Multi interventional strategies on physiological and biochemical parameters on polycystic ovarian syndrome - a pilot report

Niranjani S, G.Bhuvaneswari, M. Hemamalini, R. Viyayaragha-van. Multi Interventional Strategies on physiological and biochemical parameters on Polycystic Ovarian Syndrome – A Pilot Report. Cardiometry; Issue 23; August 2022; p. 154-160; DOI: 10.18137/cardiometry.2022.23.154160; Available from:

Polycystic ovarian Syndrome (PCOS) is one of the most common reproductive endocrinological disorders among young girls. Polycystic ovarian Syndrome (PCOS) was first reported in modern medical literature by Stein and Leventhal in 1935 and they described symptoms as complex with amenorrhea, hirsutism, and enlarged ovaries with multiple cysts. It is now recognized as a common, heterogeneous, heritable disorder affecting women throughout their lifetime. Women with Polycystic ovarian syndrome (PCOS) also exhibit symptoms like obesity, insulin resistance, high blood pressure, hyperlipidemia and also hyperandrogenic symptoms like acne, alopecia and also anxiety. According to WHO ‘Young People’ covers the age range 10-24 years. The prevalence of Polycystic Ovarian Syndrome among young girls based on the Rotterdam criteria is 11.04%. Early diagnosis of Polycystic ovarian syndrome (PCOS) among young girls is very important as it has been linked to an increased risk for developing several medical conditions including insulin resistance, type 2 diabetes, high cholesterol, high blood pressure and heart disease. The symptoms of Polycystic ovarian Syndrome(PCOS) appear insidiously and are coincident with changes that accompany normal pubertal development, so it is difficult to identify the disorder in young girls. Thus, Polycystic ovarian syndrome (PCOS) often goes unnoticed and undiagnosed during this period. Considering the magnitude and consequences of Polycystic ovarian Syndrome(PCOS), it is important to conduct more studies related to PCOS and its interventions. So far most of the studies conducted in the field of Polycystic ovarian Syndrome (PCOS) are single interventional. As Polycystic ovarian Syndrome(PCOS) is multifaceted condition, we need multiple interventions to tackle the symptoms.

Materials and methods

Study Design - Quantitative experimental and control group pre and post test design.

Study Setting : Study will be conducted in selected colleges at Chennai.( Hindu mission college of Nursing, tagore college of pharmacy and tagore engineering college)

Participants: A total of 152 young girls were screened based on Rotterdam criteria and recruited. 30 members were selected who met with the inclusion criteria. The participants were recruited from different colleges in chennai. The study protocol was duly approved by the institutional ethics committee. Written informed consent was obtained from all the participants. The following inclusion criteria were followed while recruiting the participants, Young girls between 18 to 21 years of age group. Young girls diagnosed with Polycystic ovarian Syndrome (PCOS) based on Rot- terdam diagnostic criteria, young girls available at the time of data collection.The exclusion Criteria are Participants under treatment for PCOS, participants with medical conditions like Cushing syndrome, congenital adrenal hyperplasia and hypothyroidism and Who are not willing to undergo the interventions.

After recruiting the participants, they were grouped into three groups with 10 participants in each group.

The control group (n=10): only education regarding polycystic ovarian syndrome was given.

Experimental group 1 (n=10): Multi interventional strategies - Cinnamon tea, exercise program and anxiety reduction counselling was given.

Experimental group 2 (n=10): Exercise program and anxiety reduction counselling was given.

Interventions

• I.    Oral cinnamon tea:

Method of administration:

• 1.5 grams of cinnamon powder mixed in 100ml of water was given during break time once in a day for 5 days for 3 months. The cinnamon tea was prepared daily by the researcher and provided to the students during the break time.

• II.    Exercise program:

One hour exercise program was given once a day in the evening for 5 days in a week for 3 months. Cardio exercise and strength training exercises was practiced in alternate days

Warm up exercises before the exercise session and cool down exercises after the session is compulsory, the exercise intensity and frequency are introduced gradually.

