BACKGROUND: Heavy menstrual bleeding (HMB) impacts the quality of life of otherwise healthy women. The perception of HMB is subjective and management depends upon, among other factors, the severity of the symptoms, a woman's age, her wish to get pregnant, and the presence of other pathologies. Heavy menstrual bleeding was classically defined as greater than or equal to 80 mL of blood loss per menstrual cycle. Currently the definition is based on the woman's perception of excessive bleeding which is affecting her quality of life. The intrauterine device was originally developed as a contraceptive but the addition of progestogens to these devices resulted in a large reduction in menstrual blood loss: users of the levonorgestrel-releasing intrauterine system (LNG-IUS) reported reductions of up to 90%. Insertion may, however, be regarded as invasive by some women, which affects its acceptability.
OBJECTIVES: To determine the effectiveness, acceptability and safety of progestogen-releasing intrauterine devices in reducing heavy menstrual bleeding.
SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL (from inception to June 2019); and we searched grey literature and for unpublished trials in trial registers.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) in women of reproductive age treated with LNG-IUS devices versus no treatment, placebo, or other medical or surgical therapy for heavy menstrual bleeding.
DATA COLLECTION AND ANALYSIS: Two authors independently extracted data, assessed risk of bias and conducted GRADE assessments of the certainty of evidence.
MAIN RESULTS: We included 25 RCTs (2511 women). Limitations in the evidence included risk of attrition bias and low numbers of participants. The studies compared the following interventions. LNG-IUS versus other medical therapy The other medical therapies were norethisterone acetate, medroxyprogesterone acetate, oral contraceptive pill, mefenamic acid, tranexamic acid or usual medical treatment (where participants could choose the oral treatment that was most suitable). The LNG-IUS may improve HMB, lowering menstrual blood loss according to the alkaline haematin method (mean difference (MD) 66.91 mL, 95% confidence interval (CI) 42.61 to 91.20; 2 studies, 170 women; low-certainty evidence); and the Pictorial Bleeding Assessment Chart (MD 55.05, 95% CI 27.83 to 82.28; 3 studies, 335 women; low-certainty evidence). We are uncertain whether the LNG-IUS may have any effect on women's satisfaction up to one year (RR 1.28, 95% CI 1.01 to 1.63; 3 studies, 141 women; I² = 0%, very low-certainty evidence). The LNG-IUS probably leads to slightly higher quality of life measured with the SF-36 compared with other medical therapy if (MD 2.90, 95% CI 0.06 to 5.74; 1 study: 571 women; moderate-certainty evidence) or with the Menorrhagia Multi-Attribute Scale (MD 13.40, 95% CI 9.89 to 16.91; 1 trial, 571 women; moderate-certainty evidence). The LNG-IUS and other medical therapies probably give rise to similar numbers of women with serious adverse events (RR 0.91, 95% CI 0.63 to 1.30; 1 study, 571 women; moderate-certainty evidence). Women using other medical therapy are probably more likely to withdraw from treatment for any reason (RR 0.49, 95% CI 0.39 to 0.60; 1 study, 571 women, moderate-certainty evidence) and to experience treatment failure than women with LNG-IUS (RR 0.34, 95% CI 0.26 to 0.44; 6 studies, 535 women; moderate-certainty evidence). LNG-IUS versus endometrial resection or ablation (EA) Bleeding outcome results are inconsistent. We are uncertain of the effect of the LNG-IUS compared to EA on rates of amenorrhoea (RR 1.21, 95% CI 0.85 to 1.72; 8 studies, 431 women; I² = 21%; low-certainty evidence) and hypomenorrhoea (RR 0.98, 95% CI 0.73 to 1.33; 4 studies, 200 women; low-certainty evidence) and eumenorrhoea (RR 0.55, 95% CI 0.30 to 1.00; 3 studies, 160 women; very low-certainty evidence). We are uncertain whether both treatments may have similar rates of satisfaction with treatment at 12 months (RR 0.95, 95% CI 0.85 to 1.07; 5 studies, 317 women; low-certainty evidence). We are uncertain if the LNG-IUS compared to EA has any effect on quality of life, measured with SF-36 (MD -14.40, 95% CI -22.63 to -6.17; 1 study, 33 women; very low-certainty evidence). Women with the LNG-IUS compared with EA are probably more likely to have any adverse event (RR 2.06, 95% CI 1.44 to 2.94; 3 studies, 201 women; moderate-certainty evidence). Women with the LNG-IUS may experience more treatment failure compared to EA at one year follow up (persistent