Background: Current Italian guidelines recommend 10-day bismuth-based or bismuth-free (sequential and concomitant) regimens for first-line H. pylori eradication. However, comparison among these regimens is lacking in our country. Aim: To perform a 'head-to-head' comparison among these three therapies as first-line treatment for H. pylori eradication in clinical practice. Methods: This was a prospective, open-label randomized study enrolling consecutive patients diagnosed with H. pylori infection never previously treated. Patients were randomized to receive one of the following 10-day therapies: (a) Bismuth-based therapy: esomeprazole 20mg b.i.d and Pylera 3 tablets q.i.d; (b) Concomitant therapy: esomeprazole 20mg plus amoxicyllin 1,000mg, clarithromycin 500mg and tinidazole 500mg (all b.i.d.), and (c) Sequential therapy: esomeprazole 20mg plus amoxicyllin 1,000mg for 5days followed by esomeprazole 20mg plus clarithromycin 500mg and tinidazole 500mg for 5days (all b.i.d). H. pylori eradication was assessed by using UBT 4-6 weeks after the end of therapy. Results: Overall, 187 patients were enrolled. The eradication rates achieved with Pylera, concomitant and sequential were 85.2%, 95.2%, and 93.6%, respectively, at intention to treat, and 94.5%, 96.7%, and 95.1% at per protocol analyses, without a statistically significant difference. The incidence of severe side-effects was higher with the bismuth-based therapy than with the two bismuth-free regimens (9.8% vs 1.6%; p=0.046). Conclusions: Bismuth-based and bismuth-free therapies are equally effective for first-line H. pylori eradication. However, bismuth therapy was more frequently interrupted for side-effects than bismuth-free therapies.

Quadruple, sequential, and concomitant first-line therapies for H. pylori eradication: a prospective, randomized study / De Francesco, Vincenzo; Pontone, Stefano; Bellesia, Annamaria; Serviddio, Gaetano; Panetta, Cristina; Palma, Rossella; Zullo, Angelo. - In: DIGESTIVE AND LIVER DISEASE. - ISSN 1590-8658. - STAMPA. - 50:2(2018), pp. 139-141. [10.1016/j.dld.2017.10.009]

Quadruple, sequential, and concomitant first-line therapies for H. pylori eradication: a prospective, randomized study

Pontone, Stefano
Investigation
;
Panetta, Cristina;Palma, Rossella;
2018

Abstract

Background: Current Italian guidelines recommend 10-day bismuth-based or bismuth-free (sequential and concomitant) regimens for first-line H. pylori eradication. However, comparison among these regimens is lacking in our country. Aim: To perform a 'head-to-head' comparison among these three therapies as first-line treatment for H. pylori eradication in clinical practice. Methods: This was a prospective, open-label randomized study enrolling consecutive patients diagnosed with H. pylori infection never previously treated. Patients were randomized to receive one of the following 10-day therapies: (a) Bismuth-based therapy: esomeprazole 20mg b.i.d and Pylera 3 tablets q.i.d; (b) Concomitant therapy: esomeprazole 20mg plus amoxicyllin 1,000mg, clarithromycin 500mg and tinidazole 500mg (all b.i.d.), and (c) Sequential therapy: esomeprazole 20mg plus amoxicyllin 1,000mg for 5days followed by esomeprazole 20mg plus clarithromycin 500mg and tinidazole 500mg for 5days (all b.i.d). H. pylori eradication was assessed by using UBT 4-6 weeks after the end of therapy. Results: Overall, 187 patients were enrolled. The eradication rates achieved with Pylera, concomitant and sequential were 85.2%, 95.2%, and 93.6%, respectively, at intention to treat, and 94.5%, 96.7%, and 95.1% at per protocol analyses, without a statistically significant difference. The incidence of severe side-effects was higher with the bismuth-based therapy than with the two bismuth-free regimens (9.8% vs 1.6%; p=0.046). Conclusions: Bismuth-based and bismuth-free therapies are equally effective for first-line H. pylori eradication. However, bismuth therapy was more frequently interrupted for side-effects than bismuth-free therapies.
2018
bismuth therapy; concomitant therapy; H. pylori; sequential therapy; hepatology; gastroenterology
01 Pubblicazione su rivista::01a Articolo in rivista
Quadruple, sequential, and concomitant first-line therapies for H. pylori eradication: a prospective, randomized study / De Francesco, Vincenzo; Pontone, Stefano; Bellesia, Annamaria; Serviddio, Gaetano; Panetta, Cristina; Palma, Rossella; Zullo, Angelo. - In: DIGESTIVE AND LIVER DISEASE. - ISSN 1590-8658. - STAMPA. - 50:2(2018), pp. 139-141. [10.1016/j.dld.2017.10.009]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1039594
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