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some people on reddit saying naltrexone vs baclofen success rates are higher...


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neophyte

there is a new subreddit on reddit https://www.reddit.com/r/Alcoholism_Medication/

In the side bar it lists naltrexone as having a success rate as 78%, baclofen at 42-62%

I raised concern about this, since from my understanding baclofen is much more effective, so I made a post saying this is wrong, baclofen is closer to 70% based on the studies ive seen. 

I'll admit i havent dug into the naltrexone studies but i remember reading that the naltrexone studies were not as successful as baclofen, this was mention in Dr A's book and well it has become the defacto go to here. I don't really know where to start with this to say otherwise i.e. proof. 

My post is here Baclofen should be of higher consideration than naltrexone and other medications to treat alcoholism : Alcoholism_Medication

I was responded with this, not trying to start a war or anything but genuinely curious to anyone whos done any serious research into naltrexone as a solution and done digging into the studies and literature. The 78% figure seems overly high to me across 120 studies. I don't really know where to begin other than digging through pub med and im not reading 120 studies... 120 quality studies seems like a very high number given the limited quality studies we have seen with baclofen.

I was hoping someone learned in this area could educate me on this, what they think the success rates of natrexone are and the mechanism of action. I'll post my original post to reddit below. ill cross post this to the other forum as well. Hoping smart guys like TerryK can chime in.

Quote

Welcome, Neophyte! I knew it was only a matter of time before we'd hear from you. I don't particularly care to enter a discussion with respect to which method is superior as both have their strengths and weaknesses. Instead know that the sequencing in the margin is structured by success rates. TSM arrived at a 78% figure over 120 clinical trials and 30 years of research. I reviewed your materials on your sub as well as a number of other resources with regard to BAC's rates. You yourself say 'close to 70%' so I don't think my high of 62% to be inaccurate and unlike TSM it's notably lacking in clinical studies. Personally, I hope that will soon change. Also, augmenting the statistical data Baclofen is even less known in the U.S and U.K and arguably the world (I am aware that it is sanctioned in France.), has no medical support structure and overall is a harder to obtain medication as I understand it. I don't mention that to deride and instead to address additional obstacles and access issues. In any event the effort here is not to yardstick the finish line, but to provide thorough direction and understanding of people's options. I like to think I made a pretty fair case for Baclofen here. If you think something in particular, perhaps a resource or study, is worthy of attention kindly PM me and I can make adjustments to the margin guide.
 
Both you and 'Move' are more adept at articulating the finer biological points and modes of operations than I. That said I do take issue with a few of your general assertions or find them misleading:
 
"Many people on Naltrexone dont achieve abstinence but only reduce their consumption."
The goal of The Sinclair Method which utilizes Naltrexone as a tool is not to achieve sobriety per se. Instead through 'extinction' compulsions and cravings are removed. Thereafter, it's a personal choice for the individual as to whether they wish to continue drinking having reached a 'normal' state in that practice. Per the text and clinical trials 20% elect abstinence. Interestingly, in the U.K where Nalmefeme is exclusively prescribed we're seeing an anecdatal 40% electing abstinence. The correlation theoretically being that the latter medication has notable side effects and logistically one must wait (2) instead of (1) hour before consumption.
With 'extinction' / 'deaddiction' comes an exodus from the dualistic trappings of abstinent and not abstinent. Which suggests one is better than the other for an AUD sufferer. Namely right and wrong moralistically. Instead through TSM and retraining the brain alcohol takes on a healthy impermanence. Drinking, not drinking, drinking occasionally all blends together as a non-issue with no particular draw in any direction. No darkness resides over the activity in any variation. The path is the goal.
"...it also does not address cravings directly, only indirectly by alcohol having less of a euphoric effect."
The Sinclair Method utilizing Naltrexone as a tool and through a Pavlovian process retrains the brain thus removing compulsions and cravings. It should be noted that while it does remove the euphoric effect it still allows for inebriation and many still find some pleasure in that in a responsible manner.
 
We're glad to have someone knowledgeable about treating AUD with Baclofen join us. Again, welcome.
I listed your sub in our 'Additional Resources' section for BAC.

