Nouvelle étude sur le baclofène : "un taux de succès de 68 %" - Sciences et Avenir
Translated from French (poorly):
New study on baclofen "a success rate of 68%"
Posted on 17-11-2013 at 7:47 - Updated at 7:59
Le Nouvel Observateur
By Le Nouvel Observateur
The psychiatrist Bernard Granger followed his service in 81 patients baclofen, the muscle relaxant prescribed to treat alcoholism. It provides an update on treatment.
On the same subject
" Baclofen: doctors write to the Director of MSNA
" A green light for more baclofen
" Alcoholism: with baclofen, "I healed in 18 days"
" CHAT. Baclofen: the miracle cure against alcohol?
" Alcoholism: Obs found 1,500 patients cured with baclofen
Bernard Granger is a professor of psychiatry at the University Paris-Descartes and exercises to hospital Tarnier (three half-day public consultation and two private weekly). His blog "The saga of baclofen" on Books.fr . He is also editor of the journal "Psychiatry, Human Sciences, Neurosciences."
You have just published the results of a study conducted in your service. Verdict?
- We confirm the effectiveness of baclofen in addiction to alcohol from an observational study of six months, which has been the subject of sustained success at the University Paris-Descartes the doctor thesis Nicolas Duss?re. The study covers all alcohol-dependent patients or heavy drinkers who viewed under my care who started taking baclofen as of early 2012 and that the decline was at least six months before the study , 81 patients (53 men and 28 women) with a mean age of 47 years and 6 months, 18 for the youngest and the oldest 67. The percentage of patients with concomitant psychiatric disorder was 59%. The main results are comparable to those already published by two French teams, six months show a 68% of abstainers or moderate consumption with patients. The success rate is 83% if we include those who have reduced by at least half their alcohol consumption.
How dose baclofen has he been prescribed them?
- 170 mg per day on average, for six months. This confirms that a high dose is required. In 25% of patients, it took over 200 mg.
For what side effects?
- Almost 100% of patients had side effects - only 3 of them had none. The most common are insomnia and asthenia. They were usually transient and did not require interruption of therapy for 3. Four, also had to be hospitalized (5%).
In August, the agency drug lived 405 adverse effects. What did you think of this ad?
- She did not bring anything new. These effects are known, but many rarely serious. No cases of fatal poisoning has never been registered. Often, but not always, they are transient. To reduce the occurrence must adjust the dosage and progression based on patient tolerance. At the beginning of treatment, clinical monitoring should be narrow. Sometimes there corrective treatments to eliminate them. Finally, many patients easily support a particular side effect in terms of the benefit of treatment. What are some tinnitus or sleep difficulties facing the ordeal endured by some alcohol-dependent? Cases of baclofen stop because of side effects are actually quite rare - 4% in our study.
Two double-blind studies against placebo are conducted in parallel, and Bacloville Alpadir. Where are we?
- They are well advanced on schedule. They involve more than 600 patients in total and should be completed in the month of June The results will be known in the last six months of 2014.
In the meantime, we are still awaiting the recommendation temporary use (RTU) announced in June and will allow doctors to prescribe baclofen in cases of alcohol dependence. Why Medicines Agency (MSNA) she soon grant?
- On June 3, Professor Dominique Maraninchi, CEO of MSNA, announced that RTU is given baclofen for this indication in autumn, and there is now talk of early 2014. Unbearable when we know that many physicians expect to prescribe the RTU and every day more than 130 patients die prematurely due to alcohol, which is the second leading cause of preventable death after smoking.
How ANSM she is working on this issue?
- With a lot of weight. She refused to hear the real experts, those who prescribe baclofen successfully for years. But these have a great knowledge of the product and, for some, published their findings in the international scientific press. There is for example the study of Renaud de Beaurepaire published in 2012. When we read the account of the agency, we realize that some of the people heard or even members of the commission do not know the file or do not take into account "real life." They make a theoretical medicine, on paper, disconnected from the ground and not concerned with the interests of patients. We wrote to the agency on October 12, to share our notes ( read the letter ). No response to date. Yet during his speech in June, the agency director, Professor Dominique Maraninchi took a position with great accuracy and intelligence.
On what points do you disagree?
- The agency seems to favor a maximum dose of 200 mg per day - after a vote, as if such a question were to be decided by vote of a few arbitrarily chosen! Scientific studies show that when we exclude at least 25% of patients likely to benefit from baclofen, which in this indication is effective at very different doses depending on the subject, and rather strong, can sometimes go beyond 300 mg.
