A controlled study of Trancopal in sleep disturbances due to rheumatic disease.

A placebo controlled, double-blind study was carried out in six centres in general practice to assess the effectiveness of Trancopal in treating sleep disturbances due to rheumatic disorders. Eighty-five patients received a usual dose of two tablets of Trancopal or matching placebo at night for two weeks. Patients were assessed weekly and kept a daily record of the quality of sleep. All ratings showed that patients slept significantly better on Trancopal than on placebo. Day-time rheumatic stiffness however was not significantly reduced. Six patients receiving Trancopal reported side-effects chiefly drowsiness (five patients) which was controlled by dose reduction. It was concluded that for rheumatic patients Trancopal offers an acceptable alternative to current hypnotics over which it may prove to have some advantages, particularly for the elderly.

RCT Entities:   Population Interventions Outcomes