The lessons learned from randomized clinical trials of GERD.
Despite the huge number of randomized controlled clinical trials published on gastro-oesophageal reflux disease, the translation of the information gathered into clinical practice is rather limited. The aim of this article is to summarize the results of pivotal randomized controlled clinical trials and review articles on reflux disease and evaluate to what extent their results can be applied to current clinical practice. We reviewed the most relevant randomized controlled clinical trials and reviews since the publication of the first randomized controlled clinical trial on reflux oesophagitis (1978) to date. Six areas were explored, namely: (1) diagnostic "entry" criteria, (2) efficacy parameters, (3) duration of therapy, (4) degree of antisecretory effect, (5) placebo effect, (6) follow-up data. Gastro-oesophageal reflux disease is now the most frequent upper GI disorder treated by gastroenterologists in Europe and North America. There is still a dearth of information regarding the natural history of the disease. The types of information generated through randomized controlled clinical trials have had only limited applicability to routine clinical practice. In the future, large cooperative databases accumulating the clinical histories of a great variety of gastro-oesophageal reflux disease patients may help to provide us with the much needed insights into the natural history of this common disorder.
Pace
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F
Department and Chair of Gastroenterology, L. Sacco University Hospital, Milan, Italy.
Sonnenberg
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A
Bianchi Porro
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G
D005764:Gastroesophageal Reflux / Q000175:diagnosis* / Q000628:therapy*; D006801:Humans; D015990:Placebo Effect; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D012196:Review Literature as Topic; D016896:Treatment Outcome
D054328:Proton Pump Inhibitors