Add-on trimebutine-maleate does not improve tolerability or eradication in bismuth quadruple therapy for Helicobacter pylori

Table 4 Adverse-event and discontinuation rates with bismuth quadruple therapy in comparable randomized trials and registry cohorts

Ref.	Setting/population	BQT-treated (n)	Any adverse event (%)	Discontinuation (%)
Present trial (control arm)	Korea, RCT, 14-day classical BQT	66	51.5	10.6
Nyssen et al[10]	Hp-EuReg, 28 countries	Approximately 22000 (any regimen; BQT subset)	Approximately 37 (BQT)	1.3 (whole cohort)1
Olmedo et al[34]	Hp-EuReg, 2013-2021, all BQT	15582	Approximately 30-40	10
Nyssen et al[35]	Hp-EuReg, single-capsule BQT (Pylera), 10-day	Approximately 2100	Approximately 29	1.7
Malfertheiner et al[6]	Europe, RCT, Pylera 10-day	218	Approximately 50	< 2
Liou et al[7]	Taiwan, RCT, 10-day BQT	540	67	10
Kim et al[36]	Korea, RCT, 10-day BQT	175	67.5	23 (dose reduction or discontinuation)
Gisbert et al[39]	Meta-review of Pylera studies	6482 (30 studies)	Approximately 29 (Pylera)/approximately 37 (classical)	Approximately 2

¹The 13% discontinuation rate in Nyssen et al[10] is the overall European Registry on Helicobacter pylori Management cohort value across all regimens; the bismuth quadruple therapy-specific discontinuation rate was not separately reported.

Superscripted numbers after author/year correspond to the reference list. Numbers are shown as reported in the original studies; registry estimates are rounded. BQT: Bismuth quadruple therapy; Hp-EuReg: European Registry on Helicobacter pylori Management; RCT: Randomized controlled trial.