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

Area of Science:

• Psychiatry and Clinical Psychology
• Pharmacology and Therapeutics

Background:

• Anxiety disorders are prevalent among out-patients, necessitating effective and well-tolerated treatments.
• Benzodiazepines, such as bromazepam, are commonly prescribed for anxiety, but their comparative efficacy and safety require ongoing evaluation.

Purpose of the Study:

• To compare the efficacy and tolerance of bromazepam versus placebo in an out-patient population, primarily those with neurotic conditions.
• To assess treatment response using standardized clinical ratings and the Hamilton Anxiety Rating Scale.

Main Methods:

• A double-blind, randomized crossover design involving 126 out-patients.
• Patients received 6 mg bromazepam or placebo daily for 3 weeks, followed by a crossover to the alternative treatment for another 3 weeks.

Main Results:

• Both bromazepam and placebo demonstrated improvement during the initial treatment phase, with no significant difference observed.
• In the second treatment phase after crossover, bromazepam yielded significantly better outcomes compared to placebo.
• The occurrence of side-effects, predominantly drowsiness, was comparable between bromazepam and placebo groups.

Conclusions:

• Bromazepam demonstrates superior efficacy over placebo in the later stages of treatment for neurotic out-patients.
• Bromazepam exhibits a similar side-effect profile to placebo, suggesting a favorable tolerance in this patient group.