Oh 2012.
| Methods | Randomised, open‐label, double‐arm trial Dates study was conducted: from December 2009 to December 2010 Funding sources and potential conflicts of interest: no information reported Definition of compliance: intake > 90% |
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| Participants | Number and type of participants: 246 H.pylori‐positive participants were enrolled in the study Participants were randomised to 2 different treatment groups: 7‐day standard triple regimen and 10‐day sequential regimen Number of participants randomised: 246 (ITT sample) Number of participants in the 7‐day STT arm, ITT analysis: 130 Number of participants in the 10‐day SEQ arm, ITT analysis: 116 Number of participants in the 7‐day STT arm, PP analysis: 127 Number of participants in the 10‐day SEQ arm, PP analysis: 111 Country: Korea Average age (SD) of the population in years reported by treatment group:
Sex proportions (M/F) by treatment group:
Medical condition at baseline reported as number of participants (%) in the 7‐day STT regimen/10‐day SEQ regimen:
H. pylori diagnostic methods in both treatment arms: both tests had to be positive for the participant to be classified as H. pylori‐positive
A gastric biopsy from the corpus was also taken |
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| Interventions | Participants randomised to the SEQ group were administered metronidazole Name, dose timing of antibiotics in 7‐day STT: rabeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day (during 7 days) Length of STT (days): 7 Name, dose timing of antibiotics in 10‐day SEQ: rabeprazole 20 mg twice a day + amoxicillin 1 g twice a day (during 5 days) and rabeprazole 20 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 reported Method of assessment of H. pylori status after treatment: ¹³C‐urea breath test Time for assessment of H. pylori status after treatment: 4 weeks |
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| Outcomes | The study flow chart showed that after randomisation, in the 7‐day STT arm there were 3 dropouts, whereas in the 10‐day SEQ there were 2 dropouts 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: 5 participants were excluded from the analysis as they took < 90% of the drugs Incidence and type of AEs reported as the number of participants (%) in the SEQ/STT arms respectively: Bitter taste: 6 (18.7)/6 (16.6), P = 1.000 Nausea 5 (15.6)/1 (3.2), P = 0.196 Epigastric soreness: 7 (21.8)/7 (19.3), P = 1.000 Diarrhoea: 7 (21.8)/6 (16.6), P = 1.000 Headache: 2 (6.2)/2 (6.4), P = 1.000 Dyspepsia: 1 (3.1)/5 (16.1), P = 0.104 Constipation: 1 (3.1)/1 (3.2), P = 1.000 Bloating: 2 (6.2)/2 (6.4), P = 1.000 Oral mucositis: 1 (3.1)/0 Dizziness: 0/1 (3.2) Total of AEs: 27.5 (32/116)/23.8 (31/130), P = 0.559 Incidence (%) of 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 | The trial was truly randomised as individuals were assigned into treatment groups by using a random‐number table |
| Allocation concealment (selection bias) | Unclear risk | Concealment allocation was not defined |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Primary outcome data were clearly reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | The trial was not blinded as it was reported open‐label |
| Publication format | Low risk | Full article |