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Menorrhagia multi-attribute scale scores (mean ± SD) in the two treatment groups, LNG-IUS versus CMT.
Source publication
Purpose
To evaluate the patient satisfaction and health related quality of life (HRQoL) for levonorgestrel-releasing intrauterine system (LNG-IUS) versus conventional medical treatments ([CMTs] combined oral contraceptives, oral progestins, and antifibrinolytics, alone or in combination) in Asian women with heavy menstrual bleeding (HMB).
Patients...
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Citations
... In a prospective observational study of 572 Asian women from eight countries, 437 were assigned to the LNG-IUS treatment group and 135 to the common medical therapy group [17]. The MMAS scores were recorded at all four visits, namely, baseline, three months, six months, and 12 months. ...
Background
This study aimed to examine the role of a levonorgestrel intrauterine system (LNG-IUS) in the treatment of heavy menstrual bleeding (HMB) regarding improvements in bleeding patterns and quality of life (QOL) and determine the reason for its failure or withdrawal from treatment in some patients.
Methodology
This retrospective study was conducted in a tertiary care center in eastern India. A seven-year assessment, with both qualitative and quantitative assessments, of the effect of LNG-IUS in women with HMB was performed using the Menorrhagia Multiattribute Scale (MMAS) and Medical Outcomes Study 36-Item Short-Form Health Survey (MOS SF-36) score as a tool to assess the QOL, and the pictorial bleeding assessment chart (PBAC) to assess bleeding patterns. The study population was divided into the following four groups based on duration: three months to one year, one to two years, two to three years, and more than years. The continuation, expulsion, and hysterectomy rates were evaluated.
Results
The mean MMAS and MOS SF-36 scores increased significantly (p < 0.05) from 36.73 ± 20.40 to 93.72 ± 14.62 and 35.33 ± 6.73 to 90.54 ± 15.89, respectively. The mean PBAC score decreased from 176.36 ± 79.85 to 32.19 ± 63.87. In total, 348 women (94.25%) continued the LNG-IUS, and 3.44% had uncontrolled menorrhagia. Furthermore, at the end of seven years, the expulsion rate was 2.28% due to adenomyosis and pelvic inflammatory disease, and the hysterectomy rate was 5.75%. In addition, 45.97% and 48.27% of the participants had amenorrhea and hypomenorrhea, respectively.
Conclusions
LNG-IUS improves bleeding and QOL in women with HMB. In addition, it requires less skill and is a non-invasive and nonsurgical option, which should be considered first.
... There was no significant difference in PBAC scores between patients with and without tranexamic acid (p = 1.00). The MMAS scores were worse in tranexamic acid users than in non-tranexamic acid users, although not statistically significant after correction for multiple testing (56)(57)(58)(59)(60)(61)(62)(63)(64)(65) vs. 85 , p = 0.17). The median MMAS scores in patients who used tranexamic acid were the lowest after patients with current clinical menstrual problems. ...
Immune thrombocytopenia (ITP) may cause menstrual problems. This cross‐sectional study assessed menstrual problems in premenopausal chronic ITP women by several questionnaires, including the pictorial bleeding assessment calendar (PBAC; score ≥100 indicates heavy menstrual bleeding [HMB]), and the menorrhagia multiattribute scale (MMAS). Spearman was used for assessing correlations. A literature review was performed in Pubmed. The cohort comprised 37 women (mean age 31 ± 9). A total of 29/37 (78%) had experienced clinical menstrual problems in the present or past. Of the 33 patients who returned the PBAC, 13 (39%) had a score of ≥100. The median MMAS score was 79 (IQR 60–95). The PBAC scores correlated with the MMAS. Both questionnaires were unrelated to the platelet count. Patients with a levonorgestrel intrauterine device (LNG‐IUD) had lower PBAC scores than patients with other or no hormonal therapy. MMAS scores were correlated with fatigue. The review identified 14 papers. HMB occurred in 6%–55% at ITP diagnosis and 17%–79% during disease. Menstrual symptoms influenced the quality of life, particularly in patients with a low platelet count. This explorative study suggested that HMB is frequent in women with chronic ITP despite management and platelet counts >50 *10⁹/l. An LNG‐IUD seemed to reduce blood loss significantly.
... This result is consistent with previous studies conducted in Asia and the UK. In both studies, MMAS scores were substantially improved within 3-6 months, and a slight increase in the score continued until the end of the investigational periods [35,36]. These findings suggest that the LNG-IUS can help alleviate HMB symptoms in the early phase of treatment, which leads to improvement in the QOL of these patients. ...
