Effects of the position of fibroids on fertility. Uterine fibroids: uterine artery embolization versus abdominal hysterectomy for treatment--a prospective, randomized, and controlled clinical trial. Effect of mifepristone for symptomatic leiomyomata on quality of life and uterine size: a randomized controlled trial. Mechanism of LHRH analogue action in uterine fibroids. Low-dose mifepristone in treatment of uterine leiomyoma: a randomised double-blind placebo-controlled clinical trial. Role of goserelin-depot in the clinical management of uterine fibroids. The place of Zoladex in deferred surgery for uterine fibroids. Zoladex Myoma Study Group. Uterine fibroid embolization versus myomectomy in women wishing to preserve fertility: preliminary results of a randomized controlled trial. Mifepristone for treatment of uterine leiomyoma. A prospective randomized placebo controlled trial.
This prospective, controlled study was performed in order to evaluate whether the location of uterine fibroids may influence reproductive function in women and whether removal of the fibroid prior to conception may improve pregnancy rate and pregnancy maintenance. We examined 181 women affected by uterine fibroids who had been trying to conceive for at least 1 year without success. The main outcome measures were the pregnancy rate and the miscarriage rate. Among the patients who underwent myomectomy, the pregnancy rates obtained were 43.3% in cases of submucosal, 56.5% in cases of intramural, 40.0% in cases of submucosal-intramural and 35.5% in cases of intramural-subserosal uterine fibroids, respectively. Among the patients who did not undergo surgical treatment, the pregnancy rates obtained were 27.2% in women with submucosal, 41.0% in women with intramural, 15.0% in women with submucosal-intramural and 21.43% in women with intramural-subserosal uterine fibroids, respectively. Although the results were not statistically significant in the group of women with intramural and intramural-subserosal fibroids, this study confirms the important role of the position of the uterine fibroid in infertility as well as the importance of fibroids removal before the achievement of a pregnancy, to improve both the chances of fertilization and pregnancy maintenance. To evaluate the effectiveness of uterine artery embolization (UAE) in the management of bleeding in patients with uterine fibroids and to compare UAE with hysterectomy, particularly with regard to length of hospital stay and associated complications (ie, safety).
                A prospective clinical trial was performed with patients who were randomly assigned to one of two groups: patients who were offered the option of undergoing either UAE or hysterectomy (group 1) and patients who were not informed of the alternative treatment-that is, UAE (group 2). The primary variables that were considered for evaluation of the effectiveness, efficiency, and safety of the two procedures were, respectively, bleeding cessation, total length of hospital stay, and resulting complications. The lengths of hospital stay in the two study arms were compared on an intent-to-treat basis. Owing to crossover between the treatment arms, however, effectiveness and safety were evaluated on the basis of the actual treatment received.
                The clinical success rate for the patients who underwent UAE, which was based on the cessation of bleeding, was 86% (31 of 36 patients). The mean hospital stay for group 1 was 4.14 days shorter than that for group 2 (P <.001). Ten (25%) of the 40 patients who underwent UAE experienced minor complications, in contrast to four (20%) of the 20 who underwent hysterectomy and experienced major complications.
                Compared with hysterectomy, UAE is safe and effective for treatment of bleeding fibroids, necessitates a shorter hospital stay, and results in fewer major complications. To assess the effect of low-dose mifepristone on quality of life, pain, bleeding, and uterine size among women with symptomatic leiomyomata.
                Forty-two women with symptomatic uterine leiomyomata and uterine volume of 160 mL or more were randomized to mifepristone, 5 mg daily, or placebo for 26 weeks. Quality of life (Uterine Fibroid Symptoms Quality of Life Questionnaire and Medical Outcomes Study 36-Item Short Form survey) and uterine and leiomyoma size (ultrasonography) were assessed at baseline, and at 1 month, 3 months, and 6 months of treatment. Bleeding (daily logs and pictorial charts) and pain (McGill Pain Questionnaire) were assessed monthly. Endometrial pathology was assessed at baseline and 6 months.
                Forty-two women were randomized; 37 women completed all 6 months. Women randomized to mifepristone showed an improvement in leiomyoma-specific quality of life. Forty-one percent became amenorrheic, rates of anemia improved, and adjusted uterine size was reduced by 47%. Compared with the placebo group, improvements in these outcomes in the treatment group were significantly greater (P<.05 to .001). There were no significant differences in adverse effects between the groups. No endometrial hyperplasia was noted in any participant.
                Low-dose mifepristone improves leiomyoma-specific quality of life and reduces leiomyoma size among women with symptomatic leiomyomata.
                ClinicalTrials.gov www.clinicaltrials.gov NCT00133705
                I. Luteinising hormone-releasing hormone analogues have been found to reduce the size of uterine fibroids. Further studies are required to determine their exact mechanism of action. However, they are known to induce hypo-oestrogenism, which leads to reduction in uterine arterial blood flow, one mechanism by which reduction of fibroid size is thought to occur. To evaluate the effect of low-dose mifepristone on leiomyoma-related symptoms, uterine and leiomyoma in women with symptomatic leiomyomata.
                In a double-blind placebo-controlled trial, 40 patients with symptomatic leiomyoma and normal endometrial histology were randomised to receive 10 mg mifepristone (group 1) or placebo (group 2) daily for three months. Leiomyoma-related symptoms, uterine, leiomyoma and largest leiomyoma volumes were assessed at baseline and every month for three months. Endometrial biopsy was repeated at the end of therapy.
