BACKGROUND: Heavy menstrual bleeding (HMB) is common in otherwise healthy women of reproductive age, and can affect physical health and quality of life. Surgery is usually a second-line treatment of HMB. Endometrial resection/ablation (EA/ER) to remove or ablate the endometrium is less invasive than hysterectomy. Hysterectomy is the definitive treatment and can be via open (laparotomy) approach, or via minimally invasive approaches (vaginally or laparoscopically). Each approach has its own advantages and risk profile.
OBJECTIVES: To compare the effectiveness, acceptability and safety of endometrial resection or ablation versus different routes of hysterectomy (open, minimally invasive hysterectomy, or unspecified route) for the treatment of HMB.
SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility specialised register, CENTRAL, MEDLINE, Embase and PsycINFO (July 2020), and reference lists, grey literature and trial registers.
SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared techniques of endometrial resection/ablation with hysterectomy (by any technique) for the treatment of HMB in premenopausal women.
DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane.
MAIN RESULTS: We included 10 RCTs (1966 participants) comparing EA/ER to hysterectomy (open (abdominal), minimally invasive (laparoscopic or vaginal), or unspecified (or at surgeon's discretion) route of hysterectomy). The results were rated as moderate-, low- and very low-certainty evidence. Endometrial resection/ablation versus open hysterectomy We found two trials. Women having EA/ER are probably less likely to perceive an improvement in HMB compared to women having open hysterectomy (risk ratio (RR) 0.90, 95% confidence interval (CI) 0.84 to 0.95; 2 studies, 247 women; moderate-certainty evidence) and probably have a 13% risk of requiring further surgery for treatment failure (compared to 0 on the open hysterectomy group; 2 studies, 247 women; moderate-certainty evidence). Both treatments probably lead to similar quality of life at two years (mean difference (MD) -5.30, 95% CI -11.90 to 1.30; 1 study, 155 women; moderate-certainty evidence) and satisfaction rate at one year (RR 0.91, 95% CI 0.82 to 1.00; 1 study, 194 women; moderate-certainty evidence). There may be no difference in serious adverse events (RR 1.29, 95% CI 0.32 to 5.20; 2 studies, 247 women; low-certainty evidence). EA/ER probably reduces time to return to normal activity compared to open hysterectomy (MD -21.00 days, 95% CI -24.78 to -17.22; 1 study, 197 women; moderate-certainty evidence). Endometrial resection/ablation versus minimally invasive hysterectomy We found five trials. The proportion of women with perception of improvement in HMB at two years may be similar between groups (RR 0.97, 95% CI 0.90 to 1.04; 1 study, 79 women; low-certainty evidence). Blood loss may be higher in the EA/ER group when assessed using the Pictorial Blood Assessment Chart (MD 44.00, 95% CI 36.09 to 51.91; 1 study, 68 women; low-certainty evidence). Quality of life is probably lower in the EA/ER group compared to the minimally invasive hysterectomy group at two years according to the 36-item Short Form (SF-36) (MD -10.71, 95% CI -15.11 to -6.30; 2 studies, 145 women; moderate-certainty evidence) and Menorrhagia Multi-Attribute Scale (RR 0.82, 95% CI 0.70 to 0.95; 1 study, 616 women; moderate-certainty evidence). EA/ER probably increases the risk of further surgery for HMB compared to minimally invasive hysterectomy (RR 7.70, 95% CI 2.54 to 23.32; 4 studies, 922 women; moderate-certainty evidence) and treatments probably have similar rates of any serious adverse events (RR 0.75, 95% CI 0.35 to 1.59; 4 studies, 809 women; moderate-certainty evidence). Women with EA/ER are probably less likely to be satisfied with treatment at one year (RR 0.90, 95% CI 0.85 to 0.94; 1 study, 558 women; moderate-certainty evidence). We were unable to pool data for time to return to work or normal life because of extreme heterogeneity (99%); however, the three studies reporting this all had the same direction of effect favouring EA/ER. Endometrial resection/ablation versus unspecified route of hysterectomy We found three trials. EA/ER may lead to a lower perception of improvement in HMB compared to unspecified route of hysterectomy (RR 0.89, 95% CI 0.83 to 0.95; 2 studies, 403 women; low-certainty evidence). Although EA/ER may lead to similar quality of life using the SF-36 General Health Perception at two years' follow-up (MD -1.90, 95% CI -8.67 to 4.87; 1 study, 209 women; low-certainty evidence), the proportion of women with improvement in general health at one year may be lower (RR 0.85, 95% CI 0.77 to 0.95; 1 study, 185 women; low-certainty evidence). EA/ER probably has a risk of 5.4% of requiring further surgery for treatment failure (compared to 0 with total hysterectomy; 2 studies, 374 women; moderate-certainty evidence) and reduces the proportion of women with any serious adverse event (RR 0.21, 95% CI 0.06 to 0.80; 2 studies, 374 women; moderate-certainty evidence). Both treatments probably lead to a similar satisfaction rate at one year' follow-up (RR 0.96, 95% CI 0.88 to 1.04; 3 studies, 545 women; moderate-certainty evidence). EA/ER may lead to shorter time to return to normal activity (MD -18.90 days, 95% CI -24.63 to -13.17; 1 study, 172 women; low-certainty evidence).
