A novel transcutaneous auricular neurostimulation electrode configuration for treatment of heavy menstrual bleeding: an open-label trial

Findings from this review should be interpreted with caution due to low- and very low-certainty evidence. Included trials were limited; the majority of the evidence was derived from single trials with few participants. Further research requires larger trials and improved trial reporting. The use of vitamin B1 and mefenamic acid to treat heavy menstruation and tolfenamic acid to prevent heavy menstruation associated with Cu IUD should be investigated. More trials are needed to generate evidence for the treatment and prevention of heavy and painful menstruation associated with LNG IUD.

Uterine fibroids are the most common anatomical cause of heavy menstrual bleeding. To which extent clinical practice variation is present in the treatment of fibroid-related heavy menstrual bleeding at the hospital level remains unclear. The aim of this study was to identify and evaluate the clinical practice variation in the treatment of fibroid-related heavy menstrual bleeding. In this multicenter, retrospective database study, pseudonymized real-world data were collected from electronic health records using a natural language processing and text-mining data collection tool. Women ≤ 55 years, who presented as new patients at the gynecology outpatient clinic in 2019 with heavy menstrual bleeding and fibroids, were selected. Data were extracted from the first appointment in 2019 throughout December 2022. The primary outcome was the number of treatments initiated. Secondary outcomes were the type of treatments initiated, treatments initiated prior to hysterectomy, and time to hysterectomy. From four hospitals, 623 women were included. The median age was 46 (range: 23-55) years. Overall, a median of one treatment (range: 1-4) was initiated, which significantly differed between hospitals (p < 0.01). Pharmacological treatment was initiated most frequently, which differed significantly among hospitals (392/623 [62.9%], range: 49.1%-70.5%, p = 0.02). Minimally invasive therapies were initiated in 51.2% (319/623, range: 40.6%-58.9%, p < 0.01). Only 30/319 patients (9.4%) received a minimally invasive uterus-sparing treatment. Hysterectomy was performed in 123/319 patients (38.6%), with Hospital 1 being an outlier as 52.3% underwent hysterectomy, compared to 23.9%-36.4% in the other hospitals (p < 0.01). Clinical practice variation is present in the treatment of heavy menstrual bleeding in Dutch women with fibroids. Organizational factors could partially explain clinical practice variation. Sharing data can aid in identifying, explaining, and acting on (un)warranted practice variation between healthcare clinics. While clinical practice variation remains inevitable, unwarranted practice variation should be limited by ameliorating guideline adherence, educational interventions, and patient counseling, to improve the quality, efficiency, and equity of care.

Thrombotic Outcomes Following Hormonal Treatment of Heavy Menstrual Bleeding in Pediatric Patients Taking Anticoagulation

Tranexamic acid has proven to be an effective treatment for heavy menstrual bleeding (HMB). It reduces menstrual blood loss (MBL) by 26%–60% and is significantly more effective than placebo, nonsteroidal anti-inflammatory drugs, oral cyclical luteal phase progestins, or oral etamsylate, while the levonorgestrel-releasing intrauterine system reduces MBL more than tranexamic acid. Other treatments used for HMB are oral contraceptives, danazol, and surgical interventions (endometrial ablation and hysterectomy). Medical therapy is usually considered a first-line treatment for idiopathic HMB. Tranexamic acid significantly improves the quality of life of women treated for HMB. The recommended oral dosage is 3.9–4 g/day for 4–5 days starting from the first day of the menstrual cycle. Adverse effects are few and mainly mild. No evidence exists of an increase in the incidence of thrombotic events associated with its use. An active thromboembolic disease is a contraindication. In the US, a history of thrombosis or thromboembolism, or an intrinsic risk for thrombosis or thromboembolism are considered contraindications as well. This review focuses on the efficacy and safety of tranexamic acid in the treatment of idiopathic HMB. We searched for medical literature published in English on tranexamic acid from Ovid Medline, PubMed, and Cinahl. Additional references were identified from the reference lists of articles. Ovid Medline, PubMed, and Cinahl search terms were “tranexamic acid” and “menorrhagia” or “heavy menstrual bleeding.” Searches were last updated on March 25, 2012. Studies with women receiving tranexamic acid for HMB were included; randomized controlled studies with a description of appropriate statistical methodology were preferred. Relevant data on the physiology of menstruation and the pharmacodynamics and pharmacokinetics of tranexamic acid are also included.

