Dataset Information

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

ABSTRACT: 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?

SUBMITTER: Ryan JJ

PROVIDER: S-EPMC6389760 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Ryan Jennifer Joan JJ Hanes Douglas Allen DA Corroon Jamie J Taylor Jan J Bradley Ryan R

Journal of alternative and complementary medicine (New York, N.Y.) 20180914 2

<h4>Objective</h4>To prospectively examine the long-term safety of a cardiovascular health dietary supplement by assessing a comprehensive set of safety measures.<h4>Design</h4>Single-arm, open-label study.<h4>Location</h4>National University of Natural Medicine, Portland, OR.<h4>Subjects</h4>Thirty adults with screening blood pressure readings consistent with prehypertension or stage I hypertension.<h4>Intervention</h4>One caplet per day of a dietary supplement for 6 months. The investigated he ...[more]

PMID: 30222364

Similar Datasets

Project description:BackgroundPrehypertension and hypertension are associated with cardiovascular disease, ischemic heart disease, and stroke morbidity. The purpose of this study is to evaluate the effectiveness and safety of moxibustion in patients with prehypertension or hypertension.MethodsForty-five subjects with prehypertension or stage I hypertension were randomized into three groups: moxibustion treatment group A (2 sessions/week for 4 weeks), moxibustion treatment group B (3 sessions/week for 4 weeks), and control group (nontreated group). The primary outcome measure was the change in blood pressure after 4 weeks of treatment. Safety was assessed at every visit.ResultsThere were no significant differences in systolic blood pressure (SBP) or diastolic blood pressure (DBP) among three groups after 4 weeks of treatment (p = 0.4798 and p = 0.3252, respectively). In treatment group B, there was a significant decrease in SBP and DBP from baseline to 4 weeks of treatment (mean difference (MD) -9.55; p = 0.0225, MD -7.55; p = 0.0098, respectively). There were no significant differences among groups in secondary outcome measures after 4 weeks of treatment. Six adverse events (AEs) in the treatment group A and 12 AEs in the treatment group B occurred related to the moxibustion treatment.ConclusionIn conclusion, the results of this study show that moxibustion (3 sessions/week for 4 weeks) might lower blood pressure in patients with prehypertension or stage I hypertension and treatment frequency might affect effectiveness of moxibustion in BP regulation. Further randomized controlled trials with a large sample size on prehypertension and hypertension should be conducted.Trial registrationThis study was registered with the 'Clinical Research Information Service (CRIS)', Republic of Korea (KCT0000469), and the protocol for this study was presented orally at the 15th International Council of Medical Acupuncture and Related Techniques (ICMART) in Athens, 25-27 May 2012.

Project description:Background Nonpharmacologic interventions that modify lifestyle can lower blood pressure (BP) and have been assessed in numerous randomized controlled trials and pairwise meta-analyses. It is still unclear which intervention would be most efficacious. Methods and Results Bayesian network meta-analyses were performed to estimate the comparative effectiveness of different interventions for lowering BP. From 60 166 potentially relevant articles, 120 eligible articles (14 923 participants) with a median follow-up of 12 weeks, assessing 22 nonpharmacologic interventions, were included. According to the surface under the cumulative ranking probabilities and Grading of Recommendations Assessment, Development and Evaluation (GRADE) quality of evidence, for adults with prehypertension to established hypertension, high-quality evidence indicated that the Dietary Approach to Stop Hypertension (DASH) was superior to usual care and all other nonpharmacologic interventions in lowering systolic BP (weighted mean difference, 6.97 mm Hg; 95% credible interval, 4.50-9.47) and diastolic BP (weighted mean difference, 3.54 mm Hg; 95% credible interval, 1.80-5.28). Compared with usual care, moderate- to high-quality evidence indicated that aerobic exercise, isometric training, low-sodium and high-potassium salt, comprehensive lifestyle modification, breathing-control, and meditation could lower systolic BP and diastolic BP. For patients with hypertension, moderate- to high-quality evidence suggested that the interventions listed (except comprehensive lifestyle modification) were associated with greater systolic BP and diastolic BP reduction than usual care; salt restriction was also effective in lowering both systolic BP and diastolic BP. Among overweight and obese participants, low-calorie diet and low-calorie diet plus exercise could lower more BP than exercise. Conclusions DASH might be the most effective intervention in lowering BP for adults with prehypertension to established hypertension. Aerobic exercise, isometric training, low-sodium and high-potassium salt, comprehensive lifestyle modification, salt restriction, breathing-control, meditation and low-calorie diet also have obvious effects on BP reduction.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets