NSAIDs and ulcers: is H pylori the real problem?
Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed to relieve the pain of arthritis. However, studies have shown that people taking NSAIDS for long periods of time, as is the case with arthritis, are at increased risk of developing an ulcer. In addition, the presence of the bacteria H pylori in the digestive tract has been shown to increase the risk of ulcers. A recent study published in The Lancet suggests that eradicating H pylori before giving arthritis patients NSAIDs for six months reduced their risk of getting an ulcer.
About the study
Researchers in Hong Kong enrolled 100 men and women with arthritis (average age of 62) from two outpatient clinics in Hong Kong. These patients all needed to begin long-term NSAIDs therapy, had positive breath tests for H pylori , and had moderate stomach upset, indigestion or a history of stomach ulcer. Reasons for exclusion from the study included NSAIDs use (other than low-dose aspirin) for longer than one month or within the eight weeks before enrollment; use of steroids, blood thinners, or anti-ulcer drugs; kidney problems; or previous H pylori infection, gastric surgery or serious ulcer complications.
The patients were randomly assigned to one of two medication regimens:
Eradication group: the ulcer medication omeprazole (Prilosec) and the antibiotics amoxicillin (Amoxil) and clarithromycin (Biaxin) taken twice daily for one week followed by the NSAID diclofenac (Voltaren) taken once daily for six months
Control group: the ulcer medication omeprazole (Prilosec) and placebo pills taken twice daily for one week followed by the NSAID diclofenac (Voltaren) taken once daily for six months
A research nurse interviewed each patient at week 4 and every 8 weeks for six months thereafter. The nurse monitored their compliance with taking the medication, the effectiveness of the medication in relieving pain, stomach upset, evidence of gastrointestinal bleeding, and blood tests. Each patient also underwent endoscopy to check for ulcers and H pylori , either at the end of the six months or earlier if the patient had severe stomach upset or evidence of gastrointestinal bleeding. The researchers then compared which patients developed ulcers with the medication regimens they took.
Fifteen of 49 patients in the control group developed ulcers compared with only 5 of 51 patients in the eradication group. In addition, the average size of ulcers in the control group was 1 cm in diameter compared with only 0.5 cm in the eradication group. These findings suggest that eradicating H pylori before beginning long-term NSAIDs therapy may help high-risk patients avoid developing an ulcer.
In addition, H pylori was eradicated in 90% of patients in the eradication group and 6% of patients in the control group, indicating that the antibiotic therapy was effective in eradicating H pylori .
Several limitations of this study are worth noting. First, the study was not designed to determine if H pylori and NSAIDs work together or independently to increase the risk of ulcer. It is possible that the antibiotic therapy to eradicate H pylori prevented ulcers caused by H pylori but not ulcers caused by NSAIDs. Second, because patients did not undergo endoscopy at the start of the study, the researchers were not able to evaluate the condition of the patients' stomach linings before starting therapy. Although the authors did not declare any conflict of interest, it is unclear who funded this study.
How does this affect you?
Whether H pylori increases the risk of ulcers in people taking NSAIDs regularly for a long period of time is controversial. Previous studies have tried to determine if eradicating H pylori before starting long-term NSAIDs therapy reduces the risk of ulcer, but have produced conflicting results. Another study, also published in this issue of The Lancet , confirms that both H pylori infection and NSAIDs are independent risk factors for developing ulcers.
Do you need to be tested for H pylori and take antibiotics before you take an NSAID? In most cases, no. This study suggests that only patients who are at increased risk of ulcers and need to take a prescription-strength NSAID daily for several months or more may benefit from being tested and treated for H pylori first. If you take ibuprofen for a few days for pain relief, you are probably not at risk for getting an NSAIDs-induced ulcer and do not need to take antibiotics.
Based on the findings of this study and others, you may want to consider asking your doctor about H pylori testing and treatment before taking an NSAID regularly for an extended period of time.
Chan FKL, et al. Eradication of
and risk of peptic ulcers in patients starting long-term treatment with non-steroidal anti-inflammatory drugs: a randomized trial.
Lancet . January 5, 2002;359:9-13.
and NSAIDs—the end of the debate?
Lancet . January 5, 2002;359:3-4.
Last reviewed Jan 15, 2002
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