Post-prandial reflux suppression by a raft-forming alginate (Gaviscon Advance) compared to a simple antacid documented by magnetic resonance imaging and pH-impedance monitoring: Mechanistic assessment in healthy volunteers and randomised, controlled, double-blind study in reflux patients

Alimentary Pharmacology and Therapeutics

Volumn 37, Issue 11, 2013, Pages 1093-1102

  Sweis, R ^a   Kaufman, E ^b   Anggiansah, A ^a   Wong, T ^a   Dettmar, P ^c   Fried, M ^b   Schwizer, W ^b   Avvari, R K ^d   Pal, A ^e   Fox, M ^b,f  

^a GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

^b UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^c CASTLE HILL HOSPITAL   (United Kingdom)

^d INDIAN INSTITUTE OF TECHNOLOGY KANPUR   (India)

^e INDIAN STATISTICAL INSTITUTE   (India)

^f QUEEN S MEDICAL CENTRE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALGINIC ACID; GADOTERIC ACID; GAVISCON ADVANCE; MAGNESIUM HYDROXIDE; PEPSIN A; UNCLASSIFIED DRUG;

ARTICLE; CLINICAL ASSESSMENT; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MECHANISM; DRUG MONITORING; ESOPHAGEAL PH MONITORING; ESOPHAGUS MANOMETRY; FEASIBILITY STUDY; FEMALE; GASTRIC PH MONITORING; GASTROESOPHAGEAL REFLUX; HUMAN; MAJOR CLINICAL STUDY; MALE; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; POSTPRANDIAL STATE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SALIVA LEVEL; STOMACH ACID; STOMACH PROTECTION;

ADULT; AGED; ALGINATES; ALUMINUM HYDROXIDE; ANTACIDS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; ELECTRIC IMPEDANCE; ESOPHAGEAL PH MONITORING; FEMALE; GASTROESOPHAGEAL REFLUX; HUMANS; HYDROGEN-ION CONCENTRATION; MAGNESIUM OXIDE; MAGNETIC RESONANCE IMAGING; MALE; MANOMETRY; MIDDLE AGED; POSTPRANDIAL PERIOD; SILICIC ACID; SODIUM BICARBONATE; TREATMENT OUTCOME;

EID: 84877636450     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.12318     Document Type: Article

References (46)

