Prospective Safety Evaluation of a Cardiovascular Health Dietary Supplement in Adults with Prehypertension and Stage I Hypertension

Jennifer Joan Ryan; Douglas Allen Hanes; Jamie Corroon; Jan Taylor; Ryan Bradley

doi:10.1089/acm.2018.0311

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Prospective Safety Evaluation of a Cardiovascular Health Dietary Supplement in Adults with Prehypertension and Stage I Hypertension

Journal article

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Prospective Safety Evaluation of a Cardiovascular Health Dietary Supplement in Adults with Prehypertension and Stage I Hypertension

Jennifer Joan Ryan, Douglas Allen Hanes, Jamie Corroon, Jan Taylor and Ryan Bradley

The journal of alternative and complementary medicine (New York, N.Y.), Vol.25(2), pp.249-256

20/02/2019

DOI: https://doi.org/10.1089/acm.2018.0311

PMCID: PMC6389760

PMID: 30222364

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Abstract

cardiovascular health

dietary supplements

hypertension

Original Research

prehypertension

safety

tolerability

Objective: To prospectively examine the long-term safety of a cardiovascular health dietary supplement by assessing a comprehensive set of safety measures. Design: Single-arm, open-label study. Location: National University of Natural Medicine, Portland, OR. Subjects: Thirty adults with screening blood pressure readings consistent with prehypertension or stage I hypertension. Intervention: One caplet per day of a dietary supplement for 6 months. The investigated herbal–mineral supplement contains several ingredients, most notably Rauwolfia serpentina. Outcome measures: Primary measures included b-type natriuretic peptide (NT-proBNP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), estimated glomerular filtration rate (eGFR), electrolytes, and the Patient Health Questionnaire (PHQ-9). Exploratory measures included physical vital signs, cholesterol levels, high-sensitivity cardiac troponin-I, cystatin C, endothelin, interleukin (IL)-6, IL-17a, tumor necrosis factor-α, high-sensitivity C-reactive protein, blood counts, and the Patient Reported Outcome Measure Information System (PROMIS) Sleep Disturbance Short Form 8b. Results: NT-proBNP, AST, ALT, eGFR, sodium, calcium, magnesium, PHQ-9 score, and the majority of exploratory measures did not change. However, serum potassium increased (p < 0.05), systolic blood pressure decreased (p < 0.0001), and diastolic blood pressure decreased (p < 0.0001). There were no serious adverse events, but 30% of participants withdrew citing potential side effects, most commonly nasal congestion or fatigue; most participants who reported nasal congestion also reported concomitant seasonal allergies. Adherence to the supplement was 90.9%. Conclusions: The findings of this study suggest that the investigated dietary supplement is safe for long-term use in adults with prehypertension and stage I hypertension. Additional results of this study, particularly the increase in serum potassium and decreases in systolic and diastolic blood pressure, are promising and suggest that future research on this dietary supplement, or its ingredients, should further explore effects on blood pressure and biologic mechanisms of action, which may involve potassium-sparing and diuretic effects.

Details

Title: Prospective Safety Evaluation of a Cardiovascular Health Dietary Supplement in Adults with Prehypertension and Stage I Hypertension
Creators: Jennifer Joan Ryan - National University of Natural Medicine
Douglas Allen Hanes - National University of Natural Medicine
Jamie Corroon - National University of Natural Medicine
Jan Taylor - National University of Natural Medicine
Ryan Bradley - National University of Natural Medicine
Publication Details: The journal of alternative and complementary medicine (New York, N.Y.), Vol.25(2), pp.249-256
Publisher: Mary Ann Liebert, Inc., publishers
Identifiers: 991013036339202368
Copyright: © Jennifer Joan Ryan et al. 2018; Published by Mary Ann Liebert, Inc. This Open Access article is distributed under the terms of the Creative Commons License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Academic Unit: National Centre for Naturopathic Medicine
Language: English
Resource Type: Journal article

Prospective Safety Evaluation of a Cardiovascular Health Dietary Supplement in Adults with Prehypertension and Stage I Hypertension

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