[Non-bismuth quadruple therapy versus standard triple therapy for Helicobacter pylori eradication: a randomized controlled study].
OBJECTIVE
To compare the efficacies of non-bismuth quadruple therapy for 7 days versus standard triple therapy for 7 or 10 days in initial treatment of Helicobacter pylori (H.pylori) .


METHODS
A randomized, open-labeled, controlled trial comparing non-bismuth quadruple therapy with standard triple therapy was performed at Peking University First Hospital from August 2010 to July 2012. A total of 246 patients with a diagnosis of H.pylori infection by (13)C-urea breath test and receiving no eradication therapy were randomly divided into non-bismuth quadruple therapy and standard triple therapy for 7 or 10 days. There were 110 males and 136 females with an age range of 18-75 years. Among them, 81 patients received non-bismuth quadruple therapy (esomeprazole 20 mg, amoxicillin 1 000 mg, clarithromycin 500 mg and tinidazole 500 mg given twice daily for 7 days); 82 standard triple therapy (esomeprazole 20 mg, amoxicillin 1 000 mg and clarithromycin 500 mg given twice daily) for 7 days and 83 standard triple therapy for 10 days. The efficacies were examined at Week 4 post-therapy by (13)C-urea breath test. The incidence of adverse drug reactions was recorded.


RESULTS
Among them, 242 patients completed the follow-up. The eradication rates for non-bismuth quadruple therapy and standard triple therapy for 7 or 10 days were 91.4% (74/81), 79.3% (65/82) and 79.5% (66/83) as determined by intention-to-treat analysis (ITT). The eradication rates were 92.5% (74/80), 81.3% (65/80) and 80.5% (66/82) respectively as determined by per-protocol analysis (PP).Non-bismuth quadruple therapy was superior to standard triple therapy for 7 days (ITT analysis P = 0.029, PP analysis P = 0.035) and 10 days (ITT analysis P = 0.032, PP analysis P = 0.026). The differences for the eradication rates between standard triple therapy for 7 days and for 10 days were insignificant (ITT analysis P = 0.968, PP analysis P = 0.902): Adverse reaction rates for non-bismuth quadruple therapy (8.8%, 7/80) and standard triple therapy for 7 days (7.5%, 6/80) and 10 days (9.8%, 8/82) were not significantly different (P = 0.872).


CONCLUSIONS
Non-bismuth quadruple therapy for 7 days is both effective and safe for the first-line eradication of H.pylori.
Department of Gastroenterology, Peking University First Hospital, Beijing 100034, China.
Shujun
S
Wang
Department of Gastroenterology, Peking University First Hospital, Beijing 100034, China. Email: wangweihong@medmail.com.cn.
Weihong
W
Wang
Department of Gastroenterology, Peking University First Hospital, Beijing 100034, China.
Yunxiang
Y
Chu
Department of Gastroenterology, Peking University First Hospital, Beijing 100034, China.
Guigen
G
Teng
Department of Gastroenterology, Peking University First Hospital, Beijing 100034, China.
Fulian
F
Hu
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D001729:Bismuth / Q000008:administration & dosage* / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
D000900:Anti-Bacterial Agents; D001729:Bismuth