Supplementation with Pycnogenol® relieves symptoms of chronic inflammatory diseases with a significant vasculitis component: a pilot registry study.

Gianni Belcaro, Shu Hu, Maria R Cesarone, Valeria Scipione, Claudia Scipione, Mark Dugall, Umberto Cornelli, David Cox, Morio Hosoi, Beatrice Feragalli, Francesca Coppazuccari, Roberto Cotellese
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Abstract

Background: This study investigated the potential use of a food supplement, Pycnogenol® (French maritime Pine Bark Extract) as an anti-inflammatory management during the remission phases of four conditions with a vasculitis component: systemic lupus erythematosus, Behçet's disease, Sjögren Syndrome and polyarteritis nodosa. Symptoms were minimal but persisting and the subjects did not use any chronic drug treatment.

Methods: The aim of this pilot registry study was to evaluate the safety and the preventive effects of oral Pycnogenol® on the residual symptoms of the inflammatory conditions and possible effects on the recurrence of symptoms in a 4-week, open, supplement registry study.

Results: The registry study included 124 otherwise healthy subjects, suffering from one of the vasculitis conditions with 63 patients taking Pycnogenol® 150 mg per day and 61 serving as controls. There were no dropouts. Symptom distribution was comparable in the control and in the supplement groups at baseline. No side effects of Pycnogenol® supplementation were observed. The symptom scores that ranged from 0 to 10, decreased significantly in all the Pycnogenol® groups after 4 weeks compared to controls (P<0.05). After 4 weeks ESR values decreased significantly in all Pycnogenol® groups compared to controls (P<0.05). The proportion of subjects with high IL-6 (>5.9 pg/mL) decreased significantly after 4 weeks in the Pycnogenol® group compared to controls. The proportion of subjects that needed to take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids to relieve signs and symptoms was significantly lower across all Pycnogenol® subjects at 4 weeks compared to controls. Finally, plasma oxidative stress (high, >300 Carr Units, in all subjects at inclusion) was significantly reduced (P<0.05) in the supplemented subjects, with minimal improvements in the control groups.

Conclusions: In conclusion, supplementation with Pycnogenol® may offer advantages and management possibilities for patients with vasculitis diseases allowing to avoid more potentially dangerous drug treatments. Considering a prolonged course, it is possible that chronic management with Pycnogenol® may prevent the recurrence of diseases with a vasculitis component to clinically significant levels.

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