A Randomised Controlled Trial Comparing the Efficacy and Side-Effects of Intravaginal Ring (Nuvaring®) With Combined Oral Hormonal Preparation in Dysfunctional Uterine Bleeding QC21-QC24
Dr. Sandhya Jain,
125, SFS Flats, Phase-4, Ashok Vihar, Delhi-110052, India.
Introduction: Combined Oral Contraceptive (COC) pills are being used in patients of abnormal uterine bleeding, especially adolescents and reproductive age women considering their need for contraception. It decreases the blood loss due to haemostatic effect of estrogen and also regularizes the cycle. Intravaginal route has been found to be effective and acceptable; Gastrointestinal absorption and hepatic first-pass metabolism is avoided and steady, uniform blood concentration is achieved. Bioavailability of estrogen and progestogen through oral and vaginal route are same. The convenience of once-a-month administration is another major advantage.
Materials and Mathods: Sixty women fulfilling inclusion criteria were randomised into 2 groups in 1:1 ratio. In one group (n=30), monthly insertion of Nuvaring®) was done for three consecutive months. Nuvaring® releases 15µg ethinyl estradiol and 120 µg etonogesterol daily. The other group (n=30) received COC pill containing 30µg EE and 150 µg levonorgestrel for three consecutive months. Primary outcome measures were change in menstrual cycle pattern and pictorial Blood Loss Assessment chart (PBAC) score. Other Parameters included side effects, change in haemoglobin and weight. Data was analyzed by statistical software SPSS 20.
Results: Both Nuvaring® and COC were found to significantly decrease blood loss in each cycle. Decrease in PBAC score was more in Nuvaring® group compared to COC, however difference was not significant. Ideal bleed (IB) was frequently higher for Nuvaring® group than COC in all 3 cycles, although no statistically significant difference was observed between groups (p-value=0.286). Late withdrawl, intermenstural spotting was higher in COC group. Compliance was better and women were more satisfied in Nuvaring® group compared to COC group. Minor side effects like headache, mastalgia, nausea and mood changes were seen in both groups, which were not significant. Continuation rate was significantly higher in Nuvaring® group. 30% women discontinued treatment in OCP group after 3 month compare to 10% in Nuvaring® group.
Conclusion: Present study shows Nuvaring® to be as effective as COC in controlling heavy menstural bleed, better cycle control, with minor acceptable systemic side effects.