RESUMO
BACKGROUND: There is vast preclinical evidence that indicates that extracts from several Artemisia plant species have significant antidiabetic benefits. However, clinical evidence is limited to this effect. OBJECTIVE: We sought to evaluate the effectiveness of Jena DM® (an Artemisia annua-based poly-herbal formulation) on glycemic control (Hb A1C) and insulin metabolism (HOMA), when administered as a complementary therapy in type-2 diabetes mellitus (T2DM). This study was supported by a research grant (JRD005) from Jena Herbals (U) Ltd, which is a local herbal medicines manufacturing facility in Uganda. METHODS: We conducted a 12-week quasi-experimental study, involving 118 patients under routine follow-up at a diabetes and endocrinology clinic. Random assignment to either conventional or experimental study groups was done using a random number generator (Microsoft Excel version 16.0). Participant sociodemographic and clinical data as well as whole blood samples (3-5 mL) were obtained at scheduled clinic visits. Medication adherence was assessed using the Hill-Bone Scale, and adverse drug events (ADEs) using the Naranjo causality and the National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) scales. Group differences in glycemic control (HbA1C), fasting serum insulin (FSI) indices (% HOMA2-B, HOMA-IR), and other cardiometabolic parameters were assessed using independent samples t-test, and Pearson chi-square statistical tests were used. A p-value <0.05 was considered statistically significant. Ethical approvals were obtained before the study commencement. RESULTS: 12-week daily complementary therapy with Jena DM® showed no significant effect on Hb A1C reduction (0.1 (95% CI: -0.56, 0.80) %; p=0.798); however, we observed a significant reduction in total body weight (2.0 (95% CI: 0.73, 3.28) kg; p=0.002). The overall frequency of self-reported ADEs including dizziness was significantly higher among patients that used Jena DM® (p=0.001). Epigastric pain was the most severe ADE necessitating clinical management. There was no significant difference in the homeostatic model assessment for insulin resistance (HOMA2-IR) between study groups. CONCLUSION: In contrast to a few studies that previously showed significant hypoglycemic effects of Artemisia-based extracts, this study did not show a statistically significant reduction on HbA1C during a 12-week complementary use of Jena DM® in patients with T2DM. Based on the findings of this study, future research should evaluate the long-term effects of Jena DM® on body weight, overall insulin metabolism, and the subsequent effect on glycemic control in T2DM.
RESUMO
Introduction: The prevalence of obesity among people diagnosed with Type 2 Diabetes Mellitus (T2DM) has been widely documented. However, the specific composition of this bodyweight remains largely unknown. The study aimed to understand the body composition of T2DM patients using the bioelectric impedance analysis technique, comparing findings to sex and agematched controls. Materials and Methods: A comparative case-control study was carried out among 139 known cases of Type 2 diabetes aged 18 to 78 years randomly sampled from the diabetic clinic of Mbarara Regional Referral Hospital. We matched them to 139 hospital controls who were healthy non-diabetic attendants. Body composition parameters were computed and summarized as medians and interquartile ranges. Differences in the medians of body composition parameters were further assessed using the Mann- Whitney U test. Fat-free and fat mass indices were derived to offer a precise estimation of body composition parameters adjusted for height differences among study participants. Results: Cases had significantly higher median systolic blood pressure, pulse rate, weight, Body Mass Index (BMI), Waist-Hip Ratio (WHR), total fat percentage, fat mass amount, Fat Mass Index, visceral fat, and metabolic age than their counterparts, whereas controls had significantly higher median total body water percentage versus cases. The highest significant differences occurred in fat percentage composition (Cases: ß: 6.9 (95% C.I: 4.4, 9.4); Controls: Ref) followed by visceral fat (Cases: ß: 3.5 (95% C.I: 2.5, 4.4); controls: Ref) and Fat Mass Index (Cases: 95% C.I: 2.6 (95% C.I: 1.6, 3.7). Cases had significantly higher Fat Mass Index, visceral fat and fat percentage (all p<0.05) than controls. Conclusions: Routine assessment of body composition of T2DM patients needs to be done to assess the amount, type and pattern of weight gain to prevent increases in adiposity.
