BioEnterics Intragastric Balloon Research Articles

Initial Weight Loss after Restrictive Bariatric Procedures May Predict Mid-Term Weight Maintenance: Results From a 12-Month Pilot Trial.

Background: Bariatric procedures are effective options for weight loss (WL) in the morbidly obese. However, some patients fail to lose any weight after bariatric surgery, and mid-term weight maintenance is variable. The aim of this study was to investigate whether initial WL could predict mid-term weight maintenance. Methods: Eighty patients were enrolled, of whom 44 were treated with the BioEnterics Intragastric Balloon (BIB), 21 with laparoscopic adjustable gastric lap-banding (LAGB), and 15 with laparoscopic sleeve gastrectomy (LSG). Percentage of body WL and percentage of excess weight loss (EWL) were calculated at baseline and after 1, 3, 6, and 12 months. Successful WL was defined as EWL >20% for patients treated with BIB and >50% for patients treated with LAGB and SG. Results: Success in the 6th and 12th month was achieved in 80% and 58% of patients in the BIB group, 33% and 40% in the LAGB group, and 60% and 73% in the LSG group. In the BIB group, WL in the 1st month correlated positively with WL at the 6th and 12th month, and an initial WL >6.5% best predicted success (sensitivity 50%, specificity 80%). A similar association was observed in the LAGB group at the 6th and 12th month and an initial WL >9.4% best predicted success (sensitivity 90.0%, specificity 81.2%). In patients treated with LSG, WL in the 3rd month correlated positively with EWL at the 6th and 12th month, with a cutoff value of 17% (sensitivity 66.7%, specificity 100%). Conclusions: WL in the 1st month in patients treated with BIB and LAGB and WL in the 3rd month in patients treated with LSG could be used as a prognostic factor to predict mid-term weight maintenance.

Effect of intragastric balloon-induced weight loss on body composition, fatty liver, and comorbidities in Egyptian middle-aged obese women: a 6-month follow-up study

Background Paralleling the increasing prevalence of obesity in the Egyptian population, metabolic syndrome and liver steatosis are also on the rise. Body composition measurement is used to describe the percentages of fat, bone, water, and muscle in human bodies. The available classic weight loss treatments such as low-calorie diet, exercise, behavioral modification, and pharmacotherapy usually achieve only limited weight loss. The BioEnterics Intragastric Balloon (BIB) is an endoscopic liquid-filled device for the treatment of obesity. Aim The aim of this study was to examine the safety of BIB insertion in a group of obese middle-aged Egyptian women treated with intragastric balloon to induce weight loss for 6 months and report its effect on their anthropometric measurements, body composition, fatty liver, and comorbidities. Patients and methods During the period from February 2012 until August 2013, 47 consecutive middle-aged female patients were enrolled for BIB insertion. Inclusion criteria were mainly based on the BMI (≥30.0 kg/m 2 ) and on associated comorbidities. Apart from physical and anthropometric evaluation, body composition analysis was performed using a bioelectrical impedance analyzer to estimate fat mass, body fat percentage, and fat-free mass. The Adult Treatment Panel III criteria were used to diagnose metabolic syndrome, and ultrasound evaluation of the liver for the presence and grade of steatosis was performed. BIB placement was carried out after diagnostic endoscopy, under intravenous conscious or unconscious sedation. Results The total percentage of complications from BIB insertion was 12.8%, which were mostly mild and reversible. Three (6.4%) patients had their gastric balloon removed early (two voluntarily and one due to de-novo peptic ulcer) and were excluded from the study, whereas the remaining 44 patients continued their 6-month therapy duration. Overall, BIB insertion significantly reduced weight from a mean value of 96.82 ± 14.18 kg at baseline to 83.45 ± 12.03 kg after 6 months (P Conclusion This study provides anthropometric, biochemical, and body composition evidence on significant improvement in metabolic syndrome, obesity-associated comorbidities, and fatty liver after weight loss induced by the minimally invasive and relatively safe technique. However, it is recommended to continue a weight-reducing diet after BIB removal for achieving long-term effectiveness and to add exercise programs to dietary restriction for promoting more favorable change in body composition.

