Surgery versus medical therapy for heavy menstrual bleeding

  • Review
  • Intervention

Authors


Abstract

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 I2 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 medication

Surgery (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-IUS

When 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, I2 = 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, I2 = 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, I2 = 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.

Plain language summary

Surgery versus medical therapy for heavy menstrual bleeding

Review question

Cochrane review authors compared the effectiveness, safety and acceptability of surgery versus medical therapy for heavy menstrual bleeding.

Background

Heavy menstrual bleeding is a common problem, which can impair a woman's quality of life. Surgical treatment includes hysterectomy and various methods of endometrial ablation or resection (cutting out or destroying the lining of the uterus). Medical treatment includes various oral medications and a hormone-releasing device that is implanted in the uterus (levonorgestrel-releasing intrauterine device, LNG-IUS).

Study characteristics

We included 15 randomised controlled trials that compared surgery versus oral medication or LNG-IUS. Participants were 1289 women with self reported heavy menstrual bleeding. The evidence is current to January 2016.

Key results

Hysterectomy, endometrial surgery and the LNG-IUS were all effective in reducing heavy menstrual bleeding, though surgery was most effective, at least over the short term. These treatments suited most women better than oral medication. Although hysterectomy will stop heavy menstrual bleeding, it is associated with serious complications and most women should probably try a less radical treatment as first-line therapy. Both conservative surgery and LNG-IUS appear to be safe, acceptable and effective.

Quality of the evidence

The quality of the evidence ranged from very low to moderate. The main limitations were lack of blinding, attrition and imprecision. It was difficult to interpret study findings over long-term follow-up because a large number of women randomised to medical treatment subsequently underwent surgery.

Laienverständliche Zusammenfassung

Vergleich von operativer und medikamentöser Behandlung bei schweren Monatsblutungen

Reviewfrage

Die Autoren des Cochrane Reviews verglichen die Wirksamkeit, Sicherheit und Akzeptanz von operativen versus medikamentösen Therapien für schwere Monatsblutungen.

Hintergrund

Schwere Monatsblutungen sind ein häufiges Problem, welches die Lebensqualität von Frauen beeinflussen kann. Operative Behandlungen umfassen die operative Entfernung der Gebärmutter (Hysterektomie) und verschiedene Methoden der Endometriumablation oder Resektion (Herausschneiden oder Zerstören der Gebärmutterschleimhaut). Medikamentöse Behandlungen umfassen verschiedene oral eingenommene Medikamente und eine hormonausschüttende Vorrichtung, die in den Uterus implantiert wurde (Levonorgestrel-ausschüttendes Intrauterines System, LNG-IUS).

Studienmerkmale

Wir schlossen 15 randomisierte kontrollierte Studien ein, die operative versus orale Medikationen oder LNG-IUS verglichen. Teilnehmende waren 1289 Frauen mit selbst berichteter schwerer Monatsblutung. Die Evidenz ist auf dem Stand von Januar 2016.

Hauptergebnisse

Hysterektomie, Endometriumoperationen und die LNG-IUS waren alle wirksam in der Reduktion von schweren Monatsblutungen, auch wenn Operationen am wirksamsten waren, zumindest über einen kurzen Zeitraum. Diese Behandlungen gefielen den meisten Frauen besser als orale Medikamente. Obwohl Hysterektomie dazu führt, dass die schweren Monatsblutungen aufhören, ist es mit schweren Komplikationen assoziiert und die meisten Frauen sollten als erste Behandlungslinie wahrscheinlich zunächst eine weniger radikale Behandlung versuchen. Beide, die konservative Operation und LNG-IUS, scheinen ungefährlich, akzeptiert und wirksam zu sein.

Qualität der Evidenz

Die Qualität der Evidenz reichte von sehr niedrig bis moderat. Die wichtigsten Beschränkungen waren die mangelnde Verblindung, der Verlust von Teilnehmern (Attrition-Bias) und Ungenauigkeit. Die Interpretation der Studienergebnisse aus der langfristigen Nachbeobachtung sind schwierig, da eine große Zahl der Frauen, die zufällig der medizinischen Behandlungsgruppe zugeteilt wurden, sich nachträglich einer Operation unterzogen.

Anmerkungen zur Übersetzung

I. Nolle, freigegeben durch Cochrane Deutschland.

Laički sažetak

Usporedba kirurškog zahvata i lijekova u liječenju obilnih menstrualnih krvarenja

Istraživačko pitanje

U ovom Cochrane sustavnom pregledu literature znanstvenici su analizirali kliničke pokuse u kojima je ispitana učinkovitost, sigurnost i prihvatljivost operacije u usporedbi s davanjem lijekova za liječenje obilnih menstrualnih krvarenja.

Dosadašnje spoznaje

Obilno menstrualno krvarenje je česti problem, koji može utjecati na kvalitetu ženina života. Kirurško liječenje uključuju histerektomiju i različite metode odvajanja endometrija ili resekcije (rezanje ili uništavanje sluznice maternice). Terapija lijekovima uključuje različite oralne lijekove i spiralu koja se implantira u maternicu i otpušta hormone (spirala koja otpušta levonorgestrel, LNG-IUS).

Obilježja uključenih istraživanja

Uključili smo 15 randomiziranih kontroliranih studija koje su uspoređivale kirurški zahvat i tablete ili LNG-IUS. U istraživanje je bilo uključeno 1289 žena koje su same prijavile obilno menstrualno krvarenje. Dokazi se temelje na literaturi objavljenoj do siječnja 2016.

Ključni rezultati

Histerektomija, operacija endometrija i LNG-IUS su uspješni u smanjivanju obilnog krvarenja, iako je operacija najuspješnija, barem kratkoročno. Ti su postupci odgovarali većini žena bolje negoli tablete. Iako histerektomija zaustavlja obilna krvarenja, povezana je s ozbiljnim komplikacijama i većina žena bi prvo trebala probati manje radikalne postupke. I konzervativna kirurgija i LNG-IUS se čine sigurne, prihvatljive i učinkovite.

Kvaliteta dokaza

Kvaliteta dokaza iz pronađenih studija varirala je od vrlo niskih do umjerenih. Glavna ograničenja su nedostatak zasljepljivanja (ispitanici i istraživači su znali tko je u kojoj skupini), odustajanje velikog broja sudionika iz istraživanja i nepreciznost. Bilo je teško protumačiti rezultate kroz dulje vremensko razdoblje jer je velik broj žena iz skupine koja je uzimala oralne lijekove naknadno podvrgnut kirurškom zahvatu.

Bilješke prijevoda

Hrvatski Cochrane
Prevela: Ivona Prološčić
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr