This study was a prospective interventional study. It was conducted after approval from Institutional Human Ethics Committee Letter No:IHEC/08/2021/265
Thirty-two women with PCOS,between 18 to 32 years were selected based on Rotterdam criteria i,e presence of two out of three features: oligo- or anovulation,clinicial and/or biochemical signs of hyperandrogenism, or polycystic ovaries (ovarian volume > 10cc,12 or more peripherally located follicles 2–9 mm in diameter or hypoechoic enlarged ovaries with hyperechoic central Stroman in USG)
Exclusion criteria : Pregnant and lactating women, those with signs and symptoms of PCOS but showing normal ovaries on ultrasound, those on oral contraceptive pills,metformin,antiandrogens like flutamide,spironolactone,clomiphene citrate, women on antiplatelet and fibrinolytic drugs, those with ovarian hyperstimulation syndrome ,simple/complex ovarian cyst on ultrasound and those with history of allergy to seeds.
The subjects were recruited from the department of obstetrics/Gynecology and radiology department of SDM hospital. The participants were explained about the details of the study and informed consent was obtained. A total of 32 subjects were recruited. Two subjects had dropped out, one due to inability to follow the pattern. Detailed menstrual history was taken and height, body weight,BMI,random blood sugar was measured and modified Ferriman Galleway scoring for hirsutism were done before initiation of the study. Menstrual cycle details included age at menarche,frequency,duration and severity of menstrual flow and history of dysmenorrhea.
In addition, information on marital status, parity and history of difficulty in conception was collected. They were then provided with 4 varieties seeds packets and instructed to take orally 10 gram each with spoon provided (Ealy Morning-Flaxseed ,Midmorning- Pumpkin seed, evening- Sunflower seed and bedtime- Sesame seed) every day for 3 months. Compliance to the treatment was confirmed by regular phone calls and marking on daily calendar for every successful intake which the patient had to bring on the next monthly visit. Patients were reviewed every month for three months with questionnaire and all the above parameters were measured at last visit.
An improvement in menstrual cycle and reduction in body weight were considered positive outcome.
Statistical Methods
Detailed descriptive analysis of socio-demographic and clinical parameters was done. The quantitative variables were presented as mean ± standard deviation and the categorical variables were presented as frequency and percentage. Duration of menstrual cycle were taken as outcome variables. The mean difference or percentage differences in the outcome parameters, before and after treatment were calculated. Paired t-test was used to assess the statistical significance of these differences and 95% CI of the differences were also calculated. SPSS Version were used for statistical analysis.