Table 5.
Side effects
|
Proportion (%) reporting side effects
|
95% CI* | McNemar's test | ||||||
---|---|---|---|---|---|---|---|---|---|
Reported by neither participant | Reported only by participant taking placebo | Reported only by participant taking active treatment | Reported by both | Placebo group | Active treatment group | ||||
Beneficial effects: | |||||||||
General well being | 482 | 2 | 5 | 0 | 0.4 | 1.0 | −0.4 to 1.7 | 0.45 | |
Improved circulation | 483 | 1 | 5 | 0 | 0.2 | 1.0 | −0.2 to 1.8 | 0.22 | |
Hearing better | 484 | 2 | 3 | 0 | 0.4 | 0.6 | −0.7 to 1.1 | 1.00 | |
⩾1 other good side effects | 467 | 7 | 14 | 1 | 1.6 | 3.1 | −0.4 to 3.3 | 0.19 | |
No of pairs reporting ⩾1 beneficial effect of treatment† | 456 | 9 | 22 | 2 | 2.2 | 4.9 | 0.4 to 4.9 | 0.03 | |
Adverse effects: | |||||||||
Gastrointestinal upset | 460 | 14 | 14 | 1 | 3.1 | 3.1 | −2.1 to 2.1 | 1.00 | |
Worsening of blocking or pressure in ear | 475 | 4 | 10 | 0 | 0.8 | 2.1 | −0.3 to 2.7 | 0.18 | |
Dizziness, lightheadedness, or nausea | 476 | 7 | 6 | 0 | 1.4 | 1.2 | −1.6 to 1.2 | 1.00 | |
Headache | 481 | 4 | 4 | 0 | 0.2 | 0.8 | −1.1 to 1.1 | 1.00 | |
Mouth ulcer, dryness, bad taste | 480 | 6 | 3 | 0 | 1.2 | 0.6 | −1.8 to 0.6 | 0.51 | |
Sleep or dreams worse | 482 | 3 | 4 | 0 | 0.6 | 0.8 | −0.9 to 1.3 | 1.00 | |
Flushing or redness of the face | 484 | 4 | 1 | 0 | 0.8 | 0.2 | −1.5 to 0.3 | 0.37 | |
Skin worse (dry, itchy, spots) | 484 | 3 | 2 | 0 | 0.6 | 0.4 | −1.1 to 0.7 | 1.00 | |
Awareness of heartbeat | 483 | 3 | 3 | 0 | 0.6 | 0.6 | −1.0 to 1.0 | 1.00 | |
Hearing worse | 485 | 1 | 3 | 0 | 0.2 | 0.6 | −0.4 to 1.2 | 0.62 | |
Hyperacusis | 487 | 2 | 0 | 0 | 0.4 | 0.0 | −1.0 to 0.2 | 0.50 | |
⩾1 other adverse side effects‡ | 472 | 7 | 9 | 1 | 1.6 | 2.0 | −1.2 to 2.0 | 0.80 | |
No of pairs reporting ⩾1 adverse effect of treatment | 392 | 43 | 46 | 8 | 10.4 | 11.0 | −3.2 to 4.4 | 0.83 |
Comparison between results of active treatment and placebo treatment.
Other beneficial effects included improvements in desire for sex; improvement in impotence; easier breathing; and improvements in symptoms of irritable bowel syndrome, sleep and dreams, concentration and reactions, headaches, appetite, stress, illness (colds or flu), skin, bladder control, blocked ears or pressure in ears, and dizziness.
Other adverse effects included a decrease in sexual desire, difficulty breathing, watering eyes, worsening of eyesight, more frequent urination or discoloration of urine, worsening of stiffness in the joints, night sweats, worsening of stress, anaemia, and loss of appetite.