Yong Paul J, Alsowayan Najla, Noga Heather, Williams Christina, Allaire Catherine, Lisonkova Sarka, Bedaiwy Mohamed A
Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver V6H3N1, Canada.
BC Women's Centre for Pelvic Pain and Endometriosis, Vancouver V6H3N1, Canada.
Hum Reprod Open. 2020 Feb 28;2020(2):hoz040. doi: 10.1093/hropen/hoz040. eCollection 2020.
What are the use patterns and factors associated with combined hormonal contraception (CHC) ineffectiveness or discontinuation due to side-effects in patients with endometriosis and pelvic pain?
Worse chronic pelvic pain (CPP) severity and pelvic floor myalgia were associated with continuous CHC ineffectiveness, while poorer quality-of-life was associated with continuous CHC discontinuation due to side-effects.
CHC is a first line of therapy for endometriosis-associated pelvic pain in women. However, some patients state that CHC is ineffective for their pain, while others have to discontinue CHC due to side-effects.
Analysis of a prospective patient database from a tertiary care referral center for patients with endometriosis and pelvic pain between December 2013 and April 2015 was carried out.
PARTICIPANTS/MATERIALS SETTING AND METHODS: A total of 373 patients of reproductive age with endometriosis from the database were included in the study. Data included patient self-reported questionnaires, physical examination findings and validated instruments. There were four variables of interest: history of cyclical CHC ineffectiveness (yes/no), history of cyclical CHC discontinuation due to side-effects (yes/no), history of continuous CHC ineffectiveness (yes/no) and history of continuous CHC discontinuation due to side-effects (yes/no). The primary outcome was CPP severity for the past 3 months (score of 0-10), and secondary outcomes were other pelvic pain scores, quality-of-life on the Endometriosis Health Profile 30 (EHP-30) and underlying conditions including irritable bowel syndrome, painful bladder syndrome, abdominal wall pain, pelvic floor myalgia and depression, anxiety and pain catastrophizing.
Among the 373 cases in the dataset, prior cyclical CHC use was reported by 228 (61.1%) women, of which 103 (27.6%) stated it was ineffective for their pain and 94 (25.2%) stated they discontinued CHC due to side-effects. Previous continuous CHC use was reported by 175 (46.9%) women, of which 67 (18.0%) stated it was ineffective and 59 (15.8%) stated they discontinued due to side-effects. Worse CPP severity in the last 3 months was associated with a history of continuous CHC ineffectiveness ( < 0.001). Poorer quality-of-life was present in women who reported a history of continuous CHC discontinuation due to side-effects ( = 0.005). Among the underlying conditions, pelvic floor tenderness (as a marker of pelvic floor myalgia) was associated with CHC ineffectiveness.
This study involved patient recall and no longitudinal follow-up. Also, we do not have data on the type of side-effect that led to discontinuation. Medication ineffectiveness was reported subjectively by the patient rather than using standardized criteria. Finally, the diagnosis of endometriosis was based on previous surgery or a current nodule or endometrioma on examination/ultrasound; without prospective surgical data on all the patients, it was not possible to do a sub-analysis by current surgical features (e.g. stage).
In women with endometriosis, CHC ineffectiveness was associated with worse CPP and pelvic floor myalgia, which suggests myofascial or nervous system contributors to CPP that does not respond to hormonal suppression. A tender pelvic floor, as a sign of pelvic floor myalgia, may be a clinical marker of patients with endometriosis who are less likely to have an optimal response to hormonal suppression. For women who discontinue CHC due to side-effects, research is needed to help alleviate these side-effects as these patients report worse quality-of-life.
STUDY FUNDING/COMPETING INTERESTS: This work was supported by a Canadian Institutes of Health Research (CIHR) Transitional Open Operating Grant (MOP-142273) as well as BC Women's Hospital and the Women's Health Research Institute. PY is also supported by a Health Professional Investigator Award from the Michael Smith Foundation for Health Research. MB/CA has financial affiliations with Abbvie and Allergan; the other authors have no conflicts of interest.
子宫内膜异位症和盆腔疼痛患者中,复方激素避孕药(CHC)因副作用导致避孕失败或停药的使用模式及相关因素有哪些?
慢性盆腔疼痛(CPP)严重程度加重和盆底肌痛与连续使用CHC避孕失败有关,而生活质量较差与因副作用导致连续停用CHC有关。
CHC是女性子宫内膜异位症相关盆腔疼痛的一线治疗方法。然而,一些患者表示CHC对其疼痛无效,而另一些患者则因副作用不得不停用CHC。
研究设计、规模、持续时间:对2013年12月至2015年4月期间来自三级医疗转诊中心的子宫内膜异位症和盆腔疼痛患者的前瞻性患者数据库进行了分析。
参与者/材料、设置和方法:数据库中共有373名育龄期子宫内膜异位症患者纳入研究。数据包括患者自我报告的问卷、体格检查结果和经过验证的工具。有四个感兴趣的变量:周期性CHC避孕失败史(是/否)、因副作用导致周期性CHC停药史(是/否)、连续CHC避孕失败史(是/否)以及因副作用导致连续CHC停药史(是/否)。主要结局是过去3个月的CPP严重程度(0 - 10分),次要结局是其他盆腔疼痛评分、子宫内膜异位症健康概况30(EHP - 30)上的生活质量以及包括肠易激综合征、膀胱疼痛综合征(间质性膀胱炎)、腹壁疼痛、盆底肌痛和抑郁、焦虑及疼痛灾难化在内的基础疾病。
在数据集中的373例病例中,228名(61.1%)女性报告曾使用过周期性CHC,其中103名(27.6%)表示对其疼痛无效,94名(25.2%)表示因副作用停用CHC。175名(46.9%)女性报告曾连续使用CHC,其中67名(18.0%)表示无效,59名(15.8%)表示因副作用停药。过去3个月CPP严重程度加重与连续CHC避孕失败史相关(P < 0.001)。报告因副作用导致连续停用CHC史的女性生活质量较差(P = 0.005)。在基础疾病中,盆底压痛(作为盆底肌痛的标志)与CHC避孕失败有关。
本研究涉及患者回忆且无纵向随访。此外,我们没有关于导致停药的副作用类型的数据。药物无效是由患者主观报告的,而非使用标准化标准。最后,子宫内膜异位症的诊断基于既往手术或检查/超声发现的当前结节或子宫内膜瘤;由于没有所有患者的前瞻性手术数据,无法按当前手术特征(如分期)进行亚组分析。
在子宫内膜异位症女性中,CHC避孕失败与更严重的CPP和盆底肌痛相关,这表明肌筋膜或神经系统因素导致了对激素抑制无反应的CPP。作为盆底肌痛体征的盆底压痛,可能是子宫内膜异位症患者对激素抑制反应不佳的临床标志。对于因副作用停用CHC的女性,需要开展研究以帮助减轻这些副作用,因为这些患者报告生活质量较差。
研究资金/利益冲突:本研究得到了加拿大卫生研究院(CIHR)过渡性开放运营资助(MOP - 142273)以及卑诗省妇女医院和妇女健康研究所的支持。PY还获得了迈克尔·史密斯卫生研究基金会的卫生专业人员研究奖。MB/CA与艾伯维和艾尔建存在财务关联;其他作者无利益冲突。