HMB or requirement of additional treatment) (RR 1.78, 95% CI 1.09 to 2.90; 5 studies, 320 women; low-certainty evidence); or requirement of hysterectomy may be higher at one year follow up (RR 2.56, 95% CI 1.48 to 4.42; 3 studies, 400 women; low-certainty evidence). LNG-IUS versus hysterectomy We are uncertain whether the LNG-IUS has any effect on HMB compared with hysterectomy (RR for amenorrhoea 0.52, 95% CI 0.39 to 0.70; 1 study, 75 women; very low-certainty evidence). We are uncertain whether there is difference between LNG-IUS and hysterectomy in satisfaction at five years (RR 1.01, 95% CI 0.94 to 1.08; 1 study, 232 women; low-certainty evidence) and quality of life (SF-36 MD 2.20, 95% CI -2.93 to 7.33; 1 study, 221 women; low-certainty evidence). Women in the LNG-IUS group may be more likely to have treatment failure requiring hysterectomy for HMB at 1-year follow-up compared to the hysterectomy group (RR 48.18, 95% CI 2.96 to 783.22; 1 study, 236 women; low-certainty evidence). None of the studies reported cost data suitable for meta-analysis.
AUTHORS' CONCLUSIONS: The LNG-IUS may improve HMB and quality of life compared to other medical therapy; the LNG-IUS is probably similar for HMB compared to endometrial destruction techniques; and we are uncertain if it is better or worse than hysterectomy. The LNG-IUS probably has similar serious adverse events to other medical therapy and it is more likely to have any adverse events than EA.
BACKGROUND: Heavy menstrual bleeding (HMB) is an important cause of ill health in premenopausal women. Although surgery is often used as a treatment, a range of medical therapies are also available. Non-steroidal anti-inflammatory drugs (NSAIDs) reduce prostaglandin levels, which are elevated in women with excessive menstrual bleeding and also may have a beneficial effect on dysmenorrhoea.
OBJECTIVES: To determine the effectiveness, safety and tolerability of NSAIDs in achieving a reduction in menstrual blood loss (MBL) in women of reproductive years with HMB.
SEARCH METHODS: We searched, in April 2019, the Cochrane Gynaecology and Fertility specialised register, Cochrane Central Register of Studies Online (CENTRAL CRSO), MEDLINE, Embase, PsycINFO, the clinical trial registries and reference lists of articles.
SELECTION CRITERIA: The inclusion criteria were randomised comparisons of individual NSAIDs or combined with other medical therapy with each other, placebo or other medical treatments in women with regular heavy periods measured either objectively or subjectively and with no pathological or iatrogenic (treatment-induced) causes for their HMB.
DATA COLLECTION AND ANALYSIS: We identified 19 randomised controlled trials (RCTs) (759 women) that fulfilled the inclusion criteria for this review and two review authors independently extracted data. We estimated odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes from the data of nine trials. We described in data tables the results of the remaining seven cross-over trials with data unsuitable for pooling, one trial with skewed data, and one trial with missing variances. One trial had no data available for analysis.
MAIN RESULTS: As a group, NSAIDs were more effective than placebo at reducing HMB but less effective than tranexamic acid, danazol or the levonorgestrel-releasing intrauterine system (LNG IUS). Treatment with danazol caused a shorter duration of menstruation and more adverse events than NSAIDs, but this did not appear to affect the acceptability of treatment, based on trials from 1980 to 1990. However, currently danazol is not a usual or recommended treatment for HMB. There was no clear evidence of difference between NSAIDs and the other treatments (oral luteal progestogen, ethamsylate, an older progesterone-releasing intrauterine system and the oral contraceptive pill (OCP), but most studies were underpowered. There was no evidence of a difference between the individual NSAIDs (naproxen and mefenamic acid) in reducing HMB. The evidence quality ranged from low to moderate, the main limitations being risk of bias and imprecision.
AUTHORS' CONCLUSIONS: NSAIDs reduce HMB when compared with placebo, but are less effective than tranexamic acid, danazol or LNG IUS. However, adverse events are more severe with danazol therapy. In the limited number of small studies suitable for evaluation, there was no clear evidence of a difference in efficacy between NSAIDs and other medical treatments such as oral luteal progestogen, ethamsylate, OCP or the older progesterone-releasing intrauterine system.
