Treatment of Mild to Moderate Obesity with Laparoscopic Adjustable Gastric Banding or an Intensive Medical Program
A Randomized Trial
- Paul E. O'Brien, MD;
- John B. Dixon, MBBS, PhD;
- Cheryl Laurie, RN;
- Stewart Skinner, MBBS, PhD;
- Joe Proietto, MBBS, PhD;
- John McNeil, MBBS, MSc, PhD;
- Boyd Strauss, MBBS, PhD;
- Sharon Marks, MBBS, PhD;
- Linda Schachter, MBBS;
- Leon Chapman, MBBS; and
- Margaret Anderson, BHIM
Abstract
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.
Article and Author Information
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Australian Clinical Trials Registry no. 012605000113651.
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Acknowledgment: The authors acknowledge the assistance of Dr. Michael Bailey with the statistical analyses performed in the study.
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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.
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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).
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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.
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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.
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Dr. Proietto: University of Melbourne Department of Medicine, Austin Hospital, Heidelberg, Victoria 3081, Australia.
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Dr. McNeil: Monash University Department of Epidemiology and Public Health, The Alfred Hospital, Melbourne 3004, Australia.
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Drs. Strauss and Marks: Monash University Department of Medicine, Monash Medical Centre, Clayton, Victoria 3168, Australia.
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Dr. Chapman: International Diabetes Institute, 250 Kooyong Road, Caulfield, Victoria 3162, Australia.
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Author Contributions: Conception and design: P.E. O'Brien, J.B. Dixon, J. Proietto, J. McNeil, B. Strauss, S. Marks, L. Chapman.
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Analysis and interpretation of the data: P.E. O'Brien, J.B. Dixon, S. Skinner, J. Proietto, J. McNeil, L. Schachter, L. Chapman.
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Drafting of the article: P.E. O'Brien, S. Skinner, L. Schachter, L. Chapman.
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Critical revision of the article for important intellectual content: J.B. Dixon, J. Proietto, J. McNeil, B. Strauss, S. Marks, L. Schachter, L. Chapman.
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Final approval of the article: P.E. O'Brien, J.B. Dixon, J. Proietto, J. McNeil, L. Schachter, L. Chapman.
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Provision of study materials or patients: P.E. O'Brien, J.B. Dixon, S. Skinner, B. Strauss, L. Schachter, L. Chapman.
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Statistical expertise: J.B. Dixon.
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Obtaining of funding: P.E. O'Brien, J.B. Dixon.
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Administrative, technical, or logistic support: P.E. O'Brien, J.B. Dixon, C. Laurie, M. Anderson.
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Collection and assembly of data: P.E. O'Brien, J.B. Dixon, C. Laurie, L. Chapman, M. Anderson.
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