Skip to main content
. 2016 Jun 28;2016(6):CD009034. doi: 10.1002/14651858.CD009034.pub2

De Francesco 2004a.

Methods Randomised controlled trial
Dates the study was conducted: not reported
Funding sources and potential conflicts of interest: No information reported
Definition of compliance: > 90% intake was considered as 'acceptable'
Participants Number and type of participants: 97 H.pylori‐positive participants were included in the study
Number of participants randomised: 97 (ITT sample)
Number of participants in the 10‐day SEQ arm: 45 (group A)
Number of participants in the 10‐day STT arm: 52 (group B)
Country: Italy
Average age (SD) of the ITT population in years, by treatment group:
  • 10‐day SEQ (reported as group A): 44.2 (16.2)

  • 10‐day STT (reported as group B): 46.0 (15.3)


Sex (M/F) per treatment group
  • 10‐day SEQ: 20/25

  • 10‐day STT: 21/31


Number of participants (rate) of the ITT population per treatment group with a medical condition:
‐ NUD
  • 10‐day SEQ: 36/45

  • 10‐day STT: 35/52


‐ PUD
  • 10‐day SEQ: 9/45

  • 10‐day STT: 11/52


At baseline, the groups were reported homogeneous with regard to sex, age, smoking habit and endoscopic findings (PUD/NUD)
Interventions Name, dose timing of antibiotics in 10‐day STT (group B):
rabeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day (during 10 days)
Name, dose timing of antibiotics in 10‐day SEQ (group A):
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
Time for assessment of H. pylori status after treatment: 6 ‐ 8 weeks
Outcomes 95 participants completed the study: 2/45 (2%) did not return after therapy for unreported reasons (1 PUD in group A and 1 NUD in group B)
ITT eradication rate (%) by treatment group and PP:
  • 10‐day SEQ: 43/45 (95.5)

  • 10‐day STT: 42/52 (80.7)


PP eradication rate (%) by treatment group:
  • 10‐day SEQ: 43/44 (97.7)

  • 10‐day STT: 42/51 (82.3)


ITT eradication rate (%) in NUD participants: 60/70 (85.7)
ITT eradication rate (%) in PUD participants: 25/25 (100)
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
Incidence (%) of AEs SEQ/7‐day STT ‐ 10‐day STT: not reported
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