Comparison of qid and bd administration of De-Nol in the short term treatment of duodenal ulcer.
One hundred and twelve patients (80 males, 32 females) with endoscopically proven gastroduodenal ulcer participated in a clinical trial to compare the ulcer-healing effect of colloidal bismuth subcitrate (CBS) at standard dosage, administered either twice daily (Group A) or four times a day (Group B). Endoscopic control was programmed at Week 4 and Week 8, in case of delayed healing. With an 'intention to treat' analysis, the healing percentage at four weeks was 69.6 for Group A and 82.1 for Group B (IC95 of percentage difference: -0.049 to 2.29). At Week 8, the healing percentage for Groups A and B was 87.5 and 94.6 per cent respectively (IC95: -0.05 to 0.19). The mean steady-state values of bismuth levels in plasma were well below the threshold value of 50 micrograms/l. The data confirm the efficacy and acceptability of CBS swallowing formulation tablets and suggest that administration twice daily is an acceptable alternative to the qid schedule.
Lazzaroni
M
M
Petrillo
M
M
Bianchi Porro
G
G
D000328:Adult; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001729:Bismuth / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D004341:Drug Evaluation; D004381:Duodenal Ulcer / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000627:therapeutic use*
D000897:Anti-Ulcer Agents; D009942:Organometallic Compounds; C002791:bismuth tripotassium dicitrate; D001729:Bismuth