• III.    Anxiety reduction Counselling:

Participants whose anxiety level was mild and moderate based on Hamilton anxiety scale were given counselling to reduce their anxiety level. Counselling was given by the researcher.

Ethical consideration

The present study was approved by Institutional Ethics Committee, Tagore Medical College and Hospital IEC NO: 32/MAR/2021 Dated: 18.03.202.

Data analysis

The data were expressed as mean + SE. The means were compared (parametric data) by two-way repeated measures analysis of variance (2-way RM ANO-VA), for groups, tests and the group x test interaction comparisons. When significant difference was found, multiple comparison was done by Bonferroni ‘t’ test for between group and within group comparisons.

A probability of 0.05 and less was considered statistically significant. SigmaPlot 14.5 version (Systat Software Inc., USA) was used for the statistical analysis.

Table 1

Comparison of control, experimental 1 and experimental 2 groups of pre-test, post-test 1 and post-test 2 on physiological parameters (BMI and Waist circumference) in young girls with poly cystic ovarian syndrome.

S.No.	Group comparison	Test comparison	BMI	Waist circumference
1	Control	Pre-test	28.62 + 0.49	88.79 + 0.48
	Experimental 1	Pre-test	29.44 + 0.35	89.12 + 0.39
	Experimental 2	Pre-test	29.44 + 0.44	87.82 + 1.14
	Control	Post-test 1	28.86 + 0.51	89.02 + 0.48
	Experimental 1	Post-test 1	28.88 + 0.34	88.33 + 0.37
	Experimental 2	Post-test 1	29.16 + 0.45	87.51 + 1.14
	Control	Post-test 2	28.98 + 0.49	89.11 + 0.47
	Experimental 1	Post-test 2	28.26 + 0.32	87.66 + 0.39
	Experimental 2	Post-test 2	28.65 + 0.44	87.21 + 1.13
2	Significance within Experimental 1 (Pre-test and Post-test 1)		t = 9.003 P <0.001	t = 9.997 P <0.001
	Significance within Experimental 1 (Pre-test and Post-test 2)		t = 18.970 P <0.001	t = 18.476 P <0.001
	Significance within Experimental 1 (Post-test 1 and Post-test 2)		t = 9.003 P <0.001	t = 8.479 P <0.001
	Significance within Experimental 2 (Pre-test and Post-test 1)		t = 4.501 P <0.001	t = 3.923 P <0.001
	Significance within Experimental 2 (Pre-test and Post-test 2)		t = 12.700 P <0.001	t = 7.719 P <0.001
	Significance within Experimental 2 (Post-test 1 and Post-test 2)		t = 8.199 P <0.001	t = 3.796 P <0.001
Values are mean + SE (n = 10 each)

Table 2

Comparison of control, experimental 1 and experimental 2 groups of pre-test, post-test 1 and post-test 2 on biochemical parameters (Total testosterone) in young girls with poly cystic ovarian syndrome.

S.No.	Group comparison	Test comparison	Total Testosterone
1	Control	Pre-test	72.540 + 1.180
	Experimental 1	Pre-test	71.810 + 2.621
	Experimental 2	Pre-test	72.940 + 1.376
	Control	Post-test 1	73.020 + 1.088
	Experimental 1	Post-test 1	70.660 + 2.533
	Experimental 2	Post-test 1	72.680 + 1.376
	Control	Post-test 2	73.220 + 1.055
	Experimental 1	Post-test 2	68.900 + 2.321
	Experimental 2	Post-test 2	72.280 + 1.365
2	Significance within Control (Pre-test and Post-test 1)		t = 1.605 P = 0.343
	Significance within Control (Pre-test and Post-test 2)		t = 2.274 P = 0.081
	Significance within Control (Post-test 1 and Post-test 2)		t = 0.669 P = 1.00
	Significance within Experimental 1 (Pre-test and Post-test 1)		t = 3.846 P <0.001