Obesity and gastric balloon.

Background:The obesity epidemic, which is among the most common nutritional disorders, is rising rapidly worldwide. It leads to several health problems such as metabolic disorders, stroke, and even cancer. Efforts to control obesity with exercise and diet have a limited value in obese patients and different approaches to do this have been tried. In this paper, we share our experience with bioenteric intragastric balloon (BIB) in treating obesity: Its safety, tolerability, and its efficacy in weight reduction.Materials and Methods:From January 2009 to September 2012, a total of 190 gastric balloons was inserted on patients at the endoscopy unit in King Fahd Hospital of the University, Al-Khobar. This is an evaluation of the first 100 patients. All the patients had a body mass index of over 30 kg/m2 and were within the age range of 17-55 with a mean age of 32 years. After consent, preballoon investigation tests and anesthesia evaluation, BIB was inserted under monitored anesthesia care sedation in the endoscopy suite. The balloon was filled with 500-700 mls of stained saline. All patients' were given an analgesic and antiemetic for a week and antisecretory proton pump inhibitor's for 6 months. Diet and the importance of the exercise were part of the preballoon insertion phase and protocol. The balloon was removed after 6-12 months.Results:The weight loss response to BIB in the 100 patients are classified into four groups: In the uncooperative, noncompliant patients - the maximum weight loss was 7 kg, while in the most compliant patients the weight loss reached up to 39 kg. In addition, there was significant improvement into diabetes mellitus, hypertension, dyslipidemia, and fatty liveras. Its safety and tolerability were extremely acceptable.Conclusion:Our data indicates that in well-selected patients, BIB is an effective device, which with minimum complications helps to achieve body weight loss and resolve many obesity related morbidities in cooperative and dedicated obese patients.

Does the intragastric balloon have a predictive role in subsequent LAP-BAND® surgery? Italian multicenter study results at 5-year follow-up

BackgroundThe intragastric balloon has been reported to be a safe and effective tool for temporary weight loss. The aim of this study is the evaluation of the possible predictive role of intragastric balloon when used before laparoscopic adjustable gastric banding. MethodsA longitudinal multicenter study was conducted in patients with body mass index (BMI)>35 kg/m2 who underwent gastric banding with the BioEnterics Intragastric Balloon (BIB). After balloon removal (6 mo), patients were allocated into 2 group according to their percentage of excess weight loss (%EWL): group>25 (%EWL>25%) and group<25 (%EWL<25%). Patients from both group underwent laparoscopic adjustable gastric banding (LAGB) 1–3 months after BIB removal. The LAP-BAND AP band was placed in all patients via pars flaccida. Weight loss parameters were considered in both groups. ResultsFrom January 2005 to December 2009, 1357 patients were enrolled in this study. Mean BMI at time of BIB positioning was 44.9±8.4 (range 29–82.5). After 6 months, at time of removal, mean BMI was 39.4±7.3. According to the cutoff, patients were allocated into group A (n = 699) and group B (n = 658). At this time the mean BMI was 36.4±6.4 and 42.7±6.9 (P = .001) in groups A and B, respectively. At 1-year follow-up from LAGB, mean BMI was 35.8±6.5 and 40.0±7.4 (P<.001) in groups A and B, respectively. This significant difference was confirmed at 3- and 5-year follow-ups. A similar pattern was observed with the %EWL. ConclusionSatisfactory results with BIB are predictive of a positive outcome of LASB at 1, 3, and 5 years after the procedure, and poor results do not inevitably indicate a negative outcome for gastric banding.

