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SAGE Open Medicine 2024Uterine fibroids are the commonest benign tumors of the reproductive tract in women of childbearing age. They are usually asymptomatic but can cause menorrhagia.... (Review)
Review
INTRODUCTION
Uterine fibroids are the commonest benign tumors of the reproductive tract in women of childbearing age. They are usually asymptomatic but can cause menorrhagia. Treatments include myomectomy and uterine artery embolization (UAE). The latter is a relatively new procedure, therefore of special interest.
OBJECTIVES
We conducted a systematic review and meta-analysis of all published studies to provide a comprehensive outlook on the effectiveness of UAE by comparing its outcomes to those of myomectomy. Electronic databases (PubMed and Cochrane Central) were systematically searched from January 2000 to March 2022 for published randomized control trials, observational studies, and meta-analyses that compared UAE to myomectomy for at least one of the pre-specified outcomes, namely re-intervention rates, length of hospital stay, and complications.
METHODS
We shortlisted nine studies for the final analysis. For continuous outcomes, results from random-effects meta-analysis were presented as mean differences (MDs) and corresponding 95% confidence intervals (CIs). Risk ratios (RRs) for dichotomous outcomes were pooled using a random-effects model.
RESULTS
The final analysis consisted of nine studies. Factors like re-intervention, hospitalization, and complications, each with its unique follow-up duration were assessed. Pooled analysis demonstrated significant results for greater re-intervention rates with UAE as compared to myomectomy (RR: 2.16, 95% CI: (1.27-3.66), value 0.004, heterogeneity = 85%). UAE holds a greater but statistically insignificant risk for major complications (RR: 0.62, 95% CI: (0.29-1.33), value 0.22, heterogeneity = 0%) and myomectomy shows a statistically insignificant greater risk for minor complications (RR: 1.72, 95% CI: (0.92-3.22), value 0.09, heterogeneity = 0%). UAE had a shorter but statistically insignificant duration of hospital stay (MD: -1.12, 95% CI: (-2.50 to 0.27), value 0.11, heterogeneity = 96%) (value for subgroup differences = 0.005).
CONCLUSION
Our meta-analysis of approximately 196,595 patients demonstrates that myomectomy results in a significant reduction in re-intervention rate compared to UAE.
PubMed: 38751568
DOI: 10.1177/20503121241236141 -
BJOG : An International Journal of... Sep 2016Heavy menstrual bleeding (HMB) is a common problem with a variety of treatment options and many studies have been performed evaluating treatment effects. Consistency in... (Review)
Review
BACKGROUND
Heavy menstrual bleeding (HMB) is a common problem with a variety of treatment options and many studies have been performed evaluating treatment effects. Consistency in the choice and definition of primary and secondary outcomes is important for the interpretation of data and for the synthesis of data in systematic reviews or individual patient data meta-analysis (IPDMA).
OBJECTIVE
To give insight into the primary endpoints and outcome measures chosen in randomised controlled trials (RCTs) and systematic reviews regarding the treatment of HMB.
SEARCH STRATEGY
Published systematic reviews and RCTs.
SELECTION CRITERIA
Full reports of RCTs or systematic reviews.
DATA COLLECTION AND ANALYSIS
For RCTs, we used the primary outcomes, as they were used for the sample size calculation. For systematic reviews, all outcomes listed as primary were included. Four authors selected the studies.
RESULTS
Twelve different primary outcomes were reported by 66 RCTs, most blood loss- related (44/66 studies). Amenorrhoea was the most common blood loss primary outcome (16/44 studies) and the Pictorial Blood Loss Assessment Chart (PBAC) was the most used measurement tool (27/44 studies). Satisfaction was the second most prevalent primary outcome measure (13/66 studies). In all, 14/26 (54%) systematic reviews prespecified a single primary outcome, whereas all other reviews used composite primary outcomes. Blood loss was the most studied outcome (12/26 reviews).
CONCLUSIONS
The most used primary outcomes in HMB studies relate to blood loss but there is no consistency regarding the endpoints chosen or measurement tools used to describe blood loss. Standardising outcomes will aid valid comparison and interpretation of data pertaining to the treatment of HMB.
TWEETABLE ABSTRACT
A standardised collection of outcomes in heavy menstrual bleeding research is urgently needed.