 


my original post:

Quote

I've been on baclofen since 2013 and have achieved sobriety with it. Before I started on baclofen I was looking to see if there were any medications that could assist after failed therapy, AA and abstinence only attempts.

I went through the pros and cons of each of the known drugs to help naltrexone/Nalmefene (u-opioid antagonists), baclofen (gaba-b agonist), topamax, campral and antabuse.

I narrowed it down to naltrexone and baclofen. looking over the studies baclofen has a higher success rate, more studies have since come out giving more evidence of this.

Many people on naltrexone dont achieve abstinence but only reduce their consumption, it also does not address cravings directly, only indirectly by alcohol having less of a euphoric effect. blocking u-opioid receptors is only one of the pieces of the puzzle in terms of what alcohol does in the brain to produce euphoria and cravings, by far gaba-a agonist activity and its effect on dopamine via modulation in the nucleus accumbens (reward center in the brain). The effect on the nucleus accumbens is the primary cause of cravings as over time alcohol down regulations dopamine receptors there. so alcoholics need to drink to feel normal / satisfy cravings.

Why baclofen works better as it directly addresses cravings by blocking dopamine release in the nucleus accumbens. gaba b receptors are located on the cell bodies of dopamine neurons. by activating gaba-b receptor via an agonist (baclofen) causes an inhibitory action on dopamine neurons, this is the primary mechanism through which baclofen suppresses alcohol stimulated dopamine release and in turn dopamine mediated alcohol reinforcement and motivated behaviors.

A review on alcohol: from the central action mechanism to chemical dependency

I'm not sure where the figure of 78% success rate of naltrexone in the side bar comes from, i dont recall figures exactly but they were much lower when i was looking at studies and baclofen is closer to 70%.
I hope that gives a good explanation as to why baclofen is a superior choice, there are studies that back this i.e. high success rates at abstinence and units of alcohol consumed.

I have a sub with loads of information about baclofen /r/baclofenforalcoholism not trying to steal traffic from this sub, its a good thing that there is a general discussion medication sub and I had toyed with starting one anyway. My motivation is that people simply need to be aware that there are other options than AA, which is completely unscientific or proven, and that there are better medications than naltrexone which people immediately jump to as a solution.

There is also a great forum where baclofen users discuss their experiences and theres more information there The End Of My Addiction - Forum discussing Baclofen, Naltrexone and Other Medications for the Treatment of Alcohol Dependence

other medications are discussed there too, that said if naltrexone works for you, then thats great. The only downside to using this is that in medical emergencies pain relief via opioids will not work.

 

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Baclofenman

Question 

This circa 78%?

Says who (not the /r) and what was the outcome this claim was based on? - 78% of people found, exactly what?

And this is on a TSM platform?

Regards

 

Bacman

 

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Baclofenman
Baclofenman said:

Question 

This circa 78%?

Ok - So I answered my own question

www.cthreefoundation.org said:

Of the 147 patients who had completed enough treatment tobe classified, 115 (78%) were considered successful and had a mean final drinking level of 9.4 ± 1.0 (SE) drinks weekly; 38 of the patients (26%) reached abstinence although only 3% listed it as the goal of treatment

review_nal_2001_print_us_1.pdf

Ok, maybe not but 120 Studies? - The website says 90 but actually cites, possibly two I have not looked into and a couple of books? 

I am not sure what to make on TSM, as I have not done any research on it - As I touched on before, intentions, long term are not considered or published - Other than the 23% who failed to moderate and abstained instead ;)

What I do know is here in the UK Nalmefene is only considered for prescription, in conjunction with sect like meetings etc - something that really is not me

Anyone can toss figures, whether corroborated or not but what I do know is Baclofen worked, or at least is working for me so that is all that matters on a personal level -  As for any results, unless they are under the same conditions, which they never are, they are up to the user specific and therefore any results can be spun, any which way the viewer chooses

I do love the technical equation - "Naltrexone or Nalmefene + Drinking = Cure" - The general consensus is that it is best with CBT

Regards

 

Bacman

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LarryDarrell
On August 7, 2016 at 3:39 PM, Baclofenman said:

 

What I do know is here in the UK Nalmefene is only considered for prescription, in conjunction with sect like meetings etc - something that really is not me

This is not even remotely true.

