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

Huang 2013.

Methods Prospective, multicentre, randomised controlled trial
Dates the study was conducted: from January 2008 to December 2010
Funding sources and potential conflicts of interest: study funded in full by Key Projects of the National Science & Technology Pillar Program of China, No. 2007BAI04B02. Authors declare no conflicts of interest
Definition of compliance: not defined
Adherence was monitored by telephone interview of the participant or parent and review of daily reporting card
Participants Number and type of participants: 360 H.pylori‐positive participants (all children) were enrolled in the study
Participants were randomised to 3 different treatment groups: 7‐day standard triple regimen, 10‐day standard triple regimen and 10‐day sequential regimen
Country: China
Number of participants randomised: 360 (ITT sample)
Number of participants in the 7‐day STT arm: 118
Number of participants in the 10‐day STT arm: 124
Number of participants in the 10‐day SEQ arm: 118
Mean age of the population reported as the number of participants by treatment group, 7‐day STT, 10‐day STT / 10‐day SEQ:

  • 9.7 (SD 3.8)

  • 7.9 (SD 3.4)

  • 8.7 (SD 4.1)


Sex (M/F) per treatment group

  • 7‐day STT: 70/48

  • 10‐day STT: 69/55

  • 10‐day SEQ: 71/47


Medical condition at baseline was not detailed; just confirmed H.pylori gastritis
H. pylori diagnostic methods in all treatment arms: RUT, HpSA, culture and histology
Interventions Name, dose timing of antibiotics in 7‐day STT:
omeprazole 0.8 – 1.0 mg/kg/d + clarithromycin 20 mg/kg/d + amoxicillin 30 mg/kg/d
Name, dose timing of antibiotics in 10‐day STT:
omeprazole 0.8 – 1.0 mg/kg/d + clarithromycin 20 mg/kg/d + amoxicillin 30 mg/kg/d
Name, dose timing of antibiotics in 10‐daySEQ:
omeprazole 0.8 – 1.0 mg/kg/d + amoxicillin 30 mg/kg/ (during 5 days) and omeprazole 0.8 – 1.0 mg/kg/d + clarithromycin 20 mg/kg/d + metronidazole 20 mg/kg/d (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: by a negative H. pylori stool antigen test
Time for assessment of H. pylori status after treatment: 4 weeks
Outcomes ITT eradication (%) (95% CI) by treatment group:

  • 7‐day STT: 73/118 (61.9%) (53.1 to 70.7)

  • 10‐day STT: 84/124 (67.7%) (59.5 to 75.9)

  • 10‐day SEQ: 96/118 (81.4%) (74.4 to 84.4)


PP eradication (%) by treatment group:

  • 7‐day STT: 73/103 (70.8%) (62.1 to 79.7)

  • 10‐day STT: 84/108 (77.8%) (70.0 to 85.6)

  • 10‐day SEQ: 96/107 (89.7%) (83.9 to 95.5)


Adherence (%) (95% CI) to therapy by treatment group: (n = 1314)

  • 14‐day STT: 378/434 (87.1% (83.6 to 90.1))

  • 10‐day SEQ: 355/438 (81.1% (77.1 to 84.6))


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
ITT adherence by amount of drugs taken and by treatment group 14‐day STT/10‐day SEQ:

  • All (100%): 427 (97%)/437 (93%)

  • Nearly all (> 80%): 7 (2%)/2 (< 1%)

  • Most (50% – 80%): 24 (5%)/21 (4%)

  • Less than half (< 50%): 10 (2%)/5 (11%)

  • Undetermined (but not all): 7 (2%)/5 (1%)

  • None: 0/0


Incidence of AEs by treatment group (n, %):

  • 7‐day STT: 24/103 (23.3%)

  • 10‐day STT: 37/108 (34.3%)

  • 10‐day SEQ: 32/107 (29.9%)


Incidence (%) serious AEs SEQ/STT: not reported
Outcome related to adherence was not reported
Notes The 10‐day sequential regimen was significantly more effective than standard 7‐day or 10‐day triple regimens in eradicating H. pylori infection in Chinese children
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Restricted randomisation using block randomisation
Allocation concealment (selection bias) Low risk The randomisation code was developed by using a computer random‐number generator to select random permuted blocks, with a varied block size of 4, 8 or 10
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Primary outcome data were clearly reported, however authors failed to report outcomes related to adherence
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk The details of treatment assignments were unknown to any of the investigators, study co‐ordinators or participants and were contained in a set of sealed envelopes
Publication format Low risk Full article