Purpose
The Elipse balloon is a novel, non-endoscopic option for weight
loss. It is swallowed and filled with fluid. After 4 months, the balloon
self-empties and is excreted naturally. Aim of the study was to evaluate safety
and efficacy of Elipse balloon in a large, multicenter, population.
Materials and Methods
Data from 1770 consecutive Elipse balloon patients was analyzed.
Data included weight loss, metabolic parameters, ease of placement, device
performance, and complications.
Results
Baseline patient characteristics were mean age
38.8 ± 12, mean weight
94.6 ± 18.9 kg, and mean BMI
34.4 ± 5.3 kg/m2.
Triglycerides were 145.1 ± 62.8 mg/dL, LDL
cholesterol was 133.1 ± 48.1 mg/dL, and HbA1c was
5.1 ± 1.1%. Four-month results were WL
13.5 ± 5.8 kg, %EWL
67.0 ± 64.1, BMI reduction 4.9 ± 2.0,
and %TBWL 14.2 ± 5.0. All metabolic parameters improved.
99.9% of patients were able to swallow the device with 35.9% requiring stylet
assistance. Eleven (0.6%) empty balloons were vomited after residence. Fifty-two
(2.9%) patients had intolerance requiring balloon removal. Eleven (0.6%)
balloons deflated early. There were three small bowel obstructions requiring
laparoscopic surgery. All three occurred in 2016 from an earlier design of the
balloon. Four (0.02%) spontaneous hyperinflations occurred. There was one
(0.06%) case each of esophagitis, pancreatitis, gastric dilation, gastric outlet
obstruction, delayed intestinal balloon transit, and gastric perforation
(repaired laparoscopically).
Conclusion
The Elipse™ Balloon demonstrated an excellent safety profile.
The balloon also exhibited remarkable efficacy with 14.2% TBWL and improvement
across all metabolic parameters.
Here we aimed at determining the therapeutic effect of a very low-calorie diet in overweight episodic migraine patients during a weight-loss intervention in which subjects alternated randomly between a very low-calorie ketogenic diet (VLCKD) and a very low-calorie non-ketogenic diet (VLCnKD) each for one month. In a nutritional program, 35 overweight obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order (VLCKD-VLCnKD or VLCnKD-VLCD). The primary outcome measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Secondary outcome measures were 50% responder rate for migraine days, reduction of monthly migraine attacks, abortive drug intake and body mass index (BMI) change. Only data from the intention-to-treat cohort (n = 35) will be presented. Patients who dropped out (n = 6) were considered as treatment failures. Regarding the primary outcome, during the VLCKD patients experienced −3.73 (95% CI: −5.31, −2.15) migraine days respect to VLCnKD (p < 0.0001). The 50% responder rate for migraine days was 74.28% (26/35 patients) during the VLCKD period, but only 8.57% (3/35 patients) during VLCnKD. Migraine attacks decreased by −3.02 (95% CI: −4.15, −1.88) during VLCKD respect to VLCnKD (p < 0.00001). There were no differences in the change of acute anti-migraine drug consumption (p = 0.112) and BMI (p = 0.354) between the 2 diets. A VLCKD has a preventive effect in overweight episodic migraine patients that appears within 1 month, suggesting that ketogenesis may be a useful therapeutic strategy for migraines.
This study clearly indicates the efficacy of the prescription of very low-calorie ketogenic diet improving the efficacy of intragastric balloon positioning.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.