scholarly journals Ulipristal Acetate Versus Leuprolide Acetate in Medical Management of Uterine Fibroids

2021 ◽  
Vol 10 (43) ◽  
pp. 3701-3706
Author(s):  
Veladanda Kavitha ◽  
Rachamalla Madhuri

BACKGROUND We wanted to compare the effectiveness of the treatment and the adverse effects of ulipristal acetate and leuprolide acetate in the medical management of symptomatic uterine fibroids. METHODS This is a randomised controlled study conducted in the the Department of Obstetrics and Gynaecology in Chalmeda Anand Rao Institute of Medical Sciences from January 2019 to January 2020. 60 patients with symptomatic fibroids and excessive uterine bleeding were randomly divided. They were given daily therapy of ulipristal acetate 10 mg orally for 3 months or monthly injection leuprolide acetate 3.75 mg intramuscularly for 3 months. RESULTS Controlled uterine bleeding was observed in 98 % of patients who received oral therapy of ulipristal acetate of 10 mg, and 89 % of patients who received injections of leuprolide acetate, for differences in comparison with leuprolide acetate of 8.8 % points (95 % CI, 0.4 to 18.3) for ulipristal acetate of 10 mg. Median time of amenorrhea for those taking ulipristal acetate of 10 mg was 5 days, and 21 days for leuprolide acetate. 10 % of patients receiving ulipristal acetate reported moderateto-severe hot flashes and 40 % of patients receiving leuprolide acetate reported moderate to severe hot flashes (P < 0.0010 for each dose of leuprolide acetate vs. ulipristal acetate). CONCLUSIONS Daily therapy of 10-mg ulipristal acetate was considered non inferior when compared to monthly injections of leuprolide acetate in control of uterine bleeding, moreover ulipristal acetate therapy was also significantly less likely to cause hot flashes. KEY WORDS Ulipristal Acetate; Leuprolide acetate; Abnormal Uterine Bleeding; Leiomyoma

Author(s):  
L. Thulasi Devi ◽  
Ravi Nimonkar

Background: Dysfunctional Uterine Bleeding (DUB), is the commonest cause of Abnormal Uterine Bleeding (AUB). It causes morbidity, anaemia, and unnecessary hysterectomies in women of fertile age group. This study attempts to study efficacy of medical management especially Selective Estrogen Receptor Modulator (SERM) namely Ormeloxefine (ORM) (Sevista®) in Perimenopausal women. Ormeloxifene was marketed in India for contraception under brand names Centron, Saheli, Choice-7, Novex and Novex-DS. It’s a benzopyran derivative also known as Centchroman which causes asynchronousity between ovulation and menstrual cycles possibly because of both estrogenic and anti-estrogenic actions. It has been known to cause delay in ovulation in clinical trials; however, majority have been unaffected. It causes delay in proliferation of endometrium thereby causing asynchronous cycles. It also improves motility of ciliary lining of Fallopian tubes thereby reducing the chances of implantation of fertilized egg.  Methods: This study is aimed at evaluation of subjective and objective stastical benefits and side effects in treatment of DUB in perimenopausal age group with ORM and commonly used 19 nortestosterone compound (progesterone); Norethisterone (NET).Results: Primary outcome were analyzed at the end of every 3 months and at the end of one year finally. Secondary outcomes of the study in each arm were also assessed. There was stastically significant increase in Hb and stastically significant decrease in ET. Data analysis was done for variables in each arm by t-test to estimate the mean, median, range P and t value for a conclusion. Differences were taken as significant when P<0.05.Conclusions: ORM is a safe, cost effective, non-steroidal, non-hormonal drug with convenient dosage and better compliance for medical management of perimenopausal DUB with minimum focal pathology. Side effects observed need more evaluation with larger sample size to be statistically significant.


PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0243166
Author(s):  
Godfrey Shichenje Mutakha ◽  
Emily Mwaliko ◽  
Philip Kirwa

Abnormal uterine bleeding (AUB) affects 30% of reproductive age women globally. However, there are limited local studies evaluating the management of these women. The diagnostic guideline using structural and functional causes of AUB adopts the PALM-COEIN criteria, namely: Polyp; Adenomyosis; Leiomyoma; Malignancy and Hyperplasia; Coagulopathy; Ovulatory dysfunction; Endometrial; Iatrogenic; and Not yet classified. This study aimed to determine the clinical bleeding patterns, adherence to PALM-COEIN diagnosis guidelines and management of AUB among women in their reproductive age. This was a cross-sectional study among 108 women with AUB aged 18–45 years was conducted at the gynaecology department of Moi Teaching and Referral Hospital in Western Kenya between April 2018 and April 2019. Their sociodemographic and clinical characteristics were collected using interviewer administered structured questionnaire and chart reviews. Adherence to diagnosis recommendations was assessed using PALM COEIN classification. Descriptive and inferential data analysis was conducted at 95% confidence interval. The median age was 30 (IQR: 22, 41) years with prolonged bleeding as the most predominant pattern at 41.7%. Bleeding patterns were significantly associated with age (p = 0.04). Only 16.7% were diagnosed as per the PALM-COEIN criteria with PALM and COEIN accounting for 60% and 40% respectively. Leiomyoma (44.5%) was the common cause of AUB. Laboratory evaluation included: pregnancy tests, full haemogram, hormonal profile and biopsy. Most (79.6%) of the women had abdominopelvic ultrasound done. Medical management was provided for 78.7% of women. Prolonged bleeding was the most common pattern with medical management preferred. There is need for in-hospital algorithms to ensure adherence to PALM-COEIN guidelines.


