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Avicenna J Phytomed. 2018 Nov-Dec;8(6):513-523.

Saffron (Crocus sativus) versus duloxetine for treatment of patients with fibromyalgia: A randomized double-blind clinical trial.

Author information

1
Psychosomatic Research Center, Imam Hospital, Tehran University of Medical Sciences, Tehran, Iran.
2
Equal first author.
3
Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
4
Infertility Ward, Arash Hospital, Tehran University of Medical Sciences, Tehran, Iran.
5
Neurology Ward, Imam Hospital, Tehran University of Medical Sciences, Tehran, Iran.

Abstract

Objective:

Saffron was found efficient and safe in treatment of neuropsychiatric disorders, in particular depression. We compared the efficacy of saffron with duloxetine in treatment of patients with fibromyalgia.

Materials and Methods:

In this double-blind parallel-group clinical trial, outpatients with fibromyalgia were randomized to receive either saffron 15 mg or duloxetine 30 mg starting with 1 capsule per day in the first week followed by 2 capsules per day from week 2 until the end of week 8. Participants were men and women aged 18-60 years diagnosed with fibromyalgia based on the American College of Rheumatology 2010 criteria who also had a pain scoreā‰„40 based on visual analogue scale. Participants were excluded in case they had rheumatologic diseases, inflammatory/infectious/autoimmune arthritis, comorbid neuropsychiatric disorders except depressive disorders, pain due to traumatic injuries, drug history of duloxetine or saffron use, current use of psychoactive medications, recent use of muscle relaxants, steroids, opioid analgesics, benzodiazepines, anti-epileptics, or injective analgesics. Primary outcomes included differences in mean score changes from baseline to endpoint between the treatment arms for Hamilton Rating Scale for Depression, Fibromyalgia Impact Questionnaire, and Brief Pain Inventory.

Results:

Socio-demographic characteristics and baseline scores were similarly distributed between the two treatment arms (2n=46). No significant difference was detected for any of the scales neither in terms of score changes from baseline to endpoint between the two treatment arms (Mean score changes: -4.26 to 2.37; p-values: 0.182-0.900) nor in terms of timetreatment interactions (p-values: 0.209-0.964).

Conclusions:

Saffron and duloxetine demonstrated comparable efficacy in treatment of fibromyalgia symptoms.

KEYWORDS:

Crocus sativus; Depression; Duloxetine; Fibromyalgia; Saffron

PMID:
30456199
PMCID:
PMC6235666

Conflict of interest statement

The authors of this manuscript declare that they have no conflict of interest. TUMS had no role in the design, conduct, data collection, analysis, data interpretation, manuscript preparation, review, final approval, or decision to submit this paper for publication.

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