A Fixed Combination of Palmitoylethanolamide and Melatonin (PEATONIDE) for the Management of Pain, Sleep, and Disability in Patients with Fibromyalgia: A Pilot Study.
Study Goal
The researchers aimed to assess the impact of a daily combination of palmitoylethanolamide and melatonin on pain, sleep, and quality of life in fibromyalgia patients.
Results Summary
The study found significant improvements in pain (VAS), insomnia (ISI), and health assessments (HAQ), along with reduced tender points, maintained even after discontinuation. No adverse events were reported.
Population
50 fibromyalgia patients (2016 ACR criteria), average age 54.12 years, 3:1 female-to-male ratio.
Effective Dosage
1200 mg palmitoylethanolamide and 0.2 mg melatonin daily.
Duration
3 months of treatment, with a 1-month follow-up (total 4 months).
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
daily combination of 1200 mg of palmitoylethanolamide and 0.2 mg of melatonin | decrease | VAS scores | fibromyalgia patients | - | showed significant improvements | #1 |
daily combination of 1200 mg of palmitoylethanolamide and 0.2 mg of melatonin | decrease | ISI scores | fibromyalgia patients | - | showed significant improvements | #2 |
daily combination of 1200 mg of palmitoylethanolamide and 0.2 mg of melatonin | decrease | HAQ scores | fibromyalgia patients | - | showed significant improvements | #3 |
daily combination of 1200 mg of palmitoylethanolamide and 0.2 mg of melatonin | decrease | tender points | fibromyalgia patients | - | reduction | #4 |
daily combination of 1200 mg of palmitoylethanolamide and 0.2 mg of melatonin | decrease | pain | fibromyalgia patients | - | demonstrate the efficacy | #5 |
daily combination of 1200 mg of palmitoylethanolamide and 0.2 mg of melatonin | increase | sleep | fibromyalgia patients | - | improve | #6 |
daily combination of 1200 mg of palmitoylethanolamide and 0.2 mg of melatonin | increase | quality of life | fibromyalgia patients | - | improve | #7 |
Fibromyalgia is characterized by chronic widespread pain, fatigue, and sleep disturbances. Recent theories attribute fibromyalgia to central sensitization syndromes, suggesting altered nociceptive processing leads to hyperalgesia and allodynia. Standardized effective treatments are currently lacking. Palmitoylethanolamide and melatonin have shown pain-relieving effects in chronic pain conditions, including fibromyalgia, with excellent safety. Our open-label study assessed the impact of a daily combination of 1200 mg of palmitoylethanolamide and 0.2 mg of melatonin on pain, sleep, and quality of life in fibromyalgia patients. Between June 2023 and March 2024, 50 patients (2016 ACR criteria) were treated and evaluated at baseline, 1 month, 3 months, and 4 months (1 month discontinuation). The assessments included VAS for pain, ISI for insomnia, HAQ for health assessments, and a tender points evaluation. The patients, averaging 54.12 years old with a 3:1 female-to-male ratio, showed significant improvements in VAS, ISI, and HAQ scores relative to their own baselines and a reduction in tender points at 1 and 3 months, which was maintained at 4 months. No adverse events were reported. This study is the first to demonstrate the efficacy of a palmitoylethanolamide and melatonin combination as an adjunct therapy in fibromyalgia, highlighting its potential to reduce pain and improve sleep and quality of life.