Scaccianoce 2006.

Methods	Prospective, parallel, open‐label, 2‐centre, randomised study Dates the study was conducted: not reported Funding sources and potential conflicts of interest: no information reported Definition of compliance: intake > 90% of prescribed drugs and determined by pills count at the follow‐up visit
Participants	Number and type of participants: 213 NUD and H.pylori‐positive participants 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 Number of participants randomised: 213 Number of participants in the 7‐day STT arm: 70 Number of participants in the 10‐day STT arm: 71 Number of participants in the 10‐day SEQ arm: 72 Country: Italy Average age (SD) of the population in years reported by treatment group: 7‐day STT: 54 (12) 10‐day STT: 53 (16) 10‐day SEQ: 55 (14) Sex (M/F) per treatment group 7‐day STT: 34/36 10‐day STT: 33/38 10‐day SEQ: 32/40 Medical condition at baseline reported as number of participants per treatment group, 7‐day STT/10‐day STT/10‐day SEQ: All participants were NUD Antral gastritis: 59/59/61 Pangastritits: 11/12/11 Intestinal metaplasia: 13/13/15 Bacterial density per treatment group, 7‐day STT/10‐day STT/10‐day SEQ: Low: 20/23/25 Moderate: 44/40/39 Marked: 6/8/8 H. pylori diagnostic methods in all treatment arms: all participants were considered H. pylori‐positive if both of the following tests were positive: RUT: 1 sample from the antrum Histology: endoscopy with biopsies, 2 samples from the antrum ant 2 samples from the corpus
Interventions	Participants randomised to the SEQ group were administered tinidazole Length of STT (days): 7 and 10 days Name, dose timing of antibiotics in 7‐day STT: esomeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day (during 7 days) Name, dose timing of antibiotics in 10‐day STT: esomeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day (during 10 days) Name, dose timing of antibiotics in 10‐day SEQ: esomeprazole 20 mg twice a day + amoxicillin 1 g twice a day (during 5 days) and esomeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + tinidazole 500 mg twice a day (during 5 days) (Total: 10 days) Sensitivity test (yes/no) to antibiotics before/after treatment: not specified Method of assessment of H. pylori status after treatment: ¹³C‐urea breath test Time for assessment of H. pylori status after treatment: 4 ‐ 6 weeks The breath samples were considered positive if there was > 5 per 1000 of ¹³CO₂ difference over baseline
Outcomes	Overall, 6 participants (2 in each treatment group) stopped the treatment and did not undergo the ¹³C‐urea breath test. The final PP population consisted of 207 participants ITT eradication rate (%) (95% CI) by treatment group: 7‐day STT: 53/70 (75.7) (66 to 86) 10‐day STT: 58/71 (81.7) (73 to 91) 10‐day SEQ: 68/72 (94.4) (89 to 100) PP eradication rate (%) (95% CI) by treatment group: 7‐day STT: 53/68 (77.9) (68 to 88) 10‐day STT: 58/69 (84.1) (75 to 93) 10‐day SEQ: 68/70 (97.1) (93 to 100) 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: reported as 'good' in all groups (> 95%) but for 6 participants who stopped the treatment due to side effects Incidence of AEs per type and number of participants (%) per treatment group: 7‐day STT: 7 participants (10%) in total: diarrhoea (n = 2); abdominal pain (n = 2) ; urticaria (n = 1) and glossitis (n = 1). 2 of them interrupted the treatment 10‐day STT:9 participants (12.7%) in total: abdominal pain (n = 2); diarrhoea (n = 3); glossitis (n = 2); nausea/vomiting (n = 1) and pruritus (n = 1). 2 of them interrupted the treatment 10‐day SEQ: 8 participants (11.1%) in total: diarrhoea (n = 3); abdominal pain (n = 3); nausea/vomiting (n = 1) and glossitis (n = 1), causing treatment interruption in 2 of them Incidence (%) serious AEs SEQ / STT: not reported
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	This is a truly randomised trial where treatments were assigned by a computer‐generated list
Allocation concealment (selection bias)	Unclear risk	The allocation concealment is unclear as no information with a description of the allocation 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	This is not a blinded study as it was reported open‐label
Publication format	Low risk	Full article