Study population

This single center, prospective observational study was conducted from August 2017 to December 2018. Among the 173 patients with PCOS who were enrolled from the Department of Gynecology, Guangdong Maternal and Child Health Hospital, only 140 patients completed the study treatment protocol. The study was approved by Institutional ethical committee of Guangdong Maternal and Child Health Hospital. The study was conducted in accordance with the Good Clinical Practice guidelines and Declaration of Helsinki.

Considering that the prevalence of PCOS is 610%, a minimum sample size of 122 was required at a 1% level of significance with a power of 90%. However in order to account for any attrition, a total of 140 patients were enrolled.

Patients who qualified for PCOS as per the European Society of Human Reproduction and Embryology and the American Society of Reproductive Medicine at the Rotterdam Conference in 2003 [4] were included. Additionally, patients with no contraindication to oral contraceptives, who were confident of being compliant to the drug and provided informed consent were also included. On the other hand, patients with any contraindications to oral contraceptives; desirous of conception within 6months of inclusion in the study; diagnosed with concomitant hypothyroidism, hyperprolactinemia, diabetes mellitus, renal, or adrenal insufficiency; history of drug use for PCOS before inclusion in the study, and history of smoking and drug abuse were excluded from the study.

The patients at clinicians discretion received DRSP/EE tablets (Yousiyue, Bayer Medical and Health Company, Import Drug Registration No. H20140972). Each strip contained 28 tablets; 24 active tablets and 4 placebo tablets. Every active tablet contained 20g of EE and 3mg of DRSP. Patients were instructed to take oral DRSP/EE tablets (once daily before bedtime) on the 2nd day of menstruation or on the second day of withdrawal bleeding, for 28 consecutive days for 1cycle. There were 3 consecutive treatment cycles and patients were followed up for 3months of treatment.

Although, till date no established evidence exists whether a short- or a long-term usage of COC is beneficial in terms of efficacy and safety benefits, it is considered best to review the effects after 3months. Most studies show that unscheduled bleeding is more likely in the first cycle, and some show an improvement over the first 3months, with the incidence of unscheduled bleeding remaining constant from 4 to 12months for OC in Chinese women [15]. Thus, it is recommended that women experiencing unscheduled bleeding continue their method for at least 3months before seeking advice. With this background, we set up a 3month trial period to assess the effect of 3mg DRSP/20g EE in PCOS patients for 3months.

Baseline data were collected from the patients including demographic details such as age and presenting complaints (menstrual history, drug history, etc.). Patients weight was recorded using a digital scale, height using a stadiometer (Guangzhou Quality and Technical Supervision Bureau Guangzhou Institute of Metrology and Measurement Technology Measuring Instruments No. 794067), waist-hip ratio (WHR) was measured using a standard measuring tape and body mass index (BMI) was calculated. Additionally, hormonal profile [leutinizing hormone (LH), follicular stimulating hormone (FSH), testosterone (T), free androgen index (FAI), androgen] and biochemical parameters[fasting plasma glucose (FPG), 2-hourblood glucose (oral glucose tolerance test using 83g glucose in 250300ml water), fasting insulin (FINS), total cholesterol (TC), triglycerides (TG), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C)] were measured using fasting blood samples followed by an overnight fast. Variation in Homeostasis model assessment of insulin resistance (HOMA-IR) was also assessed at end of treatment regimen [16].Ovarian volume was measured by gynecological ultrasonography (Samsung, specification model: H60, host serial number: S10LM3HHB00009A). After 3months of medication, the above indicators were reviewed and compared. Similarly, bleeding pattern during medication and presence of adverse reactions (ADRs) were also recorded.

Menstrual bleeding volume was categorized into drip, small, normal and large amount of bleeding. Drip bleeding was defined when the need of sanitary napkin was not required. When the volume was lesser than the normal menstrual bleeding, it was considered as small amount of bleeding and normal was when the bleeding volume was similar to normal menstrual cycle. Large amount of bleeding was defined as volume more than the regular cycle. As recommended by WHO, the 90days was considered as a reference period to calculate the amount / number of days and times of drip bleeding.

All statistical analyses were performed using SPSS16.0 software. Missing data were excluded from the analysis. Continuous data were expressed as meanstandard deviation and categorical data were expressed as percentages (%).25th, 50th, and 75th percentiles were also calculated. If the normal distribution was not met for Students t-test, the signed rank sum test of the paired design data was used and the difference was considered statistically significant at p<0.05.

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