Abstinence 1 Year After the Initiation of High-Dose Baclofen
This retrospective study is based on two physicians' study of the records of patients to whom they had prescribed baclofen. Both worked in the Paris metropolitan area: one general practitioner in private practice and one hospital-based psychiatrist, both of whom prescribed baclofen to outpatients with drinking problems. Neither practitioner applied any absolute contraindications to baclofen, except for allergies. Neither detoxification nor alcohol dependence was a necessary precondition to treatment. No particular management (pharmacological or non-pharmacological) was systematically offered, and the physicians were free to prescribe as they thought appropriate. Patients systematically received complete information about various characteristics of the treatment (off-label prescription, increasing dose potentially higher than for neurological indications, list of adverse effects and in particular the risk of hypersomnolence, especially if taken with alcohol, and the risk of withdrawal symptoms if the medication were to be stopped suddenly).
Patients eligible for this study were all 'high-risk' drinkers who had started baclofen more than a year before 1 November 2010, regardless of the length of their treatment or follow-up. Each physician kept an exhaustive list of patients who had taken baclofen, and subjects were identified from that list.
Data for each eligible patient were collected first by examining his or her medical record and then by an interview of the patient, either in the physician's office during a regular consultation or by telephone, by a physician–investigator. The aim of the interview was to obtain all of the necessary data (completing data for patients who had stopped treatment with the physician before a year had elapsed) and to obtain high-quality measurements of some patient characteristics (initial alcohol dependence, alcohol consumption during the 12th month after the initiation of baclofen and adverse effects) about which they were systematically questioned. The other characteristics collected came from the medical files.
We defined two satisfactory alcohol consumption profiles, based on the patient reports of their alcohol consumption during the 12th month of baclofen treatment:
Besides consumption levels during the 12th month of treatment, the following information was collected:
The patients included in the analysis were those who were eligible for the study and for whom the alcohol consumption during the 12th month of treatment could be determined, as opposed to the patients lost to follow-up. For the latter, alcohol consumption at their last visit, the number of visits and the length of the follow-up were extracted from the files. We also asked the physicians for their opinion about the principal reason that the patient stopped coming.
The patients analysed were first described, and the variations in their characteristics according to sex and alcohol dependence were examined. The two satisfactory profiles were then described, and their variations according to characteristics tested. The same analysis was conducted for the maximum baclofen doses and the doses at 1 year. Next, the adverse effects were described. Finally, we described the patients lost to follow-up and compared them with the patients analysed as a function of age, sex, alcohol dependence, initial alcohol consumption and proportion of adverse effects. We used χ tests (or Fisher's exact tests if needed) and Student t-tests (or Kruskal–Wallis tests if needed) to compare percentages and means.
All patients were informed about the study's purpose and design (and about our intention to publish the results) and gave their consent to participate. Patients seen in the physician's office signed a consent form and those interviewed by telephone gave their consent verbally. This study was not reviewed by a research ethics committee, because it is inherently an 'audit' of two physicians, which was not deemed within the purview of ethics committees.
Materials and Methods
This retrospective study is based on two physicians' study of the records of patients to whom they had prescribed baclofen. Both worked in the Paris metropolitan area: one general practitioner in private practice and one hospital-based psychiatrist, both of whom prescribed baclofen to outpatients with drinking problems. Neither practitioner applied any absolute contraindications to baclofen, except for allergies. Neither detoxification nor alcohol dependence was a necessary precondition to treatment. No particular management (pharmacological or non-pharmacological) was systematically offered, and the physicians were free to prescribe as they thought appropriate. Patients systematically received complete information about various characteristics of the treatment (off-label prescription, increasing dose potentially higher than for neurological indications, list of adverse effects and in particular the risk of hypersomnolence, especially if taken with alcohol, and the risk of withdrawal symptoms if the medication were to be stopped suddenly).
Patients eligible for this study were all 'high-risk' drinkers who had started baclofen more than a year before 1 November 2010, regardless of the length of their treatment or follow-up. Each physician kept an exhaustive list of patients who had taken baclofen, and subjects were identified from that list.
Data for each eligible patient were collected first by examining his or her medical record and then by an interview of the patient, either in the physician's office during a regular consultation or by telephone, by a physician–investigator. The aim of the interview was to obtain all of the necessary data (completing data for patients who had stopped treatment with the physician before a year had elapsed) and to obtain high-quality measurements of some patient characteristics (initial alcohol dependence, alcohol consumption during the 12th month after the initiation of baclofen and adverse effects) about which they were systematically questioned. The other characteristics collected came from the medical files.
We defined two satisfactory alcohol consumption profiles, based on the patient reports of their alcohol consumption during the 12th month of baclofen treatment:
full abstinence (vs any alcohol consumption) and
'low-risk' consumption (vs more than low risk consumption), that is, which might include occasional periods of abstinence, but had no days above 20 g (women) or 40 g (men), as defined by the WHO.
Besides consumption levels during the 12th month of treatment, the following information was collected:
sociodemographic data: age, sex, whether the patient was living with a partner;
history of their alcoholism: number of episodes of detoxification, previous treatment with drugs approved for preventing relapses (acamprosate, naltrexone or disulfiram);
alcohol consumption and smoking at the beginning of treatment;
initial alcohol dependence (diagnosed in accordance with DSM-IV, without using a questionnaire);
psychiatric disorders (diagnosed in accordance with DSM-IV criteria, without using questionnaires): anxiety, depression, bipolar disorder, psychosis or other psychiatric disorders;
addictive behaviour (food, i.e. binge eating, shopping, gambling, work or sex, without using questionnaires);
treatment with psychotropic drugs: anxiolytics, antidepressants, mood stabilizers and neuroleptics;
baclofen dosage: maximum and at 12 months;
perceived diminution in craving intensity: binary measure corresponding to the patient's perceived diminution in craving between the beginning of treatment and 12 months afterwards and
adverse effects, both those reported spontaneously and on questioning.
The patients included in the analysis were those who were eligible for the study and for whom the alcohol consumption during the 12th month of treatment could be determined, as opposed to the patients lost to follow-up. For the latter, alcohol consumption at their last visit, the number of visits and the length of the follow-up were extracted from the files. We also asked the physicians for their opinion about the principal reason that the patient stopped coming.
The patients analysed were first described, and the variations in their characteristics according to sex and alcohol dependence were examined. The two satisfactory profiles were then described, and their variations according to characteristics tested. The same analysis was conducted for the maximum baclofen doses and the doses at 1 year. Next, the adverse effects were described. Finally, we described the patients lost to follow-up and compared them with the patients analysed as a function of age, sex, alcohol dependence, initial alcohol consumption and proportion of adverse effects. We used χ tests (or Fisher's exact tests if needed) and Student t-tests (or Kruskal–Wallis tests if needed) to compare percentages and means.
All patients were informed about the study's purpose and design (and about our intention to publish the results) and gave their consent to participate. Patients seen in the physician's office signed a consent form and those interviewed by telephone gave their consent verbally. This study was not reviewed by a research ethics committee, because it is inherently an 'audit' of two physicians, which was not deemed within the purview of ethics committees.
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