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.
... These increases in the MMAS scores suggested improvements in health-related QoL over time. Our findings are consistent with previous reports of women with heavy menstrual bleeding treated with the 52-mg LNG-IUS [24,25]. ...
Purpose:
To collect real-world safety and clinical outcome data on the levonorgestrel-releasing intrauterine system (LNG-IUS) for functional/organic heavy menstrual bleeding (HMB) and dysmenorrhoea in Japanese women (J-MIRAI).
Materials and methods:
In this prospective, multicentre, single-cohort, open-label, post-authorisation study, we assessed menstrual blood loss after LNG-IUS insertion by changes from baseline in pictorial blood loss assessment chart (PBAC) scores. Scores for the menorrhagia multi-attribute scale (MMAS) were collected for 12 months to assess quality of life.
Results:
We included 47 patients with complete PBAC score and patient diary data. The median PBAC score before LNG-IUS insertion was 159.0, which decreased significantly to 6.0 at 12 months post-insertion; for patients with adenomyosis (n = 20), PBAC score decreased from 174.5 pre-insertion to 19.5 at 12 months. The number of patient-reported bleeding days was correlated with PBAC score ≥5. The proportion of women with prolonged bleeding decreased from 85.7% to 34.6% by the study's end. Some women reported no bleeding after the first 90-day reference period. The mean MMAS overall score significantly increased from 50.50 before insertion to 88.67 at 12 months.
Conclusions:
Japanese women with functional/organic HMB experienced substantial reductions in bleeding symptoms and improvements in quality of life after 12-month use of the LNG-IUS.
... This result is consistent with previous studies conducted in Asia and the UK. In both studies, MMAS scores were substantially improved within 3 to 6 months, and a slight increase in the score continued until the end of the investigational periods [35,36]. These ndings suggest that the LNG-IUS can help alleviate HMB symptoms in the early phase of treatment, which leads to improvement in the QOL of these patients. ...
Background: 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, 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 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.
... These studies were ranked from three up to eight stars on the NOS. Xu et al. (2014) compared quality of life in women with HMB treated with LNG-IUD to women receiving conventional medical treatment (CMT) for HMB (combined OCs, oral progestins and antifibrinolytics, either alone or in combination). They sampled at four time points (baseline, 3, 6, 12 months follow-up) and found a significant improvement in both groups, with a significantly higher increase in quality of life in LNG-IUD treated women compared to the CMT group. ...
... All included studies found an improvement of quality of life in women suffering from HMB, endometriosis, or adenomyosis. Women with HMB or endometriosis benefit from LNG-IUD use as they report improved quality of life after six (Adigüzel et al., 2017;Cozza et al., 2017;Flores et al., 2015;Gorgen et al., 2009;Pekin et al., 2014) or 12 months of use (Bastianelli et al., 2011;Hurskainen et al., 2001;Lete et al., 2008;Ozdegirmenci et al., 2011;Xu et al., 2014;Yucel et al., 2018). Even after five years of use, one study found a higher quality of life compared to baseline, although the difference was lower compared to 12 months after baseline (Heliovaara-Peippo et al., 2013). ...
... Concerning the risk of bias of the included studies, we found that six studies were funded by a pharmaceutical company. However, only three of them reported a positive outcome for LNG-IUD users (Cristobal et al., 2016;Lete et al., 2008;Xu et al., 2014), while two showed no effect (Boozalis et al., 2016;Toffol et al., 2011) and one study observed a negative effect (Skovlund et al., 2016), thus fitting the overall outcomes. ...
Levonorgestrel-intrauterine-devices (LNG-IUD) are one of the most used contraceptive methods worldwide. While several reviews exist on how LNG-IUDs impact physiology and gynaecological functions, this systematic review focuses on stress, mental health, quality of life, sexual functioning, and effects on brain architecture.
While data on stress is scarce, results on mental health are ambiguous. More consistently, LNG-IUD use seems to improve quality of life and sexual functioning. No studies highlighting the consequences of LNG-IUD use on the brain were found.
The reviewed studies are characterized by a substantial variation in approaches, participant groups, and study quality. More high-quality research assessing the effects of LNG-IUD on mental health, including response to stressors and brain function and structure, is needed to identify women vulnerable to adverse effects of LNG-IUD, also in comparison to oral contraceptives, and to empower women to make more informed choices concerning hormonal contraception.
