Severity Of Dysmenorrhea Research Articles

Comparison between the effects of aerobic and isometric exercises on primary dysmenorrhea

Background: Primary dysmenorrhea is a cramping pain in the lower abdomen occurring just before or during menstruation without pelvic pathology. One of the methods used to decrease this condition's severity is exercise. Objective: The aim of this study was to compare the effects of aerobic and isometric exercises on primary dysmenorrhea. Methods: This was a randomized clinical trial that included 105 females aged 18-25 years complaining of primary dysmenorrhea. The participants were divided into three groups equal in number: (1) aerobic exercise (n = 35), (2) isometric exercise (n = 35), and (3) control group (n = 35). The two intervention groups performed exercises three times a week for eight weeks (two menstrual cycles). Participants were assessed using the plasma progesterone levels, visual analogue scale, and modified menstrual symptom questionnaire. Results: The within-group comparisons before and after the training program demonstrated significant differences in the aerobic exercise group regarding the visual analogue scale (p = .001, d = 0.652), plasma progesterone levels (p = .001, d = 0.688), and modified menstrual symptoms questionnaire (p = .001, d = 0.607). Also, there were significant differences in the isometric exercise group regarding the visual analogue scale (p = .001, d = 0.633), plasma progesterone levels (p = .001, d = 0.502), and modified menstrual symptoms questionnaire (p = .001, d = 0.462); however, no significant differences were observed in the control group. In addition, after the end of the exercise program when compared with their corresponding values measured before intervention significant differences were observed regarding these parameters between the aerobic and control group (p = .001) as well as between the isometric and control group (p = .001). On the other hand, after the end of the exercise program no significant differences were observed between the aerobic and isometric groups regarding the visual analogue scale (p = .14) or plasma progesterone level (p = .14); however, a significant difference was observed in the modified menstrual symptoms questionnaire between these two groups (p = .001) with favor to the aerobic exercise group. Conclusions: Both aerobic and isometric exercises are effective in reducing the severity of dysmenorrhea.

The Association Between Severity of Dysmenorrhea and Social Support among Female Students of Ilam University of Medical Sciences

Background: Dysmenorrhea or painful menstruation is the most common periodic pain in women, which includes primary and secondary types. One of the possible factors affecting the severity of dysmenorrhea is the presence or absence of social support. Objectives: Due to the high prevalence of dysmenorrhea and its undesirable consequences on the quality of personal, social, and academic life of students, this study aimed to evaluate the association between severity of dysmenorrhea and social support among female students of Ilam University of Medical Sciences, Iran. Methods: Using purposeful sampling method, this cross-sectional and descriptive-analytical study was conducted on 286 female students of Ilam University of Medical Sciences (age range: 18 - 28 years) in 2018. Data collection tools included demographic information form, Visual Analogue Scale (VAS) to determine pain severity, and standardized Social Support Questionnaire (SSQ) to assess social support. Descriptive statistics (frequency and mean) and analytical statistics (Pearson’s correlation coefficient) were used for data analysis in SPSS software version 16. Results: The mean age of the samples was 21.62 ± 2.10 years, and the mean age of menarche was 13.57 ±1.33 years. The prevalence of primary dysmenorrhea was 86% among the samples, with 8% of them having low social support, 39.2% moderate social support, and 52.8% high social support. There was a significant association between social support and severity of dysmenorrhea so that Pearson’s correlation coefficient showed an inverse association between the two variables (r = -0.187, P = 0.002). Conclusions: The inverse association between the severity of dysmenorrhea and the level of social support highlighted the need for planning to create and enhance social support by family and community and reduce the effects that dysmenorrhea can have on physical, mental, and social health of individuals.

Ibero-American Endometriosis Patient Phenome: Demographics, Obstetric-Gynecologic Traits, and Symptomatology.

