A Comparative Study of the effect of Metformin and Metformin plus Garlic on Blood Glucose Level in patients with Type 2 Diabetes Mellitus in Iraq

 

Qayssar Joudah Fadheel

University of Kufa, Faculty of Pharmacy, Department of Pharmacology and Toxicology, Iraq

*Corresponding Author E-mail: qayssarj.fadheel@uokufa.edu.iq

 

ABSTRACT:

Diabetes mellitus is an endocrine progressive disease, characterized by either lack of the peripheral tissue response to insulin or lack of it. It requires an intensive control and monitoring of blood glucose level or it would develop into serious macro- and micro- complications. Along with pharmacological treatment represented by oral hypoglycemic medications (for type2), and non-pharmacological treatment, represented by exercise and diet; natural herbal extracts such as Garlic oil also showed an additional reduce in blood glucose level in these patients. Objective: To assess the efficacy of Garlic plus Metformin and compare their effect with metformin alone in treatment of people with type 2 diabetes mellitus. Methods: we take two groups of diabetic patients treated by metformin, Garlic is administered to one group, and the other continued on metformin only. Measurements of fasting blood glucose level is taken every ten days and for three months. Results: after three months of treatment, Garlic has made a significant decrease in fasting blood glucose level (P value is less than 0.05), as compared to those who used metformin alone. Conclusion: Garlic has a beneficial effect on blood glucose level, and can be administered to diabetic patients, in the absence of contraindications.

 

KEYWORDS: Metformin, Garlic, Diabetic, Neuropathy, Retinopathy.

 

 


INTRODUCTION:

Diabetes mellitus is a member of metabolic diseases which characterize by hyperglycemia result from problems in secretion of insulin, action of insulin, or both.1. Globally, about 422 million adults are suffer from diabetes mellitus, according to the final 2016 data from the World Health Organization. Diabetes mellitus prevalence is enhance rapidly, type 2 diabetic mellitus account up to 85-90% of all cases. Enhances in the overall diabetic mellitus prevalence rates greatly reflect an enhance in risk factors for type 2 diabetic mellitus, notably greater being obese or overweight2. According to International Diabetes Federation, 415 million individuals have diabetic mellitus in the world and greater than 35.4 million individuals in the (middle east and north Africa) MENA Region; by 2040 this will increase to 72.1 million.

 

In Iraq, there were 1.2 million cases of diabetic mellitus in 2015.3.

 

Type 1 diabetic mellitus (accounts for less than 10%), is attributed to destruction of the beta-cells of the pancreas that produce insulin4. leading to deficiency of insulin secretion absolutely5. Type2 diabetic mellitus (accounts for about 90%), attributed to lack of enough insulin production and/or absence of sensitivity to the effect of insulin (resistant to insulin)4. Type1diabetic mellitus is a chronic disease characterized by the inability of the body to make insulin due to the autoimmune destruction of the pancreaticbeta cells.

 

Onset most often happens in childhood, but the disease can also occur in adults in early 40s their late 30s.Type 2 diabetes mellitus composed of an array of malfunctions characterized by hyperglycemia and attributed the combination of resistance to the action of insulin, insufficient secretion of insulin, and excessive or inadequate glucagon secretion.


 

Figure 1: Prevalence of diabetes in Iraq, 2015.

 


Maturity onset diabetes of the young, genetic defects of beta-cell function. Gestational diabetes mellitus which diagnosed during the second or third trimester of pregnancy so that not clearly overt diabetes).6,7. Micro vascular complications of diabetic mellitus includes diabetic retinopathy. It’s the major cause of blindness in working age adults, diabetic neuropathy about 70% of individuals with diabetic mellitus have some symptoms of peripheral and/or autonomic neuropathy. Serious peripheral neuropathy combined with impairments in immune function is likely to participate to the higher rate of lower extremity amputations in individuals with diabetic mellitus, diabetic nephropathy main cause of end stage renal disease. Macrovascular complications; Diabetes mellitus itself is also one of several risk factors for macrovascular illnesses (peripheral vascular disease, cardiovascular disease and stroke). The high risk of macrovascular complications, including cardiovascular disease (congestive heart disease and stroke) and peripheral vascular disease is 2-4 times higher for individuals with diabetic mellitus.8

 

METHODS:

Patients:

This is a randomized prospective clinical trial study. It was carried out in Najaf at Al-Sadr Teaching Hospital in diabetes and endocrine center. The study was conducted between November 2016 and April 2017.

