The onset of chronic Fibromyalgia symptomatology is due to central alterations, together with peripheral neuroimmune modifications. Using positron emission tomography (PET), it has been observed for the first time that fibromyalgia patients have a high activation of microglial cells compared to normal subjects. Experimental evidence in neuroinflammation models in vitro and in vivo have demonstrated the anti-inflammatory and neuroprotective effect of Palmitoylethanolamide (PEA), effects confirmed by observational clinical investigations conducted in patients with fibromyalgia in which micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA) reduced the intensity of pain improving the quality of life. The aim of this study is to investigate the efficacy and tolerability of PEA-m + PEA-um administered as an add-on therapy with a double-blind, randomized, placebo-controlled clinical investigation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
21
Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes
Placebo was prepared to be indistinguishable from color and flavor from the Product
(antidepressants, anticonvulsants, muscle relaxants, weak opiates, etc..) consolidated for at least 3 months
Use as needed allowed
Anestesia e Rianimazione B - Azienda Ospedaliera Universitaria Integrata di Verona
Verona, VR, Italy
Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised
Change of Fibromyalgia symptoms
Time frame: 90 days
Pain Intensity assessed by Visual Analogue Scale
Change of Visual Analogue Scale every 30 days (0: no pain - 100 mm: maximum pain)
Time frame: 90 days
Health assessed by Short form-12 Health Survey
Change in Health at the end of treatment
Time frame: 90 days
Sleep Disorders assessed by Pittsburgh Sleep Quality Index
Change in sleep disorders at the end of treatment
Time frame: 90 days
Rescue Drugs consumption assessed by a daily diary
Change in rescue drugs consumption during the entire period
Time frame: 90 days
Incidence of Adverse Events
Monitoring of adverse event
Time frame: 90 days
Blood test
Clinically significant changes in blood test
Time frame: 90 days
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