Pictorial Blood Loss Assessment Chart Score Research Articles

The association between sonographic features and clinical symptoms of adenomyosis.

To investigate the association of sonographic features and clinical symptoms of adenomyosis. This was a prospective observational study. Only reproductive age women who underwent standardized transvaginal ultrasound examination were included. The diagnosis of adenomyosis was based on sonographic features proposed by Morphological Uterus Sonographic Assessment (MUSA)group. Pictorial blood loss assessment chart (PBAC) and numerical rating scale (NRS) were respectively used for the evaluation of menstrual bleeding and pain. Fifty-three women were recruited. Adenomyosis group consisted of 33 (62.3%) representative cases, whereas control group consisted of 20 (37.7%). Women with adenomyosis experienced significantly heavier menstrual bleeding (p = 0.008) and more painful menstrual periods (p = 0.003). Significant positive correlation between the number of sonographic adenomyosis features and both PBAC (r = 0.613, p < 0.001) and NRS scores (r = 0.402, p = 0.022) was found. PBAC score was significantly higher if either fan-shaped shadowing (r = 0.548, p = 0.001), interrupted junctional zone (JZ) (r = 0.548, p = 0.001) or globular uterus (r = 0.445, p = 0.011) was detected. Interrupted JZ (r = 0.440, p = 0.012) was associated with higher NRS score. Significant positive correlation between PBAC score and adenomyosis spread in uterine layers (r = 0.495, p = 0.004) was established. Certain sonographic features of adenomyosis and assessment of its involvement in uterine layers may predict the severity of adenomyosis symptoms.

Gynecological bleeding in women with congenital bleeding disorders: A comprehensive cohort from Iran

BackgroundGynecological bleeding including menorrhagia and postpartum hemorrhage (PPH) face women's quality of life constantly with difficulties, especially those suffering from inherited bleeding disorders. In this study, we aim to evaluate gynecological bleeding particularly menorrhagia among Iranian women patients with inherited bleeding disorders admitted to the Iranian Comprehensive Hemophilia Care Center (ICHCC). MethodsThis study was conducted on 156 females aged ≥ 12 diagnosed with an inherited bleeding disorder in ICHCC. Demographic and laboratory data were documented for all patients. Bleeding questionnaires (the International Society on Thrombosis and Hemostasis bleeding assessment tool (ISTH-BAT), Molecular and Clinical Markers for the Diagnosis and Management of Type 1 von Willebrand disease (MCMDM-1), and Pictorial blood loss assessment chart (PBAC)) were filled out for all patients. For comparing metric and categorical parameters, Mann-Whitney was performed. Spearman's rho test was used for analyzing correlation. ResultsThe mean age of patients was 33. Von Willebrand disease (VWD), Factor (F) VII deficiency and combined factor deficiency were the most diagnosed disorders. The median of ISTH-BAT, MCMDM-1, and PBAC was 7,7, and 517, respectively. Menorrhagia was the most common reason for diagnosis. Menorrhagia and PPH domain scores ≥ 2 were recorded in 82 and 34 patients, respectively, and PBAC scores > 100 were seen in 118 patients. Significant positive correlations were observed between bleeding scores and menorrhagia and PPH scores. No significant correlations were recorded for VWF: Ag and VWF: RCo with menorrhagia and PPH scores; however, significant correlations were seen for VWF: Ag and VWF: RCo with bleeding score questionnaires. ConclusionMenorrhagia is the most common problem in females affected by different types of inherited bleeding disorders, particularly VWD. Increased awareness among gynecologists and hematologists about bleeding disorders in cases with unexplained menorrhagia is an essential step for optimal management.

Efficacy of etonogestrel subcutaneous implants versus the levonorgestrel-releasing intrauterine system in the conservative treatment of adenomyosis.

To evaluate the clinical efficacy of etonogestrel subcutaneous implant (ENG-SCI) with that of the levonorgestrel-releasing intrauterine system (LNG-IUD) for adenomyosis treatment. A prospective randomized cohort study was conducted including 108 patients (50 patients in ENG-SCI group and 58 in the LNG-IUD group) with adenomyosis from January 2019 to July 2021. After 3 months of treatment, both ENG-SCI group and LNG-IUD group showed significant improvement in patients' visual analog scale, pictorial blood loss assessment chart (PBAC), and uterine volume (P ＜ 0.05). The uterine volume of patients in LNG-IUD group decreased more significantly than that in the ENG-SCI group since 3 months of treatment. The PBAC score in the LNG-IUD group improved better than that in the ENG-SCI group since 6 months of treatment (P ＜ 0.05). No significant difference in the occurrence rate of ideal vaginal bleeding patterns and the hemoglobin levels between the two groups was observed. The ENG-SCI group had a higher probability of weight gain and progesterone-related side effects (P ＜ 0.05). Both ENG-SCI and LNG-IUD were effective in treatment of adenomyosis. However, LNG-IUD had a more significant effect in treating adenomyosis-related dysmenorrhea, excessive menstrual flow, anemia, and uterine enlargement, with relatively fewer side effects.

Efficacy of a vaginal suppository formulation prepared with Acacia arabica (Lam.) Willd. gum and Cinnamomum camphora (L.) J. Presl. in heavy menstrual bleeding analyzed using a machine learning technique.

Objective: This study aims to determine the efficacy of the Acacia arabica (Lam.) Willd. and Cinnamomum camphora (L.) J. Presl. vaginal suppository in addressing heavy menstrual bleeding (HMB) and their impact on participants' health-related quality of life (HRQoL) analyzed using machine learning algorithms. Method: A total of 62 participants were enrolled in a double-dummy, single-center study. They were randomly assigned to either the suppository group (SG), receiving a formulation prepared with Acacia arabica gum (Gond Babul) and camphor from Cinnamomum camphora (Kafoor) through two vaginal suppositories (each weighing 3,500mg) for 7days at bedtime along with oral placebo capsules, or the tranexamic group (TG), receiving oral tranexamic acid (500mg) twice a day for 5 days and two placebo vaginal suppositories during menstruation at bedtime for three consecutive menstrual cycles. The primary outcome was the pictorial blood loss assessment chart (PBLAC) for HMB, and secondary outcomes included hemoglobin level and SF-36 HRQoL questionnaire scores. Additionally, machine learning algorithms such as k-nearest neighbor (KNN), AdaBoost (AB), naive Bayes (NB), and random forest (RF) classifiers were employed for analysis. Results: In the SG and TG, the mean PBLAC score decreased from 635.322 ± 504.23 to 67.70 ± 22.37 and 512.93 ± 283.57 to 97.96 ± 39.25, respectively, at post-intervention (TF3), demonstrating a statistically significant difference (p < 0.001). A higher percentage of participants in the SG achieved normal menstrual blood loss compared to the TG (93.5% vs 74.2%). The SG showed a considerable improvement in total SF-36 scores (73.56%) compared to the TG (65.65%), with a statistically significant difference (p < 0.001). Additionally, no serious adverse events were reported in either group. Notably, machine learning algorithms, particularly AB and KNN, demonstrated the highest accuracy within cross-validation models for both primary and secondary outcomes. Conclusion: The A. arabica and C. camphora vaginal suppository is effective, cost-effective, and safe in controlling HMB. This botanical vaginal suppository provides a novel and innovative alternative to traditional interventions, demonstrating promise as an effective management approach for HMB.

Effectiveness of Zhenqi Buxue Oral Liquid Combined with Progesterone for Treatment of Oligomenorrhea and Hypomenorrhea with Qi-Blood and Kidney (Shen) Essence Deficiency: A Randomized Controlled Trial.

To evaluate the effectiveness and safety of Zhenqi Buxue Oral Liquid (ZQ), progesterone capsules, and their combination in treating oligomenorrhea and hypomenorrhea with qi-blood and Kidney (Shen) essence deficiency. This was a prospective, randomized, multi-center controlled trial between June 2022 to December 2022. Ninety-six oligomenorrhea and hypomenorrhea patients with qi-blood and Shen essence deficiency were randomly assigned to receive ZQ (ZQ group, 29 cases), progesterone capsules (PG group, 32 cases), or the combined Chinese and Western medicine (COM group, 31 cases) at a ratio of 1:1:1. Patients in the ZQ or PG group took daily 10 mL twice a day of ZQ or 200 mg once a day of progesterone capsules for 10 consecutive days on day 15 of the menstrual cycle respectively, and patients in the COM group received the same ZQ combined with progesterone capsules. The treatment course lasted for 3 months and follow-up was performed at 1 and 3 months after the end of treatment. Primary endpoint was the menstrual Traditional Chinese Medicine Syndrome Scale (TCMSS) scores. Secondary endpoints included pictorial blood loss assessment chart (PBAC) scores, clinical efficacy rate, 36-item Short Form Health Survey (SF-36) scores, sex hormones and thickness of endometrium. Adverse events (AEs) were recorded. TCMSS scores after 1- and 3-month treatment in all groups were significantly lower than those at baseline (P<0.05). Only TCMSS scores after 3-month treatment in the ZQ and COM groups continuously decreased compared with those after 1-month treatment in the same group (P<0.01). TCMSS scores after 3-month treatment in the ZQ and COM groups were significantly lower than those in the PG group (P<0.05, P<0.01). Compared with baseline, PBAC scores in the ZQ and COM groups after 3 months of treatment were also significantly higher (both P<0.01). The total effective rates of TCM syndrome of 3-month treatment were significantly improved in all groups compared with that after 1 month of treatment (P<0.05). The total effective rate of the COM group was the highest in the 3rd month of treatment and significantly higher than that of PG group alone (P<0.05). Compared with baseline, only the SF-36 scores of COM group were significantly improved after 3 months of treatment (P<0.05). No serious adverse reactions were observed after treatment. The combination of ZQ and PG, or ZQ only had better effects on reducing TCMSS scores compared with PG, and COM showed the higher total effective rate compared with monotherapy. Besides, COM could effectively improve menstrual blood loss and quality of life. ZQ combined with PG may be an effective and safe option for oligomenorrhea and hypomenorrhea patients with qi-blood and Shen essence deficiency.

COMPARISON OF SAFETY AND EFFICACY OF ORAL PROGESTERONE WITH LEVONORGESTREL INTRAUTERINE SYSTEM IN MANAGEMENT OF DYSFUNCTIONAL UTERINE BLEEDING

The retrospective study was conducted in the Department of Obstetrics and Gynaecology, Nishtar Medical Hospital, Multan, to compare the safety and efficacy of oral progesterone and levonorgestrel-releasing intrauterine system (LNG-IUS) for the management of DUB. The study was conducted on 90 patients who fulfilled the inclusion criteria. Participants were randomly divided into groups A (LNG-IUS) and B (oral progesterone). The primary outcomes were Pictorial blood loss assessment chart (PBAC) scores. Secondary outcomes were the evaluation of adverse effects and Hb levels. A comparison of the mean PBAC score showed that LNG-IUS significantly reduced PBAC scores (P&lt; 0.0001). Comparison of post-treatment HB levels showed that LNG-IUS significantly increased Hb level, and the difference between both groups was statistically significant (P&lt; 0.0001). After 6 months, the incidence of adverse effects in group B was 60%, while in group A was 40%. However, hypomenorrhea was more prevalent in group A. It can be concluded that LNG-IUS is a more effective and safe treatment choice for Dub compared to oral progesterone.

Low-dose letrozole – an effective option for women with symptomatic adenomyosis awaiting IVF: a pilot randomized controlled trial

Research questionCan low-dose letrozole reduce dysmenorrhoea, menorrhagia and sonographic features in symptomatic women with adenomyosis awaiting IVF? DesignThis was a longitudinal randomized prospective pilot study to explore the effectiveness of low-dose letrozole and compare it with a gonadotropin releasing hormone (GnRH) agonist in reducing dysmenorrhoea, menorrhagia and sonographic features in symptomatic women with adenomyosis awaiting IVF. The women were treated for 3 months, either with the GnRH agonist goserelin 3.6 mg/month (n = 77) or the aromatase inhibitor letrozole 2.5 mg three times weekly (n = 79). Dysmenorrhoea and menorrhagia were evaluated at randomization and followed up monthly using a visual analogue score (VAS) and pictorial blood loss assessment chart (PBAC), respectively. A quantitative scoring method was used to assess the improvement of sonographic features after 3 months of treatment. ResultsBoth groups reported a marked improvement in symptoms after 3 months of treatment. In both the letrozole and GnRH agonist groups, VAS and PBAC scores decreased significantly over the 3 months (letrozole: P = 0.0001 and P = 0.0001 for VAS and PBAC, respectively; GnRH agonist: P = 0.0001 and P = 0.0001 for VAS and PBAC, respectively). Participants on letrozole had regular menstruation cycles, while most of the women who received the GnRH agonist were amenorrhoeic, with only four women reporting mild bleeding. Haemoglobin concentrations also improved after both treatments (letrozole P = 0.0001, GnRH agonist P = 0.0001). A quantitative assessment of sonographic features showed significant improvements following both treatments (diffuse adenomyosis of the myometrium: letrozole P = 0.015, GnRH agonist P = 0.039; diffuse adenomyosis of the junctional zone: letrozole P = 0.025, GnRH agonist P = 0.001). Women with adenomyoma also responded well to both therapies (letrozole P = 0.049, GnRH agonist P = 0.024), whereas the letrozole group responded comparatively better in focal adenomyosis when the outer myometrium was involved (letrozole P < 0.001, GnRH agonist P = 0.26). No noticeable side effects were observed in women receiving letrozole therapy. Additionally, letrozole therapy was found to be more cost-effective than GnRH agonist treatment. ConclusionsLow-dose letrozole treatment is a low-cost alternative to a GnRH agonist, with comparable effects in improving the symptoms and sonographic features of adenomyosis in women awaiting IVF.

Effect of Saleekha and Majeeth in Polycystic Ovarian Disease: An Open Observational Study

Pharmacognosy Research,2023,15,1,168-175.DOI:10.5530/097484900240Published:December 2022Type:Original ArticleAuthors:Shabnam Bano, Wajeeha Begum, and Syeda Sumaiya Author(s) affiliations:Shabnam Bano*, Wajeeha Begum, Syeda Sumaiya Department of Ilmul Qabalat of Amraze Niswan, National Institute of Unani Medicine, Kottigepalya, Bengaluru, Karnataka, INDIA. Abstract:Introduction: PCOD is a common, complex reproductive endocrinopathy characterized by menstrual irregularities, hyperandrogenism, polycystic ovaries, metabolic and psychological disorders and affects up to 18% of reproductive-aged women. Objectives: To evaluate the effect of Saleekha and Majeeth in PCOD. Materials and Methods: Clinically diagnosed Patients (n=30) with PCOD in age 18-35 years with oligomenorrhea or amenorrhoea were included in the study. Patients with thyroid dysfunction, systemic diseases, endometrial tuberculosis, malignancies on hormonal treatment in the last 3 months, pregnancy, and lactation were excluded. The research drug was administered orally in a dose of 3.5 gm B.D safūf (powder) of Saleekha with Joshānda (decoction) of Majeeth 7 gm BD for 14 days/ cycle for three consecutive cycles. Outcome measures were changes in subjective parameters (nature of bleeding, duration of cycles, duration of flow, amount of flow, weight reduction) and objective parameters, pictorial blood loss assessment chart (PBAC) score, basal metabolic index (BMI), modified Ferriman Gallwey (mFG) score, acanthosis nigricans scale and pelvic ultrasonography. Data were analyzed using the paired Student t-test. Results: Marked improvement was observed in menstrual irregularity and PBAC score with p<0.001 which is highly significant after the intervention. Significant change is seen in BMI, Ovarian volume, and SF-12 with p<0.001 after treatment. Safety parameters were within the normal range. Interpretation and Conclusion: Research drugs (Saleekha and Majeeth) can be used as an alternate remedy in PCOD patients, as it significant effect to regularize menstruation by reduction of BMI and probably by improving insulin resistance in PCOD. No adverse effect of the research drug was noted during the trial. Keywords:BMI, Majeeth, mFG, PBAC score, PCOD, SaleekhaView:PDF (272.5 KB)

Evaluation of effects of levonorgestrel releasing intrauterine system in heavy menstrual bleeding

Heavy menstrual bleeding (HMB), is one of the most frequently encountered problem in the gynaecology OPD. It can significantly affect women’s quality of life and overburden health-care systems. The Levonorgestrel Releasing Intrauterine System (LNG-IUS) is a highly effective long-acting reversal contraceptive, also useful for controlling HMB and promoted by National Institute for Health and Care Excellence (NICE). This prospective interventional study conducted upon 30 women, with heavy menstrual bleeding, of 30-50 years’ age, reporting in the outpatient department of a tertiary health care facility unit “between” January 2018 to June 2019. Women, who met inclusion and exclusion criteria were our study population. Data was collected during follow up at 1, 3 and 6 month and all the association were tested by mean, proportion and percentages. Chi-square test was used for comparing categorical result and p-value of less than 0.05 was considered as statistically significant. Calculation was made by using IBM SPSS 26 version of statistical software. Majority of women were from 40-45 years’ age group. Pictorial Blood Loss Assessment Chart (PBAC) score was calculated in 30 women who underwent LNG IUS insertion.There was significant reduction (p&amp;#60;0.05) in the mean PBAC score at 3and 6month compared to their initial value after LNG-IUS insertion. LNG IUS is effective and can be used as first line measure for treatment of HMB.

Quality of Life of Japanese Dysmenorrhea/Heavy Menstrual Bleeding Patients Treated with Levonorgestrel Intrauterine Delivery System in a Real-World Setting.

IntroductionThe present study collected 1-year follow-up patient-reported outcome data from Japanese women with dysmenorrhea and/or heavy menstrual bleeding (HMB) who underwent insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg. We aimed to evaluate the quality of life (QOL) of Japanese women over the course of the investigational period.MethodsThis was a multicenter, non-interventional, prospective, single-cohort, post-marketing surveillance study (J-MIRAI). The primary outcome was the median change in the Menstrual Distress Questionnaire (MDQ) and Menorrhagia Multi-Attribute Scale (MMAS) scores from baseline to 3 and 12 months after LNG-IUS insertion, with decreasing and increasing scores, respectively, indicating improvement. The secondary outcomes were the statistical relationships between the MDQ and menstrual pain (measured by a visual analog scale, VAS), and between the MMAS and pictorial blood loss assessment chart (PBAC) scores by regression analysis.ResultsIn total, 593 patients were evaluated; 376, 467, and 250 patients were diagnosed with dysmenorrhea, HMB, or both, respectively. The median MDQ score decreased significantly at 3 and 12 months after LNG-IUS insertion in both the premenstrual and menstrual periods (both p < 0.001 vs baseline), and the median MMAS score showed a similar improvement during the menstrual period. Changes in median MDQ and MMAS scores were observed regardless of patient background. Correlations between MDQ and menstrual pain (VAS) and between MMAS and PBAC scores were found (estimated regression coefficients 0.29 and − 0.15, respectively).ConclusionThe LNG-IUS contributed to improvements in the QOL of patients with dysmenorrhea, HMB, and both, regardless of patient background characteristics.Trial RegistrationRegistered at ClinicalTrials.gov (NCT02475356) on 18 June 2015.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-022-02205-2.

Bleeding patterns of women with heavy menstrual bleeding or dysmenorrhoea using the levonorgestrel-releasing intrauterine system: results from a real-world observational study in Japan (J-MIRAI)

Purpose To collect real-world safety and clinical outcome data on the levonorgestrel-releasing intrauterine system (LNG-IUS) for functional/organic heavy menstrual bleeding (HMB) and dysmenorrhoea in Japanese women (J-MIRAI). Materials and methods In this prospective, multicentre, single-cohort, open-label, post-authorisation study, we assessed menstrual blood loss after LNG-IUS insertion by changes from baseline in pictorial blood loss assessment chart (PBAC) scores. Scores for the menorrhagia multi-attribute scale (MMAS) were collected for 12 months to assess quality of life. Results We included 47 patients with complete PBAC score and patient diary data. The median PBAC score before LNG-IUS insertion was 159.0, which decreased significantly to 6.0 at 12 months post-insertion; for patients with adenomyosis (n = 20), PBAC score decreased from 174.5 pre-insertion to 19.5 at 12 months. The number of patient-reported bleeding days was correlated with PBAC score ≥5. The proportion of women with prolonged bleeding decreased from 85.7% to 34.6% by the study’s end. Some women reported no bleeding after the first 90-day reference period. The mean MMAS overall score significantly increased from 50.50 before insertion to 88.67 at 12 months. Conclusions Japanese women with functional/organic HMB experienced substantial reductions in bleeding symptoms and improvements in quality of life after 12-month use of the LNG-IUS.

Pictorial Blood Loss Assessment Chart for evaluating heavy menstrual bleeding in Asian women.

Heavy menstrual bleeding is a common gynaecological problem, but some women may prefer not to articulate their menstrual problems. The objective of this study was to evaluate the usefulness and acceptability of the Pictorial Blood Loss Assessment Chart (PBAC) as a selfscreening tool in evaluation of menstrual blood loss among Asian women in Hong Kong. This prospective cohort study recruited 206 women from the general gynaecology ward and out-patient clinic: 118 had self-perceived heavy menstrual bleeding and 88 had self-perceived normal menstrual flow. Participants were asked to fill in the PBAC for one menstrual cycle. Compared with women who had self-perceived normal menstrual flow, women with self-perceived heavy menstrual bleeding had significantly higher total PBAC scores and numbers of flooding episodes, larger clot sizes and numbers, more days of bleeding, and lower haemoglobin levels. Receiver-operating characteristic curve analysis demonstrated good pairwise associations of self-perceived symptoms with PBAC score and haemoglobin level. The PBAC can be used to differentiate self-perceived heavy and normal menstrual bleeding in Asian women in Hong Kong. It can also serve as an additional indicator of possible heavy menstrual bleeding to alert women of the need to seek early medical attention.

The Association between Heavy Menstrual Bleeding and Depressive Symptoms in Adolescents

Introduction: Heavy menstrual bleeding (HMB) is a type of abnormal uterine bleeding (AUB) that affects 30% of women of reproductive age and up to 40% of adolescents. Furthermore, 10-40% of adolescents with HMB have an underlying inherited bleeding disorder like von Willebrand disease or platelet dysfunction, requiring management by pediatric hematologists. HMB has been described as more than 80 ml of blood loss during one cycle and clinically, it is defined by several parameters such as the length of each cycle, severity of soaking through pads or tampons, size of clots passed and pictorial blood loss assessment chart (PBAC) score. Studies in adult women show a significant impact of HMB on their psychosocial and financial health. However, little is known about the psychological effects of HMB in adolescent females. In the adolescent population, depression is twice as common in females as it is in males, likely due to a combination of biological and social differences. In this study, we examine the association between heavy menstrual bleeding and depressive symptoms in adolescent girls.Methods: We conducted a retrospective records review of adolescent females aged 10-21 years that were seen as new patients at the Adolescent Medicine and Young Women's Bleeding Disorders clinics at our institution between January 1, 2018 and March 31, 2020. Patients were included in the study if they had started menses, and had a doumented menstrual history as well as a completed Patient Health Questionnaire (PHQ-9), a validated screening tool for depression.Patients with a severe underlying chronic medical disorder (Including but not limited to end stage renal disease, Juvenile Rheumatoid Arthritis, Systemic Lupus Erythematosis, severe eating disorder, previously diagnosed bipolar disorder or psychotic disorders) were excluded. HMB was determined by either a PBAC score of >100 or the presence of two or more of the following criteria:Menses lasting >7daysSoaking through pad or tampon <1hrSoaking through bed clothes or changing pads at nightPassing large clotsLow ferritin < 15ng/ml (indicative of low iron stores)Anemia with Hemoglobin < 12g/dl not due to any other cause (e.g. dietary, immunosuppression, medication induced)Depression was determined by a PHQ-9 score of 9 or greater. The two variables were dichotomized, and a chi-square test of independence was performed to test the association with a significance level of p < 0.05.Results: A total of 203 records were reviewed after meeting inclusion and exclusion criteria. The mean age was 15.94 years (median 16, mode 16) with a range of 12-20years. 42 girls (20.7%) had a PHQ-9 score of >9 and 52 (25.6%) had HMB. Eighteen of the 42 patients (42.8%) with elevated PHQ-9 score had HMB and 34/52 patients (65.3%) with HMB had an elevated PHQ-9 score. Pearson's chi-square test of independence showed a significant relation between HMB and PHQ-9 score of 9 or more with χ 2 (1, n=203) = 8.2618, p = 0.004. After the application of Yates correction, the result was still significant with χ 2 = 7.1603 and p = 0.007.Discussion and Conclusions: This study shows a significant association in the adolescent population between heavy menstrual bleeding and moderate or severe depression as defined by the presence of a PHQ-9 score of 9 or more. This retrospective analysis does not establish causation, but demonstrates a clinically noteworthy finding that has not been described before. The PHQ-9 is used widely across this population to screen for depression, but it is also important to screen young women aged 10-21years for HMB as a contributing factor to depression followed by timely and appropriate management of both problems. Additionally, it may be worthwhile to evaluate all young women with HMB through additional methods to diagnose depression as this patient population appears to be at higher risk. Future prospective studies are needed to better characterize this association. DisclosuresNo relevant conflicts of interest to declare.

Relugolix for oral treatment of uterine leiomyomas: a dose-finding, randomized, controlled trial

BackgroundUterine leiomyomas are the most common neoplasm affecting women and frequently cause heavy menstrual bleeding and pain. Gonadotropin-releasing hormone (GnRH) receptor antagonists provide fast symptom relief and show promise as a medical (non-surgical) treatment option and as a presurgical treatment to reduce leiomyoma size. The aim of this study was to evaluate the efficacy and safety of three dose levels of oral relugolix, a small molecule GnRH receptor antagonist, in Japanese women with uterine leiomyomas and heavy menstrual bleeding.Methods This phase 2, multicenter, double-blind, parallel-group study was conducted at 36 sites in Japan in women with uterine leiomyomas and heavy menstrual bleeding, defined as a pictorial blood loss assessment chart (PBAC) score of ≥ 120 in one menstrual cycle. Patients were randomized 1:1:1:1 to relugolix 10, 20, or 40 mg, or placebo, orally once daily for 12 weeks. The primary endpoint was the proportion of patients with a total PBAC score of < 10 from week 6 to 12. A sample size of 50 patients per group was estimated to provide ≥ 95% power, based on the comparison of relugolix 40 mg with placebo using a chi-square test with a significance level of 5% (two-sided).ResultsFrom November 2011 to September 2012, 216 patients were randomized and 214 patients (99.1%) were analyzed. The proportion (difference vs. placebo) of patients that achieved the primary endpoint in the placebo and 10-, 20-, and 40-mg relugolix groups were 0%, 20.8% (95% confidence interval [CI]: 9.3–32.3, P < .001), 42.6% (95% CI: 29.4–55.8, P < .001), and 83.3% (95% CI: 73.4–93.3, P < .001), respectively. Though treatment-emergent adverse events were similar between the 20- and 40-mg groups, the incidence rates were more frequent compared with the placebo group. Most of these adverse events were mild or moderate in intensity.ConclusionsRelugolix decreased menstrual blood loss in women with uterine leiomyomas in a dose–response manner, and was generally well tolerated.Clinical trial registration: ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT01452659, NCT01452659 (registered 17/10/2011); JAPIC Clinical Trial Information, https://www.clinicaltrials.jp, JapicCTI-111590 (registered 31/08/2011).

Iub™ Sead™ - A Novel Intra Uterine Ball: Spherical Endometrial Ablation Device

<h3>Study Objective</h3> The aim of this study is to assess the safety and efficacy of the IUB SEAD™ (Intra Uterine Ball: Spherical Endometrial Ablation Device) introducing silver nitrate to the uterus in women suffering from abnormal uterine bleeding. We present results of 6 months follow up period post treatment. <h3>Design</h3> Open-label multicenter study to assess the safety and efficacy of the IUB SEAD™ device in premenopausal women with predictable menstrual cycles, who suffer from AUB. Women with HMB were enrolled who had an average pictorial blood loss assessment chart (PBAC) score ≥ 150 over for 3 months. <h3>Setting</h3> The study was performed in the outpatient clinics of 2 Bulgarian medical centres between September 2019 and December 2020. <h3>Patients or Participants</h3> 16 women with HMB (PBAC>150) at least 3 months before inclusion were enrolled. <h3>Interventions</h3> Eligible subjects who met all the inclusion/exclusion criteria were treated during the first 7 days following the cessation of menses. The SEAD™ device was inserted into the uterine cavity via vaginal approach. The device was left in the uterus for 30 (±5) minutes and then removed. <h3>Measurements and Main Results</h3> A total of 16 participants aged 37-50 (mean = 43) were enrolled with a mean baseline PBAC score of 424; 14 of 16 completed follow up requirements and were evaluable at 6 months. All procedures were completed successfully without device/procedure-related adverse events. At 6 months post-treatment the mean PBAC score was 95 with 55% of the overall cohort ≤75 and 72% ≤ 100 and a mean percentage of 83% reduction. The mean procedure related pain score was ≤2 (mild).* <h3>Conclusion</h3> The IUB SEAD™ device is safe and effective in treating HMB in an outpatient environment. Future studies with larger number of patients are planned. *Results may vary until presentation date.

Clinical observation of Kuntai capsule combined with Fenmotong in treatment of decline of ovarian reserve function.

BACKGROUNDDecreased ovarian reserve function is an ovarian hypofunction disease that occurs in women before 40 years of age, leading to a decline in fertility and perimenopausal symptoms, such as irregular menstruation, amenorrhea, infertility, decreased libido, and autonomic nervous dysfunction. Fenmatong (FMT) is a compound mixture of estradiol tablets and estradiol didroxyprogesterone tablets, which can improve ovarian reserve function by supplementation of exogenous estrogen. However, this treatment has also been shown to cause breast pain, gastrointestinal discomfort, irregular vaginal bleeding, and changes in sexual desire. In severe cases, FMT can promote the development of breast cancer, endometrial cancer, and venous embolic disease.AIMTo observe the effects of Kuntai capsules and FMT on endocrine indexes and uterine artery blood circulation in patients with decreased ovarian reserve function.METHODSPatients (130) with decreased ovarian reserve function, who were treated in our hospital from May 2018 to May 2020, were divided into two groups: The FMT group, in which patients were treated with FMT, and the observation group, in which patients were treated with Kuntai capsules. Chinese medicine symptom scores, uterine artery blood flow parameters, ovarian ultrasound test indexes, pictorial blood loss assessment chart (PBAC) scores, and hormone levels were recorded, and total effective rates were calculated for both groups.RESULTSThe total effective rate in the observation group was higher than that in the FMT group (P < 0.05).After treatment, primary symptoms, including low menstrual volume, delayed menstruation, red color and thick consistency of menses, dizziness, palpitation, weakness at the waist and knee, insomnia and excessive dreaming, irritability, and dryness and astringency of the pudendal canal in the observation group decreased, and scores for primary and secondary symptoms in the observation group were significantly lower than those in the FMT group (P < 0.05).The systolic peak flow rate (PSV), end-diastolic flow rate (EDV), ovarian diameter, sinus follicle count, and resistance index (RI) of the uterine arteries in the observation group and FMT group increased after treatment. Notably, the PSV, EDV, ovarian diameter, and antral follicle count in the observation group were higher than those in the FMT group, whereas the RI in the observation group was lower than that in the FMT group (P < 0.05).The PBAC scores in the observation and FMT groups increased after treatment, with that in the observation group becoming significantly higher than that in the FMT group (P < 0.05). After treatment, estradiol (E2) and anti-Mullerian hormone (AMH) levels increased, whereas follicle-stimulating hormone (FSH) levels decreased in the observation group and FMT group; E2 and AMH levels became significantly higher and FSH levels became significantly lower in the observation group than in the FMT group (P < 0.05).CONCLUSIONCompared with FMT, Kuntai capsules promoted uterine artery blood circulation, improved menstruation, relieved symptoms, regulated endocrine function, and improved curative effects.

Ormeloxifene in acute heavy menstrual bleeding in menopausal transition

Background: Ormeloxifene, a selective estrogen receptor modulator, is a safer, cost effective and convenient dosing medical therapy in heavy menstrual bleeding of acute abnormal uterine bleeding.&#x0D; Aims and Objective: The study aimed to find the effectiveness of Ormeloxifene as 1st line therapy for heavy menstrual bleeding in menopausal transition women to prevent unnecessary hysterectomies and improve quality of life.&#x0D; Materials and Methods: This descriptive study was conducted at Lumbini Medical College for a period of one year. Sixty-five cases of acute Abnormal Uterine Bleeding with heavy menstruation during menopausal transition period were provided with Ormeloxifene therapy of 60 milligrams dose two times per week after evaluating pre treatment hemoglobin percentage, Pictorial Blood Loss Assessment Chart (PBAC) score and endometrial thickness. The dose of the drug was reduced to 60 mg weekly after 3rd month if subjective improvement was documented and continued for further 3 months.&#x0D; Results: There was a statistically significant reduction in mean PBAC score, mean endometrial thickness and rise in hemoglobin level. Eighty percentages of women had marked subjective improvement of symptoms, 87.7% women had reduction of blood clots, 15. 8% women had relief from dysmenorrheal pain and 50.8% women had regularization of menstrual pattern after 6 months. Amenorrhea (25.3%) was the most common side effect reported in 6 months therapy.&#x0D; Conclusion: Ormeloxifene is an effective 1st line medical therapy in acute heavy menstrual bleeding in menopausal transition women.

