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We read with great interest the recent randomised trial by Huang et al evaluating cyclooxygenase-2 inhibitors (COX-2-Is) in predicted severe acute pancreatitis (AP).1 Although no dose-response of COX-2-Is was undertaken, we applaud the efforts of the investigators as there continues to be no approved treatment for AP.2 COX-2-Is reduced the incidence of severe AP (≥2 modified Marshall score for respiratory, cardiovascular or renal systems>48 hours),3 duration of organ failure, infected pancreatic necrosis, serum inflammatory mediators and 30-day mortality but not the incidence of new-onset organ failure. A significant limitation is COX-2-Is do not have broad regulatory approval; for example, parecoxib has not been approved by the US Food and Drug Administration and imrecoxib is only approved in China, so a further phase 3 trial of more widely approved COX-2-Is is required. Furthermore, concerns exist over allocation concealment due to lack of centralised randomisation and reported mortality rates in severe AP (8.6%), lower than worldwide and recent comparative Chinese cohorts. Additionally, we highlight several critical points that need to be considered in the design of trials for patients with predicted severe AP (figure 1).