[Rationale for the use of bile salts after cholecystectomy: results of a controlled clinical study using tauroursodeoxycholic acid (TUDCA)]

Ann Ital Chir. 1993 Sep-Oct;64(5):533-7.
[Article in Italian]

Abstract

Cholecystectomy causes alterations in bile composition. In particular it rises the proportion of highly detergent bile acids with the possible consequence of the manifestation of dyspepsia in a high percentage of patients: this is the well-known post-cholecystectomy syndrome. In this clinical trial we studied the activity and safety of tauroursodeoxycholic acid--TUDCA--(500 mg/die) in the prevention of dyspepsia in cholecystectomized patients, in comparison with no treated group. We enrolled 203 patients (101 TUDCA--group A--and 102 control-group B). The two groups were comparable for age (47.1 years in group A and 50.7 years in group B), sex (m/f: 28/73 and 37/65 in the two groups) and for other characteristics connected to surgical procedures. After operation all patients suffered from dyspepsia symptoms. In patients treated with TUDCA we registered a prompt regression in severity of symptoms when compared with no treated group: in fact we noted a significant difference only at the first control planned after one month from operation. No difference were registered at the other controls (two and three months after operation). Two patients in A and 3 in group B manifested adverse events. In conclusion, the treatment with TUDCA, a new hydrophilic bile acid, seems to contribute to the improvement of clinical course in cholecystectomized patients.

Publication types

  • Clinical Trial
  • Comparative Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Cholecystectomy* / adverse effects
  • Dyspepsia / etiology
  • Dyspepsia / prevention & control*
  • Female
  • Follow-Up Studies
  • Humans
  • Isomerism
  • Male
  • Middle Aged
  • Postoperative Complications / prevention & control*
  • Taurochenodeoxycholic Acid / therapeutic use*

Substances

  • Taurochenodeoxycholic Acid
  • ursodoxicoltaurine