Lopez‐Román 2011.

Methods	Prospective, randomised, Phase IIB clinical trial (interim analysis) Dates the study was conducted: not reported Funding sources and potential conflicts of interest: no information reported Definition of compliance: not reported
Participants	Number and type of participants: 123 H.pylori‐positive participants were enrolled in the study Participants were randomised to 3 different treatment groups: 10‐day standard triple regimen, 10‐day sequential regimen and 14‐day sequential regimen Number of participants randomised: 123 (ITT sample) Number of participants in the 10‐day STT arm: 41 Number of participants in the 10‐day SEQ arm: 41 PP sample: not reported Country: Puerto Rico Average age (SD) of the population in years: 64.7 (9.7) Sex (M/F) of the population: 120/3; i.e. 97.5% were men Medical condition at baseline: not reported H. pylori diagnostic methods in all treatment arms: CLO test and histology
Interventions	Participants randomised to the SEQ group were administered metronidazole Length of STT (days): 10 Name, dose timing of antibiotics in 10‐day STT: omeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day (during 10 days) Name, dose timing of antibiotics in 10‐day SEQ: omeprazole 20 mg twice a day + amoxicillin 1 g twice a day (during 5 days) and omeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + metronidazole 500 mg twice a day (during 5 days) (Total: 10 days) Sensitivity test (yes/no) to antibiotics before/after treatment: not reported Method of assessment of H. pylori status both before and after treatment: ¹³C‐UBT Time for assessment of H. pylori status after treatment: 8 weeks
Outcomes	ITT cure proportion (%) by treatment group: 10‐day STT: 33/41 (80) 10‐day SEQ: 27/41 (65.9) PP cure (%) by treatment group: 10‐day STT: 84.2 10‐day SEQ: 71.1 Metronidazole resistance (%) before treatment, SEQ ITT/PP: not reported Metronidazole resistance (%) before treatment, STT ITT/PP: not reported Clarithromycin resistance (%) before treatment, SEQ ITT/PP: not reported Clarithromycin resistance (%) before treatment, STT ITT/PP: not reported Compliance was > 99.5% in both treatment arms (10‐day SEQ and 10‐day STT) Incidence (%) of AEs in the total population: 25.2% Incidence (%) serious AEs SEQ / STT: not reported
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The study is pseudo‐random as no clear statement on how the randomisation has been performed
Allocation concealment (selection bias)	Unclear risk	No clear information was provided on the sequence of randomisation
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Primary outcomes were reported as percentages. The number of participants randomised to each treatment arm was not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information was provided regarding the masking
Publication format	High risk	Abstract