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NIS - libdoc.who.int - World Health Organization

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WHO monographs on medicinal plants commonly used in the Newly Independent States (<strong>NIS</strong>)<br />

tract (1:1 in 45% alcohol) using a fixed dose (60 drops/day), in patients<br />

with Alzheimer disease, over a 4-month period. Patients with mild to<br />

moderate Alzheimer disease aged between 65 and 80 years (n = 42,<br />

18 women) with a score of ≥ 12 on the cognitive subscale of the Alzheimer’s<br />

Disease Assessment Scale (ADAS-cog) and ≤ 2 on the Clinical Dementia<br />

Rating (CDR) were randomly allocated to either receive a placebo<br />

or a fixed dose of S. officinalis extract. ADAS-cog is a subscale of<br />

11 items that evaluates selected aspects of attention, language, memory,<br />

orientation, praxis and reasoning. CDR (sum of the boxes) provides a<br />

consensus-based global clinical measure by summing the ratings from<br />

six domains: memory, orientation, judgement, problem-solving, community<br />

affairs, home and hobbies, and personal care. Over a 16-week<br />

period, the primary outcome measure was the change in the ADAS-cog<br />

score. Change in CDR (sum of the boxes) was the secondary outcome of<br />

the trial. In addition, side-effects were systematically recorded throughout<br />

the study using a checklist. The results showed that at 4 months, the<br />

extract led to a better outcome for cognitive functions than placebo<br />

(ADAS-cog: F, 4.77; df, 1; p, 0.03) (CDR-SB: F, 10.84; df, 1; p < 0.003).<br />

There were no significant differences between the two groups in terms of<br />

observed side-effects except for agitation, which appeared to be more<br />

frequent in the group treated with the placebo (p = 0.09). The results of<br />

the study indicate that the extract was efficacious in the management of<br />

mild to moderate Alzheimer disease (52).<br />

Adverse reactions<br />

After prolonged ingestion of ethanol extracts of leaves of Salvia officinalis,<br />

epileptiform convulsions can occur (38).<br />

Contraindications<br />

In view of the toxicity of the plant due to the thujone and camphor content,<br />

extracts should be used with caution and not ingested in large<br />

amounts (95). Because of the known toxic properties of thujone, the described<br />

abortifacient properties (96), and lack of safety data concerning<br />

administration of Folium Salviae and its preparations in children as well<br />

as during pregnancy and lactation, it is contraindicated in these patient<br />

groups (38, 97).<br />

Warnings<br />

Long-term use of essential oil (more than 2 weeks at a time) should be<br />

avoided (98).<br />

354

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