Lahbabi 2013.
Methods | Randomised trial Dates the study was conducted: from June 2009 to August 2011 Funding sources and potential conflicts of interest: No information reported on funding Authors declare no conflicts of interest Definition of compliance: evaluated by pill count. Compliance was considered good if ≥ 90% and poor if ≤ 60% |
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Participants | Number and type of participants: 327 H.pylori‐positive participants were enrolled in the study Participants were randomised to 3 different treatment groups: 2 groups with 7‐day standard triple regimens (different antibiotic amoxicillin versus metronidazole) and 1 group with10‐day sequential regimen. According to our study question, only the data referring to the 7‐day STT (amoxicillin group) and the 10‐day SEQ are relevant Country: Morocco Number of participants randomised: 323 (ITT sample) Number of participants in the 7‐day STT arm: 115 Number of participants in the 10‐day SEQ arm: 104 Mean age (SD) of the population reported by treatment group,
Sex ratio (M / F) by treatment group
Number (%) of PUD participants at baseline, by treatment group:
Number (%) of participants with gastric ulcer, by treatment group:
Number (%) of participants with NUD, by treatment group:
H. pylori diagnostic methods in all treatment arms: H. pylori infection was determined by at least 1 of the following tests: histology and/or PCR |
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Interventions |
Name, dose timing of antibiotics in 7‐day STT: omeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day Name, dose timing of antibiotics in 10‐day SEQ: omeprazole 20 mg twice a day + amoxicillin 1 g twice a day (during 5 days) and omeprazole 20 mg twice a day + clarithromycin 500 mg 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: 3 months |
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Outcomes | ITT eradication rate (%) by treatment group:
PP eradication rate (%) by treatment group:
Adherence rate (%) as > 90% to therapy 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 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) | Low risk | Randomisation was made by a computer‐generated list drawn up by a statistician |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Primary outcome data were clearly reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Single‐blinded |
Publication format | Low risk | Full article |