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

Lahbabi 2013.

Methods Randomised trial
Dates the study was conducted: from June 2009 to August 2011
Funding sources and potential conflicts of interest: No information reported on funding Authors declare no conflicts of interest
Definition of compliance: evaluated by pill count. Compliance was considered good if ≥ 90% and poor if ≤ 60%
Participants Number and type of participants: 327 H.pylori‐positive participants were enrolled in the study
Participants were randomised to 3 different treatment groups: 2 groups with 7‐day standard triple regimens (different antibiotic amoxicillin versus metronidazole) and 1 group with10‐day sequential regimen. According to our study question, only the data referring to the 7‐day STT (amoxicillin group) and the 10‐day SEQ are relevant
Country: Morocco
Number of participants randomised: 323 (ITT sample)
Number of participants in the 7‐day STT arm: 115
Number of participants in the 10‐day SEQ arm: 104
Mean age (SD) of the population reported by treatment group,
  • 7‐day STT: 48.5 (14.8)

  • 10‐day SEQ: 47.5 (15)

  • Total of participants: 47 (14)


Sex ratio (M / F) by treatment group
  • 7‐day STT: 0.83

  • 10‐day SEQ: 1.19


Number (%) of PUD participants at baseline, by treatment group:
  • 7‐day STT: 30/115 (26)

  • 10‐day SEQ: 21/104 (20)


Number (%) of participants with gastric ulcer, by treatment group:
  • 7‐day STT: 4/115 (3.4)

  • 10‐day SEQ: 2/104 (2)


Number (%) of participants with NUD, by treatment group:
  • 7‐day STT:85/115 (74)

  • 10‐day SEQ: 83/104 (80)


H. pylori diagnostic methods in all treatment arms: H. pylori infection was determined by at least 1 of the following tests: histology and/or PCR
Interventions Name, dose timing of antibiotics in 7‐day STT:
omeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day
Name, dose timing of antibiotics in 10‐day SEQ:
omeprazole 20 mg twice a day + amoxicillin 1 g twice a day (during 5 days) and omeprazole 20 mg twice a day + clarithromycin 500 mg 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: 3 months
Outcomes ITT eradication rate (%) by treatment group:
  • 7‐day STT: 90/115 (78.2)

  • 10‐day SEQ: 98/104 (94.2)


PP eradication rate (%) by treatment group:
  • 7‐day STT: 90/113 (79.6)

  • 10‐day SEQ: 98/102 (96.1)


Adherence rate (%) as > 90% to therapy by treatment group:
  • 7‐day STT: 106/115 (92.2)

  • 10‐day SEQ: 98/104 (94.2)


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: 32/115 (827.8)

  • 10‐day SEQ: 10/104 (9.6)


Incidence (%) serious AEs SEQ/STT: not reported
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was made by a computer‐generated list drawn up by a statistician
Allocation concealment (selection bias) Unclear risk Not 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 Single‐blinded
Publication format Low risk Full article