Objective: Alzheimer’s disease (AD) is the most common cause of dementia in mid-to-late life. AD has become a major health and economic burden to the societies especially traditional ones like Iran where the demented patients live with the other members of family and not in the nursing homes. New treatments have been presented for management of AD in the last 15 years. However, they were not fully successful. Melissa Officinalis (lemon balm) is a traditional herbal medicine that reputed to produce cognitive enhancement in light of in-vitro cholinergic binding properties. We assessed the efficacy and safety of Melissa Officinalis extract (1:4 in 50% alcohol) using a fixed dose (60 drops/day) in patients with mild to moderate AD over the four months.
Design: A randomized, double blind, placebo-controlled trial in three centers in Iran was the structure of this study.
Material and Method: Patients with mild to moderate AD aged 65 years or older (n=42, 18 women) with a score of >12 on cognitive subscale of Alzheimer’s disease assessment scale (ADAS-cog) and <2 on the Clinical Dementia Rating (CDR) scale were randomized to placebo or fixed dose of Melissa Officinalis extract. Over the 16 weeks, the main efficacy measures were changes in the ADAS-cog and CDR-SB scores compared to baseline. A physician assessed the patients at baseline and every two weeks. In addition, side effects were systematically recorded throughout the study using a checklist. The patients (or a representative) provided written informed consent to participate. A two-way repeated measures analysis of variance (time-treatment interaction) was used. The two groups as a between-subjects factor (group) and the nine measurements during treatment as the within-subjects factor (time) were considered. In addition, a one-way repeated measures analysis of variance with two-tailed post hoc Tukey mean comparison test was performed to measured the change from baseline in the each group. To compare the demographic data and frequency of side effects between the protocols, Fisher’s exact was performed.
Results: At four months Melissa Officinalis extract produced a significantly better outcome on cognitive functions than placebo (ADAD-cog: d.f.=1, F=6.93, P=0.01) (CDR: d.f.=1, F=16.78, P<0.000). There were no significant differences in the two groups in terms of observed side effects except agitation that was more often in the placebo group (P=0.03).
Conclusion: The present study indicates that patients on Melissa Officinalis extract compared with those on placebo experienced benefit in cognitive functions and basic activity of daily living. However, further studies are warranted.
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