Should we eradicate Helicobacter pylori before prescribing an NSAID? Result of a placebo-controlled study
Abstract
OBJECTIVE: (1) To determine the prevalence of gastrointestinal (GI) symptoms in patients with and without Helicobacter pylori infection and treated with non-steroidal anti-inflammatory drugs (NSAIDs) and (2) to estimate the impact of H. pylori eradication on these symptoms.
METHODS: This was a multicentric, community-based, randomized, case-control study. Patients presenting with a rheumatic disorder motivating the prescription of an NSAID for at least 2 wks were stratified in two groups (H. pylori-positive and H. pylori-negative) by a serological doctor test and H. pylori-positive patients divided further into two subgroups, receiving either an eradication treatment (group 1) or a placebo (group 2). The main outcome measure was the prevalence of GI symptoms estimated in groups 1 and 2 and in noninfected patients (group 3) at weeks 2, 6, and 12.
RESULTS: Among H. pylori-negative patients (n=145), GI symptoms were present in 42.6%, 21.4%, and 10.0% at weeks 2, 6, and 12, respectively. In groups 1 and 2, GI symptoms were present in 57.7% and 40.7%, respectively, at week 2 (p= 0.03); 24.7% and 23% at week 6 (p= 0.85); and 9.4% and 17.3% at week 12 (p= 0.13). The prevalence of GI symptoms at week 2 was similar in group 2 and in the H. pylori-negative group (p= 0.77). The highest prevalence of symptoms at week 2 in group 1 was essentially due to diarrhea. The prevalence of GI symptoms was the same for groups 1 and 3 at week 12, and higher in group 2, but the difference did not…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 145 participants or records.
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