ORIGINAL ARTICLE   

Minerva Cardioangiologica 2020 April;68(2):146-52

DOI: 10.23736/S0026-4725.19.05027-8

Copyright © 2019 EDIZIONI MINERVA MEDICA

lingua: Inglese

Supplementary management with Pycnogenol® in patients with lupus vasculitis in remission phases: a pilot, concept registry study

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

¹ IRVINE3 Labs, Department of Medical, Oral and Biotechnological Sciences, Chieti-Pescara University, Pescara, Italy; ² IAAPS, International Agency For Pharma Standard Supplements, Pescara, Italy

BACKGROUND: The aim of this pilot study was the supplementary management of minimal, residual symptoms of systemic Lupus (SLE) with vasculitis (LV) in remission phases, using a natural, anti-inflammatory, antioxidant agent (Pycnogenol®) extracted from French maritime pine bark. Pycnogenol® has a significant clinical anti-inflammatory activity; it is a standardized supplement with a high-safety profile.
METHODS: Subjects with Lupus vasculitis were included in the study. The standard management (SM) was used in all subjects for 8 weeks; one group added Pycnogenol® (150 mg/day) to SM.
RESULTS: The two groups completing 8 weeks were comparable at baseline with 12 subjects managed with SM and 14 subjects supplemented with Pycnogenol®. No side effects due to Pycnogenol® were observed; Pycnogenol® was associated with an optimal tolerability. The proportion of patients with photosensitivity, oral ulcers, renal-associated hematuria (minimal), leukopenia, lymphopenia, thrombocytopenia, positive anti-DNA and positive antiphospolipids tests were significantly lower in the Pycnogenol® group (P<0.05) at 8 weeks in comparison with controls. No difference in activity between SM and supplementation was observed for rash, serositis, anemia, neurological symptoms (all mild at inclusion) and anti-Smith. Considering additional clinical parameters such as the need for corticosteroids, peripheral ischemia, oxidative stress, the effects of Pycnogenol® appeared to be superior to SM alone (P<0.05). The decrease in oxidative stress was significantly higher with Pycnogenol® (P<0.05) compared to SM. This is particularly interesting as it has not been observed before in LV. Considering microvascular parameters, the number of subjects with ‘cold’ hypoperfused thermographic areas was significantly lower in the supplement group (P<0.05) and distal flux (laser Doppler) was higher with the supplement (P<0.05) at 8 weeks.
CONCLUSIONS: This pilot registry indicates that Pycnogenol® can be safely used in subjects with LV with mild symptoms (in remission) possibly avoiding some drug treatments that may cause side effects. A larger study in progress is evaluating the effects of Pycnogenol® on recurrent symptoms in subjects in remission.

KEY WORDS: Lupus erythematosus, systemic; Lupus vasculitis, central nervous system; Oxidative stress; Pycnogenols