Polycystic ovary syndrome (PCOS) is a hormonal disorder common among women of reproductive age. Polycystic ovarian syndrome has been looked at primarily as an endocrine disorder. Studies have shown that PCOS is a metabolic, hormonal and psychological disorder that impact a patient’s quality of life. It is extremely important to holistically treat the patients early or to help them to deal with the emotional stress that is often over looked with PCOS.¹

PCOS affects a woman’s ovaries, the reproductive organs that produce estrogen (25-75 pg/ml) and progesterone (>14 ng/ml) hormones that regulate the menstrual cycle. The ovaries also produce 0.7-3.1 ng/ml of male hormones called Androgens. This hormone imbalance causes amenorrhea,and primary and secondary infertility. PCOS also cause hair growth on the face and body and baldness. And it can contribute to long term health problems like diabetes and heart diseases.²

Ovarian cysts are fluid-filled sacs in women during their reproductive years. These cysts form on the ovaries, the almond-sized organs on each side of the uterus. It causes the ovaries to enlarge and create a thick outer covering, which may prevent ovulation from occurring. It often leads to fertility problems. Anti-Mullerian Hormone (AMH) (1.0-4.0 ng/ml) increases in women with PCOS and affects follicogenesis. AMH levels should decrease when follicles enlarge, but when levels remain high, follicles do not mature and ovulation is affected. Increased androgen levels cause a decrease in progesterone and estrogen, leading to a hypersecretion of gonadotropic-releasing hormone (GnRH) and luteinizing hormone (LH) (5-20mIU/ml) levels, which continues to stimulate immature follicles which do not mature and form cysts in the ovary.³

The signs and symptoms of PCOS often develop around the time of the first menstrual period during puberty. Sometimes PCOS develops in response to substantial weight gain. Long-standing menstrual abnormalities including irregular periods, scanty menstruation, severe menstrual cramping, or prolonged or heavy bleeding. Signs of high testosterone (>14 ng/ml) including excessive hair growth (ie. on the face, abdomen, chest, arms, etc.), acne, and male pattern baldness. Fertility issues, Insulin resistance (IR) which can present as darkening of the skin at the nape of the neck and under the arms, high BMI, high cholesterol, high blood sugar and/or high blood pressure.⁴

 Naturopathic care for PCOS takes a whole view of the woman and treats individual needs including regulating the menstrual cycle, reducing male hormones, infertility, depression, anxiety and body weight issues.  Modalities include herbal medicine, nutritional supplements, diets, exercise and lifestyle advice emphasizing workable, realistic and sustainable solutions. Medicinal Herbs such as Spearmint Tea, Flaxseeds, Aloe Vera and Cinnamon. Acupuncture,Life Style Modification such as exercise and dietary intake also helps for treat the PCOS. Other alternative medicines used to treat the PCOS include:Bitter melon, Indian madder, Sesame, Rose, Black seed, Garlic, Cumin and Betel nut. Among these Cinnamon have less side effects for treating the symptoms of PCOS.⁵

The classification of Cinnamon is; Kingdom: Plantae, Phylum: Magnoliophyta, Class: Magnoliopsida, Order: Laurales, Family: Lauraceae, Genus: Cinnamomum and Species: Cinnamomumzeylanicum. In India it is also known as “Daalchini”. Cinnamon have the chemical components such as Cinnamaldehyde, Cinnamyl Alcohol and Cinnamic Acid. Cinnamon will act as vasodilator increasing the blood flow in the uterine area which efficiently helps in regulating irregular menstruation and inducing menstruation in women. Cinnamaldehyde is used to reduce weight gain by burning energy and fat cells, Cinnamyl Alcohol is used to change the way of woman’s body metabolizes estrogen. This can cause blood estrogen levels to rise and cinnamic acid is responsible for increasing the plasma insulin level. Cinnamon is used as alternative treatment for PCOS. The study conducted by International Federation of Fertility Societies (IFFS, 2013) revealed that, cinnamon is an effective and inexpensive treatment for PCOS.⁶

