Short course acid suppressive treatment for patients with functional dyspepsia: results depend on Helicobacter pylori status

Abstract

Background and aims-Treatment of functional dyspepsia with acid inhibitors is controversial and it is not known if the presence of Helicobacter pylori infection influences the response. Methods-After a complete diagnostic workup, 792 patients with functional dyspepsia unresponsive to one week of low dose antacid treatment were randomised to two weeks of treatment with placebo, ranitidine 150 mg, omeprazole 10 mg, or omeprazole 20 mg daily. Individual dyspeptic and other abdominal symptoms were evaluated before and after treatment according to H pylori status. Results-The proportions of patients considered to be in remission (intention to treat) at the end of treatment with placebo, ranitidine 150 mg, omeprazole 10 mg, and omeprazole 20 mg were, respectively, 42%, 50%, 48%, and 59% in the H pylori positive group and 66%, 73%, 64%, and 71% in the H pylori negative group. In H pylori positive patients, the therapeutic gain over placebo was significant for omeprazole 20 mg (17.6%, 95% confidence intervals (CI) 4.2-31.0; p<0.014 using the Bonferroni-adjusted p level of 0.017) but not for omeprazole 10 mg (6.8%, 95% CI −6.7-20.4) or ranitidine 150 mg (8.9%, 95% CI −4.2-21.9). There was no significant therapeutic gain from active treatment over placebo in H pylori negative patients. Complete disappearance of symptoms and improvement in quality of life also occurred most frequently with omeprazole 20 mg and was significant in both H pylori positive and H pylori negative groups. The six month relapse rate of symptoms requiring treatment was low (<20%) in all groups. Conclusions-Omeprazole 20 mg per day had a small but significant favourable eVect on outcome in H pylori positive patients. The diVerential response in these patients may be explained by an enhanced antisecretory response in the presence of H pylori. The eVect of weaker acid inhibition was unsatisfactory. (Gut 2000;47:473-480)

Effects of the New Prokinetic Agent DA-9701 Formulated With Corydalis Tuber and Pharbitis Seed in Patients With Minimal Change Esophagitis: A Bicenter, Randomized, Double Blind, Placebo-controlled Study

“…30 Furthermore, the placebo response rates in patients with functional dyspepsia were 30-50%. [31][32][33] Because minimal change esophagitis patients who had symptoms including dyspepsia were included in the study, the placebo response rate was higher in our study than in previous studies on GERD. We believe that the high placebo response may have masked the differences in the efficacy of DA-9701 in patients with minimal change esophagitis.…”

Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study

“…Blum et al 21 reported that the efficacy of omeprazole was only evident in the H. pylori-positive subgroups. Thus, the anti-secretory effect of PPIs might be enhanced in H. pylori infection.…”

Efficacy of Acotiamide in Combination with Esomeprazole for Functional Dyspepsia Refractory to Proton-Pump Inhibitor Monotherapy

“…Although a standard treatment for FD has not been established, PPIs are widely used as the initial treatment choice in patients with EPS dominant FD. Several randomized controlled studies suggested that the efficacy of PPI therapy for FD is limited, and it may be confined to those patients who have co-existing EPS (Talley et al 1998;Blum et al 2000;Bolling-Sternevald et al 2002;Wong et al 2002;Peura et al 2004). One randomized control study compared PPI therapy to a placebo in FD patients with ulcer-like symptoms (van Rensburg et al 2008).…”