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

DOI: 10.23736/S0031-0808.20.04046-X


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

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