Table 4

Per-eradication-protocol analysis: Change over time in both worst biopsy diagnosis and stomach index score among enrolled subjects who met eradication protocol by trial arm (n = 104 placebo, 75 treatment)a

Baseline to 6 weeks6 weeks to 1 yearBaseline to 1 year
PlaceboTreatmentPbPlaceboTreatmentPPlaceboTreatmentP
Worst biopsy diagnosis,c n (%)
 Worsening15 (14.4)9 (12.0)0.7612 (11.5)6 (8.0)0.4711 (10.6)9 (12.0)0.96
 No change68 (65.4)53 (70.7)75 (72.1)52 (69.3)68 (65.4)48 (64.0)
 Improvement21 (20.2)13 (17.3)17 (16.4)17 (22.7)25 (24.0)18 (24.0)
Change in score (mean ± SD)
 Averaged−0.20 ± 2.620.27 ± 2.370.22−0.07 ± 1.99−0.84 ± 2.210.02−0.27 ± 2.42−0.57 ± 2.150.39
 Pathologist 1−0.18 ± 2.13−0.11 ± 2.420.850.15 ± 1.88−0.52 ± 1.730.02−0.03 ± 2.44−0.63 ± 2.250.10
 Pathologist 2−0.22 ± 4.490.66 ± 4.040.18−0.20 ± 2.55−1.17 ± 3.420.06−0.50 ± 3.77−0.51 ± 3.020.99
  • a Baseline H. pylori positive by histology and either (a) H. pylori positive at 6 weeks and 1 year if in the placebo group or (b) H. pylori negative at 6 weeks and 1 year if in the treatment group.

  • b χ2 test or t test, as appropriate.

  • c Normal < chronic or active gastritis < moderate or severe atrophy < mild, moderate, or severe intestinal metaplasia < moderate dysplasia.

  • d Mean of both pathologists’ difference in score. Variances were unequal for all time intervals.