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

Ali Habib HS 2013.

Methods Prospective randomised trial
Dates the study was conducted: not reported
Funding sources and potential conflicts of interest: funded by the Deanship of Scientific Research, (DSR), King Abdulaziz University (KAU), Jeddah, under grant number (332/140/1431). The authors, therefore, acknowledge with thanks DSR for technical and financial support. The authors declare no conflicts of interest
Definition of compliance: evaluated by counting the number of tablets returned
Participants Number and type of participants: 18 H.pylori‐positive children were enrolled in the study
Participants were randomised to 4 different treatment groups (groups A to D). Group A was administered a quadruple therapy and group C a quinolone‐based triple therapy (which were not of interest in this review) Groups B and D were of interest. Group B consisted of a 10‐day standard triple regimen and group D consisted of a 10‐day sequential regimen
Number of participants randomised: 18 (each group had the same number of participants)
Number of participants in the 10‐day STT arm, ITT analysis: 9
Number of participants in the 10‐day SEQ arm, ITT analysis: 9
Number of participants in the 10‐day STT arm, PP analysis: 9
Number of participants in the 10‐day SEQ arm, PP analysis: 7
Country: Saudi Arabia
Average age (standard deviation) of the population in years reported by treatment group: not reported ‐ but authors mentioned adults participants were included
Sex (M/F) per treatment group, n (%): only men and boys in both groups
Medical condition at baseline: all participants were NUD
H. pylori diagnostic method: culture of endoscopy biopsies (both from the antrum ant corpus). RUT was applied to the biopsies
Interventions Name, dose timing of antibiotics in 10‐day STT:
rabeprazole 20 mg twice a day + clarithromycin 250 mg twice a day + amoxicillin 500 mg twice a day (during 10 days)
Name, dose timing of antibiotics in 10‐day SEQ:
rabeprazole 20 mg twice a day + amoxicillin 500 mg twice a day (during 5 days) and rabeprazole 20 mg twice a day + clarithromycin 250 mg twice a day + tinidazole 500 mg twice a day (during 5 days)
Sensitivity test (yes/no) to antibiotics before/after treatment: not reported
Method of assessment of H. pylori status after treatment: UBT
Time for assessment of H. pylori status after treatment: 6 weeks
Outcomes ITT eradication rate (%) by treatment group:
  • 10‐day STT: 5/9 (55.6)

  • 10‐day SEQ: 4/9 (44.4)


PP eradication rate (%) by treatment group:
  • 10‐day STT: 5/9 (55.6)

  • 10‐day SEQ: 4/7 (57.1)


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 in ITT sample SEQ/STT: 2 boys from the SEQ group were poorly compliant, considered drop‐outs and excluded
Incidence of AEs per treatment group: not reported
WIthdrawals due to AEs: not reported.
Incidence (%) serious AEs SEQ/STT: not reported
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants were randomised in 1:1 groups; the method of randomisation is not reported
Allocation concealment (selection bias) Unclear risk The method of allocation is not reported
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Primary outcomes are not clearly reported in an ITT analysis
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No information regarding blinding
Publication format Low risk Full article