Primary and Secondary Outcomes Corrected for Differences in Ambient Temperature
| Outcome | Score, mma | Test of Fixed Effects | ||
|---|---|---|---|---|
| Mean (95% CI) | Difference (95% CI) | F Value | P Value (r>F) | |
| Primary: VOC score | ||||
| Treatment | ||||
| Nifedipine | 11.44 (6.12 to 16.75) | – | – | – |
| Placebo | 13.28 (7.96 to 18.59) | −1.84 (−6.67 to 2.99) | 0.61 | .44 |
| Arm | ||||
| Placebo first | 14.07 (7.16 to 20.98) | – | – | – |
| Nifedipine first | 10.65 (4.16 to 17.14) | 3.43 (−6.08 to 12.93) | 0.54 | .47 |
| Temperature | – | – | 3.62 | .07 |
| Secondary: VOD score | ||||
| Treatment | ||||
| Nifedipine | 4.65 (1.65 to 7.65) | – | – | – |
| Placebo | 4.09 (1.09 to 7.09) | 0.56 (−2.97 to 4.09) | 0.10 | .75 |
| Arm | ||||
| Placebo first | 4.95 (1.40 to 8.50) | – | – | – |
| Nifedipine first | 3.79 (0.46 to 7.12) | 1.17 (−3.72 to 6.05) | 0.24 | .63 |
| Temperature | – | – | 1.63 | .21 |
VAS = visual analog scale; VOC = visual analogue scale on complaints; VOD = visual analogue scale on disability.
↵a On a visual analogue scale in week 6 of treatment. Scores measured on 100-mm scales where higher values indicate more complaints (symptoms) or greater disability.