A double-blind placebo-controlled randomized trial of Melissa officinalis oil and XXXX for the treatment of @entity2146 in @entity195 .

@entity1 @entity64 @entity146 @entity2146 @entity195 @entity8124
BACKGROUND/AIMS: Behavioural and psychological symptoms (BPSD) are frequent in @entity1 with @entity195 and cause considerable stress to @entity1 and their carers. Antipsychotics have been widely used as a first-line treatment, resulting in an estimated 1,800 excess @entity64 and 1,600 excess deaths in the UK alone. Safe and effective alternatives are urgently needed. Based upon preliminary evidence from clinical trials, aromatherapy with melissa oil may be such an alternative, but initial studies have been modest in size, and adequate blinding has been problematic. Our objective was to assess the efficacy of melissa aromatherapy in the treatment of @entity2146 in @entity1 with @entity195 in an adequately powered and robustly blinded randomized controlled trial comparing it with @entity8124 , an anticholinesterase drug used with some benefit to treat BPSD. METHODS AND FINDINGS: The study was a double-blind parallel-group placebo-controlled randomized trial across 3 specialist old age psychiatry centres in England. @entity1 had probable or possible @entity195 , were resident in a care home, had clinically significant @entity2146 (defined as a score of 39 or above on the Cohen Mansfield Agitation Inventory) and were free of antipsychotics and/or anticholinesterase for at least 2 weeks. @entity1 were allocated to 1 of 3 groups: placebo medication and active aromatherapy; active medication and placebo aromatherapy or placebo of both. MAIN OUTCOME: The primary outcome measure was reduction in @entity2146 as assessed by the Pittsburgh Agitation Scale (PAS) at 4 weeks. This is an observational scale, and raters were required to wear nose clips to ensure that full blinding was maintained. The PAS, @entity146 Inventory (NPI; another measure of BPSD) and other outcome measures were completed at baseline, 4-week and 12-week follow-ups. 114 @entity1 were randomized, of whom 94 completed the week 4 assessment and 81 completed the week 12 assessment. Aromatherapy and @entity8124 were well tolerated. There were no significant differences between aromatherapy, @entity8124 and placebo at week 4 and week 12, but importantly there were substantial improvements in all 3 groups with an 18% improvement in the PAS and a 37% improvement in the NPI over 12 weeks. CONCLUSION: When assessed using a rigorous design which ensures blinding of treatment arms, there is no evidence that melissa aromatherapy is superior to placebo or @entity8124 , in the treatment of @entity2146 in @entity1 with @entity195 . However, the sizeable improvement in the placebo group emphasizes the potential non-specific benefits of touch and interaction in the treatment of @entity2146 in @entity1 with @entity195 .
