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

Rakici 2014.

Methods Randomised, controlled trial
Dates the study was conducted: from January 2010 to December 2011
Funding sources and potential conflicts of interest: no funding reported. Authors declare no conflicts of interest
Definition of compliance: Non‐compliance was defined as participants who were reluctant to take the drugs due to nausea, diarrhoea, a bitter taste in the mouth, an allergic reaction and feeling ill
Participants umber and type of participants: 514 H.pylori‐positive were enrolled in the study
Participants were randomised into to 3 different treatment groups: 14‐day STT, 10‐day SEQ and a modified triple therapy (with moxifloxacin and metronidazole). For our review purpose, only data related to STT and SEQ are relevant.
Country: Turkey
Number of participants randomised: 514
Number of participants in the 7‐day STT arm: 171
Number of participants in the 10‐day SEQ arm: 172
Average age (range) of the population in years, reported by treatment group:
  • 14‐day STT: 46.3 (18 – 75)

  • 10‐day SEQ: 46.9 (18 – 79)


Medical condition at baseline reported as number of participants (%) in the 14‐day STT regimen/10‐day SEQ regimen:
  • Normal: 13 (7.6)/1 (0.6)

  • Gastritis: 137 (80.1)/145 (84.3)

  • Peptic ulcer: 21 (12.3)/26 (15.1)


Sex (M/F) per treatment group:
  • 7‐day STT: 76/95

  • 10‐day SEQ: 72/100


H. pylori diagnostic methods in both treatment arms: histological examination and stool antigen tests
Interventions Participants randomised to the SEQ group were administered metronidazole
Name, dose timing of antibiotics in 14‐day STT:
lansoprazole 30 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day (during 7 days)
Length of STT (days): 14
Name, dose timing of antibiotics in 10‐day SEQ:
lansoprazole 30 mg twice a day + amoxicillin 1 g twice a day (during 5 days) and lansoprazole 30 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 performed
Method of assessment of H. pylori status after treatment: stool antigen testing
Time for assessment of H. pylori status after treatment: 4 ‐ 6 weeks
Outcomes The study flow chart showed that in the 14‐day STT arm there were 2 losses, and in the 10‐day SEQ there were 2 losses
ITT eradication rate (%) by treatment group:
  • 14‐day STT: 144/171 (84.2)

  • 10‐day SEQ: 146/172 (84.9)


PP eradication rate (%) by treatment group:
  • 14‐day STT: 144/169 (85.2)

  • 10‐day SEQ: 146/170 (85.8)


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
Adherence > 90% (n, (%)) in ITT sample: not reported
Incidence n (%) of AEs, by treatment group: not reported
Incidence (n, %) serious AEs, SEQ / STT: not reported
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants were reported to be randomised but method of randomisation given
Allocation concealment (selection bias) Unclear risk Concealment of the sequence was not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Primary outcomes were clearly reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not reported
Publication format Low risk Full article