RESUMEN
Baclofen is a new and promising pharmacological compound for the treatment of alcohol dependence (AD). Although several randomised trials found a reduction of craving and higher abstinence rates with low and high doses of baclofen, others failed to show positive effects. In this case study, the successful treatment of a patient with AD with daily 120 mg of baclofen is described. In addition to a decrease in alcohol use, we observed the cessation of stuttering during treatment with baclofen, reoccurrence of stuttering following discontinuation, and cessation of stuttering after reinstatement of the treatment. Based on this observation, the direct effects of baclofen on muscle relaxation and anxiety reduction and its indirect effect on dopaminergic inhibition, we believe that baclofen might be a new treatment for stuttering. Further research into the effect of baclofen on stuttering is warranted.
Asunto(s)
Alcoholismo/tratamiento farmacológico , Baclofeno/farmacología , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Tartamudeo/tratamiento farmacológico , Abstinencia de Alcohol/estadística & datos numéricos , Consumo de Bebidas Alcohólicas/tratamiento farmacológico , Ansiedad/tratamiento farmacológico , Baclofeno/administración & dosificación , Agonistas de Receptores GABA-B/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Resultado del TratamientoRESUMEN
Previous randomised placebo-controlled trials with low-to-medium doses of baclofen (30-60mg) showed inconsistent results, but case studies suggested a dose-response effect and positive outcomes in patients on high doses of baclofen (up to 270mg). Its prescription was temporary permitted for the treatment of alcohol dependence (AD) in France, and baclofen is now widely prescribed. Recently, a small RCT found a strong effect of a mean dose of 180mg baclofen. In the present study the efficacy and safety of high doses of baclofen was examined in a multicentre, double-blind, placebo-controlled trial. 151 patients were randomly assigned to either six weeks titration and ten weeks high-dose baclofen (N=58; up to 150mg), low-dose baclofen (N=31; 30mg), or placebo (N=62). The primary outcome measure was time to first relapse. Nine of the 58 patients (15.5%) in the high-dose group reached 150mg and the mean baclofen dose in this group was 93.6mg (SD=40.3). No differences between the survival distributions for the three groups were found in the time to first relapse during the ten-weeks high-dose phase (χ2=0.41; p=0.813) or the 16-weeks complete medication period (χ2=0.04; p=0.982). There were frequent dose-related adverse events in terms of fatigue, sleepiness, and dry mouth. One medication related serious adverse event occurred in the high-dose baclofen group. Neither low nor high doses of baclofen were effective in the treatment of AD. Adverse events were frequent, although generally mild and transient. Therefore, large-scale prescription of baclofen for the treatment of AD seems premature and should be reconsidered.