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.
cardiovascular
hypertension
lipids
pharmacodynamics
traditional medicine Africa
Journal
Phytotherapy research : PTR
ISSN: 1099-1573
Titre abrégé: Phytother Res
Pays: England
ID NLM: 8904486
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
received:
08
03
2020
revised:
23
05
2020
accepted:
13
06
2020
pubmed:
30
7
2020
medline:
28
1
2021
entrez:
30
7
2020
Statut:
ppublish
Résumé
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.
Substances chimiques
Antihypertensive Agents
0
Plant Extracts
0
Captopril
9G64RSX1XD
Types de publication
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
3379-3387Informations de copyright
© 2020 John Wiley & Sons, Ltd.
Références
Ali, B. H., Al Wabel, N., & Blunden, G. (2005). Phytochemical, pharmacological and toxicological aspects of Hibiscus sabdariffa L.: A review. Phytotherapy Research, 19(5), 369-375. https://doi.org/10.1002/ptr.1628
Alwan, A., Armstrong, T., & Cowan, M. R. L. (2011). Non communicable diseases country profiles 2011 (pp. 1-207). Geneva, Switzerland: World Health Organization. https://doi.org/10.2471/BLT.07.045138
Alwan, A., MacLean, D. R., Riley, L. M., D'Espaignet, E. T., Mathers, C. D., Stevens, G. A., & Bettcher, D. (2010). Monitoring and surveillance of chronic non-communicable diseases: Progress and capacity in high-burden countries. The Lancet, 376(9755), 1861-1868. https://doi.org/10.1016/S0140-6736(10)61853-3
Arauz-Pacheco, C., Parrott, M. A., & Raskin, P. (2002). The treatment of hypertension in adult patients with diabetes. Diabetes Care, 25(1), 134-147. https://doi.org/10.2337/diacare.25.1.134
Asgary, S., Soltani, R., Zolghadr, M., Keshvari, M., & Sarrafzadegan, N. (2016). Evaluation of the effects of roselle (Hibiscus sabdariffa L.) on oxidative stress and serum levels of lipids, insulin and hs-CRP in adult patients with metabolic syndrome: A double-blind placebo-controlled clinical trial. Journal of Complementary and Integrative Medicine, 13(2), 175-180. https://doi.org/10.1515/jcim-2015-0030
Bennani-Kabchi, N., Fdhil, H., & Cherrah, Y. (1999). Effects of Olea europea var. oleaster leaves in hypercholesterolemic insulin-resistant sand rats. Thérapie, 54(6), 717-723. Retrieved from http://europepmc.org/article/med/10709446
Cherif, S., Rahal, N., Haouala, M., Hizaoui, B., & Dargouth, F. (1996). A clinical trial of a titrated Olea extract in the treatment of essential arterial hypertension. Journal de Pharmacie de Belgique, 51(2), 69-71. Retrieved from http://europepmc.org/article/med/8786521
Engels, G. (2007). Herb profile: Hibiscus. The Journal of the American Botanical Council, 74, 1-6. Retrieved from http://cms.herbalgram.org/herbalgram/issue74/article3102.html?ts=1579614291&signature=05880916465417a773fbe0640db35dc8
Haji Faraji, M., & Haji Tarkhani, A. H. (1999). The effect of sour tea (Hibiscus sabdariffa) on essential hypertension. Journal of Ethnopharmacology, 65(3), 231-236. http://dx.doi.org/10.1016/s0378-8741(98)00157-3.
Hansen, K., Adsersen, A., Christensen, S. B., Jensen, S. R., Nyman, U., & Smitt, U. W. (1996). Isolation of an angiotensin converting enzyme (ACE) inhibitor from Olea europaea and Olea lancea. Phytomedicine, 2(4), 319-325. https://doi.org/10.1016/S0944-7113(96)80076-6
Herrera-Arellano, A., Flores-Romero, S., Chávez-Soto, M. A., & Tortoriello, J. (2004). Effectiveness and tolerability of a standardized extract from Hibiscus sabdariffa in patients with mild to moderate hypertension: A controlled and randomized clinical trial. Phytomedicine, 11(5), 375-382. https://doi.org/10.1016/j.phymed.2004.04.001
Herrera-Arellano, A., Miranda-Sánchez, J., Ávila-Castro, P., Herrera-Álvarez, S., Jiménez-Ferrer, J. E., Zamilpa, A., … Tortoriello, J. (2007). Clinical effects produced by a standardized herbal medicinal product of Hibiscus sabdariffa on patients with hypertension. A randomized, double-blind, lisinopril-controlled clinical trial. Planta Medica, 73(1), 6-12. https://doi.org/10.1055/s-2006-957065
Ibrahim, M. M., Rizk, H., Appel, L. J., El Aroussy, W., Helmy, S., Sharaf, Y., … Whelton, P. K. (1995). Hypertension prevalence, awareness, treatment, and control in Egypt. Hypertension, 26(6), 886-890. https://doi.org/10.1161/01.HYP.26.6.886
Ibrahim, M. M. (2014). The Egyptian hypertension society. The Egyptian Heart Journal, 66(2), 79-132. https://doi.org/10.1016/j.ehj.2014.03.001
Kearney, P. M., Whelton, M., Reynolds, K., Muntner, P., Whelton, P. K., & He, J. (2005). Global burden of hypertension: Analysis of worldwide data. The Lancet, 365(9455), 217-223. https://doi.org/10.1016/s0140-6736(05)17741-1
Lijnen, P., Staessen, J., Fagard, R., & Amery, A. (1982). Increase in plasma aldosterone during prolonged captopril treatment. The American Journal of Cardiology, 49(6), 1561-1563. https://doi.org/10.1016/0002-9149(82)90390-3
Lockyer, S., Rowland, I., Spencer, J. P. E., Yaqoob, P., & Stonehouse, W. (2017). Impact of phenolic-rich olive leaf extract on blood pressure, plasma lipids and inflammatory markers: A randomised controlled trial. European Journal of Nutrition, 56(4), 1421-1432. https://doi.org/10.1007/s00394-016-1188-y
Masoko, P., Picard, J., & Eloff, J. N. (2005). Antifungal activities of six South African Terminalia species (Combretaceae). Journal of Ethnopharmacology, 99(2), 301-308. http://dx.doi.org/10.1016/j.jep.2005.01.061.
