The Lancet, Early Online Publication, 16 November 2012

Sequential versus triple therapy for the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial

Jyh-Ming Liou MD, Chieh-Chang Chen MD, Mei-Jyh Chen MD, Chien-Chuan Chen, Chi-Yang Chang MD, Yu-Jen Fang MD, Ji—Yuh Lee MD , Shih-Jer Hsu MD, Jiing-Chyuan Luo MD, Wen-Hsiung Chang MD, Yao-Chun Hsu MD, Cheng-Hao Tseng MD, Ping-Huei Tseng MD, Hsiu-Po Wang MD, Prof Ueng-Cheng Yang PhD, Prof Chia-Tung Shun MD, Prof Jaw-Town Lin MD, Dr Yi-Chia Lee MD , Dr Prof Ming-Shiang Wu MD , for the Taiwan Helicobacter Consortium

Summary
Background   Whether sequential treatment can replace triple therapy as the standard treatment for Helicobacter pylori infection is unknown. We compared the efficacy of sequential treatment for 10 days and 14 days with triple therapy for 14 days in first-line treatment.

Methods  For this multicentre, open-label, randomised trial, we recruited patients (≥20 years of age) with H pylori infection from six centres in Taiwan. Using a computer-generated randomisation sequence, we randomly allocated patients (1:1:1; block sizes of six) to either sequential treatment (lansoprazole 30 mg and amoxicillin 1 g for the first 7 days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 500 mg for another 7 days; with all drugs given twice daily) for either 10 days (S-10) or 14 days (S-14), of 14 days of triple therapy (T-14; lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg for 14 days; with all drugs given twice daily). Investigators were masked to treatment allocation. Our primary outcome was the eradication rate in first-line treatment by intention-to-treat (ITT) and per-protocol (PP) analyses. This trial is registered with ClinicalTrials.gov, number NCT01042184.

Findings   Between Dec 28, 2009, and Sept 24, 2011, we enrolled 900 patients: 300 to each group. The eradication rate was 90·7% (95% CI 87·4—94·0; 272 of 300 patients) in the S-14 group, 87·0% (83·2—90·8; 261 of 300 patients) in the S-10 group, and 82·3% (78·0—86·6; 247 of 300 patients) in the T-14 group. Treatment efficacy was better in the S-14 group than it was in the T-14 group in both the ITT analysis (number needed to treat of 12·0 [95% CI 7·2—34·5]; p=0·003) and PP analyses (13·7 [8·3—40], p=0·003). We recorded no significant difference in the occurrence of adverse effects or in compliance between the three groups.

Interpretation   Our findings lend support to the use of sequential treatment as the standard first-line treatment for H pylori infection.