Introduction <p>Healthcare guidelines advise that z-hypnotics should not be used long-term in older patients. However, inappropriate use of these medications, characterised by prolonged use at high doses, remains common. This study aimed to evaluate the effect of a brief intervention (BI) conducted by general practitioners (GPs) for terminating inappropriate use of z-hypnotics, compared to business as usual (BAU – control group).</p> Methods <p>This study was a double-blind, randomised controlled trial comparing BI conducted by trained GPs to BAU at baseline and at a six-week follow-up. Both intention-to-treat (ITT) and per-protocol (PP) analyses were performed, utilising t-tests and Fisher’s exact tests. The predefined primary outcome was the proportion of participants with no inappropriate z-hypnotic use (defined as use for four weeks or more, or three times per week or more). Secondary outcomes included sleep problems, measured by the Global Sleep Assessment Scale, visual analogue scale for (VAS) pain intensity, and cognitive function, measured by the Montreal Cognitive Assessment (MOCA).</p> Results <p>Both study arms reduced inappropriate use and improved usage patterns (<i>n</i> = 45). No difference was found in the ITT analysis of BI (<i>n</i> = 23) and BAU (<i>n</i> = 22) at six-week follow-up (no inappropriate use BAU = 71% and BI = 57%, <i>p</i> = 0.51). There were no significant differences between the BI and BAU groups in cognitive function (MOCA) (mean (SD) BI: 18.12 (2.15); BAU: 17.61 (2.89); <i>p</i> = 0.56), and VAS pain intensity (mean (SD) BI: 1.67(1.96); BAU: 1.75(2.05); <i>p</i> = 0.90). There was no significant difference in insomnia symptoms at six-week follow-up (proportion of insomnia BAU = 9.1% and BI = 8.7%, <i>p</i>-value = 1.00). The PP analysis showed comparable results.</p> Conclusion <p>While many patients reduced their use of z-hypnotics, there was no significant difference in inappropriate use between the BI and BAU groups. The main limitation of the study was that it became underpowered. More studies are needed with a larger sample size.</p> Trial registration <p>NCT06032715 </p>

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A brief intervention to discontinue inappropriate z-hypnotics use by older patients in primary care: a randomised controlled trial

  • Tahreem Ghazal Siddiqui,
  • Tone Breines Simonsen,
  • Maria Torheim Bjelkarøy,
  • Maria Lie Selle,
  • Christofer Lundqvist

摘要

Introduction

Healthcare guidelines advise that z-hypnotics should not be used long-term in older patients. However, inappropriate use of these medications, characterised by prolonged use at high doses, remains common. This study aimed to evaluate the effect of a brief intervention (BI) conducted by general practitioners (GPs) for terminating inappropriate use of z-hypnotics, compared to business as usual (BAU – control group).

Methods

This study was a double-blind, randomised controlled trial comparing BI conducted by trained GPs to BAU at baseline and at a six-week follow-up. Both intention-to-treat (ITT) and per-protocol (PP) analyses were performed, utilising t-tests and Fisher’s exact tests. The predefined primary outcome was the proportion of participants with no inappropriate z-hypnotic use (defined as use for four weeks or more, or three times per week or more). Secondary outcomes included sleep problems, measured by the Global Sleep Assessment Scale, visual analogue scale for (VAS) pain intensity, and cognitive function, measured by the Montreal Cognitive Assessment (MOCA).

Results

Both study arms reduced inappropriate use and improved usage patterns (n = 45). No difference was found in the ITT analysis of BI (n = 23) and BAU (n = 22) at six-week follow-up (no inappropriate use BAU = 71% and BI = 57%, p = 0.51). There were no significant differences between the BI and BAU groups in cognitive function (MOCA) (mean (SD) BI: 18.12 (2.15); BAU: 17.61 (2.89); p = 0.56), and VAS pain intensity (mean (SD) BI: 1.67(1.96); BAU: 1.75(2.05); p = 0.90). There was no significant difference in insomnia symptoms at six-week follow-up (proportion of insomnia BAU = 9.1% and BI = 8.7%, p-value = 1.00). The PP analysis showed comparable results.

Conclusion

While many patients reduced their use of z-hypnotics, there was no significant difference in inappropriate use between the BI and BAU groups. The main limitation of the study was that it became underpowered. More studies are needed with a larger sample size.

Trial registration

NCT06032715