Abstract
Purpose: Onopordon acanthium L. is known for its medicinal properties. Our recent study showed that its seed extract is a novel natura angiotensin-converting-enzyme inhibitor (ACEI). This study was carried out to investigate its possible antihypertensive effects in patients receiving losartan.Methods: This uncontrolled clinical trial was carried out among 20 patients (30-60y) with uncontrolled hypertension despite receiving 50 mg losartan (stage I & II) in two hospitals in Iran. After completing informed consent, patients were treated by 2 capsules [each 1g of Onopordon acanthium seed extract (OSE)] as add-on therapy, two times per day.Results: 18 patients completed the study (50.94 ±8.37y). Mean systolic blood pressure (SBP) at the baseline was 151.9 ± 13.74mmHg and at the end of the study, it was 134.6 ± 18.25 mmHg and mean diastolic blood pressure (DBP) was 97.41 ± 10.36 at the baseline and was 85.71 ± 7.481 after 8 weeks. OSE significantly reduced SBP and DBP at the end of 8 weeks (P=0.003, 95% CI: -19.7, -15.1; P=0.0006, 95% CI: -10.23, -13.15; respectively). No evidence of hepatic or renal toxicity was detected.Conclusion: Based on the results of this study OSE has antihypertensive property with no significant adverse effects. However, because of the low number of samples, this medication may be not safely administered. The results of this study could be the basis for further studies with larger sample size. IRCT registration number: IRCT2013020712391N.
Highlights
Hypertension (HTN) is a global concern and affects approximately 75 million adults in the United States and if left untreated increases risk of stroke, myocardial infarction, vascular disease, and chronic kidney disease.[1,2] Diagnosis and treatment of high blood pressure are essential to prevent mortality and morbidity.[2,3] Hypertension may be treated by using routine drugs such as angiotensin-converting-enzyme (ACE) inhibitors, betablockers, diuretics, calcium channel blockers, alphablockers, and peripheral vasodilators,[3,4] improving lifestyle factors including weight loss, quitting smoking, reducing sodium intake, regular exercise and limiting alcohol consumption.[5]
Losartan is an oral medication that belongs to a class of drugs called angiotensin receptor blocker (ARBs) which was approved by the U.S Food and Drug Administration (FDA) in April 1995
The relationship between effective dose and effect was analyzed using Pearson's relationship and according to the results of these experiments, the lethal dose (LD50 value of 8.44 ± 0.04 g/kg) was determined. The extract of this plant was classified in "practically nonpoisonous ". Clinical trial design This open-labeled, non-randomized, uncontrolled clinical trial, a pilot study, was performed on 20 patients, who were under losartan treatment (50mg/d) for at least 6 weeks before starting the study and their blood pressure constantly remained higher than 140/90 hypertension according to the seventh report of the joint national committee (JNC VII) report.[16]
Summary
Hypertension (HTN) is a global concern and affects approximately 75 million adults in the United States and if left untreated increases risk of stroke, myocardial infarction, vascular disease, and chronic kidney disease.[1,2] Diagnosis and treatment of high blood pressure are essential to prevent mortality and morbidity.[2,3] Hypertension may be treated by using routine drugs such as angiotensin-converting-enzyme (ACE) inhibitors, betablockers, diuretics, calcium channel blockers, alphablockers, and peripheral vasodilators,[3,4] improving lifestyle factors including weight loss, quitting smoking, reducing sodium intake, regular exercise and limiting alcohol consumption.[5]. Losartan is an oral medication that belongs to a class of drugs called angiotensin receptor blocker (ARBs) which was approved by the U.S Food and Drug Administration (FDA) in April 1995. Losartan blocks the angiotensin receptor, relaxes muscle cells and dilates blood vessels and reduces blood pressure.[6,7]. It is a flowering plant belonging to the Compositae (Asteraceae) family and is widely naturalized almost globally, in Europe and Western Asia and is a vigorous biennial plant with coarse, spiny leaves and conspicuous spiny-winged stems.[11] In modern medicine, O. acanthium has been reported to be a bactericide, cardiotonic, hypotensive and hemostatic agent and is used against hypotonicity.[12,13,14] This species has several bioactive components among which sesquiterpene lactones have been found to have numerous biological properties including antibacterial,
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