Ang 2015.
| Methods | Prospective randomised controlled study Dates the study was conducted: from December 2011 to March 2014 Funding sources and potential conflicts of interest: study partially supported by research grant from Changi General Hospital. The authors declare no conflicts of interest Definition of compliance: not defined |
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| Participants | Number and type of participants: 462 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 concomitant therapy Only data regarding standard triple and sequential therapies are reported Country: Singapore Number of participants randomised: 462 (ITT sample) Number of participants in the 10‐day STT arm: 155 Number of participants in the 10‐day SEQ arm: 154 Mean age (SD) of the population reported as the number of participants by treatment group:
Sex ratio (Male/out of total) (%) per treatment group
Medical condition at baseline, as the presence of ulcer out of the total (%):
H. pylori diagnostic methods in all treatment arms: ¹³C‐UBT, rapid urease test or histology |
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| Interventions |
Name, dose timing of antibiotics in 10‐day STT: PPI* + clarithromycin 500 mg twice a day, amoxicillin 1g twice a day Name, dose timing of antibiotics in 10‐day SEQ: PPI* + amoxicillin 1 g twice a day (during 5 days) and PPI, clarithromycin 500 mg twice a day+ metronidazole 400 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 after treatment: ¹³C‐UBT Time for assessment of H. pylori status after treatment: 4 weeks |
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| Outcomes | ITT eradication rate (%) (95% CI) by treatment group :
PP eradication rate (%) (95% CI) by treatment group:
Compliance rate (%) by treatment group:
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 No data on antibiotic resistance profile and treatment arm were reported, given the small number per treatment arm did not allow further subgroup analysis of treatment outcome. However, cure proportions among the total number of participants treated reported as the rate (%) were given, stratified by antibiotic resistance:
Incidence of AEs by treatment group (n, %): not reported Incidence (%) serious AEs, SEQ/STT: not reported Adverse events causing termination of the study occurred in 1 participant on triple therapy who developed vomiting and severe abdominal discomfort |
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| Notes | We contacted the first author for the PPI use: most of the participants were given omeprazole standard doses although some of them rabeprazole or esomeprazole. We decided not to include these data in the subgroup analysis, for consistency with the remaining included studies | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was performed in blocks of 15 |
| Allocation concealment (selection bias) | Low risk | All randomisation codes were placed into sealed opaque envelopes and kept by an independent research assistant |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Primary outcomes were reported |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | The technician who performed the antibiotic susceptibility test was blinded to treatment allocation |
| Publication format | Low risk | Full article |