Journal of Pharmaceutical Negative Results

ORIGINAL ARTICLE
Year
: 2019  |  Volume : 10  |  Issue : 1  |  Page : 52--56

Effect of Otostegia persica extract on blood glucose in patients with type II diabetes


Ghazal Ataabadi1, Najmeh Shahinfar2, Gashtasb Mardani3, Mostafa Gholami4,  
1 Department of Internal Medicine, Shahrekord University of Medical Sciences, Shahrekord, Iran
2 Medical Plants Recearch Center, Shahrekord University of Medical Sciences, Shahrekord, Iran
3 Department of Environmental Health Engineering, School of Health, Shahrekord University of Medical Sciences, Shahrekord, Iran
4 Deputy of Research and Technology, Shahrekord University of Medical Sciences, Shahrekord, Iran

Correspondence Address:
Ghazal Ataabadi
Assistant Professor of Endocrinology and Metabolism, Department of Internal Medicine, Shahrekord University of Medical Sciences, Shahrekord
Iran

Abstract

Introduction: Type 2 diabetes mellitus is an important metabolic disease that causes disability and involves small and large vessels. Many herbal drugs have been used for the treatment of high blood sugar (BS) with promising results. One of these medicinal drugs used conventionally in medicine by the people and active physicians is Otostegia persica. The aim of this study was to investigate the effect of O. persica extract on blood glucose in diabetic patients with insulin therapy. Materials and Methods: A total of 56 patients with type 2 diabetes were included in the study and were divided into two groups of 28 each. The intervention and nonintervention groups included 22 (78.6%) and 6 (21.4%) female patients as well as 19 (67.9%) and 9 (32.1%) male patients, respectively. Results: Due to homogenization resulting from random selection among aspartate transaminase, alanine transaminase, creatinine, insulin, blood urea nitrogen, Antibiotics (Antib), An mdaB mutant strain in a quinone reductase (MdaB) variables, significant differences were not observed between the two groups of participants before the study. Furthermore, there was no significant difference among the variables of H1c, BS5, HD1, fasting BS (FBS), low-density lipoprotein (LDL), and triglycerides in two groups before the study. However, there were differences among variables H1c, BS5, FBS, high-density lipoprotein (HDL), LDL, and HDL between the two groups of participants after the study, but they were not statistically significant (P > 0.05). Conclusions: The results of the test did not show statistically significant differences among these variables during 3 months. Therefore, in order to conclude more comprehensive and safer application for diabetes treatment, it is suggested to examine the effects of these drugs in a more extensive area using oral and injection doses as well as investigate pure effects of active materials.



How to cite this article:
Ataabadi G, Shahinfar N, Mardani G, Gholami M. Effect of Otostegia persica extract on blood glucose in patients with type II diabetes.J Pharm Negative Results 2019;10:52-56


How to cite this URL:
Ataabadi G, Shahinfar N, Mardani G, Gholami M. Effect of Otostegia persica extract on blood glucose in patients with type II diabetes. J Pharm Negative Results [serial online] 2019 [cited 2019 Dec 15 ];10:52-56
Available from: http://www.pnrjournal.com/text.asp?2019/10/1/52/265151


Full Text



 Introduction



Diabetes is considered among metabolic diseases with multifactor disorders and recognized by chronic hyperglycemia. It is the result of impairment in secretion or action of insulin or both. Diabetes is called a silent epidemic disease and a problem in public health in the USA, the other countries, and even Iran. Type 2 diabetes is the most prevalent metabolic disorder, with an increase of the prevalence rate every day. It is estimated that more than 366 million people worldwide will involve until the year 2030.[1] High blood sugar (BS) will cause complications, including cardiovascular, optical damages, and kidney diseases. An increase in insulin, along with lipid disorders and high blood pressure, provides a ground for arterial hyperplasia.[2] The different degrees of deficiency and insulin resistance exist for type 2 diabetes patients. When treatment is not successful with a food diet, physical activity, and oral hypoglycemic drugs, medicinal therapy is necessary.[3]

