Initial treatment with lansoprazole in young dyspeptic patients with negative urea breath test result: A randomized controlled trial with 12-month follow-up

INTRODUCTION: Although empirical antisecretory drug therapy is recommended to young dyspeptic patients without alarming features, the effectiveness of this approach remains undetermined. We evaluated the long- term effects of an initial 12- wk course of lansoprazole in young dyspeptic patients without Helicobacter pylori ( H. pylori) infection. METHODS: Patients who were less than 45 yr and presented with at least 3 months of dyspepsia in the absence of alarming features were eligible. They were offered 13C- urea breath test ( UBT) to determine H. pylori status and all symptomatic patients with negative UBT were randomized to receive lansoprazole 30 mg daily or placebo for 12 wk. Those who had previous endoscopy or positive UBT were excluded. Primary end point was the proportion of patients with treatment failure, defined as worsening of global dyspeptic symptom, while on study medication. Patients were followed up for 26 wk for global dyspeptic symptom as determined by 7- point Likert scale. Quality- of- life assessment ( SF- 36), need of endoscopy, and utilization of other health- care services were monitored for 52 wk. RESULTS: A total of 157 dyspeptic patients were randomized. At the end of 12- wk treatment, the proportion of patients with treatment failure was similar in the lansoprazole ( 33.3%) and placebo ( 30.3%) groups ( P = 0.74). Patients' global assessment of their dyspeptic symptom was comparable at all time points measured. There was also no significant difference in the SF- 36 mental and physical summary scales. At the end of 52 wk, there was no difference in the proportion of patients who underwent endoscopy, had additional medical consultations, or used other nonstudy medications between the two groups. CONCLUSION: Lansoprazole is not effective in the initial management of young dyspeptic patients without H. pylori infection.