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• W3217507600 abstract "Introduction: The concept of a lack of intervention in a pre-disease population with hypercholesterolemia has not been previously reported. This study examined the concept of the effects of the absence of an intervention in the placebo group vs. supplementation of a special formulation of Panax Notoginseng (FNG) in relation to cardiovascular disease (CVD) risk markers and validated CVD-risk factor scores. Methods: Participants in this randomized, placebo-controlled, triple-blind study were supplemented with FNG or placebo for 12 weeks. Lipid profile, blood pressure (BP), and endothelial vasodilation parameters were assessed at baseline and weeks 4, 8 and 12 and safety assessed at screening and end of study. The participants in both groups followed the Therapeutic Lifestyle Change (TLC) diet during a 4-week run-in and throughout the study. The TLC diet for 4 weeks ensured all participants starting the study had similar baseline measurements and placebo effects were adequately addressed. Results: Participants in the placebo group had a non-significant 1.37% reduction in HDL-C at 8 and 12 weeks, as well, as an increase in systolic BP from baseline at week 12. Participants in the placebo had no change in estimated Framingham Heart Study 10-year risk for CVD, while the FNG group had a 0.1% reduction from baseline at week 12. A total of 67.5% of participants supplemented with FNG had improvements in at least two CVD risk factors (LDL-C, HDL-C and systolic BP) compared to 40.0% of those on placebo (p=0.007). In a post-hoc subgroup analysis of participants with baseline LDL-C >3.5 mmol/L, 41.7% of participants in the FNG group had reductions in their systolic BP and LDL-C and improvements in HDL-C levels at week 12, compared to placebo where there were no improvements. Conclusions: The lack of an intervention in a population at risk of CVD, represented by the placebo group, resulted in a negative impact on cardiovascular risk factors and warrants further investigation on the importance of pre-emptive supplementation of notoginseng in populations with mild hypertension and hypercholesterolemia. This study supports a previously defined concept in nutritional interventions which described changing from proof of efficacy to that of probable harm in pre-disease populations." @default.
• W3217507600 created "2021-12-06" @default.
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• W3217507600 date "2021-11-16" @default.
• W3217507600 modified "2023-09-27" @default.
• W3217507600 title "Abstract 12506: Exploring the Absence of an Intervention: A Randomized, Placebo-Controlled, Triple Blind Study on Notoginseng Supplementation in A Population With Normal to Mild Hypertension and Hypercholesterolemia" @default.
• W3217507600 doi "https://doi.org/10.1161/circ.144.suppl_1.12506" @default.
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