Negative, psychological, and social pressures as well as hypoglycemia cause intendancy to insulin injections, that is, a major obstacle to obtain optimal glycemic control.[4] Due to the problems by which the patients do not tend to inject insulin, adverse effects of replacing the treatment of blood glucose with herbal drugs have increased. Of course, several plants were tested to treat high BS in animals, which this plant had satisfactory results.[5],[6],[7] The efficiency of these plants in decreasing BS and increasing people's tendency will facilitate the application of this plant in the community. However, the rational use of medicinal plants requires accurate knowledge of their mechanism. One of these plants conventionally used by people and practitioners is Otostegia persica. This plant grows in the south and southeast of Iran, including Fars, Kerman, and Sistan and Baluchestan provinces.[8] This herb has long been used in traditional medicine in Iran to treat teeth and arthritis. The aqueous extract of O. persica has antihistamine, antispasm, and antiarthritis properties.[9]

It has been reported that the hydroalcoholic extract of O. persica improves morphine withdrawal syndrome.[10] In addition, its antimicrobial activity has been proved on bacteria.[11] It was proved that the methanolic extract of O. persica had an antioxidant property equivalent to green tea, and its compounds, including morin and quercetin, had the antioxidant properties.[12] However, studies have shown a decreasing effect on glucose serum and lipids in diabetic rats.[13] This effect appeared by improving pancreatic islets and insulin secretion.[14] On the other hand, not only its prescription in laboratory animals had not improper liver complications but also improved somewhat liver function.[15] Some studies conducted in this field are presented. The results of the study of Hedayati et al. showed the metabolic extract effect of O. persica on the serum level of glucose and lipids in diabetic rats at a dose of 300 mg for 3 days, and also the administration of different doses of these extracts for 6 and 14 days decreased serum glucose significantly. Moreover, for diabetic rats with different doses of the extract for 3, 6, and 14 days, a significant decrease was observed in the rate of cholesterol and triglycerides (TG) in the serum. In addition, the extract of O. persica compared with glibenclamide had a lower effect than the serum glucose and TG in diabetic rats.[13] Another study by Hedayati et al. entitled “the effect of O. persica on the serum levels of glucose and morphology of the pancreas in diabetic rats” reported that the oral administration of O. persica extract in diabetic rats for 14 days significantly decreased glucose serum level, but it only at dose of 100 mg/kg significantly increased insulin serum level (P < 0.05). Furthermore, extract improved pancreas tissue as in all doses it increased number of islets and at doses of 200 and 300 mg/kg increased the mean diameter of islets (P < 0.05).

In general, the O. persica extract has hypoglycemic effects, and its effectiveness increases by improving the pancreatic islets and insulin secretion.[14] The study results of Hedayati et al. about the methanolic extract effect of O. persica on the serum levels of glucose and enzymes indicators of liver function on the diabetic rats with streptozotocin (STZ) showed that the diabetic rats with the extract of O. persica in all values 6 and 14 days decreased significantly the serum levels of glucose. In addition, 6-day administration of 100 and 300 mg/kg of the O. persica extract, 200, 300, and 300 mg/kg decreased significantly the serum level of aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP), respectively. In addition, 14-day administration of the extract at 200, 300, and 300 mg/kg decreased significantly the serum level of AST, ALT, and ALP, respectively. The methanolic O. persica extract had hypoglycemic effects on diabetic rats and its use not only did not leave adverse liver effects but also improved liver function to some extent.[15] Nateghpour et al.[16] investigated the effect of O. persica on Plasmodium leaf in laboratory rats (surrey) and compared it with chloroquine effect on Plasmodium for the density of 450 mg/kg, whereby chloroquine significantly decreased parasitism in infected mice. The effect of chloroquine on parasites understudy was more decisive and also greater than that of O. persica at different concentrations. However, the effect of alcoholic extract of leaves in the O. persica on Plasmodium was considerable.[17] The results of Mirhosseini and Rafieian study about comparing anethum and gemfibrozil drugs on TG, cholesterol, and blood lipoproteins showed that anethum drug reduced the total cholesterol level to 18% and the level of TG to 7.38% and did not have any effect on the high-density lipoprotein (HDL) level. Gemfibrozil also caused a decrease of 32.7% in the TG level and in the total cholesterol level of 9.4%, while it caused an increase in the HDL level of 3.91%. In this study, gemfibrozil decreased TG levels more than anethum.[18]

