How is baclofen better and different than current treatments?

  1. Baclofen is effective in more patients than current treatments.
  2. Baclofen’s use has been driven by “people power”.
  3. Baclofen treatment suppresses cravings effectively.
  4. Baclofen helps anxiety as well as alcohol cravings.
  5. Baclofen is well suited to outpatient treatment.
  6. Baclofen can also be used to treat alcohol withdrawal.
  7. Baclofen treatment is cheap and not time limited.
  8. Baclofen is metabolised by the kidney, not the liver.

SECTION 1: Baclofen is effective in more patients than current treatments:

Baclofen has a much higher success rate in obtaining abstinence or low risk drinking than the currently offered treatments, Acamprosate and Naltrexone.

Table:

table

As the table shows, naltrexone and acamprosate show only a 10% improvement over placebo in the large number of studies done on these two medications. This gives a Number Needed to Treat (NNT) of 9. This means an average of 9 patients must be treated for one of them to find benefit over the placebo effect of the medication. These results have been found repeatedly and consistently – naltrexone and acamprosate are reliably ineffective for most patients (Up to Date Review: Pharmacotherapy Alcohol Use Disorder).

In contrast, the randomised controlled trials of baclofen in heavy daily drinkers show 42-49% improvement over placebo (link). This gives a NNT of 2.2 ie an average of 2.2 patients must be treated for one of them to find more benefit than placebo.

Slide

The most recent study, BACLAD showed abstinence rates at 24% for placebo vs 68% for baclofen at 3 months.

SECTION 2: Baclofen’s use has been driven by “people power” rather than pharmaceutical companies:

Another major difference between baclofen and other alcohol addiction treatments is in how it came into widespread use. It’s been made possible by the information revolution– internet forums and social media collect and then diffuse information from patients about treatments which are not being promoted by pharmaceutical companies. New, effective treatments are pushed into widespread use faster because it’s patients seeking treatment who drive the process. This phenomena was first seen in the 1980s with first HIV medications during the AIDs epidemic and is shown in the 2014 film, Dallas Buyers Club.

The usual way a medication becomes widely used is that a pharmaceutical company markets its product to doctors who, if persuaded of its benefits, prescribes it to patients. However this has frequently led to pharmaceutical companies overemphasising positives about their medications and hiding negative information in order to maximise sales and therefore profit.

In addition to this, the conservative medical profession is often slow to adopt radically new paradigms of treatment and it typically takes 10-15 years for new treatments to become widely used.

The story of baclofen for alcohol addiction has turned this process on its head. It’s patients who are driving the growth in baclofen use, without the help or even against the attempts to slow baclofen’s acceptance and widespread use by pharmaceutical companies and sceptical doctors.

Patients are finding information from sources like Olivier Ameisen’s book, press articles or internet searches. Those who want to try baclofen seek out willing prescribers or, if this is not available, obtain baclofen by other means such as the internet. They describe their experiences on internet and social media forums. It’s a bit like having “Trip Advisor” for addiction treatments. The good, the bad and the ugly are all laid bare. There’s no “polishing of turds” here: no filtering of information to conceal problems or make a treatment sound more effective than it is, all too common in pharmaceutical company promotions.

Clearly internet forums don’t replace clinical trials but they provide another source of information on how a medication performs in “the real world” as well as the patient experience of a medication. When I read patient experiences of baclofen treatment, I was struck by how dramatically it changed their relationship with alcohol. Baclofen freed them from constant thinking about and cravings for alcohol. They felt calmer and more in control. They could be around alcohol without it bothering them. I’d never heard anything quite like it.

SECTION 3: Baclofen treatment suppresses cravings effectively:

The aim of baclofen treatment is to completely suppress cravings for alcohol and replace the compulsion to drink with choice.

People who are not addicted to alcohol simply don’t comprehend how many cues to drink alcohol are around us in everyday life. They are literally everywhere: alcohol advertisements are on billboards, around sporting fields, in newspapers and magazines.  There are people drinking in TV shows and bottle shops everywhere, pubs and bars spilling out on to pavements. Pretty much every after work, evening or weekend social function includes alcohol. Non-alcoholics barely notice this stuff. But the alcohol addicted brain scans the environment constantly, thinks about alcohol constantly and is always planning how to keep the addiction “fed”. Resisting the compulsion to drink requires massive mental energy and constant willpower to resist the incessant demands of the addiction.

My patients tell me that the most extraordinary about baclofen treatment is that it stops them thinking about alcohol. Their brain behaves more like a non-addicted brain. Alcohol triggers are still around but now largely ignored. Choice replaces compulsion.  This is amazingly liberating.

SECTION 4: Baclofen helps anxiety as well as alcohol cravings:

Baclofen has a powerful anti-anxiety (anxiolytic) effect and this is immensely helpful for alcohol addicted patients. My experience is that the hardest alcoholics to treat are those with severe anxiety which they “medicate” with alcohol. This is well described by Olivier Ameisen in his book The End of my Addiction.

As an anti-anxiety agent, alcohol ticks all the boxes. It’s rapidly effective, cheap, easily available, socially acceptable and legal. Most of our population uses alcohol at some time to relax, de-stress or enhance social interactions  – at the end of a hard day’s work or at an awkward party full of strangers.

