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

Talley NJ. — Tue, 21 Jun 2011 00:00:00 GMT

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.Quadruple-drug therapy vs standard triple-drug therapy in adults with H. pylori infection†OutcomesQuadruple therapyStandard therapyAt 10 wkRBI (95% CI)NNT (CI)H. pylori eradication93% (174/188)68% (123/182)37% (24 to 54)5 (4 to 6)†Abbreviations defined in Glossary. RBI, NNT, and CI calculated from data in article.

Annals of Internal Medicine: H. Pylori Topic Collection

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