S.No.	Group comparison	Test comparison	Total Testosterone
	Significance within Experimental 1 (Pre-test and Post-test 2)		t = 9.732 P <0.001
	Significance within Experimental 1 (Post-test 1 and Post-test 2)		t = 5.886 P <0.001
	Significance within Experimental 2 (Pre-test and Post-test 1)		t = 0.870 P = 1.00
	Significance within Experimental 2 (Pre-test and Post-test 2)		t = 2.207 P = 0.095
	Significance within Experimental 2 (Post-test 1 and Post-test 2)		t = 1.338 P = 0.560
Values are mean + SE (n = 10 each)

Results

The Control, Experimental 1 and Experimental 2 groups BMI and Waist circumference are given in Table-1. The mean values of BMI of Control Pre-test, Experimental 1 Pre-test, Experimental 2 Pre-test, Control Post-test 1, Experimental 1 Post-test 1, Experimental 2 Post-test 1, Control Post-test 2, Experimental 1 Post-test 2 and Experimental 2 Post-test 2 are 28.6, 29.4, 29.4, 28.8, 28.8, 29.1, 28.9, 28.2 and 28.6 respectively. Comparison of within the Experimental 1 group of Pre-test and post-test 1, Pre-test and Post-test 2 and Post-test 1 and Post-test 2 showed significance (P < 0.001). Comparison of within the Experimental 2 group of Pre-test and post-test 1, pre-test and posttest 2 and Post-test 1 and Post-test 2 showed significance (P < 0.001). It reveals that experimental group 1 and Experimental group 2 are better than the Control group. The Experimental 1 group is better than Experimental 2 group.

The mean values of waist circumference of Control Pre-test, Experimental 1 Pre-test, Experimental 2 Pretest, Control Post-test 1, Experimental 1 Post-test 1, Experimental 2 Post-test 1, Control Post-test 2, Experimental 1 Post-test 2 and Experimental 2 Post-test 2 are 88.7, 89.1, 87.8, 89, 88.3, 87.5, 89.1, 87.6 and 87.2 respectively. Comparison of within the Experimental 1 group of Pretest and post-test 1, Pre-test and Post-test 2 and Post-test 1 and Post-test 2 showed significance (P < 0.001). Comparison of within the Experimental 2 group of Pre-test and post-test 1, pre-test and post-test 2 and Post-test 1 and Post-test 2 showed significance (P < 0.001). It reveals that experimental group 1 and Experimental group 2 are better than the Control group. The Experimental 1 group is better than Experimental 2 group.

The Control, Experimental 1 and Experimental 2 groups total testosterone are given in Table-2. The mean values of total testosterone of Control Pre-test,

Experimental 1 Pre-test, Experimental 2 Pre-test, Control Post-test 1, Experimental 1 Post-test 1, Experimental 2 Post-test 1, Control Post-test 2, Experimental 1 Post-test 2 and Experimental 2 Post-test 2 are 72.5,71.8,72.9,73,70.6,72.6,73.22,68.9 and 72.2 respectively. Comparison of within the Experimental 1 group of Pre-test and post-test 1, Pre-test and Post-test 2 and Post-test 1 and Post-test 2 showed significance (P < 0.001). Comparison of within the control group of Pre-test and post-test 1, pre-test and post-test 2 and Post-test 1 and Post-test 2 did not show significance (P = 0.34,0.08,1.0) respectively. Comparison of within the experimental 2 group of Pre-test and post-test 1, pre-test and post-test 2 and Post-test 1 and Post-test 2 did not show significance (P = 1.0,0.09,0.5) respectively. The study reveals that the Experimental 1 group is superior to Experimental 2 group and control group.

