{
  "abstract": "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).",
  "authors": [
    {
      "affiliations": [
        "West China Centre of Excellence for Pancreatitis, Institute of Integrated Traditional Chinese and Western Medicine, West China-Liverpool Biomedical Research Centre,West China Hospital, Sichuan University, Chengdu, China",
        "Liverpool Pancreatitis Research Group, Institute of Systems, Molecular and Integrative Biology and Liverpool University Hospitals NHS Foundation Trust, University of Liverpool, Liverpool, UK"
      ],
      "name": "Juan Lin"
    },
    {
      "affiliations": [
        "West China Centre of Excellence for Pancreatitis, Institute of Integrated Traditional Chinese and Western Medicine, West China-Liverpool Biomedical Research Centre,West China Hospital, Sichuan University, Chengdu, China"
      ],
      "name": "Wenhao Cai"
    },
    {
      "affiliations": [
        "Liverpool Pancreatitis Research Group, Institute of Systems, Molecular and Integrative Biology and Liverpool University Hospitals NHS Foundation Trust, University of Liverpool, Liverpool, UK"
      ],
      "name": "Arjun Kattakayam"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China"
      ],
      "name": "Wenhua He"
    },
    {
      "affiliations": [
        "Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University and Chinese Acute Pancreatitis Clinical Trials Group, Nanjing, China"
      ],
      "name": "Lu Ke"
    },
    {
      "affiliations": [
        "Liverpool Pancreatitis Research Group, Institute of Systems, Molecular and Integrative Biology and Liverpool University Hospitals NHS Foundation Trust, University of Liverpool, Liverpool, UK"
      ],
      "name": "Peter Szatmary"
    },
    {
      "affiliations": [
        "West China Centre of Excellence for Pancreatitis, Institute of Integrated Traditional Chinese and Western Medicine, West China-Liverpool Biomedical Research Centre,West China Hospital, Sichuan University, Chengdu, China"
      ],
      "name": "Tingting Liu"
    },
    {
      "affiliations": [
        "Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"
      ],
      "name": "Vikesh Singh"
    },
    {
      "affiliations": [
        "Liverpool Pancreatitis Research Group, Institute of Systems, Molecular and Integrative Biology and Liverpool University Hospitals NHS Foundation Trust, University of Liverpool, Liverpool, UK",
        "Department of Emergency General and Major Trauma Surgery, Aintree University Hospital, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK"
      ],
      "name": "Rajarshi Mukherjee"
    },
    {
      "affiliations": [
        "West China Centre of Excellence for Pancreatitis, Institute of Integrated Traditional Chinese and Western Medicine, West China-Liverpool Biomedical Research Centre,West China Hospital, Sichuan University, Chengdu, China",
        "Liverpool Pancreatitis Research Group, Institute of Systems, Molecular and Integrative Biology and Liverpool University Hospitals NHS Foundation Trust, University of Liverpool, Liverpool, UK"
      ],
      "name": "Wei Huang"
    },
    {
      "affiliations": [
        "Liverpool Pancreatitis Research Group, Institute of Systems, Molecular and Integrative Biology and Liverpool University Hospitals NHS Foundation Trust, University of Liverpool, Liverpool, UK"
      ],
      "name": "Robert Sutton"
    }
  ],
  "title": "Pharmacological trials of early intervention in predicted severe acute pancreatitis: implications for therapeutic window and core outcome set",
  "uid": "828c1514-bdc1-5557-b0de-f2652bad24c2"
}