Abstract: Background: The recommended schedule for single capsule bismuth quadruple therapy (scBQT) includes a proton-pump inhibitor (PPI) 2 times a day and 3 scBQT capsules 4 times a day. Four times a day treatments are inconvenient and reduce adherence. In contrast, adherence improves with 3 times a day schedules. In clinical practice, many gastroenterologists use 4 capsule scBQT 3 times a day. However, the effectiveness and safety of this latter approach remain uncertain.
Aim: To assess the effectiveness and safety of scBQT administered 3 times a day in the patients included in the European Registry on Helicobacter pylori Management (Hp-EuReg).
Methods: All Spanish adult patients registered in the Asociación Española de Gastroenterología Research Electronic Data Capture (REDCap) database from June 2013 to March 2021 receiving 10-day scBQT were analyzed. Modified intention-to-treat effectiveness, adherence and the safety of scBQT given 3 times a day were calculated and compared with the 4 times a day schedule. A multivariate analysis was performed to determine independent factors predicting cure of the infection.
Results: Of the 3712 cases, 2516 (68%) were 4 times a day and 1196 (32%) 3 times a day. Mean age was 51 years, 63% were women and 15% had a peptic ulcer. The 3 times a day schedule showed significantly better overall cure rates than 4 times a day (1047/1112, 94%; 95% confidence interval [CI]: 92.7?95.6 vs. 2207/2423, 91%; 95% CI: 89.9?92.2, respectively, p = 0.002). Adherence and safety data were similar for both regimens. In the multivariate analysis, 3 times a day dosage, first-line therapy, use of standard or high-dose PPIs and adherence over 90% were significantly associated with cure of the infection.
Conclusions: Single capsule bismuth quadruple therapy (scBQT) prescribed 3 times a day was more effective than the traditional 4 times a day schedule. No differences were observed in treatment adherence or safety.
