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ORIGINAL ARTICLE
Panminerva Medica 2021 December;63(4):472-7
DOI: 10.23736/S0031-0808.20.03961-0
Copyright © 2020 EDIZIONI MINERVA MEDICA
language: English
Primary benign back pain: supplementation with Pycnogenol®
David COX 1, Gianni BELCARO 1, 2, 3 ✉, Maria R. CESARONE 1, 2, 3, Roberto COTELLESE 1, Mark DUGALL 1, 2, 3, Beatrice FERAGALLI 2, Morio HOSOI 1, Marcello CORSI 1, Roberta LUZZI 1
1 IRVINE3 Vascular/Circulation Labs, Pescara, Italy; 2 Radiology, Department of Medical, Oral and Biotechnological Sciences, D’Annunzio University, Pescara, Italy; 3 IAAPS, International Agency for Pharma Standard Supplements, Pescara, Italy
BACKGROUND: Back pain (BP) is one of the most common problems seen by general practitioners. The aim of this pilot registry study was to evaluate the effects of Pycnogenol® (French Maritime Pine Bark extract) on pain, mobility and muscle spasm in patients with recurring episodes of back pain without any other clinical condition.
METHODS: The registry follow-up lasted 3 weeks. Subjects used either SM (standard management), including mild exercise and 3 days of resting or immobilization - or SM+Pycnogenol® 200 mg/day (4 cps/day).
RESULTS: Eighty-two subjects were included in the study, 23 took Pycnogenol® and 59 were in the SM group. No safety problems or tolerability problems were observed with Pycnogenol® or with the SM. The two groups, SM and SM+Pycnogenol®, were comparable at inclusion. A prevalent localization to the lower part of the back/spine was observed in all patients of both groups. The improvement in Karnofsky performance status Scale - expressing the global physical capacity of the individuals - during the 3 weeks of follow-up was significantly higher and faster in the Pycnogenol® group (P<0.05) compared to SM. Patients were able to restart physical training in 3 weeks with Pycnogenol® (in comparison with 4.5 weeks with SM only). The decrease in back pain score (VASL score) was faster and more pronounced with Pycnogenol® (P<0.05) compared to SM. Oxidative stress was significantly reduced in subjects using Pycnogenol® (P<0.05) while it remained elevated in the control group. The use of the rescue medication doses (ibuprofen) was significantly higher in the SM only (P<0.05) in comparison with SM+Pycnogenol®.
CONCLUSIONS: Pycnogenol® appears to be an effective and safe supplementary management in healthy subjects with idiopathic BP. Mobility, pain, general physical capacity and oxidative stress improved in only a week with further improvements up to 4 weeks in most patients; results appear to be better and faster with Pycnogenol® supplementation than with SM alone.
KEY WORDS: Back pain; Pycnogenols; Dietary supplements; Pain