Psychological distress and uterine fibroids: a bidirectional two-sample mendelian randomization study.

BACKGROUND: Observational data indicates a connection between emotional discomfort, such as anxiety and depression, and uterine fibroids (UFs). However, additional investigation is required to establish the causal relationship between them. Hence, we assessed the reciprocal causality between four psychological disorders and UFs utilizing two-sample Mendelian randomization (MR). METHODS: To evaluate the causal relationship between four types of psychological distress (depressive symptoms, severe depression, anxiety or panic attacks, mood swings) and UFs, bidirectional two-sample MR was employed, utilizing single nucleotide polymorphisms (SNPs) associated with these conditions. Both univariate MR (UVMR) and multivariate MR (MVMR) primarily applied inverse variance weighted (IVW) as the method for estimating potential causal effects. Complementary approaches such as MR Egger, weighted median, simple mode, and weighted mode were utilized to validate the findings. To assess the robustness of our MR results, we conducted sensitivity analyses using Cochran's Q-test and the MR Egger intercept test. RESULTS: The results of our UVMR analysis suggest that genetic predispositions to depressive symptoms (Odds Ratio [OR] = 1.563, 95% Confidence Interval [CI] = 1.209-2.021, P = 0.001) and major depressive disorder (MDD) (OR = 1.176, 95% CI = 1.044-1.324, P = 0.007) are associated with an increased risk of UFs. Moreover, the IVW model showed a nominally significant positive correlation between mood swings (OR: 1.578; 95% CI: 1.062-2.345; P = 0.024) and UFs risk. However, our analysis did not establish a causal relationship between UFs and the four types of psychological distress. Even after adjusting for confounders like body mass index (BMI), smoking, alcohol consumption, and number of live births in the MVMR, the causal link between MDD and UFs remained significant (OR = 1.217, 95% CI = 1.039-1.425, P = 0.015). CONCLUSIONS: Our study presents evidence supporting the causal relationship between genetic susceptibility to MDD and the incidence of UFs. These findings highlight the significance of addressing psychological health issues, particularly depression, in both the prevention and treatment of UFs.

Psychosocial Stress and MicroRNA Expression Profiles in Myometrial Tissue of Women Undergoing Surgical Treatment for Uterine Fibroids.

Uterine leiomyomas (fibroids) are the most common non-cancerous tumors affecting women. Psychosocial stress is associated with fibroid risk and severity. The relationship between psychosocial stress and fibroid pathogenesis may involve alterations in microRNAs (miRNAs) although this has yet to be examined. We investigated associations between two psychosocial stress measures, a composite measure of recent stressful life events and perceived social status, with expression levels of 401 miRNAs in myometrium (n = 20) and fibroids (n = 44; 20 with paired fibroid and myometrium samples) among pre-menopausal women who underwent surgery for fibroid treatment. We used linear regressions to identify psychosocial stressors associated with miRNAs, adjusting for covariates (age, body mass index, race/ethnicity, and oral contraceptive use). The association between psychosocial stressors and miRNAs was considered statistically significant at an FDR p < 0.10 and showed a monotonic response (nominal p-trend < 0.05). In the myometrium, 21 miRNAs were significantly associated with a composite measure of recent stressful events, and two miRNAs were associated with perceived social status. No fibroid miRNAs were associated with either stress measure. Pathway analyses revealed miRNA-mRNA targets were significantly enriched (FDR p < 0.05) in pathways relevant to cancer/tumor development. Of the 74 differentially expressed miRNAs between myometrium and fibroids, miR-27a-5p and miR-301b were also associated with stress exposure. Our pilot analysis suggests that psychosocial stress is associated with myometrial miRNA expression and, thus, may have a role in the pathogenesis of fibroids from healthy myometrium.

Body Image and Sexual Function Improve after Both Myomectomy and Hysterectomy for Symptomatic Fibroids.

