Clinical Drug Investigation

, Volume 11, Issue 2, pp 77–83 | Cite as

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

  • P. Ventura
  • M. Girola
  • R. Germogli
Clinical Use
  • 5 Downloads

Summary

In a controlled, randomised, parallel-group, double-blind trial the efficacy and safety of taurohyodeoxycholic acid (THDCA) was compared with 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 administered at 250mg doses twice a day for 2 months. The disturbances evaluated were: right hypochondrium pain, epigastric pain, nausea or vomiting, belching, epigastric bloating, flatulence or meteorism, lipid intolerance, constipation or diarrhoea. The degree of severity of the disturbances 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 group). Statistical analysis (Wilcoxon’s test with a test power higher than 80%) revealed significant differences between the reduction of symptoms obtained in the 2 groups (total score from 8.38 to 2.74 in the THDCA group and from 7.83 to 4.09 in the UDCA group). Adverse effects were reported in only a few patients (4.3% in the THDCA group and 8.7% in the UDCA group), without any statistically significant difference between 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.

Keywords

Bile Acid Primary Biliary Cirrhosis Drug Invest Ursodeoxycholic Acid Dyspeptic Symptom 

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Copyright information

© Adis International Limited 1996

Authors and Affiliations

  • P. Ventura
    • 1
  • M. Girola
    • 1
  • R. Germogli
    • 2
  1. 1.Medicine DivisionCivil HospitalBergamoItaly
  2. 2.Research DivisionDR Drug Research SrlMilanItaly

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