Salvia officinalis extract in the treatment of mild to moderate Alzheimer's disease: a double blind and placebo-controlled trial S. Akhondzadeh1, 2, M. Noroozian1, & M.R. Mohammadi1. 1Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences; 2Institute of Medicinal Plants, Tehran, Iran.

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Alzheimer's disease (AD) is characterized by profound memory loss sufficient to interface with social and occupational functioning. It is the most common form of dementia, affecting approximately 20 million people worldwide (Jorm & Jolly, 1998). AD has become a major health and economic burden to society. New treatments have been presented for management of AD in the last 15 years. However, they were not fully successful. Salvia officinalis (sage) is a traditional herbal medicine that is reputed to produce cognitive enhancement in light of in vitro cholinergic binding properties (Perry et al., 1999; Wake et al., 2000). The objective of this study was to assess the efficacy and safety of Salvia 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.

A randomised, double blind, placebo-controlled trial in three centres in Iran was the structure of this study. Patients with mild to moderate AD aged 65 years or older (n=39, 15 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) (Mohs & Cochen, 1988; Schneiders, 1996) were randomised to placebo or fixed dose of Salvia officinalis extract. Over the 16 weeks, the main efficacy measures were changes in the ADAS-cog and CDR-SB scores compared to baseline. Patients were assessed by a third year resident of psychiatry 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 a two-tailed post hoc Tukey mean comparison test was performed to measure 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.

At 4 months, Salvia officinalis extract produced a significant better outcome on cognitive functions than placebo (ADAS-cog: d.f.=1, F=4.77, P=0.03) (CDR: d.f.=1, F=13.10, P= 0.003). The difference between the two protocols was significant at the endpoint (week 16) (t=5.12, d.f.=28, P<0.000 and t=6.38, d.f.=28, P<0.000 for ADAS-cog and CDR-SB respectively). 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=0.09).

The present study indicates that patients on Salvia officinalis extract compare with those on placebo, experienced benefit in cognitive functions and basic activity of daily living. However, further studies are warranted.

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Mohs, R.C. & Cochen, L. (1988). Psychopharmacology Bull. 24, 627-628.
Perry, E.K. et al. (1999). Journal of Pharmacy & Pharmacology. 51, 527-534.
Schneiders, L.S. (1996). Alzheimer Insights. 2, 1-7.
Wake, G. et al. (2000). Journal of Ethnopharmacology. 69, 105-114.