Box 4.
Outcome measures for the intention‐to‐treat population
|
Intervention (n = 79) |
Control (n = 76) |
|||
|---|---|---|---|---|
|
Mean ± SEM (95% CI)* |
Mean ± SEM (95% CI)* |
Group difference (95% CI)* |
P* |
|
| Area under the curve for symptom severity on Days 2, 3, 5 and 7 | ||||
| 31.2 ± 1.8 (27.6 to 34.8) | 35.1 ± 2.3 (30.5 to 39.7) | − 3.9 (− 9.7 to 1.9) | 0.19 | |
| Symptom severity score | ||||
| Day 1 | 6.7 ± 0.3 (6.1 to 7.3) | 6.5 ± 0.2 (6.1 to 7.0) | 0.2 (− 0.6 to 0.9) | 0.69 |
| Day 2 | 6.5 ± 0.3 (5.9 to 7.2) | 7.6 ± 0.4 (6.9 to 8.3) | − 1.0 (− 2.0 to − 0.1) | 0.04 |
| Day 3 | 5.5 ± 0.4 (4.7 to 6.2) | 6.5 ± 0.5 (5.5 to 7.4) | − 1.0 (− 2.2 to 0.2) | 0.11 |
| Day 5 | 5.0 ± 0.4 (4.2 to 5.8) | 5.4 ± 0.5 (4.4 to 6.5) | − 0.5 (− 1.8 to 0.8) | 0.47 |
| Day 7 | 3.1 ± 0.4 (2.4 to 3.8) | 3.6 ± 0.5 (2.7 to 4.5) | − 0.5 (− 1.6 to 0.6) | 0.40 |
|
Percentage (95% CI)* |
Percentage (95% CI)* |
Odds ratio (95% CI)*† |
P* |
|
| Proportion of participants who took medication for common cold ‡ | ||||
| Day 1 | 3% (1% to 9%) | 15% (8% to 28%) | 0.2% (0.04% to 0.7%) | 0.01 |
| Day 2 | 6% (2% to 16%) | 9% (5% to 18%) | 0.6% (0.2% to 2%) | 0.47 |
| Day 3 | 9% (4% to 18%) | 12% (5% to 23%) | 0.7% (0.2% to 2%) | 0.56 |
| Day 4 | 9% (4% to 19%) | 12% (6% to 24%) | 0.7% (0.2% to 2%) | 0.51 |
| Day 5 | 10% (5% to 21%) | 9% (4% to 20%) | 1% (0.3% to 4%) | 0.85 |
| Day 6 | 7% (3% to 16%) | 7% (3% to 17%) | 1% (0.3% to 4%) | 0.94 |
| Day 7 | 5% (2% to 14%) | 8% (3% to 18%) | 0.7% (0.2% to 3%) | 0.56 |
|
No. (%) |
No. (%) |
P |
||
| Participant's rating of outcome on Day 7 | 0.56 | |||
| Recovery | 3 (4%) | 3 (4%) | ||
| Distinct improvement | 13 (16%) | 9 (12%) | ||
| Light improvement | 43 (54%) | 37 (49%) | ||
| No improvement | 20 (25%) | 27 (35%) | ||
| Participant's rating of effectiveness on Day 7 | 0.03 | |||
| Very effective | 2 (3%) | 1 (1%) | ||
| Effective | 30 (38%) | 22 (29%) | ||
| Small effect | 41 (52%) | 32 (42%) | ||
| No effect | 6 (8%) | 21 (28%) | ||
| Participant's guess of group allocation on Day 3 § | < 0.001 | |||
| Intervention | 41 (52%) | 14 (18%) | ||
| Control | 37 (47%) | 63 (82%) | ||
* Data were adjusted using a generalised estimation equation model.† Odds ratio < 1 indicates less medication use in intervention group.‡ From Days 1 to 7.§ Data missing for one participant in the intervention group on Day 3 (n = 79 for intervention group, n = 77 for control group).