Table 8.
Comparison of outcomes of different devices (statistically significant outcomes only)
Device (total number of studies) | Significant weight loss achieved ≤ 12 mo (number of trials) | Follow-up beyond 12 mo and significant weight loss maintained from the first 12 mo (number of trials)1 | Appetite reduction/satiety increase (number of trials) | Food and/or water intake reduction, comparing study group to control (number of trials) | Changes in gastric emptying (number of trials) | Biochemistry changes reported (number of trials)4 |
TANTALUS® (8) | 62 | None (maximum of 12 mo follow-up) | 2 (25%) | Increased (1) | 45 | |
IGS-Transcend (13) | 103 | 5 | 3 (23%) | 1 | ||
Vagal stimulation (3) | 2 | None (maximum of 12 mo follow-up) | 3 (100%) | 1 | ||
Gastric Pacing (6) | 4 | 2 | 2 | Delayed (26) | 1 | |
Total (30) | 22 | 7 | 8 (26.6%) | 3 | 5 | 7 |
Maintained weight loss means that studies had shown significant weight loss during the first year of their follow-up;
One study showed a weight loss of 3.62% from baseline at 37 wk, but p value was not given, so this was not included in the count;
One study demonstrated significant weight loss at 12 mo only after procedural correction;
Significant biochemistry changes include any gastrointestinal hormones (such as ghrelin, peptide YY, leptin, somatostatin, cholecystokinin, Glucagon-like Peptide-1), HbA1c, fasting blood glucose, cholesterol;
One study showed a reduction of -12.2% in HbA1c levels at 37 wk but P value was not given so it was not included in the count;
In one study, gastric emptying was achieved only after 45 min, and there was no significant delaying afterwards.