Background: An international collaborative study was conducted to determine the demographic and clinical profiles of Hispanic/Latinx endometriosis patients from Latin America and Spain using the Minimal Clinical Questionnaire developed by the World Endometriosis Research Foundation (WERF) Endometriosis Phenome and Biobanking Harmonization Project (EPHect).Methods: This is a cross-sectional study to collect self-reported data on demographics, lifestyle, and endometriosis symptoms of Hispanic/Latinx endometriosis patients from April 2019 to February 2020. The EPHect Minimal Clinical Questionnaire (EPQ-M) was translated into Spanish. Comprehension and length of the translated survey were assessed by Spanish-speaking women. An electronic link was distributed via social media of endometriosis patient associations from 11 Latin American countries and Spain. Descriptive statistics (frequency, means and SD, percentages, and proportions) and correlations were conducted using SPSSv26.Results: The questionnaire was completed by 1,378 participants from 23 countries; 94.6% had self-reported diagnosis of endometriosis. Diagnostic delay was 6.6 years. Most participants had higher education, private health insurance, and were employed. The most common symptoms were back/leg pain (85.4%) and fatigue (80.7%). The mean number of children was 1.5; 34.4% had miscarriages; the mean length of infertility was 3.7 years; 47.2% reported pregnancy complications. The most common hormone treatment was oral contraceptives (47.0%). The most common comorbidities were migraines (24.1%), polycystic ovary syndrome (PCOS) (22.2%), and irritable bowel syndrome (21.1%). Most participants (97.0%) experienced pelvic pain during menses; for 78.7%, pain was severe; 86.4% reported dyspareunia. The mean age of dysmenorrhea onset was 16.2 years (SD ± 6.1). Hormone treatments were underutilized, while impact was substantial. Pain catastrophizing scores were significantly correlated with pain intensity (p < 0.001).Conclusion: This is the first comprehensive effort to generate a clinical–demographic profile of Hispanic/Latinx endometriosis patients. Differences in clinical presentation compared to other cohorts included higher prevalence and severity of dysmenorrhea and dyspareunia and high levels of pain catastrophizing. Though future studies are needed to dissect the impact of race and ethnicity on pain and impact, this profile is the first step to facilitate the recognition of risk factors and diagnostic features and promote improved clinical management of this patient population. The EPHect questionnaire is an efficient tool to capture data to allow comparisons across ethnicities and geographic regions and tackle disparities in endometriosis research.

The Effect of Combined Vitamin C and Vitamin E Supplementation on Oxidative Stress Markers in Women with Endometriosis: A Randomized, Triple-Blind Placebo-Controlled Clinical Trial.

Background Endometriosis is a chronic and estrogen-dependent pelvic inflammatory disease, which may have various causes, such as oxidative stress. Dysmenorrhea, dyspareunia, and pelvic pain are well-known symptoms of endometriosis. The present clinical trial assessed the role of supplementation with antioxidant vitamins on the indices of oxidative stress as well as the severity of pain in women with endometriosis. Materials and Methods We enrolled 60 reproductive-aged (15–45 years) women with pelvic pain in this triple-blind clinical trial. They had 1–3 stages of laparoscopic-proven endometriosis. The participants were randomized to group A (n = 30), given vitamin C (1000 mg/day, 2 tablets of 500 mg each) and vitamin E (800 IU/day, 2 tablets of 400 IU each) combination, or group B (n = 30), given placebo pills daily for 8 weeks. Results Following treatment with vitamin C and vitamin E, we found a significant reduction in MDA and ROS compared with the placebo group. There was no significant decline in total antioxidant capacity after treatment. However, the severity of pelvic pain (p value <0.001), dysmenorrhea (p value <0.001), and dyspareunia (p value <0.001) significantly decreased in the treatment group after 8 weeks of supplementation. Conclusions The present findings support the potential role of antioxidants in the management of endometriosis. The intake of vitamin C and vitamin E supplements effectively reduced dysmenorrhea severity and improved dyspareunia and severity of pelvic pain.

Vitamin D supplementation for primary dysmenorrhea: a double-blind, randomized, placebo-controlled trial.

