Testing drugs in functional dyspepsia
The management of functional (non-ulcer) dyspepsia remains controversial. Furthermore, identifying useful predictors of the treatment response remains a key goal, in order to target therapy more effectively in practice.
In a large randomized controlled trial of 1262 patients, the overall therapeutic gain of the proton pump inhibitor omeprazole versus placebo was only 10% (Aliment Pharmacol Ther 1998; 12: 1055-65).
However, a priori specification of the predominant symptom, as recorded by a physician on a checklist (in ulcer-like dyspepsia: epigastric pain; in dysmotility-like dyspepsia: discomfort, bloating, nausea, fullness or early satiety), demonstrated that the response was different across these subgroups, as shown in the figure.
This clinical trial data, as well as epidemiological and clinical data, led the Rome II Working Team to recommend sub-division of functional dyspepsia based on the predominant symptom in the most recent classification of functional dyspepsia.
It remains to be prospectively established that asking patients to rank their most predominant complaint will predict response to other therapy, but seems worthy of pursuit.
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