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Vol. 31, No. 2, 2011
Issue release date: March 2011
Section title: Original Research Article
Dement Geriatr Cogn Disord 2011;31:158–164
(DOI:10.1159/000324438)

A Double-Blind Placebo-Controlled Randomized Trial of Melissa officinalis Oil and Donepezil for the Treatment of Agitation in Alzheimer’s Disease

Burns A. · Perry E. · Holmes C. · Francis P. · Morris J. · Howes M.-J.R. · Chazot P. · Lees G. · Ballard C.
aMental Health and Neurodegeneration, Age Psychiatry, University of Manchester, and bMedical Statistics, University Hospital of South Manchester, Manchester, cNeurobiology, Wolfson Centre for Age-Related Disease, and dWolfson Centre for Age-Related Disease, King’s College, London, eOld Age Psychiatry, University of Southampton, Southampton, fJodrell Laboratory, Royal Botanic Gardens, Kew, and gSchool of Biological and Biomedical Sciences and hSchool of Health, University of Durham, Durham, UK

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Article / Publication Details

First-Page Preview
Abstract of Original Research Article

Accepted: 1/13/2011
Published online: 2/19/2011

Number of Print Pages: 7
Number of Figures: 1
Number of Tables: 3

ISSN: 1420-8008 (Print)
eISSN: 1421-9824 (Online)

For additional information: http://www.karger.com/DEM

Abstract

Background/Aims: Behavioural and psychological symptoms (BPSD) are frequent in people with Alzheimer’s disease and cause considerable stress to patients and their carers. Antipsychotics have been widely used as a first-line treatment, resulting in an estimated 1,800 excess strokes 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 agitation in people with Alzheimer’s disease in an adequately powered and robustly blinded randomized controlled trial comparing it with donepezil, 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. Participants had probable or possible Alzheimer’s disease, were resident in a care home, had clinically significant agitation (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. Participants 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 agitation 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, Neuropsychiatric Inventory (NPI; another measure of BPSD) and other outcome measures were completed at baseline, 4-week and 12-week follow-ups. 114 participants were randomized, of whom 94 completed the week 4 assessment and 81 completed the week 12 assessment. Aromatherapy and donepezil were well tolerated. There were no significant differences between aromatherapy, donepezil 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 donepezil, in the treatment of agitation in people with Alzheimer’s disease. However, the sizeable improvement in the placebo group emphasizes the potential non-specific benefits of touch and interaction in the treatment of agitation in people with Alzheimer’s disease.


  

Author Contacts

Prof. Alistair Burns
Mental Health and Neurodegeneration Research Group, University of Manchester
Manchester Academic Health Science Centre, Jean McFarlane Building, Oxford Road
Manchester M13 9PL (UK)
Tel. +44 161 306 7944, E-Mail Alistair.burns@manchester.ac.uk

  

Article Information

Accepted: January 13, 2011
Published online: February 19, 2011
Number of Print Pages : 7
Number of Figures : 1, Number of Tables : 3, Number of References : 35

  

Publication Details

Dementia and Geriatric Cognitive Disorders

Vol. 31, No. 2, Year 2011 (Cover Date: March 2011)

Journal Editor: Chan-Palay V. (Boston, Mass.)
ISSN: 1420-8008 (Print), eISSN: 1421-9824 (Online)

For additional information: http://www.karger.com/DEM


Article / Publication Details

First-Page Preview
Abstract of Original Research Article

Accepted: 1/13/2011
Published online: 2/19/2011

Number of Print Pages: 7
Number of Figures: 1
Number of Tables: 3

ISSN: 1420-8008 (Print)
eISSN: 1421-9824 (Online)

For additional information: http://www.karger.com/DEM


Copyright / Drug Dosage

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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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