Lee 2015.
Methods | Prospective, multicentre, randomised controlled clinical trial Dates the study was conducted: from July 2013 to March 2014 Funding sources and potential conflicts of interest: study supported by Basic Science Research Program through the National Research Foundation of Korea funded by the Ministry of Education, Science and Technology, No. 2013R1A1A2062603. No conflicts of interest reported Definition of compliance: Compliance was considered good if ≥ 80%, otherwise participants were excluded from the PP analysis. Participants were asked to count the remaining pills |
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Participants | Number and type of participants: 680 H.pylori‐positive participants were enrolled in the study Participants were randomised to 4 different treatment groups: 2 groups to standard triple regimens (but different antibiotics used metronidazole instead of clarithromycin in 1 of them), 1 group with10‐day sequential regimen and 1 other group with concomitant therapy. According to our study question, only the data referring to the 7‐day STT therapy using clarithromycin and the 10‐day SEQ are relevant Country: Korea Number of participants randomised: 680 (ITT total sample) Number of participants in the 7‐day STT arm: 170 (ITT sample) Number of participants in the 10‐day SEQ arm: 170 (ITT sample) Mean age (SD) of the population reported by treatment group:
Sex ratio (M/F) by treatment group:
Number (%) of participants with gastric ulcer at baseline, by treatment group:
Number (%) of participants with duodenal ulcer by treatment group:
Number (%) of participants with gastritis by treatment group:
H. pylori diagnostic methods in all treatment arms: H. pylori infection was confirmed by endoscopy using histology (Warthin‐Starry stain) |
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Interventions |
Name, dose timing of antibiotics in 7‐day STT: rabeprazole 40 mg twice a day + clarithromycin 1g twice a day + amoxicillin 1 g twice a day (during 7 days) Name, dose timing of antibiotics in 10‐day SEQ: rabeprazole 40 mg twice a day + amoxicillin 1 g twice a day (during 5 days) and rabeprazole 40 mg twice a day + clarithromycin 1g twice a day + metronidazole 500 mg twice a day (during 5 days) Sensitivity test (yes/no) to antibiotics before/after treatment: not performed Method of assessment of H. pylori status after treatment: ¹³C‐urea breath test Time for assessment of H. pylori status after treatment: 6 weeks |
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Outcomes | ITT eradication rate (%) by treatment group :
PP eradication rate (%) by treatment group:
Adherence was not reported 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 Incidence rate (%) of total AEs by treatment group:
Incidence (%) serious AEs SEQ/STT: not reported |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The method of randomisation was not reported |
Allocation concealment (selection bias) | Unclear risk | The method of allocation was not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Primary outcomes were clearly reported; however the frequency of antibiotics used was not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label |
Publication format | Low risk | Full article |