Comparison of Therapeutic Efficacies of Norethisterone, Tranexamic Acid and Levonorgestrel-Releasing Intrauterine System for the Treatment of Heavy Menstrual Bleeding: A Randomized Controlled Study

Kiseli, Mine; Kayıkçıoğlu, Fulya; Evliyaoğlu, Özlem; Haberal, Alı

doi:10.1159/000443393

Cited by 20 publications

(19 citation statements)

References 31 publications

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“…A total of 13 trials (with 14 references) involving 1,677 women were included [Dong ( 17 ), Endrikat et al ( 18 ), Gupta et al ( 19 , 20 ), Irvine et al ( 21 ), Kaunitz et al ( 22 ), Kavasoglu et al ( 23 ), Kiseli et al ( 24 ), Liu ( 25 ), Malik et al ( 26 ), Reid and Susanna ( 27 ), Shabaan et al ( 28 ), Zhao and Hongyan ( 29 ), and Zhong et al ( 30 )]. Overall, 10 single-center trials were included, of which four were conducted in China ( 17 , 25 , 29 , 30 ) and the remaining six were conducted in Scotland ( 21 ), Turkey ( 24 ), the United Kingdom ( 27 ), Pakistan ( 26 ), and Egypt ( 28 ). The remaining three multicenter trials ( 18 , 20 , 22 ) recruited participants from Canada, the United Kingdom, the United States, and Brazil.…”

Section: Resultsmentioning

confidence: 99%

LNG-IUS vs. medical treatments for women with heavy menstrual bleeding: A systematic review and meta-analysis

et al. 2022

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IntroductionTo compare efficacy and safety of the levonorgestrel-releasing intrauterine system (LNG-IUS) with medical treatments for women with heavy menstrual bleeding.Materials and methodsWe searched PubMed, Embase, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure (CNKI), and Wanfang databases for relevant randomized controlled trials (RCTs) in November 2021. All meta-analyses were performed using the random-effects model. PROSPERO registration number: CRD42021295379.ResultsA total of trials (with 14 references) reporting on 1,677 women were included in this systematic review. The majority of the included RCTs were rated with low-to-unclear risk of bias in selection, detection, attrition, reporting, and other bias. All RCTs were rated as high risk in performance bias because blinding was difficult to ensure in the compared groups. Results of meta-analyses revealed that the number of clinical responders was greater in the LNG-IUS group than that in the medical treatments group at both 6-month (steroidal: five RCTs; n = 490; risk ratio [RR]: 1.72 [1.13, 2.62]; I2 = 92%; nonsteroidal: one RCT; n = 42; RR: 2.34 [1.31, 4.19]) and 12-month (steroidal: three RCTs; n = 261; RR: 1.31 [1.01, 1.71]; I2 = 74%) endpoints, with no clear differences on number of dropouts, and the incidence of adverse events.ConclusionEvidence indicates that LNG-IUS is superior to the medical treatments in short-term and medium-term clinical responses, blood loss control, compliance, and satisfaction. Meanwhile, frequency of adverse events related to LNG-IUS is acceptable.Systematic review registrationPROSPERO, identifier CRD42021259335, https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021295379.

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Section: Resultsmentioning

confidence: 99%

LNG-IUS vs. medical treatments for women with heavy menstrual bleeding: A systematic review and meta-analysis

et al. 2022

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“…This result is in concordance with Kiseli et al study, where percentage decrease in PBAC score was reported to be 85.8% in LNG IUS group and 53.1% in norethisterone group. 6 In a study done by Ashraf et al, 94.73% reduction in LNG IUS group was noted as compared to 73% in norethisterone treated group at 6 months. 7 It was observed that both the treatment modalities significantly decreased bleeding duration at completion of study (p=0.000); LNG IUS was more successful than norethisterone in lowering duration of bleeding which was also witnessed in the study done by Lee et al, who compared LNG IUS with conventional medical therapy.…”

Section: Discussionmentioning

confidence: 92%

Comparative study on levonorgestrel intrauterine system and oral progestogen in women with heavy menstrual bleeding in terms of efficacy, user satisfaction and quality of life using MMAS score