OBJECTIVES: To determine the factors that influence the choice of myomectomy, uterine fibroid embolization (UFE), or hysterectomy in women with symptomatic uterine fibroids and to assess women's perception of body image and sexual functioning before and after treatment. METHODS: In this prospective observational cohort pilot study, women scheduled to undergo hysterectomy, myomectomy, or UFE were surveyed before surgery and again at 3 to 6 months after their procedure to assess body image and sexual function using the validated 10-item Body Image Scale and 19-item Female Sexual Function Index. Logistic regression was used to determine predictive factors for surgery choice and paired t tests were used to determine changes in perceived sexual function and body image. RESULTS: Of the 71 women surveyed, 69 underwent their scheduled procedure and 68 participants completed the preoperative questionnaire completely (98%). A total of 33 participants completed the postoperative questionnaire (49%). The predictive factor for hysterectomy versus myomectomy/UFE was older age (odds ratio 1.13, P = 0.017, 95% confidence interval [CI] 1.02-1.24). Regardless of surgery type, there were significant improvements in perceived body image and sexual function, including an increase in the overall sexual satisfaction of the participant (mean difference 0.50, P = 0.021, 95% CI 0.92-0.08) and less likely to feel less sexually attractive because of their menstrual bleeding problem (P < 0.0001, 95% CI 0.637-1.675). CONCLUSIONS: Women of older age are more likely to choose hysterectomy over myomectomy or UFE for the treatment of symptomatic uterine fibroids. In addition, women who underwent any treatment for fibroids have increases in perception of body image and sexual functioning after their procedure.

Assessing burden, risk factors, and perceived impact of uterine fibroids on women's lives in rural Haiti: implications for advancing a health equity agenda, a mixed methods study.

BACKGROUND: Uterine fibroids, the most common cause of gynecologic surgery, have a reported cumulative incidence of 59% among Black women in the U.S. Uterine fibroids negatively impact the quality of women's lives. No study has been found in the literature about fibroids in Haiti. We conducted a mixed methods study to assess the burden and risk factors of uterine fibroids, as well as their effects on women's quality of life. METHODS: A convergent mixed methods study was conducted between October 1, 2019 and January 31, 2020 at MUH's (Mirebalais University Hospital) OB-GYN outpatient department. Quantitatively, in a cross-sectional study 211 women completed consecutively a structured questionnaire. In-depth interviews with 17 women with fibroids and 7 family members were implemented for the qualitative component. Descriptive statistics were calculated for clinical and social demographic variables. Logistic regression was performed to examine associations between fibroids and related risk factors. An inductive thematic process was used to analyze the qualitative data. A joint display technique was used to integrate the results. RESULTS: Of 193 women analyzed 116 had fibroids (60.1%). The mean age was 41.3. Anemia was the most frequent complication- 61 (52.6%). Compared to women without uterine fibroids, factors associated with uterine fibroids included income decline (AOR = 4.7, 95% CI: 2.1-10.9, p = < 0.001), excessive expenses for transport (AOR = 4.4, 95% CI: 1.6-12.4, p = 0.005), and family history with uterine fibroids (AOR = 4.6, 95% CI: 1.6-13.6, p = 0.005). In contrast, higher level of education and micro polycystic ovarian syndrome were associated with lower prevalence (AOR = 0.3, 95% CI: 0.1-0.9, p = 0.021) and (AOR = 0.2, 95% CI: 0.1-0.97, p = 0.044), respectively. The qualitative findings delineate how contextual factors such as health system failures, long wait times, gender inequality and poverty negatively affect the quality of women's lives. The poverty cycle of uterine fibroids emerged. CONCLUSIONS: A vicious cycle of poverty negatively impacts access to care for uterine fibroids in Haiti. Health insurance, social support, and income generating activities may be keys to promote social justice through access to adequate care for women with uterine fibroids in Haiti.

Comparison of the Effects of Total Laparoscopic Hysterectomy and Total Abdominal Hysterectomy on Sexual Function and Quality of Life.

It is known that benign gynecological diseases negatively affect sexual function. For this reason, hysterectomy provides improvement in sexual function as well as symptoms such as bleeding and pain. The effects of abdominal hysterectomy (TAH) and laparoscopic hysterectomy (TLH), which are the two most common types of hysterectomy today, are not clear. In our study, we investigated the effects of TAH and TLH on sexual function and quality of life as well as intraoperative and postoperative results. In 329 TLH and 126 TAH patients, we compared both and between themselves preoperatively and postoperatively by using the standardized and validated female sexual function index (FSFI) and European quality of life five-dimension scale (EQ-5D). In conclusion, we found that both types of hysterectomy were effective in improving sexual function, and we concluded that improvement in the laparoscopy group was statistically higher. Patients who require hysterectomy for benign gynecological reasons should be informed that TLH has a more positive effect on sexual function as well as other advantages, and if the patients' main complaint is sexual dysfunction, TLH should be preferred compared to TAH.

