Irvine3 and Nicolaides Labs, Circulation Sciences and San Valentino, Vascular Screening Center (Dpt. Med Or. Biotec, Sciences) Ch-Pe University, Pescara, Italy -
The Rohdewald Research Center, Spoltore, Pescara, Italy -
Panminerva Med. 2022 Jun;64(2):253-258. doi: 10.23736/S0031-0808.20.04046-X.
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).
Two management groups were formed: one using the standard management (SM) and one using SM and Pycnogenol 150 mg/day for 4 weeks.
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.
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.
本研究旨在评估 Pycnogenol（法国沿海松树皮，标准化提取物）的预防功效，该产品为一种抗炎和抗氧化补充剂，此前用于治疗肌肉疼痛和痉挛，现用于治疗不安腿综合征（RLS）的健康受试者。
将患者分为两组：一组使用标准治疗（SM），一组在 SM 的基础上加用 Pycnogenol 150mg/天，疗程 4 周。
45 名受试者入组，其中 21 名服用 Pycnogenol，24 名接受 SM 治疗。治疗 4 周后，未观察到任何副作用或耐受性问题。依从性极佳。两组患者基线情况相似。肢体感觉采用视觉模拟评分法（0-4 分）进行评估。SM 组所有患者的评分均有改善，但无统计学意义。补充 Pycnogenol 后，所有评估参数均有显著改善（P<0.05），且 21 名补充 Pycnogenol 的患者中，19 名报告症状有明显改善。补充 Pycnogenol 后，静息血流（纳入时轻度升高）恢复正常（P<0.05），说明轴突反射反应更好，亚临床神经改变程度更低。4 周后，补充 Pycnogenol 可显著减少（P<0.05）疼痛管理的需要，因为仅 4/21 名补充 Pycnogenol 的患者需要使用镇痛药，而 SM 组中则有 16/24 名患者需要使用镇痛药。腿部热成像未显示任何明显的灌注不对称。补充 Pycnogenol 后，血浆自由基（PFR）显著降低（P<0.05），提示氧化应激改善。同样，用水肿测试仪测量的最小水肿也明显减少。
Pycnogenol 可预防或缓解不安腿综合征相关症状，并可改善动静脉反应。未来对该疾病的研究，包括对更复杂的患者的研究，可能会提示 Pycnogenol 在这种常见但仍不清楚的综合征和亚临床肌肉和神经改变中的作用。
