De Francesco 2004a.
Methods | Randomised controlled trial Dates the study was conducted: not reported Funding sources and potential conflicts of interest: No information reported Definition of compliance: > 90% intake was considered as 'acceptable' |
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Participants | Number and type of participants: 97 H.pylori‐positive participants were included in the study Number of participants randomised: 97 (ITT sample) Number of participants in the 10‐day SEQ arm: 45 (group A) Number of participants in the 10‐day STT arm: 52 (group B) Country: Italy Average age (SD) of the ITT population in years, by treatment group:
Sex (M/F) per treatment group
Number of participants (rate) of the ITT population per treatment group with a medical condition: ‐ NUD
‐ PUD
At baseline, the groups were reported homogeneous with regard to sex, age, smoking habit and endoscopic findings (PUD/NUD) |
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Interventions |
Name, dose timing of antibiotics in 10‐day STT (group B): rabeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day (during 10 days) Name, dose timing of antibiotics in 10‐day SEQ (group A): 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 Time for assessment of H. pylori status after treatment: 6 ‐ 8 weeks |
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Outcomes | 95 participants completed the study: 2/45 (2%) did not return after therapy for unreported reasons (1 PUD in group A and 1 NUD in group B) ITT eradication rate (%) by treatment group and PP:
PP eradication rate (%) by treatment group:
ITT eradication rate (%) in NUD participants: 60/70 (85.7) ITT eradication rate (%) in PUD participants: 25/25 (100) 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: not reported Incidence (%) of AEs SEQ/7‐day STT ‐ 10‐day STT: 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) | 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 |