Obstet Gynecol Sci.  2015 Mar;58(2):162-170. 10.5468/ogs.2015.58.2.162.

Therapy of heavy menstrual bleeding in Korea: Subanalysis and results from a multinational clinical trial in the Asian region investigating the levonorgestrel-releasing intrauterine system versus conventional therapy

• Lee BS
• Ling X
• Asif S
• Kraemer P
• Hanisch JU
• Inki P
• Lee JE

• KMID: 2314041
• DOI: http://doi.org/10.5468/ogs.2015.58.2.162

Abstract

OBJECTIVE
To compare real-life clinical outcomes with the levonorgestrel-releasing intrauterine system (LNG-IUS) and conventional medical therapies (CMTs), including combined oral contraceptives and oral progestins in the treatment of idiopathic heavy menstrual bleeding (HMB) in South Korea.
METHODS
This prospective, observational cohort study recruited a total of 647 women aged 18 to 45 years, diagnosed with HMB from 8 countries in Asia, including 209 women from South Korea (LNG-IUS, 169; CMTs, 40), who were followed up to one year. The primary outcome was cumulative continuation rate (still treated with LNG-IUS and CMTs) at 12 months. Secondary outcomes included bleeding pattern, assessment of the treatment efficacy by treating physician and safety profile.
RESULTS
The continuation rate at 12 months was significantly higher with the LNG-IUS than CMTs (85.1% vs. 48.5%, respectively; P<0.0001). The 51.5% of CMTs patients discontinued treatment and 18.8% of LNG-IUS patients discontinued treatment. The most common reasons for discontinuation for CMTs were switching to another treatment and personal reasons. When compared to CMTs, the LNG-IUS offered better reduction in subjectively assessed menstrual blood loss and the number of bleeding days, tolerability and with better efficacy in HMB, as assessed by physician's final evaluation.
CONCLUSION
This study provides novel information on the real-life treatment patterns of HMB in South Korea. The efficacy of CMTs was inferior compared to the LNG-IUS in the clinical outcomes measured in this study. Due to the better compliance with LNG-IUS, the cumulative continuation rate is higher than CMTs. We conclude that the LNG-IUS should be used as the first-line treatment for HMB in Korean women, in line with international guidelines.

Keyword

Compliance; Heavy menstrual bleeding; Korea; Levonorgestrel-releasing intrauterine system

MeSH Terms

Asia
Asian Continental Ancestry Group*
Cohort Studies
Compliance
Contraceptives, Oral, Combined
Female
Hemorrhage*
Humans
Korea
Progestins
Prospective Studies
Treatment Outcome
Contraceptives, Oral, Combined
Progestins

Figure

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  Fig. 1 Current treatment preferences in the management of HMB (multiple responses allowed). Physicians (n=18) were asked to select 1st, 2nd, and 3rd line treatments for HMB according to their current prescription preference. Multiple choices were allowed for each category. The graph shows the treatment options by percentage of physicians choosing them. HMB, heavy menstrual bleeding; COCs, combined oral contraceptives; NSAIDs, non-steroidal anti-inflammatory drugs; LNG-IUS, levonorgestrel-releasing intrauterine system; GnRH, gonadotropin-releasing hormone.

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  Fig. 2 Kaplan-Maier plot of time to discontinuation of treatment stratified by treatment group: levonorgestrel-releasing intrauterine system vs. conventional medical treatment.

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  Fig. 3 Number of bleeding days (A) and spotting days (B) during last 30 days according to treatment group. LNG-IUS, levonorgestrel-releasing intrauterine system; CMT, conventional medical treatment.

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  Fig. 4 Subjective evaluation of the amount of bleeding by treatment group. (A) Levonorgestrel-releasing intrauterine system and (B) conventional medical treatment.

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