The use of antisera (‘Serocytol’) in the management of gastritis: a double-blind clinical assessment versus placebo

Abstract

A double-blind, placebo-controlled study was carried out in 40 out-patients with endoscopically confirmed hypertrophic or erosive gastritis, without ulcer, to assess the effectiveness and tolerance of treatment with equine antisera (antidiencephalon and anti-stomach tissue). Patients were assigned at random to receive a single dose in suppository form on 2 days a week for 6 weeks of both antisera (anti-diencephalon on Days 1 and 4, anti-stomach tissue on Days 2 and 5) or placebo (saline solution). No other anti-ulcer treatment was allowed except standard antacid tablets, the consumption of which was recorded and used as an evaluation parameter. Endoscopy, haematology and haematochemistry were performed before and after treatment; symptoms (daytime and night-time pain, heartburn and dyspepsia) and possible adverse reactions were scored 0 to 4 in order of increasing severity before treatment and after 1, 2, 4 and 6 weeks. Five patients in the placebo group had to be withdrawn from the trial at the second week because of therapeutic failure. This proportion was significantly in favour of the antisera group, as was the proportion of patients endoscopically healed and the extent and rate of symptomatic improvement. Concomitant antacid consumption rapidly and significantly decreased in the antisera but not in the placebo group. Signs of intolerance were not observed with either treatment, nor were there any significant alterations in haematology or haematochemistry. In particular, the immune titre of patients did not increase after treatment, thus indicating that the administered heterologous proteins did not elicit an immunization of the patients against horse protein.(ABSTRACT TRUNCATED AT 250 WORDS)