 

Inclusion and Exclusion Criteria:

Inclusion criteria: included patients with diabetes mellitus type 2 taking metformin

 

 

Exclusion criteria:

1    Patients not present to follow up.

2    Patients intolerant to drug or its side effects.

3    Patients taking drugs like aspirin or insulin.

 

Sampling:

The sample of study include two groups of patients with type 2 diabetes mellitus: the first will take the oral hypoglycemic drug (metformin), in addition to Garlic capsules. And the other group will take the oral hypoglycemic drug only. The duration of treatment is 3 months.

 

Apparatus Used:

Glucose meter.

 

Drugs used in Study:

Metformin 500mg tablet, and Garlic capsules 360 mg capsule.

 

Study Groups:

Group 1: will take the Garlic capsule oil 360 mg once or twice daily, in addition to metformin 500 mg every 8 hour (three times daily).

 

Group 2: will take metformin 500 mg every 8 hour only, with no garlic administration. The fasting blood glucose level test is the only parameter that is measured for the two groups at 10 days interval and for 3 months.

 

Data collection:

The data has been collected by a phone call with each patient every 10 days.

 

Statistical analysis:

Statistical analysis performed using SPSS16.0. An expert statistical advice was consulted for tests used. Data of quantitative variable were expressed as mean+/- SEM. Differences in each variable through treatment intervals in the same group were compared using paired sample students test. In all test, P value less than 0.05 was consider to be statistically significant unless another levels were stated.

 

RESULTS:

 

Figure (2):- A comparison of mean blood glucose level at baseline and after one month treatment with metformin

 

 

Figure (3): A comparison of mean blood glucose level at baseline and after two month treatment with metformin

 

Figure (4): A comparison of mean blood glucose level at baseline and after three month treatment with metformin

 

 

 

Figure(5):- A comparison of mean blood glucose level at baseline and after one month treatment with metformin plus garlic

 

 

 

Figure (6): A comparison of mean blood glucose level at baseline and after two month treatment with metformin plus garlic

*:-Mean significant difference

 

Figure (7): A comparison of mean blood glucose level at baseline and after three month treatment with metformin plus garlic

*:-Mean significant difference

 

 

Figure (8): A comparison of mean blood glucose level after one month between group treated with metformin and group treated with metformin plus garlic

*:-Mean significant difference

 

 

Figure (9): A comparison of mean blood glucose level after two month between group treated with metformin and group treated with metformin plus garlic

*:-Mean significant difference

 

 

Figure (10): A comparison of mean blood glucose level after three month between group treated with metformin and group treated with metformin plus garlic

*:-Mean significant difference

 

DISCUSSION:

Diabetes mellitus:

Individuals with diabetic mellitus have a greater chance of having strokes and heart attacks. Smoking, having elevated blood pressure and rise in cholesterol increase these risks even more. Controlling blood pressure, blood sugar, and levels of cholesterols are very important for preventing strokes and heart attacks. It’s essential to know that natural foods, such as garlic, believed not rich in carbohydrates, can effect on blood sugar levels. Most individuals can safely consume garlic. Some individual, odor, taste, or spiciness can be an issue. It is know that garlic consist of from more than 400 chemical constituents, many of which can assist treatment and prevention a wide range of health problems, but it is compounds including gallyl propyl disulfide, allicin, and Sally cysteine sulfoxide that increase insulin levels in the blood via the prevention of the insulin inactivation by the liver, so that more insulin is access in the body.9

 

The present study was shown that garlic oil cause a significant decrease in blood glucose level after two months of using garlic capsules plus metformin, as compared with baseline measurement (P value is less than 0.05), as shown in figure (6), which agree with the study performed by the global diabetes community, which state that moderate amounts of garlic supplements could add benefits to the patients with diabetic mellitus, and that cooked or raw garlic or aged garlic extract can assist to regulate blood glucose levels and potentially cease or decrease the effects of some diabetes complications, as well as overcome infections, decreasing bad cholesterol and assisting blood flow.9.

