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 weeks | 6 weeks to 1 year | Baseline to 1 year | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo | Treatment | Pb | Placebo | Treatment | P | Placebo | Treatment | P | |||||||
| Worst biopsy diagnosis,c n (%) | |||||||||||||||
| Worsening | 17 (13.7) | 14 (11.7) | 0.85 | 13 (10.5) | 10 (8.3) | 0.74 | 11 (8.7) | 11 (9.0) | 0.98 | ||||||
| No change | 84 (67.7) | 85 (70.8) | 87 (70.2) | 83 (69.2) | 84 (66.7) | 80 (65.6) | |||||||||
| Improvement | 23 (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 ± 2.51 | 0.27 ± 2.47 | 0.22 | −0.14 ± 1.92 | −0.77 ± 2.37 | 0.03 | −0.23 ± 2.25 | −0.5 ± 2.43 | 0.36 | ||||||
| Pathologist 1 | −0.13 ± 2.00 | −0.18 ± 2.42 | 0.86 | 0.10 ± 1.76 | −0.50 ± 1.51 | 0.005 | −0.01 ± 2.30 | −0.69 ± 2.32 | 0.02 | ||||||
| Pathologist 2 | −0.11 ± 4.30 | 0.73 ± 3.96 | 0.12 | −0.38 ± 2.58 | −1.0 ± 3.98 | 0.13 | −0.45 ± 3.46 | −0.31 ± 3.28 | 0.74 | ||||||
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.