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joesixpack

Yeah, NICE guidelines are that nalmefene should be combined with counseling, so that's the route that the UK goes, if people can get the Nalmefene in the first place. Frequently the victim gets blamed here. Many UK docs don't know about meds for post-detox and don't want to handle the case in the first place, so they kick it out to the "alcohol charities" who typically address it with 12-step/blame-the-addict nonsense. It varies by the area as to what guidelines are used. Not that I'm a huge fan of Nalmefene, but if Lundbeck hadn't pushed into the area, it might be cold turkey and Anatabuse everywhere there. Nalmefene is also prescribed only for drinking within a certain range and only with counseling. This is why CThree Europe started offering free formal counseling for people that might not qualify for Nalmefene otherwise. Docs often don't have the resources to provide the counseling and the alcohol charities (Addaction, etc.) are woefully behind the times as described above.  Naltrexone is prescribed (sometimes), but only to cut cravings while abstinent and you have to go through detox first. 

There are Primary Care Alcohol Teams (PCAT) that operate in some areas:

http://patient.info/forums/discuss/nhs-primary-care-alcohol-teams-512652

But many people are only offered a brief appointment with Dr. Numpty, who then shoves them off onto the idiot sticks at the local Alcohol Charity. 

Then there's A&E and the mental health system:

http://patient.info/forums/discuss/drunk-and-nowhere-to-go-527979?page=0&order=Oldest

Patient is a little slow today, so if you follow those links, you'll have to have... patience. 

 

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Baclofenman
30 minutes ago, LarryDarrell said:

This is not even remotely true.

Really? - Personal opinions of meetings aside:

www.nice.org.uk said:

Nalmefene should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption. It should only be started in patients who continue to have a high drinking risk level 2 weeks after initial assessment

https://www.nice.org.uk/news/press-and-media/nice-recommends-nalmefene-to-reduce-alcohol-dependence

Maybe you can offer some input into what the criteria of success is based on?

Regards

 

Bacman

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LarryDarrell

"Here is a link to Dr Sinclair's own list of the 120+ results http://cthreeeurope.com/bibliography/ This is up to 2011. 

I believe the largest successful clinical trial was the PROJECT COMBINE trial in the US, which was the largest double-blind clinical test into addiction research. I don't have the link for that handy but I am sure a google search would find it easily.

On the list, test no 115 showed if a particular receptor is present in the brain, then the results increased to 87.5% success.

On the list, test no 124 showed naltrexone is safe and effective with 75% success rate."

-Joanna (CThreeFoundation)

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LarryDarrell
1 minute ago, Nicnak said:

I was prescribed Nalmefene on the NHS but I am supposed to have counselling to go alongside it

Counseling, sure. Not a 'sect' or something resembling AA or SMART as was stated.

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Baclofenman
3 minutes ago, LarryDarrell said:

Counseling, sure. Not a 'sect' or something resembling AA or SMART as was stated.

As I mentioned before, this is a personal opinion, which in fact I would use to describe a majority of group, patronizing and belittling meetings - In fact I set it aside when I showed you to be incorrect regarding Nalmefene prescription in the UK

Maybe you would like to show me what factual part of my comment was untrue or retract

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LarryDarrell

Fair enough.  I'm not here to debate nomenclature and if I perceived what you meant to state in error I apologize.  I am not aware of any 'sects' associated with TSM that are  " patronizing and belittling" however.

 

In any event I'm here to clarify any confusion or misinformation related to the clinical trials.  Hth.

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Baclofenman
2 minutes ago, LarryDarrell said:

I'm not Joanna nor affiliated in any way with C Three. She provided those sources to Neo 8 months ago on Reddit.

Noted

I have only ever seen these sources quoted on her various associations and affiliates

In order for me to consider it with any validity (which I will as we all share the same goal) - I would like to see a citation of officialdom - or one of the 120/80/150? I have been told about

<back down a little>

@LarryDarrell

Welcome to the forum btw - I am sure this forum will embrace TSM as a tool against alcoholism but figures need backing up or stated as anecdotal - Stuff like I read it on a blog, website or the like when you are dealing with this kind of stuff is dangerous

</back down a little>

Maybe stick you head into checking in and introduce yourself

Regards

 

Bacman

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LarryDarrell
1 hour ago, Baclofenman said:

Noted

I have only ever seen these sources quoted on her various associations and affiliates

In order for me to consider it with any validity (which I will as we all share the same goal) - I would like to see a citation of officialdom - or one of the 120/80/150? I have been told about

 

 

Duly noted.  I'll get right on that. 

