Patients with
duodenal ulcer (DU; n = 79) or prepyloric
ulcer (PPU; n = 39) received
cimetidine, 400 mg twice daily, or
Novaluzid, 10 ml four times daily (
acid-neutralizing capacity, 340 mmol/day), in a multicentre, randomized, double-blind trial.
Ulcer healing was almost identical with the two treatments at 4, 6, and 12 weeks in the DU group.
Cimetidine was significantly more effective than
antacids in alleviating symptoms in PPU disease, with no significant difference in
ulcer healing. In the PPU group the symptomatic improvement was inferior irrespective of treatment, and there was a significantly lower healing rate at 4 weeks (p less than 0.05) than in the DU group. The relapse rate over a 1-year follow-up period with no
therapy did not differ between the two treatment groups or between the two
ulcer groups. No factors in history of disease or endoscopic or histologic variables were of predictive value with regard to delayed healing. The macroscopic appearance of the duodenal and
antral mucosae improved significantly when
ulcers had healed. In the subgroup of about 50% DU patients who experienced a relapse during the 1-year follow-up period, the histologic scoring of
duodenitis remained basically unchanged, contrary to the significant improvement seen in the non-relapsing subgroup. The microscopic changes of the
antral mucosa from the time of inclusion to healing seen in the PPU patients were of no predictive value with regard to relapse rate.