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-6DiclofenacMean difference(95% CI) valuea

Mean change of VAS pain (mm)
 MITT analysis−26.31 ± 16.93−27.16 ± 18.140.86(−4.39 to 6.10)0.748
 PP analysis−26.05 ± 17.38−28.03 ± 17.581.98(−3.61 to 7.56)0.486

Mean change of VAS stiffness (mm)
 MITT analysis−22.52 ± 17.70−23.26 ± 19.120.74(−4.77 to 6.25)0.791
 PP analysis−22.53 ± 17.82−23.28 ± 18.100.75(−4.98 to 6.49)0.795

Mean change of SCT (sec)
 MITT analysis−3.35 ± 3.55−3.42 ± 4.330.07(−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 analysis14.88 ± 14.9815.77 ± 15.89−0.89(−5.50 to 3.73)0.705
 PP analysis15.24 ± 15.2915.77 ± 14.54−0.53(−5.30 to 4.24)0.827

Mean change of KOOS other symptoms
 MITT analysis12.29 ± 14.9215.29 ± 16.90−3.00(−7.77 to 1.77)0.216
 PP analysis12.49 ± 15.1716.01 ± 16.22−3.53(−8.54 to 1.49)0.167

Mean change of KOOS activities of daily living
 MITT analysis13.25 ± 15.2214.46 ± 17.78−1.21(−6.17 to 3.75)0.640
 PP analysis13.62 ± 15.2314.05 ± 16.76−0.44(−5.55 to 4.67)0.866

Mean change of KOOS sport and recreation function
 MITT analysis15.18 ± 17.2818.57 ± 21.23−3.39(−9.20 to 2.41)0.250
 PP analysis15.64 ± 17.4819.27 ± 21.79−3.63(−9.91 to 2.66)0.256

Mean change of KOOS knee-related quality of life
 MITT analysis8.42 ± 16.2313.71 ± 19.65−5.30(−10.70 to 0.10)0.054
 PP analysis9.38 ± 16.3013.95 ± 18.01−4.56(−10.05 to 0.92)0.102

aStudent's t-test. KOOS, Knee Injury and Osteoarthritis Outcome Score; SCT, 10-step stair climb test; VAS, visual analog scale.