Table 2.
Efficacy outcome assessments at the end of the treatment phase.
| TMP-4 cream | Diclofenac gel | MD | (95% CI) | p valuea | |
|---|---|---|---|---|---|
| Mean changes in VAS knee pain | |||||
| MITT analysis | −31.99 ± 14.44 | −30.56 ± 13.42 | −1.43 | (−5.37 to 2.51) | 0.475 |
| PP analysis | −31.68 ± 14.18 | −31.09 ± 12.41 | −0.58 | (−4.37 to 3.20) | 0.761 |
| Mean changes in VAS knee stiffness | |||||
| MITT analysis | −26.27 ± 16.75 | −25.46 ± 15.58 | −0.81 | (−5.38 to 3.76) | 0.727 |
| PP analysis | −26.17 ± 16.81 | −25.90 ± 15.05 | −0.27 | (-4.80 to 4.26) | 0.907 |
| Mean changes in mSCT | |||||
| MITT analysis | −3.95 ± 6.76 | −3.26 ± 4.13 | −0.69 | (−2.27 to 0.89) | 0.388 |
| PP analysis | −3.95 ± 6.80 | −3.30 ± 4.13 | −0.65 | (−2.24 to 0.95) | 0.423 |
| Mean changes in TUG | |||||
| MITT analysis | −3.61 ± 5.99 | −3.29 ± 3.56 | −0.32 | (−1.71 to 1.07) | 0.648 |
| PP analysis | −3.63 ± 6.02 | −3.33 ± 3.55 | −0.30 | (−1.70 to 1.11) | 0.678 |
| Mean changes in KOOS pain | |||||
| MITT analysis | 18.19 ± 18.39 | 19.11 ± 18.16 | −0.93 | (−6.09 to 4.24) | 0.724 |
| PP analysis | 18.11 ± 18.47 | 19.39 ± 18.04 | −1.28 | (−6.46 to 3.91) | 0.628 |
| Mean changes in KOOS other symptoms | |||||
| MITT analysis | 17.55 ± 16.41 | 17.03 ± 16.10 | 0.52 | (−4.08 to 5.11) | 0.516 |
| PP analysis | 17.44 ± 16.46 | 17.13 ± 16.15 | 0.30 | (−4.33 to 4.93) | 0.897 |
| Mean changes in KOOS activities of daily living | |||||
| MITT analysis | 18.42 ± 17.13 | 21.34 ± 15.91 | −2.91 | (−7.58 to 1.76) | 0.220 |
| PP analysis | 18.16 ± 17.02 | 21.54 ± 15.87 | −3.38 | (−8.05 to 1.29) | 0.155 |
| Mean changes in KOOS sport and recreation function | |||||
| MITT analysis | 19.69 ± 21.80 | 22.50 ± 20.97 | −2.81 | (−8.85 to 3.23) | 0.360 |
| PP analysis | 19.48 ± 21.82 | 22.84 ± 20.82 | −3.36 | (−9.41 to 2.70) | 0.276 |
| Mean changes in KOOS knee-related quality of life | |||||
| MITT analysis | 15.45 ± 20.16 | 19.48 ± 16.84 | −4.03 | (−9.27 to 1.22) | 0.132 |
| PP analysis | 15.29 ± 20.20 | 20.07 ± 15.86 | −4.78 | (−9.94 to 0.38) | 0.069 |
aStudent's t-test. CI: confidence interval; KOOS: Knee Injury and Osteoarthritis Outcome Score; MD: mean difference; MITT: modified intention-to-treat; mSCT: modified 10-step stair climb test; PP: per-protocol; TMP-4: Thai Medicinal Plant-4; TUG: timed up and go test; VAS: Visual Analog Scale.