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Ultramicronized Palmitoylethanolamide (um-PEA) as Add-on Treatment in Fibromyalgia Syndrome (FMS): Retrospective Observational Study on 407 Patients

Schweiger V, Martini A, Bellamoli P, Donadello K, Schievano C, Balzo GD, Sarzi-Puttini P, Parolini M, Polati E. CNS Neurol Disord Drug Targets. 2019;18(4):326-333.

Observational studyHumans

Design
Observational study
Subjects
407 fibromyalgia patients prescribed the tablets between 2013 and 2016 at one Italian pain centre; 359 analysed
Dose used in the study
Ultramicronised PEA tablets (Normast) added to whatever other treatment the patient was on; dose not stated in the abstract
Duration
Follow-up period not stated in the abstract
What was measured
Pain VAS (0 to 100), Fibromyalgia Impact Questionnaire, adverse events, discontinuation

What the authors reported

Among those analysed, VAS fell from 75.8 to 52.5 and the impact score from 68.4 to 49.1 (both p < 0.001). 36 patients (13.7 percent) reported adverse events, mostly gastrointestinal. 151 patients (57.6 percent) stopped treatment because it did not help.

Limits of this study

Retrospective, no control group, no blinding. More than half of patients stopped for lack of effect, and the improvement figures are for those who continued, so they overstate the average result. One author (Schievano) is linked to Epitech, which makes Normast.

Source

PubMed 30827269 · doi:10.2174/1871527318666190227205359

Entry checked against the abstract on PubMed on 2026-09-22. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.