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On 18 July 64 AD, the great fire of Rome destroyed much of the ancient city, starting in the slums in the southern part and rapidly spreading north.1 The Emperor Nero was long blamed for the disaster but there is little evidence that he actually set the fire. However, he was displeased by the architectural design of the ancient Rome and the disaster provided a welcome opportunity for him to change the city building codes.
Fast forward 2000 years; the Rome criteria today are considered the global ‘gold standard’ for the diagnosis and categorisation of functional GI disorders (FGID) including the IBS and functional dyspepsia (FD), and Rome IV was released to acclaim in 2016.2 The Rome criteria are consensus and expert opinion based and anatomical region or structure focused (eg, oesophageal disorders, gastroduodenal disorders, bowel disorders, centrally mediated pain disorders and anorectal disorders)2 rather than a strictly evidence, pathophysiology or symptom-based nosology.
Undoubtedly, major progress has been achieved since the Rome criteria were first introduced in 1994.3 They were originally developed to provide guidance on positively diagnosing patients with FGIDs and are now also intended to guide therapy; subsequently, they have shaped the conduct of clinical trials particularly by defining clear inclusion and exclusion criteria.4 Most importantly, the Rome criteria have led to increased awareness and ultimately greater research interest, paving the path for systematic studies into the underlying pathophysiology, epidemiology and treatment. Thanks to the Rome criteria, arguably many more patients are now properly diagnosed by healthcare professionals although the uptake in general practice has been suboptimal.5 Regulatory authorities such as the Federal Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products rely on the Rome criteria when clinical trials are planned and assessed. Equally pharmaceutical companies rely on …
Contributors GJH and NJT prepared this invited commentary.
Funding The authors received funding from the National Health and Medical Research Council (NHMRC) and grants from the Princess Alexandra Research Foundation and Brisbane Diamantina Health Partners.
Competing interests NJT served as Chair of the Gastroduodenal Committee for Rome IV and received grant support from Rome Foundation; Abbott Pharmaceuticals; Datapharm; Pfizer; Salix; Prometheus Laboratories; Janssen, Commonwealth Laboratories and Falk. Consultant/Advisory Boards: Adelphi Values (Functional dyspepsia (patient-reported outcome measures)); GI therapies; Sax Institute; Allergens; Napo Pharmaceutical; Outpost Medicine; Samsung Bioepis; Yuhan; Synergy; Theravance. Patent Holder: Biomarkers of irritable bowel syndrome (Irritable bowel syndrome) Licensing Questionnaires (Mayo Clinic Talley Bowel Disease Questionnaire–Mayo Dysphagia Questionnaire); Nestec European Patent (Application No 12735358.9); Singapore ‘Provisional’ Patent (NTU Ref: TD/129/17 ‘Microbiota Modulation Of BDNF Tissue Repair Pathway’). GJH served on the Gastroduodenal Committee for Rome III and received unrestricted educational support from Bayer and the Falk Foundation. Research support was provided via the Princess Alexandra Hospital, Brisbane by GI Therapies, Takeda Development Center Asia, Eli Lilly Australia, F Hoffmann-La Roche, MedImmune, Celgene, Celgene International II Sarl, Gilead Sciences, Quintiles, Vital Food Processors, Datapharm Australia, Commonwealth Laboratories, Prometheus Laboratories, Falk, Nestle, and Mylan. Patent Holder: A biopsy device to take aseptic biopsies (US 20150320407 A1).
Patient consent Not required.
Provenance and peer review Commissioned; externally peer reviewed.