Perceived impact of discussions with a healthcare professional on patients' decision regarding COVID-19 vaccine.

There is evidence that advice from Healthcare Professionals (HCPs) plays an important role in patients' decision to get vaccinated, but the extent to which patients perceive this impact is unclear. The aim of this study was to assess the perceived impact of a discussion with a HCP on participants' decision to be vaccinated against COVID-19. A cross-sectional survey was conducted among adults who consulted a general practitioner (GP) or a pharmacist in Ile-de-France, France, after COVID-19 vaccines became available (October-November 2021 period). A total of 344 participants were included, 65.2% of whom reported having had a discussion about COVID-19 vaccines with a HCP. Overall, 55% of participants were advised to be vaccinated by their HCP. Most of the discussions took place with a GP (n = 203, 48.9%). According to 52.5% of participants, the discussion had a positive impact, i.e. it was perceived as encouraging vaccination. The latter reported that, among HCPs, GPs had the greatest number of discussions with a positive impact on the decision to be vaccinated against COVID-19 (93.1%). In the study population, the COVID-19 vaccine hesitancy rate, according to the WHO definition, was high (38.1%), although the COVID-19 vaccine coverage rate was 87.1%. Vaccine hesitant participants were more likely to report a discussion that had a perceived negative impact on their decision to get vaccinated (20.0%) than non-hesitant participants (5.8%, p = .004).

Baclofen in the treatment of alcohol use disorder: tailored doses matter.

AIMS: To address the question of tailored baclofen prescribing in alcohol use disorder (AUD) in relation to dose-dependent efficacy and the potential danger of high doses and to provide suggestions for the use of high doses of baclofen in the treatment of AUD. The context is the approvement in France of baclofen in the treatment of AUD without dose limitation, making French physicians, who usually prescribe baclofen in a tailored manner, often use high or very high doses. METHODS: A narrative review of the results of randomized controlled trials (RCTs) and observational studies that used tailored baclofen prescribing and of the severe adverse effects of baclofen that have been reported in the literature. RESULTS: The results show that RCTs using tailored doses of baclofen in AUD are not completely demonstrative, though they are encouraging according to certain meta-analyses, while observational studies that used tailored doses constantly show a good effectiveness of baclofen treatment. The results suggest that many severe adverse effects of baclofen could be related to a nonrespect by physicians of prescription rules and appropriate treatment monitoring. CONCLUSIONS: The use of tailored doses shows that the dose required to suppress cravings is highly variable, low or high, depending on each case. Analysis of the circumstances in which severe adverse effects occur suggest that a careful monitoring of baclofen prescribing might prevent a large majority of severe adverse effects. We propose that the education of the patients and the prescription skills, seriousness, and availability of the prescribing physicians are of major importance in the managing of tailored baclofen treatment of AUD.

Personality traits are associated with cognitive empathy in medical students but not with its evolution and interventions to improve it.

OBJECTIVE: Cognitive empathy might decrease during medical school. Factors associated with its evolution remain poorly understood, as well as whether such factors could moderate the effect of an intervention to preserve cognitive empathy. The aim was to explore the associations between personality traits and both cognitive empathy at baseline and its changes at follow-up. The possible effect of an intervention depended upon personality traits was also examined. METHODS: The cohort consisted of fourth year medical students and the associations between personality traits, using the Short Big Five Inventory, and cognitive empathy changes at 3-month, using the Jefferson Scale of Empathy-Student version (JSE-S), were examined. A randomization in two groups (Balint groups versus no intervention) allowed examining whether the effect of the intervention depended upon personality traits. Linear regressions were adjusted for gender, anticipated specialty choice, parental education, living status, financial insecurity, randomization group and baseline JSE-S. RESULTS: The cohort included 311 participants from October 2015 to December 2016 at Paris Diderot and Paris Descartes University. At follow-up, there was a JSE-S total score increase of 1.22(SD:9.10) in the intervention group, compared to a decrease of 1.64(SD:10.74) in the other group. Baseline JSE-S was positively associated with Extraversion and Conscientiousness and negatively with Neuroticism. In contrast, we found no associations between baseline personality traits and JSE-S change. There were no interactions between personality traits and randomization group. CONCLUSION: Although personality might be linked with cognitive empathy, medical students may benefit from strategies designed for improving cognitive empathy regardless of their personality.

Balint groups and narrative medicine compared to a control condition in promoting students' empathy.

