[Prazepam drops versus 10 mg prazepam tablets in anxious patients in ambulatory care].
A multicentric study has been conducted with a new prazepam formulation (drop) which has been compared with 10 mg tablets. The aim of the study was to check the clinical equivalence of the two formulations. Nine generalists and 9 psychiatrists participated in this double blind study. One hundred fifty four patients with DSM III generalized anxiety criteria were included in this study and received prazepam at an average dosage of 20 mg per day. There were 11 drop outs: 6 in the tablet group and 5 in the drop group. The statistical analysis was done on 143 patients. Before treatment the two groups were equivalent. There was a very significant decrease (p less than 10(-4) in Hamilton anxiety scale scores, physician visual analogic scale and patient visual analogic scale with no difference between both groups. The vigilance, measured by the Mini-Folstein scale, was significantly increased (p less than 10(-4) in both groups. The tolerance was also similar: 14 patients in the tablet group and 10 in the drop one complained of asthenia and somnolence.
Chabannes
J P
JP
Clinique du Nivolet, CHS de Bassens, Chambery.
Lemoine
P
P
D000328:Adult; D000368:Aged; D000553:Ambulatory Care / Q000379:methods; D001007:Anxiety / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011222:Prazepam / Q000008:administration & dosage* / Q000627:therapeutic use; D013607:Tablets
D013607:Tablets; D011222:Prazepam
Etude prazépam goutte versus prazépam comprimé 10 mg chez des patients anxieux traités en ambulatoire.