Essential oils for agitation in dementia [rELOAD]: A pragmatic, cluster-randomized, placebo-controlled, pilot feasibility trial

BACKGROUND: Clinical guidelines recommend non-pharmacological interventions as the first line of treatment for agitation in dementia. One intervention that shows some promise as a treatment for agitation is essential oils. The objective of this study was to provide preliminary evidence of the effectiveness and feasibility of using topically-administered, individualized essential oil preparations for the alleviation of agitation in persons with dementia. METHODS: We conducted a 10-week pragmatic, cluster-randomized, placebo-controlled, pilot feasibility trial to compare the effectiveness of topically-administered, individualized essential oil preparations to control (placebo) preparations. Outcomes included frequency and severity of agitation, quality of life, frequency of antipsychotic medication use and physical restraint, incidence of adverse events, and trial feasibility. Participants with dementia and clinically significant agitation were recruited from five residential aged-care facilities across regional South Australia. RESULTS: Thirty-eight participants were randomized from five sites. Accounting for random effects, we found statistically significant differences between the intervention and control groups in Pittsburgh Agitation Scale (PAS) aberrant vocalization sub score, Cohen Mansfield Agitation Inventory (CMAI) verbally agitated sub score and CMAI total score at week 4, but not at weeks 8 (post-intervention) or 10 (follow-up). No significant time-group interactions were observed for other PAS/CMAI scores or sub scores, quality of life - Alzheimer's disease total score, or frequency of physical restraint or as-needed antipsychotic medication. No adverse events were reported in any group. CONCLUSIONS: The study findings highlight some promising effects of topically-administered, individualized essential oil preparations for agitation in dementia, and indicate that a large multi-center, cluster-randomized controlled trial of this treatment is feasible. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry [ACTRN12617001159347].