NEED FOR THE STUDY

According to National Institute of Child Health and Human Disease of the U.S (2015) the prevalence of PCOS was 65%, based on Rotterdam was 19.5% and based on ultrasound was 4.41%. Also, the prevalence of hirsutism was estimated to be 13%, acne 26%, androgenic alopecia 9%, menstrual disorders 28%, overweight 21%, obesity 19% and infertility 8%.⁷

Prevalence of PCOS in Indian adolescence is a common female endocrine disorder ranging from 2.2%-2.6%. The estimated prevalence of PCOS in cohort using the NIH criteria was 8.7%. Under the Rotter Dam criteria, the prevalence was 11.9% which was increased to 17.8%. In South India, the study done with 460 girls, aged 15-18 years from a residential college in A.P, who underwent clinical examination. PCOS was found in 6-10%. It is a familial polygenic condition thought to be attributed to both genetic and environmental factors.⁷

A pilot study was done on effect of cinnamon extract on insulin resistance parameters in polycystic ovary syndrome. 15 women with PCOS (mean body mass index [BMI], 28.8-1.3 kg/m2; mean age, 31.1-2.0 years) were recruited for the study from the Center for Women’s Reproductive Care at the Columbia University, New York. All subjects had amenorrhea and polycystic ovaries (PCO) by ultrasonography. Among them, 4 had biochemical evidence of hyperandrogenism as defined by elevated serum Thyroid levels (80 mg/dL). Results shown that the 15 subjects indicated greater insulin resistance compared to those of the normo-ovulatory non-obese controls (2.33 -0.48 Vs. 1.08 - 0.14, P<.05 and 0.36 -0.01 Vs. 0.39-0.01, P<.05, respectively). The placebo and the cinnamon group differ with respect to age, BMI, FSH, Thyroid, fasting glucose and insulin, or insulin sensitivity index at baseline.⁸

A cross-sectional study was conducted for a period of one month at Balaji Hospital, Vellore, Tamil Nadu, India. The aim of the study was to determine urban and rural differences in the burden of polycystic ovarian syndrome among Indian adolescent females aged 12 to 19 years. The final sample included 126 study participants located in various urban (50%, n=63) and rural (50%, n=63) settings. Information was gathered on sociodemographic and anthropometric characteristics, clinical history, occurrence of acne and hirsutism, serum testosterone levels, obstetric history, family history of chronic diseases, menstrual history, physical activity, and dietary intake.  18% of the participants were confirmed of having PCOS. Majority of the individuals with PCOS had an average age of 16 (SD=2) (P=.02) years with an average age of menarche 12 years (SD=1). The study concluded that, the proportion of participants diagnosed with PCOS was higher among urban participants in comparison to rural participants.⁹

STATEMENT OF THE PROBLEM

 A study to assess the effect of Cinnamon on selected symptoms of Polycystic Ovarian Syndrome (PCOS) among women attending NMCH, Nellore, Andhra Pradesh.

OBJECTIVES

• To assess the symptoms of polycystic ovarian syndrome among women.
• To assess the effectiveness of cinnamon administration on PCOS.
• To associate between effectiveness of cinnamon administration on PCOS with selected demographic variables of women.

HYPOTHESIS:

NULL HYPOTHESIS:

H₀1: There is no statistically significant reduction in selected symptoms of PCOS among women in interventional group

H₀2: There is no statistically significant association between symptoms of PCOS with selected socio demographic variables.

RESEARCH HYPOTHESIS:

H₁: There is a statistically significant reduction in selected symptoms of PCOS among women in interventional group.

H₂: There is a statistically significant association between symptoms of PCOS with selected socio demographic variables.

DELIMITATIONS

The study is limited to:

• Women of reproductive age group and diagnosed with PCOS.
• Women admitted in Gynae ward at NMCH, Nellore.
• Sample size is 60 only.

METHODOLOGY:

RESEARCH APPROACH

          A quantitative research approach was adopted for the present study.

REASEARCH DESIGN

The design adopted for the study is quasi-experimental design.

