Why did the sham-treated EPISOD study subjects do so well? Important lessons for research and practice.
Why did the sham-treated EPISOD study subjects do so well? Important lessons for research and practice.
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为什么经过假治疗的 EPISOD 研究对象表现得这么好？
DOI：
10.1016/j.gie.2018.11.006
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发表时间：
2019
影响因子：
7.7
通讯作者：
Cotton,PeterB
中科院分区：
文献类型：
--
作者：
Cotton,PeterB
对疑似Oddi括约肌功能障碍患者进行的EPISOD研究显示，在ERCP时未进行括约肌切开术且对其治疗不知情的患者报告的疼痛缓解程度与接受胆道和/或胰腺括约肌切开术的患者相同（1）。这一发现也许令人惊讶，但却导致了实践中的重大变化。在这一重要结论和随之而来的讨论中，人们对假治疗患者报告的非常惊人的益处没有任何反思。所有患者在基线时的疼痛/负担评分均较高。在1年时，47%的假治疗患者疼痛减轻超过50%，34%的患者完全没有疼痛，没有任何重新干预或使用麻醉剂（表）。当使用患者总体印象变化工具询问他们在长期随访（中位数5年）时的满意度时，不少于73%的人表示他们有很大或非常大的改善（2）。括约肌切开术治疗的患者数量为47%。
The EPISOD study of patients with suspected sphincter of Oddi dysfunction showed that patients who had no sphincterotomy at ERCP, and who were blinded to their treatment, reported as much pain relief as those who underwent biliary and/or pancreatic sphincterotomy (1). This finding was perhaps surprising but has led to significant changes in practice.Lost in that important conclusion and the resulting discussions has been any reflection on the very striking benefits reported by the sham-treated patients. All had high pain/burden scores at baseline. At 1 year, 47% of the sham-treated patients had greater than 50% reduction in pain, and 34% had no pain at all, without any re-intervention or use of narcotics (Table). When asked about their satisfaction at long-term follow-up (median 5 years) using the Patient Global Impression of Change instrument, no fewer than 73% said that they were much or very much improved (2). The number for sphincterotomy-treated patients was 47%.