Table 3.
Reported Adverse Events
| Type of adverse events | Total # of patientsc | Total # of sessionsd | Detailse |
|---|---|---|---|
| Subcutaneous bleeding & hematoma | 229 (10.50%) | 370 (2.64%) | < 1 cm (286 cases), ≥1 cm (31), ≥2 cm (29), ≥3 cm (9), ≥5 cm (2), unknown (13) |
| Discomfort | 65 (2.98%) | 109 (0.78%) | Feeling of fatigue (59), drowsiness (23), dizziness (13), nausea (12), hot flash (5), faint (2), palpitation (2) |
| Residual pain of insertion points | 77 (3.53%) | 94 (0.67%) | Weak pain (75), strong pain (14), unknown (5) |
| Pain on insertion/stimulationa | 59 (2.71%) | 78 (0.56%) | Pain during insertion (55), pain during retaining (21), pain during electroacupuncture (3) |
| Bleedingb | 50 (2.29%) | 74 (0.53%) | ≥ 10 sec (14), ≥20 sec (36), ≥30 sec (16), ≥60 sec (7), unknown (1) |
| Aggravation of symptoms | 23 (1.06%) | 28 (0.20%) | Pain (15): low-back pain (6); knee pain (4); shoulder pain (2); headache (1); wrist pain (1); lower-leg pain (1) |
| Other symptoms: shoulder stiffness (4); muscle tension & entrapment (3); others (4); unknown (2) | |||
| Burn injury | 21 (0.96%) | 24 (0.17%) | Causes: heat perception moxibustion (9); pedestal moxibustion (8); indirect moxibustion (ointment “shiunko” moxibustion, 2); press moxibustion (1); moxa needle (1); pedestal moxibustion with infrared radiation (1); dropped lighter (1); unknown (1) |
| Degree: first degree (19); second degree (superficial, 4); unknown (1) | |||
| Others | 17 (0.78%) | 19 (0.14%) | Strong acupuncture sensation & heavy sensation (6), pain (4) [headache, 1], unknown, 3)], cold sensation of inserted area (2), diarrhea (2), numbness & unusual sensation (2), unknown (2), dropped needle (1) |
| Cutaneous inflammation & subcutaneous tissue inflammation | 11 (0.50%) | 12 (0.09%) | Cutaneous inflammation (11): itch (6); flare (3); wheal (2) |
| Subcutaneous tissue inflammation (1): wheal (1) | |||
| Forgotten needles | 13 (0.60%) | 13 (0.09%) | — |
| Unknown | 24 (1.10%) | 26 (0.19%) | Because of incomplete report form (26) |
| Total | 589 (27.02%) | 847 (6.03%) | — |
a
Pain on “Seppi” (skin penetration by vertically tapping a handle of the needle) is excluded.
b
Bleeding for less than 10 seconds is excluded.
c
Number in parentheses represents the percentage of each adverse event for a total of 2180 patients.
d
Number in parentheses represents the percentage of each adverse event for a total of 14,039 treatment sessions.
e
Numbers in parentheses represent the numbers of the adverse events. Some of the details are multiple answers.
sec, seconds.