Improvement in parameters of quality of life and uterine volume reduction after uterine fibroid embolization.

OBJECTIVE: To evaluate improvement in quality of life, reduction of uterine volume, and the correlation between these two variables after uterine fibroid embolization. METHODS: Data on quality of life before and after uterine fibroid embolization were collected from 60 patients using the Uterine Fibroid Symptom - Quality of Life questionnaire. In 40 of these patients, uterine volume information on magnetic resonance imaging examinations performed before and after uterine fibroid embolization was collected, and compared using the nonparametric Wilcoxon test for paired data. Correlation between quality of life and uterine volume before and after procedure was measured using Spearman's correlation coefficient. RESULTS: There was significant improvement in quality of life after uterine fibroid embolization on Uterine Fibroid Symptom - Quality of Life questionnaire, in both subscales scores and the total score. There was a significant median reduction of -37.4% after uterine fibroid embolization, but no correlations between uterine volume and quality of life scores were found before or after embolization. CONCLUSION: Uterine embolization is an alternative to treat uterine fibroids, resulting in relief of symptoms and better quality of life. Although reduction in uterine volume plays an important role in the evaluation of therapeutic success, it does not necessarily have a definitive correlation with relief of symptoms.

A systematic review of the psychosocial impact of fibroids before and after treatment.

OBJECTIVE: Despite the high prevalence of uterine fibroids, the psychosocial impact of fibroids has not been evaluated across different quality of life indicators and compared with other chronic conditions. Here, we rigorously analyzed available evidence pertaining to the psychosocial burden of uterine fibroids in premenopausal women and compared validated quality of life and symptom scores before and after treatment. DATA SOURCES: We searched PubMed, PsycINFO, ClinicalTrials.gov, Embase, and Cochrane Library for publications from January 1990 to January 2020. STUDY ELIGIBILITY CRITERIA: We considered English-language publications that evaluated the association between uterine fibroids diagnosed by imaging studies in premenopausal women and quality of life by standardized and validated questionnaires at baseline and after treatment. We used a detailed list of terms related to quality of life, questionnaires, and uterine fibroids to conduct the search. METHODS: Three reviewers screened titles and abstracts and then obtained full-text articles for further analysis. The reviewers assessed risk of bias using established Cochrane and Newcastle-Ottawa Scale guidelines. The quality of life scores of premenopausal women with fibroids were reviewed at baseline and compared with those of published quality of life scores in other disease populations in addition to after fibroid treatment. RESULTS: A total of 57 studies were included in the review: 18 randomized controlled trials and 39 observational studies. Of note, the 36-Item Short Form Survey and European Quality of Life Five-Dimension Scale questionnaires both indicated a diagnosis of uterine fibroids to have a disability score that was similar to or exceeded (was a greater psychosocial stressor) a diagnosis of heart disease, diabetes mellitus, or breast cancer. Quality of life scores were lower at baseline than after treatment in all instruments measuring these variables in women with uterine fibroids, indicating significantly impaired psychosocial functioning. Uterine fibroids were associated with significant patient-reported health disabilities related to bodily pain, mental health, social functioning, and satisfaction with sex life. CONCLUSION: A diagnosis of uterine fibroids was a significant psychosocial stressor among women at baseline and relative to other diseases. Validated quality of life instruments indicated therapeutic success and the improvement of both physical and emotional symptoms after treatment.

Randomized trial of a patient education tool about leiomyoma.

