Table 3.
Intensity of the 12 selected GASE adverse symptom items before 1st TAP assessment (baseline) and post 2nd TAP assessment.
| Placebo-Modafinil (n = 25) | Nocebo-Vividrin® (n = 25) | Natural history (n = 25) | Difference between groups post 2nd assessment (with pre 1st assessment as covariate) | |||||
|---|---|---|---|---|---|---|---|---|
| Pre 1st assessment, M (SD) |
Post 2nd assessment, M (SD) |
Pre 1st assessment, M (SD) |
Post 2nd assessment, M (SD) |
Pre 1st assessment, M (SD) |
Post 2nd assessment, M (SD) |
F(2,71) | p | |
| Placebo-Modafinil specific | ||||||||
| Headache | 0.20 (0.41) | 0.36 (0.57) | 0.28 (0.46) | 0.56 (0.65) | 0.28 (0.54) | 0.52 (0.65) | 0.49 | .616 |
| Palpitations, irregular heartbeat | 0.00 (0.00) | 0.16 (0.62) | 0.12 (0.44) | 0.08 (0.28) | 0.12 (0.33) | 0.00 (0.00) | 1.44 | .243 |
| Abdominal pain | 0.04 (0.20) | 0.00 (0.00) | 0.20 (0.65) | 0.28 (0.68) | 0.04 (0.20) | 0.04 (0.20) | 2.45 | .094 |
| Fatigue (tiredness) | 0.64 (0.64) | 0.92 (0.91) | 0.92 (0.70) | 1.76 (0.83) | 1.00 (0.76) | 1.44 (0.96) | 4.41* | .016 |
| Irritability, nervousness | 0.24 (0.44) | 0.16 (0.62) | 0.32 (0.48) | 0.20 (0.50) | 0.40 (0.58) | 0.08 (0.28) | 0.83 | .441 |
|
Nocebo-Vividrin®
specific | ||||||||
| Bitter taste | 0.12 (0.33) | 0.12 (0.33) | 0.00 (0.00) | 0.32 (0.56) | 0.04 (0.20) | 0.08 (0.28) | 2.67 | .076 |
| Nausea | 0.00 (0.00) | 0.00 (0.00) | 0.00 (0.00) | 0.08 (0.28) | 0.00 (0.00) | 0.04 (0.20) | 1.03 | .363 |
| Skin rash or itching | 0.08 (0.28) | 0.04 (0.20) | 0.12 (0.33) | 0.08 (0.28) | 0.12 (0.44) | 0.12 (0.44) | 0.75 | .477 |
| Feeling of weakness | 0.08 (0.28) | 0.12 (0.33) | 0.12 (0.33) | 0.44 (0.77) | 0.20 (0.50) | 0.28 (0.46) | 2.14 | .126 |
| Drowsiness (exhaustion) | 0.52 (0.59) | 0.84 (0.94) | 0.76 (0.66) | 1.48 (0.77) | 0.64 (0.64) | 1.32 (0.85) | 2.87 | .063 |
| Unspecific | ||||||||
| Dizziness | 0.04 (0.20) | 0.40 (0.71) | 0.04 (0.20) | 0.32 (0.56) | 0.12 (0.33) | 0.28 (0.46) | 0.65 | .525 |
| Irritation of nose or throat | 0.16 (0.47) | 1.00 (0.58) | 0.24 (0.44) | 1.04 (0.54) | 0.08 (0.28) | 0.08 (0.28) | 29.82*** | <.001 |
GASE, Generic Assessment of Side Effects Scale, Bonferroni correction of the family wise error rate led to a p-value of .02 as criterion for significance with respect to the drug specific symptoms and .05 as criterion for significance with respect to unspecific symptoms.
*p < .02, ***p < .001.