BACKGROUND: The perceived importance of clinical empathy may decline among students during medical training. Several interventions have been shown to be effective in promoting or preserving medical students' empathic abilities, such as empathy skills training or Balint groups. Although narrative medicine training shares some features with these interventions, no randomized study to date examined the efficacy of narrative medicine training. This study aimed to assess the effects of Balint groups and narrative medicine training on clinical empathy measured by the self-rated Jefferson's School Empathy Scale - Medical Student (JSPE-MS©) among fourth-year medical students. METHODS: Students who gave their consent to participate were randomly allocated in equal proportion to Balint groups, narrative medicine training or to the control group. Participants in the intervention groups received either seven sessions of 1.5-h Balint groups or a 2-h lecture and five sessions of 1.5-h narrative medicine training from October 2015 to December 2015. The main outcome was the change in JSPE-MS© score from baseline to one week after the last session. RESULTS: Data from 362 out of 392 participants were analyzed: 117 in the control group, 125 in the Balint group and 120 in the narrative medicine group. The change in JSPE-MS© score from baseline to follow-up was significantly higher in the Balint group than in the control group [mean (SD): 0.27 (8.00) vs. -2,36 (11.41), t = 2.086, P = 0.038]. The change in JSPE-MS© score in the narrative medicine group [mean (SD): - 0.57 (8.76)] did not significantly differ from the changes in the control group (t = 1.355, P = 0.18) or the Balint group (t = 0.784, P = 0.43). Adjusting for participants' characteristics at baseline, Balint groups remained associated with better outcomes compared to the control group (ß = 2.673, P = 0.030). CONCLUSIONS: Balint groups may promote clinical empathy to some extent among medical students, at least in the short run.

Titrated baclofen for high-risk alcohol consumption: a randomized placebo-controlled trial in out-patients with 1-year follow-up.

BACKGROUND AND AIMS: Baclofen is a promising drug for treating patients with alcohol-related disorders. Nevertheless, the first randomized clinical trials (mainly with target doses) reported inconsistent efficacy, possibly because of the effective dose widely varying between patients. The Bacloville study aimed to test the efficacy of titrated baclofen for achieving low-risk alcohol consumption. DESIGN: Twelve-month multicenter pragmatic double-blind randomized clinical trial from June 2012 to June 2014. SETTING: Sixty-two French primary care centers. PARTICIPANTS: Out-patients with high-risk alcohol consumption (> 40 g/day for women and > 60 g/day for men). INTERVENTION AND COMPARATOR: Patients were randomly assigned (1 : 1 ratio) to receive titrated baclofen up to 300 mg/day or placebo for 12 months. Switching to open-label baclofen was allowed in cases of perceived inefficacy. MEASUREMENTS: The primary outcome defined success as no or low-risk alcohol consumption (≤ 20 g/day for women and ≤ 40 g/day for men) during the last month of the 1-year follow up, with patients who switched to open-label baclofen classified as failures. FINDINGS: A total of 320 patients were randomized, 162 to baclofen and 158 to placebo (consumption 129 g/day in both arms). Discontinuation rates were 30 and 34% in the baclofen and placebo arms, respectively, and return rates of the last-month diaries were 42 and 34%, respectively. Primary success rates were 57 and 36% in the baclofen and placebo arms, respectively [difference: 21 percentage points, 95% confidence interval (CI) = 8-34, P = 0.003]. When switchers were not classified as failures unless they failed, the success rates were 62 versus 55% (difference: 6 percentage points, 95% CI = -7 to 20). Over 12 months, daily consumption differed between both arms (11 g less in the baclofen arm), as did the number of abstinence days (3.3 days more in the baclofen arm). Adverse events were more frequent with baclofen than placebo and were mostly drowsiness, fatigue and insomnia. Serious adverse events occurred in 85 (seven deaths) and 36 (three deaths) patients with baclofen and placebo, respectively. CONCLUSIONS: Baclofen was more effective than placebo in reducing alcohol consumption to low-risk levels. The number of adverse events and more serious adverse events was greater with baclofen than placebo.

Tailored-Dose Baclofen in the Management of Alcoholism: A Retrospective Study of 144 Outpatients Followed for 3 Years in a French General Practice.