BTW, there is a very large section in the hard-copy of, "The Cure For Alcoholism" by Dr. Espaka devoted to the studies.

Edited by LarryDarrell
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Baclofenman
1 hour ago, LarryDarrell said:

Duly noted.  I'll get right on that. 

BTW, there is a very large section in the hard-copy of, "The Cure For Alcoholism" by Dr. Espaka devoted to the studies.

Excellent - I look forward to your reply

2 hours ago, LarryDarrell said:

Counseling, sure. Not a 'sect' or something resembling AA or SMART as was stated.

The trouble with "now er days" is that words have lost their original meaning, generally through ill informed interpretation

Sect, did not start out as a word describing a bunch of nutters, shunned by their mother ship, deranged and intent on harm - In a sort of David Koresh way - This was a sect but this noun was prefixed with an adjective to enforce the word sect to mean something that it was never intended to be - Add a bias, if you like

In Etymology the word Sect, was originally a  derivative of the Latin secta, which means:

wikipedia.org said:
"a way, road", and figuratively a (prescribed) way, mode, or manner, and hence metonymously, a discipline or school of thought as defined by a set of methods and doctrines

 

I appreciate this is not very interesting but it will show us all that someones interpretation may be different from another persons

Regards

 

Bacman

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"Here is a link to Dr Sinclair's own list of the 120+ results http://cthreeeurope.com/bibliography/ This is up to 2011. 

I believe the largest successful clinical trial was the PROJECT COMBINE trial in the US, which was the largest double-blind clinical test into addiction research. I don't have the link for that handy but I am sure a google search would find it easily.

On the list, test no 115 showed if a particular receptor is present in the brain, then the results increased to 87.5% success.

On the list, test no 124 showed naltrexone is safe and effective with 75% success rate."

 

The COMBINE study showed that Naltrexone was more effective than a placebo, but only by about 10% (15% more effective than placebo in those with the Asp40 gene allelle).

from Naltrexone for the Management of Alcohol Dependence:

Quote

 

[T]he Combined Pharmacotherapies and Behavioral Interventions (COMBINE) study (ClinicalTrials.gov number, NCT00006206),20 which was conducted at 11 academic sites across the United States, enrolled 1383 patients with alcohol dependence and at least 4 days of abstinence. This trial showed that in patients who received medical treatment but not behavioral therapy, naltrexone (at a dose of 100 mg daily), given for 16 weeks, was more efficacious than placebo in increasing the percentage of days of abstinence (80.6% vs. 75.1%) and in reducing the risk of a heavy-drinking day (66.2% vs. 73.1%).

In the COMBINE study, investigators used an end point called “good clinical outcome,” which was defined as no more than 2 days of heavy drinking per week and drinking at or below a safe limit (14 drinks per week for men and 11 drinks per week for women) without significant alcohol-related problems during the last 8 weeks of the 16-week trial. In the group that received naltrexone, there was an absolute increase of approximately 15% in good clinical outcomes (73.7%, as compared with 58.2% in the placebo group; odds ratio in the naltrexone group, 2.16; 95% confidence interval, 1.46 to 3.20).

 

 

10% is in line with an nnt of 9 (for every 90 people treated with naltrexone for alcoholism, 10 would have a positive outcome) as reported by this Cochrane Systematic Review: 

Rosner S et al. Opioid antagonists for alcohol dependence. Cochrane Reviews, 2010, Issue 12. Article No. CD001867. DOI:10.1002/14651858. CD001867.pub3. This review contains 50 studies involving 7793 participants.

