INTRODUCTION:

A polycystic ovarian syndrome is a convoluted endocrine disease of the reproducing system which influences several girls with puberty and 6-8% of matured women in endemic populations and displays a complete cycle of clinical demonstration¹. Currently, PCOS is trusted to be an inharmonious disorder resulting from a cure among natural factors and a multi-factorial genetic history that leads to the progress of this endocrinopathy. In many cases, PCOS reported with various complications such as metabolic and cardiovascular abnormalities during the life span⁸. As a consequence of hormonal imbalance, PCOS leads to the development of cysts in the ovarian antral follicles beneath the tunica albuginea. In the maturational process of ovum, an outsized number of ovarian follicles arrest to make small water-filled subcortical cysts, which are characterized as PCOS².

In this syndrome, the quantity of ovary increases up to 10 cm3 and quite 12 follicles of but 10 mm in diameter within the central dense stroma, and increase within the thickness of follicular sheath and ovarian stroma thanks to increasing in angiogenesis, vasculogenesis³, ovarian blood flow and, consequently, reduction or chronic anovulation and infertility⁷. Irregular menstruation, infertility, and elevated androgens result in hirsutism and acne are one of the significant complications of PCOS. Recent years have witnessed several attempts, primarily through the management of different hormones, to care and cure of this syndrome. However, the outcome of most of the studies is far from being satisfactory⁴. To evaluate the disease progression of PCOS, Oxidative stress marker, (e.g., malondialdehyde), and different enzymatic and non-enzymatic antioxidants such as superoxide dismutase, catalase, reduced glutathione, glutathione peroxidase, and glutathione S- transferase M3 are measured. Life-style alterations, such as exercise and high anti-oxidant diets, play a major role in the prevention of oxidative stress-induced PCOS.⁵ The purpose of this mini-review is to highlight the findings which project melatonin, a primary hormone of the pineal gland, as a potential candidate in the clinical management of polycystic ovarian syndrome with a note on its genesis⁶.

Etiopathogenesis:

The exact aetiology is not clearly known; PCOS is a multi-influence disease with a constant genetic influence. Different animal models are used to identify the pathophysiology of PCOS^15,16. Various models show it limit level and rodents are widely used. It also includes mice, monkeys and recently sheep and these models show that the uterine fetal exposure to androgen level increase, and it leads to the development of PCOS^17,18. The genetic form of the disease can be evaluating the genetic basis of patients with PCOS.

Ovarian Steroidogenesis:

The ovaries produce up to 25% of the testosterone and are dependent on LH secreted in the anterior pituitary of the hypothalamus, the ovaries secrete about 50% of the androgen hormone and 20% of DHEA^19,20,21.

Treatments for PCOS^23,24,25

· Diet and Exercise.

· Laser, biopsy and electrocautery

Artificial drugs:

· Medroxyprogesterone acetate and oral contraceptives and Anti-androgens such as cyproterone acetate, spironolactone or flutamide

· Clomiphene citrate.

· Metformin

Currently, apart from surgery, the most recognized treatment of PCOS is the use of medicines like clomiphene citrate, metformin, letrozole, and tamoxifen. But they have prolonged side effects. Thus extensive research is administered to seek out medicine for treating PCOS. Nowadays, melatonin, due to its strong anti-oxidant properties, is in focal attention in the care and cure of PCOS.

Conventional Management for PCOS:

· Birth control pills are often used for women for pregnancy and often widely used for the slight reduction in reducing androgen hormone levels²⁶.

· A biguanide, metformin is commonly used in PCOS patients and identified a gradual decrease in disease symptoms PCOS symptoms,

· Fertility medications for women trying to get pregnant in balancing the hormone levels of estrogen and progesterone²⁷

Herbal treatment:

To readjust the levels of the elevated hormones to affordable levels to regulate the ovulation achieve a 28-day cycle much faster and more successfully than women who are complete without menses^28,29.

Evening Primrose^30,31^,³²

It treats hormonal imbalances that prevent women with PCOS from getting pregnant. Besides, evening primrose oil contains fatty acids that not only provide balanced hormones but also encourage our body to form a healthy atmosphere for pregnancy by triggering cervical mucus production.

Saw Palmetto:

Saw palmetto is a beneficial root for hormone balancer and been used for management of estrogen levels in females. The symptoms further linked with PCOS relate to the overproduction of hormones. In restoring the average stability of estrogen–testosterone levels in the blood, this herbal drug also assists weight loss^30,31,32

Maitake Mushroom:

This mushroom is in a position to scale back this insulin resistance and to take care of blood glucose at a healthy level, like restoring the healthy metabolism of glucose and lipids, and promoting healthy weight also^30,31,32

White Peony:

Used in the shape of tea, and is employed for altering the amount of hormone essential for fertility, progesterone. Women affected by PCOS usually have low progesterone levels, and the consumption the white pony tea regulates the hormone to stagnant level. Additional benefits include the regulation of estrogen and prolactin secretion^30,31,32

Dandelion Root:

This extract reduces PCOS symptoms by helping the body eliminate the surplus hormones accumulated within the liver. It also removes the toxins from the body, thus helping women affected by menstrual Herbal Medicine in disorders and fertility problems^30,31,32

Cinnamon:

Cinnamon is taken into account as an effective remedy for PCOS. It can help normalize the monthly cycle and may also curb sudden hunger pangs due to its high fibre content. Widely used as a spice, cinnamon has numerous beneficial effects on the body, the rise of insulin sensitivity being the standard that creates it useful within the treatment of PCOS. It helps control blood glucose levels and facilitates weight loss also.

