Variables | Treatment groups | |||
---|---|---|---|---|
All (N = 630) | Thiamin (n = 314) | Placebo (n = 316) | P-value | |
At least one adverse event | 226/630 (36%) | 101/314 (32%) | 125/316 (40%) | 0.053 |
Headache | 33/438 (7.5%) | 18/219 (8%) | 15/219 (7%) | 0.58 |
Insomnia | 36/629 (6%) | 15/313 (5%) | 21/316 (7%) | 0.32 |
Weakness | 33/629 (5%) | 15/313 (5%) | 18/316 (6%) | 0.61 |
Anorexia | 35/629 (6%) | 15/313 (5%) | 20/316 (6%) | 0.40 |
Diarrhoea | 31/630 (5%) | 10/314 (3%) | 21/316 (7%) | 0.04 |
Nightmare | 17/439 (4%) | 5/219 (2%) | 12/220 (5%) | 0.08 |
Abdominal pain | 12/447 (3%) | 6/221 (3%) | 6/226 (3%) | 0.97 |
Dizziness | 12/438 (3%) | 4/219 (2%) | 8/219 (4%) | 0.24 |
Vomiting | 14/629 (2%) | 4/313 (1%) | 10/316 (3%) | 0.10 |
Nausea | 5/440 (1%) | 2/221 (1%) | 3/219 (1%) | 0.65 |
Palpitation | 5/439 (1%) | 1/220 (0.5%) | 4/219 (2%) | 0.17 |
Itch | 5/629 (1%) | 2/313 (1%) | 3/316 (1%) | 0.66 |
Vertigo | 1/438 (0.2%) | 0 | 1/219 (0.5%) | 0.32 |
Tinnitus | 1/440 (0.2%) | 0 | 1/220 (0.45%) | 0.32 |
Rash | 1/629 (0.2%) | 1/313 (0.3%) | 0 | 0.31 |
Urticaria | 1/629 (0.2%) | 0 | 1/316 (0.3%) | 0.32 |
Irritability | 0 | 0 | 0 | - |
Dyspnoea | 1/629 (0.2%) | 1/313 (0.3%) | 0 | 0.31 |
Hearing loss | 0 | 0 | 0 | - |
Paraesthesia | 2/441 (0.5%) | 1/221 (0.5%) | 1/220 (0.5%) | 0.99 |