1. Ultramicronized palmitoylethanolamide (Um-PEA) as add-on treatment in fibromyalgia syndrome (FMS): Retrospective observational study on 407 patients
- Author
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Paola Bellamoli, Giovanna Del Balzo, Enrico Polati, Carlo Schievano, Piercarlo Sarzi-Puttini, Massimo Parolini, Alvise Martini, Vittorio Schweiger, and Katia Donadello
- Subjects
0301 basic medicine ,Adult ,Male ,medicine.medical_specialty ,Fibromyalgia Impact Questionnaire (FIQ) ,Symptoms Severity Score (SSS) ,Visual Analogue Scale (VAS) ,Widespread Pain Index (WPI) ,adverse events (AEs) ,fibromyalgia syndrome (FMS) ,mast-cells (MC) ,ultramicronized palmitoylethanolamide (um-PEA) ,Constipation ,Fibromyalgia ,Population ,Palmitic Acids ,03 medical and health sciences ,0302 clinical medicine ,Bloating ,Quality of life ,Internal medicine ,medicine ,Humans ,Adverse effect ,education ,Pain Measurement ,Retrospective Studies ,Pharmacology ,education.field_of_study ,business.industry ,General Neuroscience ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Amides ,Settore MED/16 - Reumatologia ,030104 developmental biology ,Treatment Outcome ,Italy ,Ethanolamines ,Vomiting ,Quality of Life ,Female ,medicine.symptom ,business ,030217 neurology & neurosurgery - Abstract
Background: Fibromyalgia syndrome is a chronic multifaceted disease characterized by widespread pain, muscle stiffness, fatigue, unrefreshing sleep and cognitive disorders. To date, no medication has been shown to significantly improve pain, associated symptoms and Quality of Life in fibromyalgic patients. Methods: In this retrospective observational study, we analyzed data regarding 407 patients with diagnosis of fibromyalgia syndrome who between 2013 and 2016 have been prescribed orally ultramicronized palmitoylethanolamide tablets (Normast® Epitech Group SpA, Saccolongo, Italy) regardless of the concomitant pharmacological therapy (add-on treatment). Results: Regarding efficacy, in the 359 analyzed patients, the change over time in Visual Analogue Scale pain score was statistically significant, ranging from 75.84 (±15.15) to 52.49 (±16.73) (p Conclusion: The results of ultramicronized palmitoylethanolamide treatment in this retrospective analysis represent an important step for the development of a new and well-tolerated therapy for fibromyalgia syndrome, mostly suitable for these patients who need long-term treatments. Further methodologically stronger studies will be necessary to validate our observation.
- Published
- 2019