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Commentary on Ten-year follow-up of a randomised controlled trial comparing bipolar endometrial ablation with balloon ablation for menorrhagia

机译:对双相子宫内膜消融术与球囊消融术治疗月经过多的随机对照试验十年随访的评论

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Second-generation endometrial ablation has superseded hysteroscopic resection and ablation because of improved feasibility, safety and equivalent effectiveness (Daniels et al., BMJ 2012;344:e2564.). However, head-to-head comparisons between technologies are lacking. This randomised controlled trial compared two commonly used ablative techniques. The 1- and 5-year data found amenorrhoea rates to be higher in women treated with radiofrequency ablation (RFA) as opposed to thermal balloon ablation (TBA) (Bongers et al., BJOG 2004; 111:1095-102 and Kleijn et al., BJOG 2008; 115:193-98). However, although amenorrhoea is an easily measured endpoint, its use as a primary outcome is questionable. This is because amenorrhoea is not always desired by women and, indeed, may be detrimental to the patient's psyche. The aim of treatment should be to improve health-related quality of life (HRQL), regardless of whether amenorrhoea results. Furthermore, the mean age of the women was 43 years at inception and therefore, at 10 years, many would be postmenopausal, which is likely to explain the observed increase in amenorrhoea rates over time in both treatment groups and the loss of superiority of RFA over TBA previously observed at 1 and 5 years. There was no significant difference in the amenorrhoea rates (69% versus 67%) when comparing the RFA group with the TBA group at 10 years, whereas the amenorrhoea rates were 41% versus 7%, respectively, at 1 year and 47% versus 30%, respectively, at 5 years.
机译:由于提高了可行性,安全性和等效效力,第二代子宫内膜切除术已取代宫腔镜切除和切除术(Daniels等,BMJ 2012; 344:e2564。)。但是,缺乏技术之间的正面对比。该随机对照试验比较了两种常用的消融技术。 1年和5年数据发现,经射频消融(RFA)治疗的女性的闭经率要高于热气球消融(TBA)(Bongers等,BJOG 2004; 111:1095-102和Kleijn等。 (BJOG 2008; 115:193-98)。然而,尽管闭经是易于测量的终点,但其作为主要结局的使用还是值得怀疑的。这是因为女性并非总是需要闭经,并且实际上可能对患者的心理有害。治疗的目的应是改善与健康有关的生活质量(HRQL),无论是否导致闭经。此外,女性的平均年龄在开始时为43岁,因此,在10岁时,许多人会绝经后,这很可能可以解释观察到的两个治疗组随时间推移的闭经率增加以及RFA优于TBA以前在1年和5年观察到。与RFA组和TBA组比较,在10年时,闭经率无显着差异(分别为69%和67%),而1年时的闭经率分别为41%和7%,以及47%和30岁时的闭经率分别为5年的%。

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