Effect of Acupoint Catgut Embedding for Middle-Aged Obesity: A Multicentre, Randomised, Sham-Controlled Trial

Table 11

Adverse events related to treatment^a.

Adverse event	Participant, No. (%)
	ACE group (n = 106)^b	Sham ACE group(n = 107)^b
Overall	8 (7.5%)	5 (4.7%)
Severe adverse events	0	0
Sleeplessness after ACE	1 (0.9%)	0
Dizziness after ACE	1 (0.9%)	1 (0.9%)
Fainting during ACE	1 (0.9%)	0 (0)
Nausea during ACE	0 (0)	0 (0)
Local induration after two weeks	0 (0)	0 (0)
Haematoma around the site of needling	2 (1.9%)	0 (0)
Sharp pain lasting＞2h^c	1 (0.9%)	3 (2.8%)
Bleeding/numbness/infection around the site of needling	0 (0)	0 (0)
Other discomforts after ACE^d	2 (1.9%)	1 (0.9%)

^aAdverse events were analysed in all participants who received treatment. Adverse events were counted by type rather than the frequency in the same participant. Adverse events with different types occurring in a single participant were defined as independent adverse events. An adverse event with multiple occurrences in a single participant was defined as 1 adverse event. ^bTwo participants in the ACE group and one in the sham ACE group did not receive treatment. ^cSharp pain was defined as VAS ≥4.^d Include headache, local edema, transient weakness of the hand, and mild pain.