Lasa Juan Sebastian, Zubiaurre Ignacio, Rausch Astrid, Olivera Pablo
Hospital Británico de Buenos Aires, Gastroenterology Department, Argentina.
CEMIC, Gastroenterology Department, Buenos Aires, Argentina.
Arq Gastroenterol. 2020 Jan-Mar;57(1):87-90. doi: 10.1590/S0004-2803.202000000-15.
Inflammatory bowel disease comprises two distinct conditions - Crohn's disease and ulcerative colitis - which can be treated with immunomodulators. A non-neglectable proportion of these patients will need biologic therapy, and many patients under biologic treatment will experience either primary or secondary failure. As a consequence, clinical trials evaluating new therapeutic alternatives are being developed. These trials share common features, such as being controlled with placebo. Placebo use in clinical trials is a matter of intense debate. Those who support placebo use highlight the methodologic advantages placebo-controlled trials have. Those against placebo use argue that it would be against ethical principles in clinical research to expose a patient to placebo when a valid therapeutic alternative exists. In this review, we summarize the existing arguments for and against the use of placebo in the context of inflammatory bowel disease research. We finally suggest that it is very likely that in the near future inflammatory bowel disease trials will no longer be controlled with a placebo arm, but instead they will be non-inferiority trials with an active comparator.
炎症性肠病包括两种不同的病症——克罗恩病和溃疡性结肠炎——可用免疫调节剂进行治疗。这些患者中有相当一部分需要生物疗法，而且许多接受生物治疗的患者会出现原发性或继发性治疗失败。因此，正在开展评估新治疗方案的临床试验。这些试验具有共同特点，比如采用安慰剂对照。临床试验中安慰剂的使用是一个激烈争论的问题。支持使用安慰剂的人强调安慰剂对照试验的方法学优势。反对使用安慰剂的人则认为，当存在有效的治疗方案时，让患者接受安慰剂治疗有悖于临床研究的伦理原则。在本综述中，我们总结了在炎症性肠病研究背景下支持和反对使用安慰剂的现有论据。我们最终认为，在不久的将来，炎症性肠病试验很可能不再设置安慰剂对照组，而是采用活性对照进行非劣效性试验。
