Intention to treat analysis of change in primary and secondary outcome measures over 6 weeks in the vitamin E and placebo groups
| Outcome | Vitamin E (n = 35) | Placebo (n = 37) | Difference* (95% CI) | p value |
|---|---|---|---|---|
| Visit 3 data not available for one participant so baseline data used for visit 3. | ||||
| FEV1 = forced expiratory volume in 1 second; FVC = forced vital capacity. | ||||
| *Differences in log terms for IgE were anti-logged to give ratio of IgE values, final/baseline and vitamin E/placebo. | ||||
| †Analysis by the Mann-Whitney U test with median change. | ||||
| ‡Analysis by χ2 test. | ||||
| ¶Confidence intervals not calculated for difference in medians. | ||||
| Mean (SD) change in bronchial reactivity in doubling doses | +0.08 (2.33) | −0.16 (1.50) | +0.25 (−0.67 to +1.16) | 0.59 |
| Mean (SD) change in FEV1 (ml) | +37 (163) | −26 (203) | +63 (−24 to +149) | 0.16 |
| Mean (SD) change in FVC (ml) | +27 (194) | −18 (302) | +46 (−76 to +165) | 0.46 |
| Mean (SD) change in am peak flow (l/min) | +1 (24) | −4 (21) | +5 (−6 to +16) | 0.36 |
| Median (range) change in bronchodilator use (puffs/day)† | 0 (−3 to +4) | 0 (−8 to +5) | 0¶ | 0.49 |
| Median (range) change in daytime symptom score | 0 (−1 to +1) | 0 (−1 to 2) | 0¶ | 0.58 |
| Median (range) change in median night time symptom score | 0 (−2 to +1) | 0 (−1 to +2.5) | 0¶ | 0.93 |
| Mean (SD) ratio of change in IgE* | 0.99 (1.22) | 0.99 (1.54) | 1.01 (0.86 to 1.18) | 0.95 |
| Loss of atopic response‡ | 7/35 (20%) | 5/37 (14%) | 6% (−11 to 24) | 0.46 |