                Significant change was noticed between the two groups for mean menstrual blood loss (MBL) by first month. Menstrual blood loss declined by 94.8% in group 1 at three months and 84.2% patients attained amenorrhoea in this group. In group 1 complete relief of dysmenorrhoea occurred in significant number of women (80%) but only 33% patients got rid of pelvic pain. There was no change in these symptoms in group 1 Backache, urinary complaints and dyspareunia were not relieved in either group. Uterine, leiomyoma and largest leiomyoma volume declined by 26-32% in group 1 as compared to none in group 2, and this difference was statistically significant only by the end of the third month of therapy. Mean haemoglobin increased from 9.5 to 11.2 g/dL in group 1. In group 1, at the end of therapy, 63.1% of patients had endometrial hyperplasia without atypia.
                Ten milligrams mifepristone for three months is effective in reducing MBL, increasing haemoglobin and reducing uterine and leiomyoma volume with side-effect of endometrial hyperplasia. On 30 women suffering from uterine fibroids, the monthly subcutaneous administration of goserelin depot (3.6 mg) for 6 (n = 22) or 12 months (n = 8) induced an about 50% shrinkage of uterus and fibroid volume, and within 3 months, an increase in the haematocrit value, with no metabolic side effects or detectable bone demineralization, evaluated by single photon absortiometry at distal radius. Both uterine and fibroid volumes reversed to pretreatment values after 3 months of goserelin depot withdrawal. In comparison with untreated subjects, on another 10 patients a three month administration of goserelin depot reduced the loss of blood during the surgical removal of the uterus or fibroids. Present data indicate that goserelin depot is effective and relatively safe in the medical management of uterine fibroids. Although, goserelin depot cannot yet be proposed as a definite medical therapy, it may represent a useful instrument in the presurgical management of uterine fibroids. Two hundred and forty-seven patients with uterine fibroids were randomized to surgery alone or 3 months' Zoladex (Zeneca, Macclesfield, Ches., UK) followed by surgery. Zoladex significantly reduced uterine and fibroid volumes (p = 0.0001). There was a significantly (p = 0.002) greater mean rise in haemoglobin from entry to preoperation in the Zoladex group (1 g/dl) compared with the surgery-alone group (0.3 g/dl) as well as a tendency towards easier surgery, and reduced operative blood loss. Zoladex-treated patients had a significantly (p = 0.016) shorter hospital stay and pelvic pain and abdominal pressure symptoms were significantly (p < 0.0001) reduced in this group. Zoladex was well tolerated. To compare the clinical results of surgical and endovascular treatment of uterine myomas in young women.
                In a university-affiliated, tertiary care center a prospective trial was conducted. Sixty-three women, wishing to retain fertility, with intramural fibroid(s) larger than 4 cm, were randomly selected either for uterine artery embolization or myomectomy. Invasiveness, efficacy, and complications of both procedures were compared.
                Thirty embolizations and 33 myomectomies (15 laparoscopic, 18 open) were performed. The mean follow-up was 17 months. In embolized patients, there was a significantly shorter procedure length (p<0.0001), hospital stay (p<0.001) and disability period (p<0.0001), lower CRP (p<0.001) and higher hemoglobin (p<0.0001) concentrations the 2nd day after procedure. But there was a higher incidence of re-interventions (p<0.01) and a lower rate of total symptomatic relief (p<0.1). The groups did not significantly differ in: technical success rate, febrile morbidity, FSH levels 6 months after the procedure, and complication rates.
                Although the reproductive outcomes of uterine artery embolization and myomectomy cannot be evaluated at the moment, our first results indicate that both methods are clinically successful in the majority of cases and are not connected with significant number of serious complications. Uterine leiomyomas are widely prevalent and frequently cause menorrhagia. The major therapeutic option today is hysterectomy. Medical options are of highest interest.
                A total of 30 women with uterine leiomyomas scheduled for surgical intervention were randomized to receive either 50 mg mifepristone or placebo every other day during 3 months prior to surgery. Uterine blood flow and leiomyoma volume were evaluated once a month until surgery. Endometrial biopsies were obtained prior to and at end of treatment. Relevant biochemistry, symptoms and bleeding were recorded. Primary outcome was reduction in uterine leiomyoma size.
                There was a significant percentual decrease (P = 0.021) in the total leiomyoma volume in the mifepristone-treated group, -28 (-48, -8) % (mean +/- 0, 95 confidence interval), compared with the control group values 6 (-13, 25) %. Mifepristone treatment significantly reduced the bleeding days (P = 0.001) and increased serum haemoglobin values (P = 0.046). Serum cortisol levels remained unchanged, while a mild increase in serum androgens was noted. Endometrial biopsies showed no premalignant changes or changes in mitotic indices.
                Mifepristone may offer an effective treatment option for women with uterine leiomyoma and the associated pronounced uterovaginal bleeding. Clinical Trials identifier: www.clinicaltrials.gov: NCT00579475.
There is no consistent evidence from the limited number of studies that SERMs reduce the size of fibroids or improve clinical outcomes. Further studies are required to establish evidence of benefit of SERMs in treating women with uterine fibroids. This updated review did not find any new study for inclusion.