Heartburn‐dominant, uninvestigated dyspepsia: a comparison of ‘PPI‐start’ and ‘H2‐RA‐start’ management strategies in primary care – the CADET‐HR Study
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SummaryBackground : There are few data on empiric, stepped therapy for heartburn relief or subsequent relapse in primary care.Aims : To compare heartburn relief produced by a proton pump inhibitor‐start or an H2‐receptor antagonist‐start with step‐up therapy, as needed, followed by a treatment‐free period to assess relapse.Methods : Heartburn‐dominant uninvestigated dyspepsia patients from 46 primary care centres were randomized to one of two active treatment strategies: omeprazole 20 mg daily (proton pump inhibitor‐start) or ranitidine 150 mg bid (H2‐receptor antagonist‐start) for the first 4–8 weeks, stepping up to omeprazole 40 or 20 mg daily, respectively, for 4–8 weeks for persistent symptoms. Daily diaries documented heartburn relief (score ≤3/7 on ≤1 of 7 prior days) and relapse (score ≥4 on ≥2 of 7 prior days).Results : For ‘proton pump inhibitor‐start’ (n = 196) vs. ‘H2‐receptor antagonist‐start’ (n = 194), respectively, heartburn relief occurred in 55.1% vs. 27.3% (P < 0.001) at 4 weeks and in 88.3% vs. 87.1% at 16 weeks. After therapy, 308 patients were heartburn‐free (159 vs. 149); median times to relapse were 8 vs. 9 days and cumulative relapse rates were 78.6% vs. 75.8%, respectively.Conclusions : An empiric ‘proton pump inhibitor‐start’ strategy relieves heartburn more effectively than an ‘H2‐receptor antagonist‐start’ strategy up to 12 weeks but has no effect on subsequent relapse, which is rapid in most patients.