Topics: Amenorrhea; Evidence-Based Medicine; Female; Humans; Menorrhagia; Meta-Analysis as Topic; Randomized Controlled Trials as Topic
PubMed: 27240106
DOI: 10.1111/1471-0528.14054 -
Journal of Minimally Invasive Gynecology 2008We report a case of retroperitoneal leiomyoma and a systematic review of the literature regarding this finding. A 45-year-old woman with menorrhagia and a complex pelvic... (Review)
Review
We report a case of retroperitoneal leiomyoma and a systematic review of the literature regarding this finding. A 45-year-old woman with menorrhagia and a complex pelvic mass underwent preoperative imaging and consequent total abdominal hysterectomy and bilateral salpingo-oophorectomy. Histopathology revealed a 13-cm retroperitoneal, pedunculated leiomyoma arising from the uterus anterior to the internal cervical os. Literature review identified 105 cases of retroperitoneal leiomyomata from 1941 through 2007, with 37 cases, including our own, containing sufficient information for analysis. Abstracted variables included patient age, race, obstetric and gynecologic history, presentation and duration of symptoms, investigations, management, surgical findings, pathologic and immunohistochemical characteristics, duration of follow-up, evidence of recurrence and its management. Mean age (+/-SD) of the population was 46.27 +/- 13.19 years. More than 40% of patients had either undergone hysterectomy for uterine leiomyomata previously or had concurrent uterine leiomyomata. Of patients, 25% were asymptomatic, 31.3% experienced abdominal fullness, 18.8% had urinary symptoms, 18.8% had weight loss, and 18.8% had pelvic pain. Diagnostic evaluation was inconclusive and surgical excision was undertaken in all but 1 case. Median leiomyoma size was 12.0 cm (range 2.0-37.0 cm) with most in the posterior retroperitoneum, independent of the uterus. Pathologic and immunohistochemical investigations were comparable with those of uterine leiomyomata. Surgery was mostly curative with 5 reported cases of recurrence, 3 of which were then considered sarcomatous. Retroperitoneal leiomyomata present diagnostic and therapeutic challenges, and as such require heightened surveillance.
Topics: Adult; CA-125 Antigen; Female; Humans; Leiomyoma; Middle Aged; Prognosis; Retroperitoneal Neoplasms; Retroperitoneal Space; Uterine Neoplasms
PubMed: 18312983
DOI: 10.1016/j.jmig.2007.12.009 -
Journal of Gynecology Obstetrics and... Nov 2021To evaluate the efficacy of UPA in women with fibroid induced menorrhagia. (Meta-Analysis)
Meta-Analysis
AIM
To evaluate the efficacy of UPA in women with fibroid induced menorrhagia.
METHODS
Embase, MEDLINE, CAB Abstracts, Cochrane Central Register of Controlled Trials, PsychInfo were searched up to 18th May 2020 and updated on 7th February 2021. Randomised controlled trials evaluating the efficacy of UPA in women with fibroid induced menorrhagia were included in the study.
RESULTS
Two authors independently reviewed and extracted the study data. Statistical heterogeneity was quantified using I statistics. Publication bias and data asymmetry was assessed by funnel plots. A meta-analysis was conducted where appropriate. Six studies were eligible for inclusion. UPA (5 mg and 10 mg) achieved statistically significant amenorrhoeic outcome when compared to placebo (p<0.00001). Increased adverse events (AE) profile was observed in the higher UPA dose, however, did not reach statistical significance.
CONCLUSIONS
This review demonstrates the efficacy of UPA in achieving amenorrhoea in women with fibroid induced menorrhagia. However, the favourable dose of UPA remains inconclusive when AE profile is taken into account. Evidence remains obscure regarding liver damage and further research is warranted to attain a conclusive outcome.
Topics: Adult; Contraceptive Agents; Female; Humans; Leiomyoma; Menorrhagia; Norpregnadienes; Uterine Neoplasms
PubMed: 34082168
DOI: 10.1016/j.jogoh.2021.102173 -
BJOG : An International Journal of... Jan 2001To determine whether the levonorgestrel-releasing intrauterine device (LNG-IUS), licensed at present for contraceptive use, may reduce menstrual blood loss with few side... (Review)
Review
OBJECTIVE
To determine whether the levonorgestrel-releasing intrauterine device (LNG-IUS), licensed at present for contraceptive use, may reduce menstrual blood loss with few side effects. If effective, surgery could be avoided with consequent resource savings.
METHODS
A systematic review addressing the effectiveness and cost effectiveness of the LNG-IUS for menorrhagia was undertaken.
