A Controlled Study Comparing a Three Times Daily Dose of Chlordiazepoxide with a Single Night-Time Dose of Trancopal in the Control of Anxiety, Using a Double-Blind, Double-Dummy Technique

Abstract

A double-blind, double-dummy between-patient study in general practice was carried out to compare the effectiveness of a single, night-time dosage of Trancopal and a three times daily dose of chlordiazepoxide in controlling neurotic anxiety. Ninety-three patients received either 400 mg of Trancopal at night and a chlordiazepoxide placebo capsule three times daily or 10 mg of chlordiazepoxide three times daily and one or two Trancopal placebo tablets at night. Each was treated for four weeks. Three assessments were made using a physicians' rating scale (modified Hamilton Scale). A visual analogue scale was completed by patients initially and at weekly intervals and physicians' and patients' global assessments were made at Weeks 2 and 4.Each treatment group improved considerably over the period of the study both for sleep and anxiety ratings. A statistically significant correlation was found between improvement in day-time fatigue and loss of energy and improvement in sleep disturbance only in the Trancopal group. Loss of concentration was analyzed separately in patients over 40 years old and there was a significant improvement in the physicians' rating in the Trancopal group.There was a very close correlation throughout between the physician's and patient's own assessment of improvement. Few side-effects not already reported at the start of the trial were reported on either treatment. It was concluded that Trancopal at a usual dosage of 400 mg at night offers an effective alternative to a divided dose of chlordiazepoxide. Not only is the beneficial effect on symptoms of anxiety similar but there is some suggestion of a greater improvement in sleep and less interference with day-time functioning.

Effects of acute and repeated doses of two muscle relaxants chlormezanone and thiocolchicoside, on vigilance and psychomotor performance of healthy volunteers

“…As chlormezanone improved the ease of falling asleep as well as the quality of sleep, it had already been successfully prescribed as a hypnotic (Ghosh, 1983;Clift and Burns, 1982), in particular in cases of insomnia linked to rheumatologic disorders (Cohen, 1978) or anxiety (Warnock, 1978;Khan, 1979). Chlormezanone has also been used as a tranquilliser (Rickels et al, 1974;Donald et al, 1978). It proved to be as effective at the dosage of 800 mg as 40 mg of chlordiazepoxide, while having more marked sedative effects (Rickels et al, 1974).…”

Adoption of the double dummy trial design to reduce observer bias in testing treatments

“…7 A further nine articles published in the 1970s reported use of the double dummy trial design. [8][9][10][11][12][13][14][15][16] The introduction of the double dummy trial design in the 1960s Careful reading of these 1970s studies, however, revealed that the Croatian study was not the earliest to report the use of the double dummy trial design. The earliest reports that we have identified so far were two published in 1964 and 1965.…”