OBJECTIVE: Uterine leiomyomata are a frequent indication for women seeking gynecologic care [1]. The objective of our study was to assess whether patient knowledge about leiomyomata, anxiety, or satisfaction with counseling differed in patients who received multimedia counseling versus standard counseling. METHODS: Women with leiomyomata who presented to the gynecology clinic at a single institution were randomized to standard counseling or multimedia counseling using the drawMD OB/GYN iPad™ application. Participants completed a pre-counseling questionnaire, received the designated method of counseling, and completed a post-counseling questionnaire. Outcomes of the study included assessment of patient knowledge, satisfaction, and anxiety. RESULTS: Seventy-two participants were randomized. There was no significant difference in post-counseling anxiety between the groups (p = 0.86). For both groups, anxiety significantly improved after counseling. Both groups were satisfied with the counseling they received, however, there was no difference between groups. Participants in both groups significantly improved their knowledge about fibroids post-counseling. CONCLUSION: Counseling of patients with leiomyomata improves patient satisfaction and knowledge. The addition of a multimedia tool may or may not enhance patient counseling. PRACTICE IMPLICATIONS: This is the first prospective, randomized controlled trial evaluating the impact of a multimedia tool on patient education and counseling for patients with leiomyomata.

Comparative effectiveness of hysterectomy versus myomectomy on one-year health-related quality of life in women with uterine fibroids.

OBJECTIVE: To compare long-term health-related quality of life (HRQOL) 1 year after hysterectomy or myomectomy for treatment of uterine fibroids (UFs) and to determine whether route of procedure, race, or age affected improvements in HRQOL. DESIGN: Prospective cohort study. SETTING: Eight clinical sites throughout the United States. PATIENT(S): A total of 1,113 premenopausal women with UFs who underwent hysterectomy or myomectomy as part of Comparing Options for Management: Patient-Centered Results for Uterine Fibroids. INTERVENTION(S): None. MAIN OUTCOME MEASURE (S): Self-reported HRQOL measures including Uterine Fibroid Symptom Quality of Life, the European QOL 5 Dimension Health Questionnaire, and the visual analog scale at baseline and 1-year after hysterectomy or myomectomy. RESULT (S): Hysterectomy patients were older with a longer history of symptomatic UF compared with myomectomy patients. There were no differences in baseline HRQOL. After adjustment for baseline differences between groups, compared with myomectomy, patients' HRQOL (95% confidence interval [CI], 5.4, 17.2) and symptom severity (95% CI, -16.3, -8.8) were significantly improved with hysterectomy. When stratified across race/ethnicity and age, hysterectomy had higher HRQOL scores compared with myomectomy. There was little difference in HRQOL (95% CI, 0.1 [-9.5, 9.6]) or symptom severity (95% CI, -3.4 [-10, 3.2]) between abdominal hysterectomy and abdominal myomectomy. CONCLUSION (S): HRQOL improved in all women 1 year after hysterectomy or myomectomy. Hysterectomy patients reported higher HRQOL summary scores compared with myomectomy patients. When stratified by route, minimally invasive hysterectomy had better HRQOL scores than minimally invasive myomectomy. There was little difference in scores with abdominal approaches.

Influence of Ethnicity on Clinical Presentation and Quality of Life in Women With Uterine Fibroids: Results From a Prospective Observational Registry.

OBJECTIVE: This study sought to evaluate ethnic variations in the clinical presentation of women with uterine fibroids. METHODS: A total of 996 premenopausal women with symptomatic uterine fibroids were enrolled in a prospective, non-interventional, observational registry at 19 clinical sites across Canada (CAPTURE Registry). Patient-reported outcomes were assessed using Uterine Fibroid Symptom and Health-Related Quality of Life Symptom Severity questionnaires and the Aberdeen Menorrhagia Severity Scale (Ruta score). Linear and logistic regression models, adjusted for patient and fibroid characteristics, were used to examine differences among ethnicities for continuous and binary outcomes of interest. RESULTS: Black women were 4.9 years younger (P < 0.001), were more likely to be nulligravid (P = 0.046), had a 41% longer duration of symptoms before enrolment (P = 0.01), had a 49% larger fibroid volume (P = 0.01), and were more likely to be anemic (P < 0.001) compared with White women. Black women reported lower health-related quality of life scores (-5.19 points; 95% CI -9.90 to -0.48, P = 0.03) compared with White women. East Asian women were 2.0 years younger (P = 0.01), were more likely to be nulligravid (P < 0.001), had a 53% longer duration of symptoms (P = 0.01), had 67% larger fibroid volume (P = 0.01), and were more likely to be anemic (P = 0.003) compared with White women. East Asian women had lower symptom severity scores (-5.95 points; 95% CI -11.16 to -0.75, P = 0.02). Non-White women preferred uterine-preserving treatment options (P < 0.001). CONCLUSION: Black and East Asian women have an increased burden of disease compared with White women and prefer uterine preservation. There is a discrepancy between disease burden and patient-reported outcomes that may reflect ethnocultural differences in disease experience.

