TABLE 4.
Total nasal and eye symptom score and rescue medication intake.
| Variable | Group | N | Baseline | 12 weeks | Within group | Active vs. placebo between groups | ||
|
|
|
|
|
|
||||
| Total N = 53 | Mean ± SD | Mean ± SD | Mean change ± SD | Mean diff ± SE | p-value | |||
|
| ||||||||
| (a) All (n = 53) | Nasal symptoms | |||||||
| Stuffed nose | Active | 29 | 15.9 ± 10.8 | 9.6 ± 8.6 | −6.2 ± 10.3 | 0.5 ± 3.0 | ns | |
| Placebo | 24 | 16.6 ± 9.6 | 9.9 ± 10.5 | −6.7 ± 11.7 | ||||
| Itchiness sneezing | Active | 29 | 14.9 ± 8.4 | 9.7 ± 7.4 | −5.2 ± 10.3 | 0.7 ± 3.0 | ns | |
| Placebo | 24 | 15.6 ± 9.5 | 9.8 ± 9.8 | −5.8 ± 11.7 | ||||
| Runny nose | Active | 29 | 14.1 ± 10.0 | 8.1 ± 8.9 | −6.2 ± 10.3 | −0.9 ± 3.3 | ns | |
| Placebo | 24 | 14.0 ± 9.3 | 8.8 ± 10.9 | −5.2 ± 11.8 | ||||
| Ocular symptoms | ||||||||
| Itchy eyes | Active | 29 | 12.4 ± 10.2 | 6.6 ± 8.5 | −5.8 ± 11.1 | −1.7 ± 3.1 | ns | |
| Placebo | 24 | 12.6 ± 10.3 | 8.5 ± 8.9 | −4.1 ± 11.4 | ||||
| Gritty eyes | Active | 29 | 9.1 ± 11.4 | 6.2 ± 9.1 | −3.0 ± 10.7 | 0.4 ± 2.6 | ns | |
| Placebo | 24 | 8.8 ± 8.7 | 5.4 ± 7.8 | −3.4 ± 8.5 | ||||
| Red eye | Active | 29 | 7.0 ± 10.2 | 4.3 ± 7.1 | −2.6 ± 9.0 | 0.5 ± 2.4 | ns | |
| Placebo | 24 | 9.0 ± 8.4 | 5.9 ± 8.7 | −3.1 ± 8.5 | ||||
| Watery eyes | Active | 29 | 8.8 ± 9.8 | 5.6 ± 7.9 | –3.2 ± 10.0 | −0.4 ± 2.6 | ns | |
| Placebo | 24 | 9.1 ± 9.2 | 6.0 ± 8.4 | −3.2 ± 8.7 | ||||
| Puffy eyes | Active | 29 | 6.7 ± 9.3 | 5.3 ± 8.1 | −1.3 ± 10.1 | −1.0 ± 2.6 | ns | |
| Placebo | 24 | 8.5 ± 9.0 | 6.0 ± 8.4 | −2.4 ± 8.5 | ||||
| TNESS 8 items | Active | 29 | 88.9 ± 67.8 | 55.4 ± 55.5 | −33.4 ± 74.8 | 0.4 ± 20.5 | ns | |
| Placebo | 24 | 94.3 ± 65.8 | 60.4 ± 66.6 | −33.9 ± 73.5 | ||||
| TNSS 3 items | Active | 29 | 44.9 ± 25.9 | 27.4 ± 21.6 | –17.4 ± 31.0 | 0.3 ± 8.9 | ns | |
| Placebo | 24 | 46.2 ± 26.6 | 28.5 ± 30.5 | −17.7 ± 33.3 | ||||
| TESS 5 items | Active | 29 | 44.0 ± 45.7 | 28.0 ± 36.0 | −16.0 ± 47.4 | 0.2 ± 12.6 | ns | |
| Placebo | 24 | 48.0 ± 43.8 | 31.8 ± 40.1 | −16.2 ± 43.5 | ||||
|
| ||||||||
| N | Baseline days/week | 12 weeks days/week | Within group days/week | Within group med change ## | ||||
|
|
|
|
|
|
||||
| All (n = 53) | Rescue medication # | Yes/no | Mean ± SD | Mean ± SD | Mean change ± SD | N | ||
|
| ||||||||
| 1–7 days/week | Active | 11/18 | 2.1 ± 3.0 | 1.3 ± 2.6 | −0.6 ± 1.7 | Decrease: 4 no change: 25 |
||
| Placebo | 11/13 | 1.9 ± 2.5 | 0.8 ± 1.7 | −0.95 ± 2.4 | Decrease: 6 no change: 17 Increase: 1 |
ns | ||
| ≥ 4 days/week | Active | 8/21 | −4.3 ± 2.5 | As above | ||||
| Placebo | 7/17 | −4.5 ± 1.8 | As above | ns | ||||
|
| ||||||||
| (b) Subgroup (n = 40) | Nasal symptoms | N | Mean ± SD | Mean ± SD | Mean change ± SD | Mean diff ± SE | p-value | |
|
| ||||||||
| 10–12 week intervention | Stuffed nose | Active | 22 | 15.4 ± 10.0 | 10.4 ± 8.9 | −5.0 ± 7.3 | −1.8 ± 2.6 | ns |