This double-blind trial investigated the efficacy and safety of estradiol valerate/dienogest (E(2)V/DNG) for the treatment of heavy menstrual bleeding without recognizable organic pathology. Otherwise healthy women with idiopathic heavy, prolonged or frequent menstrual bleeding, confirmed during a 90-day run-in phase, were randomized (2:1) according to a permuted-block, computer-generated schedule to E(2)V/DNG or placebo for 196 days at 34 centres in Europe and Australia. The primary efficacy end-point was the proportion of women with a 'complete' response (i.e. a return to 'menstrual normality') during a 90-day efficacy phase. Secondary end-points included changes in measured menstrual blood loss (MBL) and iron metabolism parameters. The intention-to-treat population comprised 231 women. The E(2)V/DNG response rate was much higher than with placebo (P < 0.0001). The mean reduction in MBL volume in E(2)V/DNG recipients was 69.4% (median 79.2%) versus 5.8% (median 7.4%) in placebo recipients. The between-treatment difference in MBL volume was 373 ml in favour of E(2)V/DNG (95% confidence interval 490, 255 ml; P < 0.0001). Significant improvements in iron metabolism parameters were observed with E(2)V/DNG but not placebo. Overall, 14 women (9.7%) treated with E(2)V/DNG and 5 (6.2%) treated with placebo prematurely discontinued treatment because of adverse events, headache being the most prevalent. Serious adverse events occurred in both the E(2)V/DNG and placebo groups (each n = 2). E(2)V/DNG is an effective treatment in women with heavy and/or prolonged menstrual bleeding without organic pathology. Further study of E(2)V/DNG compared with an active comparator is warranted. ClinicalTrials.gov identifier: NCT00307801.

Contraceptive vaginal ring treatment of heavy menstrual bleeding: a randomized controlled trial with norethisterone

Treatment of Women With an Endometrial Polyp and Heavy Menstrual Bleeding: A Levonorgestrel-Releasing Intrauterine Device or Hysteroscopic Polypectomy?

Heavy menstrual bleeding is a common problem that can significantly affect women's lives until menopause. There is a lack of evidence on longer-term outcomes after seeking health care and treatment for heavy menstrual bleeding. To assess the continuation rates of medical treatments and the rates of ablative and surgical interventions among women who had participated in the ECLIPSE trial (ISRCTN86566246) 10 years after initial management for heavy menstrual bleeding in primary care. To explore experiences of heavy menstrual bleeding and influences on treatment for women. This was a prospective observational cohort study, with a parallel qualitative study. Primary care. A total of 206 women with heavy menstrual bleeding who had participated in the ECLIPSE trial consented to providing outcome data via a questionnaire approximately 10 years after original randomisation. Their mean age at follow-up was 54 years (standard deviation 5 years). A purposeful sample of 36 women also participated in semistructured qualitative interviews. The ECLIPSE trial randomised participants to either the levonorgestrel-releasing intrauterine system (52 mg) or the usual medical treatment (oral tranexamic acid, mefenamic acid, combined oestrogen-progestogen or progesterone alone, chosen as clinically appropriate by general practitioners and women). Women could subsequently swap or cease their allocated treatment. The main outcome measures were rates of ablative and surgical treatments; the rate of continuation of medical treatments; and quality of life using the Short Form questionnaire-36 items and EuroQol-5 Dimensions; women's experiences of heavy menstrual bleeding; and the influences on their decisions around treatment. Over the 10-year follow-up period, 60 out of 206 (29%) women had received a surgical intervention [hysterectomy, n = 34 (17%); endometrial ablation, n = 26 (13%)]. Between 5 and 10 years post trial intervention, 89 women (43%) had ceased all medical treatments and 88 (43%) were using the levonorgestrel-releasing intrauterine system alone or in combination with other oral treatments. More women in the usual medical treatment group had also used the levonorgestrel-releasing intrauterine system than women in the levonorgestrel-releasing intrauterine system group. Fifty-six women (28%) used the levonorgestrel-releasing intrauterine system at 10 years. There was no statistically significant difference in generic quality-of-life scores between the two original trial groups, although small improvements in the majority of domains were seen in both groups across time. Women reported wide-ranging impacts on their quality of life and normalisation of their heavy menstrual bleeding experience as a result of the taboo around menstruation. Women's treatment decisions and experiences were influenced by the perceived quality of health-care interactions with clinicians and their climacteric status. Fewer than half of the original 571 participants participated; however, the cohort was clinically and demographically representative of the original trial population. Medical treatments for women with heavy menstrual bleeding can be initiated in primary care, with low rates of surgical intervention and improvement in quality of life observed 10 years later. Clinicians should be aware of the considerable challenges that women with heavy menstrual bleeding experience at presentation and subsequently over time, and the importance and value to women of patient-centred communication in this context. Any further evaluation of treatments for heavy menstrual bleeding should include long-term evaluation of outcomes and adherence. The original ECLIPSE trial was registered as ISRCTN86566246. This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 17. See the NIHR Journals Library website for further project information.