Ulipristal acetate on quality of life and sexual function of women with uterine fibromatosis.

To evaluate quality of life and sexual function of childbearing-age women, affected by uterine fibromatosis undergoing medical treatment with ulipristal acetate. The data obtained by filling the questionnaires European Quality of Life Five-Dimension Scale and modified Female Sexual Function Index, were analyzed to assess UPA usefulness in improving QoL and sexual activity. A total of 139 patients affected by uterine fibromatosis undergoing conservative ulipristal acetate treatment were enrolled in this prospective observational cohort study. Seventy-one women (average age 46.5 years) answered the questionnaires: QoL and sexuality were evaluated before and after ulipristal acetate treatment. 59 patients (83.1%) had an improvement of QoL and general health state, with a reduction of VAS score after ulipristal acetate treatment. EQ-5D-5L showed a statistically significant improvement of usual act impairment, mobility, discomfort, anxiety/depression (p < .0005). There was no difference in personal care management after therapy. Modified FSFI showed a statistically significant improvement (p < .0001) of sexual satisfaction and sexual life. A not statistically significant improvement in dyspareunia was also highlighted. This study provides a clear picture about QoL impact on women and confirms the effectiveness of the ulipristal acetate in improving different aspects of daily and sexual life of patients undergoing medical treatment.

Anxiety of myoma patients: results of standardized interviews with the State Trait Anxiety Inventory and the Kessler 10 questionnaire.

Introduction: The aim of this study was to explore a possible relation between myoma-related anxieties and general state or trait anxiety or psychological distress, to get a better understanding of the impact of anxiety on the patients.Methods: This prospective study was conducted at the myoma clinic of a large university hospital in a major European city from November 2016 to February 2017. Patients completed standardized questionnaires on myoma-related fears, the State Trait Anxiety Inventory (STAI), and the Kessler 10.Results: Eighty-five out of 88 women agreed to participate. State-anxiety on the STAI had a mean of 49.4 (11 points above the norm (p < .001)), and trait-anxiety had a mean of 42.0 (5 points above the norm (p = .001)). Thirty-seven percent of the patients had distress values on the K10 above the norm (defined as <20). More myoma-related fears correlated with higher scores on the Kessler and STAI. The scores were not related to the level of information about myomas or duration of illness.Conclusions: Myoma-related fears correlated with higher mental distress and elevated state and trait anxiety levels. Thus, physicians can contribute to the overall well-being of patients when they relieve them of the myoma-related anxiety. Further research is needed to determine whether treatment has any impact on anxiety or mental distress.

Improvement in parameters of quality of life and uterine volume reduction after uterine fibroid embolization / Melhora em parâmetros de qualidade de vida e redução do volume uterino após embolização de artérias uterinas

ABSTRACT Objective To evaluate improvement in quality of life, reduction of uterine volume, and the correlation between these two variables after uterine fibroid embolization. Methods Data on quality of life before and after uterine fibroid embolization were collected from 60 patients using the Uterine Fibroid Symptom - Quality of Life questionnaire. In 40 of these patients, uterine volume information on magnetic resonance imaging examinations performed before and after uterine fibroid embolization was collected, and compared using the nonparametric Wilcoxon test for paired data. Correlation between quality of life and uterine volume before and after procedure was measured using Spearman's correlation coefficient. Results There was significant improvement in quality of life after uterine fibroid embolization on Uterine Fibroid Symptom - Quality of Life questionnaire, in both subscales scores and the total score. There was a significant median reduction of -37.4% after uterine fibroid embolization, but no correlations between uterine volume and quality of life scores were found before or after embolization. Conclusion Uterine embolization is an alternative to treat uterine fibroids, resulting in relief of symptoms and better quality of life. Although reduction in uterine volume plays an important role in the evaluation of therapeutic success, it does not necessarily have a definitive correlation with relief of symptoms.

