Melissa officinalis L. extract in the treatment of patients with mild to moderate Alzheimer’s disease: a double blind, randomized and placebo-controlled trial

Alzheimer’s disease is a relentlessly progressive disease with cognitive, functional and behavioral changes over time. Current research into new drugs is focused on agents that will prevent, slow down and/or halt the progress of the disease process. Melissa officinalis has been used in herbal medici...

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Main Authors: S Akhondzadeh, M Noroozian, MR Mohammadi, S Ohadinia, A Jamshidi, M Khani
Format: Article
Language:English
Published: Institue of Medicinal Plants, ACECR 2002-12-01
Series:Journal of Medicinal Plants
Subjects:
Online Access:http://jmp.ir/article-1-796-en.html
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author S Akhondzadeh
M Noroozian
MR Mohammadi
S Ohadinia
A Jamshidi
M Khani
author_facet S Akhondzadeh
M Noroozian
MR Mohammadi
S Ohadinia
A Jamshidi
M Khani
author_sort S Akhondzadeh
collection DOAJ
description Alzheimer’s disease is a relentlessly progressive disease with cognitive, functional and behavioral changes over time. Current research into new drugs is focused on agents that will prevent, slow down and/or halt the progress of the disease process. Melissa officinalis has been used in herbal medicine for many centuries. It has been suggested, on the basis of traditional medicine, its in vitro cholinergic binding properties and modulation of mood and cognitive performance in humans, that Melissa officinalis might potentially provide a novel natural treatment for Alzheimer’s disease. The objective of this study was 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, over the four months. This was a 4-month, parallel group, placebo controlled trial undertaken in 3 centres in Tehran, Iran. Patients with mild to moderate Alzheimer’s disease aged between 65-80 years (n=42, 18 women) 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. Over the 16 weeks, the main efficacy measures were the change in the ADAS-cog and CDR-SB scores compared to baseline. In addition, side effects were systematically recorded throughout the study using a checklist. At 4 months, Melissa officinalis extract produced a significant better outcome on cognitive functions than placebo (ADAS-cog: d.f. = 1, F= 6.93, P=0.01) (CDR: d.f.= 1, F = 16.87, P< 0.0001). 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). The results of this study indicate the efficacy of Melissa officinalis extract in the management of mild to moderate Alzheimer’s disease. Moreover, the effect of Melissa officinalis on agitation of patients, may well prove a novel natural treatment for Alzheimer’s disease.
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spelling doaj.art-0dd0eae37c544d50a9cb5a655098b1c22022-12-21T18:28:27ZengInstitue of Medicinal Plants, ACECRJournal of Medicinal Plants2717-204X2717-20582002-12-01144757Melissa officinalis L. extract in the treatment of patients with mild to moderate Alzheimer’s disease: a double blind, randomized and placebo-controlled trialS Akhondzadeh0M Noroozian1MR Mohammadi2S Ohadinia3A Jamshidi4M Khani5 Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran Institute of Medicinal Plants, Iranian Academic Centre for Education, Culture and Research, Tehran, Iran Institute of Medicinal Plants, Iranian Academic Centre for Education, Culture and Research, Tehran, Iran Institute of Medicinal Plants, Iranian Academic Centre for Education, Culture and Research, Tehran, Iran Alzheimer’s disease is a relentlessly progressive disease with cognitive, functional and behavioral changes over time. Current research into new drugs is focused on agents that will prevent, slow down and/or halt the progress of the disease process. Melissa officinalis has been used in herbal medicine for many centuries. It has been suggested, on the basis of traditional medicine, its in vitro cholinergic binding properties and modulation of mood and cognitive performance in humans, that Melissa officinalis might potentially provide a novel natural treatment for Alzheimer’s disease. The objective of this study was 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, over the four months. This was a 4-month, parallel group, placebo controlled trial undertaken in 3 centres in Tehran, Iran. Patients with mild to moderate Alzheimer’s disease aged between 65-80 years (n=42, 18 women) 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. Over the 16 weeks, the main efficacy measures were the change in the ADAS-cog and CDR-SB scores compared to baseline. In addition, side effects were systematically recorded throughout the study using a checklist. At 4 months, Melissa officinalis extract produced a significant better outcome on cognitive functions than placebo (ADAS-cog: d.f. = 1, F= 6.93, P=0.01) (CDR: d.f.= 1, F = 16.87, P< 0.0001). 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). The results of this study indicate the efficacy of Melissa officinalis extract in the management of mild to moderate Alzheimer’s disease. Moreover, the effect of Melissa officinalis on agitation of patients, may well prove a novel natural treatment for Alzheimer’s disease.http://jmp.ir/article-1-796-en.htmldementiaalzheimermelissa officinalistraditional medicine
spellingShingle S Akhondzadeh
M Noroozian
MR Mohammadi
S Ohadinia
A Jamshidi
M Khani
Melissa officinalis L. extract in the treatment of patients with mild to moderate Alzheimer’s disease: a double blind, randomized and placebo-controlled trial
Journal of Medicinal Plants
dementia
alzheimer
melissa officinalis
traditional medicine
title Melissa officinalis L. extract in the treatment of patients with mild to moderate Alzheimer’s disease: a double blind, randomized and placebo-controlled trial
title_full Melissa officinalis L. extract in the treatment of patients with mild to moderate Alzheimer’s disease: a double blind, randomized and placebo-controlled trial
title_fullStr Melissa officinalis L. extract in the treatment of patients with mild to moderate Alzheimer’s disease: a double blind, randomized and placebo-controlled trial
title_full_unstemmed Melissa officinalis L. extract in the treatment of patients with mild to moderate Alzheimer’s disease: a double blind, randomized and placebo-controlled trial
title_short Melissa officinalis L. extract in the treatment of patients with mild to moderate Alzheimer’s disease: a double blind, randomized and placebo-controlled trial
title_sort melissa officinalis l extract in the treatment of patients with mild to moderate alzheimer s disease a double blind randomized and placebo controlled trial
topic dementia
alzheimer
melissa officinalis
traditional medicine
url http://jmp.ir/article-1-796-en.html
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