A double-blind, randomized, sham-controlled trial of the gastric bubble for obesity. Intragastric balloon in the treatment of super-morbid obesity. Double-blind, sham-controlled, crossover evaluation of 500-milliliter balloon. Laparoscopic adjustable gastric banding versus open vertical banded gastroplasty: a prospective randomized trial. Surgery for Obesity- An Update of a Randomized Trial. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial. Conceptualisation and evaluation of a cognitive-behavioural training programme for children and adolescents with obesity. Randomized clinical trial of laparoscopic Roux-en-Y gastric bypass versus laparoscopic vertical banded gastroplasty for obesity. A randomized comparison of group cognitive-behavioral therapy and group interpersonal psychotherapy for the treatment of overweight individuals with binge-eating disorder. Intragastric balloon for treatment-resistant obesity: safety, tolerance, and efficacy of 1-year balloon treatment followed by a 1-year balloon-free follow-up.
We investigated the effect of an endoscopically placed gastric balloon, the Garren-Edwards gastric bubble (GEGB), on weight loss in obese patients. Fifty-nine obese patients were entered into a prospective double-blind study and randomized into two groups. In one group (34 patients) the GEGB was inserted, and in the other group (25 patients) a sham insertion was done. All patients participated in a standard weight loss program consisting of dietary therapy, behavior modification, and physical exercise. The bubble was removed endoscopically after 3 months from both groups. Patients were followed for an additional 9 months after bubble removal and weight loss was monitored. Weight loss was the same in both groups at 3 months (18.7 lb vs. 17.2 lb). This was true whether determined by change in pounds, percentage of body weight, or body mass index. We concluded that the GEGB was of no added benefit as compared with sham insertion, when combined with a standard weight loss program. Because of the lack of proven efficacy and the relatively high cost, we recommend that such devices be restricted to controlled studies until significant benefits are proven. A prolonged randomized, prospective, double-blind, crossover study, including a sham-sham-treated group, was undertaken to evaluate the efficacy and safety of a 500-mL gastric bubble (Ballobes; DOT ApS, Rödovre, Denmark) as an adjunct to diet, physical training, and behavioral modification. Only supermorbidly obese patients who fulfilled the usual criteria for surgery were admitted. A weight loss of 38 kg in the first 17 weeks and another 12 kg in the second 18 weeks could be achieved. The body mass index, the percentage of overweight and the loss in percentage of initial weight, paralleled this impressive weight loss. In the second period, a plateau effect occurred after the massive changes in the first period, and only one third of the changes in all parameters was seen. Stratification into a sham-sham, sham-balloon, balloon-sham, and balloon-balloon group did not show any statistical difference for all parameters between the four groups. The double-blind nature of the study was affirmed by the patient's correct judgment of the presence or absence of a balloon in only 21% of the balloon and 44% of the sham procedures. Gastrointestinal complications were infrequent and consisted of erosions (three patients), asymptomatic reflux oesophagitis (one patient), and asymptomatic gastric ulcer (one patient). Only the latter patient had elevated gastrin levels. One patient could not tolerate the balloon. All balloons remained airtight during both parts of the study for a mean of 123 days. This study confirmed the safety of the balloon, but no additional benefit could be ascribed to the balloon compared with a very low-calorie diet and medical and dietary support. Laparoscopic adjustable gastric banding (LAGB) and open vertical banded gastroplasty (VBG) are treatment modalities for morbid obesity. However, few prospective randomized clinical trials (RCT) have been performed to compare both operations.
                100 patients (50 per group) were included in the study. Postoperative outcomes included hospital length of stay (LOS), complications, percent excess weight loss (%EWL), BMI and reduction in total comorbidities. Follow-up in all patients was 2 years.