RESUMO Objetivo Avaliar a melhora na qualidade de vida e a redução do volume uterino, além da correlação entre essas duas variáveis, após a embolização de artérias uterinas. Métodos Foram coletados dados de 60 pacientes sobre qualidade de vida antes e depois da embolização de artérias uterinas com a aplicação do questionário Uterine Fibroid Symptom - Quality of Life. Informações sobre o volume uterino em exames de ressonância magnética realizada antes e depois do procedimento foram coletadas em 40 dessas pacientes e comparadas por meio de teste não paramétrico de Wilcoxon para dados pareados. A correlação entre qualidade de vida e volume uterino antes e depois do procedimento foi determinada pelo coeficiente de Spearman. Resultados Houve melhora significativa na qualidade de vida das pacientes após embolização de artérias uterinas nos escores do questionário Uterine Fibroid Symptom - Quality of Life, tanto das subescalas como do total. Houve redução mediana significativa (-37,4%) no volume uterino após embolização de artérias uterinas, embora não tenha sido estabelecida qualquer correlação entre volume uterino e escores de qualidade de vida antes e depois da embolização. Conclusão A embolização de artérias uterinas é alternativa para o tratamento de fibroide uterina, resultando na melhora dos sintomas e da qualidade de vida. Embora a redução do volume uterino seja fator importante na avaliação do sucesso terapêutico, não está necessariamente correlacionada com melhora de sintomas.

Uterine Fibroid Symptom and Health-related Quality of Life Questionnaire: a Chinese translation and validation study.

INTRODUCTION: The Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) questionnaire is a validated tool in English language to assess treatment outcomes for women with fibroids. We performed a Chinese (traditional) translation and cultural adaptation of it and evaluated its reliability, validity, and responsiveness. METHODS: Overall, 223 Chinese women aged ≥18 years with uterine fibroids self-administered the UFS-QOL, Short-Form Health Survey-12, pictorial blood loss assessment chart (PBAC), and a visual analogue scale (VAS) on fibroid-related symptom severity. Demographics and haemoglobin levels were recorded; physical examination and ultrasound for size of fibroids were performed. Half of the women were followed up 6 months later for responsiveness. RESULTS: Cronbach's alpha coefficients ranged from 0.706 to 0.937, demonstrating high internal reliability. The intra-class correlation coefficients to measure test-retest reliability implied excellent stability of symptom scores (0.819, P<0.001), health-related quality of life scores (0.897, P<0.001), and all subscales (range 0.721-0.870, P<0.001). Convergent validity was demonstrated by positive correlations between the findings of various symptom severity assessment tools (PBAC, VAS on fibroid-related symptoms severity) and the symptom severity domain of Chinese UFS-QOL. In addition, there were positive correlations between health-related quality of life scores of Chinese UFS-QOL and the corresponding subscales of the Short-Form Health Survey-12. Responsiveness was shown by reduction of symptom severity scores and improvement of health-related quality of life scores after treatment. CONCLUSIONS: The Chinese version of the UFS-QOL is valid, reliable, and responsive to changes after treatment.

The association between chronic psychological stress and uterine fibroids risk: A meta-analysis of observational studies.

The association between chronic psychological stress and uterine fibroids (UFs) risk remains unclear. In this study, a meta-analysis of observational studies was performed to explore the reported association between them. A literature search was performed in PubMed, EMBASE, and Web of Science to identify relevant published articles. A random-effect model was used to examine pooled odds ratio (OR) and 95% confidence interval (CI). Additionally, subgroup analyses and two-stage random-effect dose-response meta-analysis were performed. A total of six articles with seven studies were included in this meta-analysis. For the highest versus lowest category of chronic psychological stress, the pooled OR was 1.24 (95% CI [1.15, 1.34]; p = .000). Through subgroup analyses, we found a positive association between chronic psychological stress and UFs risk especially in non-Hispanic Blacks studies (OR, 1.24, 95% CI [1.14, 1.34], p = .000). When evaluating for a dose-response, we found a weak correlation between chronic psychological stress and UFs risk, especially for the severe (OR, 1.17, 95% CI [1.07, 1.29]) and very severe (OR, 1.23, 95% CI [1.07, 1.41]) categories. Our meta-analysis shows a statistically significant association between chronic psychological stress and UFs risk particularly for non-Hispanic Blacks. Interventions aiming to reduce chronic psychological stress may be useful to decrease the prevalence of UFs.