AUTHORS' CONCLUSIONS: Endometrial resection/ablation (EA/ER) offers an alternative to hysterectomy as a surgical treatment for HMB. Effectiveness varies with EA/ER compared to different hysterectomy approaches. The perception of improvement in HMB with EA/ER is probably lower compared to open and unspecified route of hysterectomy, but may be similar compared to minimally invasive. Quality of life with EA/ER is probably similar to open and unspecified route of hysterectomy, but lower compared to minimally invasive hysterectomy. Further surgery for treatment failure is probably more likely with EA/ER compared to all routes of hysterectomy. Satisfaction rates also vary. EA/ER probably has a similar rate of satisfaction compared to open and unspecified route of hysterectomy, but a lower rate of satisfaction compared to minimally invasive hysterectomy. The proportion having any serious adverse event appears similar in all groups, but specific adverse events did reported difference between EA/ER and different routes. We were unable to draw conclusions about the time to return to normal activity, but the direction of effect suggests it is likely to be shorter with EA/ER.
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 significantly impairs the quality of life of many otherwise healthy women. Perception of heavy menstrual bleeding is subjective and management usually depends upon what symptoms are acceptable to the individual. Surgical options include conservative surgery (uterine resection or ablation) and hysterectomy. Medical treatment options include oral medication and a hormone-releasing intrauterine device (LNG-IUS).
OBJECTIVES: To compare the effectiveness, safety and acceptability of surgery versus medical therapy for heavy menstrual bleeding.
SEARCH METHODS: We searched the following databases from inception to January 2016: Cochrane Gynaecology and Fertility Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO and clinical trials registers (clinical trials.gov and ICTRP). We also searched the reference lists of retrieved articles.
SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing conservative surgery or hysterectomy versus medical therapy (oral or intrauterine) for heavy menstrual bleeding.
DATA COLLECTION AND ANALYSIS: Two review authors independently selected the studies, assessed their risk of bias and extracted the data. Our primary outcomes were menstrual bleeding, satisfaction rate and adverse events. Where appropriate we pooled the data to calculate pooled risk ratios (RRs) or mean differences, with 95% confidence intervals (CIs), using a fixed-effect model. We assessed heterogeneity with the I(2) statistic and evaluated the quality of the evidence using GRADE methods.
MAIN RESULTS: We included 15 parallel-group RCTs (1289 women). Surgical interventions included hysterectomy and endometrial resection or ablation. Medical interventions included oral medication and the levonorgestrel-releasing intrauterine device (LNG-IUS). The overall quality of the evidence for different comparisons ranged from very low to moderate. The main limitations were lack of blinding, attrition and imprecision. Moreover, it was difficult to interpret long-term study findings as many women randomised to medical interventions subsequently underwent surgery. Surgery versus oral medicationSurgery (endometrial resection) was more effective in controlling bleeding at four months (RR 2.66, 95% CI 1.94 to 3.64, one RCT, 186 women, moderate quality evidence) and also at two years (RR 1.29, 95% CI 1.06 to 1.57, one RCT, 173 women, low quality evidence). There was no evidence of a difference between the groups at five years (RR 1.14, 95% CI 0.97 to 1.34, one RCT, 140 women, very low quality evidence).Satisfaction with treatment was higher in the surgical group at two years (RR 1.40, 95% CI 1.13 to 1.74, one RCT, 173 women, moderate quality evidence), but there was no evidence of a difference between the groups at five years (RR 1.13, 95% CI 0.94 to 1.37, one RCT, 114 women, very low quality evidence). There were fewer adverse events in the surgical group at four months (RR 0.26, 95 CI 0.15 to 0.46, one RCT, 186 women). These findings require cautious interpretation, as 59% of women randomised to the oral medication group had had surgery within two years and 77% within five years. Surgery versus LNG-IUSWhen hysterectomy was compared with LNG-IUS, the hysterectomy group were more likely to have objective control of bleeding at one year (RR 1.11, 95% CI 1.05 to 1.19, one RCT, 223 women, moderate quality evidence). There was no evidence of a difference in quality of life between the groups at five or 10 years, but by 10 years 