BackgroundAlthough benzodiazepines are effective, long-term use is not recommended because of potential adverse effects; the risks of tolerance and dependence; and an increased risk of hip fractures, motor vehicle accidents, and memory impairment. The estimated prevalence of long-term benzodiazepine use in the general population is about 2,2 to 2,6%, is higher in women and increases steadily with age. Interventions performed by General Practitioners may help patients to discontinue long-term benzodiazepine use. We have designed a trial to evaluate the effectiveness and safety of two brief general practitioner-provided interventions, based on gradual dose reduction, and will compare the effectiveness of these interventions with that of routine clinical practice.Methods/DesignIn a three-arm cluster randomized controlled trial, general practitioners will be randomly allocated to: a) a group in which the first patient visit will feature a structured interview, followed by visits every 2-3 weeks to the end of dose reduction; b) a group in which the first patient visit will feature a structured interview plus delivery of written instructions to self-reduce benzodiazepine dose, or c) routine care. Using a computerized pharmaceutical prescription database, 495 patients, aged 18-80 years, taking benzodiazepine for at least 6 months, will be recruited in primary care health districts of three regions of Spain (the Balearic Islands, Catalonia, and Valencia). The primary outcome will be benzodiazepine use at 12 months. The secondary outcomes will include measurements of anxiety and depression symptoms, benzodiazepine dependence, quality of sleep, and alcohol consumption.DiscussionAlthough some interventions have been shown to be effective in reducing benzodiazepine consumption by long-term users, the clinical relevance of such interventions is limited by their complexity. This randomized trial will compare the effectiveness and safety of two complex stepped care interventions with that of routine care in a study with sufficient statistical power to detect clinically relevant differences.Trial RegistrationCurrent Controlled Trials: ISRCTN13024375
Burst-suppression anesthesia (BSA) has been previously compared with electroconvulsive therapy (ECT) in drug-resistant depression, with promising results. We have carried out a double-blind randomized clinical trial comparing BSA with sham-BSA in 20 patients meeting DSM-IV criteria for major depression with inadequate response to antidepressant drugs and who chose BSA as an alternative to ECT. After withdrawing antidepressant drugs, patients were randomized to receive four sessions of either BSA (induction with propofol followed by the anesthetic agent sevoflurane, achieving BSA for 1 hour) or sham-BSA (induction with propofol until loss of consciousness, followed by spontaneous awakening in 5-10 minutes). Decrease in the Hamilton Rating Depression Scale was larger with BSA (-6.0 +/- 7.3) than with sham-BSA (-2.5 +/- 4.5), but differences did not reach statistical significance ( t = -1.08, p = 0.3). In our sample, we have not found BSA to be superior to sham-BSA and therefore cannot consider BSA as an alternative to ECT.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.