A randomized controlled trial to study the efficacy of intravaginal hormonal ring for control of heavy menstrual bleeding as compared to combined oral contraceptive pills

Abstract

Background: Heavy menstrual bleeding (HMB) is one of the commonest presenting complaints in reproductive age group. Although combined oral contraceptives (COCs) are commonly used in such patients, combined hormones by intravaginal route has been found acceptable and effective. Aim of the study is to compare the efficacy and side effects of combined intravaginal hormonal ring (IHR) with COCs in control of HMB in these patients.Methods: Hundred women with HMB fulfilling inclusion criteria were randomized into two equal groups and treated with either IHR or COCs for three cycles. Each cycle consisted of three weeks of IHR/COC use followed by 1-week ring-free/non-hormonal pills period. Outcome measures were change in PBAC score (pictorial blood loss assessment chart), hemoglobin rise, side effects and overall patient satisfaction.Results: The percentage reduction in PBAC score, the duration of menses and increase in hemoglobin levels were statistically significant at the end of study in each group. The PBAC score reduction was 87.37% vs 61.52%, menses duration was 4.24±0.74 versus 5.16±1.67, and hemoglobin increase was 3.16 (95% CI:0.142-1.412) and 1.24 (95% CI:1.048-1.640) in the IHR versus COC group. However, the intergroup reduction of mean PBAC score was not statistically significant. Significantly more ring users were satisfied and elected to continue with treatment.Conclusions: Both the IHR and COCs are effective treatments for HMB in reproductive age group. IHR may be an attractive option for HMB due to better compliance and lesser systemic side-effects.