Another point related disorders, especially mental disorders. Patients with psychiatric problems are successfully treated with baclofen in the same proportions as the free subjects of psychiatric disorders. However, there is likely to exclude many of them ...
Is it still easy to be put on baclofen?
- Thanks to associations Dawns and baclofen , it is easy to get the coordinates of a prescriber.
Do you still feel the same skepticism among alcohologists and addictologists?
- As time passes, the more passionate or unfounded fade reactions. The evidence came to dominate. Many addictologists use this treatment, although it is not always optimal. The figures show that the social security number of patients on baclofen is very strong increase (see in this regard the communication of Dr. Alain Weill during the day of June 3, 2013 at Cochin).
You who have opened a "consultation baclofen" there three years, do you observe patients for whom this treatment can do nothing?
- Critics of baclofen have caricatured speaking ironically "miracle pill". In medicine, we do not speak of miracles, but efficiency. Baclofen works well or very well in a patient on at least two. There are cases where despite excellent motivation of the patient and the doctor, the pharmacological action does not develop. This is so far not well explained.
Can you tell us about a patient whose life has been transformed?
- I give you a testimony among others. Here's what I wrote recently a patient:
"I continue to follow the treatment and I am more than happy and my surroundings, especially my children that I have never been so close and I work with now ... Luckily I took this decision (with them), because today they are the ones who need me for their business! Fair return. I also continue to totally change my way of working and relationship ... The fact that I lost weight 26 kg allows me to have another physical presence vis-?-vis my interlocutors. Consequently, I redeveloped my professional networks. I continue to walk every day and that makes me the most good. For relationship with alcohol, I have no envy except in a few business lunches where I take one or two glasses of wine ... but that are now most often my companions tables ... It's good to have a good influence on them unlike in the past: for Father's Day, I'm inviting my children to a restaurant to thank them for saving me from this disease and allowing me to become a true Father! "
In May 2012, you said in an interview with "Nouvel Observateur" (1) the risk-benefit balance looks undeniably in favor of baclofen prescription and do not use this therapeutic approach is a form of non-assistance to people in danger . Keep up this assertion?
- It is obvious, since no other treatment has efficacy of baclofen in this indication.
Interview by Anne Crignon and Bernice Rocfort Giovanni - Le Nouvel Observateur
Translated from French (poorly):
New study on baclofen "a success rate of 68%"
Posted on 17-11-2013 at 7:47 - Updated at 7:59
Le Nouvel Observateur
By Le Nouvel Observateur
The psychiatrist Bernard Granger followed his service in 81 patients baclofen, the muscle relaxant prescribed to treat alcoholism. It provides an update on treatment.
On the same subject
" Baclofen: doctors write to the Director of MSNA
" A green light for more baclofen
" Alcoholism: with baclofen, "I healed in 18 days"
" CHAT. Baclofen: the miracle cure against alcohol?
" Alcoholism: Obs found 1,500 patients cured with baclofen
Bernard Granger is a professor of psychiatry at the University Paris-Descartes and exercises to hospital Tarnier (three half-day public consultation and two private weekly). His blog "The saga of baclofen" on Books.fr . He is also editor of the journal "Psychiatry, Human Sciences, Neurosciences."
You have just published the results of a study conducted in your service. Verdict?
- We confirm the effectiveness of baclofen in addiction to alcohol from an observational study of six months, which has been the subject of sustained success at the University Paris-Descartes the doctor thesis Nicolas Duss?re. The study covers all alcohol-dependent patients or heavy drinkers who viewed under my care who started taking baclofen as of early 2012 and that the decline was at least six months before the study , 81 patients (53 men and 28 women) with a mean age of 47 years and 6 months, 18 for the youngest and the oldest 67. The percentage of patients with concomitant psychiatric disorder was 59%. The main results are comparable to those already published by two French teams, six months show a 68% of abstainers or moderate consumption with patients. The success rate is 83% if we include those who have reduced by at least half their alcohol consumption.
How dose baclofen has he been prescribed them?
- 170 mg per day on average, for six months. This confirms that a high dose is required. In 25% of patients, it took over 200 mg.
For what side effects?
- Almost 100% of patients had side effects - only 3 of them had none. The most common are insomnia and asthenia. They were usually transient and did not require interruption of therapy for 3. Four, also had to be hospitalized (5%).
In August, the agency drug lived 405 adverse effects. What did you think of this ad?
