De Francesco 2004b.
Methods | Prospective randomised study Dates the study was conducted: not reported Funding sources and potential conflicts of interest: No funding sources reported.The authors report no conflicts of interest Definition of compliance: >95% intake |
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Participants | Number and type of participants: 347 H.pylori‐positive participants were enrolled and 342 completed the study Number of participants randomised: 347 (ITT sample) Number of participants in the 7‐day STT arm: 115 Number of participants in the 10‐day STT arm: 116 Number of participants in the 10‐day SEQ arm: 116 Average age (SD) of the population in years reported by treatment group:
Country: Italy Number of participants of the ITT population per treatment group with a medical condition: ‐ NUD, n = 228 (65.7%)
‐ PUD, n = 119 (34.3%)
Sex proportions as M/F per treatment group
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Interventions |
Name, dose timing of antibiotics in STT: rabeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day Name, dose timing of antibiotics in SEQ: rabeprazole 20 mg twice a day + amoxicillin 1 g twice a day (5 days) + rabeprazole 20 mg twice a day, clarithromycin 500 mg twice a day,tinidazole 500 mg twice a day (5 days) Sensitivity test (yes/no) to antibiotics before/after treatment: no Method of assessment of H. pylori status after treatment: ¹³C‐UBT, RUT, histology Time for assessment of H. pylori status after treatment: 6 ‐ 8 weeks |
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Outcomes | ITT eradication rate (%) by treatment group:
PP eradication rate (%) by treatment group:
Reported PP eradication rate (%) in NUD participants:
Reported PP eradication rate (%) in PUD participants:
Calculated ITT eradication rate (%) in NUD participants:
Calculated ITT eradication (%) in PUD participants:
Overall PP eradication rate (%) for both the NUD and PUD groups respectively: 177/224 (79) and 108/118 (91.5) 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: reported as > 95% in all treatment groups Incidence (%) of AEs 10‐day SEQ/7‐day STT/10‐day STT: 10.3/6/7.7 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 | Truly randomised study by a computer‐generated list |
Allocation concealment (selection bias) | Unclear risk | No information was 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 | No information was reported |
Publication format | Low risk | Full article |