BACKGROUND: Heavy menstrual bleeding (HMB) is a menstrual blood loss perceived by women as excessive that affects the health of women of reproductive age, interfering with their physical, emotional, social and material quality of life. Whilst abnormal menstrual bleeding may be associated with underlying pathology, in the present context, HMB is defined as excessive menstrual bleeding in the absence of other systemic or gynaecological disease. The first-line therapy is usually medical, avoiding possibly unnecessary surgery. Of the wide variety of medications used to reduce HMB, oral progestogens were originally the most commonly prescribed agents. This review assesses the effectiveness of two different types and regimens of oral progestogens in reducing ovulatory HMB.This is the update of a Cochrane review last updated in 2007, and originally named "Effectiveness of cyclical progestagen therapy in reducing heavy menstrual bleeding" (1998).
OBJECTIVES: To determine the effectiveness, safety and tolerability of oral progestogen therapy taken either during the luteal phase (short cycle) or for a longer course of 21 days per cycle (long cycle), in achieving a reduction in menstrual blood loss in women of reproductive age with HMB.
SEARCH METHODS: In January 2019 we searched Cochrane Gynaecology and Fertility's specialized register, CENTRAL, MEDLINE, Embase, CINAHL and PsycInfo. We also searched trials registers, other sources of unpublished or grey literature and reference lists of retrieved trials. We also checked citation lists of review articles to identify trials.
SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing different treatments for HMB that included cyclical oral progestogens were eligible.
DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, assessed trials for risk of bias and extracted data. We contacted trial authors for clarification of methods or additional data when necessary. We only assessed adverse events if they were separately measured in the included trials. We compared cyclical oral progestogen in different regimens and placebo or other treatments. Our primary outcomes were menstrual blood loss and satisfaction with treatment; the secondary outcomes were number of days of bleeding, quality of life, compliance and acceptability of treatment, adverse events and costs.
MAIN RESULTS: This review identified 15 randomized controlled trials (RCTs) with 1071 women in total. Most of the women knew which treatment they were receiving, which may have influenced their judgements about menstrual blood loss and satisfaction. Other aspects of trial quality varied among trials.We did not identify any RCTs comparing progestogen treatment with placebo. We assessed comparisons between oral progestogens and other medical therapies separately according to different regimens.Short-cycle progestogen therapy during the luteal phase (medroxyprogesterone acetate or norethisterone for 7 to 10 days, from day 15 to 19) was inferior to other medical therapy, including tranexamic acid, danazol and the progestogen-releasing intrauterine system (Pg-IUS (off of the market since 2001)), releasing 60 mcg of progesterone daily, with respect to reduction of menstrual blood loss (mean difference (MD) 37.29, 95% confidence interval (CI) 17.67 to 56.91; I2 = 50%; 6 trials, 145 women). The rate of satisfaction and the quality of life with treatment was similar in both groups. The number of bleeding days was greater on the short cycle progestogen group compared to other medical treatments. Adverse events (such as gastrointestinal symptoms and weight gain) were more likely with danazol when compared with progestogen treatment. We note that danazol is no longer in general use for treating HMB.Long-cycle progestogen therapy (medroxyprogesterone acetate or norethisterone), from day 5 to day 26 of the menstrual cycle, is also inferior to the levonorgestrel-releasing intrauterine system (LNG-IUS), releasing tranexamic acid and ormeloxifene, but may be similar to the combined vaginal ring with respect to reduction of menstrual blood loss (MD 16.88, 95% CI 10.93 to 22.84; I2 = 87%; 4 trials, 355 women). A higher proportion of women taking norethisterone found their treatment unacceptable compared to women having Pg-IUS (Peto odds ratio (OR) 0.12, 95% CI 0.03 to 0.40; 1 trial, 40 women). However, the adverse effects of breast tenderness and intermenstrual bleeding were more likely in women with the LNG-IUS. No trials reported on days of bleeding or quality of life for this comparison.The evidence supporting these findings was limited by low or very low gradings of quality; thus, we are uncertain about the findings and there is a potential that they may change if we identify other trials.
