Quality of Life of Japanese Dysmenorrhea/Heavy Menstrual Bleeding Patients Treated with Levonorgestrel Intrauterine Delivery System in a Real-World Setting

Introduction The present study collected 1-year follow-up patient-reported outcome data from Japanese women with dysmenorrhea and/or heavy menstrual bleeding (HMB) who underwent insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg. We aimed to evaluate the quality of life (Q...

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Vydané v:	Advances in therapy Ročník 39; číslo 8; s. 3616 - 3634
Hlavní autori:	Momoeda, Mikio, Akira, Shigeo, Harada, Tasuku, Kitawaki, Jo, Maeda, Nagamasa, Ota, Ikuko, Yoshihara, Keisuke, Takahashi, Noriko
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	Cheshire Springer Healthcare 01.08.2022
Predmet:	Cardiology Endocrinology Internal Medicine Medicine Medicine & Public Health NCT NCT02475356 Oncology Original Research Pharmacology/Toxicology Rheumatology Heavy menstrual bleeding Japan Levonorgestrel-releasing intrauterine system Menorrhagia multi-attribute scale (MMAS) Patient-reported outcome Menstrual distress questionnaire (MDQ) Dysmenorrhea Quality of life
ISSN:	0741-238X, 1865-8652, 1865-8652
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Abstract	Introduction The present study collected 1-year follow-up patient-reported outcome data from Japanese women with dysmenorrhea and/or heavy menstrual bleeding (HMB) who underwent insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg. We aimed to evaluate the quality of life (QOL) of Japanese women over the course of the investigational period. Methods This was a multicenter, non-interventional, prospective, single-cohort, post-marketing surveillance study (J-MIRAI). The primary outcome was the median change in the Menstrual Distress Questionnaire (MDQ) and Menorrhagia Multi-Attribute Scale (MMAS) scores from baseline to 3 and 12 months after LNG-IUS insertion, with decreasing and increasing scores, respectively, indicating improvement. The secondary outcomes were the statistical relationships between the MDQ and menstrual pain (measured by a visual analog scale, VAS), and between the MMAS and pictorial blood loss assessment chart (PBAC) scores by regression analysis. Results In total, 593 patients were evaluated; 376, 467, and 250 patients were diagnosed with dysmenorrhea, HMB, or both, respectively. The median MDQ score decreased significantly at 3 and 12 months after LNG-IUS insertion in both the premenstrual and menstrual periods (both p < 0.001 vs baseline), and the median MMAS score showed a similar improvement during the menstrual period. Changes in median MDQ and MMAS scores were observed regardless of patient background. Correlations between MDQ and menstrual pain (VAS) and between MMAS and PBAC scores were found (estimated regression coefficients 0.29 and − 0.15, respectively). Conclusion The LNG-IUS contributed to improvements in the QOL of patients with dysmenorrhea, HMB, and both, regardless of patient background characteristics. Trial Registration Registered at ClinicalTrials.gov (NCT02475356) on 18 June 2015.
