Document Detail

Effect of Gaviscon Infant on gastro-oesophageal reflux in infants assessed by combined intraluminal impedance/pH.
MedLine Citation:
PMID:  15851425     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Gaviscon Infant (GI) has been recommended for gastro-oesophageal reflux (GOR) in infants. Its efficacy has not been examined with a physiologically appropriate denominator to define the degree of GOR. AIM: To investigate the influence of Gaviscon Infant on GOR in infants using combined pH and intraluminal impedance measurement. METHODS: Twenty infants (mean age 163.5 days, range 34-319 days) exclusively bottle fed, with symptoms clinically suggestive of GOR, underwent 24 hour studies of intra-oesophageal 6 channel impedance and dual channel pH monitoring, during which six random administrations (3+3) of Gaviscon Infant (625 mg in 225 ml milk) or placebo (mannitol and Solvito N, 625 mg in 225 ml milk) were given in a double blind fashion. Impedance/pH reflux data were recorded and analysed blind by one observer. RESULTS: The median number of reflux events/hour (1.58 v 1.68), acid reflux events/hour (0.26 v 0.43), minimum distal or proximal pH, total acid clearance time per hour (time with pH below pH 4), and total reflux duration per hour were not significantly different after GI than after placebo. Reflux height was marginally lower after GI (median 66.6% v 77.3% oesophageal length) compared with placebo. CONCLUSIONS: Results showed a marginal but significant difference between Gaviscon Infant and placebo in average reflux height, and raises questions regarding any perceived clinical benefit of its use.
R Del Buono; T G Wenzl; G Ball; S Keady; M Thomson
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Archives of disease in childhood     Volume:  90     ISSN:  1468-2044     ISO Abbreviation:  Arch. Dis. Child.     Publication Date:  2005 May 
Date Detail:
Created Date:  2005-04-26     Completed Date:  2005-05-25     Revised Date:  2010-07-07    
Medline Journal Info:
Nlm Unique ID:  0372434     Medline TA:  Arch Dis Child     Country:  England    
Other Details:
Languages:  eng     Pagination:  460-3     Citation Subset:  AIM; IM    
Centre for Paediatric Gastroenterology, Royal Free and University College Medical School, London, UK.
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MeSH Terms
Alginates / therapeutic use*
Aluminum Hydroxide / therapeutic use*
Antacids / therapeutic use*
Double-Blind Method
Drug Combinations
Electric Impedance
Gastroesophageal Reflux / drug therapy*,  physiopathology
Hydrogen-Ion Concentration
Silicic Acid / therapeutic use*
Sodium Bicarbonate / therapeutic use*
Treatment Outcome
Reg. No./Substance:
0/Alginates; 0/Antacids; 0/Drug Combinations; 1343-98-2/Silicic Acid; 144-55-8/Sodium Bicarbonate; 21645-51-2/Aluminum Hydroxide; 66220-44-8/alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
Comment In:
Arch Dis Child. 2006 Jan;91(1):93   [PMID:  16371388 ]

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