Quote

Naltrexone reduced the risk of return to heavy drinking (>5 standard drinks per day in men and >4 standard drinks per day in women) to 83% of the placebo risk, decreased drinking days by about 4% and heavy drinking days by about 3%. The NNT* = 9 for return to heavy drinking or, on average, avoiding 1 additional day with heavy drinking per month. Naltrexone also reduced the amount of alcohol consumed and the level of gamma-glutamyltransferase. On days on which alcohol was consumed patients treated with naltrexone managed to refrain from about 1 drink they would have had under placebo. For injectable formulations of naltrexone, which can be advantageous for patients who have problems with taking their medication on schedule, and for the opioid antagonist nalmefene, the database was too sparse to allow final conclusions. * NNT = number needed to treat to benefit 1 individual

The caveat here is that the COMBINE study did not use targeted dosing (The Sinclair Method) - most of the other nal(x) studies out there didn't either. "test no 124" from the Sinclair's bibliography does not appear to be a study or trial in the literature, it appears to be part of a presentation made by Eskapa (or someone citing him): "Introducing naltrexone in developing countries and among endogenous people. Proceedings of the Annual meeting of the International Society on Addiction Medicine (ISAM) Calgary, Alberta, Canada, Sept. 23-29, 2009." Eskapa makes the claim that Naltrexone is effective in 78% of patients in his book "The Cure for Alcoholism" (2008, p 51) - it was not published as a peer-reviewed study. You can read about it here: http://hamsnetwork.org/sinclair1.pdf

 

The BACLAD study showed that Baclofen was 42-49% more effective than placebo:

from High-dose baclofen for the treatment of alcohol dependence (BACLAD study): a randomized, placebo-controlled trial:

Quote

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.

That would make the nnt of Baclofen 2.2, meaning that for every 22 people that are treated with Baclofen, 10 will have a positive outcome. The caveat here is, it's only one study. Linda Burlison in her book "A Prescription for Alcoholics" (available on Amazon Kindle for free) gives baclofen an nnt of 3 when using another study,  Effectiveness and safety of baclofen in the treatment of alcohol dependent patients.

 

Please stop arguing about which medication is more effective than the other - both medications are effective, to varying degrees, especially among specific populations respectively. People who are in desperate need for a solution to their alcoholism should try them both. Many, many of those people will find that one or the other may work, but *all* of those people need ENCOURAGEMENT, not DISCOURAGEMENT.


As someone who took  part of 2 naltrexone studies, and eventually got sober with the help of Baclofen, I have no issues with the notion of Naltrexone as a first line medication, and Baclofen as a second - The dosing is simpler, and most importantly, the medication can be stopped at any time with no risk of a discontinuation syndrome (that said - I, in no way believe, that Naltrexone is more effective than Baclofen).

This thinking is inline with the prescribing recommendations in France (where Baclofen is an on-label medication for alcoholism):

From Pharmacotherapy for Alcohol Dependence: The 2015 Recommendations of the French Alcohol Society, Issued in Partnership with the European Federation of Addiction Societies:

Quote

For relapse prevention, acamprosate and naltrexone are recommended as first-line medications (grade A). Disulfiram can be proposed as second-line option in patients with sufficient information and supervision (EC). For reducing alcohol consumption, nalmefene is indicated in first line (grade A). The second-line prescription of baclofen, up to 300 mg/day, to prevent relapse or reduce drinking should be carried out according to the "temporary recommendation for use" measure issued by the French Health Agency (EC).

Lastly, and again, both medications are effective: Naltrexone particularly in populations with a specific gene expression, and Baclofen - all around, especially in heavy drinkers.

-tk

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Baclofenman

 

Thank you tk

1 hour ago, terryk said:

Please stop arguing about which medication is more effective than the other - both medications are effective, to varying degrees, especially among specific populations respectively. People who are in desperate need for a solution to their alcoholism should try them both. Many, many of those people will find that one or the other may work, but *all* of those people need ENCOURAGEMENT, not DISCOURAGEMENT.

