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

摘要

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-, 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.