Etifoxine was found non-inferior (i.e. at least as effective) to the control, but a significantly higher percentage of the treatment group were classified as responders (72%) at the end of treatment compared to controls (56%). Both groups improved in CGI ratings, but etifoxine had a higher proportion of markedly improved individuals. SAS-SR and SDS scores improved comparably between groups with no significant differences. Stein RCT South African 100% Intervention: Intervention: Hamilton N = 201 (2015) outpatients adjustment Etifoxine Three capsules per Anxiety disorder with day for 28 days Rating Scale Intervention: anxiety anxiolytic) (150mg/day) (HAM-A) Age: 40.0 Control: Control: Three Self-report (11.8) Alprazolam capsules per day for the Male: 32% 39% (benzodiazepine) for 28 days Stressor: Assessment Control: interpersonal, (1.5mg/day) of Age: 38.9 (38%) Adjustment (12.8) work/school; Disorders Male: 30% economic (12%); other (11%) Alprazolam improved outcomes on HAM-A significantly more than etifoxine at day 7 but at day 35 (one week discontinuation), etifoxine demonstrated non-inferiority compared with alprazolam on HAM-A measures. There were no significant differences at day 35 for other measures. There were more adverse events reported in the alprazolam group.
Etifoxine was found non-inferior (i.e. at least as effective) to the control, but a significantly higher percentage of the treatment group were classified as responders (72%) at the end of treatment compared to controls (56%). Both groups improved in CGI ratings, but etifoxine had a higher proportion of markedly improved individuals. SAS-SR and SDS scores improved comparably between groups with no significant differences. Stein (2015) RCT South African outpatients Intervention: Age: 40.0 (11.8) Male: 32% Control: Age: 38.9 (12.8) Male: 30% 100% adjustment disorder with anxiety Stressor: 39% interpersonal, (38%) work/school; economic (12%); other (11%) Intervention: Etifoxine anxiolytic) Control: Alprazolam (benzodiazepine) Intervention: Three capsules per day for 28 days (150mg/day) Control: Three capsules per day for 28 days (1.5mg/day) Hamilton Anxiety Rating Scale (HAM-A) Self-report for the Assessment of Adjustment Disorders N = 201 Alprazolam improved outcomes on HAM-A significantly more than etifoxine at day 7 but at day 35 (one week discontinuation), etifoxine demonstrated non-inferiority compared with alprazolam on HAM-A measures. There were no significant differences at day 35 for other measures. There were more adverse events reported in the alprazolam group.
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