Abstract 17515: Randomized, Double-blind, Placebo-controlled, Assessment of the Efficacy and Safety of Dietary Supplements in Pre-hypertension - the Pre-hypertension Treament With a Combination of Dietary Supplements and Life-style Modifications (PYRAMIDS) Trial
Introduction: Individuals with prehypertension are recommended to practice life-style changes, including a greater intake of food derivatives with blood pressure (BP) lowering effect. While the association of antihypertensive drugs yields additive benefit in terms of BP reduction, it remains unknown whether combining dietary supplements may also provide additive effects.
Hypothesis: We evaluated efficacy and tolerability of a protocol including life-style modifications and a novel combination of dietary supplements in prehypertension.
Methods: A total of 161 otherwise healthy subjects with BP of 130-139 mm Hg systolic and/or 85-89 mm Hg diastolic entered a prospective, double-blind, randomized, placebo-controlled trial. Partecipants were randomized to twice daily placebo (n=80) or a commercially available combined pill (n=81), containing allium sativum (250 mg), hawthorn (250 mg), ortosiphon (150 mg), and hibiscus (125 mg). Both groups received life-style modification counseling. Primary outcome was the difference in office BP between the 2 groups at the end of the trial. Secondary outcomes included response rates (i.e. BP<130/85 mm Hg or a BP reduction>5 mm Hg at week 12), as well as tolerability, compliance and safety during the trial.
Results: Baseline characteristics were similar among the treatment groups. At 12-weeks, the supplement-group had lower systolic BP (125±9 vs 133±8 mm Hg, p=0.0001) and diastolic BP (81±7 vs 83±8 mm Hg, p=0.119) than the placebo-group. Compared with baseline, changes in BP with supplements were statistically significant for systolic (-9.1±4.1 mm Hg, p=0.01) and had a borderline effect on diastolic values (-4.4±3.8 mm Hg, p=0.09). Changes vs. baseline in systolic and diastolic BP, conversely, were not different on placebo. Response rate at week 12 was significantly higher with supplements than placebo (56% vs. 26% p=0.001). Tolerability, compliance and safety were not significantly different between the 2 groups.
Conclusions: This randomized trial shows that combination of dietary supplements with BP lowering effect is an effective and tolerable adjunct treatment to conventional lifestyle modifications for controlling systolic BP in prehypertension. (ClinicalTrials.gov Identifier: NCT01682291).
Author Disclosures: F. Pelliccia: None. A. Arrivi: None. G. Marazzi: None. L. Cacciotti: None. V. Pasceri: None. G. Rosano: None. G. Pannarale: None. C. Greco: None. C. Gaudio: None. M. Volpe: None.
- © 2014 by American Heart Association, Inc.