Long-term effectiveness of BioEnterics intragastric balloon in obese patients

The BioEnterics intragastric balloon has been considered an effective and less invasive method for weight loss. This study aimed to evaluate the effect of this method on long-term weight loss. From June 2009 to June 2011, 32 patients (14 male, 18 female) underwent BioEnterics intragastric balloon therapy for 6 months. The mean age of the subjects was 39,7±11,1 years and mean body mass index was 44,4±12 kg/m 2 . All patients were given a diet of 1100 kcal/day. Weight loss parameters [absolute weight loss, body mass index loss, percentage of body weight loss, and percentage of excess body massindex loss (excess body mass index loss%)] were recorded at baseline, after 1 month, after 6 months (time of BioEnterics intragastricballoon removal), and after 12 months from baseline. Successful weight loss was defined as ≥10% weight loss after 6 (end of treatment success) and 12 months (long-term success). Statistical analysis was done using SPSS computer program. The mean weight loss and body mass index loss were 12,4 kg (standart deviation, 13,5) and 4.3 kg/m 2 (standart deviation, 4,7), respectively (p<0.001). The mean percentage of body weight loss was 9.5% (standart deviation, 9,8). The percentage of excess body mass index loss reached 25,2% (standart deviation, 25,9). Fifteen patients (46,9%) achieved a percentage of body weight loss >10% at the end of treatment. Eleven of these patients (73%) were able to maintain weight loss of 10% at the completion of the study, resulting ina longterm success rate of 34.4%. Percentage of body weight loss and percentage of excess body mass index loss were inversely relatedto age (p< 0,05). BioEnterics intragastric balloon has been effective in long-term loss of body weight.

Incomplete stomach emptying as a complication of intragastric balloon treatment and a solution suggestion: Pineapple juice drinking

During removal of intragastric balloon, there is a great deal of gastric undigested food even after an eight-hour starvation. Bromelain, a proteolytic enzyme existing in the pineapple juice seems to be a good choice for the undigested food remnants in the stomach. We aimed to investigate the effect of drinking pineapple juice on dissolving food remnants in patients undergoing endoscopic procedure for removal of intragastric balloon. In this study, we included patients who had undergone endoscopic placement of intragastric balloon (BIB®, BioEnterics Intragastric Balloon, Inamed Health, CA, USA) between February 2009 and March 2012. First 8 patients were asked to fast the whole night before the procedure (at least 8 hours) and to apply clear liquid diet for 3 days before the endoscopic removal. A great amount of food remnants was seen in the stomach during the endoscopic balloon removal procedure. A second endoscopic procedure was planned 3 days later and, in order to decrease the food remnants, the patients were asked to drink 1 L pineapple juice per day. The next 11 patients were also advised to drink 1 liter per day of 100% pineapple juice for 3 days before the endoscopic removal. Totally, 19 obese patients (17 female, 2 male) were included in the study. Mean age was 38,68±7,95 years, mean weigh was 124,23±19,30 kg, and mean body mass index was 49,73±9,22 kg/m 2 . There was undigested food in the stomach during endoscopic removal in the first 8 patients. However, no undigested food in the stomach was found at the second endoscopic examination. In the other 11 patients, no food remnants were observed after taking pineapple juice prior to the endoscopic removal procedure. Drinking pineapple juice for 3 days before endoscopic balloon removal seems to be effective in dissolving food remnants in the stomach. Drinking pineapple juice may be recommended in all patients undergoing endoscopic procedure for removal of intragastric balloon.

Candida albicans colonization on an intragastric balloon

Here we present the case of Candida albicans colonization on an intragastric balloon placed for weight loss. A 52-year-old obese woman achieved a BMI reduction of 10.9 kg/m(2) within 7 months as a result of a BioEnterics Intragastric Balloon and a well-balanced, low-calorie diet. During endoscopy for balloon removal, the balloon, which was well impacted in the gastric fundus, was found to be lime green in color with clusters of cone-shaped cultures on its surface. Microbiology assessment revealed the presence of Candida albicans, although the patient was totally asymptomatic.