Background: More information is needed about the efficacy and safety of long-term baclofen in the treatment of alcohol use disorders. The objective of this study was to assess the effect of treatment with tailored-dose baclofen on alcohol consumption in patients with alcohol use disorders followed for 3 years after first initiating baclofen treatment. Methods: This retrospective descriptive cohort included outpatients followed in a French general practice clinic for 3 years and treated with tailored-dose baclofen to reduce or eliminate alcohol consumption. At 3 years, treatment was considered successful if alcohol consumption was at or below levels defined as low-risk by the WHO (≤ 40 g/d in men and ≤ 20 g/d in women). Results: The study population included 144 patients (88 men and 56 women). The participants' mean age was 46 ± 11 years and mean daily alcohol intake before treatment was 167 ± 77 grams. At the end of the study, treatment was successful for 91 (63.2%) patients. Participants' mean dose of baclofen at the end of study period was 100 ± 101 mg/d. We identified 75 (52.1%) patients for whom treatment was successful at each annual follow-up appointment: at 1, 2, and 3 years. The mean maximum dose of baclofen over follow-up of the 144 patients was 211 ± 99 mg/d (dose range: 40 mg/d to 520 mg/d). Conclusion: In this study, tailored-dose baclofen appears to be an effective treatment in patients with alcohol use disorders, with sustainable effect over time (3 years). There are many adverse effects but they are consistent with those already described in the literature.

The Use of Baclofen as a Treatment for Alcohol Use Disorder: A Clinical Practice Perspective.

Alcohol use disorder (AUD) is a brain disorder associated with high rates of mortality and morbidity worldwide. Baclofen, a selective gamma-aminobutyric acid-B (GABA-B) receptor agonist, has emerged as a promising drug for AUD. The use of this drug remains controversial, in part due to uncertainty regarding dosing and efficacy, alongside concerns about safety. To date there have been 15 randomized controlled trials (RCTs) investigating the use of baclofen in AUD; three using doses over 100 mg/day. Two additional RCTs have been completed but have not yet been published. Most trials used fixed dosing of 30-80 mg/day. The other approach involved titration until the desired clinical effect was achieved, or unwanted effects emerged. The maintenance dose varies widely from 30 to more than 300 mg/day. Baclofen may be particularly advantageous in those with liver disease, due to its limited hepatic metabolism and safe profile in this population. Patients should be informed that the use of baclofen for AUD is as an "off-label" prescription, that no optimal fixed dose has been established, and that existing clinical evidence on efficacy is inconsistent. Baclofen therapy requires careful medical monitoring due to safety considerations, particularly at higher doses and in those with comorbid physical and/or psychiatric conditions. Baclofen is mostly used in some European countries and Australia, and in particular, for patients who have not benefitted from the currently used and approved medications for AUD.

Promoting empathy among medical students: A two-site randomized controlled study.

OBJECTIVE: To assess the effects of Balint groups on empathy measured by the Consultation And Relational Empathy Measure (CARE) scale rated by standardized patients during objective structured clinical examination and self-rated Jefferson's School Empathy Scale - Medical Student (JSPE-MS©) among fourth-year medical students. METHODS: A two-site randomized controlled trial were planned, from October 2015 to December 2015 at Paris Diderot and Paris Descartes University, France. Eligible students were fourth-year students who gave their consent to participate. Participants were allocated in equal proportion to the intervention group or to the control group. Participants in the intervention group received a training of 7 sessions of 1.5-hour Balint groups, over 3months. The main outcomes were CARE and the JSPE-MS© scores at follow-up. RESULTS: Data from 299 out of 352 randomized participants were analyzed: 155 in the intervention group and 144 in the control group, with no differences in baseline measures. There was no significant difference in CARE score at follow-up between the two groups (P=0.49). The intervention group displayed significantly higher JSPE-MS© score at follow-up than the control group [Mean (SD): 111.9 (10.6) versus 107.7 (12.7), P=0.002]. The JSPE-MS© score increased from baseline to follow-up in the intervention group, whereas it decreased in the control group [1.5 (9.1) versus -1.8 (10.8), P=0.006]. CONCLUSIONS: Balint groups may contribute to promote clinical empathy among medical students. TRIAL REGISTRATION: NCT02681380.

'Intern life': a longitudinal study of burnout, empathy, and coping strategies used by French GPs in training.

