OBJECTIVES: The aim of this study was to compare the effect of a combination of lansoprazole, clarithromycin, and amoxicillin (LCA) versus placebo on the severity of symptoms in functional dyspepsia patients who were positive for Helicobacter pylori (H. pylori). METHODS: This was a double-blind, randomized, controlled clinical trial in adult patients with functional dyspepsia who were H. pylori positive. Patients were randomized to 7-day treatment with LCA or identical looking placebo. H. pylori status was confirmed by the urea breath test performed at baseline, at 6 wk, and at 6 and 12 months. The severity of eight upper GI symptoms was measured on a five-point Likert scale. The main outcomes were the change in average severity of the dyspepsia summary score of the eight symptoms and the proportion of patients who improved >/=4 points on the dyspepsia summary score. RESULTS:A total of 157 patients were included in the intention-to-treat analysis. LCA achieved cure of H. pylori infection in 82% of patients compared to 6% in the placebo group. The severity of dyspepsia symptoms improved over the 12-month study period, but for none of the outcome measures was there a significant difference between LCA and placebo. CONCLUSIONS: There was no difference in sustained improvement of dyspepsia symptoms when LCA was compared with placebo. An 82% cure rate of H. pylori infection was observed with LAC.
RCT Entities:
OBJECTIVES: The aim of this study was to compare the effect of a combination of lansoprazole, clarithromycin, and amoxicillin (LCA) versus placebo on the severity of symptoms in functional dyspepsiapatients who were positive for Helicobacter pylori (H. pylori). METHODS: This was a double-blind, randomized, controlled clinical trial in adult patients with functional dyspepsia who were H. pylori positive. Patients were randomized to 7-day treatment with LCA or identical looking placebo. H. pylori status was confirmed by the urea breath test performed at baseline, at 6 wk, and at 6 and 12 months. The severity of eight upper GI symptoms was measured on a five-point Likert scale. The main outcomes were the change in average severity of the dyspepsia summary score of the eight symptoms and the proportion of patients who improved >/=4 points on the dyspepsia summary score. RESULTS: A total of 157 patients were included in the intention-to-treat analysis. LCA achieved cure of H. pyloriinfection in 82% of patients compared to 6% in the placebo group. The severity of dyspepsia symptoms improved over the 12-month study period, but for none of the outcome measures was there a significant difference between LCA and placebo. CONCLUSIONS: There was no difference in sustained improvement of dyspepsia symptoms when LCA was compared with placebo. An 82% cure rate of H. pyloriinfection was observed with LAC.
Authors: Paul Moayyedi; Brian E Lacy; Christopher N Andrews; Robert A Enns; Colin W Howden; Nimish Vakil Journal: Am J Gastroenterol Date: 2017-06-20 Impact factor: 10.864
Authors: Luiz E Mazzoleni; Guilherme B Sander; Eduardo A Ott; Sérgio G S Barros; Carlos F Francesconi; Carisi A Polanczyk; André C Wortmann; Alexandro L Theil; Leandro G Fritscher; Luis F Rivero; André Cartell; Maria I A Edelweiss; Diego M Uchôa; João C Prolla Journal: Dig Dis Sci Date: 2006-01 Impact factor: 3.199
Authors: Yeon-Ji Kim; Woo Chul Chung; Byung Wook Kim; Sung Soo Kim; Jin Il Kim; Na Jin Kim; Jinho Yoo; Soo Hwan Kim Journal: J Neurogastroenterol Motil Date: 2017-10-30 Impact factor: 4.924