[Therapy and prevention of reflux esophagitis. Results of a multicenter study with cimetidine. I: Epidemiology and results of acute therapy].

In a sequential observational study efficacy and safety of two dosage regimens of cimetidine for the treatment of reflux-oesophagitis (RE) were examined. 22 office-based specialists took part in the trial. 187 patients received 1600 mg cimetidine (400 mg q.i.d.) daily and 136 patients received 800 mg cimetidine (400 mg b.i.d.) daily, over twelve weeks. The two dosages proved to be equally effective. In the group of patients with RE of stage I at the beginning of the trial, the healing rates were 82% under 1600 mg cimetidine/die and 86% under 800 mg cimetidine/die. In the group of those patients, who entered the study with RE of stage II, in both dosage groups the lesions of 87% of the patients were healed completely or had decreased to stage I. The severity of the mucosal lesions was judged endoscopically, based on a classification scheme modified according to Savary and Miller. The incidence of unwanted symptoms was not significantly different in both dosage groups (1600 mg: 5.3%, 800 mg: 3.4%); none of the symptoms which occurred was judged as definitely caused by cimetidine. The patient collective of the trial was characterized epidemiologically; out of the risk factors examined, only duration of RE history and number of previous RE episodes correlated with the severity of the disease, smoking and alcohol consumption showed no influence.