[A controlled double-blind study of tetrabamate versus lorazepam and placebo in generalized anxiety].
The anxiolytic efficacy of tetrabamate was evaluated in a multicentric double-blind study versus lorazepam and placebo, in 269 patients with a generalized anxiety disorder according to DSM III-R criteria. The anxiolytic activity of tetrabamate (at 900 mg/day) was significantly superior than that of placebo from day 7 of treatment and equivalent to lorazepam efficacy (at 4.5 mg/day). In the tetrabamate group, 55.3% were considered as "good responders" (as defined by a HARS score reduction equal or superior to 50%), versus 51.3 and 32.9% respectively in the lorazepam and the placebo groups (chi-square = 9.63, p = 0.008). Sheehan's scales (parts 1 and 2), Norris visual analogue scales, CHESS 84, CHESS complement 82 for withdrawal evaluation, physician's overall evaluation of efficacy and tolerance, were also used to assess the clinical effects of tetrabamate. The data on these measures confirmed the anxiolytic efficacy of tetrabamate and showed some advantages in the tetrabamate group in comparison with the lorazepam group: a better global tolerance at the study end point (day 35), a greater efficacy on some anxiety somatic items and lesser frequency and severity of withdrawal symptoms during treatment tapering off.
Lôo
H
H
Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique, CHS Sainte-Anne, Paris.
Malka
R
R
Hantouche
E
E
Lancrenon
S
S
Guelfi
J D
JD
D000328:Adult; D000368:Aged; D001008:Anxiety Disorders / Q000188:drug therapy*; D001463:Barbiturates / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008140:Lorazepam / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010634:Phenobarbital / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000627:therapeutic use*; D013375:Substance Withdrawal Syndrome / Q000503:physiopathology; D013997:Time Factors
D001463:Barbiturates; D004338:Drug Combinations; D010919:Placebos; D011619:Psychotropic Drugs; C006648:difebarbamate, febarbamate, phenobarbital drug combination; D008140:Lorazepam; D010634:Phenobarbital
Etude contrôlée en double aveugle du tétrabamate versus lorzépam et placebo dans l'anxiété généralisée.