TABLE 5.
TWO-way ANOVA and comparison between groups (Secondary Endpoints).
| Parameter | Mean (95% CI) of difference in mean between the groups | TWO way ANOVA | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 0 | Day 5 | Day 30 | Day 60 | Day 90 | Days | Group | Interaction | ||||||
| Placebo vs BSE-150 | Placebo vs BSE-300 | Placebo vs BSE-150 | Placebo vs BSE-300 | Placebo vs BSE-150 | Placebo vs BSE-300 | Placebo vs BSE-150 | Placebo vs BSE-300 | Placebo vs BSE-150 | Placebo vs BSE-300 | ||||
| PGA | 0.06 (−0.29–0.41) | −2.86 (−7.93 to 2.22) | −0.06 (−0.46 to 0.34) | −0.20 (−0.68 to 0.27) |
−0.41 (−0.85to 0.04) | −3.75 (−9.36 to 1.86) | −1.34 (−1.94 to −0.75) | −3.23 (−6.24 to −0.22) | −1.72 (−2.23 to −1.20) | −2.79 (−3.88 to −1.69) | F (2, 95) = 3.69 | F (1.21, 115.1) = 3.96 | F (8, 380) = 1.71 |
| p-value | 0.905 | 0.362 | 0.925 | 0.567 | 0.082 | 0.243 | <0.001 | 0.033 | <0.001 | <0.001 | 0.028 | 0.0412 | 0.094 |
| WOMAC Pain | 0.47 (−0.62–1.56) | −0.24 (−1.47 to 0.99) | 0.56 (−0.57–1.70) | 0.88 (−0.24–2.0) | 0.56 (−0.93–2.06) | 0.58 (−0.83–1.98) | 3.69 (2.08–5.29) | 3.52 (1.92–5.12) | 4.44 (2.73–6.14) | 4.55 (2.86–6.24) | F (2, 95) = 13.27 | F (2.99, 284.5) = 167.4 | F (8, 380) = 17.83 |
| p-value | 0.5568 | 0.8828 | 0.4654 | 0.1507 | 0.639 | 0.591 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
| WOMAC Stiffness |
0.13 (−0.47–0.72) | 0.10 (−0.54–0.73) | 0.47 (−0.24–1.18) | 0.42 (−0.29–1.13) | 0.84 (0.169–1.52) | 0.67 (0.025–1.36) | 1.47 (0.72–2.21) | 1.67 (0.93–2.39) | 1.63 (1.01–2.24) | 1.72 (1.11–2.32) | F (2, 95) = 16.05 | F (3.17, 300.8) = 58.21 | F (8, 380) = 7.376 |
| p-value | 0.8706 | 0.9314 | 0.2603 | 0.3388 | 0.0107 | 0.061 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
| WOMAC Function |
0.66 (−3.63–4.94) | 0.54 (−3.48–4.56) | 0.88 (−3.38–5.14) | 1.64 (−2.33–5.61) | 3.84 (−1.16–8.85) | 3.33 (−1.47–8.13) | 9.47 (4.42–14.52) | 10.28 (5.82–14.74) | 13.16 (8.89–17.42) | 14.64 (10.23–19.05) | F (2, 95) = 11.78 | F (2.81, 266.5) = 189.1 | F (8, 380) = 15.05 |
| p-value | 0.9282 | 0.9436 | 0.8749 | 0.5847 | 0.1638 | 0.2273 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
| LFI (Severity) | 0.06 (−0.67–0.79) | −0.18 (−0.93 to 0.57) | 0.89 (0.071–1.71) | 0.35 (−0.49–1.19) | 1.33 (0.38–2.27) | 1.00 (−0.160–2.15) | 2.27 (1.25–3.28) | 1.92 (0.98–2.88) | 2.39 (1.46–3.32) | 2.51 (1.59–3.43) | F (2, 95) = 12.89 | F (3.05, 289.9) = 115.6 | F (8, 380) = 9.991 |
| p-value | 0.977 | 0.830 | 0.030 | 0.57 | 0.003 | 0.104 | <0.001 | <0.001 | <0.001 | <0.001 | <0.0001 | <0.0001 | <0.0001 |
| LFI pain | −0.03 (−0.54 to 0.48) | −0.16 (−0.73 to 0.41) | 0.66 (0.010–1.32) | 0.29 (−0.35–0.93) | 0.94 (0.34–1.53) | 0.51 (−0.16–1.18) | 1.19 (0.53–1.84) | 1.03 (0.44–1.62) | 1.38 (0.78–1.96) | 1.40 (0.78–2.01) | F (2, 95) = 12.57 | F (3.63, 345.3) = 56.35 | F (8, 380) = 5.752 |
| p-value | 0.9883 | 0.7776 | 0.0524 | 0.5214 | 0.001 | 0.1735 | 0.0002 | 0.0003 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
