Table 2.
AE occurrence n (%)a |
Frequency category by CIOMSb | |
---|---|---|
Administrative problems | ||
Defective devices | ||
Defective needle (e.g., broken needle) | 31 (0.08) | Rare |
Incidents | ||
Delayed needle removal | 226 (0.60) | Uncommon |
Forgotten or lost needle | 136 (0.36) | Uncommon |
Burn due to negligence | 41 (0.11) | Uncommon |
Others | 12 (0.03) | Rare |
Local AEs | ||
Bleeding | 1,969 (5.25) | Common |
Needle site pain | 1,423 (3.80) | Common |
Bruising | 951 (2.54) | Common |
Paraesthesia | 605 (1.61) | Common |
Redness | 226 (0.60) | Uncommon |
Itching | 198 (0.53) | Uncommon |
Swelling | 147 (0.39) | Uncommon |
Burn for treatment purpose | 38 (0.10) | Uncommon |
Blister for treatment purpose | 25 (0.07) | Rare |
Nerve injury | 2 (0.01) | Very rare |
Local infection | 1 (0.003) | Very rare |
Other | 17 (0.05) | Rare |
Systemic AEs | ||
Tiredness | 150 (0.40) | Uncommon |
Somnolence | 149 (0.40) | Uncommon |
Exacerbation of symptoms | 79 (0.21) | Uncommon |
Lethargy | 77 (0.21) | Uncommon |
ANS symptoms | 45 (0.12) | Uncommon |
Pain elsewhere than needling sites | 25 (0.07) | Rare |
Sleep disturbance | 20 (0.05) | Rare |
Systemic inflammation | 15 (0.04) | Rare |
New symptoms after treatment | 10 (0.03) | Rare |
Convulsion | 7 (0.02) | Rare |
Emotional complaint | 5 (0.01) | Rare |
Others | 15 (0.04) | Rare |
Abbreviations: AE Adverse event, ANS Autonomic nervous system, CIOMS Council for International Organisations of Medical Sciences
aDenominator was 37,490 acupuncture treatments.
bVery common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1,000 and < 1/100), rare (≥ 1/10,000 and < 1/1,000), or very rare (< 1/10,000) [20]