title: Saffron in the treatment of patients with mild to moderate Alzheimer's disease: a 16-week, randomized and placebo-controlled trial.
abstract: BACKGROUND
  Herbal medicines have been used in the treatment of behavioural and psychological symptoms of dementia but with variable response. Crocus sativus (saffron) may inhibit the aggregation and deposition of amyloid β in the human brain and may therefore be useful in Alzheimer's disease (AD).
  
  
  OBJECTIVE
  The goal of this study was to assess the efficacy of saffron in the treatment of mild to moderate AD.
  
  
  METHODS
  Forty-six patients with probable AD were screened for a 16-week, double-blind study of parallel groups of patients with mild to moderate AD. The psychometric measures, which included AD assessment scale-cognitive subscale (ADAS-cog), and clinical dementia rating scale-sums of boxes, were performed to monitor the global cognitive and clinical profiles of the patients. Patients were randomly assigned to receive capsule saffron 30 mg/day (15 mg twice per day) (Group A) or capsule placebo (two capsules per day) for a 16-week study.
  
  
  RESULTS
  After 16 weeks, saffron produced a significantly better outcome on cognitive function than placebo (ADAS-cog: F=4·12, d.f.=1, P=0·04; CDR: F=4·12, d.f.=1, P=0·04). There were no significant differences in the two groups in terms of observed adverse events.
  
  
  CONCLUSIONS
  This double-blind, placebo-controlled study suggests that at least in the short-term, saffron is both safe and effective in mild to moderate AD. Larger confirmatory randomized controlled trials are called for.
authors.affiliation: Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran Institute of Medicinal Plants (ACECR), Department of Neurology, Tehran, Iran. s.akhond@neda.net
authors.forename: S
authors.initials: S
authors.lastname: Akhondzadeh
authors.forename: M Shafiee
authors.initials: MS
authors.lastname: Sabet
authors.forename: M H
authors.initials: MH
authors.lastname: Harirchian
authors.forename: M
authors.initials: M
authors.lastname: Togha
authors.forename: H
authors.initials: H
authors.lastname: Cheraghmakani
authors.forename: S
authors.initials: S
authors.lastname: Razeghi
authors.forename: S Sh
authors.initials: SSh
authors.lastname: Hejazi
authors.forename: M H
authors.initials: MH
authors.lastname: Yousefi
authors.forename: R
authors.initials: R
authors.lastname: Alimardani
authors.forename: A
authors.initials: A
authors.lastname: Jamshidi
authors.forename: F
authors.initials: F
authors.lastname: Zare
authors.forename: A
authors.initials: A
authors.lastname: Moradi
mesh_terms: D000368:Aged; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D003071:Cognition / Q000187:drug effects; D027622:Crocus / Q000009:adverse effects / Q000737:chemistry*; D005260:Female; D035264:Flowers / Q000378:metabolism; D006801:Humans; D008297:Male; D008517:Phytotherapy; D028321:Plant Preparations / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
chemical_list: D028321:Plant Preparations