Multicenter trial of sucralfate suspension for the treatment of reflux esophagitis.
The efficacy of sucralfate suspension in the treatment of reflux esophagitis was assessed in a multicenter, randomized, double-blind, placebo-controlled trial. Sixty-eight patients with symptomatic and endoscopic esophagitis received either sucralfate suspension (n = 31) or liquid placebo (n = 37) for eight weeks. The two groups were comparable at entry with the exception that despite randomization, a disproportionately high number of patients with esophageal ulcers were assigned to receive sucralfate. After four and eight weeks of treatment, both groups had reduced heartburn frequency and severity, but there was no difference in improvement between sucralfate and placebo (p greater than 0.05). Endoscopic results after eight weeks of sucralfate treatment revealed complete healing in 36 percent (placebo, 35 percent) and improvement in an additional 45 percent (placebo, 24 percent). Although neither of these differences was significant, the percent of patients in whom healing or improvement occurred with sucralfate (81 percent) was greater than with placebo (59 percent) (p = 0.07). These data fail to establish that eight weeks of treatment with sucralfate suspension improves symptoms or heals lesions in reflux esophagitis at a rate significantly greater than placebo. However, the unequal distribution of patients with ulcers and the trend toward endoscopic improvement indicate that a potential beneficial effect of sucralfate suspension for the treatment of reflux esophagitis cannot be excluded.
Williams
R M
RM
Department of Medicine, University of North Carolina School of Medicine, Chapel Hill 27514.
Orlando
R C
RC
Bozymski
E M
EM
Readling
R D
RD
Castell
D O
DO
Roufail
W M
WM
Rick
G G
GG
Rubin
S E
SE
Sinar
D R
DR
D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004724:Endoscopy; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006356:Heartburn / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009092:Mucous Membrane / Q000473:pathology; D011897:Random Allocation; D013392:Sucralfate / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D013535:Suspensions
D013535:Suspensions; D013392:Sucralfate