McKay, D. L., Chen, C.-Y. O., Saltzman, E., & Blumberg, J. B. (2010). Hibiscus sabdariffa L. tea (tisane) lowers blood pressure in prehypertensive and mildly hypertensive adults. The Journal of Nutrition, 140(2), 298-303. https://doi.org/10.3945/jn.109.115097
Mozaffari-Khosravi, H., Jalali-Khanabadi, B.-A., Afkhami-Ardekani, M., Fatehi, F., & Noori-Shadkam, M. (2009). The effects of sour tea (Hibiscus sabdariffa) on hypertension in patients with type II diabetes. Journal of Human Hypertension, 23(1), 48-54. https://doi.org/10.1038/jhh.2008.100
Perrinjaquet-Moccetti, T., Busjahn, A., Schmidlin, C., Schmidt, A., Bradl, B., & Aydogan, C. (2008). Food supplementation with an olive (Olea europaea L.) leaf extract reduces blood pressure in borderline hypertensive monozygotic twins. Phytotherapy Research, 22(9), 1239-1242. https://doi.org/10.1002/ptr.2455
Pizzorno, J. E., Murray, M. T., & Joiner-Bey, H. (2016). Hypertension. In The Clinician's handbook of natural medicine (3rd Ed., pp. 408-420). Amsterdam, Netherlands: Elsevier. https://doi.org/10.1016/B978-0-7020-5514-0.00045-2
Seck, S. M., Doupa, D., Dia, D. G., Diop, E. A., Ardiet, D.-L., Nogueira, R. C., … Diouf, B. (2018). Clinical efficacy of African traditional medicines in hypertension: A randomized controlled trial with Combretum micranthum and Hibiscus sabdariffa. Journal of Human Hypertension, 32(1), 75-81. https://doi.org/10.1038/s41371-017-0001-6
Serban, C., Sahebkar, A., Ursoniu, S., Andrica, F., & Banach, M. (2015). Effect of sour tea (Hibiscus sabdariffa L.) on arterial hypertension: A systematic review and meta-analysis of randomized controlled trials. Journal of Hypertension, 33(6), 1119-1127. https://doi.org/10.1097/HJH.0000000000000585
Sindi, H. A., Marshall, L. J., & Morgan, M. R. A. (2014). Comparative chemical and biochemical analysis of extracts of Hibiscus sabdariffa. Food Chemistry, 164, 23-29. https://doi.org/10.1016/j.foodchem.2014.04.097
Sowers, J., Epstein, M., & Frohlich, E. (2001). Diabetes, hypertension, and cardiovascular disease: An update. Hypertension, 37(3), 1053-1059. https://doi.org/10.1161/01.HYP.38.3.e11
Susalit, E., Agus, N., Effendi, I., Tjandrawinata, R. R., Nofiarny, D., Perrinjaquet-Moccetti, T., & Verbruggen, M. (2011). Olive (Olea europaea) leaf extract effective in patients with stage-1 hypertension: Comparison with captopril. Phytomedicine, 18(4), 251-258. https://doi.org/10.1016/j.phymed.2010.08.016
Vääräniemi, K., Koskela, J., Tahvanainen, A., Tikkakoski, A., Wilenius, M., Kähönen, M., … Pörsti, I. (2014). Lower glomerular filtration rate is associated with higher systemic vascular resistance in patients without prevalent kidney disease. The Journal of Clinical Hypertension, 16(10), 722-728. https://doi.org/10.1111/jch.12405
Wahabi, H. A., Alansary, L. A., Al-Sabban, A. H., & Glasziuo, P. (2010). The effectiveness of Hibiscus sabdariffa in the treatment of hypertension: A systematic review. Phytomedicine, 17(2), 83-86. https://doi.org/10.1016/j.phymed.2009.09.002
Williams, B., Mancia, G., Spiering, W., Rosei, E., Azizi, M., Burnier, M., … Zanchetti, A. (2018). 2018 ESC/ESH guidelines for the management of artterial hypertension. The task force for the management of arterial hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertenion (ESH). European Heart Journal, 39, 3021-3104. https://doi.org/10.1093/eurheartj/ehy339
World Health Organization. (2002). WHO traditional medicine strategy 2002-2005 (pp. 1-74). Geneva, Switzerland: World Health Organization WHO/EDM/TRM/2002.1. https://doi.org/WHO/EDM/TRM/2002.1.
World Health Organization. (2020). Hypertension. Retrieved from https://www.who.int/health-topics/hypertension/#tab=tab_1