Prior efforts to treat obesity with intragastric balloons were thwarted by high complication rates.
Therefore, fundamental requirements for optimal balloon designs were defined.
Professor Tytgat and colleagues from Amsterdam, The Netherlands undertook a study in order to investigate the effectiveness, the safety, and the tolerance of a new intragastric balloon.
The researchers designed a randomized, double-blind trial of balloon or sham treatment of 3 months' duration.
The research team invited adults with treatment-resistant obesity and no GI contraindications to balloon placement to participate in the study.
The researchers gave patients (sham- and balloon-treated groups) in whom a preset weight-loss goal was achieved an additional 9 months of balloon treatment.
After removal of the balloon at year 1, patients were followed for a second year without the balloon.
The researchers enrolled 43 treatment-resistant patients and 5 patients who did not meet the preset weight-loss goal.
3 patients did not tolerate the balloon, with endoscopy demonstrating severe esophagitis.
|Patients in the balloon-treatment group lost 3.9 kg (4%) during months 3 to 6|
The researchers noted that 3 other patients developed esophagitis that was related to use of nonsteroidal anti-inflammatory drugs, albeit prohibited (2 patients), or substantial weight loss with balloon treatment (1).
The research team found that on intention-to-treat analysis, sham- and balloon-treated groups had a similar mean weight loss of 11 kg and 13 kg respectively, during the first 3 months.
The researchers found that during months 3 to 6, patients who had sham therapy in months 0 to 3 lost 8.8 kg (8%) during the first 3 months of balloon treatment.
In contrast, they noted that patients in the balloon-treatment group lost 3.9 kg (4%) during months 3 to 6 (their second balloon treatment period).
After 1-year of balloon treatment, a mean weight loss of 21 kg was achieved in all patients, of which 13 kg was maintained at the end of the second balloon-free year.
In addition, the researchers found that 47% of patients sustained a greater than 10% weight loss, with considerably reduced comorbidity.
Dr Tytgat concluded, "For patients with treatment-resistant obesity, the intragastric balloon appeared to be safe but was not a treatment option in a fifth of patients."
"Although an independent benefit of balloon treatment beyond diet, exercise, and behavioral therapy could not be demonstrated in the first 3 months, balloon treatment for 1 year resulted in substantial weight loss, the greater part of which was maintained during the balloon-free second year."