Scientific study behind Selincro

Martrol · **Joined:** Sat Sep 06, 2014 8:48 am **Posts:** 25

Hi everyone,

If you are interested here's a link to the main study that made Selincro available. It's the largest study so far confirming the efficacy of TSM (667 participants):

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3746807/

plantpr0 · **Joined:** Mon Mar 31, 2014 11:06 am **Posts:** 353

Ty for the link Martrol. It's great information to have and the research seems to validate what's happing on this board. My mind isn't that scientific and it would be great if someone could break it down for me in simple laymans terms. Most of the information goes right over my head. Ha ha.....But this is what we need and more of. Thanks again.

Magda · **Joined:** Thu Jun 19, 2014 1:40 am **Posts:** 190

The difference between nalmefene and placebo, while statistically significant, is not very impressive if I'm reading this correctly.

Quote:

... a treatment effect of −2.7 HDDs/month (95% CI: −5.0 to −0.3, P = 0.0253) in favour of nalmefene.

HDDs = Heavy Drinking Days

Quote:

... a treatment effect of −10.3 g/day (95% CI: −20.2 to −0.5, P = 0.0404) in favour of nalmefene.

10 grams is a couple of teaspoons.

I wish they had done genetic testing on the participants.

Martrol · **Joined:** Sat Sep 06, 2014 8:48 am **Posts:** 25

Magda,

Thanks for your comment.

In my opinion, what's important is that the protocol works. And in a post study: http://www.ncbi.nlm.nih.gov/pubmed/24671340

They concluded that there were a 67% reduction of alcohol consumption in patients receiving Nalmefene after 1 year.

Guapo · **Joined:** Fri May 09, 2014 10:08 am **Posts:** 438

You are correct that the reduction is minimal, and there are those in Europe that believe the study is somewhat invalid and unconvincing.

This is from an editorial I read in the British medical Journal.

That being said, I did obtain some Selincro in England, but none of the pharmacies had even heard of it, and it was nearly impossible to obtain any.

It is essentially the same molecule as naltrexone, but with a chemical substitution. It lasts significantly longer in your system, actually up to a week.

Anecdotally, I don't know that it works any better than naltrexone, but it did lead to some vivid and unsettling dreams which naltrexone did not do.

Martrol · **Joined:** Sat Sep 06, 2014 8:48 am **Posts:** 25

Guapo wrote:

You are correct that the reduction is minimal, and there are those in Europe that believe the study is somewhat invalid and unconvincing.

Hi Guapo,

I think it's important to notice that the reduction is far from minimal. The reduction is around 60%.

Magda · **Joined:** Thu Jun 19, 2014 1:40 am **Posts:** 190

Martrol wrote:

They concluded that there were a 67% reduction of alcohol consumption in patients receiving Nalmefene after 1 year.

Not at the link you provided. Where are you getting that number?

Quote:

... but at month 13, nalmefene was more effective than placebo, both in the reduction of the number of heavy drinking days (HDDs) (- 1.6 days/month (95% CI - 2.9; - 0.3); p = 0.017) and the reduction of total alcohol consumption (TAC) (- 6.5 g/day last month (95% CI - 12.5; - 0.4); p = 0.036).

1.6 fewer heavy drinking days a month and 6.5 fewer grams a day reduction compared to placebo after a year. A standard drink in the US has 14 grams of alcohol.

Martrol · **Joined:** Sat Sep 06, 2014 8:48 am **Posts:** 25

Magda wrote:

Not at the link you provided. Where are you getting that number?

Hi Magda,

No, the number is not directly available in this link. It's only referring to the abstract of the study. Here is a link to a more detailed summary (read conclusion):

https://www.dropbox.com/s/abdsdqu477ysn8t/7120.jpg?dl=0

PS. In regards to TSM -- also look at the nice extinction curve.

Magda · **Joined:** Thu Jun 19, 2014 1:40 am **Posts:** 190

Thanks, but the conclusions are no different. The 67% decrease was compared to baseline, not to placebo - which, if you'll notice, also produced an impressive extinction curve.

Another weird thing:

Quote:

Large non-specific treatment response: 39% of the patients substantially reduced drinking between screening and randomization

It appears that merely screening someone for alcoholism is an effective treatment.

What I conclude after reading that study is that human alkies are really, really unpredictable.

Martrol · **Joined:** Sat Sep 06, 2014 8:48 am **Posts:** 25

@Magda

Yes, it's compared to baseline, which is what's important in my opinion. The placebo effect is of course important in regards to getting a drug approved. But nevertheless nalmenfe was still significantly more effective than placebo though not much.

Yes, humans are indeed complex. But the TMS protocol works, and frankly I don't care if it's only slightly significantly better than placebo.

Scientific study behind Selincro

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