I completely agree with you on this point, I have always put forward a “whatever works” attitude

I think the point here is that the 78% success rate claimed by Dr Sinclair’s protégé Roy Eskapa is not officially documented and therefore, certainly in my mind, at best fairly weak and misleading

I did also spend some, not inconsiderable time looking into the 125 Clinical trials and reviews, the vast majority of which are just bluff and wind, none of which mention anything to substantiate the success claim – There are a number of trials with small amounts of participants (after drop outs) with (what I would term) encouraging success, plenty of safety citations and several irrelevant (to alcohol issues)

One always needs to remember that, persons with a vested interest will always spin (anything) to meet their agenda. This is not the time for that discussion

 

Therefore, my conclusion is that, whilst it is clear the The Sinclair Method works for certain individuals as shown in a limited amount of clinical trials

Whether or not Baclofen should be considered higher than Naltrexone is something that cannot be answered – The only thing that I am certain of is that TSM success rates remain unsubstantiated

Regards

 

Bacman

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Thanks TK and everyone else

thinking about it, arguing that one is better than the other is probably not a good idea especially since im no naltrexone expert. I did take issue with the new subreddit that lists medications in order of effectiveness, for reasons you stated.

The sub says 78% across 120 studies, really? like Baclofenman said, a lot of these studies are probably poor.

I take issue that the 78% success study was combined with therapy, did any of the baclofen studies get the same thing? really we are testing two combined methods of achieving sobriety which doesnt help saying the drug itself is better.

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7 minutes ago, neophyte said:

I take issue that the 78% success study was combined with therapy, did any of the baclofen studies get the same thing? really we are testing two combined methods of achieving sobriety which doesnt help saying the drug itself is better.

You have to look at the study design, what the outcome criteria are for positive results, and how the tested medication performed compared to the placebo. The COMBINE study found that Naltrexone was ~80% effective in achieving a positive outcome (according to the study)....The issue is, that the placebo was ~75% effective in achieving the same outcome. So ~80% effective, but not much more than the placebo...

-tk

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The placebo response is a powerful thing. Drug companies suppress trials which show that an antidepressant, for instance, is only marginally better than placebo, or they pull the plug on the trial when this looks as though it's happening. Hence a lot of ADs in current use have a very poor research basis - if we were allowed to see all the trials it's unlikely the drugs would be seen as effective enough to justify using - especially given the possible SEs. At least placebos are SE free!

The baclofen trials generally show a much greater effectiveness than placebo. 

And as for "therapy" (I assume that means talking therapies) for alcoholism - is there any evidence this does any good at all?

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how do you know they suppress trials or is this a conspiracy theory? genuinely curious, though logically you would want to end a trial if its not achieving a result greater than the placebo to save money as trials are expensive, however that information should be made available.

I remember reading that the placebo effect is actually getting stronger in studies. I think this points to that most of the "low hanging fruit" in medications have already been found, so new molecules of interest have a lower marginal benefit.

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http://www.independent.co.uk/news/science/drug-trials-not-reported-in-line-with-ethical-and-legal-demands-british-medical-journal-says-a6879586.html

 

http://www.nature.com/news/half-of-us-clinical-trials-go-unpublished-1.14286

 

Yes, you're right. Neo, the info should be available. That's the point, you don't have to continue with the trial, but suppressing the information & starting again with a different trial format/different subjects skews the data used for clinical decision making.

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Terry,

what in particular do you look for in study design, id like to be better at understanding what constitutes a good study. Though I think i need to brush up on my statistics from university.

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Wow. I'm really unpleasantly surprised at the tone and tenor of this discussion. And very disconcerted by the clearly antagonistic posts made about TSM. 

It is completely clear that naltrexone can increase the chances of abstinence and/or reduction in drinking when used as a daily dose to fight cravings. As Terryk mentioned with the information above, it's a slight increase, but worth noting and certainly worth trying. That's the only way that naltrexone has been truly studied, because it is the rare researcher/doctor to recommend a medication to treat alcoholism and not insist on abstinence as the goal. 

It's not the way the amazing Joanna and the site CthreeEurope ( http://cthreeeurope.com/ ) suggest is the most effective way to use naltrexone according to the information provided by Eskapa. (I cannot speak highly enough about the site cthreeeurope and about Joanna herself, who, as it was already mentioned, got her certification as a counselor so she could help people get and keep their naltrexone prescriptions. I should also admit that I purloined a bunch of information from that site, to augment the information on this site. Thank you!) 