However for patients with chronic anxiety, the immense relief they feel after drinking alcohol is a trap. Many rapidly become dependant on its relaxing effect. With time they need to increase the amount of alcohol to get the same relaxing effect and become addicted.

For anxious patients, stopping the alcohol provokes not only withdrawal, which feels like bad anxiety, but also unmasks their underlying anxiety problem. This double whammy makes it very hard for anxious alcohol addicted patients to sustain sobriety, especially when faced with stressful situations or life events.

By reducing cravings AND anxiety, baclofen reduces the risk of relapse. For many patients this stops an endless cycling between agonising sobriety and relapsing into heavy drinking. They can experience stable sobriety and the chance to reconstruct their life.

SECTION 5: Baclofen is well suited to outpatient treatment:

The current treatments, acamprosate and naltrexone, are started after detoxification from alcohol. An alcohol free period of at least 3-10 days is needed prior to starting the medication. For most patients this means finding a place in a detox facility for which there are often long wait lists.

In contrast, the powerful anti-craving effect of baclofen mean that patients don’t need to undergo detoxification before starting baclofen treatment. This makes baclofen particularly suited to outpatient treatment and use in the general practice setting.

Baclofen treatment is usually started with the patient drinking alcohol at usual levels, this is the classic Ameisen regime. The dose of baclofen is steadily increased over time and the compulsion to drink alcohol decreases until the patient can stop drinking. For some patients there is a gradual loss of compulsion while for others the loss of compulsion occurs suddenly when the right dose of baclofen is reached. Most patients wean themself off alcohol gradually and there is no withdrawal. Other patients will stop their alcohol intake quickly but they still rarely go into withdrawal because baclofen itself is very effective for alcohol withdrawal as discussed below.

Specialist Drug and Alcohol services are required for some alcohol addicted patients, especially those who require detox or rehabilitation services. But many don’t, based on the experience in France where the vast majority of baclofen treatments for alcoholism are carried out by GPs in their consulting rooms. GPs are well placed to treat alcohol addicted patients within their practices. They know their patients, are aware of the co-existing health and social issues and can provide care of underlying anxiety as well as providing support to the patient and family over the short and long term.

My observation of our specialist system is that alcoholics with underlying anxiety tend to “slip through the cracks”. Addiction services either don’t see the anxiety problem or regard it as a separate psychiatric problem they don’t treat.  Psychiatrists see the alcoholism as the primary issue and want this dealt with by Addiction services before they will attend to the psychiatric issues. Sadly there are few “dual diagnosis” services which recognise the intertwined nature of mental health and substance abuse problems and treat both simultaneously.

The more holistic approach of GPs often serves patients better than the fragmented specialist approach described above.

SECTION 6: Baclofen can also be used to treat alcohol withdrawal:

Baclofen can be initiated very easily when an alcohol addicted patient stops drinking abruptly and goes into alcohol withdrawal. There is no slow upward titration required for the patient in alcohol withdrawal. Simply start on 10mg three times daily. This markedly reduces the severity and duration of withdrawal. Typically some diazepam is still required but the amount is much less and the patient feels much better than they normally do in withdrawal. This gives alcohol addicted patients confidence that the baclofen can help them and encourages them to stick with the titrating of the baclofen dose up until they get to the needed dose to suppress their cravings.

This makes baclofen ideal for outpatient detoxification regimes in suitable patients, because the withdrawal is milder, shorter and safer with a lower dose of diazepam required. After the withdrawal period, the patient can continue on baclofen with a rapid titration upwards over the following weeks, at the same rate as for patients who have reached the 10mg three times daily dose by the Ameisen regime.

This is further discussed in another section Baclofen Assisted Alcohol Withdrawal.

SECTION 7: Baclofen treatment is cheap and not time limited:

Baclofen is cheap. The exact cost to a patient depends on the individual dose but it won’t break the bank.

It is dispensed in a quantity of a bottle of 100 tablets of 10mg or 25mg. The latter are used if the patient requires higher doses of baclofen and will bring the cost down through using less tablets per dose. Up to 5 repeats can be given on one script.

There is no restriction on how long a patient can stay on baclofen treatment. The experience gained from 40 years of long term treatment with baclofen in patients with neurological problems shows that it is safe when taken for decades and has no long term side effects or cumulative toxicity.

SECTION 8: Baclofen is metabolised by the kidney, not the liver:

Baclofen is 80% excreted by the kidney, largely as the unchanged drug. Only about 15% is metabolised in the liver to an inactive metabolite. The remaining 5% is excreted unchanged in the faeces.

This is a very useful feature of baclofen and makes it safe in patients who already have severe liver dysfunction from alcoholism or other causes. This is because both naltrexone and acamprostate are problematic in patients with severe liver dysfunction.

A study of baclofen treatment in patients with cirrhosis of the liver showed good effectiveness and no untoward effects. The issue of treating patients with liver disease/cirrhosis is further discussed in another section (link)

However it does mean because baclofen is excreted from the body by the kidneys, care must be taken in patients with renal impairment. This is further discussed in the webinar The Side Effects of Baclofen and their Management.

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