Combination therapy of sucralfate and cimetidine, compared with sucralfate monotherapy, in patients with peptic reflux esophagitis.
A double-blind multicenter, randomized study was performed in 70 patients with endoscopically documented reflex esophagitis. Patients were randomly given 1 g sucralfate four times a day or the combination of sucralfate 1 g three times a day and 400 mg cimetidine at night. After healing of the esophagitis, patients were randomly given either sucralfate maintenance 2 g daily or placebo for a period of six months. Endoscopy was performed at the beginning of the study, after eight weeks, and, in cases with no healing, after 16 weeks of therapy. Sixty-three of the 70 patients who initially entered the study could be evaluated after eight weeks. Both groups showed good symptomatic improvement, and no side effects necessitated withdrawal of subjects. Endoscopy showed complete healing in 19.4 percent of the sucralfate group and in 21.9 percent of the combination sucralfate and cimetidine group. Endoscopic improvement was found in 50 percent of the sucralfate group and in 50 percent of the combination group. After 16 weeks, 56 patients could be evaluated. In the sucralfate group, improvement was seen in 78.6 percent, and healing in 31 percent. For the combination group these values were 59.3 percent and 37 percent (not significant). Twenty-six patients entered the maintenance phase of the study; 15 received sucralfate and 11 received placebo. Evaluation of 20 patients after six months showed endoscopic and/or symptomatic relapse of esophagitis in three of 12 patients receiving sucralfate and in two of the eight patients receiving placebo. It is concluded that sucralfate monotherapy in patients with reflux-esophagitis is effective and comparable with a combination of sucralfate during the day and cimetidine at night. No difference was found between sucralfate and placebo in terms of the relapse rate of esophagitis during long-term treatment.
Schotborgh
R H
RH
Department of Gastroenterology, Academic Medical Centre, Free University Hospital, Amsterdam, The Netherlands.
Hameeteman
W
W
Dekker
W
W
vd Boomgaard
D M
DM
Van Olffen
G H
GH
Schrijver
M
M
Vosmaer
G D
GD
Tytgat
G N
GN
D000293:Adolescent; D000328:Adult; D000368:Aged; D002927:Cimetidine / Q000008:administration & dosage* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D013392:Sucralfate / Q000008:administration & dosage* / Q000627:therapeutic use
D013392:Sucralfate; D002927:Cimetidine