Randomized and double-blinded pilot clinical study of the safety and anti-diabetic efficacy of the Rauvolfia-Citrus tea, as used in Nigerian traditional medicine |
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Authors: | Campbell-Tofte Joan I A Mølgaard Per Josefsen Knud Abdallah Zostam Hansen Steen Honoré Cornett Claus Mu Huiling Richter Erik A Petersen Henning Willads Nørregaard Jens Christian Winther Kaj |
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Affiliation: | a Dept. of Medicinal Chemistry, Faculty of Pharmaceutical Sciences, University of Copenhagen, Universtitetsparken 2, 2100 Copenhagen, Denmark b Bartholin Institute, Rigshospitalet, Section 3733 Ole Maaløes Vej 5, 2200 Copenhagen, Denmark c Dept. of Pharmaceutics & Analytical Chemistry, Faculty of Pharmaceutical Sciences, University of Copenhagen, Universitetsparken 2, 2100 Copenhagen, Denmark d Dept. of Exercise & Sport Sciences, Faculty of Natural Sciences, University of Copenhagen, Nørre Allé 51, 2200 Copenhagen, Denmark e Pharmacy Service, Dept. of Veterinary Disease Biology, University of Copenhagen, 1870 Frederiksberg, Denmark f Eye Clinic, Frederiksberg University Hospital, Nordre Fasanvej 57, 2000 Frederiksberg, Denmark g Dept. of Clinical Biochemistry, Frederiksberg University Hospital, Nordre Fasanvej 57, 2000 Frederiksberg, Denmark |
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Abstract: | Aim of the studyThe aim of this randomized and double blinded pilot clinical trial was to investigate the anti-diabetic efficacy of the Rauvolfia-Citrus (RC) tea in humans. We have earlier shown that a combination of calorie-restriction and chronic administration of the RC tea to the genetic diabetic (BKS-db) mice resulted in the normalization of blood sugar, reduction in lipid accumulated in the mice eyes and prevention of the degeneration of the otherwise brittle BKS-db pancreas. The tea is made by boiling foliage of Rauvolfia vomitoria and fruits of Citrus aurantium and is used to treat diabetes in Nigerian folk medicine.Materials and methodsThe RC tea was produced using the Nigerian traditional recipe and tested in the traditional dosage on 23 Danish type 2 diabetes (T2D) patients. The participants were divided into two equivalent groups after stratification by sex, age and BMI, in a 4-month double-blinded, placebo-controlled and randomized clinical trial. Most of the study subjects (19/23) were using oral anti-diabetic agents (OADs). Mean disease duration was 6 ± 4.6 years, mean age was 64 ± 7 years and mean BMI was 28.7 ± 3.8 kg/m2. Prior to starting the treatment, the participants received individual dietician consultations.ResultsAt the end of the 4-month treatment period, the treated group showed an 11% decrease in 2-h postprandial plasma glucose relative to the 3% increase in the placebo group (p = 0.004). The improvement in blood glucose clearance with RC tea treatment was reflected in a 6% reduction in HbA1c (p = 0.02) and in a 10% reduction in fasting plasma glucose (p = 0.02), when comparing the post 4-month treatment to pre-treatment baseline values. Though the basal levels of phosphorylated acetyl CoA carboxylase enzyme in skeletal muscle were significantly reduced in the treated group (p = 0.04), as compared to the placebo, only the pattern of reductions in the tissue fatty acids (FAs) differed in the two groups. While all types of FAs were reduced in placebo, only saturated (SFA) and monounsaturated (MUFA) FAs were reduced with treatment. Interestingly, a modest increase in the polyunsaturated FAs fraction was observed in the RC treated group. In addition, the reduction in SFA and MUFA with RC tea treatment came solely from the triglyceride fractions, as there was an increase in the skeletal muscle phospholipids.ConclusionsChronic administration of the RC tea to overweight T2D on OADs caused significant improvements in markers of glycaemic control and modifications to the fatty acid profile of skeletal muscle, without adverse effects or hypoglycaemia. Further exploration of the anti-diabetic effects of the RC tea is warranted. |
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Keywords: | FPG, fasting plasma glucose FA, fatty acid IMPDs, investigational medicinal products NKML, Nordisk Metodikkomite for Levnedsmidler OADs, oral anti-diabetic agents ACC-p, phosphorylated acetyl CoA carboxylase AMPK, 5&prime AMP-activated protein kinase PPG, postprandial plasma glucose RC, Rauvolfia-Citrus T2D, type 2 diabetes |
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