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The effect of melatonin in patients with fibromyalgia: a pilot study
G Citera1, M A Arias, J A Maldonado-Cocco
1Rheumatology Section, Instituto de Rehabilitación Psicofísica and Department of Physiology, Facultad de Medicina, Universidad de Buenos Aires, Argentina.
Abstract:
The aim of the study was to determine the possible effect of melatonin treatment on disturbed sleep, fatigue and pain symptoms observed in fibromyalgia (FM) patients. Twenty-one consecutive patients with FM were included in an open 4-week-duration pilot study. Before and after treatment with melatonin 3 mg at bedtime, patients were evaluated using tender point count by palpation of 18 classic anatomical regions, pain score in four predesignated areas, pain severity on a 10 cm visual analogue scale (VAS), sleep disturbances, fatigue, depression, anxiety, and patient and physician global assessments, also by a VAS. Urine 6-sulphatoxymelatonin levels (aMT-6S) were measured in the patients and 20 age- and sex-matched controls. Nineteen patients completed the study. One patient withdrew because of migraine and another was lost to follow-up. At day 30, median values for the tender point count and severity of pain at selected points, patient and physician global assessments and VAS for sleep significantly improved with melatonin treatment. Other variables improved but did not reach statistical significance. Adverse events were mild and transient. Lower levels of aMT-6S were found in FM patients compared with normal median controls (+/-SD, 9.16 +/- 7.9 microg/24 h vs 16.8 +/- 12.8 microg/24 h) (p = 0.06). Although this is an open study, our preliminary results suggest that melatonin can be an alternative and safe treatment for patients with FM. Double-blind placebo controlled studies are needed.
Insights
Melatonin treatment significantly improved pain and sleep disturbances in fibromyalgia patients. This pilot study suggests melatonin as a safe alternative for managing fibromyalgia symptoms.
Area of Science:
- Neuroscience
- Rheumatology
- Sleep Medicine
Background:
- Fibromyalgia (FM) is a chronic condition characterized by widespread pain, fatigue, and sleep disturbances.
- Melatonin, a hormone regulating sleep-wake cycles, has shown potential therapeutic benefits in various conditions.
- Reduced urinary 6-sulphatoxymelatonin (aMT-6S) levels have been observed in FM patients.
Purpose of the Study:
- To investigate the efficacy of melatonin treatment in alleviating sleep, fatigue, and pain symptoms in fibromyalgia patients.
- To assess the safety and tolerability of melatonin in this patient population.
- To compare urinary aMT-6S levels between FM patients and healthy controls.
Main Methods:
- An open-label, 4-week pilot study involving 21 fibromyalgia patients.
- Patients received 3 mg of melatonin at bedtime.
- Evaluations included tender point count, pain scores, visual analogue scales (VAS) for pain and sleep, fatigue, depression, anxiety, and global assessments. Urinary aMT-6S levels were measured.
Main Results:
- Significant improvements were observed in tender point count, pain severity, patient and physician global assessments, and VAS for sleep after 30 days of melatonin treatment.
- Other assessed variables showed improvement, though not reaching statistical significance.
- Adverse events were mild and transient.
- FM patients exhibited lower median urinary aMT-6S levels compared to controls (9.16 +/- 7.9 microg/24 h vs 16.8 +/- 12.8 microg/24 h, p = 0.06).
Conclusions:
- Preliminary findings suggest melatonin may be a safe and effective alternative treatment for managing fibromyalgia symptoms, particularly pain and sleep disturbances.
- Further investigation through double-blind, placebo-controlled trials is warranted to confirm these results.