BACKGROUND: More than half of French medical GP trainees (GPTs) suffer from burnout. AIM: To define and follow the evolution of risk factors, such as empathy and coping strategies, associated with burnout in this population. DESIGN & SETTING: Prospective longitudinal study involving volunteers of 577 Parisian university GPTs in 2012. METHOD: Self-reported anonymous online questionnaires were sent three times every 6 months to all participants. Stress was measured using the Intern-Life scale and burnout using the Maslach Inventory, and anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS). Sociodemographic, professional, and personal data, including coping strategies and measures of empathy were also collected. RESULTS: In total 343 questionnaires were fully completed at baseline (T0): 304 were usable at baseline, 169 were usable at 6 months (T1) and 174 at 1 year (T2). Stress rates decreased sharply between T1 (scores 42.96) and T2 (17.08), while scores for burnout remained relatively stable: more than 13% of GPTs had high scores in all three dimensions of burnout. Depersonalisation increased from 61% (T1) to 66% (T2). One hundred and four paired samples were analysed between T0 and T1, and between T1 and T2. Emotion-centred coping was associated with emotional exhaustion (P<0.05), while professional support reduced it. Experiences of aggression increased depersonalisation (P<0.05). Social support, problem-centred coping, perspective-taking empathy, and professional support improved the sense of personal accomplishment (P<0.05). CONCLUSION: Tools to help GPTs are available but are underused. More training in doctor-patient relationships and understanding of medical hidden curricula are necessary to decrease burnout among GPTs and improve their wellbeing and patient care.

Monitoring stress among internal medicine residents: an experience-driven, practical and short measure.

Residents experience severely high levels of stress, depression and burnout, leading to perceived medical errors, as well as to symptoms of impairment, such as chronic anger, cognitive impairment, suicidal behavior and substance abuse. Because research has not yet provided a psychometrically robust population-specific tool to measure the level of stress of medicine residents, we aimed at building and validating such a measure. Using an inductive scale development approach, a short, pragmatic measure was built, based on the interviews of 17 medicine residents. The Internal Medicine Residency Stress Scale (IMRSS) was then administered in a sample of 259 internal medicine residents (199 females, 60 males, MAge = 25.6) along with the Hospital Anxiety and Depression Scale, Maslach Burnout Inventory, Satisfaction With Life Scale and Ways of Coping Checklist. The IMRSS showed satisfactory internal reliability (Cronbach's α = .86), adequate structural validity - studied through Confirmatory Factor Analysis (χ2/df = 2.51, CFI = .94; SRMR = .037, RMSEA = .076) - and good criterion validity - the IMRSS was notably strongly correlated with emotional exhaustion (r = .64; p < .001) and anxiety (r = .57; p < .001). Because of its short length and robust psychometric qualities, the use of the IMRSS is recommended to quickly and frequently assess and monitor stress among internal medicine residents.

Burnout, empathy and their relationships: a qualitative study with residents in General Medicine.

Some studies have shown that burnout may have a negative impact on clinical empathy during internship. However, clinical empathy may also be a protective factor, preventing residents from experiencing burnout. Although several quantitative studies have been conducted to examine these relationships between burnout and empathy, no qualitative studies have been carried out. To examine how residents in general practice evaluate the link between burnout and empathy, 24 of them participated in a semi-structured interview. A thematic analysis was carried out to examine residents' discourses and answers to closed questions. The results indicated that residents thought that empathy and burnout were clearly related in different ways. They identified five types of relationship: regulation strategy, empathy as protection, psychological balance/imbalance, fatigue and moderating factors.

Tolerability of High-dose Baclofen in the Treatment of Patients with Alcohol Disorders: A Retrospective Study.

AIMS: The aim of this study was to describe the tolerability of high-dose baclofen taken by patients with alcohol disorders during their first year of treatment. METHODS: The medical records of all patients prescribed baclofen by one general practitioner were examined and all patients who could be contacted were retrospectively interviewed about adverse effects. RESULTS: Of the 146 eligible patients, 116 (79%) could be interviewed. Ninety (78%) reported at least one adverse effect (mean number per patient: 2.8 ± 2.7). The mean dosage of baclofen at the onset of the first adverse effect was 83 ± 57 mg/day. The most frequent group of adverse effects involved disruption of the wake-sleep cycle and affected 73 patients (63%). Persistent adverse effects occurred in 62 patients (53%). Eight patients (7%) had adverse effects that led them to stop taking baclofen. Their dosages were <90 mg/day at that time. Alertness disorders and depression were the adverse effects that most frequently led to stopping baclofen. Bouts of somnolence and hypomanic episodes were the most potentially dangerous adverse effects. Women reported significantly more adverse effects than men. CONCLUSION: High-dose baclofen exposes patients with alcohol disorders to many adverse effects. Generally persistent, some adverse effects appear at low doses and may be dangerous.

