For patients with obesity who want to lose weight but for whom conventional weight-loss strategies have failed, the combination of intragastric balloon placement and lifestyle modifications may be preferable to lifestyle modifications alone, according to new clinical practice guidelines from the American Gastroenterological Association.
In randomized clinical trials of patients with obesity (body mass index >30 kg/m2), placing an intragastric balloon (IGB) significantly improved key outcomes such as weight loss, metabolic parameters (such as fasting blood glucose, hemoglobin A1c), and rates of remission of diabetes, hypertension, and dyslipidemia, compared with standard noninvasive weight loss interventions, Thiruvengadam Muniraj, MD, MRCP, of Yale University in New Haven, Conn., and associates wrote in Gastroenterology. However, concomitant lifestyle modifications of “moderate to high intensity” are strongly recommended “to maintain and augment weight loss” after IGB placement, according to the guidelines published in Gastroenterology.
Obesity (BMI >30), affects approximately 40% of U.S. adults, but only about 1.1% of eligible patients receive bariatric weight-loss surgery, and few are aware that endoscopic treatment is an option, according to the guideline. Early IGB models were associated with “a number of devastating adverse events,” spurring their removal from the U.S. market in the 1980s and 1990s. Since then, however, several new models of IGBs have become available. The guidelines noted that, in seven randomized, controlled trials of these newer IGBs, there were no deaths and only a 5.6% overall rate of serious adverse events – most commonly injury to the gastrointestinal tract at 6-8 months’ follow-up. “More recently, postmarketing surveillance of IGB has reported additional rare adverse events of hyperinflation, acute pancreatitis, and death,” but overall, “IGBs appear to be associated with both a favorable adverse event and patient tolerability profile.”
Three models of fluid-filled balloons and two models of gas-filled balloons are currently available in the United States, the guidelines noted. The authors did not recommend one specific type or model over another. They cite limited data indicating that “fluid-filled balloons may be associated with more weight loss, lower tolerability, and less favorable safety profile, than gas filled balloons. Shared decision-making is suggested for determining device choice.”
Relatively few studies have evaluated lifestyle modifications after IGB placement. In one study of 80 patients, a very-low-calorie ketogenic diet led to significantly more weight loss (on average, 7.1 kg), compared with a conventional low-calorie diet. “Although diet does augment and sustain weight loss in patients receiving IGB therapy, it is unclear whether other lifestyle modifications (e.g., exercise) would have the same impact,” the guideline authors wrote.
They strongly recommended prophylactic proton pump inhibitor (PPI) therapy after IGB placement. The procedure can erode the gastrointestinal mucosa, and studies in which patients received prophylactic PPIs reported lower rates of serious adverse events, most notably upper GI bleeding. However, the numerous short- and long-term risks of these drugs make it “imperative that the lowest dose, frequency, and duration of PPIs be used in patients undergoing IGB therapy.”
Intragastric balloons can cause nausea and vomiting, leading to their premature removal. Therefore, when placing an IGB, concomitant antiemetic therapy is recommended along with an anesthetic that is unlikely to cause nausea. “Evidence is insufficient to recommend a specific antiemetic regimen” and “choice of regimen [should be] based on institutional policy, clinical context, and availability,” according to the guidelines.
Based on low-quality evidence, they included a conditional recommendation for daily vitamin supplementation with one to two adult-dose multivitamins after IGB placement. They suggest against perioperative laboratory screening for nutritional deficiencies, based on a lack of supporting evidence. However, since nutritional deficiencies with IGB placement have been reported, decisions about screening for nutritional deficiencies should be tailored based on clinical judgment.
To create the guideline, the authors reviewed databases for studies published through January 2020 in which patients with obesity had an IGB placed for at least 6 months. In all, 79 articles were cited, including more than 10 randomized clinical trials.
An update of the clinical practice guidelines is expected in 2024. The AGA Institute provided the only funding. Dr. Muniraj and five coauthors reported having no conflicts of interest. The other two coauthors disclosed relationships with Nestle Health Sciences, the American Society for Gastrointestinal Endoscopy, the American College of Gastroenterology, and the Association of American Indian Physicians.