BACKGROUND:Morning dose or twice-daily proton pump inhibitor (PPI) use is often prescribed to heal severe reflux esophagitis. AIM: Compare the effect of single dose morning (control arm) versus nighttime (experimental arm) omeprazole/sodium bicarbonate (Zegerid(®)) (IR-OME) on esophagitis and gastroesophageal reflux symptoms. METHODS:Adult outpatients with Los Angeles grade C or D esophagitis were allocated to open-label 40 mg IR-OME once a day for 8 weeks in a prospective, randomized, parallel design, single center study. Esophagogastroduodenoscopy (EGD) and validated self-report symptom questionnaires were completed at baseline and follow-up. Intention-to-treat and per-protocol analyses were performed. RESULTS:Ninety-two of 128 (72 %) eligible subjects participated [64 (70 %) male, mean age 58 (range 19-86), median BMI 29 (range 21-51), 58 C:34 D]. Overall, 81 (88 %) subjects healed [n = 70 (76 %)] or improved [n = 11 (12 %)] erosions. There was no significant difference (morning vs. night) in mucosal healing [81 vs. 71 %, (p = 0.44)] or symptom resolution [heartburn (77 vs. 65 %, p = 0.12), acid regurgitation (82 vs. 73 %, p = 0.28)]. Prevalence of newly identified Barrett's esophagus was 14 % with half diagnosed only after treatment. CONCLUSIONS: Once-daily IR-OME (taken morning or night) effectively heals severe reflux esophagitis and improves GERD symptoms. Results support the clinical practice recommendation to repeat EGD after 8 weeks PPI therapy in severe esophagitis patients to assure healing and exclude Barrett's esophagus.
RCT Entities:
BACKGROUND: Morning dose or twice-daily proton pump inhibitor (PPI) use is often prescribed to heal severe reflux esophagitis. AIM: Compare the effect of single dose morning (control arm) versus nighttime (experimental arm) omeprazole/sodium bicarbonate (Zegerid(®)) (IR-OME) on esophagitis and gastroesophageal reflux symptoms. METHODS: Adult outpatients with Los Angeles grade C or D esophagitis were allocated to open-label 40 mg IR-OME once a day for 8 weeks in a prospective, randomized, parallel design, single center study. Esophagogastroduodenoscopy (EGD) and validated self-report symptom questionnaires were completed at baseline and follow-up. Intention-to-treat and per-protocol analyses were performed. RESULTS: Ninety-two of 128 (72 %) eligible subjects participated [64 (70 %) male, mean age 58 (range 19-86), median BMI 29 (range 21-51), 58 C:34 D]. Overall, 81 (88 %) subjects healed [n = 70 (76 %)] or improved [n = 11 (12 %)] erosions. There was no significant difference (morning vs. night) in mucosal healing [81 vs. 71 %, (p = 0.44)] or symptom resolution [heartburn (77 vs. 65 %, p = 0.12), acid regurgitation (82 vs. 73 %, p = 0.28)]. Prevalence of newly identified Barrett's esophagus was 14 % with half diagnosed only after treatment. CONCLUSIONS: Once-daily IR-OME (taken morning or night) effectively heals severe reflux esophagitis and improves GERD symptoms. Results support the clinical practice recommendation to repeat EGD after 8 weeks PPI therapy in severe esophagitispatients to assure healing and exclude Barrett's esophagus.
Authors: P O Katz; F K Koch; E D Ballard; R G Bagin; T C Gautille; G C Checani; D L Hogan; V S V Pratha Journal: Aliment Pharmacol Ther Date: 2007-01-15 Impact factor: 8.171
Authors: K Adachi; H Fujishiro; T Katsube; M Yuki; M Ono; A Kawamura; M A Rumi; M Watanabe; Y Kinoshita Journal: J Gastroenterol Hepatol Date: 2001-11 Impact factor: 4.029
Authors: Prateek Sharma; John Dent; David Armstrong; Jacques J G H M Bergman; Liebwin Gossner; Yoshio Hoshihara; Janusz A Jankowski; Ola Junghard; Lars Lundell; Guido N J Tytgat; Michael Vieth Journal: Gastroenterology Date: 2006-08-16 Impact factor: 22.682
Authors: Judith McElhiney; Matthew R Lohse; Amindra S Arora; Joanna M Peloquin; Debra M Geno; Melissa M Kuntz; Felicity B Enders; Mary Fredericksen; Adil A Abdalla; Yulia Khan; Nicholas J Talley; Nancy N Diehl; Timothy J Beebe; Ann M Harris; Gianrico Farrugia; Darlene E Graner; Joseph A Murray; G Richard Locke; Rayna M Grothe; Michael D Crowell; Dawn L Francis; April M B Grudell; Tushar Dabade; Angelica Ramirez; MhdMaan Alkhatib; Jeffrey A Alexander; Jessica Kimber; Ganapathy Prasad; Alan R Zinsmeister; Yvonne Romero Journal: Dysphagia Date: 2009-10-24 Impact factor: 3.438