Table 4.
Secondary Outcomes over 9-months in both active treatment groups
Baseline | 3-Month | 6-Month | 9-Month | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
| ||||||||||||
N | Mean (SD) | p-value | N | Mean (SD) | p-value | N | Mean (SD) | p-value | N | Mean (SD) | p-value | |
|
||||||||||||
HAQ Score (0–3; lower=better) | ||||||||||||
Cherry extract | 41 | 0.58 (0.71) | 0.57 | 41 | 0.21 (0.38) | 0.75 | 37 | 0.21 (0.42) | 0.66 | 32 | 0.20 (0.40) | 0.90 |
Diet modification | 43 | 0.49 (0.60) | 37 | 0.18 (0.29) | 31 | 0.17 (0.31) | 26 | 0.18 (0.36) | ||||
Proportion with HAQ MCID1 | ||||||||||||
Cherry extract | N/A | 41 | 58.5% | 0.82 | 37 | 64.9% | 0.22 | 32 | 59.4% | 0.79 | ||
Diet modification | N.A | 37 | 54.1% | 31 | 48.4% | 26 | 53.9% | |||||
Maximum Pain in last 24 hrs, 0–10 | ||||||||||||
Cherry extract | 41 | 2.83 (3.07) | 0.34 | 41 | 1.46 (2.47) | 0.65 | 37 | 1.30 (2.31) | 0.81 | 32 | 1.16 (2.27) | 0.62 |
Diet modification | 43 | 2.11 (2.89) | 37 | 1.24 (1.72) | 31 | 1.16 (2.34) | 26 | 0.88 (1.77) | ||||
Any adverse event, % | ||||||||||||
Cherry extract | N/A | 40 | 2.5 | 1.00 | 37 | 8.1 | 0.25 | 32 | 3.1 | 1.00 | ||
Diet modification | N/A | 35 | 0.0 | 30 | 0.0 | 26 | 0.0 | |||||
Specific gastrointestinal adverse event, % | ||||||||||||
Cherry extract | N/A | 41 | 31.7 | 0.81 | 37 | 32.4 | 0.80 | 32 | 28.1 | 1.00 | ||
Diet modification | N/A | 37 | 35.1 | 31 | 35.5 | 26 | 26.9 |
HAQ MCID: HAQ score reduction of 0.22 or more during FU
N/A: not applicable