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. 2016 Jun 28;2016(6):CD009034. doi: 10.1002/14651858.CD009034.pub2

Lee 2015.

Methods Prospective, multicentre, randomised controlled clinical trial
Dates the study was conducted: from July 2013 to March 2014
Funding sources and potential conflicts of interest: study supported by Basic Science Research Program through the National Research Foundation of Korea funded by the Ministry of Education, Science and Technology, No. 2013R1A1A2062603. No conflicts of interest reported
Definition of compliance: Compliance was considered good if ≥ 80%, otherwise participants were excluded from the PP analysis. Participants were asked to count the remaining pills
Participants Number and type of participants: 680 H.pylori‐positive participants were enrolled in the study
Participants were randomised to 4 different treatment groups: 2 groups to standard triple regimens (but different antibiotics used metronidazole instead of clarithromycin in 1 of them), 1 group with10‐day sequential regimen and 1 other group with concomitant therapy. According to our study question, only the data referring to the 7‐day STT therapy using clarithromycin and the 10‐day SEQ are relevant
Country: Korea
Number of participants randomised: 680 (ITT total sample)
Number of participants in the 7‐day STT arm: 170 (ITT sample)
Number of participants in the 10‐day SEQ arm: 170 (ITT sample)
Mean age (SD) of the population reported by treatment group:
  • 7‐day STT: 55.6 (13.6)

  • 10‐day SEQ: 58.3 (12.3)


Sex ratio (M/F) by treatment group:
  • 7‐day STT: 102/68

  • 10‐day SEQ: 110/60


Number (%) of participants with gastric ulcer at baseline, by treatment group:
  • 7‐day STT: 81 (47.7)

  • 10‐day SEQ: 86 (50.6)


Number (%) of participants with duodenal ulcer by treatment group:
  • 7‐day STT: 36 (21.2)

  • 10‐day SEQ: 32 (18.8)


Number (%) of participants with gastritis by treatment group:
  • 7‐day STT: 53 (31.2)

  • 10‐day SEQ: 52 (30.6)


H. pylori diagnostic methods in all treatment arms: H. pylori infection was confirmed by endoscopy using histology (Warthin‐Starry stain)
Interventions Name, dose timing of antibiotics in 7‐day STT:
rabeprazole 40 mg twice a day + clarithromycin 1g twice a day + amoxicillin 1 g twice a day (during 7 days)
Name, dose timing of antibiotics in 10‐day SEQ:
rabeprazole 40 mg twice a day + amoxicillin 1 g twice a day (during 5 days) and rabeprazole 40 mg twice a day + clarithromycin 1g 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: 6 weeks
Outcomes ITT eradication rate (%) by treatment group :
  • 7‐day STT: 109/170 (64)

  • 10‐day SEQ: 119/170 (70)


PP eradication rate (%) by treatment group:
  • 7‐day STT: 109/143 (76.2)

  • 10‐day SEQ: 119/141 (84)


Adherence was not reported
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:
  • 7‐day STT: 86/152 (50.6)

  • 10‐day SEQ: 70/160 (41.2)


Incidence (%) serious AEs SEQ/STT: not reported
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The method of randomisation was not reported
Allocation concealment (selection bias) Unclear risk The method of allocation was not reported
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Primary outcomes were clearly reported; however the frequency of antibiotics used was not reported
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label
Publication format Low risk Full article