... Based on the results of a study on 1589 patients with AUB, Rae et al also rated the QOL as low in these patients and found that the score of QOL decreases more significantly with higher amounts of bleeding and more irregular periods (12). A cross-sectional study conducted by Xu et al reported the score of QOL as 41.4 in 647 AUB patients and thus this index was rated as low in this group (24). In a trial conducted by Abu-Rafea et al on Middle-Eastern women, including 61 patients with AUB and 41 healthy women of reproductive age, the QOL was found to be lower in the AUB patients compared to healthy women (16). ...
... Based on the findings of a prospective cohort study by Coulter et al on 348 patients followed up for 18 months, a lower QOL was found in women with hemorrhagic disorders compared to healthy women (26). In our findings, menorrhagic women had low QOL compared to others, which is in line with the results of the above-mentioned studies (4,12,16,18,(22)(23)(24)(25)(26) The present findings showed no significant relationships between hemoglobin levels and changes in the QOL in patients with uterine bleeding problems, which is inconsistent with the results obtained by De Souza et al on 58 AUB patients with low hemoglobin levels. They found that reduced hemoglobin affects the QOL in such patients and proposed hematocrit indices as a reliable predictor of the QOL. ...
... L'utilisation du SIU-LNG 52 mg est egalement approuv ee pour la prise en charge des saignements menstruels abondants. Ces derniers y r eagissent favorablement: le SIU-LNG 52 mg entraîne en effet une diminution des pertes de sang menstruel de l'ordre de 74 % a 98 % 33-39 , des effets favorables sur les taux d'h emoglobine [39][40][41][42] et, par cons equent, une am elioration de la qualit e de vie li ee a la sant e 43 . Dans le cadre de deux etudes ayant port e sur des femmes qui devaient subir une hyst erectomie en raison de la pr esence de SMA, de 64 % a 80 % des femmes qui ont et e affect ees au hasard a un groupe devant subir l'insertion pr eop eratoire d'un SIU-LNG 52 mg en sont par la suite venues a annuler leur hyst erectomie, par comparaison avec de 9 % a 14 % des femmes qui ont et e affect ees au hasard a un groupe devant recevoir d'autres traitements m edicaux 44,45 . ...
Objectif:
Fournir des lignes directrices aux fournisseurs de soins quant à l'utilisation de modes de contraception pour la prévention de la grossesse et quant à la promotion d'une sexualité saine.
Issues:
Orientation des praticiens canadiens en ce qui concerne l'efficacité globale, le mécanisme d'action, les indications, les contre-indications, les avantages n'étant pas liés à la contraception, les effets indésirables, les risques et le protocole de mise en œuvre des modes de contraception abordés; planification familiale dans le contexte de la santé sexuelle et du bien-être général; méthodes de counseling en matière de contraception; et accessibilité et disponibilité des modes de contraception abordés au Canada. RéSULTATS: La littérature publiée a été récupérée par l'intermédiaire de recherches menées dans MEDLINE et The Cochrane Library entre janvier 1994 et janvier 2015 au moyen d'un vocabulaire contrôlé (p. ex. contraception, sexuality, sexual health) et de mots clés (p. ex. contraception, family planning, hormonal contraception, emergency contraception) appropriés. Les résultats ont été restreints aux analyses systématiques, aux études observationnelles et aux essais comparatifs randomisés / essais cliniques comparatifs publiés en anglais entre janvier 1994 et janvier 2015. Les recherches ont été mises à jour de façon régulière et intégrées à la directive clinique jusqu'en juin 2015. La littérature grise (non publiée) a été identifiée par l'intermédiaire de recherches menées dans les sites Web d'organismes s'intéressant à l'évaluation des technologies dans le domaine de la santé et d'organismes connexes, dans des collections de directives cliniques, dans des registres d'essais cliniques et auprès de sociétés de spécialité médicale nationales et internationales.
Valeurs:
La qualité des résultats a été évaluée au moyen des critères décrits dans le rapport du Groupe d'étude canadien sur les soins de santé préventifs (Tableau 1). CHAPITRE 7 : CONTRACEPTION INTRA-UTéRINE: Déclarations sommaires RECOMMANDATIONS.
... 5yr-IUD achieved an 83.5% " satisfied " or " very satisfied " rating from 437 participants. Obese participants had the greatest improvement in MMAS satisfaction rating from baseline (27.9) to 12-months surveillance (95.5).[12]A retrospective, non-comparative study of 48 adenomyosis patients, 10 of whom had HMB, and 30 of whom had both HMB and dysmenorrhea, had an HMB subjective symptom score of 69.4 ± 26.1 prior to 5yr-IUD insertion.[39]By 6-months post-insertion the HMB subjective symptom score was more than halved to 25.3 ± 17.7 (p < .001), ...
