Patients suffering from functional gastrointestinal disorders, it means diseases without detectable morpholo- gical or biochemical abnormalities, represent an important part of clients of gastroenterical departments. The objective of this opened, prospective, multicentre study was evaluation of safety and therapeutical efficacy of Dogmatil ® 50 in the treatment of functional gastrointestinal disorders. Recommended daily dose was 150 mg. In this 28 days lasting study there was included 596 patients (211 male, 385 female, average of age 44) in 121 centres. Treatment efficacy was observed using development of scale score evaluated either by physicians (Clinical global impression, evaluation of psychical functions) or patients themselves (pain intensity, quality of life, global patients’ evaluation). 4 control checks up in one week intervals were performed during the study flow. Results of statistical analysis showed significant, progressive improvement of patients’ health conditions in all parameters assessed. Only in two cases (0.3 %) the treatment was interrupted due to lack of drug efficacy. In 20 (3.36 %) of included patients altogether 28 adverse events were recorded and only 11 (1.85 %) of them discontinuated the study due to the adverse events. 22 adverse events disappeared already during the study duration. Most frequent adverse events were: mastodynia in 7 (1.17 %) patients, somnolence in 6 (1.01 %) patients and galactorhoea in 3 (0.5 %) of included patients. Any of adverse events occurred did not fulfil criteria of serious one. Results of this clinical observation show the way how to reach the therapeutical success in the treatment of functional gastrointestinal disorders with the low risk of adverse events occurrence.

        Key words: Dogmatil ® 50 – functional gastrointestinal disorders – efficacy – safety