2A. Secondary outcomes | Â | Â | Â | Â | |
---|---|---|---|---|---|
Treatment | Mean (SD) | Mean difference (SD) | Median of the difference (Quartile 75;25) | P Value†| SDM CI 95% |
Fibromyalgia Impact Questionnaire (FIQ) score | Â | Â | Â | ||
Amitriptyline (n = 21) | 41.16 (14.61) vs. 53.78 (12.83 ) | -12.19 (16.27) | -13.78 (-24.39,-4.95)**b | 0.04 | 0.88 (0.43-1.33) |
Melatonin (n = 21) | 46.42 (16.18) vs. 64.87 (12.83) | -17.73 (13.0) | -16.30 (-22.29,-12.94)**b |  | 1.28 (0.83-1.74) |
Amitriptyline + melatonin (n = 21) | 40.89 (10.94) vs. 65.15 (9.94) | -24.65 (12.14) | -26.41 (-32.59,-14.50)**a |  | 1.79 (1.29-2.28) |
b. Mean pressure pain threshold (PPT) in (kg/cm2/second) | Â | Â | Â | ||
Amitriptyline (n = 21) | 2.34 (0.45) vs. 2.05 (0.24) | 0.29 (0.31) | 0.2 (0.1, 0.5)**b | 0.03 | 0.69 (0.34-1.04) |
Melatonin (n = 21) | 2.47 (0.33) vs. 1.99 (0.16) | 0.47 (0.34) | 0.4 (0.23, 0.55)**b |  | 1.13 (0.79-1.47) |
Amitriptyline + melatonin (n = 21) | 2.70 (0.23) vs. 2.17(0.21) | 0.54 (0.60) | 0.6 (0.5, 0.7)**a |  | 1.27 (0.9-1.64) |
Analgesic doses (mean during the last week of treatment) †|  |  |  | ||
Amitriptyline (n = 21) | 1.35 (1.2) vs. 2.07 (1.37) | -0.72 (1.40) | -0.22 (-0.82, 0.54)* | 0.98 | 1.03 (0.33-1.67) |
Melatonin (n = 21) | 1.33 (1.29) vs. 2.16 (1.20) | -0.79 (1.52) | -0.14 (-1, 0.57)* |  | 1.09 (0.51-1.66) |
Amitriptyline + melatonin (n = 21) | 1.04 (0.92) vs. 2.10 (1.03) | -1.1 (1.14) | -0.35 (-0.74, 0.47)* |  | 1.33 (0.77-1.89) |
Number of tender points | Â | Â | Â | Â | |
Amitriptyline (n = 21) | 10.62 (3.36) vs. 14.10 (2.27) | -3.45 (0.84) | - 4 (-5, 1.25)** | 0.89 | 1.99 (1.35-2.63) |
Melatonin (n = 21) | 10.95 (2.94) vs. 14.71 (1.70) | - 3.75 (2.46) | - 4 (-6.5,-2.25)** |  | 2.17 (1.53-2.80) |
Amitriptyline + melatonin (n = 21) | 10.29 (3.15) vs. 14.61 (2.32) | - 4.18 (1.91) | - 4 (-5,-3)** |  | 2.41 (1.72-3.10) |
Pittsburgh Sleep Questionnaire | Â | Â | Â | ||
Amitriptyline (n = 21) | 11.84 (5.82) vs. 19.31 (6.58) | -7.47 (7.34) | -7 (-11,-4)* | 0.94 | 1.07 (0.51-1.63) |
Melatonin (n = 21) | 16.68 (8.38) vs. 22.67 (7.69) | -6.42 (6.53) | -5 (-11,-2)* |  | 0.9 (0.38-1.44) |
Amitriptyline + melatonin (n = 21) | 16.11 (8.40) vs. 24.28 (7.79) | -7.58 (1.91) | -8 (-12,-1.5)* |  | 1.06 (0.52-1.59) |