Menstrual Patterns and Treatment of Heavy Menstrual Bleeding in Adolescents with Bleeding Disorders

The optimal treatment of heavy menstrual bleeding (HMB) remains a challenge for the physician. There is a need for further trials to compare the effectiveness and compliance between a levonorgestrel-releasing intrauterine system (LNG-IUS) and minimally invasive types of hysterectomy, for example, laparoscopic supracervical hysterectomy (LSH), in women with HMB. This article is the first to report a randomized trial aimed at comparing postoperative outcomes and effects on quality of life after LNG-IUS or LSH in women with HMB. The trial was performed at Tor Vergata University Hospital, Rome. Seventy-two women requiring treatment for HMB were randomly allocated into two treatment arms: LNG-IUS (n=36) or LSH (n=36). The primary outcome was the comparison of the effects on menstrual bleeding (pictorial blood loss assessment chart [PBAC]) at 12 months after the two procedures. The secondary outcome measures were the quality of life, improvement in bleeding patterns, intensity of postoperative pain, and early postoperative complications. A p<0.05 was considered statistically significant. The PBAC score was significantly reduced in both treatment groups. The Medical Outcomes Survey Short Form 36 (SF-36) score improved in both groups. A more significant improvement in the parameters Role and Mental health was observed after LNG-IUS. LNG-IUS can be considered as first option for the treatment of HMB unresponsive to drug therapy, and it is particularly suitable for women who want to preserve an acceptable menstrual flow. LSH may be considered the best surgical option in women with HMB unresponsive to any medical treatment.

Mechanism of action of the levonorgestrel-releasing intrauterine system in the treatment of heavy menstrual bleeding

Provider Attitudes and Practices Regarding Intrauterine System (IUS) Insertion in Adolescents With and Without Bleeding Disorders for Management of Heavy Menstrual Bleeding.

Endometrial resection and ablation offers an alternative to hysterectomy as a surgical treatment for heavy menstrual bleeding. Both procedures are effective, and satisfaction rates are high. Although hysterectomy offers permanent and immediate relief from heavy menstrual bleeding, it is associated with a longer operating time and recovery period. Hysterectomy also has higher rates of postoperative complications such as sepsis, blood transfusion and haematoma (vault and wound). The initial cost of endometrial destruction is lower than that of hysterectomy but, because retreatment is often necessary, the cost difference narrows over time.

Heavy menstrual bleeding (HMB) or menorrhagia is an important cause of ill health in women. Surgical treatment of HMB often follows failed or ineffective medical therapy and the definitive treatment is hysterectomy but this is a major surgical procedure with significant physical and emotional complications and social and economic costs. A number of less invasive surgical techniques (e.g. endometrial resection and laser ablation) have been developed with the purpose of removing the entire thickness of the endometrium. The benefits claimed for these therapies are reduced trauma and post-operative complications to the woman, reduced need for a general anaesthetic, direct cost savings to the health service due largely to a shift from inpatient to day case treatment and indirect cost savings to society as women return more quickly to their usual activities. However, endometrial hysteroscopic techniques are not always completely successful and additional surgical treatment is required in a proportion of cases. Although initially the resource and patient costs of these techniques are much cheaper than the cost of hysterectomy, the need for re treatment at a later stage may reduce the cost differential. Thus, the effectiveness of these techniques to improve a woman's perception of her own wellbeing long term has yet to be confirmed. The objective of this review is to compare endometrial destruction techniques with hysterectomy by any means for the treatment of heavy menstrual bleeding (HMB). Electronic searches for relevant randomised controlled trials of the Cochrane Menstrual Disorders and Sub fertility Group Register of Trials, MEDLINE, EMBASE, PsychLIT, Current Contents, Biological Abstracts, Social Sciences Index and CINAHL were performed. Attempts were also made to identify trials from citation lists of review articles and hand searching. In most cases, the first or corresponding author of each included trial was contacted for additional information. The inclusion criteria were randomised comparisons of endometrial destruction techniques with hysterectomy by any means for the treatment of heavy menstrual bleeding in premenopausal women. Five RCTs were identified that fulfilled the inclusion criteria for this review. For two trials, a number of publications were identified which assessed different outcomes and different follow up time points for the same patients. The reviewers extracted the data independently and odds ratios for dichotomous outcomes and weighted mean differences for continuous outcomes were estimated from the data. Outcomes analysed included improvement in menstrual blood loss, satisfaction, change in quality of life, duration of surgery and hospital stay, time to return to work, adverse events and requirement for repeat surgery because of failure of the initial surgical treatment. There was a significant advantage in favour of hysterectomy in the improvement in HMB and satisfaction rates (up to 4 years post surgery) compared with endometrial destruction techniques. Although many quality of life scales reported no differences between surgery groups, there was some evidence of a greater improvement in general health for hysterectomy patients. Duration of surgery, hospital stay and recovery time were all shorter following endometrial destruction. Most adverse events, both major and minor, were significantly more likely after hysterectomy and before discharge from hospital. After discharge from hospital, the only difference that was reported for this group was a higher rate of infection. Repeat surgery because of failure of the initial treatment, either endometrial ablation or hysterectomy, was more likely after endometrial destruction than hysterectomy. (ABSTRACT TRUNCATED)

Efficacy and safety of vilaprisan in women with uterine fibroids: data from the ASTEROID 3 randomized controlled trial