Uterine artery embolization for symptomatic uterine fibroids

 

Abstract

Background

Uterine fibroids cause heavy and prolonged bleeding, pain, pressure symptoms and subfertility but are mostly benign. The traditional method of treatment has been surgery as long term medical therapies have not shown to be effective. Uterine artery embolization (UAE - complete occlusion of both the uterine arteries with particulate emboli) has been reported to be an effective and safe alternative in the treatment of menorrhagia and other fibroid-related symptoms in women not desiring future fertility, but thus far this evidence is based on case controlled studies and case reports.

Objectives

To review the benefits and/or harms from randomised controlled trials (RCTs) of uterine artery embolization (UAE) versus other interventions for symptomatic uterine fibroids.

Search methods

We searched the Cochrane Menstrual Disorders & Subfertility Group Trials register (searched 10 August 2005), the Cochrane Central Register of Controlled Trials (CENTRAL) on the Cochrane Library, Issue 3, 2004), MEDLINE (January 1966 to November 2005) and EMBASE (January 1980 to November 2005). We also contacted authors of potential ongoing studies.

Selection criteria

RCTs of UAE versus any medical or surgical therapy for symptomatic uterine fibroids.

Data collection and analysis

Two of the authors (AS and JKG) assessed the trials and extracted the data independently. They also contacted the investigators of eligible RCTs for unpublished data.

Main results

Three trials were included in this review. Two RCTs compared UAE with abdominal hysterectomy in 234 women. Although the follow-up period was intended for two years, the available published results was only for six months follow-up. The second trial included 63 women comparing UAE with myomectomy in women who wished to preserve their fertility. The minimum follow-up reported was six months with a mean of 17 (± 9.3) months.

The clinical success rate measured by improvement in fibroid-related symptoms e.g. menstrual loss was at least 85% in the UAE group from both trials. The mean dominant fibroid volume decreased by 30 to 46% in two trials. UAE significantly reduces length of hospital stay compared to surgery for either hysterectomy or myomectomy. Women undergoing UAE resumed routine activities sooner than those undergoing surgery. UAE was associated with a higher rate of minor post procedural complications such as vaginal discharge, post puncture haematoma and post embolization syndrome (pain, fever, nausea, vomiting), as well as higher unscheduled visits and readmission rates after discharge, compared with hysterectomy. There were no major complication differences between the two groups. Three women in the myomectomy trial had elevated FSH levels post UAE indicating possible ovarian dysfunction.

Authors' conclusions

UAE offers an advantage over hysterectomy with regards to a shorter hospital stay and a quicker return to routine activities. There is no evidence of benefit of UAE compared to surgery (hysterectomy / myomectomy) for satisfaction. The higher minor complications rate after discharge in the UAE group as well as the unscheduled visits and readmission rates require more longer term follow-up trials to comment on its effectiveness and safety profile. There is currently an ongoing trial (REST, U. K.) and EMMY trial yet to report on the long term follow up, the results of which are awaited with interest.

 

Plain language summary

Uterine artery embolization for symptomatic uterine fibroids

Uterine artery embolization (UAE) for uterine fibroids that cause symptoms such as heavy bleeding, pain, pressure symptoms and subfertility.The traditional treatment for fibroids (benign tumors) that cause symptoms such as heavy and prolonged bleeding, pain, pressure symptoms and subfertility, is surgery. The two main surgical approaches are myomectomy (hysteroscopic or abdominal approach) to remove the fibroids or hysterectomy where the uterus is removed: both are associated with complications. Uterine artery embolization (UAE) was originally devised to reduce pelvic bleeding due to postpartum haemorrhage and is now being used for reduction of fibroid bulk size and heavy menstrual bleeding. There are two randomized controlled trials (RCT) comparing UAE with hysterectomy and another comparing UAE with myomectomy. Two of these trials have a minimum of six months follow-up and the other is a peri- and postprocedural complications report for up to 6 weeks follow-up only. There is no evidence of benefit of UAE compared to surgery (hysterectomy / myomectomy) for satisfaction. There are more minor complications, more unscheduled visits and readmission rates after discharge in the UAE group compared to hysterectomy. However, there are no differences between major complication rates and UAE is associated with shorter hospital stay and return to work. Further research is awaited with long term follow up. Women with symptomatic fibroids may be offered UAE as a treatment option but more research with a longer follow up is needed.

