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

Gao 2010.

Methods Prospective, parallel, open‐label, randomised study
Dates the study was conducted: from January 2005 to December 2009
Funding sources and potential conflicts of interest: no information reported
Definition of compliance: > 95%
Participants Number and type of participants: 215 H.pylori‐positive participants were enrolled in the study and all completed the treatment
Participants were randomised to 3 different treatment groups: group A received a 10‐day bismuth pectin quadruple therapy, group B received a sequential therapy and group C received a standard 1‐week triple therapy.
Note: The groups of interest for this review are B and C. Data from group A are not summarised. The participant groups did not differ in age, sex, gastritis distribution and location, and number of peptic ulcers in gastric mucosa
Number of participants randomised: 215 (ITT sample)
Number of participants in the 10‐day SEQ arm (group B): 72
Number of participants in the 7‐day STT arm (group C): 71
Country: China
Sex (M/F) per treatment group
  • 10‐day SEQ: 35/3

  • 7‐day STT: 34/37


Medical condition at baseline per treatment group:
‐ Gastric ulcer
  • 10‐day SEQ: 42/72

  • 7‐day STT: 39/71


‐ Duodenal bulb ulcer
  • 10‐day SEQ: 12/72

  • 7‐day STT: 10/71


‐ Compound ulcers
  • 10‐day SEQ: 7/72

  • 7‐day STT: 4/71


Average age (SD) of the population in years reported by treatment group:
  • 10‐day SEQ (group B): 47 (13)

  • 7‐day STT (group C): 43 (15)


Number of participants per treatment group (B and C respectively) and medical condition:
‐ Antral gastritis: 61 in group B and 57 in group C
‐ Pangastritis: 15 in group B and 19 in group C
‐ Intestinal metaplasia: 21 in group B and 17 in group C
‐ Duodenitis: 13 in group B and 10 in group C
‐ Gastric ulcer: 42 in group B and 39 in group C
‐ Duodenal bulb ulcer: 12 in group B and 10 in group C
‐ Compound ulcers:7 in group B and 4 in group C
Interventions Name, dose timing of antibiotics in 7‐day STT:
omeprazole 20 mg twice a day + amoxicillin 1 g twice a day + clarithromycin 500 mg twice a day
Name, dose timing of antibiotics in 10‐day SEQ:
omeprazole 20 mg twice a day + amoxicillin 1 g twice a day (5 days) and omeprazole 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, histology and RUT
Time for assessment of H. pylori status after treatment: 4 ‐ 6 weeks
Outcomes ITT eradication rate (%) by treatment group:
  • 10‐day SEQ (group B): 64/72 (88.89)

  • 7‐day STT (group C): 58/71 (80.56)


ITT ulcer cicatrisation rate (%) by treatment group:
  • 10‐day SEQ (group B): 55/61 (90.16)

  • 7‐day STT (group C): 45/53 (84.91)


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: > 95% / > 95%
Incidence of AEs (%) by type and treatment group:
  • AEs rate (%) in 10‐day SEQ (group B): 14/72 (19.44). 5 with abdominal pain, 1 with constipation, 2 with parageusia, 3 with nausea/vomiting and 3 with pruritus

  • AEs rate (%) in 7‐day STT (group C): 11/71 (15.49). 1 with diarrhoea, 4 with abdominal pain, 1 with parageusia, 1 with glossitis and 3 with nausea/vomiting


Incidence rate (%) of serious AEs SEQ/STT: not reported
All side effects were self‐limiting after the therapy was ended
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk It was not specified how the randomisation was performed
Allocation concealment (selection bias) Unclear risk No information regarding the allocation concealment was provided
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 We consider the study to be unblinded, as it was defined as 'open‐label'
Publication format Low risk Full article