Table 2.
Adverse event profile of the study participants
| Adverse eventa | Placebo, n (%) | Baclofen 30 mg/day, n (%) | Baclofen 60 mg/day, n (%) |
|---|---|---|---|
| Nil reported | 8 (57) | 10 (71) | 10 (71) |
| Somnolence/drowsiness | 3 (21) | 2 (14) | 3 (21) |
| Headaches | 1 (14) | 3 (21) | – |
| Fatigue | 1 (7) | 1 (7) | 2 (14) |
| Muscle aches | 1 (7) | 1 (7) | – |
| Constipation | – | 1 (7) | 1 (7) |
| Insomnia | 1 (7) | – | – |
| Dizziness | – | 1 (7) | – |
| Numbness in extremities | – | – | 1 (7) |
| Dry mouth | – | 1 (7) | 1 (7) |
| Nausea | – | 1 (7) | – |
| Anxiety | 1 (7) | – | – |
| Skin rash | – | – | 1 (7) |
aOne patient randomized to 10 mg t.i.d. experienced constipation, sedation, drowsiness and headaches while another patient randomized to 20 mg t.i.d. experienced drowsiness, fatigue and numbness in the extremities. However, following halving of the dose, both of these patients reported that these symptoms disappeared.