46% of women originally assigned to LNG-IUS had undergone hysterectomy. Adverse effects associated with hysterectomy included surgical complications such as bladder or bowel perforation and vesicovaginal fistula. Adverse effects associated with LNG-IUS were ongoing bleeding and hormonal symptoms.When conservative surgery was compared with LNG-IUS, at one year the surgical group were more likely to have subjective control of bleeding (RR 1.19, 95% CI 1.07 to 1.32, five RCTs, 281 women, low quality evidence, I(2) = 15%). Satisfaction rates were higher in the surgical group at one year (RR 1.16, 95% CI 1.04, to 1.28, six RCTs, 442 women, I(2) = 27%), but this finding was sensitive to the choice of statistical model and use of a random-effects model showed no conclusive evidence of a difference between the groups. There was no evidence of a difference between the groups in satisfaction rates at two years (RR 0.93, 95% CI 0.81 to 1.08, two RCTs, 117 women, I(2) = 1%).At one year there were fewer adverse events (such as bleeding and spotting) in the surgical group (RR 0.36, 95% CI 0.15 to 0.82, three RCTs, moderate quality evidence). It was unclear what proportion of women assigned to LNG-IUS underwent surgery over long-term follow-up, as there were few data beyond one year.
AUTHORS' CONCLUSIONS: Surgery, especially hysterectomy, reduces menstrual bleeding more than medical treatment at one year. There is no conclusive evidence of a difference in satisfaction rates between surgery and LNG-IUS, though adverse effects such as bleeding and spotting are more likely to occur with LNG-IUS. Oral medication suits a minority of women in the long term, and the LNG-IUS device provides a better alternative to surgery in most cases. Although hysterectomy is a definitive treatment for heavy menstrual bleeding, it can cause serious complications for a minority of women. Most women may be well advised to try a less radical treatment as first-line therapy. Both LNG-IUS and conservative surgery appear to be safe, acceptable and effective.
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: isterectomia addominale utilizzando un approccio rimuove l'utero sia da solo (isterectomia subtotale) o sia l'utero e il collo dell'utero (isterectomia totale). Quest'ultimo è più comune, ma i risultati non sono stati sistematicamente confrontati.
OBIETTIVI: Per confrontare i risultati a breve termine e lungo termine di isterectomia subtotale (STH) con isterectomia totale (TH) per le favorevoli condizioni ginecologiche.
Metodi di ricerca: Abbiamo cercato i Disturbi mestruali e Cochrane Group Registro Subfertility specializzata studi controllati (luglio 2011), CENTRALE (luglio 2011), MEDLINE (1966-luglio 2011), EMBASE (dal 1980 a luglio 2011), CINAHL (gennaio 2005 al luglio 2011), Biological Abstracts (dal 1980 al dicembre 2005), il Registro Nazionale delle Ricerche e gli elenchi di citazioni pertinenti.
CRITERI DI SELEZIONE: solo studi randomizzati e controllati di donne sottoposte a isterectomia sia totale o subtotale per le condizioni ginecologiche benigne sono stati inclusi.
RACCOLTA DEI DATI E ANALISI: nove studi tra cui 1553 partecipanti sono stati inclusi. Selezione indipendente dei processi, la valutazione per il rischio di parzialità e di estrazione dei dati sono state effettuate da due autori della revisione ei risultati confrontati.
PRINCIPALI RISULTATI: non c'era evidenza di una differenza nei tassi di risultati più che valutavano urinaria, intestinale o della funzione sessuale tra TH e STH, sia a breve termine (fino a due anni post-chirurgico) o lungo (nove anni dopo -chirurgia). Lunghezza di funzionamento (differenza di 11 min) e la quantità di sangue perso durante l'intervento chirurgico (differenza di 57 ml) sono stati significativamente ridotti durante isterectomia subtotale rispetto a isterectomia totale. Queste differenze sono difficilmente costituire un beneficio clinico e non vi era alcuna evidenza di una differenza nelle probabilità di trasfusione di sangue. Post-operatorio febbre e ritenzione urinaria avevano una minore probabilità (febbre: OR 0,48, IC 95% 0,3-0,8; ritenzione: OR 0,23, IC 95% 0,1-0,8) e continua emorragia ciclica vaginale fino a due anni dopo l'intervento chirurgico era più probabile ( OR 16,0, IC 95% 6,1-41,6) dopo STH rispetto ai TH. Non c'è stata evidenza di una differenza nei tassi di altre complicazioni, il recupero da un intervento chirurgico, la riduzione dei sintomi pre-operatorie o di tassi di riammissione tra i due tipi di isterectomia eseguiti per via addominale o laparoscopica, anche se gli studi hanno confrontato il percorso laparoscopica sono stati sottodimensionato per rilevare alcune differenze.
