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. 2018 Dec;20(6):575-583.
doi: 10.1007/s40272-018-0314-0.

The Effect of Alginate in Gastroesophageal Reflux in Infants

Affiliations

The Effect of Alginate in Gastroesophageal Reflux in Infants

Silvia Salvatore et al. Paediatr Drugs. 2018 Dec.

Abstract

Background: Guidelines are contradictory regarding the use of alginate in infants with persisting gastroesophageal reflux (GER). While The British National Institute for Health and Care (NICE) guidelines consider alginate as a treatment option, the guidelines of the European and North-American Societies for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN, NASPGHAN) do not recommend alginates.

Aims: We assessed the efficacy of alginate to reduce GER episodes in infants.

Methods: In a prospective, observational study, we consecutively enrolled all infants referred for pH-multiple intraluminal impedance (pH-MII) recording because of persisting GER symptoms not responsive to behavior and dietetic modifications. A 48-h pH-MII was performed in all infants; a baseline recording was performed during the first 24 h while magnesium or sodium alginate was administered during the second 24 h. The primary endpoint was the difference in the total number of GER episodes per 24 h between the baseline day and the second day during which the alginate was administered. The secondary outcome was the difference in symptoms between each period. We also compared other pH-MII data from before and during alginate administration.

Results: We recruited 43 infants (median age 68 days, range 25-306); three pH-MII tracings were excluded because of artifacts. The median number of all MII reflux episodes was significantly reduced during alginate administration (76.0 vs 69.5; p < 0.001). Crying-fussiness, cough and regurgitation episodes all significantly improved during alginate administration (p = 0.00012; p = 0.005 and p = 0.04, respectively). The following MII parameters also decreased during the alginate administration: acid (19.0 vs 14.5; p < 0.04), non-acid (52.0 vs 49.5; p < 0.004), proximal GER episodes (46.0 vs 41.4; p < 0.007), and bolus exposure index (1.9 vs 1.6; p = 0.002). At least three out of seven pH-MII parameters decreased by > 10% during the alginate period in 31/40 infants (77.5%), without a significant difference between magnesium and sodium alginate.

Conclusion: These results suggest that alginate significantly decreases the number and extension of both acid and non-acid reflux episodes and associated symptoms in infants.

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Conflict of interest statement

SS has participated as a consultant and/or speaker for Danone-Nutricia, Deca, IMS-Health, Menarini, and Nestle. YV has participated as a clinical investigator, and/or advisory board member, and/or consultant, and/or speaker for Abbott Nutrition, Biocodex, Danone, Nestle Health Science, Nestle Nutrition Institute, Nutricia, Mead Johnson, and United Pharmaceuticals. None of the above manufacturers and companies have had any input or involvement in any aspect of this study. The other authors have no conflicts of interest to disclose.

Figures

Fig. 1
Fig. 1
Total number of reflux episodes at baseline and during alginate administration. Box plot shows the number of reflux episodes detected by impedance (median, interquartiles). The number of reflux episodes was significantly decreased during alginate administration (p < 0.001)
Fig. 2
Fig. 2
Symptoms at baseline and during alginate administration. Upper panel, box plot showing the number of episodes of crying (median, interquartiles); lower panel, box plot showing the number of episodes of regurgitation (median, interquartiles). The number of episodes of crying and regurgitation were significantly decreased during alginate administration (p < 0.001 and p = 0.042, respectively)

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