Laving 2013.
Methods | Double‐blinded, randomised, controlled trial Format of publication: journal article Dates the study was conducted: from March 2007 to October 2007 Funding sources and potential conflicts of interest: No information of funding nor conflicts of interest reported Definition of compliance: not reported,although authors mentioned that parents were asked 2 weeks after treatment about the treatment schedule |
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Participants | Number and type of participants: 71 H.pylori‐positive children were enrolled in the study Participants were randomised to 2 different treatment groups: 10‐day standard triple regimen and 10‐day sequential regimen Number of participants randomised: 104 (ITT sample) Number of participants in the ITT 10‐day STT arm: 52 Number of participants in the ITT 10‐day SEQ arm: 52 PP sample: 71 Number of participants in the PP 10‐day STT arm: 45 Number of participants in the PP 10‐day SEQ arm: 26 Country: Kenya Average age (SD) of the population in years reported by treatment group: participants included in either group were under the age of 16 Sex (M/F) per treatment group:
H. pylori diagnostic methods in both treatment arm: stool antigen test and/or a repeat histology obtained at repeated endoscopy |
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Interventions |
Name, dose timing of antibiotics in 10‐day STT: pantoprazole 40 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day (during 14 days) Name, dose timing of antibiotics in 10‐day SEQ: 1 mg/kg/day omeprazole + 50 mg/ kg/ day amoxicillin (during 5 days) and 1 mg/ kg/ day omeprazole + 15 mg/kg/day + clarithromycin 20 mg/kg/day + tinidazole (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: repeated endoscopy and stool H. pylori antigen testing 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:
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 PP adherence to the therapy: not reported Incidence of AEs at PP analysis: not reported 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) | Low risk | A computer programme was used to generate random numbers to assign participants to either of the 2 arms as they were recruited |
Allocation concealment (selection bias) | Unclear risk | No information stated |
Incomplete outcome data (attrition bias) All outcomes | High risk | Data regarding eradication are confusing as authors reported the number of participants eradicated separately by stool antigen negative and histology negative testing |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both the study physicians and the participants were blinded |
Publication format | Low risk | Full article |