Journal of Neurogastroenterology and Motility : eISSN 2093-0887 / pISSN 2093-0879

Table. 2.

Compliance With Medication and Erosive Esophagitis Healing Rate at Weeks 2 and 4 in the Full Analysis Set and Per-protocol Set

Variables Prior-to-meal group (n = 89) After-meal group (n = 86) P-value
Full analysis set
Compliance with medicationa (%)b 98.17 ± 4.13 99.34 ± 4.33 0.033
Range (%) 81.25-107.14 78.95-110.71
Acceptable compliance 0.491
< 80% 0 (0.00) 1 (1.26)
≥ 80 % and ≤ 120% 89 (100.00) 85 (98.84)
> 120% 0 (0.00) 0 (0.00)
EE healing rate at weeks 2
Number of patients who underwent endoscopy 71 70
Number of completely healed patients 68 (95.77) 68 (97.14)
Common risk difference [95% CI] 1.37% [–4.73%, 7.46%]
EE healing rate at weeks 4
Number of patients who underwent 81 80
Number of completely healed patients 80 (98.77) 80 (100.00)
Common risk difference [95% CI] 1.23% [–1.17%, 3.64%]
Variables Prior-to-meal group (n = 80) After-meal group (n = 77) P-value
Per-protocol set
Compliance with medicationa (%)b 98.54 ± 3.95 99.88 ± 3.70 0.012
Range (%) 81.25-107.14 80.95-110.71
Acceptable compliance > 0.999
< 80% 0 (0.00) 0 (0.00)
≥ 80 % and ≤ 120% 80 (100.00) 77 (100.00)
> 120% 0 (0.00) 0 (0.00)
EE healing rate at weeks 2
Number of patients who underwent endoscopy 69 67
Number of completely healed patients 67 (97.10) 66 (98.51)
Common risk difference [95% CI] 1.41% [–3.50%, 6.32%]
EE healing rate at weeks 4
Number of patients who underwent endoscopy 80 77
Number of completely healed patients 79 (98.75) 77 (100.00)
Common risk difference [95% CI] 1.25% [–1.18%, 3.68%]

aCompliance of medication = The total number of tablets actually taken/the total number of tablets to be taken ×100.

bContinuous variables were summarized as mean ± SD and analyzed by the 2-sample t test or Wilcoxon rank sum test. All other data were presented as n (%) or n, and analyzed by the chi-square test. The non-inferiority analysis was performed by the Cochran-Mantel-Haenszel test.

EE, erosive esophagitis.

J Neurogastroenterol Motil 2025;31:86~94 https://doi.org/10.5056/jnm24032
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