Giuseppe Derosa1, Angela D'Angelo2, Pamela Maffioli3. 1. Department of Internal Medicine and Therapeutics, University of Pavia, and Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy; Center for the Study of Endocrine-Metabolic Pathophysiology and Clinical Research, University of Pavia, Pavia, Italy. Electronic address: giuseppe.derosa@unipv.it. 2. Department of Internal Medicine and Therapeutics, University of Pavia, and Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy. 3. Department of Internal Medicine and Therapeutics, University of Pavia, and Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy; PhD School in Experimental Medicine, University of Pavia, Pavia, Italy.
Abstract
AIM: To evaluate if the addition of Berberis aristata/Silybum marianum (Berberol(®)) leads to a reduction of insulin dose and to an improvement of glycemic control in patients with type 1 diabetes mellitus. MATERIAL AND METHODS: 85 type 1 diabetic patients were enrolled and randomized to take placebo or B. aristata/S. marianum 588/105 mg, 1 tablet at lunch and 1 tablet at dinner, for six months. We evaluated if there was a reduction of insulin dose necessary to reach an adequate glycemic control. We also evaluated at the study start, and after 6 months: body mass index (BMI), glycated hemoglobin, fasting plasma glucose (FPG), post-prandial glucose (PPG), lipid profile. RESULTS: We observed a reduction of total insulin consumption in B. aristata/S. marianum, both compared to baseline and to placebo. Regarding insulin administration at meals, we recorded that the group treated with B. aristata/S. marianum used less insulin at meals, and at bedtime. Glycated hemoglobin decreased with B. aristata/S. marianum compared to baseline, but not compared to placebo. There was a decrease of FPG, and PPG with B. aristata/S. marianum both compared to baseline and to placebo. Regarding lipid profile, we recorded a decrease of total cholesterol, triglycerides, and LDL-cholesterol and an increase of HDL-cholesterol with B. aristata/S. marianum, both compared to baseline and to placebo. CONCLUSIONS: The addition of B. aristata/S. marianum to insulin therapy in patients with type 1 diabetes mellitus leads to a reduction of the insulin dose necessary to have an adequate glycemic control.
RCT Entities:
AIM: To evaluate if the addition of Berberis aristata/Silybum marianum (Berberol(®)) leads to a reduction of insulin dose and to an improvement of glycemic control in patients with type 1 diabetes mellitus. MATERIAL AND METHODS: 85 type 1 diabeticpatients were enrolled and randomized to take placebo or B. aristata/S. marianum 588/105 mg, 1 tablet at lunch and 1 tablet at dinner, for six months. We evaluated if there was a reduction of insulin dose necessary to reach an adequate glycemic control. We also evaluated at the study start, and after 6 months: body mass index (BMI), glycated hemoglobin, fasting plasma glucose (FPG), post-prandial glucose (PPG), lipid profile. RESULTS: We observed a reduction of total insulin consumption in B. aristata/S. marianum, both compared to baseline and to placebo. Regarding insulin administration at meals, we recorded that the group treated with B. aristata/S. marianum used less insulin at meals, and at bedtime. Glycated hemoglobin decreased with B. aristata/S. marianum compared to baseline, but not compared to placebo. There was a decrease of FPG, and PPG with B. aristata/S. marianum both compared to baseline and to placebo. Regarding lipid profile, we recorded a decrease of total cholesterol, triglycerides, and LDL-cholesterol and an increase of HDL-cholesterol with B. aristata/S. marianum, both compared to baseline and to placebo. CONCLUSIONS: The addition of B. aristata/S. marianum to insulin therapy in patients with type 1 diabetes mellitus leads to a reduction of the insulin dose necessary to have an adequate glycemic control.
Authors: Erni Setiyorini; Mochammad Bagus Qomaruddin; Sony Wibisono; Titik Juwariah; Anggi Setyowati; Ning Arti Wulandari; Yeni Kartika Sari; Levi Tina Sari Journal: J Public Health Res Date: 2022-07-08
Authors: Bahare Salehi; Zeliha Selamoglu; Bilge Sener; Mehtap Kilic; Arun Kumar Jugran; Nunziatina de Tommasi; Chiara Sinisgalli; Luigi Milella; Jovana Rajkovic; Maria Flaviana B Morais-Braga; Camila F Bezerra; Janaína E Rocha; Henrique D M Coutinho; Adedayo Oluwaseun Ademiluyi; Zabta Khan Shinwari; Sohail Ahmad Jan; Ebru Erol; Zulfiqar Ali; Elise Adrian Ostrander; Javad Sharifi-Rad; María de la Luz Cádiz-Gurrea; Yasaman Taheri; Miquel Martorell; Antonio Segura-Carretero; William C Cho Journal: Foods Date: 2019-10-22