Background Weight loss causes changes in appetite and energy expenditure that promote weight regain. Ghrelin is a hormone that increases food intake in rodents and humans. If circulating ghrelin participates in the adaptive response to weight loss, its levels should rise with dieting. Because ghrelin is produced primarily by the stomach, weight loss after gastric bypass surgery may be accompanied by impaired ghrelin secretion. Methods We determined the 24-hour plasma ghrelin profiles, body composition, insulin levels, leptin levels, and insulin sensitivity in 13 obese subjects before and after a six-month dietary program for weight loss. The 24-hour ghrelin profiles were also determined in 5 subjects who had lost weight after gastric bypass and 10 normal-weight controls; 5 of the 13 obese subjects who participated in the dietary program were matched to the subjects in the gastric-bypass group and served as obese controls. Results Plasma ghrelin levels rose sharply shortly before and fell shortly after eve...

Plasma Ghrelin Levels after Diet-Induced Weight Loss or Gastric Bypass Surgery

This meta-analysis on surgical treatment of obesity supports the American College of Physicians' clinical guideline in this issue. Surgery is more effective than nonsurgical treatment for weight lo...

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Meta-analysis: surgical treatment of obesity.

Objectives To undertake a systematic review of the long-term effects of obesity treatments on body weight, risk factors for disease, and disease. Methods The study encompassed three systematic reviews that examined different aspects of obesity treatments. (1) A systematic review of obesity treatments in adults where the methods of the Cochrane Collaboration were applied and randomised controlled trials (RCTs) with a follow-up of at least 1 year were evaluated. (2) A systematic epidemiological review, where studies were sought on long-term effects of weight loss on morbidity and/or mortality, and examined through epidemiological modelling. (3) A systematic economic review that sought reports with both costs and outcomes of treatment, including recent reports that assessed the cost-effectiveness of pharmaceutical and surgical interventions. A Markov model was also adopted to examine the cost-effectiveness of a low-fat diet and exercise intervention in adults with obesity and impaired glucose tolerance. Results The addition of the drugs orlistat or sibutramine was associated with weight loss and generally improved risk factors, apart from diastolic blood pressure for sibutramine. Metformin was associated with decreased mortality after 10 years in obese people with type 2 diabetes. Low-fat diets were associated with continuing weight loss for 3 years and improvements in risk factors, as well as prevention of type 2 diabetes and improved control of hypertension. Insufficient evidence was available to demonstrate the benefits of low calorie or very low calorie diets. The addition of an exercise or behaviour programme to diet was associated with improved weight loss and risk factors for at least 1 year. Studies combining low-fat diets, exercise and behaviour therapy suggested improved hypertension and cardiovascular disease. Family therapy was associated with improved weight loss for 2 years compared to individual therapy. There was insufficient evidence to conclude that individual therapy was more beneficial than group therapy. Weight lost more quickly (within 1 year), from the epidemiology review, may be more beneficial with respect to the risk of mortality. The effects of intentional weight loss need further investigation. Weight loss from surgical and non-surgical interventions for people suffering from obesity was associated with decreased risk of development of diabetes, and a reduction in low-density lipoprotein cholesterol, total cholesterol and blood pressure, in the long term. Targeting high-risk individuals with drugs or surgery was likely to result in a cost per additional life-year or quality-adjusted life-year (QALY) of no more than 13,000 British pounds. There was also suggestive evidence of cost saving from treatment of people with type 2 diabetes with metformin. Targeting surgery on people with severe obesity and impaired glucose tolerance was likely to be more cost-effective at 2329 British pounds per additional life-year. Economic modelling over 6 years for diet and exercise for people with impaired glucose tolerance was associated with a high initial cost per additional QALY, but by the sixth year the cost per QALY was 13,389 British pounds. Results did not include cost savings from diseases other than diabetes, and therefore may be conservative. Conclusions The drugs orlistat and sibutramine appear beneficial for the treatment of adults with obesity, and metformin for obese patients with type 2 diabetes. Exercise and/or behaviour therapy appear to improve weight loss when added to diet. Low-fat diets with exercise, or with exercise and behaviour therapy are associated with the prevention of type 2 diabetes and hypertension. Long-term weight loss in epidemiological studies was associated with reduced risk of type 2 diabetes, and may be beneficial for cardiovascular disease. Low-fat diets and exercise interventions in individuals at risk of obesity-related illness are of comparable cost to drug treatments. Long-term pragmatic RCTs of obesity treatments in populations with obesity-related illness or at high risk of developing such illness are needed (to include an evaluation of risk factors, morbidity, quality of life and economic evaluations). Drug trials that include dietary advice, plus exercise and/or behaviour therapy are also needed. Research exploring effective types of exercise, diet or behaviour and also interventions to prevent obesity in adults is required.

