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Comparative efficacy of two interventions to discontinue long-term benzodiazepine use: cluster randomised controlled
C Vicens1, F Bejarano1, E Sempere1
1Caterina Vicens, PhD, Balearic Health Service Son Serra-La Vileta Health Care Centre, Palma de Mallorca; Ferran Bejarano, Catalunya Health Services, Reus, DAP Tarragona-Terres del l'Ebre; Ermengol Sempere, PhD, Valencia Health Services, Paterna Health Care Centre, Paterna, Valencia; Catalina Mateu, Francisca Fiol, Balearic Health Service, Son Serra-La Vileta Health Care Centre, Palma de Mallorca; Isabel Socias, Balearic Health Service, Manacor Health Care Centre, Palma de Mallorca; Enric Aragonès, PhD, Catalunya Health Services, Constantí Health Care Centre, Tarragona; Vicente Palop, PhD, Valencia Health Services, La Ribera Hospital, Valencia; Jose Luis Beltran, Valencia Health Services, Altabix Health Care Centre, Alicante, Valencia; Josep Lluís Piñol, PhD, Catalunya Health Services, Primary Care Research Unit, Reus-Altebrat, Tarragona; Guillem Lera, Valencia Health Services, La Ribera Hospital, Valencia; Silvia Folch, Catalunya Health Services, Constantí Health Care Centre, Tarragona; Marta Mengual, Catalunya Health Services, Falset Health Care Centre, Tarragona; Josep Basora, Catalunya Health Services, Reus Health Care Centre, Tarragona; Magdalena Esteva, PhD, Joan Llobera, PhD, Balearic Health Service, Primary Care Research Unit of Mallorca, Palma de Mallorca; Miguel Roca, PhD, Margalida Gili, PhD, Balearic Islands University, University Institute of Health and Science Research, Palma de Mallorca; Alfonso Leiva, MSc, Balearic Health Service, Primary Care Research Unit of Mallorca, Palma de Mallorca, Spain.
Background:
Benzodiazepines are extensively used in primary care, but their long-term use is associated with adverse health outcomes and dependence.
Aims:
To analyse the efficacy of two structured interventions in primary care to enable patients to discontinue long-term benzodiazepine use.
Method:
A multicentre three-arm cluster randomised controlled trial was conducted, with randomisation at general practitioner level (trial registration ISRCTN13024375). A total of 532 patients taking benzodiazepines for at least 6 months participated. After all patients were included, general practitioners were randomly allocated (1:1:1) to usual care, a structured intervention with follow-up visits (SIF) or a structured intervention with written instructions (SIW). The primary end-point was the last month self-declared benzodiazepine discontinuation confirmed by prescription claims at 12 months.
Results:
At 12 months, 76 of 168 (45%) patients in the SIW group and 86 of 191 (45%) in the SIF group had discontinued benzodiazepine use compared with 26 of 173 (15%) in the control group. After adjusting by cluster, the relative risks for benzodiazepine discontinuation were 3.01 (95% CI 2.03-4.46, P<0.0001) in the SIW and 3.00 (95% CI 2.04-4.40, P<0.0001) in the SIF group. The most frequently reported withdrawal symptoms were insomnia, anxiety and irritability.
Conclusions:
Both interventions led to significant reductions in long-term benzodiazepine use in patients without severe comorbidity. A structured intervention with a written individualised stepped-dose reduction is less time-consuming and as effective in primary care as a more complex intervention involving follow-up visits.
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