ObjectiveRecent studies have shown a possible association between vitamin D deficiency and the severity of primary dysmenorrhea. The present study aimed to investigate the effect of vitamin D supplementation on pain and systemic symptoms in patients with primary dysmenorrhea.MethodsThis double-blind, randomized, placebo-controlled trial was conducted on female students aged 18 to 32 years with primary dysmenorrhea and vitamin D deficiency (25 [OH]D <30 ng/mL). The participants (n=116) received either 50,000 IU of vitamin D3 (cholecalciferol) or placebo capsules on a weekly basis for eight consecutive weeks. The outcomes were pain intensity (scored 0 to 10), number of days with pain, number of consumed pain-relief medications (per day), and severity of systemic symptoms (fatigue, headache, nausea/vomiting, and diarrhea; total score of 0 to 12).ResultsCompared with baseline, our participants who received vitamin D experienced significant reductions in pain intensity (−1.0 and −1.5 score at weeks 4 and 8, P<0.001), the number of days with pain (−1.0 day at weeks 4 and 8, P<0.001), the number of consumed pain-relief medications (−1.0 at weeks 4 and 8, P<0.001), and systemic symptoms severity (−1.0 score at weeks 4 and 8, P<0.001). No significant improvements were observed in the placebo group in terms of these outcomes.ConclusionVitamin D supplementation in women with primary dysmenorrhea and vitamin D deficiency could improve systemic symptoms and reduce pain intensity, the number of days with pain, and the need for consuming pain-relief medications.

Efficacy of Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD) and Verbal Rating Scale (Pain and Drug) in Diagnosing and Predicting Severity of Dysmenorrhea among Adolescents: A Comparative Study

Efficacy of Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD) and Verbal Rating Scale (Pain and Drug) in Diagnosing and Predicting Severity of Dysmenorrhea among Adolescents: A Comparative Study

The effectiveness of a modified Gui Zhi Fu Ling Wan formulation (Gynoclear\u2122) for the treatment of endometriosis: a study protocol for a placebo-controlled, double-blind, randomised controlled trial

BackgroundEndometriosis is the presence of tissue similar to that of the endometrium outside the uterine cavity and is the most common cause of chronic pelvic pain. Current non-surgical treatments such as non-steroidal anti-inflammatories, oral contraceptive pills and hormonal treatments have limited effectiveness, and the side effect profile is bothersome. This study will evaluate the efficacy of Gynoclear™ by change in endometriosis-related pain based on the Endometriosis Pain Daily Diary (EPPD) scores.MethodsThis randomised, double-blind, placebo-controlled trial will recruit a minimum of 90 adult participants across Australia who have a laparoscopic visualisation/confirmation of endometriosis in the last 5 years and have current moderate or greater pelvic pain. Participants will be randomly allocated in a 1:1 ratio to receive either Gynoclear™ (active) or placebo. Gyncolear’s active ingredients are Carthamus tinctorius (Safflower), Cinnamomum cassia (Chinese cinnamon), Poria cocos (Hoelen), Paeonia suffriticosa (Tree peony), Paeonia lactiflora (Peony) and Salvia miltiorrhiza (Red sage). Participants are asked to complete a total of 5 months’ worth of pain diary entries via the EPDD v3, including 1-month screening, 2-month treatment period and 1-month post-treatment follow-up. The primary outcome variable is change in endometriosis-related pain based on the EPDD v3 scores. Secondary outcomes include change in health-related quality of life via the Endometriosis Health Profile (EHP-30), SF-12 and EQ-5D scores as well as changes in rescue analgesic usage, dyspareunia and fatigue via the EPDD.DiscussionThis study will determine the safety and efficacy of Gynoclear™ to reduce the severity and duration of non-cyclical pelvic pain, dysmenorrhoea, dyspareunia and other symptoms of endometriosis. Study outcomes will be of interest to health professionals and members of the public who suffer from endometriosis.Trial registrationAustralia and New Zealand Clinical Trials Registry ACTRN12619000807156. Registered on 3 June 2019.

The relationship between dysmenorrhea and sleep quality

Purpose: This study was conducted to determine the prevalence of dysmenorrhea and the relationship between dysmenorrhea and sleep quality. &#x0D; Materials and Methods: This was a cross-sectional study. A total of 250 volunteer female university students, who met the inclusion criteria, participated in this study. To collect data a questionnaire form, the Visual Analog Scale (VAS) and Pittsburgh Sleep Quality Index (PSQI) were used. &#x0D; Results: The prevalence of dysmenorrhea in students was 82.4%. Eighty-two percent of the students with dysmenorrhea had poor sleep quality. It was determined that 96.8% of the students with sleep division in the menstrual period and 96.3% of those with difficulty falling asleep had dysmenorrhea. In participants with dysmenorrhea, there were different level of correlation between poor sleep quality and the number of sleep divisions, severity of dysmenorrhea), and less duration of sleep.&#x0D; Conclusion: Dysmenorrhea has a negative effect on sleep quality. In accordance with these results, it is advisable to identify students with dysmenorrhea and to give training on methods of coping with it to improve their sleep quality.

