Efficacy and Safety of a Traditional Herbal Combination in Patients with Type II Diabetes Mellitus: A Randomized Controlled Trial

Abstract

Background

Capparis spinosa, Rosa canina, Securidaca securigera, Silybum marianum, Urtica dioica, Trigonella foenum-graecum and Vaccinium arctostaphylos are used traditionally as an herbal combination for treatment of diabetic patients in Iran. Despite the clinical evidence supporting their use in solitary form, no controlled human study has determined the efficacy and safety of their combination in treatment of diabetic patients.

Methods

A total 150 type II diabetic patients of both sexes under the oral anti-hyperglycemic drugs treatment (maximum 10 mg glyburide and 1000 mg metformin daily) were randomly assigned to three groups. The patients in each group received either herbal combination or placebo or metformin capsule daily for three months, without any change in their previous oral anti-hyperglycemic drugs dosage. Herbal combination, placebo and metformin capsules matched by shape and color were prepared in the Institute of Medicinal Plants Karaj, Iran. To assess the efficacy and safety of the treatments, the patients fasting plasma glucose, HbA1c, lipid profile, liver enzymes and renal function were determined at the beginning of the study and after three months.

Results

Results showed that after three months, the fasting plasma glucose, HbA1c and cholesterol levels in herbal combination were decreased significantly as compared to placebo group (20% and 12% respectively) and also compared to base line (25% and 15% respectively). The herbal combination was as effective as metformin in reduction of FPG (p = 0.001, p = 0.001) and HbA1c (p = 0.028 and p = 0.050 respectively) compared to placebo. No notable hepatic, renal and gastrointestinal side effects were observed in the trial groups.

Conclusion

The results suggest that traditional herbal combination may safely improve glycemic control in type II diabetic patients with no significant adverse effect.

Keywords:

• Anti-hyperglycemic
• complementary medicine
• diabetes
• polyherbal combination
• traditional Persian medicine

Declaration of interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Additional information

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article. This study was supported by a grant from private sector Reza Mirzaei.

Notes on contributors

Saeed Mehrzadi

Saeed Mehrzadi, PhD, is a pharmacologist and is a faculty member of Iran University of Medical Sciences. He is interested in clinical trials.

Reza Mirzaei

Reza Mirzaei, MSc in herbal medicine, is an herbal therapist and is skilled at treating patients with traditional herbal medicine.

Mojtaba Heydari

Mojtaba Heydari, MD, PhD in Traditional medicine, is interested in clinical trials on medicinal plants.

Maryam Sasani

Maryam Sasani, MD, is endocrinologist and physician in diabetic clinic in Karaj city, she is interested in clinical trials on medicinal plants.

Bahman Yaqoobvand

Bahman Yaqoobvand, MSc, is expert in laboratory of pharmacology department, he helped in every clinical trial conducting in pharmacology department in institute of medicinal plant.

Hasan Fallah Huseini

Hasan Fallah Huseini, PhD in pharmacology and head of pharmacology department in institute of medicinal plant. He has focused all his activities on clinical trial on diabetic patients with medicinal plants.