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. 2024 Aug 21;16(16):2785.
doi: 10.3390/nu16162785.

A Fixed Combination of Palmitoylethanolamide and Melatonin (PEATONIDE) for the Management of Pain, Sleep, and Disability in Patients with Fibromyalgia: A Pilot Study

Riccardo Terribili  1 , Giulia Vallifuoco  1 , Marco Bardelli  1 , Bruno Frediani  1 , Stefano Gentileschi  1
Affiliations

A Fixed Combination of Palmitoylethanolamide and Melatonin (PEATONIDE) for the Management of Pain, Sleep, and Disability in Patients with Fibromyalgia: A Pilot Study

Riccardo Terribili et al. Nutrients. .

Abstract

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.

Keywords: fibromyalgia; melatonin; nutraceuticals; pain; palmitoylethanolamide; quality of life; sleep.

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Conflict of interest statement

The authors declare no potential conflicts of interest.

Figures

Figure 1
Figure 1
Effects of PEATONIDE on pain. a: p < 0.01 vs. baseline. b: p < 0.01 vs. PEATONIDE—Month 1.
Figure 2
Figure 2
Effects of PEATONIDE on quality of life. a: p < 0.01 vs. baseline. b: p < 0.01 vs. PEATONIDE—Month 1.
Figure 3
Figure 3
Effects of PEATONIDE on sleep. a: p < 0.01 vs. baseline and history. b: p < 0.01 vs. PEATONIDE—Month 1.
Figure 4
Figure 4
Trend in fibromyalgia depending on the type of drug associated with PEATONIDE.
See this image and copyright information in PMC

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