Department of Obstetrics and Gynecology, Faculty of Medicine, University of Yamanashi, Chuo, Yamanashi, Japan.
Market Access, Bayer Yakuhin Ltd., 1-6-5, Marunouchi, Chiyoda-ku, Tokyo, 100-8265, Japan.
Adv Ther. 2022 Jun;39(6):2562-2577. doi: 10.1007/s12325-022-02118-0. Epub 2022 Apr 1.
Dysmenorrhea is a physical and mental burden for women, negatively affecting health-related quality of life (HRQL) and work productivity. However, data on HRQL and work productivity of Japanese women are scarce.
In this prospective observational study, 397 Japanese women received low-dose estrogen/progestin (LEP) or non-LEP treatment (non-steroidal anti-inflammatory drugs or Chinese herbal medicines) for primary/secondary dysmenorrhea and completed survey questionnaires online regarding menstrual symptoms, HRQL, and work productivity. Regression analysis was performed to compare the groups and evaluate outcomes over time using the paired t test. Subgroup analysis was performed using stratification by patient background, and correlations between improvement in menstrual symptoms/HRQL and work productivity were investigated using Spearman's rank correlation coefficient.
Significant reductions in the modified Menstrual Distress Questionnaire (mMDQ) total score were shown in the LEP group (n = 251) (P < 0.01), but not the non-LEP group (n = 146). Significant improvements in HRQL, measured by the 36-Item Short-Form Health Survey v2.0 (SF-36v2.0), were shown in the LEP group, but not the non-LEP group. Improvements were seen in mental component summary and 7/8 domains (role physical, bodily pain, general health, role emotional, mental health, vitality, and social functioning) in the LEP group, but not the non-LEP group. There were no differences in the physical component summary and role functioning in either group. Improvements in work productivity, measured by the modified Work Productivity and Activity Impairment Questionnaire (mWPAI), were greater in the LEP group vs. non-LEP group. Regression analysis showed differences in improvements between the groups in the mMDQ total score, SF-36v2.0, and mWPAI. A correlation between mMDQ or HRQL and work productivity was seen.
In Japanese women, dysmenorrhea is associated with reduced HRQL and work productivity. In real-world clinical practice, improvements in physical and mental menstrual symptoms, HRQL, and work productivity were observed with LEP treatment.
NCT04607382 (ClinicalTrials.gov).
痛经对女性的身心健康造成负担,降低了健康相关生活质量(HRQL)和工作生产力。然而,关于日本女性 HRQL 和工作生产力的数据十分有限。
本前瞻性观察研究共纳入 397 名原发性/继发性痛经的日本女性,她们接受低剂量雌孕激素(LEP)或非 LEP 治疗(非甾体抗炎药或中药),并在线完成关于月经症状、HRQL 和工作生产力的调查问卷。采用配对 t 检验比较组间差异,采用回归分析评估随时间的变化。采用分层分析比较患者背景不同的亚组,采用 Spearman 秩相关系数分析月经症状/HRQL 改善与工作生产力改善的相关性。
LEP 组(n=251)的改良痛经问卷(mMDQ)总分显著降低(P<0.01),而非 LEP 组(n=146)则没有(P<0.01)。LEP 组的 36 项简短健康调查 v2.0(SF-36v2.0)HRQL 显著改善,而非 LEP 组则没有。LEP 组的心理成分综合得分和 7/8 个领域(生理职能、躯体疼痛、总体健康、情感职能、心理健康、活力、社会功能)均有改善,而非 LEP 组则没有。两组的生理成分综合得分和角色职能均无差异。LEP 组的改良工作生产力和活动障碍问卷(mWPAI)的工作生产力改善程度大于非 LEP 组。回归分析显示,两组间在 mMDQ 总分、SF-36v2.0 和 mWPAI 方面的改善存在差异。mMDQ 或 HRQL 与工作生产力呈正相关。
在日本女性中,痛经与 HRQL 和工作生产力下降有关。在真实世界的临床实践中,LEP 治疗可改善痛经患者的身心月经症状、HRQL 和工作生产力。
NCT04607382(ClinicalTrials.gov)。