Double-blind controlled trial of the new preparation FZ. 560 in the symptomatic treatment of digestive disorders.

A controlled double-blind clinical trial was carried out to compare the effects of a new combination FZ. 560 in the symptomatic treatment of digestive disorders including a wide variety of symptoms. The combination contained fentonium bromide, 10 mg, dehydrocholic acid, 25 mg, pancreatin 3FU, 50 mg, and lactulose, 200 mg; it was compared with fentonium bromide 10 mg, and the other components. The three treatment groups included 37 patients, treated for a maximum of 14 days. The severity of the painful and dyspeptic symptoms was recorded daily; the overall daily scores were analyzed using persistence curves. A 50% reduction of the initial overall scores was observed in all the 12 patients in the combination groups by the third treatment day, but not until the 13th day in the fentonium group, while a 50% reduction in symptom intensity was not achieved during the trial in 7.7% of the group treated with the other components. Statistical comparison with the Wilcoxon test showed in fact that the effects of FZ. 560 were significantly superior to those of the two control preparations which did not differ significantly. These results, therefore, demonstrate clearly the advantages of the new combination FZ. 560.