OBJECTIVE: We have previously demonstrated that temporary substitution with a low-dose hypnosedative drug may lead to successful withdrawal from chronic benzodiazepine (BZD) use in the majority of patients admitted to a geriatric ward. In the present study, a withdrawal programme was evaluated in which the habitual treatment with BZDs was replaced by either 1 mg lormetazepam or placebo, defining withdrawal success rate, sleep quality and withdrawal symptoms as main outcomes. METHODS: The target population was geriatric inpatients who had been taking BZDs for at least 3 months. Subjects suffering from mental disorders were excluded. Lormetazepam or placebo were randomly assigned and given in a double-blind fashion. After 1 week, the replacement therapy was discontinued. Subjective estimations of sleep quality and withdrawal symptoms were registered at predefined intervals, four times in a period of 30 days, using standard questionnaires (the Pittsburgh Sleep Quality Index and the Benzodiazepine Withdrawal Symptom Questionnaire, respectively). RESULTS: The success rate was significantly higher in the lormetazepam substitution group (80% vs 50% in the placebo group, P < 0.05). Both the subjective quality of sleep and withdrawal symptoms were significantly better in the lormetazepam substitution group. Important withdrawal effects were observed in the control group in two patients with a history of chronic alcohol abuse. CONCLUSIONS: Initial replacement therapy with a low-dose BZD is preferred over placebo, since the latter alternative is associated with worse sleep quality and a lower success rate. Placebo must only be used under medical scrutiny, given the potential for unmasking delirious symptoms, especially in patients with concomitant alcoholism.
RCT Entities:
OBJECTIVE: We have previously demonstrated that temporary substitution with a low-dose hypnosedative drug may lead to successful withdrawal from chronic benzodiazepine (BZD) use in the majority of patients admitted to a geriatric ward. In the present study, a withdrawal programme was evaluated in which the habitual treatment with BZDs was replaced by either 1 mg lormetazepam or placebo, defining withdrawal success rate, sleep quality and withdrawal symptoms as main outcomes. METHODS: The target population was geriatric inpatients who had been taking BZDs for at least 3 months. Subjects suffering from mental disorders were excluded. Lormetazepam or placebo were randomly assigned and given in a double-blind fashion. After 1 week, the replacement therapy was discontinued. Subjective estimations of sleep quality and withdrawal symptoms were registered at predefined intervals, four times in a period of 30 days, using standard questionnaires (the Pittsburgh Sleep Quality Index and the Benzodiazepine Withdrawal Symptom Questionnaire, respectively). RESULTS: The success rate was significantly higher in the lormetazepam substitution group (80% vs 50% in the placebo group, P < 0.05). Both the subjective quality of sleep and withdrawal symptoms were significantly better in the lormetazepam substitution group. Important withdrawal effects were observed in the control group in two patients with a history of chronic alcohol abuse. CONCLUSIONS: Initial replacement therapy with a low-dose BZD is preferred over placebo, since the latter alternative is associated with worse sleep quality and a lower success rate. Placebo must only be used under medical scrutiny, given the potential for unmasking delirious symptoms, especially in patients with concomitant alcoholism.
Authors: Annemie Somers; Hugo Robays; Kurt Audenaert; Georges Van Maele; Marc Bogaert; Mirko Petrovic Journal: Eur J Clin Pharmacol Date: 2011-01-29 Impact factor: 2.953
Authors: Amy T Page; Rhonda M Clifford; Kathleen Potter; Darren Schwartz; Christopher D Etherton-Beer Journal: Br J Clin Pharmacol Date: 2016-06-13 Impact factor: 4.335