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

Shakiba, Mansoor and Moazenzadeh, Ehsan and Noorbala, Ahmad Ali and Jafarinia, Morteza and Divsalar, Parisa and Kashani, Ladan and Shahmansouri, Nazila and Tafakhori, Abbas and Bayat, Hannaneh and Akhondzadeh, Shahin (2018) Saffron (Crocus sativus) versus duloxetine for treatment of patients with fibromyalgia: A randomized double-blind clinical trial. Avicenna Journal of Phytomedicine, 8 (6). pp. 513-523.

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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 score �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 time´treatment interactions (p-values: 0.209-0.964). Conclusions: Saffron and duloxetine demonstrated comparable efficacy in treatment of fibromyalgia symptoms.

Item Type: Article
Subjects: WA Public Health
QT physiology
QU Biochemistry
QV pharmacology
Divisions: Journals > Avicenna J Phytomedicine
Depositing User: ajp ajp
Date Deposited: 27 Dec 2018 04:53
Last Modified: 27 Dec 2018 04:53
URI: http://eprints.mums.ac.ir/id/eprint/10740

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