I have yet to see any really compelling research on either TSM or HDB. High Dose Baclofen has ONE randomized control study of FIFTY NINE people. That isn't nearly enough to suggest that the results (success ~68%) can be construed to apply to the population at large. On the contrary! I am not suggesting that those results aren't promising. They are. And we know a lot of people who have had success with HDB, but some at much higher doses than the study, which stopped at 270mg. There are other studies, but nothing that I would consider bullet proof against even reasonable skepticism. 

I actually DID read the research, and many anecdotal accounts, about naltrexone (daily) and TSM and found it really compelling, which is why it's included here. I purposely wooed, cajoled and harassed friends and acquaintances who have had success with TSM to support and participate here. Which they did! (Thank you!!) 

My apologies if this thread offended. I understand that Baclofenman was simply trying to understand the factual information, but I would have been happy to share with him the info I learned when I did the research while creating this site. (Much of that information comes from the truly informative book, A Prescription for Alcoholicshttps://www.amazon.com/dp/B01A1E8YKW/ref=dp-kindle-redirect?_encoding=UTF8&btkr=1  , which I highly recommend.) Honestly, it seems irrelevant to me if the claim of 78% success is factually correct, because we don't have randomized control studies to back up the number. (And really, does it matter if it's 78% or 50% or 30%? Imagine how many people with alcoholism would be helped if they tried naltrexone--TSM or daily--and found it effective! Millions...) 

Do we really need to rate these medications? I haven't visited Reddit, but perhaps they know as little about baclofen as some of us do about naltrexone? I'm bummed out that there was information suggesting that one is better than the other, when either (or both!) could be the key for someone to get free of addiction. 

Truth is, there is a lot of rhetoric and way too much of one kind of information, not enough of the other, and we all need to help each other through this process to get to contented sobriety. 

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joesixpack

Thanks, Admin.

Yes, it seems we both rely mainly on clinical evidence (i.e. Contral Clinics for TSM), as the funding for proper studies just isn't there. Keeping our eye on the ball looks like the best strategy, spreading the word that the traditional approach yields a 10% success rate while being offered over 90% of the time (with predictable results). $40k and up for what the rehab industry refers to as a "Spin Dry", assisted detox and very expensive 12-step meetings, basically. If you're lucky, you might get some CBT thrown in on the deal, but it's still a revolving door for most. 

The battle is getting the choices in front of people where they can get some feedback and information about the nature of Alcohol Use Disorder aside from the constant and largely inaccurate rhetoric needed by proponents of the detox and immediate abstinence route, as faith and regimentation is required to get only the dismal results that particular "treatment" produces. 

We're stronger together.

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On 8/13/2016 at 8:40 PM, neophyte said:

Terry,

what in particular do you look for in study design, id like to be better at understanding what constitutes a good study. Though I think i need to brush up on my statistics from university.

I'm not Terry, but I'll start and if I get it wrong or there's more to it, he'll be sure to stop by and/or correct me. (Statistics was a fairly recent class for me!) 

  • Randomized, double blind, placebo controlled research with a large number of participants/patients is the Gold Standard. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3505292/
  • Randomization: "minimizes the possibility that the observed association between the exposure and the outcome is really caused by a third factor." 
  • Double blind: "The best comparison is placebo control that allows participants, investigators and study staff to be blinded." [No one knows which participant is getting which substance.]
  • Placebo controlled: "Factually, a placebo effect is a psychosomatic effect brought about by relief of fear, anxiety or stress because of study participation. A component of every specific treatment effect can be attributed to the placebo response. The question that a study should be asking is whether the treatment has any effect on outcome aside from the stress-relieving effect of study participation. It is important to note that NO treatment is NOT the same as placebo treatment."

The baclad study that Terryk referenced was randomized, double blind, and included 56 patients, half of whom received baclofen up to what they could tolerate or 270mg. In addition to meds, the patients were given "psychoeducation and enhancement of motivation and adherence as modeled by the COMBINE study" up to 9 sessions. 

They ruled out anyone taking any other meds, including ADs, but not exclusive to those. They ruled out people with serious physical or mental health issues. They also recruited participants from their inpatient and outpatient programs, meaning they were already motivated enough to get medical/therapeutic oversight. They also had "spontaneous referral at the study site."

They reported on 26 highly motivated patients without any comorbidity.