Introduction
Up to 30% of women will have heavy menstrual bleeding (HMB), leading to 20% of gynecology visits. HMB impairs women’s quality of life. As 80% of HMB cases have normal anatomy, generally, surgery is clinically excessive, cost-ineffective treatment. Both intramuscular medroxyprogesterone acetate (DMPA) and the 5-year, 52 mg, levonorgestrel intrauterine device (5yr-IUD) are known for potential amenorrhea. Weight gain is a known adverse effect of DMPA. Astute patients also question the 5yr-IUD’s weight gain potential. Therefore,
the comparative efficacy of DMPA and 5yr-IUD for menstrual control and the associated weight gain need clarification.
Methods
An evidence-based mini-review was performed. PubMed searches for the terms “depo provera weight gain,” “mirena weight gain,” “depo provera effectiveness treatment heavy menstrual bleeding,” and “mirena effectiveness treatment heavy menstrual bleeding” yielded 17 included articles.
Results
Up to 2-years post-insertion the 5yr-IUD is the most efficacious hormonal means of HMB control. For 31% of DMPA users, DMPA is as efficacious as the 5yr-IUD. Obese adolescents have up to 9.4 kg in 18 months DMPA associated weight gain, whereas obese endometrial and pre-endometrial cancer 5yr-IUD users can lose 5.4 kg in 12 months.
Discussion
While retrospective and prospective studies’ outcomes differ in magnitude, DMPA is consistently associated with greater weight gain than underlying population-based weight gain trends, whereas the 5yr-IUD is associated with maintenance of underlying population-based weight gain trends.
Conclusion
The 5yr-IUD is weight-neutral in comparison to the DMPA. The 5yr-IUD is most likely to normalize menstruation or result in amenorrhea within 6-months of initiation, but at 5-year surveillance all HMB hormonal control methods have similar efficacy
... HMB responds favourably to use of the LNG-IUS 52 mg, with reported reductions in menstrual blood loss of 74% to 98%, 33e39 favourable effects on hemoglobin levels, 39e42 and, as a result, improved health-related quality of life. 43 In two studies of women scheduled to undergo hysterectomy for HMB, 64% to 80% of women randomized preoperatively to receive LNG-IUS 52 mg insertion subsequently cancelled their hysterectomy, compared with 9% to 14% of women randomized to receive other medical treatments. 44,45 The LNG-IUS 52 mg is effective in the treatment of fibroid-related HMB, although less effective compared with women who do not have fibroids. ...
... L'utilisation du SIU-LNG 52 mg est également approuvée pour la prise en charge des saignements menstruels abondants. Ces derniers y réagissent favorablement : le SIU-LNG 52 mg entraîne en effet une diminution des pertes de sang menstruel de l'ordre de 74 % à 98 % 33e39 , des effets favorables sur les taux d'hémoglobine 39e42 et, par conséquent, une amélioration de la qualité de vie liée à la santé 43 . Dans le cadre de deux études ayant porté sur des femmes qui devaient subir une hystérectomie en raison de la présence de SMA, de 64 % à 80 % des femmes qui ont été affectées au hasard à un groupe devant subir l'insertion préopératoire d'un SIU-LNG 52 mg en sont par la suite venues à annuler leur hystérectomie, par comparaison avec de 9 % à 14 % des femmes qui ont été affectées au hasard à un groupe devant recevoir d'autres traitements médicaux 44,45 . ...
Objective:
To provide guidelines for health care providers on the use of contraceptive methods to prevent pregnancy and on the promotion of healthy sexuality.
Outcomes:
Overall efficacy of cited contraceptive methods, assessing reduction in pregnancy rate, safety, ease of use, and side effects; the effect of cited contraceptive methods on sexual health and general well-being; and the relative cost and availability of cited contraceptive methods in Canada.
Evidence:
Published literature was retrieved through searches of Medline and The Cochrane Database from January 1994 to January 2015 using appropriate controlled vocabulary (e.g., contraception, sexuality, sexual health) and key words (e.g., contraception, family planning, hormonal contraception, emergency contraception). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies published in English from January 1994 to January 2015. Searches were updated on a regular basis in incorporated in the guideline to June 2015. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies.
Values:
The quality of the evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). CHAPTER 8: PROGESTIN-ONLY CONTRACEPTION: Summary Statements Recommendations.
