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Abstract
Objective
Up to 60% of women discontinue using the levonorgestrel-releasing intrauterine system (LNG-IUS) within 5 years because of bleeding irregularities, pain and/or systemic progestogenic adverse effects. The aim of the study was to assess treatment options for bleeding irregularities in women using the 52 mg LNG-IUS.
Methods
Database searches of Medline, Embase/Ovid and the Cochrane Library were carried out, and journals were searched by hand, for relevant studies published from database inception to March 2020. Inclusion criteria were randomised controlled trials (RCTs), prospective cohort studies and case–control studies of premenopausal women using the LNG-IUS and receiving medical treatment for bleeding irregularities. Screening, data extraction and quality assessment of retrieved articles were carried out independently by two pairs of reviewers. The primary outcome was the reduction of bleeding/spotting days.
Results
Of the 3061 studies identified, eight met our inclusion criteria: six RCTs and two prospective cohort studies. The eight studies enrolled a total of 677 women who were treated with tamoxifen, mifepristone, ulipristal acetate, naproxen, oestradiol, mefenamic acid, tranexamic acid or the progesterone receptor modulator CDB 2914. The results of our analysis indicated that naproxen may be effective for the prophylactic treatment of bleeding immediately (<12 weeks) after LNG-IUS insertion (high level of evidence). Oestradiol may be effective in treating ongoing bleeding irregularities >6 months after insertion (low level of evidence).
Conclusion
Evidence for the medical treatment of (ongoing) bleeding irregularities during use of the LNG-IUS is lacking and more research is needed on the topic.
Chinese abstract
目的：由于不规则子宫出血、疼痛和/或孕激素的全身性不良反应, 5年内中断左炔诺孕酮宫内缓释系统(LNG-IUS)的比例达到60%。本研究的目的是评估对于应用52mgLNG-IUS的妇女发生不规则出血的治疗方式。
方法：对Medline, Embase / Ovid和Cochrane Library数据库进行搜索搜索, 并手动搜索了学术期刊, 以搜集从数据库建立到2020年3月的相关研究。纳入标准为应用LNG-IUS的绝经前妇女并针对不规则出血接受医学治疗的随机对照试验（RCT）, 前瞻性队列研究和病例对照研究。检索文章的筛选, 数据提取和质量评估由两对审阅者独立进行。主要结局为出血/点滴性出血的减少。
结果：在确定的3061项研究中, 有8项符合我们的纳入标准：6项RCT和2项前瞻性队列研究。八项研究共纳入677名接受他莫昔芬, 米非司酮, 醋酸乌利司他, 萘普生, 雌二醇, 甲芬那酸, 氨甲环酸或孕激素受体调节剂CDB 2914治疗的妇女。我们的分析结果表明, 萘普生可能对LNGIUS植入后短期（<12周）出血有效（证据级别高）。雌二醇可有效治疗植入后的> 6个月的持续性不规则出血（证据级别低）。
结论：缺乏在应用LNG-IUS期间（持续性）不规则出血的药物治疗的证据, 因此需要对该问题进行更多研究。
Acknowledgements
The authors would like to thank Maria Kamphuis and Jaklien Leemans (Máxima Medical Center) for their valuable comments on our article.
Author contribution
The study was conceived by MB and PG. PH, RT and ED carried out the database searches. PH, PG and RT selected eligible articles. PH and LB assessed the risk of bias. PH and PG drafted the manuscript. RT, PG, SV, LB, BB and MB critically revised the manuscript.
Disclosure statement
The authors declare that there is no conflict of interest associated with this article.