Systematic review of the long-term effects and economic consequences of treatments for obesity and implications for health improvement

American association of clinical endocrinologists and american college of endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity.

Objectives: to assess the clinical effectiveness and cost-effectiveness of bariatric surgery for obesity. Data sources: seventeen electronic databases were searched [MEDLINE; EMBASE; PreMedline In-Process & Other Non-Indexed Citations; The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, DARE, NHS EED and HTA databases; Web of Knowledge Science Citation Index (SCI); Web of Knowledge ISI Proceedings; PsycInfo; CRD databases; BIOSIS; and databases listing ongoing clinical trials] from inception to August 2008. Bibliographies of related papers were assessed and experts were contacted to identify additional published and unpublished references Review methods: two reviewers independently screened titles and abstracts for eligibility. Inclusion criteria were applied to the full text using a standard form. Interventions investigated were open and laparoscopic bariatric surgical procedures in widespread current use compared with one another and with non-surgical interventions. Population comprised adult patients with body mass index (BMI) ? 30 and young obese people. Main outcomes were at least one of the following after at least 12 months follow-up: measures of weight change; quality of life (QoL); perioperative and postoperative mortality and morbidity; change in obesity-related comorbidities; cost-effectiveness. Studies eligible for inclusion in the systematic review for comparisons of Surgery versus Surgery were RCTs. For comparisons of Surgery versus Non-surgical procedures eligible studies were RCTs, controlled clinical trials and prospective cohort studies (with a control cohort). Studies eligible for inclusion in the systematic review of cost-effectiveness were full cost-effectiveness analyses, cost-utility analyses, cost-benefit analyses and cost-consequence analyses. One reviewer performed data extraction, which was checked by two reviewers independently. Two reviewers independently applied quality assessment criteria and differences in opinion were resolved at each stage. Studies were synthesised through a narrative review with full tabulation of the results of all included studies. In the economic model the analysis was developed for three patient populations, those with BMI ? 40; BMI ? 30 and Results: a total of 5386 references were identified of which 26 were included in the clinical effectiveness review: three randomised controlled trials (RCTs) and three cohort studies compared surgery with non-surgical interventions and 20 RCTs compared different surgical procedures. Bariatric surgery was a more effective intervention for weight loss than non-surgical options. In one large cohort study weight loss was still apparent 10 years after surgery, whereas patients receiving conventional treatment had gained weight. Some measures of QoL improved after surgery, but not others. After surgery statistically fewer people had metabolic syndrome and there was higher remission of Type 2 diabetes than in non-surgical groups. In one large cohort study the incidence of three out of six comorbidities assessed 10 years after surgery was significantly reduced compared with conventional therapy. Gastric bypass (GBP) was more effective for weight loss than vertical banded gastroplasty (VBG) and adjustable gastric banding (AGB). Laparoscopic isolated sleeve gastrectomy (LISG) was more effective than AGB in one study. GBP and banded GBP led to similar weight loss and results for GBP versus LISG and VBG versus AGB were equivocal. All comparisons of open versus laparoscopic surgeries found similar weight losses in each group. Comorbidities after surgery improved in all groups, but with no significant differences between different surgical interventions. Adverse event reporting varied; mortality ranged from none to 10%. Adverse events from conventional therapy included intolerance to medication, acute cholecystitis and gastrointestinal problems. Major adverse events following surgery, some necessitating reoperation, included anastomosis leakage, pneumonia, pulmonary embolism, band slippage and band erosion. Bariatric surgery was cost-effective in comparison to non-surgical treatment in the reviewed published estimates of cost-effectiveness. However, these estimates are likely to be unreliable and not generalisable because of methodological shortcomings and the modelling assumptions made. Therefore a new economic model was developed. Surgical management was more costly than non-surgical management in each of the three patient populations analysed, but gave improved outcomes. For morbid obesity, incremental cost-effectiveness ratios (ICERs) (base case) ranged between £2000 and £4000 per QALY gained. They remained within the range regarded as cost-effective from an NHS decision-making perspective when assumptions for deterministic sensitivity analysis were changed. For BMI ? 30 and Conclusions: bariatric surgery appears to be a clinically effective and cost-effective intervention for moderately to severely obese people compared with non-surgical interventions. Uncertainties remain and further research is required to provide detailed data on patient QoL; impact of surgeon experience on outcome; late complications leading to reoperation; duration of comorbidity remission; resource use. Good-quality RCTs will provide evidence on bariatric surgery for young people and for adults with class I or class II obesity. New research must report on the resolution and/or development of comorbidities such as Type 2 diabetes and hypertension so that the potential benefits of early intervention can be assessed.