Acupressure to Reduce Dysmenorrhea in Adolescent

Background: Dysmenorrhea is uncomfort symptom which suffered by adolescents during menstruation period. Adolescents experienced with dysmenorrhea and this commonly primary. Dysmenorrhea affects almost half of all woman, and it is need the safe and effective pain management. One of non-medical treatment techniques is acupressure. The purpose of this study to analize the effect of acupressure to reduce dysmenorrhea in adolescents. Methods: The design was quantitative experiment with intervention group and control group for each 26 respondents. The acupoints are SP6, Li4, and PC6. Intervention group got acupressure for 2 days in early period with 30times massage for each accupoint twice a day. The pain was measured using visual analog scale (VAS) before and after intervention. Data analize using SPSS software. Results: The result showed diffreneces in pain severity after acupressure to intervention group with mean 2,43 and p value 0.027(p&lt;0,005). Conclution: Acupressure at the SP6, Li4 and PC6 can reduce pain severity of dysmenorrhea in adolescents.

Relationship between Cyst Fluid Concentrations of Iron and Severity of Dysmenorrhea in Patients with Ovarian Endometrioma

Objectives and Design: Endometriosis-related pain can be caused by anatomical distortions as well as environmental factors such as inflammation and oxidative stress. The aim of this study is to investigate the relationship between the severity of dysmenorrhea in patients with ovarian endometrioma (OMA) and cyst fluid (CF) concentrations of irons, including total iron, heme iron, and free iron. Method: Eighty-three patients who were histologically diagnosed with OMA were enrolled in the Department of Gynecology, Nara Medical University Hospital, between 2013 and 2019. The patients were divided into 4 groups according to the severity of dysmenorrhea: no pain, mild, moderate, and severe. Iron concentration was measured by the inductively coupled plasma optical emission spectrometry method. Results: There were no significant differences among the 4 groups in variables such as age at diagnosis, preoperative CA125, preoperative CA19-9, cyst size, and tumor laterality (unilateral or bilateral). There was a positive correlation between the severity of dysmenorrhea and total iron (p < 0.001) and heme iron (p = 0.016) concentrations. Multiple regression analyses revealed that the CF concentration of total iron (hazard ratio 18.75, 95% confidence interval: 2.26–155.35, p = 0.007) was a significant independent variable associated with the severity of dysmenorrhea. A receiver operating characteristic curve analysis showed that a total iron exceeding 290.8 mg/L was associated with severe dysmenorrhea with a sensitivity of 90.9% and a specificity of 65.7%. Limitations: This study excluded patients with adenomyosis, superficial endometriosis, or deep endometriosis, resulting in a smaller number of cases. Iron levels could not be compared to the endometriosis stage using the r-ASRM score. Conclusions: There is no clear evidence that iron predicts the severity of endometriosis-related pain. However, iron may be closely associated with dysmenorrhea.

Immunoreactivity of Plasminogen Activator Inhibitor 1 and Its Correlation with Dysmenorrhea and Lesional Fibrosis in Adenomyosis

Adenomyosis is associated with dysmenorrhea, infertility, and lesional fibrosis. The pathogenesis of adenomyosis is still unclear. Plasminogen activator inhibitor 1 (PAI-1) plays important roles in pathological activities like tumor metastasis and endometriosis. Our objective was to investigate the expression and localization of PAI-1 in eutopic and ectopic endometrium with adenomyosis and in endometrium without adenomyosis. We also sought to determine the relationship between PAI-1 immunoreactivity and the severity of dysmenorrhea and the extent of lesional fibrosis in adenomyosis. PAI-1 expression was significantly higher in the ectopic endometrium of patients with adenomyosis than in both the eutopic endometrium of patients with adenomyosis and the endometrium of controls. Ectopic PAI-1 expression correlated positively with dysmenorrhea visual analog scale (VAS) scores and the extent of lesional fibrosis in adenomyosis. High PAI-1 expression increased the likelihood of moderate to severe dysmenorrhea in adenomyosis. These results suggest that PAI-1 is involved in the adenomyosis-associated dysmenorrhea and lesional fibrosis, which provide a potential target in treating symptomatic adenomyosis.