Health-related quality of life in pregnancy with uterine fibroid: a cross-sectional study in China.

BACKGROUND: Uterine fibroids (UFs) are the most common benign tumors in women. They are likely to cause numerous clinical symptoms, such as pain, menorrhagia, and other obstetric complications in pregnant women. This study aimed to determine the health-related quality of life (HRQoL) during pregnancy with uterine fibroids (UF), thus providing a utility-based case value in pregnant women with UF and understanding of whether HRQoL is associated with clinical outcomes in pregnant women with UFs. METHOD: This study was conducted in a cross-sectional manner. This study was based on questionnaire surveys completed by sequential out- and in-patients and was conducted in a regional university hospital in Guangzhou, China. The EuroQoL five-dimension-five-level (EQ-5D-5 L) questionnaire was used, and demographic data were collected. An electronic record of the clinical outcomes of pregnant women with UF was retrieved from the hospital's electronic medical record system. The association between UF and HRQoL was evaluated by ordered regression. RESULTS: Seven-hundred-sixty-seven pregnant women with a mean age (SD) of 32.7 (4.8) years completed 707 questionnaires. Overall, when comparing the UF with non-UF groups, we detected statistical differences in age, body mass index (BMI), gravidity and abortion times, partner's smoking and alcoholic habits, advanced maternal age, and uterine scars (p <  0.05). Furthermore, pregnant women without UF scored significantly higher than those with UF on the EQ-5D value system (0.84 versus 0.79; p = 0.017). Moreover, pregnant women with UF suffered more health-related problems, especially with respect to self-care (odds ratio [OR] = 3.69, p <  0.01) and usual activity dimensions (OR = 2.11; p = 0.01). CONCLUSION: We found that UF has a negative impact on the HRQoL of pregnant women with respect to self-care and usual activity dimensions. Also, the EQ-5D score was a better index than the EQ-VAS score for HRQoL when evaluating of the QoL of our population of pregnant women.

Health-Related Quality of Life With Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial.

OBJECTIVE: To investigate effects of ulipristal acetate on health-related quality of life (QOL) and symptom severity in women with symptomatic uterine leiomyomas and abnormal uterine bleeding. METHODS: Women were randomized to ulipristal (5 mg, 10 mg) or placebo in two phase 3, multicenter, double-blind, placebo-controlled trials (VENUS I and II). Health-related QOL and symptom severity were assessed at baseline, and over one (VENUS I and II) and two (VENUS II) 12-week treatment courses using the Uterine Fibroid Symptom Health-Related Quality of Life questionnaire. In pooled VENUS I and II data, change from baseline to the end of the first course for each Uterine Fibroid Symptom Health-Related Quality of Life scale was analyzed, including a Revised Activities subscale that measured physical and social activities. The proportion of women achieving meaningful change in the Symptom Severity (20 or more points), Health-Related QOL Total (20 or more points), and Revised Activities (30 or more points) scales was calculated. In VENUS II data, change from baseline to the end of each course in each scale was analyzed for each treatment arm. RESULTS: In pooled analyses, the intent-to-treat population included 589 patients (placebo, n=169; ulipristal 5 mg, n=215; ulipristal 10 mg, n=205). Significantly greater improvements from baseline in all Uterine Fibroid Symptom Health-Related Quality of Life scales were observed with both ulipristal doses compared with placebo (P<.001). A meaningful change in Revised Activities was achieved by 51 patients receiving placebo (34.9%), compared with 144 (73.5%; OR 5.0 [97.5% CI 2.9-8.6]) and 141 (80.6%; OR 7.9 [97.5% CI 4.3-14.6]) patients receiving ulipristal 5 mg, and 10 mg, respectively. In VENUS II, at end of courses 1 and 2, both ulipristal doses demonstrated significant improvements from baseline compared with placebo for all Uterine Fibroid Symptom Health-Related Quality of Life scales (P<.01). Mean Revised Activities scores showed that beneficial ulipristal effects were maintained in course 2, and improvements occurred on switching to ulipristal; results for other scales were similar. CONCLUSION: Ulipristal was associated with significant improvements in health-related QOL and symptom severity compared with placebo for women with symptomatic uterine leiomyomas. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02147197 and NCT02147158. FUNDING SOURCE: Allergan plc, Dublin, Ireland.

