That's what is misleading, in my opinion. Considering the side-effects of nalmefene (which make some people quit taking it or unable to take it) when it looks like one can get comparable results by taking no drug at all.

When one considers the dropouts due to adverse events, I wonder if placebo doesn't come out on top.


Nalmefene was statistically significantly more effective. It's misleading to say it was significantly more effective, because it wasn't in the general use of that word.


People who experience side-effects would probably disagree. And it wasn't slightly significantly better than placebo. It was just slightly better than placebo. That use of language just sounds like drug company spin.


Are you really this impressed that 13 months of taking a drug that has side-effects made participants ingest an average of a teaspoon less alcohol a day? Because I'm actually dismayed by the results.

Anyone have a link to the full paper? The abstract didnt have enough detail for me to really draw any conclusions. In particular, Id like to know more information on the "as needed" is in regards to dosing, and data on compliance and if non-complying subjects were seperated out in the data. I also found the directive to dose including the instructions saying something like "or soon after starting to drink" troubling.

@Magda

Yes, I meant statistically significant, thanks for pointing that out.


"Mean number of HDD decreased from 19,1 to 6,9 days/month and the mean TAC decreased from 100 to 33,3 g/day in the nalmefene group at month 13."

I believe that's a noteworthy result. Ex. it means that you decreased your daily alcohol consumption by 8,4 units (UK) or about 23 teaspoons of pure alchohol (UK).

@sideeffect2

Can't help you with that sorry.

The horse is clearly dead, but... The placebo produced a similar "noteworthy" result. Do you think the results merit using nalmefene over a sugar pill, considering the side-effect profiles and cost of each? I don't.

The reason these things are double-blinded is so a more accurate conclusion about efficacy can be drawn. I hate to feel that you need this pointed out, but there is evidence that you do: Conclusions about efficacy are drawn by comparing placebo group results to treatment group results, not by comparing before and after of the treatment group and ignoring the placebo group outcomes.

For the life of me I don't see how posting impressive-looking stats (e.g. "67% reduction") that leave out the fact that the majority of the improvement is due to placebo effect is helpful to anyone.

Incidently, Lundbeck (the makers of Selincro) funded the study in question.

@Magda

I appreciate your comments.

Nevertheless, the link is there if people want to read the study that paved the way for making nalmefene available to the public in Europe and with the right indication in regards to TSM protocol. Hopefully this makes it much easier for people getting help using TSM.

So, according to this site http://www.rupissed.com/standarddrinks.html, 10 grams of alcohol is approximately one standard drink - at least in Australia. So the report is saying (at least I think it is) that, at the six month mark, the Nalmafene group is consuming between one and one and a half standard drinks a day less than the control group, and a reduction of approximately 3 days per month of heavy drinking compared to the control group. That does seem statistically significant, but hardly the cure in three months promised by the Sinclair Method.

c