An International Multi-Clinic Study Comparing the Therapeutic Efficacy of Colloidal Bismuth Subcitrate Coated Tablets with Chewing Tablets in the Treatment of Duodenal Ulceration

Abstract

The results of a randomized, single-blind, multi-clinic study comparing the therapeutic efficacy and degree of oral staining of new colloidal bismuth subcitrate (CBS) coated tablets over 4 weeks of treatment in patients suffering from duodenal ulceration are reported. The data were collected from 9 clinics in the Netherlands, Belgium, Ireland, the United Kingdom, and Italy. The results from 94 patients treated with CBS coated tablets and 95 patients treated with CBS chewing tablets were statistically evaluated. Healing rates after 4 weeks of therapy appeared to be 76% for CBS coated tablets and 72% for CBS chewing tablets, so no statistically significant difference in therapeutic efficacy was seen. A highly significant degree of discolouration of all parts of the oral cavity was observed in patients treated with CBS chewing tablets, whereas only a few patients treated with CBS coated tablets experienced a slight staining of the tongue. Blood bismuth concentrations during the study had a range of ⩽3 to 33 μg/l. The new CBS coated tablet form has an excellent patient compliance as compared to the chewing tablets.

Key Words:

• Blood bismuth level
• chewing tablets
• coated tablets
• colloidal bismuth subcitrate
• oral cavity staining