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Comparative efficacy of two interventions to discontinue long-term benzodiazepine use: cluster randomised controlled trial in primary care

  • Caterina Vicens (a1), Ferran Bejarano (a2), Ermengol Sempere (a3), Catalina Mateu (a4), Francisca Fiol (a4), Isabel Socias (a5), Enric Aragonès (a6), Vicente Palop (a7), Jose Luis Beltran (a8), Josep Lluís Piñol (a9), Guillem Lera (a7), Silvia Folch (a6), Marta Mengual (a10), Josep Basora (a11), Magdalena Esteva (a12), Joan Llobera (a12), Miguel Roca (a13), Margalida Gili (a13) and Alfonso Leiva (a14)...
Abstract
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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Copyright
Corresponding author
Caterina Vicens Caldentey, Centro de Salud Son Serra-La Vileta, C/Matamusinos no. 22, 07011 Palma de Mallorca, Balearic Islands, Spain. Email: caterinavicens@gmail.com
Footnotes
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The study was funded by the Carlos III Health Institute of the Ministry of Economy and Competitiveness (contract PS09/00947). The Ministry had no role in the design and conduct of the study, the collection, management, analysis or interpretation of the data, and the preparation, review, and approval of the manuscript or in the decision to submit for publication. The research was conducted independently from the funding body.

Declaration of interest

None.

Footnotes
References
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Comparative efficacy of two interventions to discontinue long-term benzodiazepine use: cluster randomised controlled trial in primary care

  • Caterina Vicens (a1), Ferran Bejarano (a2), Ermengol Sempere (a3), Catalina Mateu (a4), Francisca Fiol (a4), Isabel Socias (a5), Enric Aragonès (a6), Vicente Palop (a7), Jose Luis Beltran (a8), Josep Lluís Piñol (a9), Guillem Lera (a7), Silvia Folch (a6), Marta Mengual (a10), Josep Basora (a11), Magdalena Esteva (a12), Joan Llobera (a12), Miguel Roca (a13), Margalida Gili (a13) and Alfonso Leiva (a14)...
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