Clinical effects produced by a standardized herbal medicinal product of Hibiscus sabdariffa on patients with hypertension. A randomized, double-blind, lisinopril-controlled clinical trial.

摘要: Hibiscus sabdariffa L. (Malvaceae) has been used in different countries as an antihypertensive. Pharmacological work demonstrated that this effect is probably produced by a diuretic activity and inhibition of the angiotensin-converting enzyme (ACE). Two clinical trials have confirmed antihypertensive using watery infusions, which natriuretic was also detected. To compare therapeutic effectiveness, tolerability, safety, well on serum electrolytes ACE inhibitory herbal medicinal product prepared from dried extract H. calyxes (HsHMP) with those lisinopril patients hypertension (HT), randomized, controlled, double-blind trial conducted. Patients either sex, 25 - 61 years age, stage I or II, were daily treated for 4 weeks HsHMP, 250 mg total anthocyanins per dose (experimental group), 10 (control group). Outcome variables included effectiveness (diastolic blood pressure [DBP] reduction, >or= mmHg), safety (absence pathological modifications biochemical tests hepatic renal function), tolerability intense side effects), electrolytes, activity. Basal analysis 193 subjects (100 experimental while outcome variable integrated 171. Results showed treatment decreased (BP) 146.48/97.77 to 129.89/85.96 mmHg, reaching absolute reduction 17.14/11.97 mmHg (11.58/12.21%, p < 0.05). The 65.12 % 100 %. BP reductions lower than obtained (p Under treatment, chlorine level increased 91.71 95.13 mmol/L = 0.0001), sodium tendency decrease (from 139.09 137.35, 0.07), potassium not modified. plasmatic inhibited HsHMP 44.049 30.1 Units (Us; 0.0001). In conclusion, exerted important wide margin it significantly reduced plasma reduce (Na) concentrations without modifying (K) levels. Further studies are necessary evaluating dose-dependency detecting effective doses.