Combined cimetidine-alginate antacid therapy versus single agent treatment for reflux oesophagitis: results of prospective double-blind randomised clinical trial
Eriksen, C.A.; Cheadle, W.G.; Cranford, C.A.; Cuschieri, A.
Annales Chirurgiae et Gynaecologiae 77(4): 133-137
1988
ISSN/ISBN: 0355-9521 PMID: 2855391 Document Number: 636
This randomised double-blind study compared the effects of cimetidine 400 mg four times daily (q.d.s.), Gastrocote (alginic acid, aluminium hydroxide gel, magnesium trisilicate, sodium bicarbonate) two tablets q.s.s. and a combination of both on ambulatory 24-hour oesophageal pH, endoscopic findings and symptoms in patients with reflux oesophagitis. Patients were treated for ten weeks with assessments at entry, after four weeks and at the end of the study. Before treatment, oesophageal pH was less than 5.0 for 25% overall of the 24 hours monitoring in all three treatment groups. After ten weeks, the percentage of time with an oesophageal pH < 5.0 was 26% on Gastrocote, 26% on cimetidine and 14% on the combination (P < 0.05, combined therapy versus cimetidine alone). The severity of the heartburn was reduced on all three treatments. The averaged number of days with heartburn per week was 5.0, 3.6 and 3.4 in the Gastrocote, cimetidine and combined groups respectively. The difference between Gastrocote and the combination was statistically significant (P < 0.05). There was a clear trend towards improvement of endoscopic oesophagitis at ten weeks in the combined therapy group when compared to single agent treatment with cimetidine or Gastrocote although the difference was not significant due to inadequate numbers. This study indicates that combined cimetidine and Gastrocote is a more effective treatment for reflux oesophagitis than single agent therapy with either drug.
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