Eradication of Helicobacter pylori in functional dyspepsia

doi:10.1136/bmj.319.7207.451

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Study had several weaknesses

Kenneth E L McColl, professor of gastroenterology (K.E.L.McColl@clinmed.gla.ac.uk),
Derek Gillen, lecturer in gastroenterology,
Anthea S Dickson, clinical research supervisor

University Department of Medicine and Therapeutics, Western Infirmary, Glasgow G11 6NT
Department of Medicine, University of Sydney, Nepean Hospital, Penrith, New South Wales 2751, Australia
Department of Medical Gastroenterology, Odense University, Denmark 5000
Department of Biomedicine and Surgery, University of Linkøping, Molndal, Sweden 581 85

EDITOR—Several weaknesses in Talley et al's study may explain its failure to detect symptomatic benefit from eradicating infection with Helicobacter pylori in functional dyspepsia.1 The first is inadequate follow up. Of the three quarters of patients said to have completed the study, some did not reach their one year assessment. The outcome measurement even in those reaching the one year end point seems to have been inadequate as symptom diary cards in which only three fifths were completed were considered acceptable. The proportion of randomised patients reaching the one year end point with complete outcome documentation needs to be reported.

In our study, funded by the Medical Research Council, 318 patients were randomised and 97% were fully reassessed one year after treatment.2 This reassessment showed a significant benefit of active compared with placebo treatment of 14% (95% confidence interval 7% to 22%; P<0.001). Even before the problems with follow up are taken into account, Talley et al's study only had the power to detect a benefit of 20%, and its negative result in no way refutes the findings of our study.

Another problem in …