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 |
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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 |
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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 |
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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 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 |
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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 |