medwireNews: Closed-loop gastric electrical stimulation (CLGES) is noninferior to adjustable gastric band (LAGB) for weight loss and has markedly fewer adverse effects, show the 1-year findings of a randomised trial.
At 12 months after implantation, the body mass index (BMI) of 106 patients assigned to CLGES had fallen by an average of 5.3 kg/m2, compared with 7.0 kg/m2 among the 54 given a gastric band, which the researchers chose as a comparator because, like CLGES, it is “a reversible, minimally invasive procedure.”
The patients all had a baseline BMI of 45–55 kg/m2 or of 35–45 kg/m2 with an obesity-related disorder.
The BMI reduction between the two groups was significant in favour of LAGB, but the difference between the proportion of patients who lost at least 20% of their excess weight was not significant, at 74.5% with CLGES versus 81.5% with LAGB.
And the slightly lower efficacy of CLGES was offset by its improved safety profile. The study’s composite primary endpoint – of at least 20% excess weight loss with no major adverse procedure- or device-related events and no major adverse change in quality of life – was achieved by 73.0% of patients in the CLGES group versus 66.7% of those in the LAGB group, meeting the researchers’ prespecified noninferiority criteria.
“Despite their classification as ‘minor’ or ‘moderate’, the frequent occurrence of symptoms, such as nausea, vomiting, dyspepsia, dysphagia, belching and other complications of LAGB, interferes prominently with daily life and may have major repercussions on the patient’s mood and mental stability”, write Antonio Torres (Hospital Clinico San Carlos, Madrid, Spain) and study co-authors in the International Journal of Obesity.
Indeed, Beck Depression Inventory II scores decreased significantly among patients in the CLGES group, from about 13 to 9 points. Although patients assigned to the LAGB group had an initial improvement, at 6 months, this had disappeared by month 12, with their scores not differing significantly from baseline.
“Furthermore, in contrast to LAGB, which imposes considerable limitations to the types of food that can be consumed, patients who have undergone CLGES are free to eat what they want and are allowed to lose weight without mechanical restriction”, says the team.
“Instead, they learn to recognize satiety and develop healthy eating habits from the feedback of the sensor. Such behavioral reinforcement of habits is critical to the long-term maintenance of weight loss and control of concomitant disorders.”
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