                LOS was significantly shorter in the LAGB group. 3 LAGB were converted to open (1 to gastric bypass). Directly after VBG, 3 patients needed relaparotomies due to leakage, of which one (2%) died. After 2 years, 100% follow-up was achieved. BMI and %EWL were significantly decreased in both groups but significantly more in the VBG group compared to the LAGB group (31.0 kg/m2 and 70.1% vs 34.6 and 54.9% respectively). Co-morbidities significantly decreased in both groups in time. 2 years after LAGB, 20 patients needed reoperation for pouch dilation/slippage (n=12), band leakage (n=2), band erosion (n=2) and access-port problems (n=4). In the VBG group, 18 patients needed revisional surgery due to staple-line disruption (n=15), narrow outlet (n=2) or insufficient weight loss (n=1). Furthermore, 8 VBG patients developed an incisional hernia.
                This RCT demonstrates that, despite the initial better weight loss in the VBG group, based on complication rates and clinical outcome, LAGB is preferred. It had a shorter LOS and less postoperative morbidity. BACKGROUND: A prospective, randomized trial comparing vertical banded gastroplasty (VBG) and gastric bypass (GB) was performed on 106 patients between 1987 and 1990. METHODS AND RESULTS: Failures of these two operations (manifested by failure to lose weight, late weight gain or intolerance of adequate oral intake) were treated by means of a third operation, isolated gastric bypass (IGB), in which the small gastric pouch was isolated from the gastric fundus. The latter operation was significantly better than VBG or GB and achieved a 63% success rate, i.e. body mass index (BMI) < 35 kg m(2) and less than 50% excess weight. During the year following this trial an additional 54 patients underwent IGB. When this operation was performed for morbid obesity and was the Initial procedure, 96% of the patients achieved a successful result. If IGB was performed as a revision procedure or for super obesity (BMI > 50 kg m(2)), the success rate was 63% with 100% follow-up at 40 months. Major morbidity occurred in six of the 160 patients who underwent 195 operations (the trial period and subsequent year). There were no deaths and follow-up was 98%. CONCLUSIONS: The ideal gastric operation based on this study emphasizes the following requirements: a small pouch (< 15 ml) totally separated from the stomach, a pouch not dependent on staples, placed in the dependent position to prevent stasis, constructed without foreign material and with an anastomosis which permits ingestion of solid food. 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.
                To ascertain whether surgical therapy for obesity achieves better weight loss, health, and quality of life than nonsurgical therapy.
                Randomized, controlled trial.
                University departments of medicine and surgery and an affiliated private hospital.
                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).
                Outcome measures were weight change, presence of the metabolic syndrome, and change in quality of life at 2 years.
                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).
                The study included mildly and moderately obese participants, was not powered for comparison of adverse events, and examined outcomes only for 24 months.
                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. Obesity is common in children and adolescents with incidence rates increasing both nationally and internationally. Its causes are complex and multifaceted, and obesity is associated with high morbidity and mortality as well as psychological distress. Multidimensional programmes are necessary in the treatment of this chronic disease in order to change eating and physical activity habits. A cognitive-behavioural training programme was developed and evaluated. In combination with diet and exercise, this special group programme that includes well established behavioural methods, was expected to result in long-term weight reduction and decrease of psychological distress in connection with obesity.
                As part of the six week in-patient rehabilitation for children and adolescents at Viktoriastift in Bad Kreuznach, the three-part programme (experimental group, EG) was compared with a programme that differed only in the psychological intervention component (instead of the specific training programme they undertook muscle relaxation training, comparison group, CG).
                In total, 197 children and adolescents between 9 and 19 y-of-age were recruited into the study.
                Somatic (eg weight status), behavioural (eg eating behaviour) and psychological (eg quality of life) outcomes were assessed at five points in time: two weeks before the intervention, at the beginning and end of the programme, as well as six months and one year post-intervention. The study started in spring 1997. Main outcomes will be presented.