 

摘要

背景

子宮動脈栓塞治療有症狀的子宮肌瘤

子宮肌瘤會造成大量和長期的出血、疼痛、壓迫症狀和生育力低下，但大多數是良性的。傳統的治療方法是手術治療，因為長期的內科療法並沒有顯示出有效的治療效果。已經有報告顯示子宮動脈栓塞 (Uterine artery embolization UAE使用栓塞微粒完全閉塞兩側的子宮動脈) 是一個有效且安全的替代方法，針對不需求未來生育力的婦女，來治療月經過多和其他肌瘤相關症狀，但迄今為止這方面的證據是基於病例對照研究 (case controlled studies) 和病例報告 (case reports) 。

目標

從隨機對照試驗 (randomised controlled trials; RCTs) 中去探討子宮動脈栓塞相對於其他治療方式治療有症狀子宮肌瘤的好處和/或危害

搜尋策略

我們搜尋了Cochrane Menstrual Disorders & Subfertility Group Trials register(搜尋2005年8月10日)，the Cochrane Central Register of Controlled Trials (CENTRAL) on the Cochrane Library, Issue 3, 2004) ，MEDLINE(1966年1月至2005年11月)和EMBASE(1980年1月至2005年11月)。我們也跟一些進行中研究的作者做聯繫。

選擇標準

子宮動脈栓塞相對於其他內科或外科治療來治療有症狀子宮肌瘤之隨機對照試驗

資料收集與分析

本文兩位作者 (AS and JKG) 獨立的評估這些試驗和擷取數據資料。他們也聯繫了一些符合條件的隨機對照試驗的研究者以獲取未發表的數據。

主要結論

這篇回顧文獻中共收納了三篇試驗。其中兩篇隨機對照試驗是比較子宮動脈栓塞與經腹子宮切除術，共收納了234位婦女，雖然預計的追蹤時間是兩年，但可得到已發表的結果只有六個月的追蹤時間。另外一篇試驗則是比較子宮動脈栓塞與肌瘤切除術，共收納了63個病人，他們是想要保留生育能力的，最短的追蹤時間是六個月，平均是17 (�.3) 個月。臨床上的成功率是用肌瘤相關症狀的改善來衡量，例如：月經的流失量在子宮動脈栓塞這組的兩篇試驗中至少85% 。在兩篇試驗中，平均的主要肌瘤體積減少了30% 到46% 。子宮動脈栓塞跟手術，不管是子宮切除術或肌瘤切除術相比，顯著的減少了住院的天數。接受子宮動脈栓塞的女性跟接受手術相比，較快恢復日常活動。子宮動脈栓塞與子宮切除術相比，有較高的處置後小併發症的發生率，例如陰道分泌物、穿刺後血腫、栓塞後症候群(疼痛，發燒，噁心，嘔吐)，以及較高的非計畫性就診和出院後再入院率。在這兩組病人間，重大併發症的發生並沒有差異性。在子宮肌瘤切除的這組試驗中，有三個婦女在子宮動脈栓塞後有FSH升高的現象，顯示可能有卵巢功能障礙。

作者結論

子宮動脈栓塞跟子宮切除術相比，在較短的住院時間和較快返回到日常活動上提供一個優勢。在滿意度方面，目前並無證據顯示子宮動脈栓塞跟手術 (子宮切除術/肌瘤切除術) 相比是有好處的。在子宮動脈栓塞這組中，較高的出院後小併發症發生率、非預期性就診和再住院率，使得我們需要更長追蹤時間的試驗來評論它的有效性及安全性。目前有一個正在進行中的試驗 (REST, U.K.) 和EMMY試驗尚未在長期的追蹤上提出報告，我們也持續關注等待這些試驗的結果。

翻譯人

本摘要由高雄醫學大學附設醫院郭昱伶翻譯。

此翻譯計畫由臺灣國家衛生研究院 (National Health Research Institutes, Taiwan) 統籌。

總結

Plain language summary  子宮動脈栓塞治療有症狀的子宮肌瘤如大量出血、疼痛、壓迫症狀和生育力低下  針對有症狀的子宮肌瘤 (良性的腫瘤) 如大量及延長的出血、疼痛、壓迫症狀和生育力低下，傳統的治療方法是手術治療。兩種主要的手術方法包括肌瘤切除術 (經子宮鏡或經腹) 移除肌瘤和子宮切除術以移除子宮，兩種方法都與併發症的發生有相關。子宮動脈栓塞原本是用來治療產後出血以減少骨盆腔的出血，現在也被用來減少子宮肌瘤的體積和大量的月經出血。現在有兩篇隨機對照試驗來比較子宮動脈栓塞與子宮切除術，而另一篇是子宮動脈栓塞與肌瘤切除術。其中兩篇試驗最短有六個月的追蹤時間，另外一篇則是處置中和處置後的併發症報告，追蹤時間只到六個星期。並沒有證據顯示子宮動脈栓塞跟手術 (子宮切除術/肌瘤切除術) 相比在滿意度方面是有利的。在子宮動脈栓塞這組跟子宮切除術相比，出院後有較高的小併發症發生率、非預期性就診和再住院率。然而在重大併發症的發生率上，兩組是沒有差異的，且子宮動脈栓塞與較短住院時間及較快恢復工作是有相關聯的。我們等待更進一步更長追蹤時間的研究。針對有症狀子宮肌瘤的婦女，子宮動脈栓塞是一個可以提供的治療選擇，但我們仍需要追蹤更長時間的研究。