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The clinical effectiveness and cost-effectiveness of bariatric (weight loss) surgery for obesity: a systematic review and economic evaluation

Background: This study is a trial to compare the effects and outcomes of three different bariatric procedures performed in two centers. Standard Roux-en-Y gastric bypass was performed by Dr. Norman Samuels in Fort Lauderdale (Florida); vertical banded gastroplasty and laparoscopic adjustable silicone gastric banding were done in Hallein (Salzburg) by Dr. Emanuel Hell and Dr. Karl Miller. Methods: In a prospective comparative study 30 matched patients from each group were followed to assess post-operative improvement in health status and quality of life, to compare the three different techniques. The Bariatric Analysis and Reporting Outcome System (BAROS) as described by Oria and Moorehead has been used for evaluation. Results:The observation time was at least 3 years (3 to 8 years) in each individual case. A significant increase in quality of life and health status in 75% of the surgically-treated patients was observed when compared with a non-operated control group of morbidly obese patients. Conclusions: By utilizing BAROS it has been found possible to compare the results of different procedures done by different surgeons with different techniques, utilizing patients from different cultures and with different languages. The results of this comparative study favor the standard gastric bypass for the treatment of morbid obesity.This operation is superior to purely gastric restrictive procedures in weight loss and improvement of quality of life.

Evaluation of Health Status and Quality of Life after Bariatric Surgery: Comparison of Standard Roux-en-Y Gastric Bypass, Vertical Banded Gastroplasty and Laparoscopic Adjustable Silicone Gastric Banding

The development of cholesterol gallstones is associated with certain well-defined risk factors.1–4 The risk for developing gallstones during active weight reduction is well accepted.5–11 Between 10% and 25% of persons having lost weight through very low-calorie dieting (VLCD) develop gallstones.12,13 In addition, 35–38% of patients with morbid obesity develop gallstones as they lose weight after bariatric surgery.5,14,15 A routine synchronous cholecystectomy during bariatric surgery is recommended by some centers.5,16 Concomitant cholecystectomy in bariatric surgery can be a very difficult procedure with a higher incidence of complications.17,18 Therefore, a preventive therapy for gallstone formation is recommended in several studies. Ursodeoxycholic acid administered during VLCD seems to inhibit the development of biliary cholesterol crystals.8 Ursodeoxycholic acid (600 mg/d) is highly effective in preventing gallstone formation in patients undergoing dietary-induced weight reduction.19 In prospective randomized studies, the prophylactic administration of ursodeoxycholic acid has been shown to be effective in gastric bypass procedures20–22, as well as in a small series with vertical banded gastroplasty.23

This randomized double-blind, prospective trial was designed to determine the safety and efficacy of 500 mg/d ursodeoxycholic acid (Ursofalk; Falk Corporation, Dortmund, Germany) versus placebo for reducing the incidence of gallstones in morbidly obese patients undergoing adjustable gastric banding and vertical banded gastroplasty surgery for morbid obesity and the effect of long-term follow-up.