Effectiveness of Intragastric Balloon Treatment for Obese Patients: One-Year Follow-up After Balloon Removal

The Bioenterics Intragastric Balloon (BIB) is effective for weight loss. However, comparisons of its effectiveness between groups with different body mass index (BMI) are rare. This study compared the effectiveness of BIB treatment in patients with BMI <32 kg/m(2) and those with BMI ≥ 32 kg/m(2) at the time of BIB removal and at 1 year later. Between April 2009 and June 2011, 28 obese patients who completed a full course of BIB treatment were enrolled. There are 16 patients with BMI <32 and 12 with BMI ≥ 32. Patients who lost more than 20 % of excess weight (% EWL) were categorized as responders. The BMI significantly fell from 32.4 ± 3.7 to 28.5 ± 3.7 kg/m(2) (P < 0.01) at the time of BIB removal. All biochemical measurements except for cholesterol level were significantly improved. The median value of %EWL of all patients at BIB removal was 40.1, and 20 patients (71.4 %) were responders. Adherence to dietitian counseling was significantly better in responders than in non-responders (85 vs. 25 %, respectively; P < 0.01). The percentage of responders at 1 year after BIB removal was significantly higher among patients with BMI <32 than those with ≥ 32 (62.5 vs. 16.7 %, respectively; P = 0.02). BIB placement can achieve significant weight loss and improvement of co-morbidities in obese patients. Better adherence to dietitian counseling is associated with better response. Patients with BMI <32 maintain better weight loss at 1 year after BIB removal.

Adjustable Intragastric Balloon vs Non-Adjustable Intragastric Balloon: Case–Control Study on Complications, Tolerance, and Efficacy

The objective of this study is the comparison of a new intragastric balloon recently introduced, the Adjustable Balloon System (ABS), with the BioEnterics intragastric balloon (BIB) in terms of tolerance, safety, and weight loss parameters. A case-control study was done: 40 patients were matched with 80 controls. To achieve the same duration therapy (12 months), a single ABS positioning was compared with a BIB followed by another BIB (6 + 6 months). Length of procedure, hospital stay, complications, and weight loss parameters after 6 months (time of first BIB removal) and after 12 months from baseline (time of Spatz and second BIB removal) were considered. Statistical analysis was done by means of Student's t test, χ2 test, or Fisher's test. P < 0.05 was considered significant. Mortality, positioning, and extraction complications were absent. Both the devices were well tolerated with slight duration of post placement symptoms. During this study, the Spatz balloon was adjusted with inflation of 200 cm(3) of saline (total, 800 cm(3)) in 9/40 (22.5 %) patients, for poor weight loss after first 6-months treatment. In the Spatz group, there occurred 7/40 complications linked to the device and in 6/7 patients the balloon was removed. At the end of the study, the weight loss parameters were similar between groups: BMI 31.0 ± 11.8 (Spatz group) vs 31.3 ± 12.3 (BIB group) (p = Ns). The idea of dynamic balloon therapy needs to be confirmed with wider series. The rate of complication reported is very high, and several studies regarding safety and efficacy are needed.

Five Percent Weight Lost in the First Month of Intragastric Balloon Treatment May Be a Predictor for Long-Term Weight Maintenance

