Digestive System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Consecutive adults aged 18 to 80 years, regardless of sex, naive to any previous eradication treatment, with documented HP infection were included in this study. The diagnosis of HP infection was made by anatomopathological assessment after upper endoscopy. Gastric biopsies according to the Sydney protocol were taken (2 from antrum, 2 from fundus and 1 from incisura angularis). The biopsies were fixed in formalin and then sent to the pathology department of Farhat Hached Hospital where they were studied by an experienced pathologist.
Exclusion criteria
Exclusion criteria: Exclusion criteria were: previous HP eradication treatment history of gastrectomy the use of antibiotics within four weeks, or PPI within two weeks of the study a known history of allergic reaction to any of the study drugs a neoplasia during the last 5 years severe comorbidities such as cirrhosis kidney or heart failure severe psychiatric or neurological disorders excessive alcohol intoxication, or the use of drugs. Likewise, pregnant and breastfeeding women have been excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| B-14 group achieved a better eradication rate compared to Q-14 in intention to treat (78.3% versus 53.3%, p = 0.004) and per protocol (90.4% versus 65%, p = 0.003) with a statistically significant difference. Similarly, compliance and tolerance were better with the B-14 group (p = 0.001, p <0.0001, respectively). Conclusion: The dual therapy was more effective than concomitant quadruple therapy in the eradicating of helicobacter pylori with better compliance and tolerance in Tunisian population. | — |
Secondary
| Measure | Time frame |
|---|---|
| The mean age was 49.5 years [18 - 78 years] for the B-14 group versus 42.2 years [18-76 years] for the Q-14 group. No statistically significant differences were found between the two groups in terms of socio-demographic characteristics, lifestyle and risk factors for primary antimicrobial resistance. | — |
Countries
Tunisia
Contacts
Faculty of Medicine of Sousse University of Sousse