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

BACKGROUND: Although 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/DESIGN: In 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. DISCUSSION: Although 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 REGISTRATION: Current Controlled Trials: ISRCTN13024375.

Withdrawal from long-term benzodiazepine use: randomised trial in family practice.

BACKGROUND: The long-term use of benzodiazepines is highly prevalent in developed societies and is not devoid of risks. Withdrawing patients from these drugs is often difficult. Tapering off benzodiazepines has been shown to be a good strategy for discontinuing their long-term use. AIM: To establish the efficacy of an intervention programme for reducing the chronic use of benzodiazepines. DESIGN OF STUDY: Randomised, two-arm, parallel, non-blinded controlled trial. SETTING: Three urban healthcare centres covering a population of 50,000 inhabitants (Mallorca, Spain). METHOD: Adult patients (n = 139) taking benzodiazepines daily for more than a year and visited by their family physician were randomised into an intervention group (n = 73) that received standardised advice and a tapering off schedule with biweekly follow-up visits, or into a control group (n = 66), that was managed following routine clinical practice. Both were followed for a year. RESULTS: Patients achieved withdrawal or reduced their dose by at least 50% after 6 and 12 months. Abstinence and withdrawal symptoms were also measured. Both groups were homogeneous for personal, clinical and psychological characteristics and for benzodiazepine use. Only two patients from each group were lost to follow-up. After 12 months, 33 (45.2%) patients in the intervention group and six (9.1%) in the control group had discontinued benzodiazepine use; relative risk = 4.97 (95% confidence interval [CI] = 2.2 to 11.1), absolute risk reduction = 0.36 (95% CI = 0.22 to 0.50). For every three interventions, one patient achieved withdrawal. Sixteen (21.9%) subjects from the intervention group and 11 (16.7%) controls reduced their initial dose by more than 50%. CONCLUSION: Standardised advice given by the family physician, together with a tapering off schedule, is effective for withdrawing patients from long-term benzodiazepine use and is feasible in primary care.

Uso de antidepresivos en pacientes diagnosticados de trastorno depresivo mayor y trastorno adaptativo / Use of antidepressants in major depression versus adjustment disorder

Introducción: En los últimos años ha aumentado mucho el uso de antidepresivos, incluso en enfermedades con una indicación poco clara, como los trastornos adaptativos. En España se ha incrementado en un 247% entre 1985 y 1994. En la mayoría de los estudios consultados se observa un incremento del uso de inhibidores selectivos de la recaptación de serotonina a expensas fundamentalmente de los inhibidores de la monoaminooxidasa y los heterocíclicos. Aunque el uso de los antidepresivos está muy extendido, hay pocos estudios centrados en el tratamiento psicofarmacológico en la depresión menor o en el trastorno adaptativo. Es importante el balance riesgo/beneficio de éste, sobre todo por los posibles efectos nocivos a largo plazo. En los trastornos depresivos menores, incluidos los adaptativos, se ha preconizado el tratamiento psicoterapéutico. El pronóstico en estos casos no es tan favorable como parecería: alrededor del 25% desarrolla una forma de depresión más grave. Hay pocas evidencias con antidepresivos, pero parecen mostrar resultados prometedores en el tratamiento a corto-medio plazo. Material y métodos: Estudiamos el uso de antidepresivos en nuestra población en 2 grupos, uno de 91 pacientes con diagnóstico de trastorno depresivo mayor (TDM) y otro de 81 con diagnóstico de trastorno adaptativo (TA). Resultados: Detectamos datos de mejor cumplimiento en los pacientes deprimidos: el 54,5% dice no olvidar nunca el tratamiento, frente al 39,7% de los pacientes con trastorno adaptativo. La adaptación laboral es menor en el grupo de TDM, pero los pacientes con TA tienden a vivir menos con compañía. En el TDM hay antecedentes de más episodios previos. Conclusiones: Los pacientes con trastorno depresivo mayor y con trastorno adaptativo reciben un tratamiento antidepresivo similar, aunque en el primer grupo hay tendencia a ser más "agresivo"

Introduction: In the last few years, the use of antidepressants has risen substantially and has been extended to disorders in which their suitability is unclear, such as adjustment disorders. In Spain, the consumption of antidepressants increased by 247% between 1985 and 1994. Most of the studies consulted show a greater use of selective serotonin reuptake inhibitors, mainly at the expense of monoamine oxidase inhibitors and heterocyclics. Despite the widespread use of antidepressants, few studies have investigated the pharmacological treatment of minor depression or adjustment disorder (AD). The risk-benefit balance of this therapy is important, especially because of the potential harmful effects in the long term. In minor depressive disorders, including AD, psychotherapeutic treatment has been recommended. The prognosis in these patients is not as favorable as it would appear: around 25% of patients develop a more severe form of depression. There is little evidence on antidepressant agents, but these drugs appear to show promising results in short- to medium-term treatment. Material and methods: We compared the use of antidepressants in 2 groups of patients: one group (n = 91) with a diagnosis of major depression (MDD) and another (n = 81) with a diagnosis of AD. Results: Compliance was better in patients with MDD: 54.5% reported full compliance compared with 39.7% of patients with AD. Adaptation to the work environment was poorer in the group with MDD, but patients with AD had a greater tendency to live alone. A personal history of prior episodes was more common in patients with MDD. Conclusions: Patients with MDD and AD received similar antidepressant treatment, although the former tended to be more "aggressive"