A placebo-controlled trial of 10-day bismuth-based quadruple therapy to eradicate Helicobacter pylori infection; a pilot study for the large Linqu County trial.
OBJECTIVE
To explore a low-cost and highly-effective therapy for eradication of Helicobacter pylori (H. pylori), a placebo-controlled trial of quadruple therapy was conducted in a population at high risk of gastric cancer in Linqu County of Shandong Province, China.


METHODS
Two hundred and seventy-seven adults aged 35-54 years with H. pylori infection in three villages were assigned to two groups: treatment (n=189 in two villages) and placebo (n=88 in one village). Participants received either a 10-day oral quadruple therapy regimen with omeprazole (20 mg, twice daily); tetracycline (750 mg, three times daily); metronidazole (500 mg, three times daily) and bismuth potassium citrate (300 mg, twice daily), or a similar lookalike placebo regimen. The status of H. pylori infection in each trial participant before and after six weeks of treatment was determined by a 13C-urea breath test.


RESULTS
One hundred and seventy-four of 189 participants completed the quadruple therapy (92.1%) and 84 participants completed the placebo therapy (95.5%). The H. pylori eradication rate by intention-to-treat analysis was 76.7% (145 of 189) in the treatment group and 1.1% (1 of 88) in the placebo group, respectively; by per-protocol analysis it was 83.3% (145 of 174) in the treatment group and 1.2% (1 of 84) in the placebo group, respectively.


CONCLUSIONS
In a high-risk area of gastric cancer, we conducted a high compliance, tolerable, low side-effect and lowcost therapy of anti-H. pylori. The eradication rate of the 10-day quadruple treatment was more than 80% and significantly higher than the triple therapy regimen used in this population in an earlier trial.
Ma
Junling
J
Key Laboratory of Carcinogenesis and Translation Research (Ministry of Education), Department of Epidemiology, Peking University School of Oncology, Beijing Cancer Hospital, Beijing, China.
Liu
Weidong
W
Zhang
Lian
L
Pan
Kaifeng
K
Zhao
Hongjun
H
Zhou
Tong
T
Winawer
Sidney
S
Zauber
Ann
A
Classen
Meinhard
M
You
Weicheng
W
D000328:Adult; D000863:Antacids / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D000890:Anti-Infective Agents / Q000008:administration & dosage; D000897:Anti-Ulcer Agents / Q000008:administration & dosage; D001729:Bismuth / Q000008:administration & dosage*; D001944:Breath Tests; D002247:Carbon Isotopes; D002681:China / Q000453:epidemiology; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage; D010349:Patient Compliance; D010865:Pilot Projects; D010919:Placebos; D012424:Rural Population; D013752:Tetracycline / Q000008:administration & dosage; D014508:Urea / Q000378:metabolism
D000863:Antacids; D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D000897:Anti-Ulcer Agents; D002247:Carbon Isotopes; D010919:Placebos; D008795:Metronidazole; D014508:Urea; D013752:Tetracycline; D009853:Omeprazole; D001729:Bismuth