[Disease burden on uterine fibroids in China, 1990 and 2016].

Objective: To assess the disease burden on uterine fibroids in China in 1990 and 2016. Methods: Data were extracted from the Global Burden of Disease Study 2016. Burdens of uterine fibrosis among different age groups and provinces were measured in 1990 and 2016, with key indicators including number of cases, prevalence rates, disability-adjusted life year (DALY) and the rates of DALY. The WHO world standard population, 2010-2035 was used to calculate the age- standardized rates. Results: In 1990 and 2016, there were 13 695 567 and 27 169 312 women aged 15 years and older, suffered from uterine fibrosis respectively, with prevalence rate as 2.48% and 4.10%, DALY as 146 045.05 life years and 281 976.67 life years, and the DALY rate as 26.40/100 000 and 42.50/100 000, in 1990 and 2016 respectively. Both the prevalence rate and the DALY rate increased with age, reaching the peak on the 45-49 years-old, in both 1990 and 2016. Women aged 40-54 years accounted for 55.60% (1990) and 66.74% (2016) of the total cases while 48.37% (1990) and 60.65% (2016) of the total DALY. The first three provinces with highest DALYs were Shandong (1990: 12 574.67 life year; 2016: 22 728.12 life year), Henan (1990: 10 849.29 life year; 2016: 18 454.32 life year) and Jiangsu (1990: 10 501.55 life year; 2016: 18 274.10 life year), while the three provinces with leading standardized DALY rates were Heilongjiang (1990: 48.20/100 000; 2016: 47.00/100 000), Shanxi (1990: 44.50/100 000; 2016: 47.70/100 000) and Tianjin (1990: 43.80/100 000; 2016: 46.40/100 000) in both 1990 and 2016. Compared with 1990, the number of cases with uterine fibroids increased by 13 473 745 (with rate of change as: 98.38%), standardized prevalence rate increased by 1.88%, DALY value increased by 135 931.62 life years (with the rate of change as 93.08%) and standardized DALY rate increased by 5.92% among Chinese women, in 2016. Conclusion: Menopausal women were the ones hard hit by uterine fibrosis. Compared with data from 1990, the disease burden of uterine fibrosis increased rapidly in China, in 2016.

Burden, Prevalence, and Treatment of Uterine Fibroids: A Survey of U.S. Women.

BACKGROUND: Most women will experience uterine fibroids by the age of 50, yet few data exist describing the overall patient experience with fibroids. The objective of this population-based survey was to characterize symptom burden, patient awareness, and treatment decision-making for fibroids, including a comparison among women of varying backgrounds. MATERIALS AND METHODS: Women (≥18 years) were recruited via email from GfK KnowledgePanel®, a representative panel of US households, or identified with opt-in consumer panels. The Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QOL) questionnaire and Aberdeen Menorrhagia Severity Scale (AMSS) were included. RESULTS: Eligible women were grouped into three cohorts: "at-risk" (symptoms suggestive of fibroids without clinical diagnosis, n = 300), "diagnosed" (n = 871), and fibroid-related "hysterectomy" (n = 272). Cohort and intracohort race/ethnicity and income analyses revealed differences in symptom burden, awareness/perception, and treatment history. Based on UFS-QOL scores, at-risk women reported significantly greater symptom severity and decreased health-related QOL versus diagnosed women; Hispanic women reported greater symptom severity versus white and black women. At-risk women also reported heavy menstrual bleeding and significant impact on work productivity. Among diagnosed women, 71% used pharmacologic therapy for symptom relief, and 30% underwent surgical or procedural treatment. Initial discussions with healthcare providers significantly impacted treatment outcomes; the hysterectomy cohort was most likely to first discuss hysterectomy. CONCLUSIONS: Women with fibroids or symptoms suggestive of fibroids experience significant distress that reduces QOL, particularly racial minorities and women in lower income brackets. Survey results suggest that many women are likely undiagnosed, underscoring the need for improved awareness and education.