A Study of the Efficacy and Safety of Combination of Omega-3 Fatty Acids and Vitamin E versus Combined Oral Contraceptive Pills in Polycystic Ovarian Syndrome

Polycystic ovarian syndrome (PCOS) is one of the most common endocrine disorders affecting women of reproductive age. Infertility, hirsutism, acne, obesity and menstruation disruption are some of the manifestations of this chronic and diverse illness.

According to the WHO, Polycystic ovarian syndrome (PCOS) affects 8–13% of women who are of reproductive age. PCOS is a common condition among Indian women. The pooled prevalence of PCOS was 5.8% when using NIH criteria, compared to nearly 10% when utilizing Rotterdam’s and AES criteria.

In the modern era, it is acknowledged that mitochondria-generated oxidative stress and chronic inflammation, which are linked to hyperglycemia (HG), anovulation, hyperandrogenemia and insulin resistance (IR) are the primary causal factors of PCOS. Patients with PCOS have also been observed to have higher total oxidant status and greater IR.

Treatment for polycystic ovarian syndrome, a condition that affects a sizeable portion of women globally, is still centered on certain goals that may vary from woman to woman. Although causative therapy is preferable, it is not always possible because of our incomplete understanding of the syndrome’s pathophysiology.

Combined Oral Contraceptive Pills commonly prescribed for PCOS address two main symptoms i.e. irregular cycles and clinical signs of hyperandrogenism but having arterial hypertension, nausea, vomiting, headache, dermal lesions (acne, hirsutism), body weight gain, turgid breasts, leg cramps, vaginal staining or bleeding as their common side effects while the combination of Omega-3 Fatty Acids + Vitamin E has shown to provide good results in taking care of all domains i.e. endocrine, metabolic as well as the quality of life with minimal side effects.

A total of 60 patients will be enrolled and written informed consent will be taken from patients. Primary and secondary outcomes will be analyzed at baseline, 45 days and 90 days while we will monitor for any Adverse Drug Reactions (Safety Assessment) throughout the study.

The present study is therefore being taken to compare the efficacy and safety of combination of Omega-3 Fatty acids + Vitamin E with Combined Oral Contraceptive Pills in PCOS women. This study is ethically justified because the drugs; Combined Oral Contraceptives Pills, Vitamin E and Omega-3 Fatty Acids are already marketed and are in use individually for the treatment of PCOS symptoms.