DOI: http://dx.doi.org/10.18203/2320-1770.ijrcog20200901

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

Tarnima Saha, Meenakshi K. Bharadwaj, Shakti Vardhan

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.


Keywords


Combined oral contraceptive pills, Heavy menstrual bleeding, Intravaginal hormonal ring, Pictorial blood loss assessment chart

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References


Munro MG, Critchley HO, Broder MS, Fraser IS. FIGO classification system (PALM-COEIN) for causes of abnormal menstrual bleeding in non-gravid women of reproductive age. FIGO Working Group on Menstrual Disorders. Int J Gynaecol Obstet. 2011;113:3-13.

National Collaborating Centre for Women's and Children's Health/National Institute for Health and Clinical Excellence. Heavy menstrual bleeding. NICE clinical guideline 44. London, UK: RCOG Press; 2007. Available at: https://www.rcog.org.uk/en/guidelines-research-services/guidelines/heavy-menstrual-bleeding-nice-clinical-guideline-44/. Accessed on 6th January 2020.

Higham JM, O'Brien PMS, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990;97:734-98.

Janssen CA, Scholten PC, Heintz AP. A simple visual assessment technique to discriminate between menorrhagia and normal menstrual blood loss. Obstet Gynecol. 1995;85:977-82.

Lethaby A, Irvine G, Cameron I. Cyclical progestogens for heavy menstrual bleeding. Cochrane Database Syst Rev. 2008(1):CD001016.

Roumen FJME, Dieben TOM. Comparison of uterine concentrations of ethinylestradiol and etonogestrel - after use of a contraceptive vaginal ring and an oral contraceptive. Fertil Steril. 2006;85:57-62.

Roumen FJME. Review of the combined contraceptive vaginal ring, Nuvaring. Therap Clin Risk Manag. 2008;4(2):441-51.

Timmer CJ, Mulders TMT. Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring. Clin Pharmaco. 2000;39:233-42.

Milsom I, Lete I, Bjertnaes A. Effects on cycle control and body weight of the combined contraceptive ring, NuvaRing, versus an oral contraceptive containing 30 microg ethinyl estradiol and 3 mg drospirenone. Hum Reprod. 2006;21:2304-11.

Roumen FJ. The contraceptive vaginal ring compared with the combined oral contraceptive pill: a comprehensive review of randomized controlled trials. Contracept. 2007;75:420-9.

Mulders TM, Dieben TO. Use of the novel combined contraceptive vaginal ring NuvaRing for ovulation inhibition. Fertil Steril. 2001;75:865-70.

Oddsson K, Leifels-Fischer B, Wiel-Masson D. Superior cycle control with a contraceptive vaginal ring compared with an oral contraceptive containing 30 microgethinylestradiol and 150 microg levonorgestrel: a randomized trial. Hum Reprod. 2005;20:557-62.

Abu Hashim H, Alsherbini W, Bazeed M. Contraceptive vaginal ring treatment of heavy menstrual bleeding: a randomized controlled trial with norethisterone. Contracept. 2012;85:246-52.

Agarwal N, Gupta M, Kriplani A, Bhatla N, Singh N. Comparison of combined hormonal vaginal ring with ultralow-dose COC Pills in management menstrual bleeding: a pilot study (RCT). J Obs Gynae. 2016;36(1):71-5.

Dahiya P, Dalal M, Yadav A. Dahiya P, Dalal M, Yadav A, et al. Efficacy of combined hormonal vaginal ring in comparison to combined hormonal pills in heavy menstrual bleeding. Eur J Obstet Gynecol Reprod Biol. 2016;203:147-51.

Jain S, Vaid NB, Narang Y, Suneja A, Guleria K. A randomized controlled trial comparing the efficacy and side-effects of intravaginal ring (Nuvaring®) with combined oral hormonal preparation in dysfunctional uterine bleeding. Journal of clinical and diagnostic research: JCDR. 2016;10(3):QC21.