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. 2016 Jun 28;2016(6):CD009034. doi: 10.1002/14651858.CD009034.pub2

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
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:
  • 10‐day STT: 24/21

  • 10‐day SEQ: 14/12


H. pylori diagnostic methods in both treatment arm: stool antigen test and/or a repeat histology obtained at repeated endoscopy
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
Outcomes ITT eradication rate (%) by treatment group:
  • 10‐day STT: 22/52 (42.3)

  • 10‐day SEQ: 22/52 (42.3)


PP eradication rate (%) by treatment group:
  • 10‐day STT: 22/45 (48.8)

  • 10‐day SEQ: 22/26 (84.6)


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
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