Abstract
Adjustment Disorders With Anxiety (ADWA) account for almost 10% of psychologically motivated consultations in primary care. The aim of this doubleโblind randomised parallel group study was to compare (nonโinferiority test) the efficacies of etifoxine, a nonโbenzodiazepine anxiolytic drug, and lorazepam, a benzodiazepine, for ADWA outpatients followed by general practitioners. 191 outpatients (mean age: 43, female: 66%) were assigned to receive etifoxine (50โmg tid) or lorazepam (0.5โ0.5โ1โmg /day) for 28 days. Efficacy was evaluated on days 7 and 28 of the treatment. The main efficacy assessment criterion was the Hamilton Rating Scale for Anxiety score (HAMโA) on Day 28 adjusted to Day 0. The anxiolytic effect of etifoxine was found not inferior to that of lorazepam (HAMโA score decrease: 54.6% vs 52.3%, respectively, pโ=โ0.0006). The two drugs were equivalent on Day 28. However, more etifoxine recipients responded to the treatment (HAMโA score decreased by โฅ50%, pโ=โ0.03). Clinical improvement (based on Clinical Global Impression scale CGI, Social Adjustment Scale SelfโReport SASโSR, and Sheehan scores) was observed in both treatment arms, but more etifoxine patients improved markedly (pโ=โ0.03) and had a marked therapeutic effect without side effects as assessed by CGI, pโ=โ0.04. Moreover, 1 week after stopping treatment, fewer patients taking etifoxine experienced a rebound of anxiety, compared to lorazepam (1 and 8, respectively, pโ=โ0.034). Copyright ยฉ 2006 John Wiley & Sons, Ltd.