Quality of life and illness perception in primary biliary cirrhosis: a controlled cross-sectional study.

OBJECTIVE: The aim of this study was to understand better the quality of life (QOL) and illness perception in women with primary biliary cirrhosis (PBC) through a comparison with women having diabetes. METHODS: One hundred and ninety-four women took part in this study: 130 with PBC, 64 with type 2 diabetes. They were administered the SF-12 to measure QOL and the Brief Illness Perception Questionnaire to assess representations of their illness. Analysis of covariance with bootstrapping was used to compare QOL and illness perception scores by controlling age and mean disease duration. RESULTS: Physical QOL was significantly worse for women with PBC than for women with diabetes. Women with PBC felt their disease would last longer and reported more symptoms and concerns related to their disease than women with diabetes. Significant differences were also observed for causes: women with PBC mainly reported autoimmune, emotional, unknown/unlucky and medical causes whereas women with diabetes reported mostly lifestyle and hereditary causes. Marginally significant differences were observed regarding consequences on daily life, feeling of control over the disease and emotional responses, which were shown to be worse in PBC. Mental QOL, treatment control and overall understanding of the disease was similar in both groups. CONCLUSIONS: This study shows that women with PBC have a worse QOL and somewhat different illness perception than women with diabetes. Further research could help understand PBC specificities better in order to improve patient care, especially if factors such as fatigue or rarity of the disease explain these results.

Vaccine knowledge in students in Paris, France, and surrounding regions.

INTRODUCTION: In France, young adults are legally freed from parental authority at the age of 18 years and are, thus, responsible for their own vaccine record. This young adult population is more frequently exposed to vaccine-preventable infectious diseases. OBJECTIVE: To determine the factors associated with students' knowledge of the interval between two antitetanus boosters and their report of having up-to-date vaccinations. METHODS: In April 2009, a survey was conducted involving a random sample of students between 18 and 25 years of age eating lunch at university dining facilities in Paris and its suburbs (Ile de France). RESULTS: Among the 677 students approached, 583 agreed to participate. Only 207 (36%) of respondents knew the recommended dosing interval between two doses of tetanus vaccine booster (10 years). The majority of students (69%) reported having up-to-date vaccinations. Declaring having up-to-date vaccinations was significantly associated with having a general practitioner (OR 3.03 [95% CI 1.69 to 5.55]). Health care students were significantly more likely to know the decennial interval between two antitetanus boosters (OR 2 [95% CI 1.28 to 3.25]). Most of responding students (n=519 [89%]) believed that vaccines were very useful. CONCLUSIONS: An overall lack of knowledge of vaccines was observed among this student population. Health care providers, such as GPs and university medical practice staff, who interact with these young individuals have an essential role to promote better vaccination coverage in this population.

INTRODUCTION: En France, les jeunes adultes sont légalement libérés de l'autorité parentale à 18 ans et deviennent donc responsables de leur dossier de vaccination. La population de jeunes adultes est davantage exposée aux maladies infectieuses évitables par la vaccination. OBJECTIF: Déterminer les facteurs associés aux connaissances des étudiants sur l'intervalle entre les deux doses de rappel du vaccin contre le tétanos et sur leur déclaration d'avoir une couverture vaccinale. MÉTHODOLOGIE: En avril 2009, un sondage a été mené auprès d'un échantillon aléatoire d'étudiants de 18 à 25 ans qui, le midi, mangent aux cafétérias universitaires de Paris et des banlieues (Île de France). RÉSULTATS: Sur les 677 étudiants abordés, 583 ont accepté de participer. Seulement 207 des répondants (36 %) connaissaient l'intervalle recommandé entre deux doses de rappel du vaccin contre le tétanos (dix ans). La majorité des étudiants (69 %) déclarai avoir une couverture vaccinale à jour. Cette déclaration s'associait de manière significative au fait d'avoir un praticien général (RC 3,03 95 % IC 1,69 à 5,55]). Les étudiants du milieu de la santé étaient considérablement plus enclins à connaître l'intervalle de dix ans entre deux doses de rappel du vaccin antitétanique (RC 2 [95 % IC 1,28 à 3,25]). La plupart des étudiants répondants (n=519 [89 %]) croyaient en l'utilité des vaccins. CONCLUSIONS: Les chercheurs ont constaté une ignorance globale des vaccins au sein de cette population de patients. Les dispensateurs de soins, tels que les praticiens généraux et le personnel médical en milieu universitaire, qui dialoguent avec ces jeunes, ont un rôle essentiel à jouer pour promouvoir une meilleure couverture vaccinale au sein de cette population.