RESULTS
Five controlled trials and five case series were found which measured menstrual blood loss. Nine studies recorded statistically significant average menstrual blood loss reductions with LNG-IUS (range 74%-97%). Another showed reduction in menstrual disturbance score. The LNG-IUS was more effective than tranexamic acid, but slightly less effective than endometrial resection at reducing menstrual blood loss. In one study, 64% of women cancelled surgery at six months, compared with 14% of control group women. In another, 82% were taken off surgical waiting lists at one year. No cost effectiveness studies were found.
DISCUSSION
Small studies of moderate quality indicate the LNG-IUS is an effective treatment for menorrhagia. Costs may be less than for tranexamic acid in primary and secondary care. Although its use may reduce surgical waiting lists, cost effectiveness assessment requires longer follow up.
CONCLUSION
Effectiveness and cost effectiveness relative to other treatments and the effect on surgical waiting lists can only be established in larger trials measuring patient-centred outcomes in women with menorrhagia.
Topics: Adult; Delayed-Action Preparations; Female; Humans; Intrauterine Devices, Medicated; Levonorgestrel; Menorrhagia; Middle Aged; Patient Satisfaction; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 11213008
DOI: 10.1111/j.1471-0528.2001.00020.x -
BMJ Clinical Evidence May 2007Between 5-77% of women may have fibroids, depending on the method of diagnosis used. Fibroids may be asymptomatic, or may present with menorrhagia, pain, infertility, or... (Review)
Review
INTRODUCTION
Between 5-77% of women may have fibroids, depending on the method of diagnosis used. Fibroids may be asymptomatic, or may present with menorrhagia, pain, infertility, or recurrent pregnancy loss. Risk factors for fibroids include obesity, having no children, and no long-term use of the oral contraceptive pill. Fibroids tend to shrink or fibrose after the menopause.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of: medical treatment alone; preoperative medical treatments for women scheduled for surgery; and surgical treatments in women with fibroids? We searched: Medline, Embase, The Cochrane Library and other important databases up to November 2006 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 41 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: gonadorelin analogues (with progestogen, raloxifene, tibolone, or combined oestrogen-progestogen); hysterectomy (plus oophorectomy); hysteroscopic resonance-focused ultrasound; laparoscopic myomectomy; laparoscopically assisted vaginal hysterectomy; rollerball endometrial ablation; thermal balloon ablation; thermal myolysis with laser; total abdominal hysterectomy; total abdominal myomectomy; total laparoscopic hysterectomy; total vaginal hysterectomy.
Topics: Humans; Hysterectomy; Hysterectomy, Vaginal; Leiomyoma; Uterine Neoplasms
PubMed: 19454074
DOI: No ID Found -
BJOG : An International Journal of... Apr 2024From menarche until menopause, the average menstruator will use over 11 000 tampons or sanitary pads. Vaginal and vulvar tissue is highly permeable, and chemicals are... (Review)
Review
BACKGROUND
From menarche until menopause, the average menstruator will use over 11 000 tampons or sanitary pads. Vaginal and vulvar tissue is highly permeable, and chemicals are absorbed without undergoing first-pass metabolism.
OBJECTIVES
To conduct a review of the literature to determine exposure to environmental chemicals in menstrual products.
SEARCH STRATEGY
This review identified 15 papers over the past 10 years.
SELECTION CRITERIA
Papers that measured chemicals in menstrual products and that measured human biomarkers of chemical exposure were included. Papers had to also be available in English.
DATA COLLECTION AND ANALYSIS
Reviewers assessed the articles and data provided. Multiple chemical groups were found.
MAIN RESULTS
Phthalates, volatile organic compounds, parabens, environmental phenols, fragrance chemicals, dioxins and dioxin-like compounds were detected in menstrual products. Research gaps were identified, including the lack of studies on newer products such as menstrual underwear and cups/discs. In addition to measuring chemicals in these products, future research should focus on clarifying the exposure per menstrual cycle to these chemicals to understand how menorrhagia and cycle length influence exposure from menstrual products.
CONCLUSION
Menstrual products contained measurable levels of a range of endocrine disrupting chemicals including phthalates, phenols and parabens. This reflects a potentially important route of exposure to chemicals that can impact women's reproductive health.
Topics: Humans; Female; Menstrual Hygiene Products; Parabens; Reproduction; Phthalic Acids; Phenols
PubMed: 37743685
DOI: 10.1111/1471-0528.17668 -
Health Technology Assessment... Apr 2011The aim of this project was to determine the clinical effectiveness and cost-effectiveness of hysterectomy, first- and second-generation endometrial ablation (EA), and... (Review)
Review
OBJECTIVE
The aim of this project was to determine the clinical effectiveness and cost-effectiveness of hysterectomy, first- and second-generation endometrial ablation (EA), and Mirena® (Bayer Healthcare Pharmaceuticals, Pittsburgh, PA, USA) for the treatment of heavy menstrual bleeding.
