Vaira 2007.
| Methods | Randomised, double‐blind, placebo‐controlled trial Dates the study was conducted: from September 2003 to April 2006 Funding sources and potential conflicts of interest: Dr. Vakil was paid at a conference by Altana Pharma (Nicomed) (manufacturer of pantoprazole). Authors declare potential financial conflicts: grant received, consultancies and stock ownership Definition of compliance: > 90% |
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| Participants | Number and type of participants: 300 participants with dyspepsia or peptic ulcers Participants were randomised to 2 different treatment groups: 10‐day standard triple regimen and 10‐day sequential regimen Number of participants randomised: 300 Number of participants in the 10‐day SEQ arm: 150 Number of participants in the 10‐day STT arm: 150 ITT sample: 300 participants PP sample: 289 participants ‐ Number of participants in the 10‐day SEQ arm: 143 ‐ Number of participants in the 10‐day STT arm: 146 Country:Italy Average age (SD) of the population in years by treatment group:
Sex proportions (%) reported as M/F, by treatment group:
Medical condition at baseline reported as the proportion of participants by treatment group: ‐ peptic ulcer:
‐ antral gastritis:
‐ intestinal metaplasia:
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| Interventions | Participants randomised to the SEQ group were administered tinidazole Name, dose timing of antibiotics in 10‐day STT: pantoprazole 40 mg + amoxicillin 1 g + clarithromycin 500 mg Name, dose timing of antibiotics in 10‐day SEQ: pantoprazole 40 mg twice a day + amoxicillin 1 g twice a day + placebo twice a day (5 days) and pantoprazole 40 mg twice a day + clarithromycin 500 mg twice a day + tinidazole 500 mg twice a day (5 days) Length of STT (days): 10 days Sensitivity test (yes/no) to antibiotics before/after treatment: not reported Method of assessment of H. pylori status after treatment: ¹³C‐UBT Time for assessment of H. pylori status after treatment: at both 4 and 8 weeks |
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| Outcomes | ITT eradication rate (%) by treatment group:
PP eradication rate (%) by treatment group:
Regarding the influence of resistance, data for 246 participants, including 127 who were treated with 10‐day SEQ and 119 who were treated with the 10‐day STT, were available for the PP analysis: metronidazole resistance rate (%) before treatment:
*metronidazole‐susceptible proportion (%) before treatment: (P = 0.009)
*clarithromycin‐resistance proportion (%) before treatment: (P = 0.0034)
*Differences between groups were statistically significant PP clarithromycin‐susceptible proportion (%) before treatment:
PP both clarithromycin and metronidazole resistance (%):
Adherence to treatment < 90% reported as the number of participants (%) by treatment group:
Incidence rate (%) of minor AEs:
The most frequent side effects in both groups were epigastric pain (5.6% vs 4.8%; P = 0.902) and mild diarrhoea (4.8% vs 2.8%; P = 0.54) Incidence rate (%) of serious AEs by treatment group SEQ/STT: not reported |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A computer‐generated randomisation chart was used to determine allocation, which was stratified according to centre by using a block design and a block size of 4 |
| Allocation concealment (selection bias) | Low risk | Participant allocation was determined with a random‐number chart that was concealed from investigators and participants by using numbered blister packs of the study medication that corresponded to the random‐number chart Allocation was concealed with an opaque envelope, which contained a number that corresponded to the numbered blister packs |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Primary outcome data were clearly reported |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | A placebo that was identical in colour and shape to the clarithromycin capsule was administered during the first 5 days of sequential therapy to maintain blinding |
| Publication format | Low risk | Full article |