Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial
Table 3
Cumulative adverse events related to device, procedure, or therapy through 18 months.
Adverse event
vBloc
Sham control
Number (%) of patients
Number of events
% events mild/moderate severity
Number (%) of patients
Number of events
% events mild/moderate severity
Pain, neuroregulator site
61 (38)
76
96%
32 (42)
36
100%
Heartburn/dyspepsia
41 (25)
45
100%
3 (4)
3
100%
Pain, other
40 (25)
48
96%
0 (0)
0
—
Pain, abdominal
22 (14)
30
100%
2 (3)
2
100%
Eructation/belching
14 (9)
14
100%
0 (0)
0
—
Dysphagia
13 (8)
13
100%
0 (0)
0
—
Chest pain
13 (8)
13
92%
2 (3)
2
100%
Nausea
12 (7)
17
94%
1 (1)
1
100%
Incision pain
12 (7)
14
100%
7 (9)
7
100%
Cramps, abdominal
8 (5)
8
100%
0 (0)
0
—
Wound redness or irritation
8 (5)
8
100%
5 (7)
5
100%
Bloating, abdominal
7 (4)
8
100%
1 (1)
2
100%
Constipation
7 (4)
7
100%
7 (9)
7
100%
Emesis/vomiting
6 (4)
8
88%
2 (3)
2
100%
Headache
6 (4)
6
100%
2 (3)
2
100%
Appetite increased
5 (3)
6
100%
2 (3)
3
100%
Only adverse events attributed by the investigator to the device, procedure, or therapy that occurred in at least 3% of vBloc group participants are displayed.
