title: Aromatherapy as a safe and effective treatment for the management of agitation in severe dementia: the results of a double-blind, placebo-controlled trial with Melissa.
abstract: BACKGROUND
  Behavioral and psychological symptoms in dementia are frequent and are a major management problem, especially for patients with severe cognitive impairment. Preliminary reports have indicated positive effects of aromatherapy using select essential oils, but there are no adequately powered placebo-controlled trials. We conducted a placebo-controlled trial to determine the value of aromatherapy with essential oil of Melissa officinalis (lemon balm) for agitation in people with severe dementia.
  
  
  METHODS
  Seventy-two people residing in National Health Service (U.K.) care facilities who had clinically significant agitation in the context of severe dementia were randomly assigned to aromatherapy with Melissa essential oil (N = 36) or placebo (sunflower oil) (N = 36). The active treatment or placebo oil was combined with a base lotion and applied to patients' faces and arms twice a day by caregiving staff. Changes in clinically significant agitation (Cohen-Mansfield Agitation Inventory [CMAI]) and quality of life indices (percentage of time spent socially withdrawn and percentage of time engaged in constructive activities, measured with Dementia Care Mapping) were compared between the 2 groups over a 4-week period of treatment.
  
  
  RESULTS
  Seventy-one patients completed the trial. No significant side effects were observed. Sixty percent (21/35) of the active treatment group and 14% (5/36) of the placebo-treated group experienced a 30% reduction of CMAI score, with an overall improvement in agitation (mean reduction in CMAI score) of 35% in patients receiving Melissa balm essential oil and 11% in those treated with placebo (Mann-Whitney U test; Z = 4.1, p < .0001). Quality of life indices also improved significantly more in people receiving essential balm oil (Mann-Whitney U test; percentage of time spent socially withdrawn: Z = 2.6, p = .005; percentage of time engaged in constructive activities: Z = 3.5, p = .001).
  
  
  CONCLUSIONS
  The finding that aromatherapy with essential balm oil is a safe and effective treatment for clinically significant agitation in people with severe dementia, with additional benefits for key quality of life parameters, indicates the need for further controlled trials.
authors.affiliation: Wolfson Research Centre, Newcastle General Hospital, Institute for Ageing and Health, Newcastle upon Tyne, United Kingdom. c.g.ballard@ncl.ac.uk
authors.forename: Clive G
authors.initials: CG
authors.lastname: Ballard
authors.forename: John T
authors.initials: JT
authors.lastname: O'Brien
authors.forename: Katharina
authors.initials: K
authors.lastname: Reichelt
authors.forename: Elaine K
authors.initials: EK
authors.lastname: Perry
mesh_terms: D000287:Administration, Topical; D000368:Aged; D019341:Aromatherapy / Q000379:methods*; D003704:Dementia / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology*; D004311:Double-Blind Method; D004655:Emulsions / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D006801:Humans; D019686:Lamiaceae; D008297:Male; D009822:Oils, Volatile / Q000008:administration & dosage / Q000627:therapeutic use; D010919:Placebos; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D011595:Psychomotor Agitation / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D004655:Emulsions; D009822:Oils, Volatile; D010919:Placebos; D010936:Plant Extracts