• Gianni Belcaro, Shu Hu, Maria R Cesarone, Mark Dugall, Claudia Scipione, Valeria Scipione, Morio Hosoi, Andrea Ledda, Umberto Cornelli, Beatrice Feragalli, and Roberto Cotellese.
• IRVINE3 Labs & San Valentino Vascular Screening Project, Department of Medical, Oral and Biotechnological Sciences, Ch-Pe University, Pescara, Italy - cardres@abol.it.
• Panminerva Med. 2021 Mar 1; 63 (1): 46-50.

BackgroundThe 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).MethodsA 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.ResultsFifty 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).ConclusionsPycnogenol® 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.

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