Considering the above, this study aimed to investigate the effect of O. persica on the blood glucose in patients with diabetes who consumed at least 10 mg of glibenclamide and 1500 mg of metformin (the dose of these two drugs has the effect of lowering BS), but their BS was not controlled.

 Materials and Methods



This study was a double-blind clinical trial conducted on 56 patients in two groups that were selected randomly at first time and then at a later stage matched together and divided into two groups of 28 patients. O. persica collected from Jiroft area in the south of Kerman province was identified and approved by the experts in the Research Center of Medicinal Plants in Shahrekord University of Medical Sciences. Then, the leaves were crushed by an electric mill. The obtained powder was soaked in methanol for 48 h and was extracted. The solvent of the obtained extract was separated and dried. Finally, 300 mg capsule provided by the rotational evaporator and freeze-dryer at the temperature of −50°C.

The inclusion criteria were being patients with type 2 diabetes who they had higher than 7% level of glycosylated despite the use of 10 mg of glibenclamide and 1500 mg of metformin blood. The exclusion criteria for patients included the following items: having the acute complications of diabetes, diabetic ketoacidosis, and nonketotic hyperglycemia; being exacerbated with the vascular complications of diabetes: kidney, heart, and liver failures; suffering from diabetic foot ulcer; and undergoing treatment with effective drugs on the blood glucose levels, including corticosteroids. Fifty-six patients with type 2 diabetes with the selection criteria referred to the endocrinology ward of Imam Ali Clinic were selected. Patients received adequate information about the research project and the effects of the medication, and also written consent form was received for participation in the project. Plant and placebo drugs in the two-blind forms were administered three times a day for 3 months. Patients were tested at the beginning and end of the study in terms such biochemical tests as fasting blood glucose (FBS), BS 2 h after eating food, blood glucose 5 in the afternoon, the glycated hemoglobin of serum lipids, TG, total cholesterol, low-density lipoprotein, HDL, liver enzymes (serum glutamic oxaloacetic transaminase and serum glutamic pyruvic transaminase), blood urea nitrogen (BUN), creatinine (Cr), and insulin.

After a month of receiving O. persica, patients were visited again by an endocrinologist and gave the BS test (FBS and BS 2 h after eating), and their potential adverse complications were controlled. At the end of the 3rd month, all preliminary tests were repeated. In addition, at the beginning and end of the study, the antioxidant capacities of blood and O. persica were measured. Moreover, the level of cooperation for drug consumption was assessed on a monthly basis.

All patients with diabetes were educated about hypoglycemic symptoms to be treated as outpatients in addition to being referred to the hospital. A glucometer was delivered to the patients for monitoring themselves precisely and checking their BS on a daily basis. In this study, patients' medication doses were not changed. Finally, the laboratory experts evaluated the blood biochemical parameters, and the results were analyzed and recorded in the checklist.

Statistical analysis of data was conducted using the SPSS software and the statistical test of paired t-test. This project approved in the Deputy of Research and Technology in Shahrekord University of Medical Sciences, with the number code of 1270. Moreover, this project was approved by the ethical code number of 94-10-4.

 Results



A total of 56 patients with type 2 diabetes were divided into two groups of 28 patients in each and participated in this study. In the control group, 19 (67.9%) patients were female and 9 (32.1%) were male. The intervention group included 22 (78.6%) female patients and 6 (21.4) male patients. The Chi-square test showed no difference in terms of gender distribution in the two groups (P = 0.2 57).

The mean age of the control group was 60.6 ± 7.03 years, with a median of 63.5 years. Besides, the mean age of the intervention group was 59.07 ± 8.6 years, with a median of 59.5 years. In addition, the independent t-test showed no significant difference between the two groups (P = 0.469).

