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

Hsu 2014.

Methods Open‐label, randomised controlled trial (registration no. NCT1769365)
Dates the study was conducted: not reported
Funding sources and potential conflicts of interest: funded by research grant NSC 99‐2314‐B‐075B‐009‐MY2 from the National Science Council. Authors declare no conflicts of interest
Definition of compliance: assessed by pill counts. Good compliance was defined as taking 80% of the total medication
Participants umber and type of participants: 307 H.pylori‐positive participants were enrolled in the study
Participants were randomised to 3 different treatment groups: 7‐day standard triple regimen, 10‐day sequential therapy and 7‐day concomitant therapy. Only data related to STT and SEQ are relevant
Country: Japan
Number of participants randomised: 307 (ITT sample)
Number of participants in the ITT 7‐day STT arm: 103
Number of participants in the ITT 10‐day SEQ arm: 102
Number of participants in the PP sample: 303
Number of participants in the PP 7‐day STT arm: 101 (1 insufficient compliance and 1 lost to follow‐up)
Number of participants in the PP 10‐day SEQ arm: 100 (2 insufficient compliance)
Mean age of the population reported as the number of participants by treatment group:

  • 7‐day STT: 56.08 (SD 14)

  • 10‐day SEQ: 54.96 (SD 12)


Sex (M/F) per treatment group

  • 7‐day STT: 62/41

  • 10‐day SEQ: 52/50


Medical condition at baseline (endoscopic findings) reported as n (%) in STT and SEQ respectively:

  • Gastritis: 25 (25)/18 (18)

  • Gastric ulcer: 34 (33)/43 (42)

  • Duodenal ulcer: 17 (17)/18 (18)

  • Gastric and duodenal ulcer: 27 (27)/23 (23)


H. pylori diagnostic methods in all treatment arms: by RUT, histology or culture
Interventions Name, dose timing of antibiotics in 7‐day STT:
pantoprazole 40 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day (7 days)
Name, dose timing of antibiotics in 10‐day SEQ:
pantoprazole 40 mg twice a day + amoxicillin 1 g twice a day (5 days) followed
 by pantoprazole 40 mg twice a day + clarithromycin 500 mg twice a day + metronidazole 500 mg twice a day (5 days)
Sensitivity test (yes/no) to antibiotics before/after treatment: Yes. Antibiotic susceptibility was determined by Etest (AB Biodisk, Solna, Sweden). H. pylori strains were tested for clarithromycin, amoxicillin, and metronidazole susceptibilities using the Etest (AB Biodisk). H. pylori strains with MICs of 1 g/ml, 0.5 g/ml, and 8 g/ml were considered to be resistant to clarithromycin, amoxicillin, and metronidazole, respectively
A total of 127 (elsewhere reported 129 ‐ not clear) strains were isolated of the 160 participants receiving endoscopy and bacterial culture on enrolment
Results are reported as (n of susceptible/n of resistant) by antibiotic and treatment arms respectively:

  • Clarithromycin:

  • STT: 32/7

  • SEQ: 39/5

  • Amoxicillin:

  • STT: 39/0

  • SEQ: 44/0

  • Metronidazole:

  • STT: 8/11

  • SEQ: 31/13


Method of assessment of H. pylori status after treatment:
Eradication defined as the negative results of all RUT, histology, and culture, or (ii) a negative result from the UBT
Time for assessment of H. pylori status after treatment: 6 weeks
Outcomes ITT eradication rate (%) (95% CI) by treatment group:

  • 7‐day STT: 84/103 (81.6) (74.1 to 89.0)

  • 10‐day SEQ: 91/102 (89.2) (83.2 to 95.2)


PP eradication rate (%) (95% CI) by treatment group:

  • 7‐day STT: 83/101 (82.2) (74.8 to 89.6)

  • 10‐day SEQ: 90/100 (90.0) (84.1 to 95.9)


Eradication (%) in SEQ and STT according to antibiotic resistances:
Metronidazole‐resistant strains:

  • 7‐day STT: 7/8 (87.5)

  • 10‐day SEQ: 10/11 (90.9)


Claritromycin‐resistant strains rate (%) by treatment group:

  • 7‐day STT: 2/4 (50)

  • 10‐day SEQ: 2/3 (66.7)


Dual resistant strains rate (%) by treatment group:

  • 7‐day STT: 2/3 (66.7)

  • 10‐day SEQ: 1/2 (50)


Adherence: not reported.
Compliance rate (%) (95% CI) by treatment group: (n = 1314)

  • 7‐day STT: 102/103 (99) (97.1 to 100.9)

  • 10‐day SEQ: 100/102 (98) (95.3 to 100.7)


Incidence rate (%) (95% CI) of AEs by treatment group :

  • 7‐day STT: 9/103 (8.7) (3.3 to 14.2)

  • 10‐SEQ: 9/102 (8.8) (3.3 to 14.3)


Incidence (%) serious AEs SEQ/STT: not reported
Outcome related to adherence was not reported
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A computer‐generated number sequence was used
Allocation concealment (selection bias) Low risk An independent research assistant assigned the therapies according to the treatment allocations kept in the envelopes
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Primary outcome data were clearly reported
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label
Publication format Low risk Full article