PMID- 21537361
OWN - NLM
STAT- MEDLINE
DCOM- 20110929
LR  - 20220309
IS  - 1572-0241 (Electronic)
IS  - 0002-9270 (Linking)
VI  - 106
IP  - 8
DP  - 2011 Aug
TI  - Response of regurgitation to proton pump inhibitor therapy in clinical trials of 
      gastroesophageal reflux disease.
PG  - 1419-25; quiz 1426
LID - 10.1038/ajg.2011.146 [doi]
AB  - OBJECTIVES: The typical symptoms of gastroesophageal reflux disease (GERD) are 
      heartburn and regurgitation. Extensive analysis has characterized heartburn and 
      its responsiveness to proton pump inhibitor (PPI) therapy, but regurgitation has 
      received relatively little attention. This study aimed to evaluate the response 
      of regurgitation to PPI therapy in GERD trials. METHODS: Studies were identified 
      by systematic searches in PubMed and Embase, as well as searching congress 
      abstracts and the reference lists of Cochrane reviews. RESULTS: Regurgitation was 
      not an entry criterion or the primary end point in any of the 31 clinical trials 
      reporting the response of regurgitation to PPI treatment in GERD. The definitions 
      of regurgitation and responsiveness varied among trials and over half used 
      investigator assessment of response. Owing to these inconsistencies, no 
      meta-analysis was attempted. In seven placebo-controlled trials of PPI therapy, 
      the therapeutic gain for regurgitation response averaged 17% relative to placebo 
      and was >20% less than that observed for heartburn. Studies comparing PPIs with 
      histamine-2 receptor antagonists or prokinetics found the comparator drug 
      response similar to the placebo response rates seen in the placebo-controlled 
      trials. CONCLUSIONS: The therapeutic gain with PPIs over placebo or comparator 
      agents for the relief of regurgitation is modest, and considerably lower than for 
      heartburn. Thus, regurgitation is likely to be an important factor for 
      determining incomplete response to PPI treatment in GERD. Future trials would 
      benefit from using regurgitation as a primary end point, applying an unambiguous 
      definition of the symptom and of a positive treatment response, and using a 
      validated patient-reported instrument for regurgitation assessment.
FAU - Kahrilas, Peter J
AU  - Kahrilas PJ
AD  - Division of Gastroenterology, Northwestern University, Feinberg School of 
      Medicine, Chicago, Illinois 60611-2951, USA. p-kahrilas@northwestern.edu
FAU - Howden, Colin W
AU  - Howden CW
FAU - Hughes, Nesta
AU  - Hughes N
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20110503
PL  - United States
TA  - Am J Gastroenterol
JT  - The American journal of gastroenterology
JID - 0421030
RN  - 0 (Histamine H2 Antagonists)
RN  - 0 (Proton Pump Inhibitors)
SB  - IM
MH  - Controlled Clinical Trials as Topic
MH  - Gastroesophageal Reflux/complications/*drug therapy/*physiopathology
MH  - Heartburn/etiology/*physiopathology/*prevention & control
MH  - Histamine H2 Antagonists/therapeutic use
MH  - Humans
MH  - Peristalsis
MH  - Proton Pump Inhibitors/*therapeutic use
MH  - Research Design
MH  - Treatment Outcome
MH  - Vomiting/prevention & control
EDAT- 2011/05/04 06:00
MHDA- 2011/10/01 06:00
CRDT- 2011/05/04 06:00
PHST- 2011/05/04 06:00 [entrez]
PHST- 2011/05/04 06:00 [pubmed]
PHST- 2011/10/01 06:00 [medline]
AID - ajg2011146 [pii]
AID - 10.1038/ajg.2011.146 [doi]
PST - ppublish
SO  - Am J Gastroenterol. 2011 Aug;106(8):1419-25; quiz 1426. doi: 
      10.1038/ajg.2011.146. Epub 2011 May 3.