Anti-Helicobacter pylori treatment in bleeding ulcers: randomized controlled trial comparing 2-day versus 7-day bismuth quadruple therapy.
BACKGROUND
One-week bismuth triple therapy has been established to be highly effective in curing H. pylori infection, but patient compliance has been the major factor of success in therapy. For patients hospitalized for ulcer bleeding, an effective regimen that can completed before discharge will ensure full compliance.


OBJECTIVE
To compare 2-day versus 1-wk bismuth triple therapy plus omeprazole in curing H. pylori infection and bleeding peptic ulcers.


METHODS
100 patients with non-actively bleeding duodenal (DU) or gastric ulcers (GU) and confirmed H. pylori infection were randomized to receive either bismuth subcitrate 120 mg, tetracycline 500 mg, and metronidazole 400 mg four times daily for 1 wk (OBTM-7) or bismuth subcitrate 240 mg, tetracycline 500 mg, and metronidazole 400 mg four times daily for 2 days (OBTM-2). Both groups of patients also received omeprazole 20 mg twice daily for the first week. In the OBTM-2 group, the anti-Helicobacter therapy was finished during hospitalization. Endoscopy was repeated 5 wk after randomization to monitor ulcer healing and determine H. pylori status. Side effects related to the anti-Helicobacter therapy was graded as follows: A, mild discomfort, which did not affect daily activity; B, moderate discomfort affecting daily activity; and C, severe discomfort and patients discontinued therapy.


RESULTS
Forty-six patients in the OBTM-2 group and 50 in the OBTM-7 group returned for follow-up endoscopy. With an intention-to-treat analysis, ulcer healing was achieved in 44 of 46 patients (95.7%) in the OBTM-2 group versus 49 of 50 (98%) in the OBTM-7 group, p = 0.61. H. pylori eradication was successful in 35 of 46 patients (76.1%) in the OBTM-2 and in all 50 patients (100%) in the OBTM-7 group, p = 0.00024. There was no difference in the severity of side effects experienced by the patients in the OBTM-2 group than in the OBTM-7 group (19 vs 32%, p = 0.16). None of the patients had rebled during the period of follow-up.


CONCLUSIONS
Despite similar efficacy in ulcer healing, the 2-day quadruple therapy is less effective than the 1-wk regimen in curing H. pylori infection.
Kung
N N
NN
Department of Medicine, United Christian Hospital, Hong Kong.
Sung
J J
JJ
Yuen
N W
NW
Ng
P W
PW
Wong
K C
KC
Chung
E C
EC
Lim
B H
BH
Choi
C H
CH
Li
T H
TH
Ma
H C
HC
Kwok
S P
SP
D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001729:Bismuth / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004381:Duodenal Ulcer / Q000188:drug therapy / Q000382:microbiology; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006760:Hospitalization; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000009:adverse effects; D009942:Organometallic Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D010349:Patient Compliance; D010438:Peptic Ulcer Hemorrhage / Q000188:drug therapy* / Q000382:microbiology; D013276:Stomach Ulcer / Q000188:drug therapy / Q000382:microbiology; D013752:Tetracycline / Q000008:administration & dosage / Q000009:adverse effects
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D009942:Organometallic Compounds; D008795:Metronidazole; D013752:Tetracycline; C002791:bismuth tripotassium dicitrate; D009853:Omeprazole; D001729:Bismuth