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

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