Eradication of Helicobacter pylori and risk of peptic ulcers in patients starting long-term treatment with non-steroidal anti-inflammatory drugs: a randomised trial.
BACKGROUND
Whether Helicobacter pylori increases the risk of ulcers in patients taking non-steroidal anti-inflammatory drugs (NSAIDs) is controversial. We hypothesised that eradication of H pylori infection would reduce the risk of ulcers for patients starting long-term NSAID treatment.


METHODS
Patients were enrolled if they were NSAID naïve, had a positive urea breath test, had dyspepsia or an ulcer history, and required long-term NSAID treatment. They were randomly assigned omeprazole triple therapy (eradication group) or omeprazole with placebo antibiotics (placebo group) for 1 week. All patients were given diclofenac slow release 100 mg daily for 6 months from randomisation. Endoscopy was done at 6 months or if severe dyspepsia or gastrointestinal bleeding occurred. The primary endpoint was the probability of ulcers within 6 months. Analyses were by intention to treat.


RESULTS
Of 210 arthritis patients screened, 128 (61%) were positive for H pylori. 102 patients were enrolled, and 100 were included in the intention-to-treat analysis. H pylori was eradicated in 90% of the eradication group and 6% of the placebo group. Five of 51 eradication-group patients and 15 of 49 placebo-group patients had ulcers. The 6-month probability of ulcers was 12.1% (95% CI 3.1-21.1) in the eradication group and 34.4% (21.1-47.7) in the placebo group (p=0.0085). The corresponding 6-month probabilities of complicated ulcers were 4.2% (1.3-9.7) and 27.1% (14.7-39.5; p=0.0026).


CONCLUSIONS
Screening and treatment for H pylori infection significantly reduces the risk of ulcers for patients starting long-term NSAID treatment.
Chan
Francis K L
FK
Departments of Medicine and Therapeutics, The Chinese University of Hong Kong, Special Administrative Region of China, Hong Kong. fklchan@cuhk.edu.hk
To
K F
KF
Wu
Justin C Y
JC
Yung
M Y
MY
Leung
W K
WK
Kwok
Timothy
T
Hui
Y
Y
Chan
Henry L Y
HL
Chan
Cynthia S Y
CS
Hui
Elsie
E
Woo
Jean
J
Sung
Joseph J Y
JJ
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects* / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001168:Arthritis / Q000188:drug therapy; D003692:Delayed-Action Preparations; D004008:Diclofenac / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D010437:Peptic Ulcer / Q000139:chemically induced / Q000209:etiology / Q000517:prevention & control*; D011336:Probability; D012307:Risk Factors
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D003692:Delayed-Action Preparations; D004008:Diclofenac; D009853:Omeprazole