| Placebo | 18 | 14.5 ± 9.6 | 11.4 ± 11.0 | −3.1 ± 9.0 | ||||
| Itchiness sneezing | Active | 22 | 13.8 ± 6.6 | 9.5 ± 7.4 | −4.3 ± 6.8 | 1.3 ± 2.3 | ns | |
| Placebo | 18 | 14.3 ± 8.1 | 11.2 ± 10.3 | −3.1 ± 7.5 | ||||
| Runny nose | Active | 22 | 14.3 ± 8.4 | 8.5 ± 8.9 | −5.9 ± 8.8 | −5.1 ± 2.5 | 0.04 | |
| Placebo | 18 | 11.1 ± 7.8 | 10.3 ± 11.5 | −0.7 ± 6.7 | ||||
| Ocular symptoms | ||||||||
| Itchy eyes | Active | 22 | 12.6 ± 9.0 | 6.3 ± 8.1 | −6.3 ± 8.0 | −6.1 ± 2.4 | 0.01 | |
| Placebo | 18 | 10.3 ± 9.4 | 10.1 ± 9.0 | −0.2 ± 7.0 | ||||
| Gritty eyes | Active | 22 | 9.2 ± 10.4 | 6.3 ± 9.1 | −2.9 ± 7.1 | −2.0 ± 2.0 | ns | |
| Placebo | 18 | 6.9 ± 8 0 | 6.0 ± 7.6 | −0.9 ± 5.1 | ||||
| Red eyes | Active | 22 | 6.3 ± 8.6 | 4.2 ± 6.8 | −2.0 ± 4.7 | −1.2 ± 1.6 | ns | |
| Placebo | 18 | 7.5 ± 8.2 | 6.6 ± 8.7 | −0.9 ± 5.5 | ||||
| Watery eyes | Active | 22 | 9.0 ± 8.1 | 5.6 ± 7.6 | −3.3 ± 5.4 | −2.1 ± 1.6 | ns | |
| Placebo | 18 | 7.9 ± 8.9 | 6.7 ± 8.4 | −0.9 ± 5.1 | ||||
| Puffy eyes | Active | 22 | 6.2 ± 7.1 | 5.1 ± 7.9 | −1.1 ± 4.7 | −1.1 ± 1.6 | ns | |
| Placebo | 18 | 7.0 ± 8.6 | 7.0 ± 8.9 | 0 ± 5.1 | ||||
| TNESS 8 items | Active | 22 | 86.6 ± 52.3 | 55.8 ± 53.2 | −30.8 ± 37.1 | −20.8 ± 12.4 | ns | |
| Placebo | 18 | 79.4 ± 61.4 | 69.4 ± 67.2 | −10.1 ± 41.5 | ||||
| TNSS 3 items | Active | 22 | 43.5 ± 20.9 | 28.3 ± 21.5 | −15.1 ± 19.5 | −8.2 ± 6.5 | ns | |
| Placebo | 18 | 39.8 ± 24.4 | 32.9 ± 32.0 | −6.9 ± 21.3 | ||||
| TESS 5 items | Active | 22 | 43.2 ± 36.2 | 27.5 ± 34.3 | −15.7 ± 23.3 | −12.5 ± 7.5 | 0.07 | |
| Placebo | 18 | 39.6 ± 41.0 | 36.4 ± 40.1 | −3.2 ± 24.2 | ||||
|
| ||||||||
| N | Baseline days/week | 12 weeks days/week | Within group days/week | Within group med change ## | ||||
|
|
|
|
|
|
||||
| Subgroup (N = 40) | Rescue medication # | Yes/no | Mean ± SD | Mean ± SD | Mean change ± SD | N | ||
|
| ||||||||
| 1–7 days/week | Active | 9/13 | 2.8 ± 3.0 | 1.4 ± 2.7 | −0.5 ± 1.3 | Decrease: 3 no change: 19 |
||
| Placebo | 8/10 | 2.0 ± 2.8 | 0.9 ± 1.8 | −1.1 ± 2.6 | Decrease: 5 no change: 12 Increase: 1 |
ns | ||
| ≥ 4 days/week | Active | 6/16 | 6.7 ± 0.8 | 5.0 ± 2.9 | −1.7 ± 2.3 | As above | ||
| Placebo | 6/12 | 5.7 ± 1.2 | 1.8 ± 2.6 | −3.8 ± 2.5 | As above | ns | ||
(a) All available data with baseline peak 2 (20 October 2020) and end of study peak 10 (25 December 2020) adjusted for intention-to-treat analysis.
(b) Subgroup of participants who received full 10–12 week intervention.
N, number; SD; standard deviation; ns, not significant; med, medication; TNESS, total nasal eye symptom score (8 items); TNSS, total nasal symptom score (3 items); TESS, total eye symptom score (5 items), #Rescue medication includes oral antihistamine and nasal and oral steroids; ##medication change includes type and frequency of medication, e.g., antihistamines 4 days/week.