INTRODUCTION:

Polycystic ovary syndrome (PCOS) is considered as the commonest endocrine disorder in women at child-bearing age¹. It affects more than 10% of women and is defined by ovulatory dysfunction, elevated biochemical androgen levels in the blood, and polycystic ovaries². Numerous studies have shown that subjects supplied with CoQ10 therapy improves the metabolic and endocrine profiles of women with polycystic ovary syndrome, as well as those with insulin resistance and endothelial cell performance³. There are several possible mechanisms through which CoQ10 may improve ovarian function⁴. Many of CoQ10's characteristics are antioxidant and anti-apoptotic, such as attempting to improve mitochondrial ATP production and the stability of the cell membrane⁵. To a certain extent, CoQ10 helps the mitochondria operate more efficiently and increases mitochondrial energy production⁶.

Mitochondrial energy generation is required for steroid hormone biosynthesis as well as female reproductive functions such as oocyte maturation, fertilization, and early embryonic production⁷. Since the energy-producing capabilities of the mitochondria are reduced because of a dysfunctional mitochondrial metabolism⁸, a woman's reproductive success is greatly affected by reduced mitochondrial ATP production⁹, resulting in decreased oocyte quality¹⁰, decreased ovarian reserve¹¹, abnormal fertilization¹², and abnormal preimplantation embryo development¹³. The purpose of this study was to assess the effect of CoQ10 on glycemic control parameters and lipid profiles in women subjects with PCOS¹⁴.

MATERIALS AND METHODS:

This randomized double blind clinical-trial. The total number of subject registered in the current study was 100 patients were divided randomly into: Group 1 (patient group) consisting of 50 patients with poly cystic ovary syndrome. Those will receive coenzyme Q10 200mg once daily for three months' duration and Group 2 (control group) which consists of 50 patients with poly cystic ovary syndrome do not receive coenzyme Q10. This study examines all the women patients who have recently been diagnosed with PCOS using the Rotterdam criteria, who do not have hypothyroidism or adrenal problems, and who are not on any medication to treat their condition prior to having their weight and height measured¹⁵. They range in age from 25 to 33. The study took place in the Iraqi city of Mosul.

Fasting venous blood sample (10ml) was taken from each patient. Blood sample was divided in two portions. The first portion (2ml) is collected in EDTA tube and the other (3ml) is collected in a gel tube and then centrifuged at 3000 round per minute (for 5 minutes) to separate serum. For glucose control purposes, serum glucose level and glycated hemoglobin (HbA_1C) is being reported and considered as metabolic markers. FSG levels were determined using the enzyme glucose oxidase method¹⁶.

The blood samples were collected for assessing biochemical parameters studied were measured by using standard (commercial) kits available. The tests were performed on serum samples that had been defrosted. Serum Q10 levels were determined prior to and following intervention using a high-pressure liquid chromatography (HPLC) method (Immunodiagnostik/Bensheim, Germany) and an Immunodiagnostik kit (Immunodiagnostik/Bensheim, Germany). Triglyceride levels were determined in serum samples using the GOP-PAP method and a Pars Azmoon kit. Total TC was determined in the same manner as previously described using the Liasys autoanalyzer kit (Liasys, Roma, Italy). We used the same kit to determine serum high density lipoprotein TC (HDL-C -C) levels in addition to the sedimentary method. Low density lipoprotein TC (LDL-C -C) levels were calculated using the Friedewald Equation.

RESULTS:

A total of one hundred patients with PCOS were joined this study. The first Fifty patients were treated with Coenzyme Q10 (cases) and the second fifty were taking placebo (control). Table.1 and 2.

