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

Vicens C, Socias I, Mateu C, Leiva A, Bejarano F, Sempere E, Basora J, Palop V, Mengual M, Beltran JL, Aragonès E, Lera G, Folch S, Piñol JL, Esteva M, Roca M, Arenas A, Del Mar Sureda M, Campoamor F, Fiol F - BMC Fam Pract (2011)

Bottom Line: 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.The secondary outcomes will include measurements of anxiety and depression symptoms, benzodiazepine dependence, quality of sleep, and alcohol consumption.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Son Serra- La Vileta Health Care Centre, Balearic Mental Health Research Group, Balearic Health service-IbSalut, Mallorca, Spain. cvicenscaldentey@ibsalut.caib.es

ABSTRACT

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.

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Related in: MedlinePlus

Flow-Chart of participants.
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Figure 1: Flow-Chart of participants.

Mentions: The study is designed as a multicenter three-armed clustered randomized clinical trial in primary care settings in three Spanish Primary Care Health Regions, with evaluation at 6 months and blind evaluation at 12 months (Figure 1). Long-term BZD users will be assigned to one of three parallel groups:


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

Vicens C, Socias I, Mateu C, Leiva A, Bejarano F, Sempere E, Basora J, Palop V, Mengual M, Beltran JL, Aragonès E, Lera G, Folch S, Piñol JL, Esteva M, Roca M, Arenas A, Del Mar Sureda M, Campoamor F, Fiol F - BMC Fam Pract (2011)

Flow-Chart of participants.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3105938&req=5

Figure 1: Flow-Chart of participants.
Mentions: The study is designed as a multicenter three-armed clustered randomized clinical trial in primary care settings in three Spanish Primary Care Health Regions, with evaluation at 6 months and blind evaluation at 12 months (Figure 1). Long-term BZD users will be assigned to one of three parallel groups:

Bottom Line: 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.The secondary outcomes will include measurements of anxiety and depression symptoms, benzodiazepine dependence, quality of sleep, and alcohol consumption.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Son Serra- La Vileta Health Care Centre, Balearic Mental Health Research Group, Balearic Health service-IbSalut, Mallorca, Spain. cvicenscaldentey@ibsalut.caib.es

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus