Blood Loss Assessment Chart Score Research Articles

A 52-mg levonorgestrel-releasing intrauterine system vs bipolar radiofrequency nonresectoscopic endometrial ablation in women with heavy menstrual bleeding: long-term follow-up of a multicenter randomized controlled trial

BACKGROUNDThe symptom of heavy menstrual bleeding has a significant impact on professional, physical and social functioning. In 2021, results from a randomized controlled trial comparing a 52 mg levonorgestrel-releasing intrauterine system and radiofrequency non-resectoscopic endometrial ablation as treatments for women with heavy menstrual bleeding were published. Both treatment strategies were equally effective in treating heavy menstrual bleeding during a two-year follow-up. However, long-term results are also relevant for both patients and health care providers. OBJECTIVEThe aim of this study was to assess long-term differences in reintervention risk and menstrual blood loss in women with the symptom of heavy menstrual bleeding treated according to a strategy starting with a 52 mg levonorgestrel-releasing intrauterine system or radiofrequency non-resectoscopic endometrial ablation. STUDY DESIGNThis study was a long-term follow-up study of a multi-center randomized controlled trial (MIRA trial) in which women were allocated to either a 52 mg levonorgestrel-releasing intrauterine device (n=132) or radiofrequency non-resectoscopic endometrial ablation (n=138). Women from the original trial were contacted to fill out six questionnaires. The primary outcome was reintervention rate after allocated treatment. Secondary outcomes included surgical reintervention rate, menstrual bleeding measured by the Pictorial Blood Loss Assessment Chart, (disease-specific) quality of life, sexual function and patient satisfaction. RESULTSFrom the 270 women that were randomized in the original trial, 196 women (52 mg levonorgestrel-releasing intrauterine system group: n=94; radiofrequency non-resectoscopic endometrial ablation group: n=102) participated in this long-term follow-up study. Mean follow-up duration was 7.4 years (range 6-9 years). The cumulative reintervention rate (including both medical and surgical reinterventions) was 40.0% (34/85) in the 52 mg levonorgestrel-releasing intrauterine system group and 28.7% (27/94) in the radiofrequency non-resectoscopic endometrial ablation group (relative risk: 1.39; 95% confidence interval: 0.92-2.10). The cumulative rate of surgical reinterventions only was significantly higher for patients with a treatment strategy starting with a 52 mg levonorgestrel-releasing intrauterine system compared to radiofrequency non-resectoscopic endometrial ablation (35.3% [30/85] vs. 19.1% [18/94]; relative risk: 1.84; 95% confidence interval: 1.11-3.10). However, hysterectomy rate was similar: 11.8% [10/94] in the 52 mg levonorgestrel-releasing intrauterine system group and 18.1% [17/102] in the radiofrequency non-resectoscopic endometrial ablation group (relative risk: 0.65; 95% confidence interval: 0.32-1.34). Most reinterventions took place during the first 24 months of follow-up. A total of 171 Pictorial Blood Loss Assessment Chart scores showed a median bleeding score of 0.0. No clinically relevant differences were found regarding quality of life, sexual function and patient satisfaction. CONCLUSIONThe overall risk of reintervention after long-term follow-up was not different for women treated according to a treatment strategy starting with a 52 mg levonorgestrel-releasing intrauterine system as compared to a strategy starting with radiofrequency non-resectoscopic endometrial ablation. Yet, women allocated to a treatment strategy starting with a 52 mg levonorgestrel-releasing intrauterine system had a significantly higher risk for surgical reintervention, which was driven by an increase in subsequent endometrial ablation. Both treatment strategies remain effective in lowering menstrual blood loss over the long-term. The results of this long-term follow-up study help physicians to optimize counseling of women suffering from the symptom of heavy menstrual bleeding. Optimized counseling will enable women to make a well-informed choice regarding treatment.

Effect of Ayurvedic Formulations on Abnormal Uterine Bleeding (Asrigdara): A Prospective Uncontrolled Multicenter Clinical Study

IntroductionAsrigdara in Ayurveda simulates the dysfunctional type of abnormal uterine bleeding (AUB) and is a common gynaecological complaint. It negatively affects the quality of life and is associated with the poor health of women. This study aimed to evaluate the effect of Ayurvedic formulations, Pushyanuga churna (PC) and Usheerasava (UA) in managing AUB. MethodsA multicenter, single-arm clinical study was conducted on 80 diagnosed patients of AUB. PC 3 g and UA 20 ml were given twice daily for 90 days. Clinical assessment was done at baseline, every 15th day for the initial 3 months, and on 120th day. Pictorial blood loss assessment chart score, visual analogue scale, and Psychological General Well-being Index were utilised to measure the outcome parameters. The safety of formulations was evaluated by reporting adverse drug reactions and changes in liver function tests and renal function tests at baseline and on 90th day. ResultsSixty-eight participants completed the trial. Data were analysed using SPSS version 28.0. The mean age of the participants was 31.7 ± 6.3 years and majority (73.5%) were multiparous. The most typical presentation was heavy menstrual bleeding in 92.6%, followed by frequent bleeding (52.9%). At baseline, 94.2% participants had a pictorial blood loss assessment chart score >100, which decreased to 30.7% at the end of the study. Highly significant changes (P < 0.001) were observed in frequent, prolonged bleeding and psychological general well-being index score. No adverse drug reactions and significant changes in safety parameters were found. ConclusionsPC and UA are effective, well-tolerable, and safe in managing AUB.

Feasibility and Effectiveness of Hysteroscopic Suture Fixation of the Levonorgestrel-Releasing Intrauterine System in the Treatment of Adenomyosis

To evaluate the feasibility and effectiveness of hysteroscopic suture fixation of the levonorgestrel-releasing intrauterine system (LNG-IUS) for the treatment of adenomyosis. A retrospective case series. Two teaching hospitals with the technology of hysteroscopic suture fixation of the LNG-IUS. The study reviewed 79 adenomyosis patients who received the hysteroscopic suture fixation of the LNG-IUS from January 2021 to May 2022. Hysteroscopic suture fixation of the LNG-IUS to the posterior uterine wall with nondissolvable suture. All patients underwent one-year postoperative follow-up to evaluate the LNG-IUS expulsion rate, postoperative efficacy, and side effects. Two patients (2.6%) experienced expulsion of the LNG-IUS at 8 months and 12 months postoperatively, respectively. The visual analog pain scale, pictorial blood loss assessment chart score and carbohydrate antigen 125 markedly decreased after the suture fixation of the LNG-IUS compared with baseline in all patients (p <.001). Hemoglobin increased significantly (p <.001). The most common side effect was irregular bleeding, which accounted for 44.3%. The second common side effect was weight gain, which accounted for 29.2%. The composite effectiveness based on pain and bleeding showed that the effective treatment rates at 1, 3, 6, and 12 months after surgery were 92.4%, 97.4%, 96.2%, and 97.4% respectively. Hysteroscopic suture fixation of the LNG-IUS to the uterine fundus was associated with low expulsion rates and significantly improved dysmenorrhea and bleeding.

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.

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.

Real-World Experience of Direct Oral Anticoagulant Use in a Single Pediatric Center

Background: Pediatric venous thromboembolism (VTE), a disease comprising deep venous thrombosis and pulmonary embolism, has increased by 130-220%. Anticoagulation therapy is the mainstay of treatment, and direct oral anticoagulants (DOACs) offer several advantages. Recently, two DOACs (Dabigatran and Rivaroxaban) have been approved for use in children in the United States. Nonetheless, DOACs have been used "off-label” in children on an individualized basis, subject to approval from insurance plans. This study aims to evaluate real-world epidemiological and outcome data from a single-center cohort of pediatric patients treated with DOACs. Methods: In this single-center, IRB-approved study, 54 patients from the pediatric hematology oncology VTE database were identified and analyzed using SPSS statistical software, and a descriptive statistical analysis was conducted. Results: Epidemiological features: Of the 54 patients, 21 (39%) subjects were males, and 33 (61%) were females. Ages ranged from 4 to 22 years, with a mean age of 16.3 years. The majority of the subjects, 94%, were greater than 12 years old. Most (94%) of patients had venous thrombosis, 2% had an arterial thrombus, and 4 % had both arterial and venous. A breakdown of primary thromboembolism location highlights that the majority, 30%, had a pulmonary embolism on diagnosis, and the most common risk factors included obesity, catheterization, and infection (Tables 1 and 2). Of the 54 patients, 11% were started on DOACs as their initial anticoagulation treatment, 82% were switched to a DOAC on follow-up after initial treatment with heparin or low molecular weight heparin; four patients (7%) were started on DOACs after recurrent VTE on another anticoagulant. Twenty-one (39%) patients were on Apixaban, 32 (59%) were on Rivaroxaban, and 1 (2%) was on Dabigatran. One patient transitioned from Rivaroxaban to Apixaban due to an allergic reaction to the medication. Patients were on various durations of therapy ranging from 3 months to an extended duration depending on their clinical status and risk factors. Outcomes on DOACs: One (2%) patient had a major bleeding episode per ISTH definition. This was an episode of tonsillar artery bleeding status post tonsillectomy that required cauterization and surgical mesh placement in the operating room. Of the 33 females, two were premenarchal at the time of anticoagulation; therefore, 4 (13%) had evidence of heavy menstrual bleeding (HMB) that required medical intervention. HMB was identified by patients’ recall of menstrual bleeding; only one patient had a pictorial blood loss assessment chart (PBAC) score. Per ISTH definitions, 5 (9%) had clinically relevant non-major bleeding, including 4 patients with HMB and one additional patient with bloody diarrhea secondary to underlying ulcerative colitis that required medical intervention. One patient (2%) had minor bleeding with bloody secretions from a chest tube resulting in temporary holding of anticoagulantion. Five (9%) had recurrent VTE while on a DOAC (2 were on Apixaban, and 3 were on Rivaroxaban) and were transitioned to other forms of anticoagulation. Conclusion: The bleeding and recurrent VTE rates after DOACs appear comparable to other anticoagulants in pediatric VTE; heavy menstrual bleeding should be investigated in adolescent females. Given the recent approval of DOACs for pediatric patients, additional multi-centered outcome studies are needed to determine recurrence and bleeding risks. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Comparison of Efficacy and Safety between Dienogest and Danazol in Women with Endometriosis

Background: Endometriosis is a common gynecologic disease associated with a significant burden on women's health and healthcare systems. Currently approved hormonal treatments for Endometriosis can effectively control symptoms but may have clinically relevant side effects that limit their use. Objective: This study aimed to compare the Efficacy and safety of commonly used drugs dienogest and danazol in patients with Endometriosis. Methods and Material: This randomized clinical trial was conducted at the department of Obst and Gynae in Rajshahi Medical College Hospital from June 2020 to May 2021. A total of 100 diagnosed cases of Endometriosis were included in this study according to inclusion and exclusion criteria. The study population was divided into two groups randomly by flipping a coin; group A is the dienogest group (experimental group), and group B is the danazol group (control group). Informed written consent was obtained from all cases. Patients were followed up after 3 months of treatment following a standard management plan. After data collection, data analysis was done using SPSS version 23. Result: Mean age of the study patients was 28.72±4.71 (SD) years in group A and 29.52±5.23 (SD) years in group B patients with a majority in the age group 26-30 years. Age and other socio-demographic variables were statistically similar in both groups. Symptomatic improvement was observed with statistical significance in both groups regarding visual analog scale (VAS) pain score and severity of dyspareunia and bleeding pattern according to pictorial blood loss assessment chart (PBAC) score (p&lt;.05). But post-treatment VAS pain score and severity of dyspareunia and bleeding pattern was similar in both groups (p&gt;.05). Pre-treatment size of ovarian endometrioma was 4.02±0.227 cm (SD) in group A patients and 3.98±0.212 cm (SD) in group B patients. After treatment, ovarian endometrioma significantly (p&lt;.05) reduced to 1.33±0.698 cm (SD) in group A and 1.47±0.967 cm ......

Endometrial Cryoablation for the Treatment of Heavy Menstrual Bleeding: 36-Month Outcomes from the CLARITY Study.

Study ObjectiveTo examine long-term outcomes from the pivotal study that evaluated the safety and effectiveness of the Cerene® Cryotherapy Device (Channel Medsystems, Berkeley, CA) in premenopausal women with heavy menstrual bleeding due to benign causes who have completed childbearing.MethodsThe prospective, multicenter, single-arm, open-label study had eight sites in the USA, one in Mexico, and two in Canada. Inclusion criteria included uterine sound ≤10 cm, endometrial cavity length 2.5 to 6.5 cm, age 25 to 50 years, a pictorial blood loss assessment chart score of ≥150, no submucosal myomata and/or uterine obstruction, distortion, or abnormality. A total of 242 subjects underwent a 2.5-minute cryoablation. Long-term follow-up visits were conducted at Month 24 and Month 36. Data collected included gynecological adverse events, description of last menstrual period, contraception status, self-report of pregnancy, medical or surgical interventions to treat abnormal uterine bleeding, satisfaction, recommendation, and quality of life (QoL). QoL outcomes were measured with the Menorrhagia Impact Questionnaire (MIQ) and the Premenstrual Symptoms Impact Survey (PMSIS™).Results201 subjects completed their Month 36 final study visit. Subject outcomes were comparable to those at Month 12. Eighty-nine percent of subjects reported amenorrhea, a lighter-than-normal, or normal period, 91% of subjects had no or slight limitations in MIQ measured activities, and 85% reported premenstrual symptoms at a low frequency. Eighty-five percent of the subjects were satisfied or very satisfied. The cumulative incidence of hysterectomy was 5% and reintervention was 8.7%. Forty-nine gynecologic adverse events (AE) were reported; one non-serious AE, postcoital bleeding, was reported as related to the procedure. No serious device-related or procedure-related AEs were reported.ConclusionStudy data demonstrate that the positive effects of Cerene Cryotherapy Device treatment are sustained through Month 36 and that the risks associated with the device and procedure are low (ClinicalTrials.gov; NCT02842736).

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.

A comparative prospective observational study on the use of ulipristal acetate versus mifepristone in reduction of the size of uterine leiomyoma

Background: Fibroid or uterine leiomyoma is the most common benign tumor of the uterus in the reproductive age group and found in one out of every four women. They are symptomatic in 50% of women, with the peak incidence occurring among women in their 30s or 40s. Fibroid can cause a variety of symptoms which include menstrual disturbances commonly menorrhagia and dysmenorrhea. It is a common indication of hysterectomy in Indians. An effective medical treatment option may reduce hysterectomy-associated morbidity and mortality. This study is undertaken to evaluate the efficacy and safety of medical management of myoma and contribution in the reduction of myoma size comparing the two drugs ulipristal and mifepristone. Aims and Objectives: The study was conducted to compare reduction of menorrhagia (By pictorial blood loss assessment chart score), reduction of fibroid size (using transvaginal ultrasonography), and improvement of hemoglobin (Hb) level. We are also evaluating safety or side effects using these drugs. Materials and Methods: The study includes 210 patients who are divided into two groups. Group A includes 105 patients who are treated with tablet Ulipristal Acetate 5 mg daily for 3 months and Group B includes 105 patients who are treated with tablet mifepristone 25 mg daily for 3 months. Results: Ulipristal and mifepristone both are effective in reduction of menorrhagia and improvement of Hb levels, but Ulipristal is more effective in reduction of size of uterine myoma than mifepristone after 3 months of treatment. Conclusion: Multicentric study over a larger population is required to reach a valid conclusion.

Evaluation of the efficacy of levonorgestrel intrauterine system in the management of heavy menstrual bleeding: An analytical observational study

Background: Heavy menstrual bleeding (HMB) poses threat to the quality of life among women. To prevent HMB, the levonorgestrel-releasing intrauterine system (LNG-IUS) is a well-known nonsurgical, long-performing, and alternative method. Objectives: The objective of this study was to determine the efficacy of LNG-IUS in women with HMB through an analytical observational study. Materials and Methods: This study was performed among 60 patients who visited the gynecology and obstetrics outpatient department (OPD) at the Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital (IPGMER and SSKMH), Kolkata, West Bengal, India from May 2019 to April 2020 due to HMB. The mean demographic and clinical profiles were evaluated, and comparative analysis was performed for hemoglobin (Hb), spotting, pain, and endometrial thickness on day 0 and follow-up 3 months, 6 months, and 12 months. Results: The mean age of patients was 37.77 ± 4.58 years was obtained. The Hb level was significantly (P < .001) increased, whereas pictorial blood loss assessment chart (PBAC) score, endometrial thickness, spotting, and pain were significantly (P < .01 and P < .001) reduced. The majority of patients had pallor, but the rates of spontaneous expulsion and hysterectomy were observed lower after using LNG-IUS among studied patients. Conclusion: the usage of LNG-IUS is potential in the treatment of HMB in women, which may lead to a better quality of life. This can be the alternative to hysterectomy and oral pills for long-term use. It is suggested in a future study with larger sample size and multicentric approach to minimize hospital biasness.

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.

Mifepristone in Fibroids: Comparative Study of Safety and Efficacy of Biweekly Dosage Vs Daily Dosage Schedule.

Background:Leiomyomas are the most prevalent benign tumors of the uterus and are seen more with increasing age. 50 mg biweekly dose was compared with 25 mg daily dose in terms of efficacy and safety in symptomatic women as the biweekly dose maybe an economically better alternative. Two different dosages of mifepristone for medical management of fibroids were compared in terms of efficacy and safety in symptomatic women.Materials and Methods:Ninety-two women were recruited who fulfilled the criteria after informed consent and were randomized in two groups. Sample size was calculated on the basis of earlier literature, for response in terms of reduction in fibroid volume, assuming 1% level of significance and 95 % power of study, the optimum sample size came out to be minimum 27 in each group. Assuming loss to follow up of few patients, we took 45 patients in group 1 and 47 patients in group 2. Group 1 was given mifepristone in a dose of 25 mg once a day and Group 2 was given mifepristone 50 mg biweekly for 3 months. Fibroid volume, uterine volume, endometrial thickness, pictorial blood loss assessment chart score, hemoglobin levels, and liver transaminases were recorded at the beginning and at the end of treatment. Side effects were noted at the end of the treatment.Results:Both the dosages lead to improvement in symptoms of the patients. Mifepristone significantly reduced fibroid volume in both the groups, but the difference between the groups was not significant (P = 0.99). Mifepristone treatment significantly reduced bleeding and increased hemoglobin levels in both the groups. The side effects were mild and tolerable.Conclusion:Mifepristone in both dosages is highly efficacious in causing amenorrhea, improving anemia, and enhancing the quality of life, and hence 50 mg biweekly dosage shows potential for being cost efficient.