AbstractList	The present study collected 1-year follow-up patient-reported outcome data from Japanese women with dysmenorrhea and/or heavy menstrual bleeding (HMB) who underwent insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg. We aimed to evaluate the quality of life (QOL) of Japanese women over the course of the investigational period.INTRODUCTIONThe present study collected 1-year follow-up patient-reported outcome data from Japanese women with dysmenorrhea and/or heavy menstrual bleeding (HMB) who underwent insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg. We aimed to evaluate the quality of life (QOL) of Japanese women over the course of the investigational period.This was a multicenter, non-interventional, prospective, single-cohort, post-marketing surveillance study (J-MIRAI). The primary outcome was the median change in the Menstrual Distress Questionnaire (MDQ) and Menorrhagia Multi-Attribute Scale (MMAS) scores from baseline to 3 and 12 months after LNG-IUS insertion, with decreasing and increasing scores, respectively, indicating improvement. The secondary outcomes were the statistical relationships between the MDQ and menstrual pain (measured by a visual analog scale, VAS), and between the MMAS and pictorial blood loss assessment chart (PBAC) scores by regression analysis.METHODSThis was a multicenter, non-interventional, prospective, single-cohort, post-marketing surveillance study (J-MIRAI). The primary outcome was the median change in the Menstrual Distress Questionnaire (MDQ) and Menorrhagia Multi-Attribute Scale (MMAS) scores from baseline to 3 and 12 months after LNG-IUS insertion, with decreasing and increasing scores, respectively, indicating improvement. The secondary outcomes were the statistical relationships between the MDQ and menstrual pain (measured by a visual analog scale, VAS), and between the MMAS and pictorial blood loss assessment chart (PBAC) scores by regression analysis.In total, 593 patients were evaluated; 376, 467, and 250 patients were diagnosed with dysmenorrhea, HMB, or both, respectively. The median MDQ score decreased significantly at 3 and 12 months after LNG-IUS insertion in both the premenstrual and menstrual periods (both p < 0.001 vs baseline), and the median MMAS score showed a similar improvement during the menstrual period. Changes in median MDQ and MMAS scores were observed regardless of patient background. Correlations between MDQ and menstrual pain (VAS) and between MMAS and PBAC scores were found (estimated regression coefficients 0.29 and - 0.15, respectively).RESULTSIn total, 593 patients were evaluated; 376, 467, and 250 patients were diagnosed with dysmenorrhea, HMB, or both, respectively. The median MDQ score decreased significantly at 3 and 12 months after LNG-IUS insertion in both the premenstrual and menstrual periods (both p < 0.001 vs baseline), and the median MMAS score showed a similar improvement during the menstrual period. Changes in median MDQ and MMAS scores were observed regardless of patient background. Correlations between MDQ and menstrual pain (VAS) and between MMAS and PBAC scores were found (estimated regression coefficients 0.29 and - 0.15, respectively).The LNG-IUS contributed to improvements in the QOL of patients with dysmenorrhea, HMB, and both, regardless of patient background characteristics.CONCLUSIONThe LNG-IUS contributed to improvements in the QOL of patients with dysmenorrhea, HMB, and both, regardless of patient background characteristics.Registered at ClinicalTrials.gov (NCT02475356) on 18 June 2015.TRIAL REGISTRATIONRegistered at ClinicalTrials.gov (NCT02475356) on 18 June 2015. The present study collected 1-year follow-up patient-reported outcome data from Japanese women with dysmenorrhea and/or heavy menstrual bleeding (HMB) who underwent insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg. We aimed to evaluate the quality of life (QOL) of Japanese women over the course of the investigational period. This was a multicenter, non-interventional, prospective, single-cohort, post-marketing surveillance study (J-MIRAI). The primary outcome was the median change in the Menstrual Distress Questionnaire (MDQ) and Menorrhagia Multi-Attribute Scale (MMAS) scores from baseline to 3 and 12 months after LNG-IUS insertion, with decreasing and increasing scores, respectively, indicating improvement. The secondary outcomes were the statistical relationships between the MDQ and menstrual pain (measured by a visual analog scale, VAS), and between the MMAS and pictorial blood loss assessment chart (PBAC) scores by regression analysis. In total, 593 patients were evaluated; 376, 467, and 250 patients were diagnosed with dysmenorrhea, HMB, or both, respectively. The median MDQ score decreased significantly at 3 and 12 months after LNG-IUS insertion in both the premenstrual