Research Article
Clinical Efficacy and Safety of Thai Herbal Formulation-6 in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized-Controlled Trial
Table 2
Efficacy outcome assessments.
| | THF-6 | Diclofenac | Mean difference | (95% CI) | valuea |
| Mean change of VAS pain (mm) | | | | | | MITT analysis | −26.31 ± 16.93 | −27.16 ± 18.14 | 0.86 | (−4.39 to 6.10) | 0.748 | PP analysis | −26.05 ± 17.38 | −28.03 ± 17.58 | 1.98 | (−3.61 to 7.56) | 0.486 |
| Mean change of VAS stiffness (mm) | | | | | | MITT analysis | −22.52 ± 17.70 | −23.26 ± 19.12 | 0.74 | (−4.77 to 6.25) | 0.791 | PP analysis | −22.53 ± 17.82 | −23.28 ± 18.10 | 0.75 | (−4.98 to 6.49) | 0.795 |
| Mean change of SCT (sec) | | | | | | MITT analysis | −3.35 ± 3.55 | −3.42 ± 4.33 | 0.07 | (−1.12 to 1.26) | 0.148 | PP analysis | −3.44 ± 3.61 | −3.27 ± 4.09 | −0.17 | (−1.40 to 1.06) | 0.786 |
| Mean change of KOOS pain | | | | | | MITT analysis | 14.88 ± 14.98 | 15.77 ± 15.89 | −0.89 | (−5.50 to 3.73) | 0.705 | PP analysis | 15.24 ± 15.29 | 15.77 ± 14.54 | −0.53 | (−5.30 to 4.24) | 0.827 |
| Mean change of KOOS other symptoms | | | | | | MITT analysis | 12.29 ± 14.92 | 15.29 ± 16.90 | −3.00 | (−7.77 to 1.77) | 0.216 | PP analysis | 12.49 ± 15.17 | 16.01 ± 16.22 | −3.53 | (−8.54 to 1.49) | 0.167 |
| Mean change of KOOS activities of daily living | | | | | | MITT analysis | 13.25 ± 15.22 | 14.46 ± 17.78 | −1.21 | (−6.17 to 3.75) | 0.640 | PP analysis | 13.62 ± 15.23 | 14.05 ± 16.76 | −0.44 | (−5.55 to 4.67) | 0.866 |
| Mean change of KOOS sport and recreation function | | | | | | MITT analysis | 15.18 ± 17.28 | 18.57 ± 21.23 | −3.39 | (−9.20 to 2.41) | 0.250 | PP analysis | 15.64 ± 17.48 | 19.27 ± 21.79 | −3.63 | (−9.91 to 2.66) | 0.256 |
| Mean change of KOOS knee-related quality of life | | | | | | MITT analysis | 8.42 ± 16.23 | 13.71 ± 19.65 | −5.30 | (−10.70 to 0.10) | 0.054 | PP analysis | 9.38 ± 16.30 | 13.95 ± 18.01 | −4.56 | (−10.05 to 0.92) | 0.102 |
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aStudent's t-test. KOOS, Knee Injury and Osteoarthritis Outcome Score; SCT, 10-step stair climb test; VAS, visual analog scale.
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