Yap C, Furness S, Farquhar C
Department of Obstetrics & Gynaecology, Singapore General Hospital, Outram Road, Singapore, Singapore, 169608.
Cochrane Database Syst Rev. 2004;2004(3):CD003678. doi: 10.1002/14651858.CD003678.pub2.
Endometriosis is a common gynaecological condition which affects approximately 10% of women of reproductive age (Askenazi 1997). There is a range of symptoms and most commonly women present with dysmenorrhoea, pelvic pain, infertility or a pelvic mass. Direct visualisation and biopsy during laparoscopy or laparotomy is the gold standard diagnostic test for this condition and enables the gynaecologist to identify the location, extent and severity of the disease. Surgical therapy can be performed concurrently with diagnostic surgery and may include removal (excision) or destruction (ablation) of endometriotic tissue, division of adhesions and removal of endometriotic cysts. Laparoscopic excision or ablation of endometriosis has been shown to be effective in the management of pain in mild-moderate endometriosis. Adjunctive medical treatment pre or post-operatively may prolong the symptom-free interval.
To determine the effectiveness of systemic medical therapies used for hormonal suppression before or after surgery for endometriosis, or before and after surgery for endometriosis in the eradication of endometriosis, improvement of symptoms, pregnancy rates and overall tolerability by comparing them with no treatment or placebo.
We searched the Cochrane Menstrual Disorders and Subfertility group trials register (searched 10 September 2003), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3 2003), MEDLINE (January 1966 to September 2003), EMBASE (January 1985 to September 2003) and reference lists of articles. We also contacted researchers in the field.
Trials were included if they were randomised controlled trials of the use of systemic medical therapies for hormonal suppression before or after, or before and after surgery for endometriosis.
Data extraction and quality assessment was performed independently by using relative risk or weighted mean difference and 95% confidence intervals.
Eleven trials were included in the review. One study comparing pre-surgical medical therapy with surgery alone showed a significant improvement in AFS scores in the medical therapy group (WMD -9.60, 95% CI -11.42 to -7.78) but this may or may not be associated with better outcomes for the patients. Post surgical hormonal suppression of endometriosis compared to surgery alone (either no medical therapy or placebo) showed no benefit for the outcomes of pain or pregnancy rates but a significant improvement in disease recurrence (AFS scores (WMD -2.30, 95% CI -4.02 to -0.58)). There were no trials identified in the search that compared hormonal suppression of endometriosis before and after surgery with surgery alone. There is no significant difference between pre surgery hormonal suppression and post surgery hormonal suppression for the outcome of pain in the one trial identified (RR 1.01, 95% CI 0.49 to 2.07). Information concerning AFS scores and ease of surgery was reported only as a descriptive summary so any difference between the groups can not be quantified from the information in the report of this trial.
REVIEWERS' CONCLUSIONS: There is insufficient evidence from the studies identified to conclude that hormonal suppression in association with surgery for endometriosis is associated with a significant benefit with regard to any of the outcomes identified. There may be a benefit of improvement in AFS scores with the pre-surgical use of medical therapy. The possible benefit should be weighed in the context of the adverse effects and costs of these therapies.
子宫内膜异位症是一种常见的妇科疾病,影响约10%的育龄妇女(阿斯克纳齐,1997年)。其症状多样,最常见的是痛经、盆腔疼痛、不孕或盆腔肿块。腹腔镜检查或剖腹手术期间的直接可视化和活检是该疾病的金标准诊断测试,能使妇科医生确定疾病的位置、范围和严重程度。手术治疗可与诊断性手术同时进行,可能包括切除( excision )或破坏( ablation )子宫内膜组织、分离粘连以及切除子宫内膜囊肿。腹腔镜下切除或消融子宫内膜异位症已被证明对轻 - 中度子宫内膜异位症的疼痛管理有效。术前或术后的辅助药物治疗可能会延长无症状期。
通过将用于子宫内膜异位症手术前或手术后、或手术前后激素抑制的全身药物治疗与不治疗或安慰剂进行比较,确定其在根除子宫内膜异位症、改善症状、提高妊娠率和总体耐受性方面的有效性。
我们检索了Cochrane月经紊乱与生育力低下组试验注册库(2003年9月10日检索)、Cochrane对照试验中央注册库(CENTRAL)(《Cochrane图书馆》2003年第3期)、MEDLINE(1966年1月至2003年9月)、EMBASE(1985年1月至2003年9月)以及文章的参考文献列表。我们还联系了该领域的研究人员。
如果试验是关于子宫内膜异位症手术前或手术后、或手术前后使用全身药物治疗进行激素抑制的随机对照试验,则纳入研究。
使用相对风险或加权平均差以及95%置信区间独立进行数据提取和质量评估。
该综述纳入了11项试验。一项比较术前药物治疗与单纯手术的研究表明,药物治疗组的美国生育学会(AFS)评分有显著改善(加权平均差 -9.60,95%置信区间 -11.42至 -7.78),但这可能与患者更好的预后相关,也可能无关。与单纯手术(不进行任何药物治疗或使用安慰剂)相比,术后对子宫内膜异位症进行激素抑制在疼痛或妊娠率方面没有益处,但疾病复发(AFS评分)有显著改善(加权平均差 -2.30,95%置信区间 -4.02至 -0.58)。检索中未发现将手术前后激素抑制子宫内膜异位症与单纯手术进行比较的试验。在唯一确定的试验中,术前激素抑制和术后激素抑制在疼痛结局方面无显著差异(相对风险1.01,95%置信区间0.49至2.07)。关于AFS评分和手术难易程度的信息仅作为描述性总结报告,因此无法从该试验报告中的信息量化两组之间的任何差异。
从所纳入的研究中没有足够证据得出结论,即子宫内膜异位症手术联合激素抑制在任何所确定的结局方面都有显著益处。术前使用药物治疗可能对改善AFS评分有益。应在考虑这些治疗的不良反应和成本的背景下权衡这种可能的益处。