Effectiveness of Jena DM® Herbal Formulation as Complementary Therapy to Conventional Oral Hypoglycemic Agents in Type-2 Diabetes Mellitus: A Quasi-experimental Study.

ABSTRACT

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.