[Anxiolytic efficacy and tolerance of tetrabamate in anxious patients abusing alcohol. Multicenter double-blind versus placebo study].
The anxiolytic efficacy of tetrabamate was evaluated in 68 out-patients presenting an anxiety state with alcohol abuse according to DSM III criteria. The study followed a double-blind placebo-controlled design with parallel groups and lasted for 21 days. Anxiety was evaluated by the Hamilton anxiety scale, Norris visual analog scales, and the Hopkins Symptom Check List, along with the investigator's assessment. Safety was evaluated in terms of somatic symptoms (CHESS 84) and the physician's overall evaluation. The anxiolytic activity of tetrabamate (three 300 mg tablets/day) was significantly greater than that of placebo from seventh day on. There were no statistically significant differences in safety profile between tetrabamate and placebo. Moreover, in the tetrabamate group the significantly greater improvement in the scores of somatic symptoms indicates that the compound caused no notable adverse effects and its activity on somatic complaints (psychopathologic and/or toxic).
D000437:Alcoholism / Q000150:complications / Q000188:drug therapy*; D001007:Anxiety / Q000150:complications / Q000188:drug therapy*; D001463:Barbiturates / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004338:Drug Combinations / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D010634:Phenobarbital / Q000009:adverse effects / Q000627:therapeutic use*; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000627:therapeutic use*
D001463:Barbiturates; D004338:Drug Combinations; D011619:Psychotropic Drugs; C006648:difebarbamate, febarbamate, phenobarbital drug combination; D010634:Phenobarbital
Efficacité anxiolytique et tolérance du tétrabamate chez des patients anxieux abusant de l'alcool. Etude multicentrique en double insu contre placebo.