Maria R Cesarone, Shu Hu, Gianni Belcaro, Umberto Cornelli, Beatrice Feragalli, Giovanni B Agus, Marcello Corsi, Claudia Scipione, Valeria Scipione, Ezio Bombardelli, Roberto Cotellese, Francesca Coppazuccari, Morio Hosoi, Pietromaria Bavera, Lars Rosenkvist
{"title":"Supplementary management of chronic Lyme disease with Pycnogenol®.","authors":"Maria R Cesarone, Shu Hu, Gianni Belcaro, Umberto Cornelli, Beatrice Feragalli, Giovanni B Agus, Marcello Corsi, Claudia Scipione, Valeria Scipione, Ezio Bombardelli, Roberto Cotellese, Francesca Coppazuccari, Morio Hosoi, Pietromaria Bavera, Lars Rosenkvist","doi":"10.23736/S0026-4806.25.09703-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The aim of this pilot supplement registry study was to investigate the efficacy of the anti-inflammatory supplement Pycnogenol<sup>®</sup> in subjects with history of Lyme disease and persistent symptoms with no active bacteria present (Stage 2 and 3 of Lyme disease), on the reduction of inflammation and the relieve of the main symptoms. There is currently no specific treatment for this condition.</p><p><strong>Methods: </strong>The subjects were divided into two groups: one group received 150 mg/day of Pycnogenol<sup>®</sup> alongside standard management, while the control group received only standard management. The observation period lasted for six months.</p><p><strong>Results: </strong>Forty subjects with history of Lyme Disease and persistent symptoms completed the study: 20 in the Pycnogenol<sup>®</sup> group, 20 in the control group. No side effects from the supplementation were observed. The tolerability was optimal as no supplemented subject had to stop management and compliance was optimal with 97% of the Pycnogenol<sup>®</sup> capsules correctly used. The two groups were comparable for sex, age distribution and for their main clinical findings and signs/symptoms at inclusion. During the study, corticosteroids at low dose were used on demand in 10% of subjects using Pycnogenol<sup>®</sup> and significantly more, in 45% of the control patients (P<0.05). After 6 months, the number of patients experiencing symptoms was significantly lower in the Pycnogenol<sup>®</sup> group compared to the control group across all symptoms (P<0.05). After 6 months, the intensity of all symptoms in the Pycnogenol<sup>®</sup> group, was significantly lower, according to the scores in comparison with the control group (P<0.05). Plasma oxidative stress was significantly reduced in subjects of the Pycnogenol<sup>®</sup> group (P<0.05) in comparison with controls. The improvement in plasma oxidative stress was seen in all subjects using Pycnogenol<sup>®</sup>. Knee effusion on ultrasound was seen in 12 subjects of the supplement group at inclusion and in 3 Pycnogenol<sup>®</sup> subjects at the end of the study in comparison with 12/20 subjects in the control group at inclusion and 8/20 at the end of the study. (P<0.05). Finally, ESR (Erythrocyte sedimentation rate, a global marker of inflammation) was significantly more reduced in the Pycnogenol<sup>®</sup> group by the end of the study compared to controls (P<0.05).</p><p><strong>Conclusions: </strong>In conclusion, the present registry study showed that Pycnogenol<sup>®</sup> intake for 6 months in patients with persistent symptoms of Lyme disease can help relieve the main symptoms by reducing inflammation and oxidative stress. Pycnogenol's anti-inflammatory and antioxidant double activity may help safely and effectively controlling the chronic inflammatory process.</p>","PeriodicalId":94143,"journal":{"name":"Minerva medica","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Minerva medica","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.23736/S0026-4806.25.09703-4","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Background: The aim of this pilot supplement registry study was to investigate the efficacy of the anti-inflammatory supplement Pycnogenol® in subjects with history of Lyme disease and persistent symptoms with no active bacteria present (Stage 2 and 3 of Lyme disease), on the reduction of inflammation and the relieve of the main symptoms. There is currently no specific treatment for this condition.
Methods: The subjects were divided into two groups: one group received 150 mg/day of Pycnogenol® alongside standard management, while the control group received only standard management. The observation period lasted for six months.
Results: Forty subjects with history of Lyme Disease and persistent symptoms completed the study: 20 in the Pycnogenol® group, 20 in the control group. No side effects from the supplementation were observed. The tolerability was optimal as no supplemented subject had to stop management and compliance was optimal with 97% of the Pycnogenol® capsules correctly used. The two groups were comparable for sex, age distribution and for their main clinical findings and signs/symptoms at inclusion. During the study, corticosteroids at low dose were used on demand in 10% of subjects using Pycnogenol® and significantly more, in 45% of the control patients (P<0.05). After 6 months, the number of patients experiencing symptoms was significantly lower in the Pycnogenol® group compared to the control group across all symptoms (P<0.05). After 6 months, the intensity of all symptoms in the Pycnogenol® group, was significantly lower, according to the scores in comparison with the control group (P<0.05). Plasma oxidative stress was significantly reduced in subjects of the Pycnogenol® group (P<0.05) in comparison with controls. The improvement in plasma oxidative stress was seen in all subjects using Pycnogenol®. Knee effusion on ultrasound was seen in 12 subjects of the supplement group at inclusion and in 3 Pycnogenol® subjects at the end of the study in comparison with 12/20 subjects in the control group at inclusion and 8/20 at the end of the study. (P<0.05). Finally, ESR (Erythrocyte sedimentation rate, a global marker of inflammation) was significantly more reduced in the Pycnogenol® group by the end of the study compared to controls (P<0.05).
Conclusions: In conclusion, the present registry study showed that Pycnogenol® intake for 6 months in patients with persistent symptoms of Lyme disease can help relieve the main symptoms by reducing inflammation and oxidative stress. Pycnogenol's anti-inflammatory and antioxidant double activity may help safely and effectively controlling the chronic inflammatory process.