TABLE 3.
Treatment-emergent adverse events (safety population)a.
Adverse events | Acupuncture group (n = 86) |
Medication group (n = 84b) |
||
Participants, N (%) | Events, N | Participants, N(%) | Events, N | |
Total | 8 (9.30%) | 8 | 14 (16.67%) | 16 |
Related to acupuncture overall | 3 (3.49%)c | 3 | 4 (4.76%)d | 4 |
Dermorrhagia | 3 (3.49%) | 3 | 2 (2.38%) | 2 |
Numbness | 0 | 0 | 1 (1.19%) | 1 |
Lassitude | 0 | 0 | 1 (1.19%) | 1 |
Related to medication overall | 5 (5.81%)e | 5 | 10 (11.90%)f | 12 |
Nausea | 0 | 0 | 2 (2.38%) | 2 |
Palpitations | 0 | 0 | 2 (2.38%) | 2 |
Dyspepsia | 2 (2.33%) | 2 | 1 (1.19%) | 2 |
Upper abdominal pain | 1 (1.16%) | 1 | 1 (1.19%) | 1 |
Heartburn | 0 | 0 | 1 (1.19%) | 2 |
Somnolence | 1 (1.16%) | 1 | 1 (1.19%) | 1 |
Dizziness | 0 | 0 | 1 (1.19%) | 1 |
Sweating attack | 1 (1.16%) | 1 | 1 (1.19%) | 1 |
aAdverse events were analyzed in all participants who received at least one session of treatment. Adverse events experienced by the same participant were counted according to type rather than frequency. Adverse events of different types experienced by a single participant were defined as independent adverse events. Multiple occurrences of an adverse event in a single participant was defined as one adverse event.
bTwo participants in the medication group did not receive treatment.
cAdverse events related to true acupuncture.
dAdverse events related to sham acupuncture.
eAdverse events related to placebo naproxen.
fAdverse events related to naproxen.