Deprescribing to optimise health outcomes for frail older people: a double-blind placebo-controlled randomised controlled trial-outcomes of the Opti-med study

BACKGROUND: potentially harmful polypharmacy is very common in older people living in aged care facilities. To date, there have been no double-blind randomised controlled studies of deprescribing multiple medications.

METHODS: three-arm (open intervention, blinded intervention and blinded control) randomised controlled trial enrolling people aged over 65 years (n = 303, noting pre-specified recruitment target of n = 954) living in residential aged care facilities. The blinded groups had medications targeted for deprescribing encapsulated while the medicines were deprescribed (blind intervention) or continued (blind control). A third open intervention arm had unblinded deprescribing of targeted medications.

RESULTS: participants were 76% female with mean age 85.0 ± 7.5 years. Deprescribing was associated with a significant reduction in the total number of medicines used per participant over 12 months in both intervention groups (blind intervention group -2.7 medicines, 95% CI -3.5, -1.9, and open intervention group -2.3 medicines; 95% CI -3.1, -1.4) compared with the control group (-0.3, 95% CI -1.0, 0.4, P = 0.053). Deprescribing regular medicines was not associated with any significant increase in the number of 'when required' medicines administered. There were no significant differences in mortality in the blind intervention group (HR 0.93, 95% CI 0.50, 1.73, P = 0.83) or the open intervention group (HR 1.47, 95% CI 0.83, 2.61, P = 0.19) compared to the control group.

CONCLUSIONS: deprescribing of two to three medicines per person was achieved with protocol-based deprescribing during this study. Pre-specified recruitment targets were not met, so the impact of deprescribing on survival and other clinical outcomes remains uncertain.