PMID- 24448652
OWN - NLM
STAT- MEDLINE
DCOM- 20150421
LR  - 20211021
IS  - 1573-2568 (Electronic)
IS  - 0163-2116 (Linking)
VI  - 60
IP  - 1
DP  - 2015 Jan
TI  - Once-daily omeprazole/sodium bicarbonate heals severe refractory reflux 
      esophagitis with morning or nighttime dosing.
PG  - 146-62
LID - 10.1007/s10620-013-3017-y [doi]
AB  - 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((R))) (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.
FAU - Orbelo, Diana M
AU  - Orbelo DM
AD  - Department of Otolaryngology, Mayo Clinic, 200 First St., SW, Rochester, MN, 
      55905, USA, orbelo.diana@mayo.edu.
FAU - Enders, Felicity T
AU  - Enders FT
FAU - Romero, Yvonne
AU  - Romero Y
FAU - Francis, Dawn L
AU  - Francis DL
FAU - Achem, Sami R
AU  - Achem SR
FAU - Dabade, Tushar S
AU  - Dabade TS
FAU - Crowell, Michael D
AU  - Crowell MD
FAU - Geno, Debra M
AU  - Geno DM
FAU - DeJesus, Ramona S
AU  - DeJesus RS
FAU - Namasivayam, Vikneswaran
AU  - Namasivayam V
FAU - Adamson, Steven C
AU  - Adamson SC
FAU - Arora, Amindra S
AU  - Arora AS
FAU - Majka, Andrew J
AU  - Majka AJ
FAU - Alexander, Jeffrey A
AU  - Alexander JA
FAU - Murray, Joseph A
AU  - Murray JA
FAU - Lohse, Matthew
AU  - Lohse M
FAU - Diehl, Nancy N
AU  - Diehl NN
FAU - Fredericksen, Mary
AU  - Fredericksen M
FAU - Jung, Kee Wook
AU  - Jung KW
FAU - Houston, Margaret S
AU  - Houston MS
FAU - O'Neil, Angela E
AU  - O'Neil AE
FAU - Katzka, David A
AU  - Katzka DA
LA  - eng
GR  - DK 02956/DK/NIDDK NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20140122
PL  - United States
TA  - Dig Dis Sci
JT  - Digestive diseases and sciences
JID - 7902782
RN  - 0 (Drug Combinations)
RN  - 0 (Proton Pump Inhibitors)
RN  - 0 (omeprazole, sodium bicarbonate drug combination)
RN  - 8MDF5V39QO (Sodium Bicarbonate)
RN  - KG60484QX9 (Omeprazole)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Barrett Esophagus/epidemiology
MH  - Comorbidity
MH  - Drug Combinations
MH  - Endoscopy, Digestive System
MH  - Endoscopy, Gastrointestinal
MH  - Esophagitis, Peptic/*drug therapy/epidemiology
MH  - Female
MH  - Humans
MH  - Intention to Treat Analysis
MH  - Male
MH  - Middle Aged
MH  - Mucous Membrane/pathology
MH  - Omeprazole/*administration & dosage
MH  - Prospective Studies
MH  - Proton Pump Inhibitors/*administration & dosage
MH  - Sodium Bicarbonate/*administration & dosage
EDAT- 2014/01/23 06:00
MHDA- 2015/04/22 06:00
CRDT- 2014/01/23 06:00
PHST- 2013/07/05 00:00 [received]
PHST- 2013/12/27 00:00 [accepted]
PHST- 2014/01/23 06:00 [entrez]
PHST- 2014/01/23 06:00 [pubmed]
PHST- 2015/04/22 06:00 [medline]
AID - 10.1007/s10620-013-3017-y [doi]
PST - ppublish
SO  - Dig Dis Sci. 2015 Jan;60(1):146-62. doi: 10.1007/s10620-013-3017-y. Epub 2014 Jan 
      22.