Effect of a new benzodiazepine derivate, clobazam, in anxious patients with gastrointestinal disorders.

Thirty-four anxious patients with gastrointestinal disorders were studied in order to evaluate the effectiveness of a new 1,5-benzodiazepine antianxiety agent (HR 376). The disorders were classified as organic or functional according to the presence or absence of radiologic signs of ulcer. Dietetic measures, gastric antacids, anticholinergic agents, and antianxiety treatment were applied for six weeks. Anxiolytic treatment consisted of 30 mg/day clobazam (HR 376) or 15 mg/day diazepam, given in a randomized, double-blind manner. Clinical follow-up was performed with the PEN Personality Inventory (PEN), Taylor Manifest Anxiety Scale (TMAS), Hamilton Anxiety Scale (HAS), and Wittenborn Psychiatric Rating Scales (WPRS). The score of the psychoticism dimension of the PEN inventory was significantly higher in organic than in functional patients. Significant differences occurred in the reduction of the rating scores of HAS and WPRS before/after treatment in the clobazam and diazepam groups. This would express a modification of state anxiety. The TMAS, which evaluates trait anxiety, disclosed statistically significant improvement in the clobazam group. This group showed an early reduction of the HAS and TMAS scores, which would suggest an early onset of action.

RCT Entities:   Population Interventions Outcomes