Ten-day bismuth-containing quadruple therapy versus 7-day proton pump inhibitor-clarithromycin containing triple therapy as first-line empirical therapy for the Helicobacter pylori infection in Korea: a randomized open-label trial

Table 2 First-line, crossover and overall eradication rates

	7-day STT		10-day BQT		P value
	no./total no. (%)	95% CI	no./total no. (%)	95% CI
Eradication rate with first-line therapy
Intention-to-treat analysis^a	101/177 (57.1)	49.4–64.5	130/175 (74.3)	67.1–80.6	0.001
Modified intention-to-treat analysis^b	101/147 (68.7)	60.5–76.1	130/149 (87.2)	80.8–92.1	< 0.001
Per-protocol analysis^c	94/134 (70.1)	61.6–77.7	105/113 (92.9)	86.5–96.9	< 0.001
Eradication rate with crossover therapy
Modified intention-to-treat analysis^b	30/33 (90.9)	75.7–98.1	11/13 (84.6)	54.6–98.1	0.612
Per-protocol analysis^c	24/24 (100)	85.8–100	11/13 (84.6)	54.6–98.1	0.117
Overall eradication rate after crossover therapy
Intention-to-treat analysis^a	131/177 (74.0)	66.9–80.3	141/175 (80.6)	73.9–86.2	0.142
Modified intention-to-treat analysis^b	131/134 (97.8)	93.6–99.5	141/143 (98.6)	95.0–99.8	0.676
Per-protocol analysis^c	117/117 (100)	96.9–100	108/109 (99.1)	95.0–100.0	0.482

STT, proton-pump inhibitor-clarithromycin containing standard triple therapy; BQT, bismuth-containing quadruple therapy; CI, confidence interval
^aThis analysis was performed in the intention-to-treat population, which included all participants who underwent randomization
^bThe modified intention-to-treat analysis for the first-line therapy and crossover therapy was performed in participants who started the assigned therapies and underwent the follow-up urea breath test. For overall eradication rate after crossover therapy, participants who achieved eradication success with first-line therapy and those who started the crossover therapy after failure of first-line therapy and underwent the follow-up urea breath test were included
^cThe per-protocol analysis for the first-line therapy and crossover therapy was performed in participants who took at least 80% of the therapies and underwent the follow-up urea breath test. For overall eradication rate after crossover therapy, participants who achieved eradication success with first-line therapy in the per-protocol population and those who took at least 80% of the crossover therapy after failure of first-line therapy and underwent the follow-up urea breath test were included

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