1. Vakil N, Van Zanten SV, Kahrilas P, et al,. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol 2006; 101: 1900-20.
2. Vela MF, Camacho-Lobato L, Srinivasan R, et al,. Simultaneous intraesophageal impedance and pH measurement of acid and nonacid gastroesophageal reflux: effect of omeprazole. Gastroenterology 2001; 120: 1599-606.
3. Emerenziani S, Zhang X, Blondeau K, et al,. Gastric fullness, physical activity, and proximal extent of gastroesophageal reflux. Am J Gastroenterol 2005; 100: 1251-6.
4. Hungin AP, Hill C, Molloy-Bland M, et al,. Systematic review: patterns of proton pump inhibitor use and adherence in gastroesophageal reflux disease. Clin Gastroenterol Hepatol 2012; 10: 109-16.
5. Mainie I, Tutuian R, Shay S, et al,. Acid and non-acid reflux in patients with persistent symptoms despite acid suppressive therapy: a multicentre study using combined ambulatory impedance-pH monitoring. Gut 2006; 55: 1398-402.
6. Sifrim D,. Relevance of volume and proximal extent of reflux in gastro-oesophageal reflux disease. Gut 2005; 54: 175-8.
7. Johnston N, Bulmer D, Gill GA, et al,. Cell biology of laryngeal epithelial defenses in health and disease: further studies. Ann Otol Rhinol Laryngol 2003; 112: 481-91.
8. Bardhan KD, Strugala V, Dettmar PW,. Reflux revisited: advancing the role of pepsin. Int J Otolaryngol 2012; 2012: 646-901.
9. McQuaid KR, Laine L, Fennerty MB, et al,. Systematic review: the role of bile acids in the pathogenesis of gastro-oesophageal reflux disease and related neoplasia. Aliment Pharmacol Ther 2011; 34: 146-65.
10. McCarthy DM,. Adverse effects of proton pump inhibitor drugs: clues and conclusions. Curr Opin Gastroenterol 2010; 26: 624-31.
11. Zerbib F, Duriez A, Roman S, et al,. Determinants of gastro-oesophageal reflux perception in patients with persistent symptoms despite proton pump inhibitors. Gut 2008; 57: 156-60.
12. Kahrilas PJ, Howden CW, Hughes N,. Response of regurgitation to proton pump inhibitor therapy in clinical trials of gastroesophageal reflux disease. Am J Gastroenterol 2011; 106: 1419-25.
13. Kahrilas PJ, Jonsson A, Denison H, et al,. Regurgitation is less responsive to acid suppression than heartburn in patients with gastroesophageal reflux disease. Clin Gastroenterol Hepatol 2012; 10: 612-9.
14. Bredenoord AJ, Weusten BL, Curvers WL, et al,. Determinants of perception of heartburn and regurgitation. Gut 2006; 55: 313-8.
15. Marciani L, Little SL, Snee J, et al,. Echo-planar magnetic resonance imaging of Gaviscon alginate rafts in-vivo. J Pharm Pharmacol 2002; 54: 1351-6.
16. Hampson FC, Farndale A, Strugala V, et al,. Alginate rafts and their characterisation. Int J Pharm 2005; 294: 137-47.
17. Lambert JR, Korman MG, Nicholson L, et al,. In-vivo anti-reflux and raft properties of alginates. Aliment Pharmacol Ther 1990; 4: 615-22.
18. McKay AP, Wraight EP, Hunter JO,. The alginate raft: a scintigraphic evaluation. Br J Clin Pract Suppl 1989; 66: 20-4.
19. Fletcher J, Wirz A, Young J, et al,. Unbuffered highly acidic gastric juice exists at the gastroesophageal junction after a meal. Gastroenterology 2001; 121: 775-83.
20. Goetze O, Treier R, Fox M, et al,. The effect of gastric secretion on gastric physiology and emptying in the fasted and fed state assessed by magnetic resonance imaging. Neurogastroenterol Motil 2009; 21: 725-e42.
21. Strugala V, Avis J, Jolliffe IG, et al,. The role of an alginate suspension on pepsin and bile acids-key aggressors in the gastric refluxate. Does this have implications for the treatment of gastro-oesophageal reflux disease? J Pharm Pharmacol 2009; 61: 1021-8.
22. Tran T, Lowry AM, El-Serag HB,. Meta-analysis: the efficacy of over-the-counter gastro-oesophageal reflux disease therapies. Aliment Pharmacol Ther 2007; 25: 143-53.
23. ® vs. omeprazole in symptomatic treatment of moderate gastroesophageal reflux. A direct comparative randomised trial. BMC Gastroenterol 2012; 12: 18.
24. Manabe N, Haruma K, Ito M, et al,. Efficacy of adding sodium alginate to omeprazole in patients with nonerosive reflux disease: a randomized clinical trial. Dis Esophagus 2012; 25: 373-80.