Conclusioni degli autori: Questa recensione non ha confermato la percezione che l'isterectomia subtotale offre migliori risultati per sessuale, la funzione urinaria o intestinale, quando confrontato con isterectomia totale addominale. Le donne hanno maggiori probabilità di avere emorragie in corso ciclico fino a un anno dopo l'intervento chirurgico con isterectomia subtotale rispetto all'isterectomia totale.
STUDIO OBIETTIVO: Per confrontare isterectomia con alternative meno invasive per sanguinamento uterino anomalo (AUB) in 7 domini clinicamente importanti.
DESIGN: revisione sistematica.
IMPOSTAZIONE: studi clinici randomizzati di confronto sanguinamento, la qualità della vita, il dolore, la salute sessuale, la soddisfazione, la necessità di un intervento chirurgico successivo, e gli eventi avversi tra isterectomia e opzioni di trattamento meno invasive.
PAZIENTI: Donne con AUB, prevalentemente da disturbi ovulatori e cause endometriali.
INTERVENTI: revisione sistematica della letteratura (da inizio a gennaio 2011), confrontando l'isterectomia con alternative per il trattamento AUB. Prove ammissibili sono stati estratti in forme standardizzate. Le prove sono state classificate con un rating di 3 livello predefinito, ed i punti di forza di prova per ogni risultato sono stati valutati con i gradi di raccomandazione, la valutazione, lo sviluppo e il sistema di valutazione.
Misure e risultati principali: nove studi clinici randomizzati (18 articoli) erano ammissibili. Ablazione endometriale, sistema di levonorgestrel intrauterino, e farmaci sono stati associati con un minor rischio di eventi avversi, ma più alto rischio di trattamenti aggiuntivi rispetto a isterectomia. Rispetto alla ablazione, isterectomia aveva dolore superiore a lungo termine e il controllo di sanguinamento. Rispetto al sistema di levonorgestrel intrauterino, isterectomia aveva il controllo superiore di sanguinamento. Non sono state trovate altre differenze tra i trattamenti.
CONCLUSIONE: opzioni di trattamento meno invasive per risultato AUB in un miglioramento della qualità della vita, ma portano un rischio significativo di ritrattamento causata da risultati insoddisfacenti. Anche se l'isterectomia è il trattamento più efficace per AUB, porta il più alto rischio di eventi avversi.
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) is common in otherwise healthy women of reproductive age, and can affect physical health and quality of life. Surgery is usually a second-line treatment of HMB. Endometrial resection/ablation (EA/ER) to remove or ablate the endometrium is less invasive than hysterectomy. Hysterectomy is the definitive treatment and can be via open (laparotomy) approach, or via minimally invasive approaches (vaginally or laparoscopically). Each approach has its own advantages and risk profile.
OBJECTIVES:
To compare the effectiveness, acceptability and safety of endometrial resection or ablation versus different routes of hysterectomy (open, minimally invasive hysterectomy, or unspecified route) for the treatment of HMB.
SEARCH METHODS:
We searched the Cochrane Gynaecology and Fertility specialised register, CENTRAL, MEDLINE, Embase and PsycINFO (July 2020), and reference lists, grey literature and trial registers.
SELECTION CRITERIA:
Randomised controlled trials (RCTs) that compared techniques of endometrial resection/ablation with hysterectomy (by any technique) for the treatment of HMB in premenopausal women.