Most of the weight loss with the BioEnterics intragastric balloon (BIB) has occurred during the first 3-4 months. This study aimed to evaluate the effect of initial weight loss on long-term weight maintenance. From 2008 to 2011, 50 patients who had mean body mass index (BMI) of 44.7 ± 12.4 kg/m(2) underwent BIB therapy for 6 months. All patients were given a diet of 1,100 kcal/day. Weight loss parameters [absolute weight loss, BMI loss, percentage of body weight loss (BWL%), and percentage of excess BMI loss] were recorded at the baseline, 1 month, 6 months (time of BIB removal), 12 months, and 18 months from the baseline. Successful weight loss was defined as ≥ 10 % weight loss after 6, 12, and 18 months. Twenty-seven patients (54 %) achieved a percentage of BWL ≥ 10 at the time of removal. Eighteen (36 %) and 12 (24 %) patients were able to maintain weight loss of 10 % at 12 and 18 months. Percentage of BWL after 1 month was positively correlated with BWL% after 6, 12, and 18 months (r = 0.77, 0.65, and 0.62, p < 0.001, respectively). Twenty-four patients who lost 5 % of the BWL after 1 month of treatment succeeded in maintaining a lasting percentage of BWL ≥ 10 after the BIB removal: more precisely, this cutoff point was achieved in 96 % at the time of removal and in 71 %, 50 % at 12 months, and 18 months of follow-up. Five percent BWL after 1 month of treatment may be a predictor for long-term weight maintenance.

Conservative therapy versus intra-gastric balloon in treatment of Prader-Willi Syndrome morbid obesity

Background and purposePrader-Willi Syndrome (PWS) is a complex multisystemic disorder characterized by hyperphagia, severe obesity and muscular hypotonia. So, it is essential to seek an ideal program to help in solving such a widespread problem. The purpose of this study was to investigate the effect of conservative therapy (diet and exercises) versus intra-gastric balloon in PWS patients. Ten children born with PWS from both sexes ranging in age from 8 to 15years were assigned into two groups of equal number. Study group I received conservative therapy in the form of diet regimen (a low caloric diet) and aerobic exercises on a stationary bicycle while study group II underwent intra-gastric balloon. Evaluation procedures in the form of initial evaluation and measurement of Body mass index (BMI) and lipid profile parameters were conducted for each child of the two groups before and after 6months of treatment. The results revealed no significant difference when comparing the pre-treatment mean values of the two study groups (I and II), while significant improvement was observed in all the measuring variables of the two groups when comparing their pre- and post-treatment mean values. Significant difference was also observed when comparing the post-treatment results of the two groups in favor of the study group I. It concluded that conservative therapy could be the first choice of treatment of PWS morbid obesity, while BioEnterics Intra-gastric balloon (BIB) came in the second choice.

Gastric balloon to treat obesity: Filled with air or fluid?

Our aim was to study the efficacy and safety of different types of intragastric balloon in morbidly obese patients. From 2005 to 2011, intragastric balloons were inserted endoscopically into 32 patients. Intragastric balloons were used in morbidly obese (body mass index [BMI] ≥ 35 kg/m(2) ) individuals who were non-responsive to 6-month medical therapy and diet. Balloons were endoscopically removed after 6 months. Thirty-six balloons were inserted in a total of 32 patients. Mean age of the patients was 37.28 ± 12.08 (17-64) years and mean height was 169.81 ± 8.17 (150-185) cm. Initial mean weight was 128.87 ± 23.31 kg and BMI was 45.26 ± 8.48 kg/m(2) . At month 6, mean bodyweight was 116.93 ± 23.18 and BMI was 40.96 ± 7.96 kg/m(2) (P < 0.001, P < 0.001, respectively). At the end of 6 months, while the excessweight loss (EWL) median was 13.0 kg, [interquartile range IQR: 5.0-16.0] and percent EWL median was 21.92, [IQR: 12.72-28.49] in the Heliosphere BAG patients, the EWL median was 19.0 kg, [IQR: 14.47-26.72] and the percent EWL median was 38.26, [IQR: 19.73-47.79] in the BioEnterics Intragastric Balloon patients (P = 0.006, P = 0.010, respectively for EWL median and percent EWL median). One patient died (3.1%) of cardiac arrest due to aspiration at day 13 after BIB placement. Although not without risk, intragastric balloon placement is an effective method for weight loss. BioEnterics Intragastric Balloon is more effective in helping weight loss than the Heliosphere BAG balloon.

Efficacy of Intragastric Balloon in Obese Egyptian Patients and the Value of Extended Liquid Diet Period in Mounting the Weight Loss

Abstract Background: The surgical management of morbid obesity is faced by several challenges. Alternative therapeutic strategies could have an important role in the perioperative risk reduction. The BioEnterics(®) intragastric balloon (BIB) (Inamed Health, Santa Barbara, CA) has been described as being effective in weight reduction and is used as a bridge before bariatric surgery. This study examined the efficacy of BIB in obese Egyptian patients and the value of the extended low caloric liquid diet program in weight loss. A retrospective review of a prospectively maintained bariatric database was conducted. Weight changes and complications data were analyzed. Indications for BIB placement were discussed. Records of 55 patients (11 males and 44 females) were retrieved. The mean initial body mass index (BMI) was 45.3±11 kg/m(2). The mean of excess body weight percentage was 111.96±53.2%. Nausea was reported in 30 patients (54.5%). Epigastric discomfort was reported in 23 patients (41.8 %), and vomiting was reported in 27 patients (49.1%). Six patients (10.9%) had an early removal of the balloon, whereas 4 (7.2%) had delayed removal (more than 6 months). The mean excess weight loss percentage (EWL%) was 17.2%. There was significant reduction in patients' BMI from 45.3 to 38.3 kg/m(2) (P<.001). There was no significant correlation between the EWL% and the gender, age, or initial BMI. Two patients had second balloon insertions without complications. There was no significant difference in the EWL% between the 1-week liquid diet group and the extended (4-week) low caloric diet group. The BIB is effective and safe in weight reduction in obese Egyptian patients. The impact of extended liquid dieting period is not significant.

Innovative approach using an intragastric balloon for weight loss in a morbidly obese patient undergoing liver transplantation

Morbid obesity is associated with poor outcomes after liver transplantation.1, 2 Bariatric surgery or weight loss by lifestyle modification is often not possible because of the presence of decompensated cirrhosis. A 61-year-old male presented with decompensated alcoholic cirrhosis (jaundice, low albumin level, high international normalized ratio, and mild ascites). His comorbidities included diabetes mellitus and morbid obesity (body mass index = 48.3 kg/m2). He had residual esophageal varices (after endoscopic variceal ligation) but no fundal varices. He was listed for deceased donor liver transplantation, and a BioEnterics intragastric balloon was placed endoscopically to promote weight loss. He lost 24 kg over 6 months (body mass index at transplantation = 39.2 kg/m2), and his diabetic control improved significantly (with his hemoglobin A1c level decreasing from 9.2 to 5.4 g/dl). He underwent deceased donor liver transplantation 3 months later; the balloon was removed endoscopically just before surgery in order to facilitate a better operative field. His postoperative recovery was uneventful, and he was doing well 3 months after deceased donor liver transplantation without any rebound weight gain. Patients with decompensated cirrhosis have a significant risk of perioperative mortality after bariatric surgery in comparison with patients with compensated cirrhosis (16.3% versus 0.9%).3 Intragastric balloon placement is a nonsurgical approach, and it has been shown to improve parameters of insulin resistance,4 obesity-related complications, and quality of life for obese patients.5 A meta-analysis including 3608 patients has shown that an intragastric balloon is more effective than a placebo for weight loss, with nausea and vomiting being the most common side effects (8.6%).6 We could not find any reports regarding the use of intragastric balloons to promote liver transplantation in morbidly obese patients. Although long-term weight loss has not been described with the use of balloons,6 improved diabetic control and a lower body mass index decrease the perioperative complications of liver transplantation. In conclusion, in a decompensated patient with cirrhosis who is morbidly obese and does not have significant gastroesophageal varices, the placement of an intragastric balloon is a useful and innovative modality for promoting short-term weight loss and thereby making the patient fit for surgery and reducing perioperative morbidity and mortality. Narendra S. Choudhary, D.M.1 Sanjiv Saigal, D.M.1 Neeraj Saraf, D.N.B.1 Rajesh Puri, D.M.2 Arvinder Soin, M.S.1,2 Institutes of 1Liver Transplantation and Regenerative Medicine and 2Digestive and Hepatobiliary Sciences Medanta-The Medicity, Gurgaon, India

