A DOUBLE-BLIND CONTROLLED TRIAL OF THE EFFICACY AND SAFETY OF TAUROHYODEOXYCHOLIC ACID IN THE TREATMENT OF DYSPEPTIC DISTURBANCES ASSOCIATED WITH GALLSTONES OR OTHER HEPATIC DISORDERS

In a controlled, randomised, parallel-group, double-blind trial the ef ficacy and safety of taurohyodeoxycholic acid (THDCA) was compared wit h another commonly used biliary acid, ursodeoxycholic acid (UDCA), in 100 patients with pain or other dyspeptic disturbances associated with hepatic or biliary disorders. THDCA and the reference drug were admin istered at 250mg doses twice a day for 2 months. The disturbances eval uated were: right hypochondrium pain, epigastric pain, nausea or vomit ing, belching, epigastric bloating, flatulence or meteorism, lipid int olerance, constipation or diarrhoea. The degree of severity of the dis turbances was recorded using an arbitrary 4-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe), and the total score was calculated as the sum. Dyspeptic symptoms were reduced or completely disappeared in 87.2% of patients treated with THDCA (80.4% in the UDCA-treated gr oup). Statistical analysis (Wilcoxon's test with a test power higher t han 80%) revealed significant differences between the reduction of sym ptoms obtained in the 2 groups (total score from 8.38 to 2.74 in the T HDCA group and from 7.83 to 4.09 in the UDCA group). Adverse effects w ere reported in only a few patients (4.3% in the THDCA group and 8.7% in the UDCA group), without any statistically significant difference b etween the 2 groups. On the basis of the clinical evidence, and with a good level of statistical confidence, THDCA can be considered useful in the treatment of dyspeptic disturbances associated with gallstones or other hepatic disorders.