Although Avicena had already, almost perfectly described how to conduct a good clinical trial, and some prior isolated examples exist, it was not until the 1940s and 1950s that the group formed by Archie Cochrane and other enthusiasts, in their passion to transform medicine into not only an empirical observational science, but also an experimental science, laid the foundations of the modern clinical trial. A few years before, Philip Hench, a rheumatologist at the Mayo Clinic, had started to use adrenal hormone extracts in the treatment of rheumatoid arthritis; in 1950 he won the Nobel Prize, together with Edward Kendall and Tadeus Reichstein. The lack of effective treatments for practically all chronic diseases rapidly led to corticosteroids being tested for several diseases. Lloyd Witts and Sidney Truelove designed an elegant study, inventing an activity index and assessing mucosal healing by sigmoidoscopy, randomising patients to receive hydrocortisone or placebo. Hydrocortisone reduced mortality, although prolonged treatment gave rise to serious adverse effects. This study, which was published in three papers, remains the model to be followed in the design of clinical trials on inflammatory bowel disease.
Please cite this article as: Gomollón F, Marín-Jiménez I. Año 1955: primer ensayo clínico en enfermedad inflamatoria: los corticoides reducen la mortalidad. Gastroenterol Hepatol. 2020;43:367–368.