Gallstone formation prophylaxis after gastric restrictive procedures for weight loss: a randomized double-blind placebo-controlled trial

Background: Gastric restriction is a treatment option for morbid obesity. Currently there are several types of adjustable gastric bands available, with two leading but conceptionally different systems, not just from a technical point of view but also from the long-term complication rates. Methods: A literature search of articles published from January 1997 to December 2002 dealing with prospective or restrospective studies comparing results of treatment with the Swedish band and LapBand® was carried out. Results: 7 comparative studies fulfilled inclusion criteria, with a total of 1,031 patients in the Swedish band (41-597) and 1,305 patients in the Lap-band® groups (34-821). Pouch dilatation/slippage and/or erosion in Swedish vs Lap-band® were reported in the studies as follows: 1 vs 2 in study group 1, 0 vs 9 in study group 2, 0 vs 3 in 3, 3 vs 38 in 4, 0 vs 64 (slippages) and 4 vs 4 (erosions) in group 5. In study 6, 3 vs 3 dilatations and 0 vs 1 erosions were reported. Study 7 found 12 vs 42 long-term complications of this origin. Port-site infections, total reoperation rates and length of hospital stay were also compared. Conclusion:The results of this meta-analysis reveal that fall in BMI is similar with both laparoscopic bands. Long-term complication rates, despite the fact that they have been defined in a similar way in all the included studies, may be higher with more reoperation rates in Lap-band® patients.

Literature Review of Comparative Studies of Complications with Swedish Band and Lap-Band®

BACKGROUND The surgery to place the implantable gastric stimulator (IGS) is described. METHODS There are two implantable components to the IGS. One is the electrical stimulator itself, which is placed in the anterior abdominal wall. It is connected to a bipolar lead that is positioned in the muscle wall of the stomach. We describe the procedure that is necessary to safely place the components. RESULTS 4 patients have been implanted using techniques that were developed and refined around the world. There were no operative deaths. All procedures were successfully completed laparoscopically. Two (2/4) connections required revision because the leads were not fully inserted into the header of the generator. CONCLUSIONS The operation to implant the IGS is safe and simple to perform. Attention to technical details is essential.

Implantable Electrical Gastric Stimulation to Treat Morbid Obesity in the Human: Operative Technique

Background: The detection of a leakage in the system of the adjustable silicone gastric band (ASGB) may be difficult. Gastrografin injection into the port should be avoided because it acts like a glue and blocks the system. Methods: A syringe containing saline and a syringe containing Thallium-201 chloride is connected to the 4-way stopcock which is connected to the needle. The needle is pushed into the port. The position is confirmed by injection and aspiration of saline. 2 ml of TL-201 chloride (74 MBp) is injected to locate the leakage in the system with planar images with a gamma camera (Elscint SP 6), 30 min, 2, 3, and 24 h after injection. Results: The original ASGB was provided with an injection reservoir which, in our series, was found to be leaking in four cases (3%). Conclusions: Our technique for adjustments and leak detection appears to be simple and effective. Band-related problems such as reservoir leak should disappear with improvement of the material.

Karl Miller

Papers

Evaluation of Health Status and Quality of Life after Bariatric Surgery: Comparison of Standard Roux-en-Y Gastric Bypass, Vertical Banded Gastroplasty and Laparoscopic Adjustable Silicone Gastric Banding

Gallstone formation prophylaxis after gastric restrictive procedures for weight loss: a randomized double-blind placebo-controlled trial

Literature Review of Comparative Studies of Complications with Swedish Band and Lap-Band®

Implantable Electrical Gastric Stimulation to Treat Morbid Obesity in the Human: Operative Technique

Adjustments and Leak Detection of the Adjustable Silicone Gastric Band (ASGB) and Lap-Band™ Adjustable Gastric Band (LAGB) System