Table 1. BMI and glycemic control for PCOS patients [cases] before intervention

Parameters	Mean ± SD	Range
BMI (kg/m²)	29.14 ± 6.96	16.23 – 45.37
FSG (mg/dl)	87.0 ± 15.86	57.00 – 120.00
HbA1c %	5.26 ± 0.54	4.50 – 6.80

Table 2. Body mass index and glycemic control parameters of PCOS patients [control] before intervention

Parameters	Mean ± SD	Range
BMI (kg/m²)	30.10 ± 5.40	16.82 – 39.06
FSG (mg/dl)	92.06 ± 15.63	71.00 – 128.00
HbA1c %	5.09 ± 0.42	4.20 – 5.80

The result of Table (2) show the mean BMI, FSG and HbA1C% in PCOS patients [control] at the beginning of the study, [n = 50].

Table 3. BMI and glycemic control for cases after intervention

Parameters	Mean ± SD	Range
BMI (kg/m²)	28.84 ± 6.74	17.04 – 44.44
FSG (mg/dl)	92.28 ± 10.70	63.00 – 132.00
HbA1c %	4.91 ± 0.50	4.10 – 6.30

The result in Table (3) show the mean BMI, FSG and HbA1C% in PCOS patients after three months' coenzyme Q10 supplement therapy, [n = 50].

Table 4. BMI and glycemic control for control group at the end of the course of the study.

Parameters	Mean ± SD	Range
BMI (kg/m²)	30.12 ± 5.46	16.82 – 39.06
FSG (mg/dl)	99.57 ± 11.37	71.00 – 123.00
HbA1c %	5.21 ± 0.44	4.30 – 5.90

The result of Table (4) shows the BMI, FSG and HbA1C% of control group at the end of the study, [n = 50].

Table 5. Comparison in BMI and glycemic control parameters between the two groups before intervention.

Parameters	Cases [n = 50] Mean ± SD	Controls [n = 50] Mean ± SD	P-value*
BMI (kg/m²)	29.14 ± 6.96	30.10 ± 5.40	0.568
FSG (mg/dl)	87.0 ± 15.86	92.06 ± 15.63	0.215
HbA1c %	5.26 ± 0.54	5.09 ± 0.42	0.178

* Unpaired T-test was used.

Table (5) shows non-significant difference in BMI (P-value =0.568), non-significant difference in FSG (P-value =0.215) non-significant difference HbA1c% (P-value =0.178) between cases and control at the beginning of the study.

Table 6. Comparison in lipid profile between the two groups at the beginning of study.

Lipid profile parameters	Cases [n =50] Mean ± SD	Controls [n = 50] Mean ± SD	P-value*
TC (mg\dl)	176.13 ± 37.56	156.2 ± 35.10	0.040
LDL-C (mg\dl)	123.86 ± 35.00	100.10 ± 34.60	0.011
HDL-C (mg\dl)	29.93 ± 1.10	29.83 ± 0.58	0.674
TG (mg\dl)	124.62 ± 46.47	129.80 ± 47.00	0.666
AI	0.590 ± 0.162	0.616 ± 0.142	0.518

* Unpaired T-test was used.

The result of Table (6) shows nonsignificant difference in HDL-C (P-value =0.674), nonsignificant difference in TG (P-value =0.666), and nonsignificant difference in AI (P-value = 0.518) between cases and control while there is a significant difference in total TC (P-value =0.040) and significant difference in LDL-C (P-value =0.011) at the beginning of the study between the two group.

Table 7. Comparison in BMI and glycemic control parameters between the two groups at the end of the course of the study.

Parameters	Cases [n = 50] Mean ± SD	Controls [n = 50] Mean ± SD	P-value*
BMI (kg/m²)	28.84 ± 6.74	30.12 ± 5.46	0.436
FSG (mg/dl)	92.28 ± 10.70	99.57 ± 11.37	0.013
HbA1c %	4.91 ± 0.50	5.21 ± 0.44	0.016

* Unpaired T-test was used.

The result of Table (7) shows non-significant difference in BMI (P-value =0.436), while there is a significant difference in FSG (P-value =0.013), significant difference in HbA1c% (P-value =0.016) between cases and control at the beginning of the study.

Table 8. Comparison in lipid profile between the two groups at the end of the course of the study.

