizures, requiring long hospital admissions and ICU admission."

Scanning a couple of other references, and they're just plain wrong. For example, Ref 2, 'Effectiveness and safety of baclofen in the treatment of alcohol dependent patients," is Leggio et al 2010, not Addolorato (Lancet 2007). Peer review would have caught this. Annales M?dico-Psychologiques is not indexed in PubMed, meaning it does not meet the minimum quality standards for inclusion.

Under Conflict of Interest it lists "none." At a minimum, Ameisen should disclose that he receives royalties on his book, but more important, he should disclose that he has a pending patent application on baclofen. TREATMENT OF ADDICTIVE DISORDERS - Patent application - the treatment of addiction and particularly to addictions with a chemical dependency component

The only reliable information in the article is this: "The removal of alcohol dependence by the high-dose baclofen should be evaluated by randomized clinical trials." Absolutely true, but there haven't been any clinical trials of baclofen for alcohol use disorders in humans at doses > 30 mg, and, of the 3 RCTs for doses up to 30 mg, results were inconsistent.

I'm NOT pro or con baclofen; it appears to have worked at high doses for several people here, and I couldn't be happier about that. I am con bad science, though, and I urge people to seriously weigh the merits of an article that claims to "completely remove the dependency on alcohol without effort." They might hold water, but as in this case, they might not.

**Lo0p** · September 18, 2010, 11:09 AM

Here's a Google translation of the full study

I'm very disappointed now that I've read the entire thing. It seems much more of a fanfare piece than a description of a study.

These need to be performed correctly in the future and Ameisen's protocol tested...but not by him.

**Rusty** · September 18, 2010, 11:34 AM

Here's a Google translation of the full study

Lo0p,

Thanks so much for taking the time to post this information. I really appreciate it.

**wort** · September 18, 2010, 03:15 PM

Here's a Google translation of the full study

Pride before Fall,

I'm not sure I agree completely with your assessment.

First, the manuscript is fairly clear in that this is not a Randomized Controlled Trial (RCT); the title refers to it as an "open trial" and in the Conclusion as an "observational study." This manuscript merely reports the results of offering high-dose baclofen treatment to a fairly large number of patients with serious alcohol dependence.

I agree with you that a RCT would be more interesting. There is a useful Wikipedia article on RCT's that points out an issue that has been discussed on this site frequently. RCT's are very expensive, an so are commonly funded by the pharmaceutical industry. Note that baclofen is "out of patent," so there are no pharmaceutical industries with an incentive to fund a trial. Even if there were, the results might be questionable. According to the Wiki,

"Pro-industry findings in industry-funded RCTs
Some RCTs are fully or partly funded by the health care industry (e.g., the pharmaceutical industry) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986-2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome.[63] A 2004 study of 1999-2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs "are more likely to be associated with statistically significant pro-industry findings."[64] One possible reason for the pro-industry results in industry-funded published RCTs is publication bias.[64]"

Perhaps at some point, there will be federal funds for an unbiased RCT; until then, I am grateful for whatever observational evidence becomes available.

I have a few more quibbles. I found this on Reference [14]:

"Results: There were 23 presentations, of which eight patients ingested baclofen alone. Seizures were reported in four cases, a decreased level of consciousness (GCS < 9) occurred in eight patients and delirium was recorded in eight patients. Five patients had miosis and seven patients had dilated pupils, 13 patients had absent or depressed reflexes. The only arrhythmias were sinus bradycardia in six patients and sinus tachycardia in five. Hypertension occurred in 13 patients and hypotension in one. The reported total ingested dose of baclofen was known in 19 patients (Mean 630 mg, SD 730 mg; 80?2500 mg). A higher ICU admission rate, rate of mechanical ventilation and prolonged length of stay occurred in those ingesting 200 mg or more. Coma, delirium and seizures occurred only with doses of 200 mg or more, and hypertension was more common with higher doses."

Somehow, in the translation, this becomes:

"The safety of baclofen is considered particularly remarkable: a series of suicide attempts of 23 consecutive patients..." Clearly, there is a disconnect between the ideas communicated on either side of the colon. My guess is that this is an artifact of the Google Translator.

Finally, you say: "Scanning a couple of other references, and they're just plain wrong. For example, Ref 2, 'Effectiveness and safety of baclofen in the treatment of alcohol dependent patients," is Leggio et al 2010, not Addolorato (Lancet 2007)..."

Google returns this:

Lancet. 2007 Dec 8;370(9603):1915-22.
Effectiveness and safety of baclofen for maintenance of alcohol abstinence in alcohol-dependent patients with liver cirrhosis: randomised, double-blind controlled study.
Addolorato G, Leggio L, Ferrulli A, Cardone S, Vonghia L, Mirijello A, Abenavoli L, D'Angelo C, Caputo F, Zambon A, Haber PS, Gasbarrini G. ...

Best,
-wort

**AllyB** · September 18, 2010, 03:43 PM

Here's a Google translation of the full study

Pride before Fall;962289 wrote: Under Conflict of Interest it lists "none." At a minimum, Ameisen should disclose that he receives royalties on his book, but more important, he should disclose that he has a pending patent application on baclofen. TREATMENT OF ADDICTIVE DISORDERS - Patent application - the treatment of addiction and particularly to addictions with a chemical dependency component
What is the date of this application? In interviews from last spring Ameisen said he was dropping his patent application.

Ameisen has filed a patent application, but for "prevention of relapse on baclofen". He says this was solely to block rehab centres from doing so, and that he is dropping it because it is "costly and useless". Though he could have done so, he says, he never applied for a patent for his treatment.

