Rakici 2014.
Methods | Randomised, controlled trial Dates the study was conducted: from January 2010 to December 2011 Funding sources and potential conflicts of interest: no funding reported. Authors declare no conflicts of interest Definition of compliance: Non‐compliance was defined as participants who were reluctant to take the drugs due to nausea, diarrhoea, a bitter taste in the mouth, an allergic reaction and feeling ill |
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Participants | umber and type of participants: 514 H.pylori‐positive were enrolled in the study Participants were randomised into to 3 different treatment groups: 14‐day STT, 10‐day SEQ and a modified triple therapy (with moxifloxacin and metronidazole). For our review purpose, only data related to STT and SEQ are relevant. Country: Turkey Number of participants randomised: 514 Number of participants in the 7‐day STT arm: 171 Number of participants in the 10‐day SEQ arm: 172 Average age (range) of the population in years, reported by treatment group:
Medical condition at baseline reported as number of participants (%) in the 14‐day STT regimen/10‐day SEQ regimen:
Sex (M/F) per treatment group:
H. pylori diagnostic methods in both treatment arms: histological examination and stool antigen tests |
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Interventions | Participants randomised to the SEQ group were administered metronidazole Name, dose timing of antibiotics in 14‐day STT: lansoprazole 30 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day (during 7 days) Length of STT (days): 14 Name, dose timing of antibiotics in 10‐day SEQ: lansoprazole 30 mg twice a day + amoxicillin 1 g twice a day (during 5 days) and lansoprazole 30 mg twice a day + clarithromycin 500 mg twice a day + metronidazole 500 mg twice a day (during 5 days) (Total: 10 days) Sensitivity test (yes/no) to antibiotics before/after treatment: not performed Method of assessment of H. pylori status after treatment: stool antigen testing Time for assessment of H. pylori status after treatment: 4 ‐ 6 weeks |
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Outcomes | The study flow chart showed that in the 14‐day STT arm there were 2 losses, and in the 10‐day SEQ there were 2 losses 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: not reported Adherence > 90% (n, (%)) in ITT sample: not reported Incidence n (%) of AEs, by treatment group: not reported Incidence (n, %) 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 reported to be randomised but method of randomisation given |
Allocation concealment (selection bias) | Unclear risk | Concealment of the sequence was not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Primary outcomes were clearly reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
Publication format | Low risk | Full article |