Levonorgestrel-releasing intrauterine device versus hysteroscopic endometrial resection in the treatment of dysfunctional uterine bleeding. A randomized controlled trial of levonorgestrel releasing IUD and thermal balloon ablation in the treatment of menorrhagia. Effect of hysterectomy vs medical treatment on health-related quality of life and sexual functioning: the medicine or surgery (Ms) randomized trial. Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system or hysterectomy for treatment of menorrhagia: randomized trial 5-year follow-up. Long-term treatment of menorrhagia with levonorgestrel intrauterine system versus endometrial resection. A randomized prospective trial comparing the levonorgestrel-releasing intrauterine system with thermal balloon ablation for the treatment of heavy menstrual bleeding. A randomised trial comparing the levonorgestrel intrauterine system and thermal balloon ablation for heavy menstrual bleeding. A randomised comparison of medical and hysteroscopic management in women consulting a gynaecologist for treatment of heavy menstrual loss. Health status function after treatment with thermal balloon endometrial ablation and levonorgestrel intrauterine system for idiopathic menorrhagia: a randomized study.
To compare the effect of a levonorgestrel-releasing intrauterine device with that of endometrial resection on menstrual bleeding, patient satisfaction, and quality of life in menorrhagic women during 12 months of follow-up.
                Seventy premenopausal women with dysfunctional uterine bleeding were enrolled in a prospective, open, parallel-group, controlled trial. They were randomized to either insertion of an intrauterine system releasing 20 micrograms/day of levonorgestrel (n = 35) or endometrial resection (n = 35). The women were evaluated at baseline, and thereafter, uterine bleeding was assessed monthly with a pictorial blood loss assessment chart. Clinical gynecologic examination was performed bimonthly, and the hematologic variables were measured at 6 and 12 months. On the latter occasion, the women were requested to rate the degree of satisfaction with the effect of their treatment and to complete the Short Form 36 General Health Survey questionnaire.
                Recurrent menorrhagia was observed at 12 months in four women in the intrauterine device group (including two with partial expulsion of the device) and in three women in the resection group. Compared with baseline values, at 1 year, the pictorial blood loss assessment chart score was reduced by 79% in the former group and by 89% in the latter. Amenorrhea or hypomenorrhea at 12 months was reported by 65% of the women with an intrauterine device compared with 71% who underwent endometrial resection. The degree of satisfaction with treatment was high in both groups, with 29 of 34 (85%) women being satisfied or very satisfied in the intrauterine device group versus 33 of 35 (94%) in the resection group. Health-related quality of life perception was not significantly different in the two treatment groups.
                Somewhat less satisfactory results were obtained with a levonorgestrel-releasing intrauterine system compared with endometrial resection for dysfunctional uterine bleeding at 1 year of follow-up. Our aim was to compare the treatment of menorrhagia either with a levonorgestrel-releasing intrauterine device or with endometrial thermal balloon ablation. The primary endpoints of evaluation were menstrual blood flow reduction and the increase in hemoglobin values, while the secondary end points were adverse side effects; health related quality of life. After randomization, 36 women underwent outpatient thermal balloon ablation under local anesthesia and an intrauterine device releasing 20 microgram/day of levonorgestrel, were inserted within the first 7 days of menses to 36 women. Both techniques were found to be significantly effective in reducing the menstrual blood loss but in comparison thermal balloon ablation was more effective in Deltamean +/- SD decrease of pictorial sores (388.2 +/- 21 vs 343 +/- 27; p < 0.001). We noted a significant but similar increases in Deltamean +/- SD hemoglobin values (3.9 +/- 1.7 vs 3.7 +/- 1.4; p:.21). Patients treated by thermal balloon ablation reported fewer side effects and perceived a higher health related quality of life in physical role functioning. At one year of follow-up, the medicated device was effective but not as effective as thermal balloon ablation in reducing the menstrual blood loss. However it was found to be as effective as thermal balloon ablation in increasing the hemoglobin values. The side effect profile of the medicated device may alter its acceptability by reducing the perceived health related quality of life in menorrhagic women with no desire for further childbearing. Although a quarter of US women undergo elective hysterectomy before menopause, controlled trials that evaluate the benefits and harms are lacking.
                To compare the effect of hysterectomy vs expanded medical treatment on health-related quality of life.
                A multicenter, randomized controlled trial (August 1997-December 2000) of 63 premenopausal women, aged 30 to 50 years, with abnormal uterine bleeding for a median of 4 years who were dissatisfied with medical treatments, including medroxyprogesterone acetate. The participants, who were patients at gynecology clinics and affiliated practices of 4 US academic medical centers, were followed up for 2 years.
                Participants were randomly assigned to undergo hysterectomy or expanded medical treatment with estrogen and/or progesterone and/or a prostaglandin synthetase inhibitor. The hysterectomy route and medical regimen were determined by the participating gynecologist.
                The primary outcome was mental health measured by the Mental Component Summary (MCS) of the 36-Item Short-Form Health Survey (SF-36). Secondary outcomes included physical health measured by the Physical Component Summary (PCS), symptom resolution and satisfaction, body image, and sexual functioning, as well as other aspects of mental health and general health perceptions.