- She did not bring anything new. These effects are known, but many rarely serious. No cases of fatal poisoning has never been registered. Often, but not always, they are transient. To reduce the occurrence must adjust the dosage and progression based on patient tolerance. At the beginning of treatment, clinical monitoring should be narrow. Sometimes there corrective treatments to eliminate them. Finally, many patients easily support a particular side effect in terms of the benefit of treatment. What are some tinnitus or sleep difficulties facing the ordeal endured by some alcohol-dependent? Cases of baclofen stop because of side effects are actually quite rare - 4% in our study.
Two double-blind studies against placebo are conducted in parallel, and Bacloville Alpadir. Where are we?
- They are well advanced on schedule. They involve more than 600 patients in total and should be completed in the month of June The results will be known in the last six months of 2014.
In the meantime, we are still awaiting the recommendation temporary use (RTU) announced in June and will allow doctors to prescribe baclofen in cases of alcohol dependence. Why Medicines Agency (MSNA) she soon grant?
- On June 3, Professor Dominique Maraninchi, CEO of MSNA, announced that RTU is given baclofen for this indication in autumn, and there is now talk of early 2014. Unbearable when we know that many physicians expect to prescribe the RTU and every day more than 130 patients die prematurely due to alcohol, which is the second leading cause of preventable death after smoking.
How ANSM she is working on this issue?
- With a lot of weight. She refused to hear the real experts, those who prescribe baclofen successfully for years. But these have a great knowledge of the product and, for some, published their findings in the international scientific press. There is for example the study of Renaud de Beaurepaire published in 2012. When we read the account of the agency, we realize that some of the people heard or even members of the commission do not know the file or do not take into account "real life." They make a theoretical medicine, on paper, disconnected from the ground and not concerned with the interests of patients. We wrote to the agency on October 12, to share our notes ( read the letter ). No response to date. Yet during his speech in June, the agency director, Professor Dominique Maraninchi took a position with great accuracy and intelligence.
On what points do you disagree?
- The agency seems to favor a maximum dose of 200 mg per day - after a vote, as if such a question were to be decided by vote of a few arbitrarily chosen! Scientific studies show that when we exclude at least 25% of patients likely to benefit from baclofen, which in this indication is effective at very different doses depending on the subject, and rather strong, can sometimes go beyond 300 mg.
Another point related disorders, especially mental disorders. Patients with psychiatric problems are successfully treated with baclofen in the same proportions as the free subjects of psychiatric disorders. However, there is likely to exclude many of them ...
Is it still easy to be put on baclofen?
- Thanks to associations Dawns and baclofen , it is easy to get the coordinates of a prescriber.
Do you still feel the same skepticism among alcohologists and addictologists?
- As time passes, the more passionate or unfounded fade reactions. The evidence came to dominate. Many addictologists use this treatment, although it is not always optimal. The figures show that the social security number of patients on baclofen is very strong increase (see in this regard the communication of Dr. Alain Weill during the day of June 3, 2013 at Cochin).
You who have opened a "consultation baclofen" there three years, do you observe patients for whom this treatment can do nothing?
- Critics of baclofen have caricatured speaking ironically "miracle pill". In medicine, we do not speak of miracles, but efficiency. Baclofen works well or very well in a patient on at least two. There are cases where despite excellent motivation of the patient and the doctor, the pharmacological action does not develop. This is so far not well explained.
Can you tell us about a patient whose life has been transformed?
- I give you a testimony among others. Here's what I wrote recently a patient:
"I continue to follow the treatment and I am more than happy and my surroundings, especially my children that I have never been so close and I work with now ... Luckily I took this decision (with them), because today they are the ones who need me for their business! Fair return. I also continue to totally change my way of working and relationship ... The fact that I lost weight 26 kg allows me to have another physical presence vis-?-vis my interlocutors. Consequently, I redeveloped my professional networks. I continue to walk every day and that makes me the most good. For relationship with alcohol, I have no envy except in a few business lunches where I take one or two glasses of wine ... but that are now most often my companions tables ... It's good to have a good influence on them unlike in the past: for Father's Day, I'm inviting my children to a restaurant to thank them for saving me from this disease and allowing me to become a true Father! "
In May 2012, you said in an interview with "Nouvel Observateur" (1) the risk-benefit balance looks undeniably in favor of baclofen prescription and do not use this therapeutic approach is a form of non-assistance to people in danger . Keep up this assertion?
- It is obvious, since no other treatment has efficacy of baclofen in this indication.
Interview by Anne Crignon and Bernice Rocfort Giovanni - Le Nouvel Observateur
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