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

De Francesco 2004b.

Methods Prospective randomised study
Dates the study was conducted: not reported
Funding sources and potential conflicts of interest: No funding sources reported.The authors report no conflicts of interest
Definition of compliance: >95% intake
Participants Number and type of participants: 347 H.pylori‐positive participants were enrolled and 342 completed the study
Number of participants randomised: 347 (ITT sample)
Number of participants in the 7‐day STT arm: 115
Number of participants in the 10‐day STT arm: 116
Number of participants in the 10‐day SEQ arm: 116
Average age (SD) of the population in years reported by treatment group:
  • 7‐day STT (reported as group A): 47 (13.5)

  • 10‐day STT(reported as group B): 49 (13.8)

  • 10‐day SEQ (reported as group C): 46 (12.3)


Country: Italy
Number of participants of the ITT population per treatment group with a medical condition:
‐ NUD, n = 228 (65.7%)
  • 10‐day SEQ: 79/116

  • 7‐day STT: 67/115

  • 10‐day STT: 82/116


‐ PUD, n = 119 (34.3%)
  • 10‐day SEQ: 37/116

  • 7‐day STT: 48/115

  • 10‐day STT: 34/116


Sex proportions as M/F per treatment group
  • 10‐day SEQ: 54/62

  • 7‐day STT: 65/50

  • 10‐day STT: 57/59

Interventions Name, dose timing of antibiotics in STT:
rabeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day
Name, dose timing of antibiotics in SEQ:
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, RUT, histology
Time for assessment of H. pylori status after treatment: 6 ‐ 8 weeks
Outcomes ITT eradication rate (%) by treatment group:
  • 10‐day SEQ: 110/116 (94.8)

  • 7‐day STT: 82/115 (71.3)

  • 10‐day STT: 93/116 (80.1)


PP eradication rate (%) by treatment group:
  • 10‐day SEQ: 110/115 (65.6)

  • 7‐day STT: 82/114 (71.9)

  • 10‐day STT: 93/113 (82.3)


Reported PP eradication rate (%) in NUD participants:
  • 10‐day SEQ: 74/79 (93.6)

  • 7‐day STT: 42/66 (63.6)

  • 10‐day STT: 61/79 (77.2)


Reported PP eradication rate (%) in PUD participants:
  • 10‐day SEQ: 36/36 (100)

  • 7‐day STT: 40/48 (83.3)

  • 10‐day STT: 32/34 (94.1)


Calculated ITT eradication rate (%) in NUD participants:
  • 10‐day SEQ: 74/79 (93.6)

  • 7‐day STT: 42/67 (63.6)

  • 10‐day STT: 61/82(77.2)


Calculated ITT eradication (%) in PUD participants:
  • 10‐day SEQ: 36/37 (100)

  • 7‐day STT: 40/48 (83.3)

  • 10‐day STT: 32/34 (94.1)


Overall PP eradication rate (%) for both the NUD and PUD groups respectively: 177/224 (79) and 108/118 (91.5)
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: reported as > 95% in all treatment groups
Incidence (%) of AEs 10‐day SEQ/7‐day STT/10‐day STT: 10.3/6/7.7
Incidence (%) serious AEs SEQ / STT: not reported
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