The Effect of Hesperidin and Diosmin Individually or in Combination on Metabolic Profile and Neuropathy among Diabetic Patients with Metabolic Syndrome: A Randomized Controlled Trial

Abstract

Current evidence supports the association of metabolic syndrome (MetS) with neuropathy. Limited data are available on proper strategies to control metabolic disorders and neuropathy among patients with type2 diabetes mellitus (T2DM). We aimed to determine hesperidin and diosmin efficacy individually and in combination among T2DM patients with neuropathy and meet MetS criteria. In this parallel-group designed trial, 129 T2DM patients with MetS and neuropathy were recruited and randomized to receive their oral hypoglycemics with either hesperidin (1g/day), or diosmin (1g/day), or combination of both or oral hypoglycemics without intervention for 12 weeks. Diabetic neuropathy was evaluated using Michigan Neuropathy Screening Instrument (MNSI) at baseline and after trial. Anthropometric parameters, blood glucose and lipid profile were also assessed before and after the intervention using paired student t-test within groups. The trial is registered at clinicaltrials.gov as NCT05243238. By completion of the trial duration, both hesperidin and diosmin groups showed significant reduction in blood glucose, triglycerides (TGs) and low density lipoprotein (LDL) from baseline (p<0.05). However, the magnitude of improvement in metabolic components significantly increased with hesperidin and diosmin combination. Although MNSI scores improved significantly in both groups, the reduction was more significant with the combination of hesperidin and diosmin. Moreover, the change in MNSI score was significantly correlated with the improvement in metabolic profile components including LDL, TGs and fasting blood glucose. Oral supplementation of hesperidin and diosmin was associated with improvement in metabolic syndrome and diabetic neuropathy and the combination of both was superior in efficacy.

Keywords:

• hesperidin
• diosmin
• metabolic syndrome
• diabetic neuropathy
• citrus flavonoids
• integrative medicine
• phytotherapy

Disclosure statement

The authors declare no conflicts of interest. The authors alone are responsible for the content and writing of the article.

Data availability statement

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Funding

The author(s) reported there is no funding associated with the work featured in this article.

Additional information

Notes on contributors

Hasnaa Osama

Hasnaa Osama is a lecturer of clinical pharmacy at clinical pharmacy department, Faculty of pharmacy, Beni-suef University. She has published many articles on different clinical pharmacy related disciplines including clinical nutrition, supplementary vitamins role during COVID-19 pandemic, in addition to pharmacokinetic related published articles.

Ehdaa O. Hamed

Ehdaa O. Hamed is a researcher in the Department of Chemistry, Toxicology And Nutritional Deficiency, Toxicology Unit, Animal Health Research Institute (AHRI), Agricultural Research Center (ARC), El-Fayoum Governorate Laboratory, Egypt. She did her MSc. and PhD at Beni-Suef University in natural plants use for therapeutic purposes and participated in many toxicological and epidemiological studies.

Muhammed A. Mahmoud

Muhammed A. Mahmoud is an independent pharmacist working at the national organization for drug control and development in Egypt. He is responsible for developing clinical initiatives for optimization of drug therapy and nutrition support among patients with chronic diseases. He is active in research and senior care pharmacy practice.

Mohamed E. A. Abdelrahim

Mohamed E.A. Abdelrahim is a Professor of clinical pharmacy at clinical pharmacy department, Faculty of pharmacy, Beni-Suef University and the head of a research group devoted to different aspects of pharmaceutical research including drug delivery, formulation and optimization.