                At 6 months, women in the hysterectomy group had greater improvement in MCS scores than women in the medicine group (8 vs 2, P =.04). They also had greater improvement in symptom resolution (75 vs 29, P<.001), symptom satisfaction (44 vs 7, P<.001), interference with sex (41 vs 22, P =.003), sexual desire (21 vs 3, P =.01), health distress (33 vs 13, P =.009), sleep problems (13 vs 1, P =.03), overall health (12 vs 2, P =.006), and satisfaction with health (31 vs 14, P =.01). By the end of the study, 17 (53%) of the women in the medicine group had requested and received hysterectomy, and these women reported improvements in quality-of-life outcomes during the 2 years that were similar to those reported by women randomized to the hysterectomy group. Women who continued medical treatment also reported some improvements (P<.001 for within-group change in many outcomes), with the result that most differences between randomized groups at the end of the study were no longer statistically significant in the intention-to-treat analysis.
                Among women with abnormal uterine bleeding and dissatisfaction with medroxyprogesterone, hysterectomy was superior to expanded medical treatment for improving health-related quality-of-life after 6 months. With longer follow-up, half the women randomized to medicine elected to undergo hysterectomy, with similar and lasting quality-of-life improvements; those who continued medical treatment also reported some improvements. Because menorrhagia is often a reason for seeking medical attention, it is important to consider outcomes and costs associated with alternative treatment modalities. Both the levonorgestrel-releasing intrauterine system (LNG-IUS) and hysterectomy have proven effective for treatment of menorrhagia but there are no long-term comparative studies measuring cost and quality of life.
                To compare outcomes, quality-of-life issues, and costs of the LNG-IUS vs hysterectomy in the treatment of menorrhagia.
                Randomized controlled trial conducted between October 1, 1994, and October 6, 2002, and enrolling 236 women (mean [SD] age, 43 [3.4] years) referred to 5 university hospitals in Finland for complaints of menorrhagia.
                Participants were randomly assigned to treatment with the LNG-IUS (n = 119) or hysterectomy (n = 117) and were monitored for 5 years.
                Health-related quality of life (HRQL) as measured by the 5-Dimensional EuroQol and the RAND 36-Item Short-Form Health Survey, other measures of psychosocial well-being (anxiety, depression, and sexual function), and costs.
                After 5 years of follow-up, 232 women (99%) were analyzed for the primary outcomes. The 2 groups did not differ substantially in terms of HRQL or psychosocial well-being. Although 50 (42%) of the women assigned to the LNG-IUS group eventually underwent hysterectomy, the discounted direct and indirect costs in the LNG-IUS group (2817 dollars [95% confidence interval, 2222 dollars-3530 dollars] per participant) remained substantially lower than in the hysterectomy group (4660 dollars [95% confidence interval, 4014 dollars-5180 dollars]). Satisfaction with treatment was similar in both groups.
                By providing improvement in HRQL at relatively low cost, the LNG-IUS may offer a wider availability of choices for the patient and may decrease costs due to interventions involving surgery. The purpose of this study was to compare the long-term efficacy of the levonorgestrel intrauterine system and transcervical resection of the endometrium in the treatment of menorrhagia.
                This study was an open, randomized 3-year trial. Patients with menorrhagia were assigned randomly to either the levonorgestrel intrauterine system (n = 30) or endometrial resection (n = 29). Pictorial blood loss assessment charts were used to measure menstrual blood loss. A pictorial blood-loss assessment chart score exceeding 75 (representing menstrual blood loss >/=60 mL) was used to diagnosis the patient as having menorrhagia. Discontinuations and cases requiring repeat operations were evaluated.
                Pictorial blood loss scores decreased from a baseline median of 261.5 (range, 60-1503) to 7 (range, 0-101; P < .001) for the levonorgestrel intrauterine system and from 311 (range, 81-2506) to 4 (range, 0-182; P < .001) for transcervical resection of the endometrium. Nineteen women of 30 using the levonorgestrel intrauterine system completed the 3-year follow-up compared with 22 of 29 for transcervical resection of the endometrium.
                Both treatments efficiently reduced menstrual bleeding. The high continuation rate suggests that the levonorgestrel intrauterine system is comparable with transcervical resection of the endometrium. Use of the levonorgestrel-releasing intrauterine system (LNG-IUS) was compared with thermal balloon ablation (TBA) for the treatment of heavy menstrual bleeding (HMB).
                A prospective randomized trial comparing the LNG-IUS (n=30 women) and TBA (n=28 women).
                Hemoglobin levels increased (p<.001) and blood loss was reduced (p<.001) in both groups after 1 year of treatment. Menstrual bleeding was less in the LNG-IUS group compared to the TBA group at 6 and 12 months of treatment (p=.035 and p=.048, respectively). Intermenstrual bleeding was significantly less in the TBA group at 6 months compared to the LNG-IUS group (p=.044); however, there was no significant difference at 12 months (p=.129). No difference was found in psychological aspects between pre- and posttreatment variables in either of the groups (p=.537).