Evaluation of the severity and self-management practice in primary dysmenorrhea in medical and dental students: A cross-sectional study in a teaching hospital

Background: Primary dysmenorrhea is the commonest gynecological problem in females of childbearing age. The severity of dysmenorrhea catalyzed females to use home remedies or self-medication to relieve pain.&#x0D; Aims and Objectives: The study aimed to find out the severity of primary dysmenorrhea and self-management practices in medical and dental students.&#x0D; Materials and Methods: Female students who had painful menstrual cycles were included. A self-responding semi-structured questionnaire was used to collect information related to demographic, menstrual characteristics and self-management practices. The severity of primary dysmenorrhea was estimated by using the Verbal Multidimensional Scoring System (VMSS). Descriptive statistics were used to present the study findings using SPSS version 11.5.&#x0D; Results: Out of 143 students, mild severity of primary dysmenorrhea was more common 85 (59.4%), followed by moderate 44 (30.8%) and severe 14 (9.8%) dysmenorrhea. Over two-thirds 124 (86.7%) of respondents used home remedies alone or in combination with analgesic drugs 87 (60.8%). Mefenamic acid 44 (50.6%) was the most common self-medicated drug. Among the respondents who practiced self-medication, the majority had used drugs once a day 68 (78.2%), and more than half of them 57 (65.5%) took medication for one day, and 59 (67.8%) had insufficient knowledge about drug dose.&#x0D; Conclusion: Most of the respondents experienced the mild severity of primary dysmenorrhea. Home remedies were the most commonly used methods of self-management. The majority of the respondents did not receive medical consultation, but they were preferred self-medication. Encouragement for medical consultation along with the implementation of educational awareness programs to control morbidity associated with primary dysmenorrhea is recommended.

Elevated Circular RNA PVT1 Promotes Eutopic Endometrial Cell Proliferation and Invasion of Adenomyosis via miR-145/Talin1 Axis

Several theories on the origin of adenomyosis (ADS) have been proposed, of which the most widely accepted is the fundamental pathogenic role of uterine eutopic endometrium. Emerging evidence suggests that circular RNAs participate in the multiple tumorgenesis. The vital importance of circular RNA PVT1 (circPVT1) in the pathological progress like malignancies has been well documented. Nevertheless, its underlying correlation with ADS remains elusive yet. The purpose of this study was to investigate the expression pattern, regulatory effect, and internal mechanism of circPVT1 in ADS. qRT-PCR was performed to detect the relative mRNA expression of circPVT1, miR-145, and Talin1 in ADS endometrial tissue and cells. The protein level of Talin1 was measured by Western blot and immunochemistry. Immunofluorescence was used to identify the primary endometrial epithelial and stromal cells. circPVT1 knockdown in vitro was achieved by transfecting with specific lentivirus vector CCK-8, and colony formation assays were utilized to assess cell proliferation; meanwhile, the transwell assay was employed for evaluating cell invasion ability. By conducting bioinformatics, dual-luciferase reporter assay, or RNA immunoprecipitation (RIP) experiment, the interaction between miR-145 and circPVT1 or Talin1 was verified. Rescue experiments further determined the regulatory effect of circPVT1/miR-145/Talin1 axis. We found both circPVT1 and Talin1 were markedly upregulated in ADS endometrial tissue and cells, whereas miR-145 was decreased. Elevated expression of circPVT1 was closely related to the severity of dysmenorrhea, menorrhagia, and uterine enlargement of patients with ADS. Knockdown of circPVT1 inhibited adenomyotic epithelial and stromal cell proliferation and invasion. Further mechanistic experiments revealed that circPVT1 negatively regulated miR-145 through serving as a molecular sponge. And the facilitating effect of circPVT1 was partially reversed by miR-145. Talin1 was demonstrated to be a down target of miR-145 and indirectly affected by circPVT1. Our findings unveiled that enhanced circPVT1 may be involved in the pathogenesis of ADS via stimulating endometrial cell proliferation and invasion. The establishment of circPVT1/miR-145/Talin1 pathway might present a novel therapeutic insight for ADS.