AUTHORS' CONCLUSIONS: Low- or very low-quality evidence suggests that short-course progestogen was inferior to other medical therapy, including tranexamic acid, danazol and the Pg-IUS with respect to reduction of menstrual blood loss. Long cycle progestogen therapy (medroxyprogesterone acetate or norethisterone) was also inferior to the LNG-IUS, tranexamic acid and ormeloxifene, but may be similar to the combined vaginal ring with respect to reduction of menstrual blood loss.
OBIETTIVO: Per confrontare l'efficacia di trattamenti non chirurgici abnormal sanguinamento uterino per sanguinamento controllo, la qualità della vita (QOL), il dolore, la salute sessuale, la soddisfazione del paziente, i trattamenti aggiuntivi necessari, e gli eventi avversi.
FONTI DI DATI: MEDLINE, database Cochrane, e Clinicaltrials.gov state perquisite da inizio a maggio 2012. Sono stati inclusi studi randomizzati controllati di trattamenti non chirurgici per sanguinamento uterino anomalo presunti secondaria a disfunzione endometriale e sanguinamento uterino anomalo presume secondaria a disfunzione ovulatoria. Gli interventi inclusi il sistema intrauterino di levonorgestrel, contraccettivi orali combinati (OCP), progestinici, farmaci anti-infiammatori non steroidei (FANS), e antifibrinolitici. Gonadotropina-agonisti dell'ormone rilasciante, danazolo, e placebo sono stati autorizzati come comparatori.
MODALITA 'DI SELEZIONE DEGLI STUDI: Due revisori proiettati independently 5848 citazioni ed estratti prove ammissibili. Gli studi sono stati valutati per la qualità e la forza delle prove.
Tabulazione, INTEGRAZIONE, E RISULTATI: Ventisei articoli incontrato i criteri di inclusione. Per la riduzione del sanguinamento mestruale nelle donne con sanguinamento uterino anomalo presume secondaria a disfunzione endometriale, il sistema intrauterino di levonorgestrel (71-95% di riduzione), OCP combinati (35-69% di riduzione), estesa progestinici orali ciclabili (87% di riduzione), tranexamico acido (26-54% di riduzione), e FANS (10-52% di riduzione) sono stati tutti i trattamenti efficaci. Il sistema intrauterino di levonorgestrel, OCP combinati, e antifibrinolitici erano tutti superiori ai progestinici luteale-fase (20% di aumento di sanguinamento riduzione del 67%). Il sistema intrauterino di levonorgestrel è stata superiore a OCP combinati e FANS. Antifibrinolytics erano superiori ai FANS per la riduzione del sanguinamento mestruale. I dati sono stati limitati su altri risultati importanti come la qualità di vita per le donne con sanguinamento uterino anomalo presume secondaria a disfunzione endometriale e per tutti gli esiti per le donne con sanguinamento uterino anomalo presume secondaria a disfunzione ovulatoria.
CONCLUSIONE: Per la riduzione della perdita ematica media nelle donne con sanguinamento mestruale pesante presume secondario al sanguinamento uterino anomalo presume secondaria a disfunzione endometriale, si consiglia l'utilizzo del sistema intrauterino di levonorgestrel oltre OCP, progestinici fase luteale, e FANS. Per gli altri risultati (QOL, il dolore, la salute sessuale, la soddisfazione del paziente, i trattamenti aggiuntivi necessari, e gli eventi avversi) e per il trattamento di sanguinamento uterino anomalo presume secondaria a disfunzione ovulatoria, siamo stati in grado di formulare raccomandazioni sulla base dei limitati dati disponibili.
BACKGROUND: Una varietà di trattamenti farmacologici e chirurgici sono stati sviluppati per sanguinamento mestruale pesante (HMB), che possono avere conseguenze negative fisiche, sociali, psicologici ed economici. Abbiamo condotto una revisione sistematica della letteratura e-trattamento-confronto misto (MTC) meta-analisi dei dati disponibili di studi clinici controllati randomizzati (RCT) di ricavare stime di efficacia per 8 classi di trattamenti per l'HMB, per informare l'analisi salute-economica e studi futuri .