25. Washington N, Denton G,. Effect of alginate and alginate-cimetidine combination therapy on stimulated post-prandial gastro-oesophageal reflux. J Pharm Pharmacol 1995; 47: 879-82.
26. Washington N, Greaves JL, Iftikhar SY,. A comparison of gastro-oesophageal reflux in volunteers assessed by ambulatory pH and gamma monitoring after treatment with either Liquid Gaviscon or Algicon Suspension. Aliment Pharmacol Ther 1992; 6: 579-88.
27. Zentilin P, Dulbecco P, Savarino E, et al,. An evaluation of the antireflux properties of sodium alginate by means of combined multichannel intraluminal impedance and pH-metry. Aliment Pharmacol Ther 2005; 21: 29-34.
28. Curcic J, Fox M, Kaufman E, et al,. Gastroesophageal junction: structure and function as assessed by using MR imaging. Radiology 2010; 257: 115-24.
29. Roman S, Zerbib F, Belhocine K, et al,. High resolution manometry to detect transient lower oesophageal sphincter relaxations: diagnostic accuracy compared with perfused-sleeve manometry, and the definition of new detection criteria. Aliment Pharmacol Ther 2011; 34: 384-93.
30. Banerjee S, Fox M, Schwizer W, et al,. A novel image analysis tool 'MRI3D' for detailed assessment of gastrointestinal structure in three dimensions. Gastroenterology 2010; 138: S-662.
31. Saritas Yuksel E, Hong SK, Strugala V, et al,. Rapid salivary pepsin test: blinded assessment of test performance in gastroesophageal reflux disease. Laryngoscope 2012; 122: 1312-6.
32. Sweis R, Anggiansah A, Wong T, et al,. Normative values and inter-observer agreement for liquid and solid bolus swallows in upright and supine positions as assessed by esophageal high-resolution manometry. Neurogastroenterol Motil 2011; 23: 509-e198.
33. Sifrim D, Holloway RH, Tack J, et al,. Effect of sumatriptan, a 5HT1 agonist, on the frequency of transient lower esophageal sphincter relaxations and gastroesophageal reflux in healthy subjects. Am J Gastroenterol 1999; 94: 3158-64.
34. Fox M, Barr C, Nolan S, et al,. The effects of dietary fat and calorie density on esophageal acid exposure and reflux symptoms. Clin Gastroenterol Hepatol 2007; 5: 439-44.
35. Chey WD, Mody RR, Izat E,. Patient and physician satisfaction with proton pump inhibitors (PPIs): are there opportunities for improvement? Dig Dis Sci 2010; 55: 3415-22.
36. Kahrilas PJ, Boeckxstaens G,. Failure of reflux inhibitors in clinical trials: bad drugs or wrong patients? Gut 2012; 61: 1501-9.
37. Hampson FC, Jolliffe IG, Bakhtyari A, et al,. Alginate-antacid combinations: raft formation and gastric retention studies. Drug Dev Ind Pharm 2010; 36: 614-23.
38. Manabe N, Haruma K, Ito M, et al,. Efficacy of adding sodium alginate to omeprazole in patients with nonerosive reflux disease: a randomized clinical trial. Dis Esophagus 2012; 25: 373-80.
39. Clarke AT, Wirz AA, Manning JJ, et al,. Severe reflux disease is associated with an enlarged unbuffered proximal gastric acid pocket. Gut 2008; 57: 292-7.
40. Pandolfino JE, Zhang Q, Ghosh SK, et al,. Acidity surrounding the squamocolumnar junction in GERD patients: "acid pocket" versus "acid film". Am J Gastroenterol 2007; 102: 2633-41.
41. Kwiatek MA, Roman S, Fareeduddin A, et al,. An alginate-antacid formulation (Gaviscon Double Action Liquid) can eliminate or displace the post-prandial 'acid pocket' in symptomatic GERD patients. Aliment Pharmacol Ther 2011; 34: 59-66.
42. Fox M,. Bravo wireless versus catheter pH monitoring systems. Gut 2006; 55: 434-5.
43. Mandel KG, Daggy BP, Brodie DA, et al,. Review article: alginate-raft formulations in the treatment of heartburn and acid reflux. Aliment Pharmacol Ther 2000; 14: 669-90.
44. Fletcher J, Wirz A, Henry E, et al,. Studies of acid exposure immediately above the gastro-oesophageal squamocolumnar junction: evidence of short segment reflux. Gut 2004; 53: 168-73.
45. Lazarescue A, Bisschops R, Demedts I, et al,. Short segment acid reflux: characterization with 24-hour esophageal impedance-double ph monitoring. Gastroenterology 2008; 134: A-594.
46. Woodland P, Lee C, Duraysami Y, et al,. Assessment and protection of esophageal mucosal integrity in patients with heartburn without esophagitis. Am J Gastroenterol 2013; 108: 535-43.