Compare that to the COMBINE study:

  • ...1,383 alcohol-dependent, treatment-seeking patients from 11 US sites. 
  • ...any given patient could be assigned to one of nine different treatments. The nine treatments were naltrexone in combination with acamprosate, with or without CBI (2 treatment conditions); naltrexone in combination with placebo pills, with or without CBI (2 treatment conditions); acamprosate in combination with placebo pills, with or without CBI (2 treatment conditions); placebo pills only, with or without CBI (2 treatment conditions); and CBI with no pills (1 treatment condition).

I didn't read the "detailed information on the study's conceptual, methodological, and practical issues" because they were in a supplement and I didn't think I need to look it up. I'm going to go ahead and suggest that they used the Gold Standard to treat patients, and made similar exclusions as the Baclad study. (No major comorbid factors, etc. Sadly, because baclofen wasn't then and still isn't approved for AUD, it wasn't included.) If someone with more time than I have finds something different, please correct me! 

To suggest that the results of a study with 26 people can be extrapolated to the population with alcoholism at large, or even just to the people with alcoholism who seek treatment, is unreasonable. 

This does not make baclofen less or more effective, obviously. It will work for some, and it won't work for others. Some people can see a difference below the FDA approved amount of 80mg, and some will have to take 2 or 3 or 4 times that amount. But we don't have any more "proof" of efficacy in the general population than any other off-label medication treatment. Which is what The Sinclair Method (TSM) is. 

If I had my money on a clear way to get free of alcoholism, with the support of a doctor, I'd choose naltrexone. In the traditional method (daily, promoting abstinence, it increases the chances of abstinence) and TSM has a lot of support, using naltrexone only when combined with drinking. Without question or hesitation it would be my first choice if I had to do it over again.

It's, as Terryk noted, a good first line medication. If one tries it, and it doesn't work, then it's very easy to increase, decrease or stop. There is certainly no more (or less) evidence that TSM works better than baclofen. But it is, as Terryk says:

On 8/10/2016 at 10:10 AM, terryk said:

...I have no issues with the notion of Naltrexone as a first line medication, and Baclofen as a second - The dosing is simpler, and most importantly, the medication can be stopped at any time with no risk of a discontinuation syndrome (that said - I, in no way believe, that Naltrexone is more effective than Baclofen).

This thinking is inline with the prescribing recommendations in France (where Baclofen is an on-label medication for alcoholism):

Cheers. 

EDIT: There is also the P-value, which I've recently struggled with. I won't bother to explain it here, even if I knew I could get it right, but the P-value can be an important indication of whether the result can be extrapolated to the general public. The higher the P-value, the less likely it is to be "true" for the general public. I hope I'm right about this, because otherwise I'm going to get a schooling from someone. 

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Baclofenman
5 hours ago, Admin2 said:

 

My apologies if this thread offended. I understand that Baclofenman was simply trying to understand the factual information, but I would have been happy to share with him the info I learned when I did the research while creating this site. (Much of that information comes from the truly informative book, A Prescription for Alcoholicshttps://www.amazon.com/dp/B01A1E8YKW/ref=dp-kindle-redirect?_encoding=UTF8&btkr=1  , which I highly recommend.) Honestly, it seems irrelevant to me if the claim of 78% success is factually correct, because we don't have randomized control studies to back up the number. (And really, does it matter if it's 78% or 50% or 30%? Imagine how many people with alcoholism would be helped if they tried naltrexone--TSM or daily--and found it effective! Millions...) 

 

Unfortunately this IS the title of the thread - It is not a discussion on the effectiveness of TSM but about the claims made on /r/ - Therefore it is totally relevant to this thread

As far as I am concerned the 78% does not add up and I have yet to be presented (either here, through my findings or from any third party information) with any ACTUAL evidence that 78% is correct

cthreeeurope.com said:

Studies show it works 40-78% of the time, depending on which international expert you follow.  Perhaps how it is specifically used would explain the range of 40-78%.  Regardless, 40-78% is extraordinarily effective by medical standards.

I have made no mention of what is better as this is not the topic of the thread - If others choose to discuss that topic all fair and good - As I mentioned before I do not know a whole lot (I know a lot more now) about TSM but what I do know is that something that seems too good to be true

 

 

Probably is.....

Regards

 

Bacman

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