Sucralfate in the Treatment and Prevention of Gastric Ulcer: Multicentre Double Blind Placebo Controlled Study
Gut, 1990,31,825-830 825 CLINICAL TRIAL Gut: first published as 10.1136/gut.31.7.825 on 1 July 1990. Downloaded from Sucralfate in the treatment and prevention of gastric ulcer: multicentre double blind placebo controlled study A L Blum, H Bethge, J Ch Bode, W Domschke, G Feurle, K Hackenberg, B Hammer, W Huttemann, M Jung, G Kachel, H Kaess, B C Manegold, P Peter, T Pfleiderer, H G Rohner, U Rasenack, R Sanwald, G A Stalder, J-J Vallotton Abstract following reasons: a small number of patients A randomised controlled multicentre trial was admitted to the trial,33 a short duratiqh of only performed in 160 patients with gastric ulcer, six months,432 ' failure to standardise initial proved by endoscopy and biopsy, to compare ulcer treatment,203335 administration of different ulcer healing with sucralfate and ranitidine doses of sucralfate during maintenance treat- (double blind double dummy design) and to ment,42032-35 problems with randomisation and assess the effect of maintenance treatment blinding,4 and inclusion of patients with pyloric with sucralfate on ulcer recurrence (double ulcers in the gastric ulcer group.20 Some groups blind placebo controlied design). The healing of patients appear in more than one publica- rates were similar with 4 g sucralfate suspen- tion3336 but are often quoted as belonging to sion per day and 300 mg ranitidine per day (82% different studies. Information on 497 patients and 88% after 12 weeks, respectively). Of the with gastric ulcer is available from these 109 patients with healed ulcers, 92 were trials.42032-35 The four placebo controlled trials entered into the maintenance trial and treated lasting for six months gave widely differing http://gut.bmj.com/ with sucralfate tablets (2 g per day) or placebo results; the overall recurrence rate was lower tablets.
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