Melissa officinalis extract in the treatment of patients with mild to moderate Alzheimer's disease: a double blind, randomised, placebo controlled trial.
OBJECTIVE
To assess the efficacy and safety of Melissa officinalis extract using a fixed dose (60 drops/day) in patients with mild to moderate Alzheimer's disease.


METHODS
A four month, parallel group, placebo controlled trial undertaken in three centres in Tehran, Iran.


METHODS
Patients with mild to moderate Alzheimer's disease aged between 65 and 80 years (n = 42; 18 women, 24 men) with a score of >or= 12 on the cognitive subscale of Alzheimer's disease assessment scale (ADAS-cog) and <or= 2 on the clinical dementia rating (CDR) were randomised to placebo or fixed dose of Melissa officinalis extract. The main efficacy measures were the change in the ADAS-cog and CDR-SB scores compared with baseline. Side effects were systematically recorded.


RESULTS
At four months, Melissa officinalis extract produced a significantly better outcome on cognitive function than placebo (ADAS-cog: df = 1, F = 6.93, p = 0.01; CDR: df = 1, F = 16.87, p < 0.0001). There were no significant differences in the two groups in terms of observed side effects except agitation, which was more common in the placebo group (p = 0.03).


CONCLUSIONS
Melissa officinalis extract is of value in the management of mild to moderate Alzheimer's disease and has a positive effect on agitation in such patients.
Akhondzadeh
S
S
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran. s.akhond@neda.net
Noroozian
M
M
Mohammadi
M
M
Ohadinia
S
S
Jamshidi
A H
AH
Khani
M
M
D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy*; D003071:Cognition / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D031334:Melissa; D008517:Phytotherapy; D010919:Placebos; D010936:Plant Extracts / Q000627:therapeutic use; D028321:Plant Preparations / Q000627:therapeutic use*; D011595:Psychomotor Agitation / Q000188:drug therapy / Q000209:etiology; D016896:Treatment Outcome
D010919:Placebos; D010936:Plant Extracts; D028321:Plant Preparations