Elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroid: a systematic review and meta-analysis

Background Elagolix is effective and safe for treating menorrhagia in women with uterine fibroid. However, it is reported to be associated with hypoestrogenism that can be alleviated by adding estradiol/norethindrone acetate. This systematic review and meta-analysis aimed to determine the effectiveness of elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroid by comparing: elagolix versus placebo and elagolix versus estradiol/norethindrone acetate. Methodology The Cochrane Central Register of Controlled Trials (CENTRAL 2021, Issue 3 of 12), MEDLINE databases (1980 to December week 1, 2020), and trial registries for relevant randomized clinical trials were used. All randomized clinical trials were reviewed and evaluated. Random effects models were used to estimate the dichotomous outcomes and mean differences with 95% confidence intervals. Data for risk of bias, heterogeneity, sensitivity, reporting bias and quality of evidence were assessed. Results Four randomized controlled trials with 1949 premenopausal women from 323 locations were included. Elagolix improved menstrual blood loss of less than 80 ml (RR 4.81, 95% CI 2.45 to 9.45; four trials, 869 participants; moderate quality evidence) or more than 50% reduction from baseline (RR 4.87, 95% CI 2.55 to 9.31; four trials, 869 participants; moderate quality evidence) compared to placebo. There was no difference in menstrual blood loss of less than 80 ml (RR 1.08, 95% CI 1.00 to 1.16; five trials, 1365 participants; moderate quality evidence) or more than 50% reduction from baseline between the elagolix (RR 1.08, 95% CI 1.01 to 1.15; five trials, 1365 participants; high quality evidence) and elagolix with estradiol/norethindrone acetate. In both comparisons, elagolix has reduced the mean percentage change in uterine and fibroid volume, improved symptoms, and health-related quality of life. More patients had hot flush, and bone mineral density loss in the elagolix treatment compared to both placebo and elagolix with estradiol/norethindrone acetate. Conclusions Elagolix appeared to be effective in reducing heavy menstrual bleeding caused by uterine fibroid and combination with estradiol/norethindrone acetate was able to alleviate the hypoestrogenism side effects in premenopausal women. Review registration PROSPERO CDR 42021233898.

Randomised Controlled Trial of Particles Used in Uterine fibRoid Embolisation (PURE): Non-Spherical Polyvinyl Alcohol Versus Calibrated Microspheres

Purpose The PURE study is a randomised controlled trial (RCT) comparing the clinical and MRI outcomes of patients treated with non-spherical polyvinyl alcohol, ns-PVA (Contour PVA–Boston Scientific–355–500 & 500–700 microns) versus calibrated hydrogel microspheres (Embozene–Varian Inc–700 & 900 microns) for symptomatic uterine fibroids. Materials and Methods Prospective, ethically approved non-sponsored RCT in 84 patients in a single UK tertiary IR unit, ISRCTN registry trial number ISRCTN18191539 in 2013 and 2014. All patients with symptomatic fibroid disease were eligible. UAE followed a standardised protocol with UFS-QOL and contrast-enhanced MRI before and 6 months post UAE. Outcome measures included: (1) Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QOL). (2) Percentage total and dominant fibroid infarction. (3) Uterine and dominant fibroid volume reduction. (4) Volume of embolics. Results Sixty-three patients completed the QOL follow-up (33 ns-PVA vs 30 Embozenes), the groups were equivalent at baseline. Patients were followed up for 6 months following UAE. There was no significant difference in symptom scores or HR-QOL between ns-PVA and Embozenes, p = 0.67 and 0.21, respectively. 92.7% of patients treated with ns-PVA achieved > 90% dominant fibroid infarction versus 61.8% treated with Embozenes (p = 0.0016). 66% of patients treated with ns = PVA achieved > 90% total fibroid percentage infarction compared with 35% in the Embozene group (p = 0.011). The mean vials/syringes used were 5.2 with Embozenes versus 4.1 using PVA (p = 0.08). Conclusion The PURE study informs IRs regarding the efficacy of embolic agents in UAE, with superior fibroid infarction on MRI using ns-PVA versus Embozenes however no significant difference in clinical outcomes at 6 months after UAE.

Incidence of amenorrhea and premature ovarian failure in women who underwent uterine fibroid embolization: single centre study

Purpose: To retrospectively determine the incidence of amenorrhea and premature ovarian failure in women who underwent uterine fibroid embolization (UFE) in King Fahad Specialist Hospital in Dammam (KFSH-D). Patients and methods: All women who had undergone UFE in KFSH-D from August 2007 to October 2015 were included for a total of 82 patients. Follow up consisted of a questionnaire inquiring about symptoms, improvement after the procedure and whether menstruation resumed or not. The pre-procedure and post-procedure pelvis MRI as well as UFE images and reports were reviewed for all patients. Results: One patient (1.5 %) was found to have amenorrhea out of the 67 patients we were able to contact. She was 52 years old at the time of UFE and had irregular period. Menstruation did not resume following UFE along with menopausal symptoms including night sweats, mood swings and irritability, likely due to premature ovarian failure (POF). The rest of patients had normal resumption of menses. Conclusion: The incidence of amenorrhea is less than what’s reported in the literature could be due to advances in UFE since its introduction as a treatment for uterine fibroids, likely due to advances in image quality, tans-catheter embolization equipments/techniques and embolic material used in UFE.

LAPROSCOPIC MYOMECTOMY VERSUS OPEN MYOMECTOMY FOR UTERINE FIBROIDS

Fibroids are common benign tumours arising in the uterus.Myomectomy is the surgical treatment of choice forwomenwith symptomatic fibroids who prefer or want uterine conservation. Myomectomy can be performed by laparoscopy or open myomectomy. Aim of study is to determine the benefits and harms of laparoscopic myomectomy compared with open myomectomy.It is a comparative study conductedover 1 year in Department of Obstetrics and Gynecology, GMC ,Akola,Maharashtra . 50 patients were included in study who were having uterine fibroid. Subjects were explained about surgery as treatment.30 subject undergone Laproscopic myomectomy and 20 subjects undergone open myomectomy.The clinical data of patients who underwent OM and LM was analyzed. The data recorded comprised patientdemographic information and clinical characteristics includingage, weight, type, and size of myoma and myomectomyindications; and perioperative data including estimation ofblood loss, duration of surgery, complications, and lengthof hospital stay. Keywords: Laproscopic myomectomy (LM), open myomectomy(OM), uterine fibroid.

Development of an Algorithm To Differentiate Uterine Sarcoma From Fibroid Using MRI and LDH Levels

This study aimed to establish an evaluation method for detecting uterine sarcoma with 100% sensitivity using MRI and serum LDH levels. One evaluator reviewed the MRI images and LDH values of a total of 1801 cases, including 36 cases of uterine sarcoma and 1765 cases of uterine fibroids. The reproducibility of the algorithm was also examined using a test set of 61 cases, including 14 cases of uterine sarcoma, by four evaluators with different imaging experience and abilities. From the MRI images and LDH values of 1801 cases of uterine sarcoma and uterine fibroid, we found that all sarcomas were included in the group with high T2WI and either high T1WI, unclear margin, or high LDH value. In addition, when cases with DWI were examined, all sarcomas had high DWI. Among the 36 sarcoma cases, the group with positive findings in T2WI, T1WI, margin, and serum LDH levels all had a poor prognosis (p = 0.015). The reproducibility of the algorithm was examined by four evaluators, and the sensitivity of sarcoma detection ranged from 71–93%. We established an algorithm that is not uterine sarcoma if tumors in the myometrium with low T2WI and DWI.