                Pre- vs post-intervention-tests showed significant improvements in self-reported eating behaviours for the EG compared with the CG (F=6.38, P<0.05); these changes were independent of age and sex. The weight status measured as the percentage of overweight dependent on height was reduced in both groups immediately after the intervention and at follow-up (F=16.51, P<0.01). Reduction in the prevalence of obesity tended to be higher in the EG than in the CG (15% vs 10%). Self-reported quality of life increased from before the intervention to follow-up more in the EG than in the CG (F=3.27, P=0.08). In all, the acceptance of the behavioural patient education programme was good.
                In summary, evaluation results indicate that the cognitive-behavioural training programme is a promising approach to alter obesity-related habits and to reduce somatic and psychosocial consequences. Long-term effects after two years are expected to underscore these results. Laparoscopic techniques have been developed for performing Roux-en-Y gastric bypass (LRYGBP) and vertical banded gastroplasty (LVBG) in patients with morbid obesity. It is not certain, however, which is the better technique in non-superobese patients (body mass index less than 50 kg/m(2)).
                Eighty-three patients (LRYGBP 37, LVBG 46) were assessed in a randomized clinical trial. Perioperative complications were recorded together with preoperative and postoperative respiratory function and mobilization rate. Patients were monitored for 2 years after operation with regard to weight change and the need for remedial surgery.
                There were no conversions to open surgery. The mean operating time was longer for LRYGBP than LVBG (138 versus 105 min). Five early reoperations were performed after LRYGBP (three for haemorrhage, one for ileus and one suspected leak) and one after LVBG (suspected leak). There were no differences in postoperative respiratory function or mobilization. Weight reduction was greater after LRYGBP (excess weight loss 78.3 versus 62.9 per cent 1 year after surgery, P = 0.009; 84.4 versus 59.8 per cent at 2 years, P < 0.001). Remedial surgical intervention was required in eight patients after LVBG (conversion to Roux-en-Ygastric bypass) and none after LRYGBP.
                LRYGBP and LVBG were comparable in terms of operative safety and postoperative recovery, but weight reduction was better after LRYGBP.
                Copyright (c) 2005 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but its long-term impact and time course on other BED-related symptoms remain largely unknown. This study compares the effects of group CBT and group IPT across BED-related symptoms among overweight individuals with BED.
                One hundred sixty-two overweight patients meeting DSM-IV criteria for BED were randomly assigned to 20 weekly sessions of either group CBT or group IPT. Assessments of binge eating and associated eating disorder psychopathology, general psychological functioning, and weight occurred before treatment, at posttreatment, and at 4-month intervals up to 12 months following treatment.
                Binge-eating recovery rates were equivalent for CBT and IPT at posttreatment (64 [79%] of 81 vs 59 [73%] of 81) and at 1-year follow-up (48 [59%] of 81 vs 50 [62%] of 81). Binge eating increased slightly through follow-up but remained significantly below pretreatment levels. Across treatments, patients had similar significant reductions in associated eating disorders and psychiatric symptoms and maintenance of gains through follow-up. Dietary restraint decreased more quickly in CBT but IPT had equivalent levels by later follow-ups. Patients' relative weight decreased significantly but only slightly, with the greatest reduction among patients sustaining recovery from binge eating from posttreatment to 1-year follow-up.
                Group IPT is a viable alternative to group CBT for the treatment of overweight patients with BED. Although lacking a nonspecific control condition limits conclusions about treatment specificity, both treatments showed initial and long-term efficacy for the core and related symptoms of BED. 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.
                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.
                Forty-three treatment-resistant patients (mean body mass index 43.3 kg/m 2) 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).
                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.
Evidence from this review is limited for decision making, since there was large heterogeneity in IGB trials, regarding both methodological and clinical aspects. However, a co-adjuvant factor described by some authors in the loss and maintenance of weight has been the motivation and the encouragement to changing eating habits following a well-organized diet and a program of behavioural modification. The IGB alone and the technique of positioning appear to be safe. Despite the evidence for little additional benefit of the intragastric balloon in the loss of weight, its cost should be considered against a program of eating and behavioural modification.