Table 3

Intention-to-treat analysis: Change over time in both worst biopsy diagnosis and stomach index score among all enrolled subjects by trial arm (n = 126 placebo, 122 treatment)a

Baseline to 6 weeks6 weeks to 1 yearBaseline to 1 year
PlaceboTreatmentPbPlaceboTreatmentPPlaceboTreatmentP
Worst biopsy diagnosis,c n (%)
 Worsening17 (13.7)14 (11.7)0.8513 (10.5)10 (8.3)0.7411 (8.7)11 (9.0)0.98
 No change84 (67.7)85 (70.8)87 (70.2)83 (69.2)84 (66.7)80 (65.6)
 Improvement23 (18.6)21 (17.5)24 (19.4)27 (22.5)31 (24.6)31 (25.4)
Change in score (mean ± SD)
 Averaged−0.12 ± 2.510.27 ± 2.470.22−0.14 ± 1.92−0.77 ± 2.370.03−0.23 ± 2.25−0.5 ± 2.430.36
 Pathologist 1−0.13 ± 2.00−0.18 ± 2.420.860.10 ± 1.76−0.50 ± 1.510.005−0.01 ± 2.30−0.69 ± 2.320.02
 Pathologist 2−0.11 ± 4.300.73 ± 3.960.12−0.38 ± 2.58−1.0 ± 3.980.13−0.45 ± 3.46−0.31 ± 3.280.74
  • a Four subjects (two placebo, two treatment) were missing their second endoscopy.

  • b χ2 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.