METODI: Una revisione sistematica ha identificato studi randomizzati che hanno fornito dati sulla perdita di sangue mestruale (MBL) al basale e una o più volte di follow-up. Sono state considerate otto classi di trattamento: COC, danazolo, ablazione endometriale, LNG-IUS, placebo, progestinici dato per meno di 2 settimane di 4 durante il ciclo mestruale, progestinici dato per quasi tre settimane di 4, e TXA. La misura primaria di efficacia era la percentuale di donne che hanno raggiunto MBL <80 ml per ciclo (al mese), misurata con il metodo ematina alcalino. Un punteggio inferiore a 100 su un grafico pittorico valutazione di sangue perdita consolidata (PBAC) era considerato un sostituto accettabile per MBL <80 mL. Stime di efficacia per classe di trattamento e il tempo sono stati ottenuti da un modello bayesiano MTC. Il modello include anche gli effetti per classe di trattamento, lo studio, e la combinazione di classe di trattamento e di studio e di un adeguamento per valore basale medio di MBL. Diverse sfide metodologiche complicato l'analisi. Alcuni studi hanno riportato varie statistiche riassuntive per MBL o PBAC, che richiede la stima (con minore precisione) del% MBL <80 ml o% PBAC <100. Inoltre, ha riferito il follow-up volte variavano notevolmente.
RISULTATI: La rete prove coinvolti 34 studi randomizzati, con follow-up tempi di 1-36 mesi. Efficacia a 3 mesi di follow-up (stimato come la mediana posteriore) variava dal 87,5% per il sistema intrauterino a rilascio di levonorgestrel (LNG-IUS), al 14,2% per i progestinici somministrati per meno di 2 settimane su 4 a ciclo mestruale. Gli intervalli credibili al 95% per la maggior parte delle stime erano piuttosto ampia, soprattutto a causa della limitata evidenza per molte combinazioni di classe trattamento e follow-up tempo e l'incertezza di fare previsioni% MBL <80 ml o% PBAC <100 da statistiche riassuntive.
CONCLUSIONI: LNG-IUS e ablazione endometriale sono molto efficaci nel trattamento di HMB. Lo studio ha dato indicazioni utili sull'utilizzo di MTC in reti di prove sparse. La diversità delle misure di risultato e dei tempi di follow-up in letteratura HMB presentato notevoli sfide. Gli intervalli credibili bayesiani riflettono le varie fonti di incertezza.
BACKGROUND: Ci sono due strategie principali per la prevenzione delle infezioni post-abortal tratto genitale superiore: antibiotici dato tutto il tempo di intervento chirurgico per tutte le donne, e 'screen-and-treat', in cui tutte le donne che presentano per l'aborto vengono proiettati per le infezioni genitali e quelli con risultati positivi sono trattati.
OBIETTIVI: determinare:
1. l'efficacia della profilassi antibiotica nella prevenzione delle infezioni post-abortal tratto genitale superiore;
2. il regime più efficace antibiotico;
3. la strategia più efficace.
Metodi di ricerca: Abbiamo cercato il Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, mussole e lillà. La ricerca è stata aggiornata nel maggio 2011.
CRITERI DI SELEZIONE: studi controllati randomizzati (RCT) in qualsiasi lingua, tra cui donne sottoposte indotto l'aborto primo trimestre di gravidanza chirurgica o medica, il confronto: 1) qualsiasi regime antibiotico al placebo, nulla, o un altro antibiotico, 2) schermo-e-trattamento contro gli antibiotici. L'endpoint primario era la percentuale di donne con diagnosi di infezione post-abortal tratto genitale superiore.
RACCOLTA DEI DATI E ANALISI: Due revisori riferimenti scelti indipendentemente e dati estratti. Abbiamo calcolato i rapporti di rischio (RR) con intervalli di confidenza al 95% (CI). Abbiamo usato meta-analisi ha esaminato se del caso e tra eterogeneità prova utilizzando la statistica I2. In presenza di eterogeneità tra prova anche stimato l'intervallo di predizione 95% (PI).
RISULTATI PRINCIPALI: Un totale di 703 pezzi unici è stato identificato. Sono stati inclusi 19 RCT. Non c'era evidenza di bias piccolo studio (Egger test, P = 0,002). In 15 studi randomizzati e controllati con placebo vi è stato un effetto della profilassi antibiotica (pool RR 0,59, IC 95% 0,46-0,75, PI 95% 0,30-1,14, I2 = 39%). Non esistono dati sufficienti (tre prove) per determinare se un regime è stato superiore ad un altro. In uno studio, l'incidenza di infezioni post-abortal tratto genitale superiore è risultata più alta nelle donne assegnate alla strategia dello schermo-e-trattamento (RR 1,53, IC 95% 0,99-2,36).