The results showed that 8 (28.5%) patients in the control group and 11 (29.2%) patients in the intervention group were infected by hypertension. The Chi-square test showed no significant difference in hypertension distribution between the two groups [Table 1].{Table 1}

†The independent t-test was used for quantitative variables. The statistical level was considered statistically significant at P < 0.05.

Due to the homogenization result of randomized selection among variables FBS, BS 5 (BS5), H1c, HDL, intermediate density lipoprotein (IDL), and TG, the two groups of the participants showed no significant difference (P < 0.05) before the study (P > 0.05).

While the mentioned homogenization result among the variables FBS, BS5, H1c, HDL, IDL, and TG in the two groups of participants after the study was different, the results were not statistically significant over 3 months (P > 0.05) [Table 2].{Table 2}

†The independent t-test was used for quantitative variables. The statistical level was considered statistically significant at P < 0.05.

Because of the homogenization result of randomized selection among the variables mdab, antib, BUN, creatinine, insulin, ALT, and AST, the two groups of participants showed no significant difference (P < 0.05). While this result was different among the variables mdab, antib, BUN, creatinine, insulin, ALT, and AST in the two groups of participants after the study, the results did not show statistically significant differences among these variables over 3 months (P > 0.05).

It has been shown that the methanol extract of O. persica has the antioxidant property equal to that of tea green, and morin and quercetin are two main combinations that have the very same properties. Morin has the potential ability to collect radicals of hydroxyl and superoxide and prevents the peroxidation of lipids.

 Discussion



Although the homogenization result was different among the variables FBS, BS5, H1c, HDL, IDL, and TG in the two groups of participants before and after the study over 3 months, this difference was not significant.

Moreover, while the variables mdab, antib, BUN, creatinine, insulin, ALT, and AST in the two groups of participants before and after the study were different, these differences were not considerable over 3 months.

However, the study results of Hedayati et al. showed the metabolic effect of O. persica extract on the serum level of glucose and lipids in Type 1 diabetic rats at the dose of 300 mg for 3 days. Besides, the administration of different doses of these extracts for 6 and 14 days decreased serum glucose significantly. This result is not in agreement with our results. Perhaps, our samples are few or a study should be recruited to recognize the reasons. Moreover, different doses of the extract for 3, 6, and 14 days in diabetic rats decreased significantly the rate of cholesterol and TG in the serum. Compared with glibenclamide, the extract of O. persica had the further effect of lowering serum glucose and TG in diabetic rats. The extract of O. persica had a decreasing effect on the serum level of glucose and lipids in diabetic rats.[13]O. persica Bioss (Goldar) has the decreasing and inducing effects of glucose level and antioxidant effect of insulin secretion. This study also is not in adjustment with the results of this study.[18],[19],[20] Rezaian studied the potential bone protective effects of O. persica ethanolic extract in STZ-induced diabetic rats. The results show that ethanolic extract of O. persica had bone protective effects in STZ-treated rats with 300 and 450 mg/kg of the extract, but the dosage of 200 mg/kg had not any considerable effect.[21] This study is in agreement with the study in the low dosage. Perhaps, if we use the high dosage of O. persica extract, it will be effective to change blood glucose in patients with type 2 diabetes. It is necessary to do further study.

 Conclusions



Although the homogenization result of randomized selection among the variables FBS, BS5, H1c, HDL, IDL, and TG in the two groups of participants was different before and after the study over 3 months, the difference was not significant and considerable.

Moreover, while the variables mdab, antib, BUN, creatinine, insulin, ALT, and AST in the two groups of participants before and after the study showed different results, these differences were not significant over 3 months. It is suggested that the study be conducted with more samples of the patients.

Acknowledgments

Hereby, we thank the Deputy of Research and Technology in Shahrekord University of Medical Sciences to support financially the project. We also would like to appreciate Medical Plants Research Center and all the individuals who collaborated in the process of complementation and performance of this project.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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