Lipid profile parameters	Cases [n = 50] Mean ± SD	Controls [n = 50] Mean ± SD	P-value*
TC (mg\dl)	150.93 ± 18.32	162.70 ± 12.10	0.007
LDL-C (mg\dl)	99.29 ± 31.03	105.7 ± 36.10	0.449
HDL-C (mg\dl)	29.74 ± 0.76	29.78 ± 0.74	0.844
TG (mg\dl)	103.36 ± 42.04	134.30 ± 53.61	0.012
AI	0.508 ± 0.162	0.624 ± 0.160	0.007

* Unpaired T-test was used.

The result of Table (8) shows non-significant difference in HDL-C (P-value =0.844), non-significant difference in LDL-C (P-value =0.449), while there is a significant differences in AI (P-value = 0.007), there is a significant differences in total TC (P-value =0.007), and significant differences in TG (P-value =0.012) between cases and control at the beginning of the study .

Table 9. The effect of coenzyme Q10 supplement on BMI, FSG and HbA1c % in PCOS patients, [n = 50].

Parameters	Baseline Mean ± SD	After three months coenzyme Q10 200 mg Mean ± SD	% Improvement rate*	P-value**
BMI (kg/m²)	29.14 ± 6.96	28.84 ± 6.74	1.1 %	0.092
FSG (mg/dl)	87.0 ± 15.86	92.28 ± 10.70	- 6.1 %	0.067
HbA1c %	5.26 ± 0.54	4.91 ± 0.50	6.8 %	0.001

* Paired T-test was used. ** % Improvement rate = [(before – after) / Before] × 100.

The result of Table (9) shows non-significant difference in BMI (P-value =0.092), there is non-significant difference in FSG (P-value =0.067), while there is a significant difference in HbA1c% (P-value =0.001) between cases and control at the beginning of the study.

Table 10. The effect of coenzyme Q10 supplement on lipid profile in PCOS patients, [n = 50].

Lipid profile parameters	Baseline Mean ± SD	After three months' Coenzyme Q10 200 mg Mean ± SD	% Improvement rate*	P-value**
TC (mg\dl)	176.13 ± 37.56	150.93 ± 18.32	14.3 %	0.001
LDL-C (mg\dl)	123.86 ± 35.00	99.29 ± 31.03	19.9 %	0.001
HDL-C (mg\dl)	29.93 ± 1.10	29.74 ± 0.76	0.6 %	0.345
TG (mg\dl)	124.62 ± 46.47	103.36 ± 42.04	17.1 %	0.005
AI	0.590 ± 0.162	0.508 ± 0.162	13.8 %	0.003

** % Improvement rate = [(before – after) / Before] × 100.

*Paired T-test was used.

The result of Table (10) shows non-significant difference in HDL-C (P-value =0.345), while there is a significant difference in LDL-C (P-value =0.001), there is a significant difference in total TC (P-value =0.001), and significant differences in TG (P-value =0.005), there is a significant difference in AI (P-value = 0.003) in cases group before and after treatment with co enzyme Q10.

Table 11. The difference in % improvement rate in BMI and glycemic control parameters between the two groups at the end of the course of the study.

Parameters	% Improvement rate		P-value*
Parameters	Cases	Control	P-value*
BMI (kg/m²)	1.1 %	- 0.1 %	0.215
FSG (mg/dl)	- 6.1 %	- 8.2 %	0.154
HbA1c %	6.8 %	- 2.5 %	0.001

* Z-test for two proportions was used.

The result of Table (11): shows non-significant difference in improvement rate regarding BMI (P-value =0.215), there is non-significant difference in improvement rate in FSG (P-value =0.154) and there is a significant difference in improvement rate regarding HbA1c % (P-value =0.001) between cases and control group at the end of the study.

Table 12. The difference in % improvement rate regarding lipid profile between the two groups at the end of the course of the study.

lipid profile parameters	% Improvement rate		P-value*
lipid profile parameters	Cases	Control	P-value*
TC (mg\dl)	14.3 %	- 4.1 %	0.001
LDL-C (mg\dl)	19.9 %	- 5.6 %	0.001
HDL-C (mg\dl)	0.6 %	0.1 %	0.325
TG (mg\dl)	17.1 %	- 3.4 %	0.001
AI	13.8 %	- 1.4 %	0.002

* Z-test for two proportions was used.

