Treatment of Mild to Moderate Obesity with Laparoscopic Adjustable Gastric Banding or an Intensive Medical Program

A Randomized Trial

2 May 2006 | Volume 144 Issue 9 | Pages 625-633

Background: Obesity is a major, growing health problem. Observational studies suggest that bariatric surgery is more effective than nonsurgical therapy, but no randomized, controlled trials have confirmed this.

Objective: To ascertain whether surgical therapy for obesity achieves better weight loss, health, and quality of life than nonsurgical therapy.

Design: Randomized, controlled trial.

Setting: University departments of medicine and surgery and an affiliated private hospital.

Patients: 80 adults with mild to moderate obesity (body mass index, 30 kg/m² to 35 kg/m²) from the general community.

Interventions: Patients were assigned to a program of very-low-calorie diets, pharmacotherapy, and lifestyle change for 24 months (nonsurgical group) or to placement of a laparoscopic adjustable gastric band (LAP-BAND System, INAMED Health, Santa Barbara, California) (surgical group).

Measurements: Outcome measures were weight change, presence of the metabolic syndrome, and change in quality of life at 2 years.

Results: At 2 years, the surgical group had greater weight loss, with a mean of 21.6% (95% CI, 19.3% to 23.9%) of initial weight lost and 87.2% (CI, 77.7% to 96.6%) of excess weight lost, while the nonsurgical group had a loss of 5.5% (CI, 3.2% to 7.9%) of initial weight and 21.8% (CI, 11.9% to 31.6%) of excess weight (P < 0.001). The metabolic syndrome was initially present in 15 (38%) patients in each group and was present in 8 (24%) nonsurgical patients and 1 (3%) surgical patient at the completion of the study (P < 0.002). Quality of life improved statistically significantly more in the surgical group (8 of 8 subscores of Short Form-36) than in the nonsurgical group (3 of 8 subscores).

Limitations: The study included mildly and moderately obese participants, was not powered for comparison of adverse events, and examined outcomes only for 24 months.

Conclusions: Surgical treatment using laparoscopic adjustable gastric banding was statistically significantly more effective than nonsurgical therapy in reducing weight, resolving the metabolic syndrome, and improving quality of life during a 24-month treatment program.

Editors' Notes Context Observational studies have shown sustained weight loss after surgery for extreme obesity. No randomized trial of contemporary surgical methods has been performed. Contribution The authors randomly assigned 80 mildly to moderately obese (body mass index, 30 to 35 kg/m2) adults to laparoscopic placement of an adjustable gastric band or to an intensive nonsurgical weight loss program. After 2 years, the surgical group had lost 21.6% of initial weight, and the nonsurgical group had lost 5.5% of initial weight. Four patients required laparoscopic revision of the gastric band. Cautions The study was not designed to detect uncommon adverse events. Implications Laparoscopic gastric banding is effective treatment for mild to moderate obesity. —The Editors

 

Author and Article Information

From Monash University and University of Melbourne, Melbourne, Victoria, Australia.

Australian Clinical Trials Registry no. 012605000113651.

Acknowledgment: The authors acknowledge the assistance of Dr. Michael Bailey with the statistical analyses performed in the study.

Grant Support: By the Department of Surgery, Monash University. INAMED Health, manufacturer of the LAP-BAND System; Novartis, manufacturer of Optifast; and U.S. Surgical Corp., manufacturer of disposable laparoscopic instruments, provided the equipment devices or products.

Potential Financial Conflicts of Interest: Consultancies: J.B. Dixon (INAMED Health, Novartis), S. Marks (Novartis); Grants received: P.E. O'Brien (INAMED Health, Novartis, U.S. Surgical Corp.), J.B. Dixon (INAMED Health, Novartis).

Requests for Single Reprints: Professor Paul O'Brien, MD, Centre for Obesity Research and Education, Monash University Medical School, The Alfred Hospital, Melbourne 3004, Australia; e-mail, paul.obrien{at}med.monash.edu.au.

Current Author Addresses: Drs. O'Brien, Dixon, Skinner, and Schachter and Ms. Laurie and Ms. Anderson: Centre for Obesity Research and Education, Monash University Medical School, The Alfred Hospital, Melbourne 3004, Australia.

Dr. Proietto: University of Melbourne Department of Medicine, Austin Hospital, Heidelberg, Victoria 3081, Australia.

Dr. McNeil: Monash University Department of Epidemiology and Public Health, The Alfred Hospital, Melbourne 3004, Australia.

Drs. Strauss and Marks: Monash University Department of Medicine, Monash Medical Centre, Clayton, Victoria 3168, Australia.

Dr. Chapman: International Diabetes Institute, 250 Kooyong Road, Caulfield, Victoria 3162, Australia.

Author Contributions: Conception and design: P.E. O'Brien, J.B. Dixon, J. Proietto, J. McNeil, B. Strauss, S. Marks, L. Chapman.

Analysis and interpretation of the data: P.E. O'Brien, J.B. Dixon, S. Skinner, J. Proietto, J. McNeil, L. Schachter, L. Chapman.

Drafting of the article: P.E. O'Brien, S. Skinner, L. Schachter, L. Chapman.

Critical revision of the article for important intellectual content: J.B. Dixon, J. Proietto, J. McNeil, B. Strauss, S. Marks, L. Schachter, L. Chapman.

Final approval of the article: P.E. O'Brien, J.B. Dixon, J. Proietto, J. McNeil, L. Schachter, L. Chapman.

Provision of study materials or patients: P.E. O'Brien, J.B. Dixon, S. Skinner, B. Strauss, L. Schachter, L. Chapman.

Statistical expertise: J.B. Dixon.

Obtaining of funding: P.E. O'Brien, J.B. Dixon.

Administrative, technical, or logistic support: P.E. O'Brien, J.B. Dixon, C. Laurie, M. Anderson.

Collection and assembly of data: P.E. O'Brien, J.B. Dixon, C. Laurie, L. Chapman, M. Anderson.

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LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING FOR OBESE PATIENTS WITH BMI < 35 kg/m2

Antonio E. Pontiroli, et al.

Annals Online, 3 Jan 2007 [Full text]