and menstrual periods (both p < 0.001 vs baseline), and the median MMAS score showed a similar improvement during the menstrual period. Changes in median MDQ and MMAS scores were observed regardless of patient background. Correlations between MDQ and menstrual pain (VAS) and between MMAS and PBAC scores were found (estimated regression coefficients 0.29 and - 0.15, respectively). The LNG-IUS contributed to improvements in the QOL of patients with dysmenorrhea, HMB, and both, regardless of patient background characteristics. Registered at ClinicalTrials.gov (NCT02475356) on 18 June 2015. Introduction The present study collected 1-year follow-up patient-reported outcome data from Japanese women with dysmenorrhea and/or heavy menstrual bleeding (HMB) who underwent insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg. We aimed to evaluate the quality of life (QOL) of Japanese women over the course of the investigational period. Methods This was a multicenter, non-interventional, prospective, single-cohort, post-marketing surveillance study (J-MIRAI). The primary outcome was the median change in the Menstrual Distress Questionnaire (MDQ) and Menorrhagia Multi-Attribute Scale (MMAS) scores from baseline to 3 and 12 months after LNG-IUS insertion, with decreasing and increasing scores, respectively, indicating improvement. The secondary outcomes were the statistical relationships between the MDQ and menstrual pain (measured by a visual analog scale, VAS), and between the MMAS and pictorial blood loss assessment chart (PBAC) scores by regression analysis. Results In total, 593 patients were evaluated; 376, 467, and 250 patients were diagnosed with dysmenorrhea, HMB, or both, respectively. The median MDQ score decreased significantly at 3 and 12 months after LNG-IUS insertion in both the premenstrual and menstrual periods (both p < 0.001 vs baseline), and the median MMAS score showed a similar improvement during the menstrual period. Changes in median MDQ and MMAS scores were observed regardless of patient background. Correlations between MDQ and menstrual pain (VAS) and between MMAS and PBAC scores were found (estimated regression coefficients 0.29 and − 0.15, respectively). Conclusion The LNG-IUS contributed to improvements in the QOL of patients with dysmenorrhea, HMB, and both, regardless of patient background characteristics. Trial Registration Registered at ClinicalTrials.gov (NCT02475356) on 18 June 2015.
Author	Akira, Shigeo Harada, Tasuku Kitawaki, Jo Ota, Ikuko Momoeda, Mikio Yoshihara, Keisuke Maeda, Nagamasa Takahashi, Noriko
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CitedBy_id	crossref_primary_10_1016_j_contraception_2022_08_006 crossref_primary_10_7759_cureus_49569 crossref_primary_10_3390_disabilities5020051
Cites_doi	10.1093/epirev/mxt009 10.4103/jfmpc.jfmpc_209_18 10.1093/humupd/dmv039 10.1016/j.ajog.2020.08.016 10.1016/0885-3924(96)00128-5 10.1111/hae.12886 10.1007/s00404-011-1902-1 10.2147/IJWH.S99705 10.1017/S0033291700009934 10.1016/j.ijgo.2014.09.027 10.3109/07853899009147248 10.1016/S0091-2182(99)00029-4 10.1007/s00404-011-1937-3 10.1097/00000542-200112000-00013 10.2147/IJWH.S238460 10.1111/jog.14487 10.1136/ard.38.6.560 10.1089/jwh.2018.7615 10.3111/13696998.2013.830974 10.1136/ard.37.4.378 10.3109/03009730903457218 10.1080/ejc.6.4.192.198 10.1016/S0049-3848(17)30072-5 10.1186/s40834-017-0047-4 10.1016/j.ijgo.2004.09.004 10.1186/s12905-018-0533-0 10.1056/NEJMoa1204724 10.1111/j.1471-0528.1990.tb16249.x 10.1007/s12325-020-01564-y 10.1002/14651858.CD002126.pub4
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Keywords	Heavy menstrual bleeding Japan Levonorgestrel-releasing intrauterine system Menorrhagia multi-attribute scale (MMAS) Patient-reported outcome Menstrual distress questionnaire (MDQ) Dysmenorrhea Quality of life
Language	English
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Snippet	Introduction The present study collected 1-year follow-up patient-reported outcome data from Japanese women with dysmenorrhea and/or heavy menstrual bleeding... The present study collected 1-year follow-up patient-reported outcome data from Japanese women with dysmenorrhea and/or heavy menstrual bleeding (HMB) who...
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SubjectTerms	Cardiology Endocrinology Internal Medicine Medicine Medicine & Public Health NCT NCT02475356 Oncology Original Research Pharmacology/Toxicology Rheumatology
Title	Quality of Life of Japanese Dysmenorrhea/Heavy Menstrual Bleeding Patients Treated with Levonorgestrel Intrauterine Delivery System in a Real-World Setting
URI	https://link.springer.com/article/10.1007/s12325-022-02205-2 https://www.ncbi.nlm.nih.gov/pubmed/35705788 https://www.proquest.com/docview/2677572820 https://pubmed.ncbi.nlm.nih.gov/PMC9309137
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