Table 5.
Decrease in POMWP (cm) of at least 30% and 50% from baseline at day 2 evening, 1 h post dosing – logistic regression analysis – TS
| Diclofenac + capsaicin | Diclofenac | Capsaicin | Placebo | |
|---|---|---|---|---|
| Number of patients, N (%) | 225 (100.0) | 223 (100.0) | 223 (100.0) | 75 (100.0) |
| Decrease from baseline, N (%) | ||||
| ≥ 30% | 134 (59.6) | 107 (48.0) | 150 (67.3) | 34 (45.3) |
| 95% CI, % | 54.1, 67.4 | 42.1, 55.7 | 61.3, 74.0 | 33.8, 57.3 |
| Comparison vs. diclofenac + capsaicina | ||||
| Odds ratio | 1.629 | 0.732 | 1.882 | |
| 95% CI | 1.11, 2.39 | 0.49, 1.09 | 1.10, 3.21 | |
| P value | 0.0122 | 0.1206 | 0.0202 | |
| Decrease from baseline, N (%) | ||||
| ≥ 50% | 85 (37.8) | 50 (22.4) | 95 (42.6) | 20 (26.7) |
| 95% CI, % | 32.2, 45.4 | 17.4, 29.0 | 36.4, 49.8 | 17.1, 38.1 |
| Comparison vs. diclofenac + capsaicina | ||||
| Odds ratio | 2.125 | 0.833 | 1.729 | |
| 95% CI | 1.40, 3.22 | 0.57, 1.22 | 0.97, 3.09 | |
| P value | 0.0004 | 0.3479 | 0.0643 | |
CI confidence interval, POMWP pain on movement worst procedure, TS treated set
aModel includes country and application site; an odds ratio > 1 is in favor of the combination treatment.