Efficacy of cyclic and extended regimens of ethinylestradiol 0.02mg -levonorgestrel 0.09mg for dysmenorrhea: A placebo-controlled, double-blind, randomized trial.

PurposeWe aimed to evaluate the efficacy and safety of 28‐day Cyclic and 84‐day Extended regimens of NPC‐16 (ethinylestradiol 0.02 mg plus levonorgestrel 0.09 mg) in patients with dysmenorrhea.MethodsThis was a placebo‐controlled, double‐blind, randomized trial conducted in Japan. A total of 251 primary and secondary dysmenorrhea patients were randomly assigned to the NPC‐16‐Cyclic group, NPC‐16‐Extended group, or the Placebo group. The primary end point was a comparison of the efficacy and safety of the Cyclic and Extended NPC‐16 regimen for the treatment of dysmenorrhea relative to the Placebo.Main findingsSignificantly greater reductions in total dysmenorrhea score and visual analog scale score were observed in the Cyclic and Extended groups compared with the Placebo group. Compared with the Cyclic regimen as a secondary end point, the Extended regimen exhibited greater efficacy in the treatment of dysmenorrhea over the course of the study period, particularly in patients with severe dysmenorrhea. The incidence of adverse drug reactions (ADRs) was significantly higher in the Cyclic and Extended groups than in the Placebo group.ConclusionThe Cyclic and Extended regimens of NPC‐16 significantly reduced dysmenorrhea severity compared to placebo. The Extended regimen was superior to cyclic regimen in reducing the dysmenorrhea.

Possible involvement of neuropeptide and neurotransmitter receptors in Adenomyosis

BackgroundAccumulating data indicate that sensory nerve derived neuropeptides such as substance P and calcitonin gene related-protein (CGRP) can accelerate the progression of endometriosis via their respective receptors, so can agonists to their respective receptors receptor 1 (NK1R), receptor activity modifying protein 1 (RAMP-1) and calcitonin receptor-like receptor (CRLR). Adrenergic β2 receptor (ADRB2) agonists also can facilitate lesional progression. In contrast, women with endometriosis appear to have depressed vagal activity, concordant with reduced expression of α7 nicotinic acetylcholine receptor (α7nAChR). The roles of these receptors in adenomyosis are completely unknown.MethodsAdenomyotic tissue samples from 30 women with adenomyosis and control endometrial tissue samples from 24 women without adenomyosis were collected and subjected to immunohistochemistry analysis of RAMP1, CRLR, NK1R, ADRB2 and α7nAChR, along with their demographic and clinical information. The extent of tissue fibrosis was evaluated by Masson trichrome staining.ResultsWe found that the staining levels of NK1R, CRLR, RAMP1 and ADRB2 were all significantly elevated in adenomyotic lesions as compared with control endometrium. In contrast, α7nAChR staining levels were significantly reduced. The severity of dysmenorrhea correlated positively with lesional ADRB2 staining levels.ConclusionsOur results suggest that SP, CGRP and noradrenaline may promote, while acetylcholine may stall, the progression of adenomyosis through their respective receptors on adenomyotic lesions. Additionally, through the activation of the hypothalamic-pituitary-adrenal (HPA)-sympatho-adrenal-medullary (SAM) axes and the lesional overexpression of ADRB2, adenomyosis-associated dysmenorrhea and adenomyotic lesions may be mutually promotional, forming a viscous feed-forward cycle.

Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix.