O₁: Pre-test

X₁: Intervention (Cinnamon powder with hot water)

X₂: Placebo

O₂: Post-test

SETTING OF THE STUDY

 The study was conducted in Gynaecology department in Narayana Medical College Hospital, located at Chinthareddypalem, Nellore.

POPULATION

TARGET POPULATION

All women with polycystic ovarian syndrome.

ACCESSIBLE POPULATION

All women with PCOS visiting Gynaecology OPD & IPD, NMCH, Nellore.

SAMPLE

Sample of the present study was women with PCOS and visiting Gynaecology OPD & IPD,NMCH and who fulfilled the inclusion criteria.

SAMPLING TECHNIQUE

Non-Probability purposive sampling technique was used for selecting the samples.

SAMPLE SIZE

A sample of 60 women with PCOS visiting Gynaecology OPD & IPD, NMCH, Nellore. 30 women were assigned in control group and 30 women were in interventional group respectively.

CRITERIA FOR SAMPLE SELECTION

INCLUSION CRITERIA

• Women in reproductive age (15-45 years)
• Women who are diagnosed with PCOS
• Women who are willing to participate in the study

EXCLUSION CRITERIA

• Women with pregnancy and lactating mothers
• Women with Diabetes Mellitus

VARIABLES

INDEPENDENT VARIABLE

Administration of Cinnamon powder with hot water, placebo.

DEPENDENT VARIABLE

Symptoms of PCOS.

DEMOGRAPHIC VARIABLES

Age, education, dietary habit, occupation, family income, age at menarche, marital status, number of the children and duration of PCOD.

EXTRANEOUS VARIABLES: Drugs

DESCRIPTION OF THE TOOL

PART-A: It consists of demographic data.

PART-B: It consists of checklist to assess the symptoms of PCOS. The check list consists of 9 statements; each question has Yes and No option. Yes =1mark & No=0 mark.

SCORE INTERPRETATION

INTERVENTION PROTOCOL

Cinnamon administration:

Introduction:

The classification of Cinnamon is; Kingdom: Plantae, Phylum: Magnoliophyta, Class: Magnoliopsida, Order: Laurales, Family: Lauraceae, Genus: Cinnamomum and Species: Cinnamomumzeylanicum. In India it is also known as “Daalchini”. Cinnamon have the chemical components such as Cinnamaldehyde, Cinnamyl Alcohol and Cinnamic Acid.

Cinnamon administration preparation:

• One table spoon of cinnamon powder is mixed in one glass (100ml) of hot water.
• Taking it 2 times a day once before breakfast and once before dinner.

Mechanism of action:

Cinnamon will act as vasodilator increasing the blood flow in the uterine area which efficiently helps in regulating irregular menstruation and inducing menstruation in women. The powder is administered to control the symptoms of PCOD by regulating hormone levels.Cinnamon administration reduces weight gain by burning energy and to change the way of woman’s body metabolizes estrogen, have insulin sensitizing effect and improve menstrual cyclicity.

RELIABILITY

The reliability of the tool was established by split half method by using the formula =2r/1+r and “r” value was obtained. The “r” value is 0.8.

PILOT STUDY

The pilot study was conducted among 6 women with PCOS.

DATA COLLECTION PROCEDURE

The data collection procedure was conducted for a period of 4 weeks. The permission was obtained from Medical Superintendent and Nursing Superintendent and the main study was conducted in Narayana Medical College Hospital for a period of 4 weeks from 8/02/2019 to 8/03/2019. A total of 60 women with PCOS are selected by using non-probability purposive sampling technique who are admitted in NMCH Nellore. The women were informed by the investigator about the cinnamon administration and consent was obtained from the women who meet the inclusion criteria and confidentiality of the shared information was assured.

The selected participants were grouped under interventional group and control group. Checklist was used to assess the symptoms of PCOS. Oral administration of cinnamon administration consists of 10 gm of cinnamon powder with one glass of hot water given twice daily; once before breakfast and once before dinner to the interventional group, and roasted wheat flour, in the same proportion was administered to the control group as placebo. Post-test was conducted after 25 days with the same tool to the both groups.