Soy Isoflavones:

Women with PCOS often have infertility due to anovulation. Soy isoflavones have effects almost like clomiphene, a prescription widely used for treating ovulation disorders successfully^30,31,32

Chasteberry:

(Vitex agnus-castus) is another herb used for PCOS. Chasteberry inhibits prolactin synthesis and Raises progesterone levels restoring balance to 2 important hormones involved within the cycle. Low progesterone levels are quite common during puberty and known to offer the formation of ovarian cysts³²

Physiological basis of PCOS:

Hormonal imbalance:

The genesis of PCOS are largely thanks to life-style errors. The pathophysiology of this syndrome chiefly results from endocrinological deformities, including deregulation of impairing androgen steroidogenesis by pituitary axis. The increased amount of the GnRH neurons fastens increased androgen secretion from the theca cells mediated by high LH/FSH ratio and increased androgen levels arrest follicular growth and impair follicular maturation. Aside from this, ovarian steroidogenic enzyme deficiencies like 3β-hydroxysteroid dehydrogenase and aromatase can trigger hyperandrogenemia and hypoestrogenic, leading to the phenotype of PCOS. Several hormonal markers like insulin- like growth factor-1, total/free testosterone, androstenedione, dehydroepiandrosterone, and 17-hydroxyprogesterone are identified within the PCOS patients accordingly³³.

Oxidative stress:

The generation of oxidative stress within the ovary may cause PCOS with several clinical phenotypes like atherosclerotic lesions, insulin resistance, obesity, hyperandrogenemia, and infertility³⁴. the amount of oxidative stress marker, (e.g., malondialdehyde), and different enzymatic and non-enzymatic antioxidants like SOD, catalase, reduced glutathione, peroxidase, paraoxonase, and glutathione S-transferase M3 are measured to gauge the amount of oxidative stress within the women with PCOS. Life-style adjustments, exercise, optimizing caloric intake and a diet loaded with anti-oxidants favourably modulate the redox imbalance with a resultant decline in oxidative stress-induced PCOS³⁵.

The action of melatonin on steroidogenesis:

Melatonin is understood for exerting a really relevant role in modulating ovarian functions and oocyte maturation. Within the ovary, melatonin is understood to be related to progesterone production by the reworking granulosa cells after ovulation by regulating the activities of steroidogenic enzymes or their expression at the gene level in theca and granulosa cells to decrease the extent of androgens³⁶. Though the entire story is yet untold, it's hypothesized that melatonin treatment may significantly help to take care of LH/FSH balance also because the level of gonadal androgens to regulate the event of PCOS through MT1 and MT2 receptor proteins³⁷. Melatonin is additionally effective within the regulation of LH receptor organic phenomenon, and gonadotropin-releasing hormone receptor biological phenomenon in human granulosa-lutein cells through the mitogen-activated protein kinase pathway³⁸.

The action of melatonin on oxidative stress:

In PCOS, generation of mononuclear cells and lipid peroxidation products in serum are expressively elevated, and activities of anti-oxidative enzymes become reduced, that ultimately contribute to oxidative stress-mediated apoptosis in atretic follicles³⁹. Melatonin prevents apoptosis by inducing Bcl2 expression and reducing Casp3 activity. Melatonin may increase IGF-1 and transform growth factor-beta production, which is anti-apoptotic. Thus, usually, the rise in follicular melatonin concentrations within the growing follicles might be a crucial think about avoiding atresia. A recent study suggested that melatonin (10mg/kg) significantly decreases the PCOS phenotypes in mice thanks to its anti-oxidant properties. In women, chronic administration of melatonin with PCOS (2mg/day for six months) significantly decreased testosterone levels and reduced menstrual irregularities. Sleep disturbances in women with PCOS are frequently-reported. Ovarian follicles could also be rescued from PCOS by melatonin and thus allow a pre-ovulatory follicle to ultimately develop and supply a healthy gamete for fertilization⁴⁰.

