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Fatigue due to mild heart failure: effects of Robuvit® in a concept, pilot registry study
Gianni Belcaro1,2, Maria R Cesarone3,4, Valeria Scipione3,4
1Irvine3 labs & PAP/PEA Screening Project and the International Irvine Network, Department SMO Biotec and Cardiology School, G. D'Annunzio University, Chieti-Pescara, Pescara, Italy - cardres@abol.it.
Background:
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.
Methods:
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.
Results:
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.
Conclusions:
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.
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