Full Title: Adjuvant use of melatonin for treatment of fibromyalgia.
Authors: Hussain SA, Al-Khalifa II, Jasim NA, Gorial FI.
Publication: Journal of Pineal Research
Publication Date: 16th December 2010
Department of Pharmacology and Toxicology, College of Pharmacy, University of Baghdad, Baghdad, Iraq Department of Medicine, College of Medicine, University of Baghdad, Baghdad, Iraq Department of Rheumatology and Rehabilitation, Baghdad Teaching Hospital, Medical City, Baghdad, Iraq.
Fibromyalgia syndrome (FMS) is a chronic musculoskeletal disorder characterized by generalized muscular pain accompanied by fatigue and tenderness at specific anatomic sites called tender points. Although preliminary evidence indicates that melatonin may be effective in treating the pain associated with FMS, no definitive evidence supports this claim. This study was designed to evaluate the significance of using different doses of melatonin, alone or in combination with fluoxetine for the management of FMS. A double-blind, placebo-controlled clinical study was performed on 101 patients (95 women and 6 men) who fulfilled the criteria of the American College of Rheumatology (ACR) of FMS. The patients were randomized into four groups: group A (24 patients) treated with 20mg/day fluoxetine alone; group B (27 patients) treated with melatonin 5mg alone; group C (27 patients) treated with 20mg fluoxetine plus 3mg melatonin; group D (23 patients) treated with 20mg fluoxetine plus 5mg melatonin. Both drugs were given once daily in the morning and night time, respectively, for 8wk. Each patient was clinically evaluated through direct interview with the patients using the Fibromyalgia Impact Questionnaire (FIQ) at zero time and after 8wk. Using melatonin (3mg or 5mg/day) in combination with 20mg/day fluoxetine resulted in significant reduction in both total and different components of FIQ score compared to the pretreatment values. In conclusion, administration of melatonin, alone or in a combination with fluoxetine, was effective in the treatment of patients with FMS.