2011 - Quadruple-drug therapy was better than triple-drug therapy for eradicating Helicobacter pylori in adults

Talley, Nicholas J.
June 2011
ACP Journal Club;6/21/2011, Vol. 154 Issue 6, p1
Academic Journal
Question What are the efficacy and safety of quadruple-drug therapy compared with standard triple-drug therapy for eradicating Helicobacter pylori infection? Methods Design Randomized controlled trial. ClinicalTrials.gov NCT00669955. Allocation Concealed.* Blinding Unblinded.* Follow-up period 10 weeks. Setting 39 centers in France, Germany, Ireland, Italy, Poland, Spain, and the UK. Patients 440 patients >18 years of age (mean age 48 y, 54% men among 438 patients treated) with confirmed H. pylori infection (positive urea breath test; positive rapid urease test; and positive histology, culture, or polymerase chain reaction assay) and upper gastrointestinal (GI) symptoms. Women of child-bearing potential had to use medically acceptable contraception during and up to 30 days after the end of the study. Exclusion criteria included substantial organ impairment; severe or unstable cardiopulmonary or endocrine disease; history of upper GI tract surgery; bleeding or iron-deficiency anemia; Barrett esophagus or high-grade dysplasia; dysphagia; history of cancer; drug or alcohol misuse in the past year; past use of antibiotics for H. pylori; continuous use of antiulcer drugs, antibiotics or bismuth compounds, systemic glucocorticoids, nonsteroidal antiinflammatory drugs, or anticoagulation or platelet aggregation inhibitors other than acetylsalicylic acid >100 mg/d; and pregnancy or nursing. Intervention Quadruple therapy for 10 days (n =>218) or standard therapy for 7 days (n =>222). Quadruple therapy comprised omeprazole, 20 mg, twice daily, plus 3 capsules 4 times daily; each capsule contained a combination of bismuth subcitrate potassium, 140 mg; metronidazole, 125 mg; and tetracycline hydrochloride, 125 mg. Standard therapy comprised omeprazole, 20 mg; amoxicillin, 500 mg; and clarithromycin, 500 mg, each twice daily. Outcomes H. pylori eradication (negative urea breath tests at 6 and 10 wk) and adverse events. Patient follow-up 91% completed the study (intention-to-treat analysis). Main results Quadruple therapy was better than standard therapy for eradicating H. pylori (Table). The proportion of patients with treatment-emergent adverse events was similar in both groups (all events 47% vs 51%, P =>0.44; severe events 5% vs 7%, P =>0.36; P values calculated from data in article). Conclusion Quadruple-drug therapy was better than standard triple-drug therapy for eradicating H. pylori in adults.


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