ORIGINAL ARTICLE   

Panminerva Medica 2021 March;63(1):46-50

DOI: 10.23736/S0031-0808.20.03955-5

Copyright © 2020 EDIZIONI MINERVA MEDICA

lingua: Inglese

Idiopathic myalgic pain (fibromyalgia): supportive management and prevention with Pycnogenol®

Gianni BELCARO ^{1, 2} ✉, Shu HU ^{1, 2}, Maria R. CESARONE ^{1, 2}, Mark DUGALL ¹, Claudia SCIPIONE ¹, Valeria SCIPIONE ¹, Morio HOSOI ¹, Andrea LEDDA ¹, Umberto CORNELLI ¹, Beatrice FERAGALLI ¹, Roberto COTELLESE ¹

¹ IRVINE3 Labs & San Valentino Vascular Screening Project, Department of Medical, Oral and Biotechnological Sciences, Ch-Pe University, Pescara, Italy; ² IA-PSS: International Agency for Pharma-Standard Supplements, Pescara, Italy

BACKGROUND: The aim of this registry study was the prospective evaluation of the efficacy of Pycnogenol^® in idiopathic fibromyalgia (FM), over 4 weeks in comparison with the standard management (SM).
METHODS: A SM and a Pycnogenol^®+SM group were formed. Pycnogenol^® supplementation was used at the dose of 150 mg/day (4 weeks). The study considered the most important/frequent symptoms of FM.
RESULTS: Fifty patients with idiopathic fibromyalgia were included: 26 in the Pycnogenol^® group and 24 served as controls. The two groups were comparable at inclusion. No other disease or condition was present. All subjects were otherwise healthy women (BMI<26), not using any drug. All subjects had an elevated level of oxidative stress (OS) at inclusion. All routine blood tests - and all inflammatory and rheumatic tests - were within the normal range at inclusion and at the end of the study. No safety or tolerability problems were observed. The percentage of patients using NSAIDs (non-steroidal anti-inflammatory drugs) as rescue medications in the observation period was significantly higher in the SM management group (P<0.05) in comparison with the supplement group. The percentage of patients using corticosteroids as rescue medication was significantly higher in the SM group (P<0.05). The percentage of subjects with the symptoms/complaints decreased significantly, considering each symptom, with Pycnogenol^® after 4 weeks in comparison with the SM (P<0.05).
CONCLUSIONS: Pycnogenol^® supplementation appears to control and reduce the intensity of common symptoms and complaints - especially pain-related - associated with FM. Pycnogenol^® could be a ‘soft’, safe supplementation and prevention method to manage the symptoms of most of these patients, even for longer periods, reducing the need for drugs.

KEY WORDS: Pycnogenols; Fibromyalgia; Fatigue; Oxidative stress; Prevention and control