                Both the LNG-IUS and TBA appear to be effective in controlling HMB; however, posttreatment uterine bleeding patterns are different.
                Copyright (c) 2010 Elsevier Inc. All rights reserved. To compare the levonorgestrel intrauterine system (LNG-IUS) (Mirena); Schering Co., Turku, Finland) and thermal balloon ablation (Thermachoice; Gynecare Inc., Menlo Park, CA, USA) for the treatment of heavy menstrual bleeding.
                An open, pragmatic, prospective randomised trial.
                A menstrual disorders clinic at National Women's Hospital, Auckland, New Zealand.
                Seventy-nine women with heavy menstrual bleeding randomised to the LNG-IUS (40 women) or the thermal balloon ablation (39 women).
                Women were randomised to treatment with the LNG-IUS or thermal balloon ablation and followed up by a postal and telephone questionnaire.
                Menstrual loss measured by a pictorial bleeding assessment chart (PBAC) at 3, 6, 12 and 24 months. Patient satisfaction, quality of life and menstrual symptoms were assessed by questionnaire administered at 3, 6, 12 and 24 months. Treatment side effects and treatment failures were also recorded.
                Both the treatments resulted in a significant reduction in PBAC scores. At 12 and 24 months, median PBAC scores were significantly lower in women treated with the LNG-IUS compared with women treated by thermal balloon ablation (11.5 versus 60.0 at 12 months [P= 0.002]; 12.0 versus 56.5 [P= 0.002] at 24 months). At 24 months, nine (35%) women still using the LNG-IUS had amenorrhoea compared with one (5%) woman successfully treated by thermal balloon ablation (P = 0.025). There were no significant differences in patient satisfaction between two treatments during follow up. Treatment failed in 11 (28%) women using the LNG-IUS and in 10 (26%) women treated with thermal balloon ablation. Overall, women in both groups showed an increased quality of life as a result of the treatment, with Short Form-36 scores increasing from 63.7 at randomisation to 76.1 at 24 months.
                At 12 and 24 months of follow up, women with heavy menstrual bleeding treated with the LNG-IUS have significantly lower PBAC scores than women treated with thermal balloon ablation. Both the treatments resulted in a significant increase in overall quality of life, but there were no significant differences between either treatment in quality of life, patient satisfaction or the number of women requesting an alternative treatment during 24 months of follow up. To compare medical with hysteroscopic management in women referred to a gynaecologist complaining of heavy menstrual loss.
                Single-centre randomised trial.
                A teaching hospital in the United Kingdom.
                One hundred and ninety-seven women seeking specialist treatment of heavy menstrual loss for the first time and willing to accept either treatment.
                1. Medical treatments not previously used by the women prescribed by experienced gynaecologists in standard doses and timings for a minimum of three cycles (n = 94), and 2. transcervical resection of the endometrium performed under general anaesthesia five weeks after goserelin preparation (n = 93).
                Treatment satisfaction and acceptability, relief of symptoms, change in haemoglobin, and improvement in health related quality of life, all after four months.
                Women allocated transcervical resection were more likely to be totally or generally satisfied (76% versus 27%, P < 0.001), to find the treatment acceptable (93% versus 36%, P < 0.001), and willing to have the treatment again (93% versus 31%, P < 0.001). Although pain and bleeding were significantly reduced by medical treatment this was modest in comparison with transcervical resection (P < 0.001). Haemoglobin levels were significantly increased only following transcervical resection. Short form 36 scores were also improved in both arms, although only transcervical resection returned them to normal values.
                Medical treatment was less effective than transcervical resection of the endometrium, irrespective of previous treatment or type of medical management. Early hysteroscopic endometrial surgery should be considered by such woman with the choice made by the woman after a full discussion of the advantages and disadvantages of all the options. To compare patients' health status function after treatment with thermal balloon endometrial ablation (TBEA) and levonorgestrel intrauterine system (LNG-IUS) for idiopathic menorrhagia.
                Forty-four patients were recruited into a randomized trial comparing their health status after treatment with TBEA or LNG-IUS for idiopathic menorrhagia.
                At 1 year follow-up, the mean haemoglobin was significantly higher in women treated with TBEA (12.6 g/dl vs. 10.3 g/dl, p = 0.018). Iron deficiency occurred in 13.3% from the TBEA arm and in 50% from the LNG-IUS arm (p = 0.026). The women's mean Short Form 36 Questionnaire general health perception scores (54.9 vs. 40.5, p = 0.024) and mental health scores (49.5 vs. 38.3, p = 0.021) in TBEA arm were significantly higher than in the LNG-IUS arm. The mental health domain score was also significantly lower in the LNG-IUS arm (46.1 vs. 38.3, p = 0.041).
                TBEA appears to offer better health status function at 1 year follow-up and to be more acceptable to our Chinese population in the treatment of idiopathic menorrhagia following failed medical treatment.
Surgery, especially hysterectomy, reduces menstrual bleeding more than medical treatments at one year but LNG-IUS may be comparable in improving quality of life. The evidence for longer-term comparisons is weak and inconsistent. Oral medication suits a minority of women long term.