Dahiya

Mahipal

Dahiya

et al. 2019

Int J Reprod Contracept Obstet Gynecol

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Background: To compare the efficacy, safety and user satisfaction of levonorgestrel intrauterine system (LNG-IUS) with oral progestogen in medical management of heavy menstrual bleeding (HMB).Methods: This prospective study was conducted on 80 women with HMB in age group of 35-55 years. Patients were divided into two groups of 40 each and followed for six months. In Group I, LNG-IUS was inserted in post menstrual period and in Group II, patients received oral norethisterone 5 mg twice a day during 5th-25th day of cycle for 6 months. Patients were evaluated about amount and duration of blood loss by pictorial blood assessment chart (PBAC) along with haemoglobin estimation on each follow up visit. MMAS (Menorrhagia Multi-Attribute Scale) score comparison between two groups was done to measure the improvement in quality of life. The results were analysed by using Chi-square test and Student t-test.Results: Percentage reduction in PBAC score after six cycles of treatment was 89.3% in LNG IUS group as compared to 68% in norethisterone group. LNG-IUS was found to be more efficient in correcting anemia, lowering duration of bleeding and improving MMAS score as compared to norethisterone.Conclusions: Present study showed that LNG IUS was superior to oral progestogen in decreasing quantity and duration of bleeding and improving overall quality of life over time.

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“…Another randomized controlled study reported that the satisfaction rate was 70% with norethisterone in heavy menstrual bleeding. 23…”

Section: Discussionmentioning

confidence: 99%

Real-world Safety and Effectiveness Analysis of Norethisterone in the Management of Abnormal Uterine Bleeding

Jaiswal¹,

Boruah²,

Jaiswal³

et al. 2022

Journal of South Asian Federation of Obstetrics and Gynaecology

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Objective: To assess the real-world safety and effectiveness of norethisterone 10 mg-controlled release (CR) formulation in the management of abnormal uterine bleeding (AUB). Methods: This was a retrospective analysis of real-world data collected between January 2021 and March 2021 across 40 centers in India. A total of 308 women in the reproductive age-group (18-45 years) with ovulatory AUB were treated with norethisterone CR 10 mg once a day for 10 days. The data from women with a confirmed diagnosis of AUB were included in the study. The clinical records that were analyzed for the primary objectives included the time required for arresting heavy menstrual bleeding after initiating medication, the incidence of breakthrough bleeding, safety and tolerability, and the secondary objectives included the timing of withdrawal bleeding after the last tablet was taken, assessment of heaviness of bleeding, and treatment compliance. Results:The mean age [± standard deviation (SD)] was 33.8 ± 8.3 years. Out of the 308 women with AUB, the majority of women (n = 193, 63%) experienced styptic action of norethisterone 10 mg CR within 4 hours of administration of the medication, 61% of the women (n = 187) did not report any incidence of breakthrough bleeding, and 70% of the women (n = 216) reported withdrawal bleeding within 24-72 hours of administration of the last medication dose. No adverse events were reported. Heavy bleeding was noted in only 7% of the women. More than 80% of compliance with therapy was observed in 94% of women (n = 290). Conclusion: Our analyses of the retrospective data suggested that norethisterone 10 mg CR was safe and effective for the treatment of AUB in Indian women. Clinical significance: To the best of our knowledge, this is the first real-world study to show that norethisterone 10 mg CR effectively treats AUB, is safe, and is associated with a high compliance rate in Indian women of reproductive age-group (18-45 years).

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Comparison of Therapeutic Efficacies of Norethisterone, Tranexamic Acid and Levonorgestrel-Releasing Intrauterine System for the Treatment of Heavy Menstrual Bleeding: A Randomized Controlled Study

Cited by 20 publications

References 31 publications

LNG-IUS vs. medical treatments for women with heavy menstrual bleeding: A systematic review and meta-analysis

LNG-IUS vs. medical treatments for women with heavy menstrual bleeding: A systematic review and meta-analysis

Comparative study on levonorgestrel intrauterine system and oral progestogen in women with heavy menstrual bleeding in terms of efficacy, user satisfaction and quality of life using MMAS score

Real-world Safety and Effectiveness Analysis of Norethisterone in the Management of Abnormal Uterine Bleeding

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