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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
[+] Article and Author 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@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.


Ann Intern Med. 2006;144(9):625-633. doi:10.7326/0003-4819-144-9-200605020-00005
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In our randomized, controlled trial of surgical and nonsurgical intervention, both groups showed improvement in weight, health, and quality of life. Patients in the surgical group had statistically significantly better outcomes in each area than those in the nonsurgical group. The extent of weight loss was equal for the 2 groups at 6 months. The nonsurgical group regained weight at 2 years, whereas the surgical patients continued to lose weight. Therapy did not fail in any surgical patient, except for the patient who withdrew before surgery.

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Figures

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Figure 1.
The laparoscopic adjustable gastric band (LAP-BAND System, INAMED Health, Santa Barbara, California) with no added fluid (top) and with 2 mL of fluid added (bottom).

The band is placed laparoscopically around the most proximal region of the stomach. When saline is added to the subcutaneous access port, the balloon expands, thereby generating an increased feeling of satiety before meals and earlier satiety after eating.

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Figure 2.
Participant flow chart.

BMI = body mass index. *Longitudinal analysis was used for weight changes. †Case analysis was used for changes in comorbid conditions and quality of life.

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Figure 3.
Mean (±SE) percentage of initial weight lost with initial data carried forward for missing values.
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Figure 4.
Mean (95% CI) Short Form-36 quality-of-life domain scores for the surgical and nonsurgical groups at baseline and at 2 years.20, 21

Mean age- and sex-matched general community domain scores are physical function, 88 (SD, 17); physical role, 83 (SD, 32); pain, 75 (SD, 23); general health, 74 (SD, 19); energy, 59 (SD, 19); social function, 83 (SD, 23); emotional role, 81 (SD, 34); and mental health, 73 (SD, 17) (data from Ware et al. [ ]). *Statistically significantly greater improvement in the surgical group at 2 years compared with the nonsurgical group.

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Comments

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LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING FOR OBESE PATIENTS WITH BMI < 35 kg/m2
Posted on December 15, 2006
Antonio E. Pontiroli
Università degli Studi di Milano, Ospedale San Paolo, Milano, Italy
Conflict of Interest: None Declared

Sir, in their randomized trial, O'Brien and associates (1) showed that a surgical approach (laparoscopic adjustable gastric banding, LAGB) is superior to medical treatment in obese subjects with BMI < 35 kg/m2, i.e. in a "gray zone" of patients not recommended for a surgical approach according to current NIH guidelines (2), and confirmed the positive results of an italian retrospective survey based on decrease of BMI and disappearance of co-morbidities (3). During our 1996-2003 experience with LAGB (4), we were faced with subjects that, in spite of co-morbidities, were not eligible for LAGB (2) because of BMI <35 kg/m2. The local Ethics Committee stated that, in a comprehensive evaluation of the risk- benefit ratio, medical judgement should prevail on guidelines and for choosing a lower BMI threshold in selected cases, such as deteriorating glucose metabolism or arterial hypertension or personal concern for health. 15 patients, 1 man and 14 women, aged 34.9±1.51 years, height 162±1.1 cm, weight 90.2±1.42 kg underwent LAGB (LapBand, Inamed, Santa Barbara, CA, USA). Peri-operative mortality was 0.0%; diabetes or impaired glucose tolerance (3 cases) and arterial hypertension (2 cases) disappeared.

Baseline6 months12 months24 months
BMI kg/m234.2±0.2229.1±0.61*28.9±0.68*30.5±0.69*
Waist (cm)106.2±1.6790.1±1.77*88.6±1.87*92.6±2.25*
Hdl-cholesterol (mg/dl)49.8±3.6253.2±2.8257.4±4.29*56.2±6.69*
Triglycerides (mg/dl)146.9±21.8492.0±8.47*91.5±12.25*120.1±17.62*
Uric acid (mg/dl)5.2±0.263.8±0.26*3.8±0.31*4.1±0.54
*p<_0.05 or="or" less="less" vs="vs" baseline="baseline" td="td" />

Also in light of the possibile prevention of co-morbidities of obesity (5), our data, similar to those obtained in patients with higher BMI (4), support results obtained by O'Brien (1), and are in favour of a re-examination of current NIH guidelines (2), also on the basis of a cost- benefit ratio (1, 4).

References

1. O'Brien PE, Dixon JB, Laurie C, Skinner S, et al. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial. Ann Intern Med. 2006; 144: 625-633.

2. NIH Consensus Development Panel. Gastrointestinal surgery for severe obesity. Ann Intern Med 1991; 115: 956"“961.

3. Angrisani L, Favretti F, Furbetta F, Iuppa A, et al for the Italian Group for Lap-Band System: results of multicenter study on patients with BMI < or =35 kg/m2. Obes Surg. 2004; 14: 415-418.

4. Pontiroli AE, Pizzocri P, Librenti MC, Vedani P, et al. Laparoscopic adjustable gastric banding for the treatment of morbid (grade 3) obesity and its metabolic complications: a three-year study. J Clin Endocrinol Metab 2002; 87: 3555-3561.

5. Pontiroli AE, Folli F, Paganelli M, Micheletto G, et al. Laparoscopic gastric banding prevents type 2 diabetes and arterial hypertension and induces their remission in morbid obesity: a 4-year case-controlled study. Diabetes Care. 2005; 28: 2703-2709.

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Summary for Patients

Treating Obesity: Laparoscopic Gastric Banding versus a Nonsurgical Weight Loss Program

The summary below is from the full report titled “Treatment of Mild to Moderate Obesity with Laparoscopic Adjustable Gastric Banding or an Intensive Medical Program. A Randomized Trial.” It is in the 2 May 2006 issue of Annals of Internal Medicine (volume 144, pages 625-633). The authors are P.E. O'Brien, J.B. Dixon, C. Laurie, S. Skinner, J. Proietto, J. McNeil, B. Strauss, S. Marks, L. Schachter, L. Chapman, and M. Anderson.

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