Self-Reported Outcomes | Experimental | Control | ||||||||||||
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T1 | T2 | T3 | Mean differences T1 - T2 | t (p) value T1 - T2 | Mean differences T1 - T3 | t (p) value T1 - T3 | T1 | T2 | T3 | Mean differences T1 - T2 | t (p) value T1 - T2 | Mean differences T1 - T3 | t (p) value T1 - T3 | |
POMS | ||||||||||||||
 Tension/Anxiety | 9.85 (0–17) | 6.05 (−4–17) | 5.40 (−4–17) | 3.80 | 3.98 (0.001) | 4.45 | 4.45 (0.00) | 7.00 (−2–24) | 6.5 (−3–20) | 6.5 (− 2–19) | 0.50 | 0.45 (0.65) | 0.5 | 0.63 (0.53) |
 Depression/Dejection | 12.90 (0–40) | 8 (0–31) | 6.35 (0–24) | 4.90 | 3.54 (0.002) | 6.55 | 3.90 (0.001) | 9.10 (0–36) | 10.05 (0–33) | 9.3 (0–33) | −0.95 | −0.62 (0.54) | − 0.2 | − 0.13 (0.89) |
 Anger/Hostility | 9.50 (0–26) | 5.40 (0–15) | 4.25 (1–12) | 4.10 | 3.2 (0.005) | 5.25 | 3.63 (0.002) | 8.65 (0–25) | 5.75 (0–28) | 6.6 (0–28) | 2.90 | 2.05 (0.05) | 2.05 | 1.54 (0.13) |
 Vigor/Activity | 24.40 (10–42) | 24.80 (9–43) | 28.10 (10–43) | −0.4 | −0.28 (0.78) | −3.70 | −2.98 (0.008) | 28.75 (17–43) | 26.70 (11–40) | 25.9 (11–40) | 2.05 | 1.91 (0.07) | 2.85 | 2.18 (0.04) |
 Fatigue/Inertia | 11.75 (2–21) | 8.85 (0–21) | 6.40 (0–15) | 2.90 | 2.86 (0.01) | 5.35 | 4.42 (0.00) | 9.20 (2–16) | 8.75 (2–16) | 8.00 (0–18) | 0.45 | 0.56 (0.57) | 1.20 | 1.45 (0.16) |
 Confusion/Bewilderment | 8.6 (0–23) | 5.95 (−2–19) | 3.75 (−3–17) | 2.65 | 2.80 (0.01) | 4.85 | 4.50 (0.00) | 6.55 (−3–24) | 7.10 (−2–24) | 5.00 (− 2–24) | − 0.55 | − 0.72 (0.47) | 1.55 | 1.38 (0.18) |
 TMD | 128.20 (84–189) | 109.90 (80–166) | 98.05 (68–153) | 18.30 | 3.45 (0.003) | 30.15 | 5.97 (0.00) | 111.75 (67–193) | 111.30 (68–194) | 109.4 (63–194) | 0.45 | 0.11 (0.90) | 2.35 | 0.53 (0.59) |
EORTC QLQ-C30 | ||||||||||||||
 Global health status/QoL | 53.76 (0–83.33) | 67.49 (4–83.33) | 76.66 (50–100) | −13.75 | −3.62 (0.002) | −22.91 | −4.18 (0.00) | 57.08 (0–83.33) | 63.74 (33.33–91.66) | 62.91 (33.33–83.33) | −6.66 | − 1.39 (0.18) | − 5.83 | − 1.16 (0.25) |
Functional scales | ||||||||||||||
 Physical functioning | 67.61 (0–100) | 78.68 (27–100) | 80.18 (20–100) | −11.06 | −2.41 (0.26) | − 12.56 | − 2.75 (0.01) | 76.91 (33.33–100) | 74.03 (27–100) | 75.03 (27–100) | 2.88 | 0.96 (0.34) | 1.88 | 0.82 (0.41) |
 Role functioning | 75.83 (0–100) | 85.83 (0–100) | 91.66 (33.33–100) | −10 | −2.34 (0.03) | − 15.83 | −3.22 (0.004) | 79.16 (0–100) | 70.83 (0–100) | 79.16 (33–100) | 8.33 | 1.20 (0.24) | 0.001 | 0.00 (1.00) |
 Emotional functioning | 72.56 (16.66–100) | 83.78 (50–100) | 85.90 (50–100) | −11.21 | −2.95 (0.008) | −13.33 | −2.53 (0.02) | 79.68 (25–100) | 77.96 (25–100) | 81.36 (33.33–100) | 1.71 | 0.39 (0.69) | −1.68 | −0.38 (0.70) |
 Cognitive functioning | 81.66 (16.66–100) | 91.66 (16.66–100) | 92.49 (33.33–100) | −10 | −1.98 (0.62) | − 10.83 | −2.66 (0.01) | 79.99 (16.66–100) | 84.99 (0–100) | 84.16 (16.66–100) | −5.00 | −1.37 (0.18) | −4.16 | − 0.72 (0.48) |
 Social functioning | 79.99 (0–100) | 87.49 (0–100) | 91.66 (33.33–100) | −7.50 | −1.69 (0.10) | − 11.66 | −2.40 (0.02) | 90.83 (50–100) | 86.66 (0–100) | 94.99 (66.66–100) | 4.16 | 0.62 (0.54) | −4.16 | −0.81 (0.42) |