Conclusioni degli autori: profilassi antibiotica al momento del primo trimestre di gravidanza l'aborto chirurgico è efficace nel prevenire l'infezione post-abortal tratto genitale superiore. La prova di eterogeneità tra studio suggerisce che l'effetto non può essere applicato a tutte le impostazioni, i gruppi di popolazione o interventi.
Questa recensione non ha determinato il regime più efficace profilassi antibiotica. La scelta degli antibiotici deve tener conto della epidemiologia locale delle infezioni del tratto genitale, comprese le infezioni sessualmente trasmesse.
Ulteriori RCTs confronto differenti antibiotici o combinazioni di antibiotici con l'altro sarebbe utile. Tali prove potrebbe essere fatto nei Paesi a reddito medio-basso e in cui la prevalenza di infezioni del tratto genitale nelle donne che presentano per l'aborto è alta.
Sistemi intrauterini a rilascio di Levonorgestrel (LNG-IUS) sono stati originariamente sviluppati come metodo di contraccezione a metà degli anni 1970. L'unica LNG-IUS approvato per l'uso pubblico è il Mirena LNG-IUS, che rilascia 20 mcg di levonorgestrel al giorno direttamente nella cavità uterina. Tuttavia, la nuova dose più bassa (10 e 14 mcg al giorno) e di dimensioni più ridotte LNG-IUS (MLS, FibroPlant-LNG) sono attualmente in fase di sviluppo clinico e di indagine. La ricerca sugli usi non-contraccettivi di LNG-IUS è in rapida espansione. Nel Regno Unito, LNG-IUS è concesso in licenza per l'utilizzo in menorragia e per fornire protezione endometriale di donne in perimenopausa e postmenopausa in terapia estrogenica sostitutiva. Vi è una limitata evidenza per suggerire che LNG-IUS può anche essere utile nelle donne con endometriosi, adenomiosi, fibromi, iperplasia endometriale e carcinoma dell'endometrio in fase iniziale (in cui il paziente viene ritenuto inadatto per la terapia chirurgica primaria). La richiesta e panoramica sistematica valuta la qualità delle prove relative alle non-contraccettivi usi terapeutici di LNG-IUS in ginecologia.
Heavy menstrual bleeding (HMB) impacts the quality of life of otherwise healthy women. The perception of HMB is subjective and management depends upon, among other factors, the severity of the symptoms, a woman's age, her wish to get pregnant, and the presence of other pathologies. Heavy menstrual bleeding was classically defined as greater than or equal to 80 mL of blood loss per menstrual cycle. Currently the definition is based on the woman's perception of excessive bleeding which is affecting her quality of life. The intrauterine device was originally developed as a contraceptive but the addition of progestogens to these devices resulted in a large reduction in menstrual blood loss: users of the levonorgestrel-releasing intrauterine system (LNG-IUS) reported reductions of up to 90%. Insertion may, however, be regarded as invasive by some women, which affects its acceptability.
OBJECTIVES:
To determine the effectiveness, acceptability and safety of progestogen-releasing intrauterine devices in reducing heavy menstrual bleeding.
SEARCH METHODS:
We searched the Cochrane Gynaecology and Fertility Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL (from inception to June 2019); and we searched grey literature and for unpublished trials in trial registers.
SELECTION CRITERIA:
We included randomised controlled trials (RCTs) in women of reproductive age treated with LNG-IUS devices versus no treatment, placebo, or other medical or surgical therapy for heavy menstrual bleeding.
DATA COLLECTION AND ANALYSIS:
Two authors independently extracted data, assessed risk of bias and conducted GRADE assessments of the certainty of evidence.