The result of Table (12): shows non-significant difference in improvement rate regarding HDL-C (P-value =0.325), while there is significant difference in improvement rate in total TC (P-value =0.001) , there is a significant difference in improvement rate regarding LDL-C (P-value =0.001), there is a significant difference in improvement rate regarding TG (P-value =0.001) and there is a significant difference in improvement rate regarding AI (P-value =0.002) between cases and control group at the end of the study.

DISCUSSION:

The result of this current study showed significant improvement in glycated haemoglobin (HbA1c %) and fasting serum glucose (FSG) in the cases group after two month of treatment with coenzyme Q10 200 mg daily as compared with control group who receiving placebo as represented in Table (9).This finding agrees with study done by Yen et al. 2018 who reported that supplementation with Co enzyme Q10 the result show that glycated Hb (HbA1c) concentration was reduced in the liquid ubiquinol subjects (P value =0·03), when compared with plasma levels of placebo group (P value =0·03)¹⁷. In another study fifty diabetic patients with diabetes were randomly placed on 150mg CoQ10 daily for 12 weeks and only forty subjects completed the trial. After intervention fasting plasma glucose and HbA1C were significantly lowered in the CoQ10 group compared to the placebo group¹⁸.

The result of this current study showed significant improvement in total cholesterol, LDL, AI, and triglycerides in cases group after two month of treatment with CoQ10 /200mg per day as compared with control group who receiving placebo as shown in Table (10).This result agrees with the study conducted by Zhang et al. 2018 whom study was a 12-week randomized double-blind placebo-controlled experiment in which sixty-four type 2 diabetics were randomly assigned to receive either 200 mg Q10 or placebo daily19. The results of this study revealed that serum HbA1C levels fell in the Q10-using group, while mean differences in TC and LDL-C levels were regulated between the two groups (P value=0.027 and 0.039 respectively).Other study which approve our result done by Samimi et al. 2017.In this study which is a randomized double-blind, placebo-controlled trial in which 60 patients suffering from PCOS that are in accordance to the inclusion criteria which is parallel to Rotterdam criteria and were enrolled in the study²⁰.

The result of the current study showed non-significant improvement in HDL in cases group after two month of treatment as compared with control group who receiving placebo as showed in Table (10). This agree with the study conducted by Sharifi et al. 2018 in which a total of 21 randoised-controlled trials (514 patients and 525 controls) were included²¹. The meta-analysis demonstrated that there was a decrease serum level of triglycerides (p-value 0.005). CoQ10 supplementation also decreased total-cholesterol, increased LDL while its effect on HDL-cholesterol levels, not statistically significant. Another study approved our result done by Kolahdouz Mohammadi et al.2013 whose study on diabetic patients having low level of CoQ10²². A study compared the impact of coenzyme Q10 against placebo-treated on glycaemic control and lipid parameters in type 2 diabetic patients. The study is a randomized double-blind placebo-controlled trial, in which patient with type 2 diabetic were randomly placed on either Q10 200 mg or placebo daily for 12 weeks^23,24.

CONCLUSION:

Coenzyme Q10 has important metabolic effect and has improved metabolic parameters in PCOS patients. Therefore, its recommended to be added to the course of the therapy in patient with PCOS

ACKNOWLEDGMENTS:

We thank the regional research ethics committees at the University of Mosul, College of Pharmacy and Health Administration Research Technical Support for their Ethics approval of the study. We are grateful to all of the medical staff of out-patient clinic in Alsalam Teaching Hospital in Mosul city for their support in carrying out the requirement of the research study.

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Received on 08.07.2021 Modified on 25.07.2021

Research J. Pharm.and Tech 2022; 15(3):1157-1161.

DOI: 10.52711/0974-360X.2022.00194