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% |
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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
Medical condition at baseline per treatment group: ‐ Gastric ulcer
‐ Duodenal bulb ulcer
‐ Compound ulcers
Average age (SD) of the population in years reported by treatment group:
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 |
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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 |
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Outcomes | ITT eradication rate (%) by treatment group:
ITT ulcer cicatrisation rate (%) by treatment group:
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:
Incidence rate (%) of serious AEs SEQ/STT: not reported All side effects were self‐limiting after the therapy was ended |
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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 |