DESIGN
Individual patient data (IPD) meta-analysis of existing randomised controlled trials to determine the short- to medium-term effects of hysterectomy, EA and Mirena. A population-based retrospective cohort study based on record linkage to investigate the long-term effects of ablative techniques and hysterectomy in terms of failure rates and complications. Cost-effectiveness analysis of hysterectomy versus first- and second-generation ablative techniques and Mirena.
SETTING
Data from women treated for heavy menstrual bleeding were obtained from national and international trials. Scottish national data were obtained from the Scottish Information Services Division.
PARTICIPANTS
Women who were undergoing treatment for heavy menstrual bleeding were included.
INTERVENTIONS
Hysterectomy, first- and second-generation EA, and Mirena.
MAIN OUTCOME MEASURES
Satisfaction, recurrence of symptoms, further surgery and costs.
RESULTS
Data from randomised trials indicated that at 12 months more women were dissatisfied with first-generation EA than hysterectomy [odds ratio (OR): 2.46, 95% confidence interval (CI) 1.54 to 3.93; p = 0.0002), but hospital stay [WMD (weighted mean difference) 3.0 days, 95% CI 2.9 to 3.1 days; p < 0.00001] and time to resumption of normal activities (WMD 5.2 days, 95% CI 4.7 to 5.7 days; p < 0.00001) were longer for hysterectomy. Unsatisfactory outcomes associated with first- and second-generation techniques were comparable [12.2% (123/1006) vs 10.6% (110/1034); OR 1.20, 95% CI 0.88 to 1.62; p = 0.2). Rates of dissatisfaction with Mirena and second-generation EA were similar [18.1% (17/94) vs 22.5% (23/102); OR 0.76, 95% CI 0.38 to 1.53; p = 0.4]. Indirect estimates suggested that hysterectomy was also preferable to second-generation EA (OR 2.32, 95% CI 1.27 to 4.24; p = 0.006) in terms of patient dissatisfaction. The evidence to suggest that hysterectomy is preferable to Mirena was weaker (OR 2.22, 95% CI 0.94 to 5.29; p = 0.07). In women treated by EA or hysterectomy and followed up for a median [interquartile range (IQR)] duration of 6.2 (2.7-10.8) and 11.6 (7.9-14.8) years, respectively, 962/11,299 (8.5%) women originally treated by EA underwent further gynaecological surgery. While the risk of adnexal surgery was similar in both groups [adjusted hazards ratio 0.80 (95% CI 0.56 to 1.15)], women who had undergone ablation were less likely to need pelvic floor repair [adjusted hazards ratio 0.62 (95% CI 0.50 to 0.77)] and tension-free vaginal tape surgery for stress urinary incontinence [adjusted hazards ratio 0.55 (95% CI 0.41 to 0.74)]. Abdominal hysterectomy led to a lower chance of pelvic floor repair surgery [hazards ratio 0.54 (95% CI 0.45 to 0.64)] than vaginal hysterectomy. The incidence of endometrial cancer following EA was 0.02%. Hysterectomy was the most cost-effective treatment. It dominated first-generation EA and, although more expensive, produced more quality-adjusted life-years (QALYs) than second-generation EA and Mirena. The incremental cost-effectiveness ratios for hysterectomy compared with Mirena and hysterectomy compared with second-generation ablation were £1440 per additional QALY and £970 per additional QALY, respectively.
CONCLUSIONS
Despite longer hospital stay and time to resumption of normal activities, more women were satisfied after hysterectomy than after EA. The few data available suggest that Mirena is potentially cheaper and more effective than first-generation ablation techniques, with rates of satisfaction that are similar to second-generation techniques. Owing to a paucity of trials, there is limited evidence to suggest that hysterectomy is preferable to Mirena. The risk of pelvic floor surgery is higher in women treated by hysterectomy than by ablation. Although the most cost-effective strategy, hysterectomy may not be considered an initial option owing to its invasive nature and higher risk of complications. Future research should focus on evaluation of the clinical effectivesness and cost-effectiveness of the best second-generation EA technique under local anaesthetic versus Mirena and types of hysterectomy such as laparoscopic supracervical hysterectomy versus conventional hysterectomy and second-generation EA.
FUNDING
The National Institute for Health Research Health Technology Assessment programme.