 

The current study show that garlic oil cause a significant decrease (presenting by P value of less than 0.05) in blood glucose level after three months of using garlic capsules plus metformin as compared to baseline, and that agree with a study published in the Journal of Medicinal Food 10, which was found that garlic was highly effective in improved glucose tolerance and enhancing  insulin content in the body, as well as to having the potential to keep heart from diabetes-induced cardiomyopathy.

 

The current study was shown that garlic oil has a significant decline in mean blood glucose level after one month of using garlic capsules plus metformin, compared to the use of metformin alone (P value is less than 0.05), as shown in figure (8) and as stated in the study published in the Journal of Nutrition11, it found that raw garlic might assist decrease blood glucose levels, as well as decrease the risk of atherosclerosis. This is very important point, as diabetes enhances a person’s risk of atherosclerosis-related complications.

 

The result of present study show a significant decline in blood glucose level in group treated with metformin plus garlic after two months compared with those treated with metformin only,(P value is less than 0.05) as shown in figure (9), and this findings agree with a study in Davidson’s Principle and Practice of Medicine, which stated that, garlic (Allium sativum) has significant effect on improvement of glycemic status with decreasing fasting and postprandial blood glucose level.12.

 

The current study show that garlic has a significant decrease (P value is less than 0.05) in mean blood glucose level, after three months of using garlic capsules plus metformin, in comparison to metformin alone, as shown in figure (10).This finding is similar with that of investigator Kumar R et al 201313, which notice it could be due to garlic enhanced insulin secretion and improved tissue sensitivity to its suitable amount.

 

CONCLUSION:

Based on the results of our study, we conclude that as this drug has minimal complications and useful effects on blood glucose levels, it can be used as a supplementary drug for treatment of patients with diabetes mellitus.

 

REFERENCES:

1.      Foster, Corey; Mistry. Washington manual of medical therapeutics, 33rd edition2010 by Lippincott Williams and Wikins.

2.      World Health Organization, Global Report on Diabetes. Geneva, 2016. Accessed 30 August 2016.

3.      International Diabetes Federation. IDF Diabetes Atlas. 7th edition 2015.

4.      Nadia Bukhari, David Kearney. Fasttrack therapeutics, first edition 2009 by pharmaceutical press.

5.      Leon S, Alan H. M.  Comprehensive pharmacy review. Fifth edition 2007.

6.      Aathira R, Jain V. Advances in management of type 1 diabetes mellitus. World J Diabetes. 2014 Oct 15.

7.      William J M, Marta L, Andrew P, Day MA Ruth M. Ayling. Clinical biochemistry metabolic and clinical aspects.3rd edition 2014.

8.      Koda –Kimble and Young's. Applied therapeutics: the clinical use of drugs 10th edition 2013 by Lippincott Williams and Wikins.

9.      The global diabetes community, 2017.

10.   US National Library of Medicine National Institutes of Health, Journal of medicinal food, by Islam MS, Choi H., 11th Mars., 2008.

11.   Journal of nutrition, Supplement, Significance of Garlic and Its Constituents in Cancer and Cardiovascular Disease by J. Nutr. March 2006.

12.   Pearson ER, McCrimmon RJ. Diabetes mellitus. In: Colledge NR, Walker BR, Ralston, SH. (eds.). Davidson’s Principle and Practice of Medicine. 22th ed. China. Churchil Livingstone Elsevier. 2014; pp. 809.

13.   Kumar R, Chatwal S, Arora S, Sharma S, Singh J, Singh N, Bhandari V, Khurana A. Antihyperglycemic, antihyperlipidemic, anti-inflammatory and adenosine deaminase–lowering effects of garlic in patients with type 2 diabetes mellitus with obesity. J. of Diabetes,2013.

 

 

 

 

 

 

Received on 11.09.2018         Modified on 18.10.2018

Accepted on 10.01.2019         © RJPT All right reserved

Research J. Pharm. and Tech. 2019; 12(4):1806-1810.

DOI: 10.5958/0974-360X.2019.00301.9