Appropriate training based on Balint groups can improve the empathic abilities of medical students: a preliminary study.

OBJECTIVE: Although empathy is critical in a doctor-patient relationship, empathic abilities seem to decline throughout medical school. This study aimed at examining changes in empathic abilities of fourth-year medical students who participated in an optional certificate based on Balint groups. METHODS: Thirty-four students were included in the "Balint group" certificate and compared with 129 participating in other certificates. Before the training sessions and 4 months later, they filled up the interpersonal reactivity index (IRI) and were asked to rate their emotional reactions in response to two case-reports: the first described a woman with diabetes, borderline- personality traits and a history of childhood trauma; the second, a woman with histrionic traits suffering from multiple sclerosis and hospitalized for functional symptoms. A principal component analysis extracted four factors from the 8 questions asked: empathic-approach (e.g. finding the patient touching), rejecting-attitude, intellectual-interest and fear of emotion contagion. RESULTS: At baseline, there were no socio-demographic or psychological differences between groups. At follow-up, an increase of IRI fantasy-scale (p=0.02) and a decrease of IRI empathic-concern (p=0.006) were observed, regardless of the group. Empathic-approach only increased in the "Balint group" and for the first case-report (p=0.023), with a difference between the groups at follow-up (p=0.003). CONCLUSION: Results suggest that Balint groups may enable medical students to better handle difficult clinical situations such as those presented by borderline personalities. Our findings encourage assessing training initiatives designed at helping young medical students to take into account the emotional component of a doctor-patient relationship.

Empathic concern and professional characteristics associated with clinical empathy in French general practitioners.

OBJECTIVE: Clinical empathy, i.e. the ability of physicians to adopt patient perspective, is an essential component of care, which depends in part on empathic concern, i.e. compassionate emotions felt for others. However, too much empathic concern can be challenging for physicians. Aim of this study was to examine physician practice characteristics that could explain clinical empathy beyond empathic concern. We were also interested in testing whether professional reflective activities, such as Balint group attendance or clinical supervision, might make clinical empathy less dependent on empathic concern. METHODS: A total of 295 French general practitioners (response rate of 37%) completed self-reported questionnaires on empathic concern and clinical empathy, using the Toronto empathy questionnaire (TEQ) and the Jefferson scale of physician empathy (JSPE), respectively. We also recorded information on their professional practice: professional experience, duration of consultations, and participation in Balint groups or being a clinical supervisor. Hierarchical regression analyses were carried out with clinical empathy as dependent variable. RESULTS: Empathic concern was an important component of clinical empathy variance. The physician practice characteristics 'consultation length' and 'being a Balint attendee or a supervisor,' but not 'clinical experience' made a significant and unique contribution to clinical empathy beyond that of empathic concern. Participating to one reflective activity (either Balint group attendance or clinical supervision) made clinical empathy less dependent on empathic concern. CONCLUSION: Working conditions such as having enough consultation time and having the opportunity to attend a professional reflective activity support the maintenance of clinical empathy without the burden of too much empathic concern.

Abstinence and 'low-risk' consumption 1 year after the initiation of high-dose baclofen: a retrospective study among 'high-risk' drinkers.

AIMS: The aim of the study was to assess the proportions of 'high-risk' drinkers' abstinent or with 'low-risk' consumption levels 1 year after the initiation of high-dose baclofen. METHODS: This is a retrospective 'open' study; the outcome of this study was to assess the level of alcohol consumption in the 12th month of treatment. RESULTS: Of the 181 patients included, a follow-up evaluation was possible in 132 patients. The initial alcohol consumption of the 132 patients analysed averaged 182 ± 92 g/day. After 1 year, 80% of the 132 (i.e. 58% of 181) were either abstinent (n = 78) or drinking at low-risk levels (n = 28) in their 12th month of treatment. The mean baclofen dose at 1 year was 129 ± 71 mg/day. CONCLUSION: High-dose baclofen should be tested in randomized placebo-controlled trials among high-risk drinkers.