Efficacy of ormeloxifene versus oral contraceptive in the management of abnormal uterine bleeding due to uterine leiomyoma

Kriplani, Alka; Srivastava, Astha; Kulshrestha, Vidushi; Kachhawa, Garima; Agarwal, Nutan; Bhatla, Neerja; Hari, Smriti

doi:10.1111/jog.13105

Cited by 12 publications

(4 citation statements)

References 28 publications

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“…28 Other side effects observed are giddiness, abdominal pain, headache and development of ovarian cyst noticed when Centchroman was given at a higher dose as a treatment trial for dysfunctional uterine bleeding. 29,30 In our study, 24 (40%) complained of scanty menses, 16 (26.67%) had delayed menses and 4 (6.67%) patients had absence of menses during therapy as the only side effects which may be attributed to the low dose and alternate day regime.…”

Section: Discussionmentioning

confidence: 46%

A prospective study on the role of centchroman in regression of fibroadenoma

et al. 2021

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Background: Fibroadenoma commonly present as painless breast lump in young girls. Nearly 10-15% regress spontaneously over the period of 6-60 months, rest are managed surgically. Centchroman (Saheli), a novel non-steroidal, selective anti-estrogen has been used for the treatment of mastalgia and its effectiveness in the treatment of fibroadenoma is being tested in the ongoing trials. Methods: A total of 60 patients between 15-35 years of age with painless lump breast of size 2 to 5 centimeters confirmed as fibroadenoma by fine needle aspiration cytology (FNAC) were included in the study. Detailed patient's characteristics, clinical history, physical examination (for size in 2 dimensions), ultrasound findings (for size in 3 dimensions) were assessed. All participants included in the study were given tablet Centchroman (Saheli) 30 mg thrice weekly orally for 3 months. Size of Fibroadenoma was reassessed clinically for size in two dimensions and ultrasonologically for size in three dimensions at 4 weeks and 3 months of starting of therapy.Results: Out of 60 patients, 18 patients (30%) had complete response, 40 patients (66.66%) showed a decrease in the size of fibroadenoma and only 2 patients (3.33%) had no response to this therapy. None showed an increase in size.Conclusions: It may prove to be the most effective modality for the treatment of small sized fibroadenoma breast especially in unmarried girls with minimal side effects. Ultrasonology may be relied upon for follow up measurements since it is more accurate in measuring the dimensions.

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Section: Discussionmentioning

confidence: 46%

A prospective study on the role of centchroman in regression of fibroadenoma

et al. 2021

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“…Improvement in dysmenorrhea is also an added benefit with Ormeloxifene therapy as seen in the study where out of 22 only 1 patient reported dysmenorrhea after treatment. In the study by Kriplani et al, 14 improvements in dysmenorrhea with a reduction in the visual analog scale (VAS) score from 6.3 to 1.5 was observed on treatment with Ormeloxifene.…”

Section: Discussionmentioning

confidence: 97%

Ormeloxifene: The Perfect Alternative for the First-line Management of Abnormal Uterine Bleeding

Sarbhai¹,

Kumari²

2023

Journal of South Asian Federation of Obstetrics and Gynaecology

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Aim:The aim of this work was to study the role of Ormeloxifene in the management of abnormal uterine bleeding (AUB). Methods: Fifty-one patients with heavy menstrual bleeding with ages between 18 and 50 years were included in the study. The women with post-menopausal bleeding, fibroids, uterus size of more than 8 weeks, polycystic ovarian syndrome (PCOS), and ovarian cysts were excluded. Ormeloxifene (60 mg) twice a week for 12 weeks and then once a week for the next 12 weeks was given to every patient in the study group. The outcome was assessed by the pictorial blood assessment chart (PBAC) score, hemoglobin (HB) level, and endometrial thickness. Results: About 88.24% of patients responded well to treatment as depicted by a significant reduction in the PBAC score to a level <100. The mean PBAC score decreased linearly from 354 to 40 at the end of 24 weeks of treatment. Mean endometrial thickness reduced from 8.25 to 6.01. The mean level of hemoglobin level increased from 11.41 to 11.86. P-value of all the parameters were <0.05 and hence statistically significant. Conclusion: Ormeloxifene can be used as a first-line drug for the management of AUB.

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“…The appropriate time point to test efficacy will need to be considered, subject to the type and purpose of therapy. Medical treatments designed to rapidly reduce MBL tend to have short follow-up times of between 1 month and 12 months [44,[110][111][112][113], whereas surgical interventions, such the levonorgestrel intrauterine system and endometrial ablation, are designed for long-term reduction of MBL. Monitoring of menstrual loss has been reported for up to 5 years after surgery at various time intervals, depending on the study [59,106,107,114].…”

Section: Recognition Of Limitationsmentioning

confidence: 99%

Pictorial methods to assess heavy menstrual bleeding in research and clinical practice: a systematic literature review

Magnay¹,

O’Brien

Gerlinger

et al. 2020

BMC Women's Health

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Background: Pictorial blood loss assessment charts (PBACs) represent the most widely used method to assess menstrual blood loss (MBL) in clinical trials. The aims of this review were to: (1) determine the diagnostic accuracy of PBACs that have been validated against the reference alkaline hematin technique; (2) categorize the pitfalls of using obsolete and nonvalidated charts; (3) provide guidelines for development of a new PBAC or use of an existing chart to measure MBL in clinical trials; and (4) consider the feasibility of using pictorial charts in primary care. Methods: A literature review was conducted using Embase and MEDLINE databases. The review identified reports of women with self-perceived or actual heavy menstrual bleeding (HMB), bleeding disorders, abnormal uterine bleeding, leiomyomata (uterine fibroids) or endometriosis, and women undergoing treatment for HMB, as well as those with normal menstrual periods. Data were reviewed from studies that focused on the development and validation of PBACs and from those that used derivative noncertified charts to assess HMB. Results: Nine studies reported validation of PBAC scoring systems against the alkaline hematin technique. Across these studies, the sensitivity was 58-97%, the specificity was 7.5-95.5%, the positive and negative likelihood ratios were 1.1-13.8 and 0.14-0.56, respectively, and the diagnostic odds ratio was 2.6-52.4. The cut-off score above which the diagnosis of HMB was made ranged from 50 to 185. Several modifications of these PBACs were used in other studies; however, objective confirmation of their validity was not reported. Overall, there was widespread inconsistency of chart design, scoring systems, diagnostic cut-off limits and post-treatment outcome measures. Conclusions: PBACs are best suited to the controlled and specific environment of clinical studies, where clinical outcome parameters are defined. The current lack of standardization precludes widespread use of the PBAC in primary care. Review registration number: PROSPERO international prospective register of systematic reviews: CRD42016030083.

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Efficacy of ormeloxifene versus oral contraceptive in the management of abnormal uterine bleeding due to uterine leiomyoma

Abstract: Ormeloxifene with its convenient twice-weekly dosage schedule was effective in treating AUB-L, with 72% of patients responding to 6-month treatment compared with 8% with COC, even though leiomyoma volume increased insignificantly with both ormeloxifene and COCs.

Cited by 12 publications

References 28 publications

A prospective study on the role of centchroman in regression of fibroadenoma

A prospective study on the role of centchroman in regression of fibroadenoma

Ormeloxifene: The Perfect Alternative for the First-line Management of Abnormal Uterine Bleeding

Pictorial methods to assess heavy menstrual bleeding in research and clinical practice: a systematic literature review

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