[Helicobacter pylori eradication therapy with bismuth citrate/amoxycillin combination therapy].
The efficacy of a new combination preparation containing bismuth citrate and amoxicillin in one tablet was compared with the efficacy of bismuth citrate monotherapy in a randomised double-blind study on the eradication of Helicobacter pylori. The study involved 70 H. pylori positive (antrum biopsies showing a positive urease test) patients with non-ulcer dyspepsia and chronic gastritis. The treatment period was 14 days; 35 patients in group 1 received 2 tablets tid containing the bismuth citrate amoxicillin combination (BIAM tablet; 250 mg amoxicillin base and 120 mg bismuth); 35 patients in group 2 were treated with 2 tablets tid containing bismuth citrate (BI tablet; 120 mg bismuth). Total daily dose was therefore 1500 mg amoxicillin + 720 mg bismuth in group 1 patients resp. 720 mg bismuth in group 2 patients. 4 weeks after therapy H. pylori could not be histologically detected in the antrum of 22 patients (63%) in group 1 and 8 patients (24%) in group 2. Thus in group 1 (BIAM) a significantly higher eradication rate (p < 0.001) was shown than in group 2 (BI). Inflammation characterized by the infiltration of polymorphonuclear cells was significantly (p < 0.01) less pronounced in group 1 (BIAM) than in group 2 (BI) 4 weeks after the end of treatment. Gastrointestinal distress was quantified by evaluation of 13 different symptoms using a fourpoints scale at the beginning of the study and after 2 and 6 weeks. The sum of scores decreased by 81% in group 1 (BIAM) and 71% in group 2 (BI) after 6 weeks.
Stanescu
A
A
Abteilung für Allgemeinchirurgie, Universitätsklinik Ulm.
Mayer
D
D
Gabard
B
B
Jost
G
G
Baczako
K
K
Dragici
A
A
Malfertheiner
P
P
D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage* / Q000009:adverse effects; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D005756:Gastritis / Q000188:drug therapy*; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage* / Q000009:adverse effects
D000897:Anti-Ulcer Agents; D004338:Drug Combinations; D009942:Organometallic Compounds; D000658:Amoxicillin; C002791:bismuth tripotassium dicitrate