A clinical observational study on the efficacy of subcutaneous etonogestrel implants for adenomyosis in 20 patients

Objective: To evaluate the efficacy of subcutaneous etonogestrel implants for adenomyosis. Methods: We conducted a clinical observational study of 20 patients suffering from adenomyosis treated with subcutaneous etonogestrel implants from August 2015 to July 2017 and followed up for 36 months. We evaluated the efficacy of subcutaneous etonogestrel implants primarily based on the following indicators: the pictorial blood loss assessment chart (PBAC) for menstrual blood volume, changes in bleeding patterns, the visual analog scale (VAS) pain score for dysmenorrhea, uterine volume, serum cancer antigen 125 (CA125) levels, hemoglobin levels and side effects. Results: During the 3 years of follow-up, subcutaneous etonogestrel implants were removed from six patients, among whom one was diagnosed with endometrial cancer, four had an increased menstrual blood volume, and one entered menopause. In total, 14 patients were treated with subcutaneous etonogestrel implants for 3 years. Among these patients, the number of patients with heavy menstrual bleeding and high PBAC and VAS scores and serum CA125 levels was significantly decreased after implantation compared with that before implantation. In the eight patients with anemia, hemoglobin levels increased gradually. However, the uterine volumes did not significantly change. Bleeding patterns were changed but were tolerable. Conclusion: Subcutaneous etonogestrel implants represent a new option for the clinical treatment of adenomyosis for patients who refuse surgery.

Heavy menstrual bleeding on direct factor Xa inhibitors: Rationale and design of the MEDEA study

BackgroundIn premenopausal women, treatment with direct oral factor Xa inhibitors is associated with an increased risk of heavy menstrual bleeding (HMB) compared with vitamin K antagonists (VKA). Treatment with the direct oral thrombin inhibitor dabigatran appears to be associated with a reduced risk of HMB compared with VKA. These findings come from small observational studies or post hoc analyses of trials in which HMB was not a primary outcome. Use of tranexamic acid during the menstrual period may be effective in patients with HMB, but prospective data regarding efficacy and safety in patients on anticoagulant treatment are lacking. Rationale and DesignA direct comparison of a factor Xa inhibitor and a thrombin inhibitor with HMB as primary outcome, as well as an evaluation of the effects of adding tranexamic acid in women with anticoagulant‐associated HMB is highly relevant for clinical practice. The MEDEA study is a randomized, open‐label, pragmatic clinical trial to evaluate management strategies in premenopausal women with HMB associated with factor Xa inhibitor therapy. OutcomesWomen using factor Xa inhibitors with proven HMB, as assessed by a pictorial blood loss assessment chart (PBAC) score of >150, will be randomized to one of three study arms: (i) switch to dabigatran; (ii) continue factor Xa inhibitor with addition of tranexamic acid during the menstrual period; or (iii) continue factor Xa inhibitor without intervention. The primary outcome is the difference in PBAC score before and after randomization. Here, we present the rationale and highlight several unique features in the design of the study.

Comparison of Bipolar Ball Endometrial Ablation and Transcervical Resection of the Endometrium in the Treatment of Heavy Menstrual Bleeding: A Randomized Clinical Trial.

Objectives:To compare the operative time, effectiveness, and patient satisfaction between ball endometrial ablation and transcervical resection of the endometrium (TCRE) using a bipolar resectoscope.Materials and Methods:Forty-four women with heavy menstrual bleeding who were unresponsive to at least 3 months' medical management were included in this randomized, controlled clinical trial. After randomization, patients underwent either TCRE or ball endometrial ablation using a bipolar resectoscope. The operative time, fluid deficit, and postoperative pain were recorded. The patients were evaluated postoperatively at 3, 6, and 12 months after surgery. Patient satisfaction, amenorrhea rate, reintervention rate, and pictorial blood-loss-assessment chart (PBAC) score were compared between the two groups.Results:The mean operative time in ball endometrial ablation group was 11.17 ± 2.24 min and in TCRE group was 22.33 ± 5.26 min (P < 0.001). There was no significant difference in the postoperative PBAC score, amenorrhea rates, patient satisfaction, and need for reintervention between the two groups.Conclusion:Operative time with ball endometrial ablation is significantly less when compared to TCRE when using a bipolar resectoscope.