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 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 | 15 (14.4) | 9 (12.0) | 0.76 | 12 (11.5) | 6 (8.0) | 0.47 | 11 (10.6) | 9 (12.0) | 0.96 | ||||||
| No change | 68 (65.4) | 53 (70.7) | 75 (72.1) | 52 (69.3) | 68 (65.4) | 48 (64.0) | |||||||||
| Improvement | 21 (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 ± 2.62 | 0.27 ± 2.37 | 0.22 | −0.07 ± 1.99 | −0.84 ± 2.21 | 0.02 | −0.27 ± 2.42 | −0.57 ± 2.15 | 0.39 | ||||||
| Pathologist 1 | −0.18 ± 2.13 | −0.11 ± 2.42 | 0.85 | 0.15 ± 1.88 | −0.52 ± 1.73 | 0.02 | −0.03 ± 2.44 | −0.63 ± 2.25 | 0.10 | ||||||
| Pathologist 2 | −0.22 ± 4.49 | 0.66 ± 4.04 | 0.18 | −0.20 ± 2.55 | −1.17 ± 3.42 | 0.06 | −0.50 ± 3.77 | −0.51 ± 3.02 | 0.99 | ||||||
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.