No placebo effect beyond regression to the mean on the six minute walk test in pulmonary arterial hypertension trials

HIGHLIGHTS

SUMMARY

Pulmonary arterial hypertension (PAH) is a rare disease in which patients suffer from progressive loss of their pulmonary vascular bed, leading to elevated pressure in the pulmonary circulation and subsequent right heart failure. The aim of this study was to simulate and analyze whether observational studies in PAH using the 6MWD-test show a "vulnerability" to RTM and whether a significant amount of placebo effect remained after correction for RTM. From the 43 observational studies, 50 different "study arms" (each with individual 6MWD data) could be extracted, while the 25 RCTs consisted of 38 . . .

 



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