Multi-Centre European Experience with Intragastric Balloon in Overweight Populations: 13 Years of Experience

The request to lose weight is expanding not only in obese and morbidly obese patients but also in overweight patients affected by co-morbidities as diabetes and hypertension and who do not tolerate diet regimen or lifestyle changes. The aim of this study is a multicenter evaluation of outcomes of intragastric balloon in overweight patients. Patients (BMI 27-30 kg/m2) treated with a BioEnterics Intragastric Balloon (BIB) between 1996 and 2010 were extracted from the database of the participating centres in Rome (Italy), Liège (Belgium) and Madrid (Spain). Primary endpoints were the efficacy and safety at 6 and 42 months from balloon positioning. Secondary endpoints included resolution of co-morbidities. A total of 261 patients were included in this study. The most common indication for balloon placement was a psychological disorder (54%). Mean body mass index (BMI) fell from 28.6 ± 0.4 at baseline to 25.4 ± 2.6 kg/m2 at 6 months and to 27.0 ± 3.1 kg/m2 at 3 years from BIB removal. The mean %EWL was 55.6% at 6 months and 29.1% at 3 years. Forty-seven patients (18%) had complications associated with placement of the intragastric balloon (leak = 28, intolerance = 14, duodenal ulcer = 2, gastritis = 1, oesophagitis = 1, duodenal polyps = 1). The rate of patients with hypertension decreased from 29% at baseline to 16% at 3 years. Diabetes decreased from 15 to 10%, dyslipidaemia decreased from 20 to 18%, hypercholesterolaemia decreased from 32 to 21% and osteoarthropathy decreased from 25 to 13%. The intragastric balloon is safe and effective in overweight patients, helping to reduce progression to obesity and decreasing the prevalence of a number of important co-morbidities.

Intragastric balloon significantly improves nonalcoholic fatty liver disease activity score in obese patients with nonalcoholic steatohepatitis: a pilot study

There is no satisfactory treatment for nonalcoholic steatohepatitis (NASH). The Bioenterics intragastric balloon (BIB) can be an effective treatment for weight reduction in obese patients. We evaluated the efficacy of the BIB in improving the histology of NASH in obese patients. Randomized, controlled study. University hospital. Obese patients with body mass indexes (BMI) ≥27 kg/m(2) and who had histologic evidence of NASH were recruited. Patients were randomly assigned to a step 1 American Heart Association (AHA) diet plus exercise and BIB placement or step 1 AHA diet plus exercise and sham BIB placement for a period of 6 months. Liver histology was the primary outcome measure recorded before and after treatment. A total of 18 patients completed the study. Baseline characteristics of the BIB and sham groups were similar. At 6 months, a significant reduction in the mean BMI was seen in the BIB group (1.52 vs 0.8; P = .0008). The median nonalcoholic fatty liver disease activity scores at the end of treatment were significantly lower in the BIB-treated compared with the sham-treated groups (2 [0.75] vs 4 [2.25]; P = .03). There was a trend toward improvement in the median steatosis scores (1 [0.75] vs 1 [1]; P = .075). There was no change in the median loblular inflammation, hepatocellular ballooning, or fibrosis scores in both groups after treatment. Pilot study with small numbers and short duration. Results from this pilot study demonstrated that addition of BIB for 6 months provided a greater loss of BMI and improvement in 2 of 5 histologic parameters of nonalcoholic fatty liver disease. A longer study with larger numbers will be required to prove whether or not the therapy is meaningful in the treatment of NASH.