ObjectiveIn this post hoc analysis, we evaluated the impact of elagolix on dysmenorrhea and nonmenstrual pelvic pain across menstrual period (bleeding days) and nonmenstrual (nonbleeding) days.MethodsData from two randomized, 6-month, placebo-controlled trials (Elaris Endometriosis (EM)-I and EM-II) of elagolix (150 mg once daily (QD) and 200 mg twice daily (BID)) in premenopausal women with moderate to severe endometriosis-associated pain (N = 1686) were pooled. Women recorded the presence of menstrual period and severity of dysmenorrhea or nonmenstrual pelvic pain in a daily electronic diary.ResultsAt baseline, women in the placebo group and both elagolix treatment groups reported moderate or severe dysmenorrhea, on average, 81% of their menstrual period days and moderate/severe nonmenstrual pelvic pain, on average, 56% of their nonmenstrual (nonbleeding) days. Compared with placebo at month 6, elagolix-treated women had a significantly lower mean (standard deviation (SD)) percentage of menstrual period days with moderate or severe dysmenorrhea (elagolix 150 mg QD = 52.4 (38.9), p = 0.002; elagolix 200 mg BID = 38.5 (43.6), p < 0.001, placebo = 61.3 (33.7)) and a significantly lower mean (SD) percentage of nonmenstrual (nonbleeding) days with moderate or severe nonmenstrual pelvic pain (elagolix 150 mg QD = 31.1 (35.8), p < 0.001; elagolix 200 mg BID = 19.7 (29.9), p < 0.001; placebo = 35.6 (33.9)).ConclusionFollowing 6 months of elagolix treatment, women who still menstruated had a lower proportion of menstrual period days with moderate or severe dysmenorrhea compared with placebo, demonstrating pain reduction despite continued menses. Additionally, pain did not shift from dysmenorrhea to nonmenstrual pelvic pain, as the percentage of days with moderate or severe nonmenstrual pelvic pain was also reduced for elagolix-treated women compared with placebo.Trial RegistrationThe Elaris EM-I study is registered with the US National Library of Medicine, www.ClinicalTrials.gov, NCT01620528. The Elaris EM-II study is registered with the US National Library of Medicine, www.ClinicalTrials.gov, NCT01931670. Both studies are registered with the EU Clinical Trial Register, www.clinicaltrialsregister.ed, 2011-004295-11.

Diffusion-weighted imaging of uterine adenomyosis: Correlation with clinical backgrounds and comparison with malignant uterine tumors.

To elucidate correlation between signal intensity on diffusion-weighted images (SI-DWI) and clinical backgrounds for uterine adenomyosis and to compare SI-DWI of adenomyosis and malignant uterine tumors. This study examined 46 adenomyosis patients diagnosed using magnetic resonance imaging and 25 patients with surgically confirmed malignant uterine myometrial tumor. First, adenomyosis cases were classified visually into high-intensity and low-intensity groups based on the SI-DWI compared with that of normal uterine myometrium. Secondly, correlation was assessed between SI-DWI of adenomyosis and patient clinical background information such as age, menopausal status, menstrual cycle and dysmenorrhea severity. Third, quantitative comparison was made of low-intensity adenomyosis (LIA), high-intensity adenomyosis (HIA) and malignant tumor groups for the signal intensity ratio (SIR) on DWI and the apparent diffusion coefficient (ADC). Their diagnostic performance was evaluated using logistic regression analysis and receiver operating characteristic (ROC) analysis. The 46 adenomyosis cases were classified as 26 low-intensity and 20 high-intensity cases. Significant correlation was found only for menstrual cycle phases. HIA had significantly lower SIR and higher ADC than malignant tumor. The ADC of HIA was significantly higher than that of LIA. The combination of SIR and ADC showed excellent diagnostic performance (area under ROC curve, 0.99). There is a variation in signal intensity on DWI of uterine adenomyosis and it is associated with menstrual cycle phase. Adenomyosis with high signal intensity on DWI can be differentiated from malignant lesions by its lower signal intensity on DWI and higher ADC than that found for malignant uterine tumors, however overlaps exist.

Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial

BackgroundEpidemiological studies have shown that young women often suffer from primary dysmenorrhea (PD) which is a common cause that affects their routine work and quality of life. Chinese herbal medicine has been widely used for PD in China. A systematic review found that Xuefu Zhuyu (XFZY) has a promising effect on PD management, yet there is a dearth of high-quality evidence in support of this claim. We want to conduct a randomized controlled trial to evaluate the efficacy and safety of XFZY for PD patients.MethodsThis is a protocol for a multicenter, randomized, placebo-controlled trial. A total of 248 participants with PD will be recruited at 6 centers and randomized into two groups—a herbal treatment group and a placebo group. The participants will receive either XFZY or placebo, three times per day, for 3 menstrual cycles, with a 12-week follow-up. The primary outcome will be the mean change in pain intensity as measured by VAS, while the change in menstrual pain duration, the change in peak pain intensity as measured by VAS, the Cox Menstrual Symptom Scale (CMSS), quality of life EQ-5D-5L, cumulative painkiller consumption, and health economics will be included as secondary outcomes. Adverse events will also be reported.DiscussionThis protocol describes a multicenter, double-blind, randomized, placebo-controlled trial that investigates the efficacy and safety of XFZY for primary dysmenorrhea. Validated evaluation tools will assess dysmenorrhea severity. We believe that this research will provide important evidence regarding the use of XFZY to treat dysmenorrhea.Trial registrationChinese Clinical Trial Registry ChiCTR1900026819. Registered on 23 October 2019

Role of vitamin D and calcium in the relief of primary dysmenorrhea: a systematic review.

Dysmenorrhea is one of the well-established problems among women of reproductive age and can have adverse effects on the quality of life of the individual. Some studies suggest a relationship between vitamin D (Vit D) and calcium deficiency and the emergence of early dysmenorrhea. Accordingly, a systematic study was performed to investigate the role of calcium and Vit D in the relief of primary dysmenorrhea. A systematic literature search was performed in PubMed, Web of Science, Scopus, Science Direct, and Google Scholar for papers published between 2010 and 2020. The Consolidated Standards of Reporting Trials and Strengthening the Reporting of Observational Studies in Epidemiology checklists were used to assess the quality of the studies. The risk of bias was assessed using the Cochrane risk-of-bias assessment tool. Low calcium levels lead to an increase in uterine muscle contraction and can cause pain after decreased uterine blood flow. Furthermore, low levels of Vit D can increase primary dysmenorrhea by increasing prostaglandin production or reducing intestinal calcium absorption. That being the case, Vit D and calcium intake can be effective in reducing the severity of primary dysmenorrhea and in reducing the rate of analgesic use. Low levels of Vit D and calcium are inversely related to the severity of primary dysmenorrhea, and Vit D and calcium intake can reduce the severity of primary dysmenorrhea and its associated systemic symptoms. Therefore, the use of calcium and Vit D supplements can be recommended to relieve dysmenorrhea.

Effect of Vitamin D3 supplementation on symptomatic uterine leiomyoma in women with Hypovitaminosis D

Objective:The objective of this study is to evaluate the effect of Vitamin D3 on symptoms, uterine and leiomyoma volume in women with symptomatic leiomyoma and hypovitaminosis D.Materials and Methods:In this pilot, interventional, prospective study, 30 premenopausal women with uterine leiomyoma and concomitant hypovitaminosis D (<30 ng/ml) received Vitamin D3 in doses of 60,000 IU weekly for 8 weeks followed by 60,000 IU every 2 weeks for another 8 weeks. Change in symptoms, uterine, and leiomyoma volume was evaluated at 8 weeks and 16 weeks. Serum Vitamin D3 levels were repeated at 16 weeks of therapy.Results:A significant negative correlation was observed between the baseline 25-hydroxy Vitamin D (25(OH) Vitamin D3) and leiomyoma volume (r = –0.434, P < 0.001). There was significant reduction of menstrual blood loss by 29.89% (P = 0.003) and severity of dysmenorrhea, pelvic pain, and backache by 44.12%, 35%, and 50% (P < 0.001, 0.019, and 0.002), respectively, at 16 weeks. At end of therapy, there was 6% reduction in mean uterine volume and 11% in leiomyoma volume which was not significant. Serum 25(OH) Vitamin D3 was significantly higher than baseline level (17.44 ± 5.82 vs. 39.38 ± 8.22, P < 0.001) at end of therapy.Conclusion:Vitamin D3 supplementation is effective in reducing leiomyoma-related symptoms and stabilizing uterine and leiomyoma volume.