The little pill that could cure alcoholism | Society | The Observer

**Otter** · September 18, 2010, 04:51 PM

Here's a Google translation of the full study

I feel responsible for creating this monster, having posted the clinical findings.

When I saw the study was done by Ameisen my first thought was that it was going to be criticized as self promoting.

I wonder whether we are losing sight of the fact that people have been drinking alcohol presumably for thousands of years and it is a poison created by yeast to ward off animal predators. It is lethal to small animals, and humans, of course. We seem to have some sort of symbiotic relationship with the yeast that we yield huge swathes of land to allow it go spew forth its poison so that we can all have a few giddy moments of pleasure before it rots away our livers.

For the same length of time we have also had the idea that there is no antidote for this poison and this has turned into the cornerstone of alcohol treatment around the world.

Less than two years ago there were only a handful of people who had used Baclofen; now there are thousands who are free of alcohol.

The next step is to try to get the medical profession to take this seriously.

Maybe there are better forms of Baclofen; better methods of delivery of it. Maybe it needs to be taken more carefully and more patiently to avoid side effects. Maybe the people for whom it does not work need some different approach or complementary therapy.

The theory behind it though is probably correct, in that it is the GABA B receptors which are affected by alcohol. I would rather see some threads on where we go next rather than on whether it is all wrong because this or that study in which a lot of people stopped drinking did not disclose that Olivier Ameisen wants to help other people get well and wrote a book, applied for a patent etc. etc.. Really, who cares.

**Ne/Neva Eva** · September 19, 2010, 10:16 PM

Here's a Google translation of the full study

Hmmmm.
I've gotta take issue, here. I am sort of hoping to be completely shut down. But, dammit, what are the facts?
First. Why are you apologizing Otter? It works for you and yours, right? But suggesting something for us all to see? If we're all on board, and I am, we should all have as much access as possible.
That said, and with a nod to those that are free of this disease...
I want to be completely clear:
There are 60 people in this? selected because they sought treatment. (Could that be right?) 23 of them end up in emergency care...as suicide attempts. The 23 leave without a death among them. (Thankful about that.) I'm not clear about what they were taking or when.

THREE months? Seriously? This can't be suggested as a solution, much less a cure, if the follow up is 3 months. And it was published when? And please tell me I'm wrong about the 60 patients. That's what? you and me and a few others on here. Highly motivated...Read the book...Done the research...Willing to take the risk...In a place to actually take it...Done with being an alcoholic.
I was sober for longer in AA. Without the SEs.
lo0p and Tip, Dr. A's study seems to prove you're the exception, not the rule.
Seriously?

**Ne/Neva Eva** · September 19, 2010, 10:18 PM

Here's a Google translation of the full study

And thousands, Otter? Really? Where?

**terryk** · September 19, 2010, 10:36 PM

Here's a Google translation of the full study

neva eva;963499 wrote:
I want to be completely clear:
There are 60 people in this? selected because they sought treatment. (Could that be right?) 23 of them end up in emergency care...as suicide attempts. The 23 leave without a death among them. (Thankful about that.) I'm not clear about what they were taking or when.

Just to clear up - The 23 patients mentioned here were *not* part of the 60 in the study. That part of the document describes the safety of baclofen referring to other published medical literature (23 cases of overdoses - up to 2500mg of baclofen where no one died)
-tk

Edit: follow the reference 14 in the original document and do a medlines search on PubMed, this is what you get:

Emerg Med Australas. 2006 Feb;18(1):77-82.
Baclofen overdose: defining the spectrum of toxicity.

Leung NY, Whyte IM, Isbister GK.

Department of Clinical Toxicology and Pharmacology, Newcastle Mater Misericordiae Hospital, Waratah, New South Wales, Australia.
Abstract

OBJECTIVES: To describe the spectrum of toxicity of baclofen in overdose, and investigate dose-related clinical effects.

METHODS: Consecutive baclofen overdoses were identified from a prospective database of all poisoning admissions presenting to a regional toxicology service. Ingestion was corroborated on more than one occasion and from multiple sources. Demographic, clinical and outcome variables were extracted for each presentation for a retrospective review, and the data sets were divided into high dose (> or = 200 mg) and low dose (< 200 mg) groups for comparison of clinical effects.

RESULTS: There were 23 presentations, of which eight patients ingested baclofen alone. Seizures were reported in four cases, a decreased level of consciousness (GCS < 9) occurred in eight patients and delirium was recorded in eight patients. Five patients had miosis and seven patients had dilated pupils, 13 patients had absent or depressed reflexes. The only arrhythmias were sinus bradycardia in six patients and sinus tachycardia in five. Hypertension occurred in 13 patients and hypotension in one. The reported total ingested dose of baclofen was known in 19 patients (Mean 630 mg, SD 730 mg; 80-2500 mg). A higher ICU admission rate, rate of mechanical ventilation and prolonged length of stay occurred in those ingesting 200 mg or more. Coma, delirium and seizures occurred only with doses of 200 mg or more, and hypertension was more common with higher doses.

CONCLUSIONS: Baclofen overdose causes mainly neurological effects and excepting hypertension cardiovascular effects were uncommon. Doses greater than 200 mg were predictive of patients developing delirium, coma and seizures, requiring long hospital admissions and ICU admission.

**Lo0p** · September 20, 2010, 01:53 PM

Here's a Google translation of the full study

Seethepony;962076 wrote: how the hell do you obtain 2.5 grams of a substance that comes in 25mg tablets?!

*Ahem* No comment...

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