RBE-baclofen

Opinion of the experience based research group of baclofen users in The Netherlands



on the outcome of the study published in Neuropsychopharmacology, december 2016 (doi: 10.1016/j.euroneuro.2016.10.006. Epub 2016 Nov 11.) Efficacy and safety of high-dose baclofen for the treatment of alcohol dependence: A multicentre, randomised, double-blind controlled trial.

Beraha EM, Salemink E, Goudriaan AE, Bakker A, de Jong D, Smits N, Zwart JW, Geest DV, Bodewits P, Schiphof T, Defourny H, van Tricht M, van den Brink W, Wiers RW.

Abstract on http://www.ncbi.nlm.nih.gov/pubmed/27842939:

In the present study the efficacy and safety of high doses of baclofen was examined in a multicentre, double-blind, placebo-controlled trial. 151 patients were randomly assigned to either six (start/buil-up) + ten weeks high-dose baclofen (58 patients, average was 93.6mg), low-dose baclofen (31 patients, 30mg), or placebo (62 patients).

The primary outcome measure was time to first relapse. No differences between the three groups were found in the time to first relapse during the 16-weeks complete medication period.
There were frequent dose-related adverse events in terms of fatigue, sleepiness, and dry mouth, although generally mild and transient.

Therefore, large-scale prescription of baclofen for the treatment of AD seems premature and should be reconsidered.

Half a million euros from an anonymous donor for 5 years of study in multiple (I think 4!) 12-steps-like addiction centres, for ONLY, mind you, 151 patients with max 16 weeks of trial, led by professor Wiers RW, Faculty of Social and Behavioural Sciences - University of Amsterdam, who only published or was co-author of studies in the field of a psychological approach to addiction.

With the combination of an old school addiction program! In addiction centres with no interest whatsoever in a cheap patent free, already decades long widely prescribed and proved very save, substitution for their core-business: long, expensive, difficult, with relapse after relapse, guilt-overloaded, 90-95% useless proven methods for treating addiction.

Why 4 centers? Why 5 years? Why only 151 patients? Why in combination with old fashioned therapies? Why the time to first relapse as the primary measure for the efficacy of (high doses of) baclofen? Why call 94 mg a high dose of baclofen? (this is actually considered a medium dose of baclofen). Why led by a professor in Social and Behavioural Sciences with almost only publications in the field of a psychological approach to addiction?

We, an experience based group of baclofen users in Amsterdam, The Netherlands, are very sad about the (though already expected AND predicted by other scientists) outcome of the very (too) long awaited result of this study. And of course sad that the real story and the real working of this medication is once again compromised.

In short the working of this medication is that it doesn't make you not drink or take other substances, but that it reduces the craving, the sickly seeking and wanting the alcohol or substance of abuse. It takes the addiction away from the using as non addicts do. It goes even further, in that way that it makes you just forget about taking another drink or something else. You open a bottle of wine and the next day you realise only half the bottle is gone! THAT's, in short, the main working of this medication!

We can imagine that while talking the whole day about not noticing the pink elephant in the room in one of these addiction centers has the opposite effect for all groups, high dose, low dose or placebo. And finally there is this recent study on how strong placebo is working even when people are told they are the ones getting the placebo! A lot of studies are worthless in this new light.

Then there is this new argument: Maybe baclofen itself is a drug that is addictive! OK, well, physicians with a need for an excuse NOT to prescribe baclofen: let's wait another 20 years to see if there is a substantially amount of baclofen-addicts! We can tell you, that if there is a "drug"-element to baclofen it is not more a drug than a SSRI is for depression. So please, don't let your patients needlessly die or dwindle in any way related to this really bad and sad condition without any perspective on a normal life, called addiction, while you CAN really help them with for a start 80 mg's of baclofen (maximum in the Dutch Farmacotherapeutisch Kompas for non-off-lable use).

It actually has things in common with depression. Not that it makes euphoric but it can take a depressed mood subtly away. Avoiding you to grab a bottle that is! As "normal" people won't experience these mood swings anyway and won't feel the effect of baclofen. Let's also put it this way: If you feel good already, you won't feel better with baclofen. Actually on the contrary!

Greetings from The Netherlands!



to compare:

https://www.ncbi.nlm.nih.gov/pubmed/26048580: "related to the low to medium dosages of baclofen used in these studies (30-80mg/d)."

and a completly different conclusion!







in text:

Send to Eur Neuropsychopharmacol. 2015 Aug;25(8):1167-77. doi: 10.1016/j.euroneuro.2015.04.002. Epub 2015 Apr 14.

High-dose baclofen for the treatment of alcohol dependence (BACLAD study): a randomized, placebo-controlled trial. Müller CA1, Geisel O2, Pelz P2, Higl V2, Krüger J2, Stickel A2, Beck A2, Wernecke KD3, Hellweg R2, Heinz A2. Author information


Abstract
Previous randomized, placebo-controlled trials (RCTs) assessing the efficacy of the selective γ-aminobutyric acid (GABA)-B receptor agonist baclofen in the treatment of alcohol dependence have reported divergent results, possibly related to the low to medium dosages of baclofen used in these studies (30-80mg/d). Based on preclinical observations of a dose-dependent effect and positive case reports in alcohol-dependent patients, the present RCT aimed to assess the efficacy and safety of individually titrated high-dose baclofen for the treatment of alcohol dependence. Out of 93 alcohol-dependent patients initially screened, 56 were randomly assigned to a double-blind treatment with individually titrated baclofen or placebo using dosages of 30-270mg/d. The multiple primary outcome measures were (1) total abstinence and (2) cumulative abstinence duration during a 12-week high-dose phase. More patients of the baclofen group maintained total abstinence during the high-dose phase than those receiving placebo (15/22, 68.2% vs. 5/21, 23.8%, p=0.014). Cumulative abstinence duration was significantly higher in patients given baclofen compared to patients of the placebo group (mean 67.8 (SD 30) vs. 51.8 (SD 29.6) days, p=0.047). No drug-related serious adverse events were observed during the trial. Individually titrated high-dose baclofen effectively supported alcohol-dependent patients in maintaining alcohol abstinence and showed a high tolerability, even in the event of relapse. These results provide further evidence for the potential of baclofen, thereby possibly extending the current pharmacological treatment options in alcohol dependence.

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see also Dutch Wikipedia page about baclofen for more references, page itself is in Dutch, but you can push the translate button. The references are most in English though