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.
Design: 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 ≥ 12 on the cognitive subscale of Alzheimer’s disease assessment scale (ADAS-cog) and ≤ 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.
- Alzheimer’s disease herbal medicine
- Melissa officinalis
- ADAS-cog, cognitive subscale of the Alzheimer’s disease assessment scale
- CDR, clinical dementia rating
- CDR-SB, clinical dementia rating sum of the boxes
- LOCF, last observation carried forward procedure
- OC, observed cases
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Competing interests: none declared
↵* The roles in the study of the coauthors are given in the appendix