Articles: heavy-menstrual-bleeding.
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Journal of women's health · Feb 2023
Observational StudySensitivity to Change of the SAMANTA Questionnaire, a Heavy Menstrual Bleeding Diagnostic Tool, After 1 Year of Hormonal Treatment.
Background: The validated SAMANTA questionnaire allows identification of women with heavy menstrual bleeding (HMB); that is, with excessive menstrual bleeding that interferes with quality of life (QoL). We assessed its value for monitoring HMB treatment in clinical practice. Material and Methods: This is a prospective observational study conducted between December 2018 and March 2021 in consecutively recruited women with HMB attending gynecologists' offices who started a hormonal treatment. ⋯ SF-36 domains improved significantly; changes being inversely associated with changes in the SAMANTA questionnaire score. Conclusions: The SAMANTA questionnaire seems a valuable tool for monitoring hormonal treatment for HMB. ClinicalTrials.gov identifier NCT03751800.
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Background and Objectives: Hysteroscopic endometrial resection (ER) or global endometrial ablation (GEA) are feasible methods to treat heavy menstrual bleeding (HMB). The aim of this systematic review and meta-analysis of randomized controlled trials (RCTs) was to assess patient's quality of life (QoL) in women treated with ER/GEA compared to hysterectomy. Materials and Methods: Electronic searches in MEDLINE Scopus, ClinicalTrials.gov, EMBASE, PROSPERO and Cochrane CENTRAL were conducted from their inception to July 2022. ⋯ Relative to uterine balloon therapy, amenorrhea was more common with EA/GER (relative risk 1.51 [95% CI 1.03 to 1.20] I2 = 28%), but posttreatment satisfaction was similar. Conclusions: Women's perception of QoL might be seen to be less improved after hysteroscopic ER/GEA rather than hysterectomy. However, such findings need to be confirmed by additional trials due to the high number of outdated studies and recent improvements in hysteroscopic instrumentation and techniques.
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Journal of women's health · Sep 2022
Impact of von Willebrand Disease on Women's Health Outcomes: A Matched Cohort Database Study.
Objective: To understand the impact of von Willebrand disease (VWD) on women's health, a retrospective cohort study was conducted using UK Clinical Practice Research Datalink (CPRD) GOLD database and Hospital Episode Statistics (HES) Admitted Patient Care data from 1988 to 2016. Materials and Methods: Hysterectomy and heavy menstrual bleeding (HMB) events were identified by recorded disease/clinical codes and compared in women with and without VWD (matched 1:10 by birth and CPRD record start years [±2 years], and general practice attended). Incidence rates and incidence rate ratios (IRR) were calculated; risks were estimated using the Kaplan-Meier method. ⋯ The cumulative incidence of hysterectomy was higher for women with versus without VWD (p < 0.0001), and highest among women aged ≥30 years at cohort entry. Women with VWD aged 30 - 39 years were more likely to undergo hysterectomy than women without VWD; IRR adjusted for prior HMB was 3.58 (95% CI: 2.36 - 5.44). Conclusions: These findings highlight the substantial impact of VWD on women's health.
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Journal of women's health · Jun 2022
Health Care Costs and Treatment Patterns Associated with Uterine Fibroids and Heavy Menstrual Bleeding: A Claims Analysis.
Background: Heavy menstrual bleeding (HMB) is one of the most common distressing complications of uterine fibroids (UF); however, data on the health care costs for treatments in women experiencing HMB associated with UF are lacking. The objective of this study was to compare the direct costs and treatments patterns for women diagnosed with UF+HMB, UF only, and HMB only in the United States. Materials and Methods: The study design was retrospective matched cohort study using claims data. ⋯ The mean diagnosis-related costs were significantly higher for UF+HMB ($8,741) than for UF only ($4,550) and HMB only ($3,081) (all, p < 0.0001). Surgery/procedure costs comprised 80% of diagnosis-related medical costs for UF+HMB. Conclusions: UF with HMB were associated with significant economic burden, driven primarily by surgical/procedural costs and treatment patterns.
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Journal of women's health · May 2022
Randomized Controlled TrialReduction of Heavy Menstrual Bleeding in Women Not Designated as Responders to Elagolix Plus Add Back Therapy for Uterine Fibroids.
Objective: To assess outcomes of women with uterine fibroids (UFs) and heavy menstrual bleeding (HMB) treated with 300 mg elagolix twice daily plus add-back therapy (E2 1 mg/NETA 0.5 mg once daily) or placebo who were not considered responders in pooled analysis of two phase 3, 6-month randomized clinical trials (Elaris UF-1 and UF-2). Methods: Responders were defined as women who met both primary end point bleeding criteria (<80 mL menstrual blood loss [MBL] during the final month and ≥50% reduction in MBL from baseline to the final month) and either completed the study or discontinued due to predefined reasons. Thus, women termed nonresponders who were analyzed in this study who met neither or one bleeding end point or met both criteria but prematurely discontinued treatment because of adverse events, perceived lack of efficacy, or required surgical or interventional treatment for UFs were analyzed in this study. ⋯ No differences in adverse events were observed between responders and nonresponders. Conclusion: Forty of 89 (45%) women with HMB and UFs who were classified as nonresponders in the UF-1 or UF-2 trials may have had a clinically meaningful response to elagolix with add-back therapy because they met at least one of the objective bleeding criteria. Clinical Trial Registration: Clinicaltrials.gov, NCT02654054 and NCT02691494. (NEJM 2020; 382:328-340) DOI: 10.1056/NEJMoa1904351.