Original Article
Intragastric balloon for treatment-resistant obesity: safety, tolerance, and efficacy of 1-year balloon treatment followed by a 1-year balloon-free follow-up

https://doi.org/10.1016/S0016-5107(04)02406-XGet rights and content

Background

Prior efforts to treat obesity with intragastric balloons were thwarted by high complication rates. Therefore, fundamental requirements for optimal balloon designs were defined. The aim of the present study was to investigate the effectiveness, the safety, and the tolerance of a new intragastric balloon.

Methods

Adults with treatment-resistant obesity and no GI contraindications to balloon placement were invited to participate in a randomized, double-blind trial of balloon or sham treatment of 3 months' duration. Patients (sham- and balloon-treated groups) in whom a preset weight-loss goal was achieved were given 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.

Results

Forty-three treatment-resistant patients (mean body mass index 43.3 kg/m2) were enrolled. Five patients did not meet the preset weight-loss goal (nonresponse 11.6%). Three patients did not tolerate the balloon (7.0%), with endoscopy demonstrating severe esophagitis. Three 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). In intention-to-treat analysis, sham- and balloon-treated groups had a similar mean weight loss of 11.2 kg (9.0%) and 12.9 kg (10.4%), respectively, during the first 3 months. During months 3 to 6, patients who had sham therapy in months 0 to 3 lost 8.8 kg (7.9%) during the first 3 months of balloon treatment. In contrast, patients in the balloon-treatment group lost 3.9 kg (3.5%) during months 3 to 6 (their second balloon treatment period). The overall weight loss was 20 kg (16.1%) and 16.7 kg (13.4%) after 6 months in the sham/balloon and in the balloon/balloon treated groups (not significant), respectively. After 1-year of balloon treatment, a mean weight loss of 21.3 kg (17.1%) was achieved in all patients, of which 12.6 kg (9.9%) was maintained at the end of the second balloon-free year; 47% of patients sustained a greater than 10% weight loss, with considerably reduced comorbidity. In 33 patients who completed the study per protocol, weight loss was 25.6 kg (20.5%) after 1 year and 14.6 kg (11.4%) after 2 years; 55% maintained a weight loss of greater than 10%. Interventional complications occurred in 1.6% (2/128) and balloon deflations in 2.3% (3/128).

Conclusions

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.

Section snippets

Patients and methods

The study protocol was approved by the ethical committee of our hospital. Written informed consent was obtained from each participating patient.

Results

Fifty-six patients were screened for inclusion in the study. Of these, 13 were ineligible for the following reasons: a large hiatal hernia (4), a peptic ulcer (1), treatment with anticoagulant medication (2), prior bariatric surgery (1), intra-abdominal adhesions (1), BMI less than 32 kg/m2 (2), and no prior weight-reduction program (2). Thus, 43 patients (7 men, 36 women; mean age 41.4 years, range 22-64 years) entered the study. Mean weight and BMI were 125.2 kg (range 93.2-187.7), and 43.3

Discussion

The complex design of the present study ensued from problems encountered with prior versions of intragastric balloons. The FDA acted as an adviser and had a major influence on the design of the study protocol.4 To maximize safety and to prevent unduly long exposure of nonresponding patients to a potentially hazardous treatment, balloons had to be removed every 3 months, and strict weight-loss goals were defined as a requirement for continuation of treatment. Although the protocol was approved

Acknowledgments

The authors are greatly indebted to H. Reitsma, MD, PhD, Department of Clinical Epidemiology and Biostatistics, for statistical help and to BioEnterics Corp. (Carpinteria, Calif.) for providing the balloons and the sham placement assemblies.

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