BACKGROUND AND AIM: Epidemiology of Helicobacter pylori infection has regional variation. Effect of eradication of H. pylori on symptoms of functional dyspepsia is uncertain, and the data in Asian scenario are scanty. The study aimed to see H. pylori positivity rate in patients of functional dyspepsia and the effect of its eradication on symptoms. METHODS: Randomized, double-blind, placebo-controlled study was the study design used. Patients of functional dyspepsia defined as per Rome 2 criteria were tested for H. pylori infection by rapid urease test and gastric biopsy. H. pylori-positive patients were randomly allocated to triple therapy (20 mg of omeprazole, 500 mg of clarithromycin, and 1000 mg of amoxicillin orally two times daily) and omeperazole plus identical placebo for 2 weeks. Symptoms were assessed with the weekly Likert scale. RESULTS:H. pylori positivity rate in functional dyspepsia was 1160/2000 (58%). At 6 weeks, the eradication rate for H. pylori in triple therapy and placebo group was (181/259 [69.8%] and 13/260 [5.0%], P = 0.001), respectively. On intention-to-treat analysis, the symptom resolution at 1 month was (157/259 [60.7%] and 136/260 [52.3%], P = 0.38), respectively. At 12 months, H. pylori eradication and healing of gastritis in triple therapy and placebo group were (116/174 [66.7%] and 12/180 [6.7%], P = 0.001) and (132/174 [75.9%] and 11/180 [6.1%], P = 0.001), respectively. On intension to treat, the resolution of symptoms in triple therapy and placebo group was (95/217 [43.7%] and 72/195 [36.9%], P = 0.13). CONCLUSION: There is high H. pylori positivity rate in patients of functional dyspepsia. The eradication of H. pylori does not resolve the symptoms despite healing of gastritis.
RCT Entities:
BACKGROUND AND AIM: Epidemiology of Helicobacter pylori infection has regional variation. Effect of eradication of H. pylori on symptoms of functional dyspepsia is uncertain, and the data in Asian scenario are scanty. The study aimed to see H. pylori positivity rate in patients of functional dyspepsia and the effect of its eradication on symptoms. METHODS: Randomized, double-blind, placebo-controlled study was the study design used. Patients of functional dyspepsia defined as per Rome 2 criteria were tested for H. pylori infection by rapid urease test and gastric biopsy. H. pylori-positive patients were randomly allocated to triple therapy (20 mg of omeprazole, 500 mg of clarithromycin, and 1000 mg of amoxicillin orally two times daily) and omeperazole plus identical placebo for 2 weeks. Symptoms were assessed with the weekly Likert scale. RESULTS: H. pylori positivity rate in functional dyspepsia was 1160/2000 (58%). At 6 weeks, the eradication rate for H. pylori in triple therapy and placebo group was (181/259 [69.8%] and 13/260 [5.0%], P = 0.001), respectively. On intention-to-treat analysis, the symptom resolution at 1 month was (157/259 [60.7%] and 136/260 [52.3%], P = 0.38), respectively. At 12 months, H. pylori eradication and healing of gastritis in triple therapy and placebo group were (116/174 [66.7%] and 12/180 [6.7%], P = 0.001) and (132/174 [75.9%] and 11/180 [6.1%], P = 0.001), respectively. On intension to treat, the resolution of symptoms in triple therapy and placebo group was (95/217 [43.7%] and 72/195 [36.9%], P = 0.13). CONCLUSION: There is high H. pylori positivity rate in patients of functional dyspepsia. The eradication of H. pylori does not resolve the symptoms despite healing of gastritis.
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: Eric M Nelsen; Abby Lochmann-Bailkey; Ian C Grimes; Mark E Benson; Deepak V Gopal; Patrick R Pfau Journal: Dig Dis Sci Date: 2016-12-19 Impact factor: 3.199