Irvine3 labs & PAP/PEA Screening Project and the International Irvine Network, Department SMO Biotec and Cardiology School, G. D'Annunzio University, Chieti-Pescara, Pescara, Italy -
The International Agency for Pharma Standard Supplements, Pescara, Italy -
Minerva Cardioangiol. 2020 Jun;68(3):216-223. doi: 10.23736/S0026-4725.19.05029-1.
The aim of this supplement registry study was the evaluation of possible benefits of Robuvit® (oak wood extract) as a standardized supplement (in an 8-week registry) in stable, mild, heart failure patients.
All subjects received the standard management (SM) for this condition. Otherwise healthy subjects with mild, initial symptoms (mild shortness of breath and/or angina) and slight limitation during their normal daily activity were included. This corresponds to the New York Heart Association (NYHA) Functional Classification class II.
Forty subjects were included in the study. The two groups completing 8 weeks were comparable at baseline with 20 subjects managed with SM and 20 subjects supplemented with Robuvit® in addition to SM. Tolerability and compliance were optimal (with more than 95% of the capsules correctly used). The age and symptoms of the supplemented patients and the controls were comparable at baseline. There were no dropouts. At 8 weeks, systolic-diastolic pressure, heart rate, respiratory rate were minimally (non-significantly) lowered with the supplement without differences in controls. Ultrasound-derived ejection fraction was significantly increased in the supplement group (P<0.05) while there were minimal, non-significant differences in controls. Walking distance on treadmill was also significantly increased in the supplement group (P<0.05) and significantly less in controls. The microcirculation (laser Doppler parameters and transcutaneous PO2, PCO2) improved significantly in the Robuvit® group (P<0.05) in comparison with the non-supplemented controls. Oxidative stress was significantly decreased (P<0.05) with the supplement while there were minimal, non-significant changes in controls.
In conclusion in this pilot, supplement registry Robuvit® seems to help and improve patients with mild heart failure and should be considered for larger studies.
本补充注册研究的目的是评估 Robuvit®（橡木木提取物）作为标准化补充剂（在 8 周注册期内）在稳定、轻度心力衰竭患者中的可能益处。
所有受试者均接受该疾病的标准治疗（SM）。纳入了其他健康的、有轻度初始症状（轻度呼吸急促和/或心绞痛）和在正常日常活动中轻微受限的受试者。这符合纽约心脏协会（NYHA）功能分类 II 级。
40 名受试者纳入研究。完成 8 周的两组在基线时具有可比性，其中 20 名受试者接受 SM 治疗，20 名受试者在 SM 治疗的基础上补充 Robuvit®。耐受性和依从性最佳（超过 95%的胶囊使用正确）。补充组和对照组患者的年龄和症状在基线时相似。无脱落。8 周时，补充组的收缩-舒张压、心率、呼吸频率略有（无统计学意义）降低，对照组无差异。超声心动图射血分数在补充组显著增加（P<0.05），而对照组则略有增加，无统计学意义。补充组的跑步机步行距离也显著增加（P<0.05），对照组则显著减少。Robuvit®组的微循环（激光多普勒参数和经皮 PO2、PCO2）显著改善（P<0.05），而非补充对照组则略有改善，无统计学意义。补充组的氧化应激显著降低（P<0.05），而对照组则略有变化，无统计学意义。
总之，本试验中，补充剂 Robuvit®似乎对轻度心力衰竭患者有帮助和改善作用，应考虑进行更大规模的研究。