DIAGNOSIS OF PCOS IN HUMAN:

Menstrual irregularity:

· Infertility and Eight menstrual cycles in a year

· lack of menopause for more than 4months and prolonged amenorrhea

· Irregular and excessive bleeding

Skin complication:

· Pubertal acne

· Hirsutism and Balding

· Acanthosis nigricans

Insulin resistance:

· Weight gain, especially abound trunk

· Insulin sensitivity as well both type of diabetes

Ayurvedic Plants used for PCOS^41,42,43

S. No	Drug name	Latin name	Part used	Mode of action on pcos
1	Yastimadhu	Glycyrriza glabra linn	Root	Reduces serum testosterone and
3	Atasi	Linum usitatissimum linn	Seed	Decrease in androgen level
4	Twak	Cinnamomum Zeylanicum breyn	Bark oil, leaf	Reduces insulin resistance
5	Methika	Trigonella foenum graceam linn	Seed	Lowers cholesterol and fasting glucose level
6	Gokshura	Tribulus terrestris linn	Fruit, root	Female fertility tonic ovarian
7	Shatavari	Asparagus racemosus willd	Root	Correct the hormonal influence and enhance follicular maturity
8	Guduchi	Tinospora Cordifolia	Stem	Increase the immunity of patient
9	Shatpushpa	Peucedanum Graveolens	Flower	Enhance follicular maturity correct menstrual irregularity
10	Atibala	Abutilon indicum linn	Stem	Correct hormonal disturbances
11	Sahchara	Barleria prionitis	Leaf	Removes unwanted follicles
12	Vijaysara	Pterocarpus marsuptium roxb	Niryas	Insulin sensitizer
13	Amla	Emblica officinalis gaertn	Fruit	Cardioprotective anti-oxidant
14	Haldi	Curcuma longa linn	Root	Hypolipidemic antiobesity Anti-oxidant
15	Nimba	Azadirachta indica	Leaf	Anti-Diabetic
16	Manjistha	Rubica cordifolia	Root	Correct menstrual regularities

OBESITY FACTOR:

Elevated glycerides and cholesterol was observed in 50% of patient with PCOS. Abnormal waist circumference indicates a cardiovascular complications. Metabolic syndrome conditions are generally recognized in PCOS patients.⁴⁴ Impaired glucose tolerance were seen in one-third of obesity and diabetes mellitus type 2 in 10%. These lesions can also be found on the nape of the neck, inner thigh and below the breast. Women with severe insulin resistance can develop HAIR-AR syndrome consisting of hyperandrogenism, i.e. hirsutism, Insulin resistance and Acanthosis nigricans⁴⁵. PCOS patients may have elevated testosterone and fasting insulin levels of greater than 25IU/dL, which results in alteration of steroidogenesis in PCOS and affects the insulin-like growth factor receptors in the ovarian tissue.⁴⁶

MANAGEMENT OF PCOS:

Management comprises treatment of the presenting symptoms, as well as any other abnormalities discovered on an investigation. Depending on the problems, management of PCOS can include lifestyle modifications, weight reduction, and treatment with hormones or medications. The modality depends on the desire for fertility Research has shown that even a five to 10 per cent loss of weight in those who are overweight can restore average hormone production and helps regulate periods and improve fertility.

PCOS patient counselling:

PCOS can be diagnosed when a women with history of irregular periods with followed by facial acne, alopecia, hirsutism and acanthosis nigricans. Patients must be counselled about the long duration of treatment which includes life-style modifications along with the systemic therapy. Ineffective management for the woman with PCOS is through a synchronized effort between the dermatologist, endocrinologist, gynaecologist, nutritionist and physical trainer.

ONGOING RESEARCH ON STATINS:

Statins, widely used for reduction for the cardiovascular complication but still long term use of statins causes hyperandrogenemia and insulin resistance. Thus, use of statins in pregnant women leads to teratogenic effects. Use of statin in this condition is still experimental.⁴⁷

ACKNOWLEDGEMENT:

The authors are grateful to the support and key tool to attain the knowledge. SRM College of Pharmacy. SRM-IST.

CONFLICT OF INTEREST:

The authors declare no conflict of interest.

CONCLUSION:

· The pineal hormone melatonin is known to regulate a variety of central and peripheral actions related to circadian rhythms. It is a powerful free radical scavenger which involves in many gynaecological and obstetrical pathology. Though the studies advocating the possible role of melatonin as a new therapeutic agent for PCOS diagnosed women, more multi-dimensional studies are warranted to validate the treatment and eventually aim at reducing as the treatment goal of PCOS.

· Herbal products like Yastimadhu (Glycyrrhiza glabra), Kumari (Aloe vera), Tvaka (Cinnamomum zeylanicum), and Mostly the Ayurvedic drugs used for the PCOS, all are Vata-Kapha shamaka. These can be used to treat various symptoms of PCOS with no or mild side effects.

· Neurological associated in PCOS is still in the platform of research; no drugs melatonin an essential modulator in PCOS can be concentrated to cure PCOS. Melatonin might be effective against neurological associate PCOS. In an ayurvedic way of treatment, it can be cured with several natural drugs available.

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Received on 03.01.2020 Modified on 13.05.2020

Research J. Pharm. and Tech. 2021; 14(9):5029-5033.

DOI: 10.52711/0974-360X.2021.00877