The Clinical Efficacy of Sequential Use of Gonadotropin-Releasing Hormone Analog - Levonorgestrel-Releasing Intrauterine System in Medically Ill Women With Symptomatic and Relatively Large Adenomyosis

Abstract

Objectives:To evaluate the clinical outcome of sequential therapy of gonadotropin-releasing hormone (GnRH) analog, followed by the levonorgestrelreleasing intrauterine system in medically ill women with relatively large and symptomatic adenomyosis. Methods:A prospective cohorts study conducted in the Obstetrics and Gynaecology Department, Al-Yarmouk teaching hospital in Baghdad/Iraq from June 2016 to January 2018. 32 women, 40 years and above who complete their family and had significant medical disease along with symptomatic and relatively large adenomyosis (≥150 cm 3 ) were included in the study. The primary outcome measure was to evaluate the clinical outcome of this sequential therapy in the form of improving menstrual blood loss and pelvic pain and the secondary outcome was decreasing uterine volume.Results: There were significant improvements in both menstrual blood loss volume and dysmenorrhea at the end of the 1 st year with p˂0.001, mainly in the first 6 months. There were also significant reductions in the uterine volume (197.2±30.7-91.5±6.0 mm 3 ). The expulsion rate was 15.6%. Conclusion:Sequential treatment protocol of GnRH agonist -LNG-IUS in symptomatic and relatively large adenomyosis (˃150 cm 3 ) is effective in relieving symptoms and decreasing uterine volume with less possible expulsion rate, making the protocol good substitutions to surgery, especially in medically ill women were surgery carry more risk.

A systematic review of outcome reporting and outcome measures in studies investigating uterine-sparing treatment for adenomyosis

“…We included 38 trials, reporting on data from 5175 women ( Table I ) ( Fedele et al , 1997 ; Maia et al , 2003 ; Hadisaputra and Anggraeni, 2006 ; Bragheto et al , 2007 ; Kim et al , 2007 ; Cho et al , 2008 ; Kang et al , 2009 ; Sheng et al , 2009 ; Kang et al , 2010 ; Ozdegirmenci et al , 2011 ; Zhou et al , 2011 ; Kelekci et al , 2012 ; Ekin et al , 2013 ; Liu et al , 2014 ; Zhang et al , 2014 ; Huang et al , 2015 ; Lee et al , 2015 , 2019 ; Long et al , 2015 ; Chong et al , 2016 ; Liu et al , 2016 ; Park et al , 2016 ; Hai et al , 2017 ; Huang et al , 2017 ; Liu et al , 2017 ; Osuga et al , 2017 ; Yang et al , 2017 , 2019 ; Alizzi, 2018 ; Guo et al , 2018 ; Jun-Min et al , 2018 ; Li et al , 2018 , 2020 ; Huang et al , 2020 ; Lin et al , 2020 ; Sun et al , 2020 ; Kwack et al , 2021 ; Sun et al , 2021 ). There were six (16%) randomized controlled trials (RCTs) ( Hadisaputra and Anggraeni, 2006 ; Kang et al , 2010 ; Ozdegirmenci et al , 2011 ; Zhang ...…”

“…Only seven (18%) studies had a clearly defined primary outcome ( Fedele et al , 1997 ; Maia et al , 2003 ; Sheng et al , 2009 ; Chong et al , 2016 ; Liu et al , 2017 ; Osuga et al , 2017 ; Sun et al , 2021 ) and 11 (29%) studies stated multiple or all reported outcomes to be the primary ( Hadisaputra and Anggraeni, 2006 ; Bragheto et al , 2007 ; Kang et al , 2010 ; Ozdegirmenci et al , 2011 ; Zhou et al , 2011 ; Kelekci et al , 2012 ; Ekin et al , 2013 ; Liu et al , 2014 ; Long et al , 2015 ; Li et al , 2018 ; Huang et al , 2020 ). Twenty studies (53%) did not define a primary outcome at all ( Kim et al , 2007 ; Cho et al , 2008 ; Kang et al , 2009 , 2010 ; Zhang et al , 2014 ; Huang et al , 2015 ; Lee et al , 2015 , 2019 ; Liu et al , 2016 ; Park et al , 2016 ; Hai et al , 2017 ; Huang et al , 2017 ; Yang et al , 2017 , 2019 ; Alizzi, 2018 ; Guo et al , 2018 ; Jun-Min et al , 2018 ; Li et al , 2018 ; Lin et al , 2020 ; Sun et al , 2020 ; Kwack et al , 2021 ). Most of these studies described the aims in non-specific terms, such as ‘clinical efficiency’, but without defining the terms ‘clinical’ or ‘efficiency’.…”

“…However, only 19 studies reported on all their outcomes at all the predetermined time points according to the described methods. Several studies provided only a visual or summarized outcome reporting for at least one of the outcomes, without values, SD or 95% CI ( Maia et al , 2003 ; Bragheto et al , 2007 ; Ozdegirmenci et al , 2011 ; Ekin et al , 2013 ; Alizzi, 2018 ).…”