Antihypertensive efficacy and safety of a standardized herbal medicinal product of Hibiscus sabdariffa and Olea europaea extracts (NW Roselle): A phase-II, randomized, double-blind, captopril-controlled clinical trial.

Nabil Elkafrawy, Khaled Younes, Ahmed Naguib, Hytham Badr, Shimaa Kamal Zewain, Mai Kamel, Gehan Fawzy Abdel Raoof, Ahmed M El-Desoky, Shanaz Mohamed

Journal: Phytotherapy research : PTR 2021;34(12):3379-3387

PMID: 32725873

Abstract

Hypertension is a public health concern that needs immediate attention upon diagnosis. The demand for natural alternatives is on the rise; Hibiscus sabdariffa and Olea europaea are traditionally used for hypertension management in Egypt. In this study, we aimed to investigate the antihypertensive efficacy and safety of two doses of an herbal product of Hibiscus sabdariffa calyxes and Olea europaea leaves (NW Roselle) in Egyptian patients with grade 1 essential hypertension. We equally randomized 134 patients to receive captopril 25 mg, low-dose NW Roselle, or high-dose NW Roselle BID for 8 weeks. No significant decrease was found in systolic blood pressure or diastolic blood pressure when we compared low-dose NW Roselle and high-dose NW Roselle to captopril (p > .05). In all groups, mean reduction in BP at 8 weeks was significant; 16.4/9.9 mmHg (p < .0001), 15.4/9.6 mmHg (p < .0001), and 14.9/9.4 mmHg (p < .0001) with captopril, low-dose NW Roselle, and high-dose NW Roselle respectively. In addition, low-dose NW Roselle induced a significant reduction in the mean level of triglycerides (17.56 mg/dL; p = .038). In conclusion, NW Roselle had comparable antihypertensive efficacy and safety to captopril in Egyptian patients with grade 1 essential hypertension.

© 2020 John Wiley & Sons, Ltd.

Address: Internal Medicine and Diabetology, Faculty of Medicine, Menoufia University, Menoufia, Egypt.; Internal Medicine Department, Medical Division, National Research Centre, Giza, Egypt.; Faculty of Medicine, Cardiology and Angiology, Alexandria University, Alexandria, Egypt.; Faculty of Medicine, Internal Medicine, Diabetes and Endocrinology, Menoufia University, Menoufia, Egypt.; Pharmacognosy Department, Pharmaceutical and Drug Research Industries Division, National Research Centre, Giza, Egypt.; Molecular Biology, Genetic Engineering and Biotechnology Research Institute, University of Sadat City, Sadat City, Egypt.; School of Pharmaceutical Sciences, Universiti Sains Malaysia, Gelugor, Malaysia.
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