ORIGINAL ARTICLE   

Panminerva Medica 2022 June;64(2):253-8

DOI: 10.23736/S0031-0808.20.04046-X

Copyright © 2020 EDIZIONI MINERVA MEDICA

language: English

Restless legs syndrome: prevention with Pycnogenol® and improvement of the venoarteriolar response

Gianni BELCARO ^{1, 2} ✉, Peter ROHDEWALD ¹, Maria R. CESARONE ^{1, 2}, Claudia SCIPIONE ^{1, 2}, Valeria SCIPIONE ¹, Umberto CORNELLI ¹, Roberta LUZZI ¹, Roberto COTELLESE ¹, Mark DUGALL ¹, Morio HOSOI ¹, Marcello CORSI ¹, Beatrice FERAGALLI ¹

¹ Irvine3 and Nicolaides Labs, Circulation Sciences and San Valentino, Vascular Screening Center (Dpt. Med Or. Biotec, Sciences) Ch-Pe University, Pescara, Italy; ² The Rohdewald Research Center, Spoltore, Pescara, Italy; ³ International Agency For Pharma Standard Supplements, Pescara, Italy

BACKGROUND: The aim of this registry study was to evaluate the preventive efficacy of Pycnogenol^® (French maritime pine bark, standardized extract), an anti-inflammatory and antioxidant supplement, previously used for muscular pain and cramps, in otherwise healthy subjects with restless legs syndrome (RLS).
METHODS: Two management groups were formed: one using the standard management (SM) and one using SM and Pycnogenol^® 150 mg/day for 4 weeks.
RESULTS: Forty-five subjects were included in the study, 21 took Pycnogenol^® and 24 were in the SM group. After 4 weeks no side effects or tolerability problems were observed. Compliance was optimal. The two groups were comparable at baseline. Limb sensations were assessed with a Visual Analogue Scale Line (0 to 4). There was a statistically non-significant improvement with SM in all subjects. Improvement with Pycnogenol^® supplementation was significant (P<0.05) for all assessed parameters with important clinical meanings as 19 out of 21 supplemented subjects reported a clear benefit from supplementation. Resting flux - slightly elevated at inclusion - was normalized in the supplemented group (P<0.05) as seen by a decrease in flux. The venoarteriolar response - affected at inclusion in all subjects with RLS - was improved with the supplement, indicating a better axon-axon reflex response and a lower level of subclinical neural alteration. The need for pain managements was significantly reduced (P<0.05) with supplementation after 4 weeks, as only 4/21 supplemented subjects vs. 16/24 in the SM-only group had to use analgesics. Thermography of the leg did not reveal any significant asymmetry of perfusion. Oxidative stress as plasma free radicals (PFR) was significantly improved (reduced) (P<0.05) in subjects using Pycnogenol^®. Likewise, minimal edema, measured with the edema tester, was significantly decreased with Pycnogenol^®.
CONCLUSIONS: Pycnogenol^® prevents or relieves symptoms associated with restless leg syndrome and positively affects the venoarteriolar response. Future studies in this condition, including more complex subjects may indicate the role of Pycnogenol^® in this common and still obscure syndrome and in subclinical muscular and neurological alterations.

KEY WORDS: Restless legs syndrome; Microcirculation; Pycnogenol; Leg