| LFI Daily living | 0.00 (−0.61 to 0.61) | −0.03 (−0.69 to 0.63) | 0.27 (−0.27–0.80) | −0.03 (−0.59 to 0.52) | 0.36 −0.18–0.89) |
0.33 (−0.28–0.95) | 0.98 (0.44–1.52) | 0.92 (0.39–1.44) | 0.80 (0.233–1.36) | 0.96 (0.42–1.50) | F (2, 95) = 4.470 | F (3.05, 290.1) = 60.13 | F (8, 380) = 5.091 |
| p-value | >0.9999 | 0.9944 | 0.4648 | 0.9876 | 0.2529 | 0.3984 | 0.0001 | 0.0003 | 0.0036 | 0.0003 | 0.0140 | <0.0001 | <0.0001 |
| EQ5D index | −0.01 (−0.04 to 0.02) | −0.03 (−0.06 to 0.001) | −0.01 (-0.05 to 0.034) | −0.02 (−0.07 to 0.03) | −0.06 (−0.11 to −0.004) | −0.06 (−0.11 to −0.002) | −0.13 (−0.17 to −0.08) | −0.15 (−0.19 to −0.10) | −0.15 (−0.23 to −0.07) | −0.19 (−0.26 to −0.11) | F (2, 95) = 23.93 | F (2.83, 269.5) = 113.4 | F (8, 380) = 8.814 |
| p-value | 0.8084 | 0.0401 | 0.8757 | 0.5779 | 0.0312 | 0.038 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
| EQ5D Health Score |
2.28 (−1.69–6.26) | −2.17 (−5.87 to 1.53) | 0.00 (−4.31 to 4.31) | −0.24 (−4.34 to 3.87 | −0.97 (−6.04 to 4.11) | 0.64 −4.46–5.74) |
−7.88 −13.40 to −2.35) | −8.77 (−13.51 to −4.04) | −8.06 −15.35 to −0.78) |
−11.22 (−18.33 to −4.10) | F (2, 95) = 5.131 | F (2.49, 236.7) = 96.53 | F (8, 380) = 5.067 |
| p-value | 0.359 | 0.343 | 0.99 | 0.989 | 0.890 | 0.951 | 0.003 | 0.0001 | 0.026 | 0.001 | 0.0077 | <0.0001 | <0.0001 |
| No. of laps | 0.06 (−0.67–0.79) | −0.18 (−0.93 to 0.56) | −0.13 (−0.77 to 0.52) | 0.15 (−0.55–0.86) | 1.33 0.38–2.27) | 1.00 (−0.160–2.15) | 2.27 (1.25–3.28) | 1.92 (0.97–2.88) | 2.39 (1.46–3.32) | 2.51 (1.59–3.43) | F (2, 95) = 19.55 | F (2.82, 268.0) = 68.18 | F (8, 380) = 8.615 |
| p-value | 0.977 | 0.830 | 0.888 | 0.862 | 0.003 | 0.104 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
| Total distance walked | 13.44 (−25.11–51.99) | 24.64 (−17.35–66.62) | −10.00 (−47.32 to 27.32) | 11.37 (−28.85 to 51.59) | −23.44 (−58.21 to 11.33) | −15.13 (−52.24 to 21.99) | −27.81 (−60.01 to 4.38) | −29.67 (−63.74 to 4.39) | −45.00 (−74.90 to −15.10) | −33.82 (−64.78 to −2.86) | F (2, 95) = 1.052 | F (3.16, 300.7) = 36.90 | F (8, 380) = 8.237 |
| p-value | 0.679 | 0.342 | 0.796 | 0.776 | 0.244 | 0.592 | 0.1031 | 0.099 | 0.002 | 0.029 | 0.3533 | <0.0001 | <0.0001 |
The difference in Mean value between the groups and the 95% of the difference are presented. Two-way ANOVA, was computed with groups and time as factors. Post hoc analysis was carried out by Turkey’s multiple comparisons between placebo and BSE-150, and BSE-300, and the p values are given for this comparison at different days. F distribution (the distribution of the ratio of two estimates of variance), degrees of freedom numerator (dfn) and degrees of freedom denominator (dfd) and the Two-way ANOVA p values for days, group and their interactions are represented in the last three columns. p < 0.05 was considered significant. PGA: physicians’ global assessment, WOMAC: Western Ontario McMaster Index, LFI: lequesne functional index.