MAIN RESULTS:
We included 25 RCTs (2511 women). Limitations in the evidence included risk of attrition bias and low numbers of participants. The studies compared the following interventions. LNG-IUS versus other medical therapy The other medical therapies were norethisterone acetate, medroxyprogesterone acetate, oral contraceptive pill, mefenamic acid, tranexamic acid or usual medical treatment (where participants could choose the oral treatment that was most suitable). The LNG-IUS may improve HMB, lowering menstrual blood loss according to the alkaline haematin method (mean difference (MD) 66.91 mL, 95% confidence interval (CI) 42.61 to 91.20; 2 studies, 170 women; low-certainty evidence); and the Pictorial Bleeding Assessment Chart (MD 55.05, 95% CI 27.83 to 82.28; 3 studies, 335 women; low-certainty evidence). We are uncertain whether the LNG-IUS may have any effect on women's satisfaction up to one year (RR 1.28, 95% CI 1.01 to 1.63; 3 studies, 141 women; I² = 0%, very low-certainty evidence). The LNG-IUS probably leads to slightly higher quality of life measured with the SF-36 compared with other medical therapy if (MD 2.90, 95% CI 0.06 to 5.74; 1 study: 571 women; moderate-certainty evidence) or with the Menorrhagia Multi-Attribute Scale (MD 13.40, 95% CI 9.89 to 16.91; 1 trial, 571 women; moderate-certainty evidence). The LNG-IUS and other medical therapies probably give rise to similar numbers of women with serious adverse events (RR 0.91, 95% CI 0.63 to 1.30; 1 study, 571 women; moderate-certainty evidence). Women using other medical therapy are probably more likely to withdraw from treatment for any reason (RR 0.49, 95% CI 0.39 to 0.60; 1 study, 571 women, moderate-certainty evidence) and to experience treatment failure than women with LNG-IUS (RR 0.34, 95% CI 0.26 to 0.44; 6 studies, 535 women; moderate-certainty evidence). LNG-IUS versus endometrial resection or ablation (EA) Bleeding outcome results are inconsistent. We are uncertain of the effect of the LNG-IUS compared to EA on rates of amenorrhoea (RR 1.21, 95% CI 0.85 to 1.72; 8 studies, 431 women; I² = 21%; low-certainty evidence) and hypomenorrhoea (RR 0.98, 95% CI 0.73 to 1.33; 4 studies, 200 women; low-certainty evidence) and eumenorrhoea (RR 0.55, 95% CI 0.30 to 1.00; 3 studies, 160 women; very low-certainty evidence). We are uncertain whether both treatments may have similar rates of satisfaction with treatment at 12 months (RR 0.95, 95% CI 0.85 to 1.07; 5 studies, 317 women; low-certainty evidence). We are uncertain if the LNG-IUS compared to EA has any effect on quality of life, measured with SF-36 (MD -14.40, 95% CI -22.63 to -6.17; 1 study, 33 women; very low-certainty evidence). Women with the LNG-IUS compared with EA are probably more likely to have any adverse event (RR 2.06, 95% CI 1.44 to 2.94; 3 studies, 201 women; moderate-certainty evidence). Women with the LNG-IUS may experience more treatment failure compared to EA at one year follow up (persistent HMB or requirement of additional treatment) (RR 1.78, 95% CI 1.09 to 2.90; 5 studies, 320 women; low-certainty evidence); or requirement of hysterectomy may be higher at one year follow up (RR 2.56, 95% CI 1.48 to 4.42; 3 studies, 400 women; low-certainty evidence). LNG-IUS versus hysterectomy We are uncertain whether the LNG-IUS has any effect on HMB compared with hysterectomy (RR for amenorrhoea 0.52, 95% CI 0.39 to 0.70; 1 study, 75 women; very low-certainty evidence). We are uncertain whether there is difference between LNG-IUS and hysterectomy in satisfaction at five years (RR 1.01, 95% CI 0.94 to 1.08; 1 study, 232 women; low-certainty evidence) and quality of life (SF-36 MD 2.20, 95% CI -2.93 to 7.33; 1 study, 221 women; low-certainty evidence). Women in the LNG-IUS group may be more likely to have treatment failure requiring hysterectomy for HMB at 1-year follow-up compared to the hysterectomy group (RR 48.18, 95% CI 2.96 to 783.22; 1 study, 236 women; low-certainty evidence). None of the studies reported cost data suitable for meta-analysis.
AUTHORS' CONCLUSIONS:
The LNG-IUS may improve HMB and quality of life compared to other medical therapy; the LNG-IUS is probably similar for HMB compared to endometrial destruction techniques; and we are uncertain if it is better or worse than hysterectomy. The LNG-IUS probably has similar serious adverse events to other medical therapy and it is more likely to have any adverse events than EA.