2015 ◽  
Vol 19 (61) ◽  
pp. 1-194 ◽  
Author(s):  
T Justin Clark ◽  
Lee J Middleton ◽  
Natalie AM Cooper ◽  
Lavanya Diwakar ◽  
Elaine Denny ◽  
...  

BackgroundUterine polyps cause abnormal bleeding in women and conventional practice is to remove them in hospital under general anaesthetic. Advances in technology make it possible to perform polypectomy in an outpatient setting, yet evidence of effectiveness is limited.ObjectivesTo test the hypothesis that in women with abnormal uterine bleeding (AUB) associated with benign uterine polyp(s), outpatient polyp treatment achieved as good, or no more than 25% worse, alleviation of bleeding symptoms at 6 months compared with standard inpatient treatment. The hypothesis that response to uterine polyp treatment differed according to the pattern of AUB, menopausal status and longer-term follow-up was tested. The cost-effectiveness and acceptability of outpatient polypectomy was examined.DesignA multicentre, non-inferiority, randomised controlled trial, incorporating a cost-effectiveness analysis and supplemented by a parallel patient preference study. Patient acceptability was evaluated by interview in a qualitative study.SettingOutpatient hysteroscopy clinics and inpatient gynaecology departments within UK NHS hospitals.ParticipantsWomen with AUB – defined as heavy menstrual bleeding (formerly known as menorrhagia) (HMB), intermenstrual bleeding or postmenopausal bleeding – and hysteroscopically diagnosed uterine polyps.InterventionsWe randomly assigned 507 women, using a minimisation algorithm, to outpatient polypectomy compared with conventional inpatient polypectomy as a day case in hospital under general anaesthesia.Main outcome measuresThe primary outcome was successful treatment at 6 months, determined by the woman’s assessment of her bleeding. Secondary outcomes included quality of life, procedure feasibility, acceptability and cost per quality-adjusted life-year (QALY) gained.ResultsAt 6 months, 73% (166/228) of women who underwent outpatient polypectomy were successfully treated compared with 80% (168/211) following inpatient polypectomy [relative risk (RR) 0.91, 95% confidence interval (CI) 0.82 to 1.02]. The lower end of the CIs showed that outpatient polypectomy was at most 18% worse, in relative terms, than inpatient treatment, within the 25% margin of non-inferiority set at the outset of the study. By 1 and 2 years the corresponding proportions were similar producing RRs close to unity. There was no evidence that the treatment effect differed according to any of the predefined subgroups when treatments by variable interaction parameters were examined. Failure to completely remove polyps was higher (19% vs. 7%; RR 2.5, 95% CI 1.5 to 4.1) with outpatient polypectomy. Procedure acceptability was reduced with outpatient compared with inpatient polyp treatment (83% vs. 92%; RR 0.90, 95% CI 0.84 to 0.97). There were no significant differences in quality of life. The incremental cost-effectiveness ratios at 6 and 12 months for inpatient treatment were £1,099,167 and £668,800 per additional QALY, respectively.ConclusionsWhen treating women with AUB associated with uterine polyps, outpatient polypectomy was non-inferior to inpatient polypectomy at 6 and 12 months, and relatively cost-effective. However, patients need to be aware that failure to remove a polyp is more likely with outpatient polypectomy and procedure acceptability lower.Trial registrationCurrent Controlled Trials ISRCTN 65868569.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 61. See the NIHR Journals Library website for further project information.


Author(s):  
Manjiri R. Podder ◽  
Rahul Podder ◽  
Poonam V. Shivkumar

Background: Uterine fibroids are commonest benign uterine tumors. Only about 25% women with fibroids are symptomatic. Around 70-80% are discovered incidentally during routine pelvic examination. Using ultrasonography screening, some authors have estimated a cumulative incidence of 70% in all women by age 50. Symptoms attributable to fibroids are mainly abnormal uterine bleeding (AUB), pelvic pressure, pain, and reproductive dysfunction. Heavy and/or prolonged menses is the typical bleeding pattern with myomas. Uterine fibroids are a leading cause of hysterectomy in perimenopausal women, thus, this study was done to find out its prevalence and demography in women presenting with AUB. The objectives of the present investigation were to find out the prevalence of uterine fibroid in women with AUB and to find out the various demographic features of womenMethods: The study was done for 2 years in the Dept of Obstetrics and Gynecology of a rural tertiary institute after taking clearance from institutional ethical committee. All the women presenting with AUB were included in the study. History and demographic features was enquired and entered in a predesigned proforma. All women were clinically examined after consent. Women with suspicion of fibroid were subjected to diagnostic modalities and the reports were followed and correlated.Results: Total 11,841 patients came to Gynaeological OPD during the study period. Out of these 3,878 (32.75%) presented with AUB, 2,126 were diagnosed as having fibroids after examination and investigations. Hence, the prevalence of fibroids amongst the women with AUB was 54.82% and 17.95% amongst all gynaecological patients. Maximum women were between 31-40 years, (64.78% rural and 62.73% urban). Majority were having parity between 1-2 (40.73% in urban, 38.96% in rural).Conclusions: Uterine fibroids are the commonest reason of AUB in reproductive age group with the prevalence of 54.82%. The trends in age incidence have remained the same over the years, commonly affecting women in third decade. There is no difference in incidence of fibroids amongst various socioeconomic classes. 


2015 ◽  
Vol 79 (3) ◽  
pp. 145-152 ◽  
Author(s):  
Rafael M. Moroni ◽  
Wellington P. Martins ◽  
Sabrine V. Dias ◽  
Carolina S. Vieira ◽  
Rui A. Ferriani ◽  
...  

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