Bromazepam ('Lexotanil') compared with placebo: a double-blind, crossover study

A double-blind, crossover study was carried out in 126 out-patients, most of them neurotics, to compare the efficacy and tolerance of bromazepam and placebo. Patients received either 6 mg bromazepam or placebo daily for 3 weeks and were then crossed over to the alternative treatment for a further 3 weeks. Treatment sequence was randomized. Clinical ratings of the severity of individual symptoms and the Hamilton Anxiety Rating Scale were used to measure response to treatment at the end of each period. During the first period, both bromazepam and placebo produced improvement and there was no statistically significant difference between the two groups. During the second period after crossover, however, significantly better results were achieved in patients on bromazepam than those on placebo. The incidence of side-effects, mainly drowsiness, was similar with bromazepam and placebo.