Washington N, Denton G
Effect of alginate and alginate-cimetidine combination therapy on stimulated postprandial gastro-oesophageal reflux. [Clinical Trial, Journal Article, Randomized Controlled Trial]
J Pharm Pharmacol 1995 Nov; 47(11):879-82.
This randomized, single-blind cross-over study compared the effectiveness of a conventional alginate reflux barrier formulation (20 mL single dose of Liquid Gaviscon; sodium alginate, sodium bicarbonate, calcium carbonate) with a 20 mL single dose of an alginate-cimetidine combination formulation (Algitec Suspension; sodium alginate, cimetidine) in the suppression of food and acid reflux into the oesophagus after a test meal in 12 healthy volunteers. Subjects were fasted overnight before the study. A pH electrode and gamma detector were accurately positioned 5 cm above the cardia. The volunteers received a 99mTc-labelled meal designed to provoke reflux and then either remained untreated, or 30 min later were given either Algitec Suspension or Liquid Gaviscon. Reflux of both food and acid into the oesophagus was measured for 3 h. There was a seven day wash-out period between each treatment. Food reflux in the control group was 22,878 +/- 14,385 counts x 10(3) and this was significantly suppressed by both Liquid Gaviscon (174 +/- 128 (s.e.) counts x 10(3); P = 0.003); however, although the reduction of food reflux to 3812 +/- 2322 counts x 10(3) observed after Algitec treatment was considerable, this did not reach statistical significance (P > 0.05) due to the large intersubject variation. Liquid Gaviscon was significantly better at reducing food reflux than Algitec (P = 0.001). Gaviscon also significantly reduced acid reflux when compared with the control group (1.08 +/- 0.73 vs 5.87 +/- 3.27% recording time oesophageal pH < 4, respectively) (P = 0.03). The slight reduction in acid reflux after Algitec treatment (3.25 +/- 1.82% recording time oesophageal pH < 4) also did not reach statistical significance. The difference between Algitec and Gaviscon treatment was also not significant.
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