Therapeutic effects of Bioenterics Intragastric Balloon for obesity

Objective To study the therapeutic effects of Bioenterics Intragastric Balloon （BIB） on obesity under gastroscopy. Methods Data of 47 patients treated with Bioenterics Intragastric Balloon under gastrscopy were reviewed from July, 2010 to May, 2011. Results Weight loss （mean 15.4 kg） was successfully achieved in all the patients during 6 months. BMI decreased by 3. 2 - 6. 4 kg/m^2 （ mean 4. 7 kg/m^2 ）. There was no serious side effect with a better result for obesity according to the follow-up. Conclusion BIB is effective for obesity for noninvasiveness, stable speed of weight loss and less pain. Key words: Obesity, morbid; Bulimia; Bioenterics intragastric balloon; Gastrscopes

500 Intragastric Balloons: What Happens 5 Years Thereafter?

The BioEnterics Intragastric Balloon (BIB) has been considered an effective, less invasive method for weight loss, as it provides a permanent sensation of satiety. However, various non-randomized studies suggest BIB is a temporary anti-obesity treatment, which induces only a short-term weight loss. The purpose of this study was to present data of 500 obese who, after BIB-induced weight reduction, were followed up for up to 5 years. The BioEnterics BIB was used, and remained for 6 months. At 6, 12, and 24 months post-removal (and yearly thereafter), all subjects were contacted for follow-up. From 500 patients enrolled, 26 were excluded (treatment protocol interruption); 474 thus remained, having initial body weight of 126.16 ± 28.32 kg, BMI of 43.73 ± 8.39 kg/m2, and excess weight (EW) of 61.35 ± 25.41. At time of removal, 79 (17%) were excluded as having percent excessive weight loss (EWL) of <20%; the remaining 395 had weight loss of 23.91 ± 9.08 kg (18.73%), BMI reduction of 8.34 ± 3.14 kg/m2 (18.82%), and percent EWL of 42.34 ± 19.07. At 6 and 12 months, 387 (98%) and 352 (89%) presented with weight loss of 24.14 ± 8.93 and 16.31 ± 7.41 kg, BMI reduction of 8.41 ± 3.10 and 5.67 ± 2.55 kg/m2, and percent EWL of 42.73 ± 18.87 and 27.71 ± 13.40, respectively. At 12 and 24 months, 187 (53%) and 96 (27%) of 352 continued to have percent EWL of >20. Finally, 195 of 474 who completed the 60-month follow-up presented weight loss of 7.26 ± 5.41 kg, BMI reduction of 2.53 ± 1.85 kg/m2, and percent EWL of 12.97 ± 8.54. At this time, 46 (23%) retained the percent EWL at >20. In general, those who lost 80% of the total weight lost during the first 3 months of treatment succeeded in maintaining a percent EWL of >20 long term after BIB removal: more precisely, this cutoff point was achieved in 83% at the time of removal and in 53%, 27%, and 23% at 12-, 24-, and 60-month follow-up. BIB seems to be effective for significant weight loss and maintenance for a long period thereafter, under the absolute prerequisite of patient compliance and behavior change from the very early stages of treatment.

A Morbid Obese Japanese Woman with a Body Mass Index of 83.2 kg/m&lt;sup&gt;2&lt;/sup&gt;: Before and after Sleeve Gastrectomy

A 34-year-old Japanese woman presented at our institution weighing 182.7 kg, 148.2 cm tall, and with a body mass index of 83.2 kg/m(2). She had been overweight since childhood, but no abnormality was found to explain her obesity. Treatments, including mazindol, bofu-tsusho-san, dietary restriction, and BioEnterics Intragastric Balloon, did not result in improvement of her obesity. Finally, we performed sleeve gastrectomy, and she has maintained her weight within 130-140 kg without rebounding for 2 and a half years. We followed the clinical changes before and after the operation. This case provides potentially interesting information regarding operative treatment for morbid obesity in Japanese.

Intestinal occlusion as unusual complication of new intragastric balloon Spatz Adjustable Balloon system for treatment of morbid obesity

Intestinal occlusion as unusual complication of new intragastric balloon Spatz Adjustable Balloon system for treatment of morbid obesity