Efficacy of Kinkeliba in non-complicated hypertensive patients: a randomized controlled trial

AUTHORS: 

SECK SM^1,2, DIOP EA³, DOUPA D^1,2, CISSE MM⁴, KA EF⁴, NIANG A⁴, DIOUF B⁴.

^{1. Faculty of Health Sciences, University Gaston berger, Saint-Louis, Senegal,}

^{2 Unit? mixte internationale UMI 3189 “Environnement Sante Societe”}

^{3. D?partement de Phytochimie et Pharmacognosie, university of geneva, swizerland}

^{4. Nephrology Department, Faculty of Medecine, University Cheikh Anta Diop, Dakar, Senegal.}

BACKGROUND

Hypertension represents a worldwide public health issue. Combretum micranthum (kinkeliba) is a popular beverage in West Africa also widely used in traditional medicine. In vitro studies identified many compounds in kinkeliba leaves with anti-hypertensive activity but such effects have not yet been measured in clinical practice. The purpose of this study was to assess the clinical efficacy of kinkeliba in non-complicated hypertensive patients.

PATIENTS AND METHODS

Design: Prospective, randomized controlled trial. Settings: University Hospital of Saint-Louis. Patients: We enrolled 83 patients aged ?18 years and diagnosed with systolic blood pressure between 140 and 179 mm Hg and a diastolic BP between 90 and 109 mm Hg) without any visceral complication and without any prior therapy. Interventions: After signing a free consent form, all enrolled patients were randomly assigned in either intervention group (low sodium diet + kinkeliba leaves 500 mg x 2/day) or control group (low sodium diet + ramipril 5 mg/day) during 04 weeks. At day 0 and day 28, investigators collected clinical and biological parameters (glycemia, serum cholesterol, triglycerides, serum creatinine and electrolytes).

Statistical analysis: Descriptive and statistics were performed using SPSS 18.0. Change in systolic/diastolic blood pressure (SBP/DBP) between baseline and the end of intervention was considered as the main outcome measures.

RESULTS

The two groups were comparable: group A (42 patients, mean age 54.7 ± 15.5 and group B (41 patients, mean age 56.2 ± 14.3 years). After 04 weeks, the mean systolic BP (SBP) in the kink?liba group decreased from 152.4 ± 21.6 mm Hg at baseline to 140.6 ±15.2 mm Hg (reduction of 12.2 ± 6.6 mm Hg, p-value <0.001), whereas it changed from 156.2 ±24.3 mm Hg to 139.5 ±14.8 mm Hg (reduction of 16.7 ± 8.4 mm Hg, p-value <0.001) in the ramipril group. In the same time mean DBP changed in kinkeliba group from 95.5 ±4.3 mm Hg to 90.4 ±4.0 mm Hg after (reduction of 5.0 ±3.0, p-value <0.001), while in group B it dropped from 93.9 ±16.4 mm Hg to 87.3 ±10.3 mmHg (reduction of 6.7 ±3.6, p-value <0.001). The systolic and diastolic BP reductions were more important with ramipril compared to kinkeliba. After 04 weeks of treatment, 36.6% and 39.0% of patients normalized their BP in kink?liba and ramipril group respectively. Three patients in kinkeliba group presented abdominal discomfort and two patients in ramipril arm complained with allergic cough.

CONCLUSION: 

These results support efficacy of kinkeliba leaves in patients with non-complicated hypertension. However, the amplitude of this effect is inferior to the one obtained with ramipril 5 mg/day. This small sized trial can lay the groundwork for future larger comparative studies with other antihypertensive drugs.