Whether sequential treatment can replace triple therapy as the standard treatment for Helicobacter pylori infection is unknown.
The efficacy of sequential treatment for 10 days and 14 days with triple therapy for 14 days in first-line treatment, was compared.
For this multicentre, open-label, randomised trial, we recruited patients ( greater than or equal to 20 years of age ) with Helicobacter pylori infection from six centres in Taiwan.
Patients ( 1:1:1; block sizes of six ) were randomly allocated 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 ).
The primary outcome was the eradication rate in first-line treatment by intention-to-treat ( ITT ) and per-protocol ( PP ) analyses.
During the period 2009-2011, researcers enrolled 900 patients: 300 to each group.
The eradication rate was 90.7% ( 272 of 300 patients ) in the S-14 group, 87.0% ( 261 of 300 patients ) in the S-10 group, and 82.3% ( 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, NNT, of 12.0; p=0.003 ) and PP analyses ( 13.7; p=0.003 ).
No significant difference in the occurrence of adverse effects or in compliance between the three groups, was recorded.
The findings lend support to the use of sequential treatment as the standard first-line treatment for Helicobacter pylori infection. ( Xagena )
Liou J-M et al, The Lancet 2013; 381: 205-213