PLAN FOR DATA ANLYSIS:

Fig-1: SCHEMATIC PRESENTATION OF METHODOLOGY

Data Analysis & DISCUSSION:

Table -1: Frequency and percentage distribution of symptoms of PCOS among women in experimental and control group in pre-test.                                                                                 (N=60)                                                                                  

Fig-1: Percentage distribution of symptoms of PCOS among women in experimental and control group in pre-test.

Table-2: Frequency and percentage distribution of symptoms of PCOS among women in experimental and control group in post-test.                                                                                                (N=60)                                                                                                                                                                  

Fig-2: Percentage distribution of symptoms of PCOS among women in experimental and control group in post-test.

Table-3: Comparison of effectiveness of cinnamon administration on symptoms of PCOS among women in experimental group and control group.                                                (N=60)

Table-4: Comparison of mean and standard deviation of post test scores of symptoms of PCOS among women in experimental and control group.                                                             (N=60)

Table-5: Association between post-test symptoms of PCOS with demographic variables among women in experimental group.                                                                                                                (N= 30)

MAJOR FINDINGS OF THE STUDY:

1. Level of PCOS symptoms in experimental and control group:

• Symptoms of PCOS among women in pre-test, in experimental group, 5(16.67%) had mild symptoms, 20(66.66%) had moderate symptoms and 5(16.66%) had severe symptoms, whereas in control group, 8(26.67%) had mild symptoms, 16(53.33%) had moderate symptoms and 6(20%) had severe symptoms.
• Symptoms of PCOS among women in post-test. In experimental group, 17(56.66%) had mild symptoms, 11(36.67%) had moderate symptoms and 2(6.67%) had severe symptoms, whereas in control group 13(43.33%) had mild symptoms, 14(46.67%) had moderate symptoms and 3(10%) had severe symptoms.

1. Comparison of effectiveness of cinnamon administration on symptoms of PCOS among women in experimental and control group:

Paired ‘t’ test & Independent ‘t’ test showed that, post test mean and standard deviation was higher than the pre-test in experimental group thnan the control group. It shows that the calculated value is greater than the table value at P<0.05 level of significance. It is evident that Cinnamon administration has significantly reduced the symptoms of PCOS. Hence the research hypothesis (H₁) was rejected and the null hypothesis (H₀1) was accepted.

III: Association between post test symptoms of PCOS with demographic variables among women in the experimental and control group:

In experimental group, there was a significant association found between post-test symptoms of PCOS with all demographic variables such as age, educational status, dietary habits, occupation, family income, age at menarche, marital status number of children, taking any medications and duration of PCOS at P<0.05 level.

In control group, there was a significant association found between post-test symptoms of PCOS with the demographic variables such as age, educational status, dietary habits, occupation, family income, age at menarche, marital status number of children, taking any medications and duration of PCOS at P<0.05 level.

CONCLUSION:

The study concluded that there was a significant reduction of symptoms of PCOS after administration of Cinnamon. Since, majority of adolescents and women found to have PCOS. Various herbal medicine may be helpful to control the PCOS symptoms and PCOS related complications. Adequate education and awareness to be created among public regarding the cinnamon administration and its various health benefits.

1. C. DUTTA’S Text book of Gynaecology, 9^th edition, page no:374-378.
2. http://natural.fertility.info.com
3. https://www.mayoclinic.org/diseases-conditions/pcos/symptoms-causes/syc-20353439
4. https://www.drweil.com/health-wellness/health-centers/women/are-there-natural-treatments-for-polycystic-ovarian-syndrome/
5. obgyn.net
6. Chitra varanasi. L, (2017) polycystic ovarian syndrome prevalence and its impact on wellbeing of Australian women.
7. Anahita Jalilian, M.D (2015) A meta-analysis on prevalence of polycystic ovary syndrome and its associated complications in Iranian women.Iranian Journal of Reproductive Medicine
8. Nidhi R (2011) A prospective study on prevalence of polycystic ovarian syndrome in Andhra Pradesh, South India.
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   Volume 2015, Article ID 15895.