Discussion

This study finding reveal that consuming cinnamon tea with 1.5 g/day in warm water, 1 hour of exercise program and anxiety reduction counselling for 3 months leads to significant reduction in the BMI and waist circumference at the level of P < 0.001 which was in concordance with a study conducted by Thenmozhi P et al. They had conducted a study with 30 samples. In pretest, 70% of them had overweight and 30% of them had Class I obesity with the body mass index mean value of 28.75 and 2.72 standard deviation. In post-test, 20% of them were normal weight, 66.67% of them were overweight, and 13.33% of them were Class I obesity. The post-test body mass index mean was 27.45 with 3.34 standard deviation. Paired t-test revealed that cinnamon tea was found to be effective in reducing weight at the level of p<0.05.

Hajimon farednejad M et al (2017) observed that Out of 80 women were diagnosed as PCOS by Rot

Issue 23. August 2022 | Cardiometry | 157

terdam Criteria, 66 were enrolled in this randomized double‐blind placebo‐controlled clinical trial. The cases were randomly allocated to 2 groups. The women in the first group were treated by cinnamon powder capsules 1.5 g/day in 3 divided doses for 12 weeks and the second group by similar placebo capsules. Anthropometric measurements, fasting blood sugar, fasting insulin, blood glucose 2 hr after taking 75 g oral glucose, HbA1c, testosterone before and after the intervention were evaluated and compared as outcome measures. Fasting insulin ( p = .024) and homeostatic model assessment for insulin resistance ( p = .014) were reduced after 12 weeks in the cinnamon group compared with the placebo. There was also a significant decrease in low‐density lipoprotein in cinnamon group ( p = .004) as compared with baseline that caused significant difference with placebo ( p = .049). However, changes in other outcome measurements did not lead to statistically significant difference with placebo. The study results suggest that complementary supplementation of cinnamon significantly reduced fasting insulin and insulin resistance in women with PCOS. This study shows that there is a significant reduction in the total testosterone at the level of P < 0.001 among experimental 1 group, whereas the experimental 2 group and control group did not show any significance.

cinnamon can reduce insulin resistance by increasing activation of the IRS/PI-3 kinase insulin signalling pathway. The cinnamon stimulates autophosphorylation of the insulin receptor and inhibit protein tyrosine phosphatase I. Through these two mechanisms cinnamon make adipocytes to increase the glucose uptake and glycogen synthesis. Cinnamon is also the well-known anti-oxidant which reduces the oxidative stress in the body and thus reducing the symptoms of polycystic ovarian syndrome. Exercise also plays a major role in reducing body weight, waist circumference and total testosterone levels. The present study was undertaken to observe the effectiveness of multi interventional strategies (cinnamon tea, exercise and anxiety reduction counselling) in physiological and biochemical parameters of polycystic ovarian syndrome among young girls. There was a significant reduction (P<0.001) in the physiological and biochemical parameters of experimental group 1 with multi interventional strategies (cinnamon tea, exercise and anxiety reduction counselling). There was also slight reduction in the physiological and biochemical parameters of experimental group 2 with interventions 158 | Cardiometry | Issue 23. August 2022

like exercise program and anxiety reduction counselling. Whereas there is no significant reduction in the physiological and biochemical parameters of control group.

Conclusion:

The present study results support the beneficial effects of multi interventional strategies in reducing the physiological and bio chemical parameters of young girls with Polycystic ovarian syndrome. The study also recommends further detailed studies in this area to recommend application of multi interventional strategies to women with PCOS. Consuming cinnamon tea is cost-effective and it is effective in decreasing the BMI and waist circumference and certain bio-chemical parameters which will help to reduce the PCOS symptoms. In conclusion, the findings of this study revealed that the prescribed multi interventional strategies resulted in an improvement reduction of BMI, waist circumference and Total testosterone level. Hence, the study recommends multi interventional strategies for young girls with Polycystic ovarian syndrome. However, we need further studies with larger samples to investigate the effect of cinnamon, exercise program and counselling in reducing the different factors like blood glucose, lipid profile and hyper androgenic symptoms among young girls with Polycystic ovarian syndrome.

Source of Funding

Self-funding

Conflicts of Interest

The authors declared no competing interests.