TABLE 3.
Impact of gender and age in mean change of VAS and WOMAC- Total scores at different time points.
| 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 | ||||
| VAS Male | −3.95 (−10.90 to 3.003) | −5.71 (−13.84 to 2.411) | 1.60 (−11.99–15.18) | 3.49 (−10.86–17.84) | 6.64 (−5.150–18.43) | 4.29 (−10.12–18.69) | 12.35 (−4.073–28.78) | 13.33 (−3.060–29.73) | 21.26 (6.711–35.81) | 30.48 (15.68–45.27) | F (2, 30) = 6.023 | F (3.302, 99.06) = 38.76 | F (10, 150) = 7.470 |
| p-value | 0.331 | 0.193 | 0.946 | 0.796 | 0.320 | 0.722 | 0.140 | 0.107 | 0.008 | 0.0007 | 0.0063 | <0.0001 | <0.0001 |
| VAS Female | 0.27 (−4.539–5.072) | −5.60 (−10.60 to −0.6035) | 1.73 (−4.368–7.835) | 0.00 (−6.217 to 6.217) | 2.53 (−5.848–10.92) | 3.20 (−2.441–8.841) | 11.87 (4.727–19.01) | 11.20 (5.180–17.22) | 16.33 (8.875–23.79) | 21.40 (13.69–29.11) | F (2, 62) = 8.726 | F (3.593, 222.7) = 70.06 | F (10, 310) = 11.43 |
| p-value | 0.990 | 0.025 | 0.762 | >0.9999 | 0.733 | 0.363 | 0.0008 | 0.0001 | <0.0001 | <0.0001 | 0.0005 | <0.0001 | <0.0001 |
| VAS <55 | −2.83 (−7.828 to 2.171) | −6.40 (−11.09 to −1.715) | −1.06 (−7.897 to 5.776) | 0.10 (−6.294–6.491) | 3.13 (−4.317–10.58) | 2.65 (−2.186–7.483) | 11.26 (4.489–18.04) | 10.73 (5.013–16.45) | 14.87 (8.362–21.39) | 19.32 (11.84–26.80) | F (2, 60) = 8.163 | F (3.755, 225.3) = 74.91 | F (10, 300) = 9.839 |
| p-value | 0.358 | 0.005 | 0.922 | 0.999 | 0.557 | 0.387 | 0.0007 | 0.0001 | <0.0001 | <0.0001 | 0.0007 | <0.0001 | <0.0001 |
| VAS >55 | −1.14 (−10.49 to 8.200) | −4.00 (−13.34 to 5.336) | 3.86 (−6.787–14.50) | 3.27 (−8.342–14.89) | 6.43 (−5.151–18.01) | 5.91 (−8.257–20.08) | 11.43 (−1.771–24.63) | 13.64 (0.3072–26.97) | 21.57 (7.462–35.68) | 31.64 (17.49–45.78) | F (2, 32) = 5.796 | F (3.007, 96.22) = 44.97 | F (10, 160) = 8.270 |
| p-value | 0.947 | 0.522 | 0.630 | 0.756 | 0.351 | 0.550 | 0.094 | 0.045 | 0.004 | 0.0002 | 0.0071 | <0.0001 | <0.0001 |
| WOMAC TS- Male | 2.18 (−5.787–10.14) | 3.56 (−7.733–14.84) | 0.52 (−8.251–9.293) | 2.40 (−9.531–14.33) | 6.89 (−2.203–15.98) | 7.38 (−6.157–20.92) | 17.14 (9.467–24.82) | 22.92 (16.74–29.10) | 22.40 (17.20–27.60) | 27.84 (22.87–32.81) | F (2, 30) = 6.367 | F (3.150, 94.51) = 68.58 | F (8, 120) = 8.178 |
| p-value | 0.772 | 0.685 | 0.988 | 0.856 | 0.161 | 0.342 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | 0.0050 | <0.0001 | <0.0001 |
| WOMAC TS (Female) | 1.75 (−4.760–8.254) | −0.60 (−7.073 to 5.873) | 3.32 (−3.414–10.05) | 3.12 (−3.126–9.366) | 5.92 (−2.868–14.71) | 4.92 (−3.195–13.04) | 15.41 (7.250–23.58) | 13.12 (5.171–21.07) | 18.97 (11.29–26.65) | 18.72 (10.89–26.55) | F (2, 62) = 8.786 | F (2.353, 145.9) = 119.5 | F (8, 248) = 9.993 |
| p-value | 0.790 | 0.972 | 0.459 | 0.453 | 0.239 | 0.316 | 0.0001 | 0.0008 | <0.0001 | <0.0001 | 0.0004 | <0.0001 | <0.0001 |
| WOMAC -TS <55 | −0.13 (−7.791 to 7.528) | −0.06 (−7.506 to 7.384) | 2.46 (−5.664–10.58) | 2.64 (−4.305–9.581) | 4.13 (−5.150–13.40) | 4.94 (−3.513–13.40) | 10.89 (1.221–20.57) | 12.27 (3.848–20.69) | 16.76 (8.564–24.95) | 18.07 (9.802–26.34) | F (2, 60) = 5.299 | F (2.517, 151.0) = 123.7 | F (8, 240) = 7.793 |
| p-value | 0.999 | 1.000 | 0.741 | 0.629 | 0.528 | 0.340 | 0.024 | 0.003 | <0.0001 | <0.0001 | 0.0076 | <0.0001 | <0.0001 |
| WOMAC TS > 55 | 3.57 (−4.635–11.78) | 1.41 (−6.591–9.409) | 1.91 (−6.031–9.860) | 3.66 (−5.485–12.79) | 7.67 (−2.873–18.22) | 6.46 (6.275–19.20) | 21.84 (13.98–29.71) | 22.43 (14.54–30.32) | 24.90 (18.37–31.43) | 27.13 (19.99–34.27) | F (2, 32) = 14.81 | F (2.536, 81.15) = 80.72 | F (8, 128) = 12.70 |
| p-value | 0.526 | 0.896 | 0.814 | 0.576 | 0.182 | 0.418 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <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) are given. Two-way ANOVA p values for days, group and their interactions are represented in the last three columns. Study participants were grouped into two age groups <55 years (40–55 years) and >55 years (56–70 years). The parameters are analyzed in male and female participants and in the two age groups. p < 0.05 was considered significant. VAS: visual analog scale for pain, WOMAC: Western Ontario McMaster Index.