Topics: Contraceptive Agents, Female; Cost-Benefit Analysis; Endometrial Ablation Techniques; Female; Humans; Hysterectomy; Levonorgestrel; Menorrhagia; Patient Satisfaction; Postoperative Complications; Quality-Adjusted Life Years; Time; Treatment Outcome
PubMed: 21535970
DOI: 10.3310/hta15190 -
The use of dienogest in treatment of symptomatic adenomyosis: A systematic review and meta-analysis.Journal of Gynecology Obstetrics and... May 2024Adenomyosis is a gynaecological problem that impacts women's quality of life by causing dysmenorrhea, chronic pelvic pain, and menorrhagia. The search continues for the... (Review)
Review
Adenomyosis is a gynaecological problem that impacts women's quality of life by causing dysmenorrhea, chronic pelvic pain, and menorrhagia. The search continues for the best medical treatment for symptomatic adenomyosis. This systematic review and meta-analysis investigated the role of dienogest, an oral progestin, in reducing pain and bleeding associated with adenomyosis. Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, MEDLINE, Scopus, and Web of Science were searched in January 2024. The primary outcome was pain scores for dysmenorrhea, whereas secondary outcomes were chronic pelvic pain (CPP), uterine volume (UV), and menorrhagia. One comparison was performed comparing outcomes in symptomatic adenomyosis before and after treatment with dienogest. Pooled analysis of included studies reported a statistically significant reduction of dysmenorrhea pain score after dienogest treatment (mean difference -5.86 cm on a 10-cm visual analogue scale, 95 % CI -7.20 to -4.53, I2 = 97 %). Regarding chronic pelvic pain, a meta-analysis of included studies showed a significant decline in pain after treatment (standardized mean difference -2.37, 95 % CI -2.89 to -1.86, I2 = 60 %). However, uterine volume did not differ significantly after treatment (mean difference -4.65 cm, 95 % CI -43.22 to 33.91). Menorrhagia was improved significantly after treatment (Peto odds ratio 0.07, 95 % CI 0.03 to 0.18). In conclusion, dienogest seems to be effective in controlling painful symptoms and uterine bleeding in women with adenomyosis at short and long-term therapy.
PubMed: 38729430
DOI: 10.1016/j.jogoh.2024.102795 -
Obstetrics and Gynecology May 2009To compare the effects of the levonorgestrel intrauterine system and endometrial ablation in reducing heavy menstrual bleeding. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To compare the effects of the levonorgestrel intrauterine system and endometrial ablation in reducing heavy menstrual bleeding.
DATA SOURCES
Medline and EMBASE were searched online using Ovid up to January 2009, as well as the reference lists of published articles, to identify randomized controlled trials comparing the levonorgestrel intrauterine system with endometrial ablation in the treatment of heavy menstrual bleeding.
METHODS OF STUDY SELECTION
This systematic review and meta-analysis was restricted to randomized controlled trials in which menstrual blood loss was reported using pictorial blood loss assessment chart scores.
TABULATION, INTEGRATION, AND RESULTS
Six randomized controlled trials that included 390 women (levonorgestrel intrauterine system, n=196; endometrial ablation, n=194) were retrieved. Three studies pertained to first-generation endometrial ablation (manual hysteroscopy) and three to second-generation endometrial ablation (thermal balloon). Study characteristics and quality were recorded for each study. Data on the effect of treatment on pictorial blood loss assessment chart scores were abstracted, integrated with meta-analysis techniques, and presented as weighted mean differences. Both treatment modalities were associated with similar reductions in menstrual blood loss after 6 months (weighted mean difference, -31.96 pictorial blood loss assessment chart score [95% confidence interval (CI), -65.96 to 2.04]), 12 months (weighted mean difference, 7.45 pictorial blood loss assessment chart score [95% CI, -12.37 to 27.26]), and 24 months (weighted mean difference, -26.70 pictorial blood loss assessment chart score [95% CI, -78.54 to 25.15]). In addition, both treatments were generally associated with similar improvements in quality of life in five studies that reported this as an outcome. No major complications occurred with either treatment modality in these small trials.
CONCLUSION
Based on the meta-analysis of six randomized clinical trials, the efficacy of the levonorgestrel intrauterine system in the management of heavy menstrual bleeding appears to have similar therapeutic effects to that of endometrial ablation up to 2 years after treatment.
Topics: Contraceptive Agents, Female; Endometrial Ablation Techniques; Female; Humans; Intrauterine Devices, Medicated; Menorrhagia
PubMed: 19384127
DOI: 10.1097/AOG.0b013e3181a1d3ce