Symptoms scales | ||||||||||||||
 Fatigue | 51.07 (11–88.66) | 26.62 (11–77.66) | 21.62 (0–77.66) | 24.45 | 5.66 (0.00) | 29.44 | 7.25 (0.00) | 40.53 (0–77.77) | 37.76 (0–77.77) | 39.42 (0–77.77) | 2.76 | 0.75 (0.46) | 1.10 | 0.26 (0.79) |
 Nausea and vomiting | 0.87 (0–16.66) | 0.00 | 1.75 (0–16.66) | 0.87 | 1.00 (0.33) | −0.87 | −0.56 (0.57) | 1.66 (0–16.66) | 0.83 (0–16.66) | 0.00 | 0.83 | 1.00 (0.33) | 1.66 | 1.45 (0.16) |
 Pain | 50.83 (0–100) | 29.16 (0–83.33) | 19.99 (066.66) | 21.66 | 4.61 (0.00) | 30.83 | 5.80 (0.00) | 38.33 (0–83.33) | 31.66 (0–66.66) | 34.16 (0–66.66) | 6.66 | 1.32 (0.20) | 4.16 | 1.04 (0.30) |
 Dyspnoea | 6.66 (0–100) | 5.00 (0–100) | 3.33 (0–66.66) | 1.66 | 1.00 (0.33) | 3.33 | 1.45 (0.16) | 8.33 (0–100) | 8.33 (0–100) | 4.99 (0–66.66) | 0.00 | 0.00 (1.00) | 3.33 | 1.00 (0.33) |
 Insomnia | 53.33 (0–100) | 29.99 (0–100) | 23.33 (0–66.66) | 23.33 | 2.89 (0.009) | 29.99 | 4.41 (0.00) | 44.99 (0–100) | 29.99 (0–100) | 23.33 (0–100) | 15 | 2.43 (0.02) | 21.66 | 3.32 (0.004) |
 Appetite loss | 14.99 (0–100) | 11.66 (0–66.66) | 11.66 (0–66.66) | 3.33 | 0.69 (0.49) | 3.33 | 0.81 (0.42) | 14.99 (0–66.66) | 18.33 (0–100) | 14.99 (0–66.66) | −3.33 | −0.49 (0.62) | 0.00 | 0.00 (1.00) |
 Constipation | 4.99 (0–66.66) | 1.66 (0–33.33) | 1.66 (0–33.33) | 3.33 | 1.00 (0.33) | 3.33 | 0.80 (0.42) | 8.33 (0–66.66) | 9.99 (0–66.66) | 6.66 (0–66.66) | −1.66 | −0.32 (0.74) | 1.66 | 0.27 (0.78) |
 Diarrhoea | 11.66 (0–66.66) | 8.33 (0–66.66) | 3.33 (0–33.33) | 3.33 | 0.62 (0.54) | 8.33 | 1.75 (0.09) | 6.66 (0–66.66) | 4.99 (0–66.66) | 8.33 (0–66.66) | 1.66 | 0.43 (0.66) | −1.66 | −0.37 (0.71) |
 Financial difficulties | 8.33 (0–100) | 3.33 (0–66.66) | 3.33 (0–66.66) | 5.00 | 1.00 (0.33) | 5.00 | 1.00 (0.33) | 14.99 (0–66.66) | 8.33 (0–66.66) | 4.99 (0–66.66) | 6.66 | 1.45 (0.16) | 9.99 | 1.83 (0.08) |
 VAS | 7.4 (5–10) | 6.1 (4–9) | 4.90 (1–8) | 1.30 | 7.93 (0.00) | 2.50 | 8.01 (0.00) | 6.65 (4–9) | 6.15 (2–9) | 6.45 (3–9) | 0.50 | 2.12 (0.47) | 0.20 | 1.16 (0.25) |
 SFI | 57.40 (8–84) | 67.20 (20–84) | 66.80 (0–92) | −9.8 | −5.24 (0.00) | −9.40 | −1.74 (0.09) | 56.90 (6–96) | 59.80 (44–88) | 59.20 (40–84) | −2.90 | −0.93 (0.36) | −2.30 | −0.65 (0.51) |
 ULFI | 61.80 (16–84) | 72.60 (28–92) | 72.40 (0–92) | −10.80 | −6.89 (0.00) | −10.60 | − 2.05 (0.05) | 69.60 (40–100) | 72.20 (48–100) | 70.60 (48–96) | −2.60 | −0.95 (0.35) | −1.00 | −0.26 (0.79) |
 BAI | 0.59 (0.07–1.00) | 0.42 (0.13–0.93) | 0.33 (0.07–0.93) | 0.17 | 4.01 (0.001) | 0.25 | 4.52 (0.00) | 0.42 (0–0.86) | 0.44 (0–0.80) | 0.40 (0–0.80) | −0.02 | −0.90 (0.37) | 0.01 | 0.44 (0.66) |
 MBS | 0.40 (0.00–1.00) | 0.19 (0–0.80) | 0.17 (0–0.80) | 0.21 | 3.46 (0.003) | 0.23 | 3.61 (0.002) | 0.33 (0–0.80) | 0.33 (0–0.80) | 0.33 (0–0.80) | 0.00 | 0.00 (1.00) | 0.00 | 0.00 (1.00) |
 BADIX | 0.53 (0.02–1.00) | 0.35 (0.01–0.90) | 0.28 (0.02–0.90) | 0.18 | 4.80 (0.00) | 0.25 | 5.59 (0.00) | 0.40 (0–0.80) | 0.42 (0–0.75) | 0.39 (0–0.75) | −0.02 | −0.93 (0.36) | 0.01 | 0.49 (0.62) |