Comparative efficacy of two primary care interventions to assist withdrawal from long term benzodiazepine use: A protocol for a clustered, randomized clinical trial

Abstract

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

Efficacy of two interventions on the discontinuation of benzodiazepines in long-term users: 36-month follow-up of a cluster randomised trial in primary care

“…GPs recruited the patients before randomisation; cluster randomisation was used to avoid potential cross-contamination bias. A detailed research protocol 24 and details of the efficacy of the SIF and SIW interventions after 12 months were published elsewhere. The study design, procedures, and reporting followed the CONSORT guidelines for cluster randomised controlled trials 25 (Trial Registration: ISRCTN13024375).…”

Prescrição de medicamentos potencialmente inapropriados para idosos: um estudo transversal em instituição psiquiátrica

“…O diazepam, o clordiazepóxido e o clonazepam são benzodiazepínicos de longa ação classificados como MPIs em qualquer condição clínica e a depender da doença ou síndrome. Possuem meia-vida longa em idosos, produzindo sedação prolongada, alterações psicomotoras, falta de coordenação, aumento do risco de quedas e fraturas, além de delírios, perturbações cognitivas e elevação da mortalidade 2,27,28 .…”

Utilización de benzodiacepinas según el motivo de ingreso

“…El porcentaje global hallado es similar a los descritos previamente en pacientes mayores en otros países 4 , aunque la mayoría de las series se realizan desde la comunidad 6 .…”