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

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 The development of a safe and effective treatment for obesity is a leading challenge in health care today. Obesity is an increasing health problem across the world with a prevalence of more than 20% among the adult population in Western countries and more than 30% in the United States (1, 2). The increasing prevalence is associated with a parallel increase of several obesity-related diseases, in particular, the diseases of the metabolic syndrome (3, 4), which include type 2 diabetes, hypertension, and dyslipidemia, and are linked to nonalcoholic steatohepatitis, obstructive sleep apnea, and the polycystic ovary syndrome. For obese individuals, the options are limited. Behavioral therapies of reduced energy intake, improved eating practices, and increased exercise and activity, supplemented by pharmacotherapy, generally achieve only modest and often transient effects (5, 6). Observational studies have shown that bariatric surgical therapies involving gastric restriction by various forms of stapling with or without diversion of the gut to generate malabsorption of food are effective in achieving major weight loss and clinically significant improvements in health and quality of life (7-11). Strong direct evidence from randomized, controlled trials of the relative benefits of nonsurgical and surgical therapies is lacking. We are aware of only a single study, performed in the 1980s, in which 60 morbidly obese patients were randomly assigned, without informed consent, to diet plus an early form of gastric stapling or to diet alone (12). The maximum weight losses did not differ between the groups. However, the weight regain was greater in the diet-only group. The advent of the laparoscopic adjustable gastric band has provided a new bariatric surgical option, which has proved to be safe, minimally invasive in its application, gentle in its use through its adjustability and easy reversibility, and similarly effective to the other bariatric procedures (10, 13, 14). Figure 1 shows the LAP-BAND System (INAMED Health, Santa Barbara, California) and demonstrates the key feature of adjustability of the area within the band through which it induces satiety (15). Patients require no more than an overnight hospital stay, and the procedure has been shown to be markedly safer than gastric bypass surgery (13). 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 ). We hypothesized that surgical therapy would induce more weight loss, health benefit, and improvement in quality of life than nonsurgical therapy and have conducted a randomized, controlled trial comparing the effectiveness of current nonsurgical therapy with laparoscopic adjustable gastric banding in a group of mildly to moderately obese adults (body mass index, 30 kg/m2 to 35 kg/m2). We did not study patients with a body mass index greater than 35 kg/m2 because current observational data suggest that outcomes after nonsurgical treatment were unlikely to be equal to those after surgical care for these patients. The principal outcome measures were weight change, health, quality of life, and complications of therapy. Methods Patient Recruitment We recruited patients for the study through a newspaper advertisement. All patient assessments and outpatient treatments were conducted at a community clinic dedicated to obesity management or in the clinics of a university department of surgery. Surgical procedures were conducted at a private community hospital experienced in the care of bariatric surgical patients. Patients in both groups did not pay any medical costs generated by the study. The human ethics committees of The Alfred Hospital and The Avenue Hospital approved the study in accordance with the guidelines of the National Health and Medical Research Council (www.nhmrc.gov.au/publications/synopses/e35syn.htm) and with the Helsinki Declaration of 1975, as revised in 2000 (www.wma.net/e/ethicsunit/pdf/draft_historical_contemporary_perspectives.pdf). Inclusion Criteria We considered patients to be eligible if they were between 20 and 50 years of age; had a body mass index of 30 kg/m2 to 35 kg/m2; had identifiable problems, including an obesity-related comorbid condition (such as hypertension, dyslipidemia, diabetes, obstructive sleep apnea, or gastroesophageal reflux disease), severe physical limitations, or clinically significant psychosocial problems associated with their obesity; had attempted to reduce weight over at least the previous 5 years; could understand the options offered and the randomization process; and were willing to comply with the requirements of each program. Exclusion Criteria We excluded candidates with a history of bariatric surgery or medical problems that contraindicated treatment in either study group, such as impaired mental status, drug or alcohol addiction, or portal hypertension. In addition, we excluded participants if they had undergone an intensive, physician-supervised program that used very-low-calorie diets or pharmacotherapy or if they did not attend the 2 initial patient information visits. Assessment We provided detailed information about the problems of obesity and about the 2 study groups through at least 2 discussion periods and a patient information booklet. Initial assessment included anthropometric measures; identification of medical, physical, or psychosocial problems (both weight-related and other); and a discussion of previous weight loss efforts. The assessment included a detailed dietary history by the trial dietitian and a review by a specialist physician to determine the presence and severity of associated medical conditions. Initial investigations included measurements of fasting blood glucose level; serum insulin level; and a lipid profile, including HDL cholesterol and LDL cholesterol levels. After initial assessment, we instituted a program of advice on appropriate eating patterns and exercise and followed each patient on a monthly basis for 3 months. During this time, we assessed the patients' fulfillment of tasks, such as completion of a food diary, and overall adherence to appointments. Randomization Process We randomly allocated eligible patients to receive a conventional, intensive, nonsurgical program or laparoscopic adjustable gastric banding. A computer-derived random allocation sequence, without blocking or stratification, performed the randomization. This was prepared at the trial office. The trial coordinator enrolled participants and informed them of the trial allocation. After assessment had confirmed a participant's suitability for randomization, the coordinator contacted the trial office by telephone for allocation. The study was not blinded. Description of Nonsurgical and Surgical Interventions Common Program We instructed and encouraged all patients to follow appropriate lifestyle behavior of good eating practices and increased exercise and activity. We also encouraged them to exercise for at least 200 minutes per week. Nonsurgical Program This program centered on the use of behavioral modification, very-low-calorie diet, and pharmacotherapy with education and professional support on appropriate eating and exercise behavior. During the 2-year period, 3 trained physicians developed a program using all the available modalities for each individual on the basis of guidelines prepared and continually reviewed by a panel of experienced bariatric physicians. The program began with an intensive 6-month period of very-low-calorie diet (500 to 550 kcal/d) using 1 to 3 packets of Optifast (Novartis, Fremont, Michigan) daily for 12 weeks, followed by a transition phase over 4 weeks combining some very-low-calorie meals with 120 mg of orlistat before nonvery-low-calorie diet meals, and then 120 mg of orlistat before all meals until the completion of the intensive phase. This intensive 6-month program was followed by further courses of very-low-calorie diets or orlistat as tolerated, as well as continual behavioral, dietary, and exercise advice to assist the participant in maintaining weight loss over a prolonged period. Sibutramine was not approved for use in Australia during the first 12 months of the study and, therefore, was not incorporated into the medical program. The management program for each individual was designed to reflect good clinical practice. A physician saw each patient every 2 weeks during the very-low-calorie diet program and every 4 to 6 weeks during the rest of the study. All patients were seen at least every 6 weeks. Surgical Program Two experienced surgeons performed the laparoscopic adjustable gastric band (LAP-BAND System) procedure, by a standardized method (14), within 1 month of randomization. The band was placed along the perigastric pathway in all cases (16). The treating surgeon reviewed patient progress every 4 to 6 weeks during the study period and made adjustments to the volume of saline within the band in the office by using standard clinical criteria (17). Adverse Events All patients in the study were questioned about the occurrence of adverse events at each consultation, and physicians recorded the resul