DATA COLLECTION AND ANALYSIS:
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS:
We included 10 RCTs (1966 participants) comparing EA/ER to hysterectomy (open (abdominal), minimally invasive (laparoscopic or vaginal), or unspecified (or at surgeon's discretion) route of hysterectomy). The results were rated as moderate-, low- and very low-certainty evidence. Endometrial resection/ablation versus open hysterectomy We found two trials. Women having EA/ER are probably less likely to perceive an improvement in HMB compared to women having open hysterectomy (risk ratio (RR) 0.90, 95% confidence interval (CI) 0.84 to 0.95; 2 studies, 247 women; moderate-certainty evidence) and probably have a 13% risk of requiring further surgery for treatment failure (compared to 0 on the open hysterectomy group; 2 studies, 247 women; moderate-certainty evidence). Both treatments probably lead to similar quality of life at two years (mean difference (MD) -5.30, 95% CI -11.90 to 1.30; 1 study, 155 women; moderate-certainty evidence) and satisfaction rate at one year (RR 0.91, 95% CI 0.82 to 1.00; 1 study, 194 women; moderate-certainty evidence). There may be no difference in serious adverse events (RR 1.29, 95% CI 0.32 to 5.20; 2 studies, 247 women; low-certainty evidence). EA/ER probably reduces time to return to normal activity compared to open hysterectomy (MD -21.00 days, 95% CI -24.78 to -17.22; 1 study, 197 women; moderate-certainty evidence). Endometrial resection/ablation versus minimally invasive hysterectomy We found five trials. The proportion of women with perception of improvement in HMB at two years may be similar between groups (RR 0.97, 95% CI 0.90 to 1.04; 1 study, 79 women; low-certainty evidence). Blood loss may be higher in the EA/ER group when assessed using the Pictorial Blood Assessment Chart (MD 44.00, 95% CI 36.09 to 51.91; 1 study, 68 women; low-certainty evidence). Quality of life is probably lower in the EA/ER group compared to the minimally invasive hysterectomy group at two years according to the 36-item Short Form (SF-36) (MD -10.71, 95% CI -15.11 to -6.30; 2 studies, 145 women; moderate-certainty evidence) and Menorrhagia Multi-Attribute Scale (RR 0.82, 95% CI 0.70 to 0.95; 1 study, 616 women; moderate-certainty evidence). EA/ER probably increases the risk of further surgery for HMB compared to minimally invasive hysterectomy (RR 7.70, 95% CI 2.54 to 23.32; 4 studies, 922 women; moderate-certainty evidence) and treatments probably have similar rates of any serious adverse events (RR 0.75, 95% CI 0.35 to 1.59; 4 studies, 809 women; moderate-certainty evidence). Women with EA/ER are probably less likely to be satisfied with treatment at one year (RR 0.90, 95% CI 0.85 to 0.94; 1 study, 558 women; moderate-certainty evidence). We were unable to pool data for time to return to work or normal life because of extreme heterogeneity (99%); however, the three studies reporting this all had the same direction of effect favouring EA/ER. Endometrial resection/ablation versus unspecified route of hysterectomy We found three trials. EA/ER may lead to a lower perception of improvement in HMB compared to unspecified route of hysterectomy (RR 0.89, 95% CI 0.83 to 0.95; 2 studies, 403 women; low-certainty evidence). Although EA/ER may lead to similar quality of life using the SF-36 General Health Perception at two years' follow-up (MD -1.90, 95% CI -8.67 to 4.87; 1 study, 209 women; low-certainty evidence), the proportion of women with improvement in general health at one year may be lower (RR 0.85, 95% CI 0.77 to 0.95; 1 study, 185 women; low-certainty evidence). EA/ER probably has a risk of 5.4% of requiring further surgery for treatment failure (compared to 0 with total hysterectomy; 2 studies, 374 women; moderate-certainty evidence) and reduces the proportion of women with any serious adverse event (RR 0.21, 95% CI 0.06 to 0.80; 2 studies, 374 women; moderate-certainty evidence). Both treatments probably lead to a similar satisfaction rate at one year' follow-up (RR 0.96, 95% CI 0.88 to 1.04; 3 studies, 545 women; moderate-certainty evidence). EA/ER may lead to shorter time to return to normal activity (MD -18.90 days, 95% CI -24.63 to -13.17; 1 study, 172 women; low-certainty evidence).
AUTHORS' CONCLUSIONS:
Endometrial resection/ablation (EA/ER) offers an alternative to hysterectomy as a surgical treatment for HMB. Effectiveness varies with EA/ER compared to different hysterectomy approaches. The perception of improvement in HMB with EA/ER is probably lower compared to open and unspecified route of hysterectomy, but may be similar compared to minimally invasive. Quality of life with EA/ER is probably similar to open and unspecified route of hysterectomy, but lower compared to minimally invasive hysterectomy. Further surgery for treatment failure is probably more likely with EA/ER compared to all routes of hysterectomy. Satisfaction rates also vary. EA/ER probably has a similar rate of satisfaction compared to open and unspecified route of hysterectomy, but a lower rate of satisfaction compared to minimally invasive hysterectomy. The proportion having any serious adverse event appears similar in all groups, but specific adverse events did reported difference between EA/ER and different routes. We were unable to draw conclusions about the time to return to normal activity, but the direction of effect suggests it is likely to be shorter with EA/ER.
