Sleeve gastrectomy (SG) has become the most frequent bariatric surgery procedure. Secondary gastroesophageal reflux (GERD) may indicate conversion to Roux-en-Y gastric bypass (RYGB). However, in patients with sufficient weight loss, there is no clear answer in the literature as to whether RYGB should be performed with loop lengths leading to metabolic effect, or whether it should be performed solely for anti-reflux purposes. We aimed to evaluate current surgical practices and limb-length preferences among French-speaking bariatric surgeons managing GERD after SG in patients with satisfactory weight loss. A cross-sectional survey was distributed to members of the Société Française et Francophone de Chirurgie de l'Obésité et des Maladies Métaboliques (SOFFCO-MM). The questionnaire included demographics, criteria for “satisfactory weight loss”, diagnostic workup for GERD and RYGB technical configurations. Fifty-three surgeons responded. Only 22.6
Timely metabolic surgery improves glycaemic control and reduces cardiovascular risk for patients with type 2 diabetes. Young age is a known predictor of favourable metabolic outcome, but Roux-en-Y gastric bypass (RYGB) is often delayed owing to reported surgical and psychological risks in young adults. We hypothesised that use of RYGB in adults aged 18–35 years would result in higher rates of diabetes remission compared with older individuals, without an associated increase in morbidity. We analysed prospective registry data from three expert centres where young adults (29.5±5 years) and older adults (48±6.8 years) (means ± SD) who were living with non-insulin-dependent type 2 diabetes underwent RYGB. Younger adults were matched in a 1:2 ratio to their older counterparts for duration of preoperative diabetes, sex, BMI and American Society of Anesthesiologists physical status score. The rates of diabetes remission and adverse events in both groups were compared five years postoperatively. A total of 79.1
BACKGROUND:Since 2007, single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) has been proposed as an alternative to Roux-en-Y gastric bypass (RYGB) in the treatment of obesity. We conducted a multicentre randomised trial, with the hypothesis that SADI-S could be more effective than RYGB at 2-year follow-up. METHODS:This multicentre, open-label, individually randomised superiority trial was conducted in France; patients were recruited from 22 bariatric institutions, mostly public academic hospitals. Key inclusion criteria were patients with a BMI ≥40 kg/m2 or ≥35 kg/m2 with obesity-related comorbidities (type 2 diabetes, hypertension, dyslipidaemia, sleep apnoea, or osteoarthrosis), and a candidate for SADI-S or RYGB gastric bypass as a primary surgery or after a sleeve gastrectomy. Main key exclusions included previous bariatric surgery (other than sleeve gastrectomy), inflammatory bowel disease, type 1 diabetes, and untreated Helicobacter pylori infection. Participants were randomly assigned (1:1) to SADI-S or RYGB, stratified by centre, failure of sleeve gastrectomy, and presence of type 2 diabetes. The primary endpoint was percentage excess weight loss (%EWL) at 2 years (%EWL=[(weight at 2 years - initial weight)/(initial weight - ideal weight)] × 100). The study is registered with ClinicalTrials.gov, NCT03610256 and is completed. FINDINGS:Between Nov 8, 2018, and Sept 29, 2021, a total of 381 patients were randomly assigned (intention-to-treat population) and included in the primary analysis (SADI-S: 190, RYGB: 191). Mean age was 44·4 years (SD 10·64), mean BMI was 46·2 kg/m2 (6·40), 265 (70%) were female, and 79 (21%) had a primary sleeve gastrectomy. 43 (12%) of 370 participants were lost to follow-up. At 2 years, the mean %EWL was statistically significantly higher in the SADI-S group compared with the RYGB group (-76·0% [SD 26·7] vs -68·1% [28·7], confirming the superiority of SADI-S (mean difference -6·72% [95% CI -12·64 to -0·80], p=0·026). The primary outcome was missing for 78 (20%) of 381 participants, with 46 (59%) of 78 participants in the SADI-S group and 32 (41%) of 78 in the RYGB group, p=0·09. The number of serious adverse events related to the surgical technique in the safety population, including all operated patients, was 40 in the SADI-S group including three anastomotic leaks and eight severe diarrhoea compared with 35 in the RYGB group including five internal hernia and five severe abdominal pain cases of which two required diagnostic laparoscopy. INTERPRETATION:SADI-S showed superior weight loss compared with RYGB at 2 years, with a similar safety profile. FUNDING:French Ministry of Health (Direction Générale de l'offre de Soin - DGOS).
Is ESG effective in the treatment of obesity and associatedcomorbidities? Endoscopic Sleeve Gastroplasty (ESG) is more effective than lifestyle modifications alone for weight loss and improving obesity-related comorbidities. While it has less effect on weight loss compared to Laparoscopic Sleeve Gastrectomy (LSG) in the short to medium term, it offers similar comorbidities resolution to LSG. Is ESG a safe procedure, and what are its risks? The safety profile of ESG is consistently supported in the literature. Surgical complications after ESG, ranging from 1.5 to 2.3%, such as bleeding, perforation, fistula, or upper bowel obstruction, are rare and typically managed endoscopically. The incidence of new-onset gastro-esophageal reflux disease (GERD) is deemed negligible and occurs less frequently after ESG compared to SG. What are the indications and management methods? Multidisciplinary care for patients undergoing ESG should be provided in an accredited center authorized to perform bariatric and metabolic surgery, with validation through a multidisciplinary consultation meeting (RCP). Perioperative management should be personalized and ideally modeled after the protocols already in place for bariatric and metabolic surgery to ensure satisfactory and lasting weight and metabolic outcomes. Adherence to follow-up visits is a significant predictor of successful weight loss outcomes after ESG. Additionally, all endoscopic surgical procedures should be documented in a registry affiliated with a recognized scientific society, as is standard for other bariatric surgical procedures. Which healthcare professionals can perform ESG? ESG must be performed by a practitioner trained in endoscopy and obesity management, capable of ensuring thorough preoperative care and comprehensive postoperative follow-up, supported by an experienced multidisciplinary team. In France, Notice No. 2021.0040/AC/SEAP of June 10, 2021, issued by the Haute Autorité de santé (HAS) college, specifies that “the technology of ESG via the trans-oral approach, involving wide plication of the greater gastric curvature […] with an endoscopic suture placement device, enables a gastroenterologist or a visceral and digestive surgeon to perform gastric plication through digestive endoscopy by placing sutures in the stomach”. Ideally, this should take place in an accredited center authorized to perform bariatric and metabolic surgery, such as those approved by the Agence régionale de santé (ARS), in accordance with Article R6123-212 of December 2022 of the French Public Health Code. What are the recommendations and views of other international scientificsocieties? ESG is an integral part of the therapeutic arsenal available to bariatric and metabolic surgeons, offering an effective and valuable treatment option for obesity in specific patient populations. The International Federation for the Surgery of Obesity (IFSO) Bariatric Endoscopy Committee, following a comprehensive systematic review and meta-analysis, endorsed ESG as an effective and valuable treatment for obesity. ESG is particularly beneficial for patients with class I and II obesity, as well as for those with class III obesity who are not suitable candidates for metabolic bariatric surgery. Additionally, it can be proposed as an addition to lifestyle interventions in adolescent patients with class II obesity. The SOFFCOMM endorses endoscopic sleeve gastroplasty (ESG) as an effective and valuable treatment for obesity and highlights the importance of appropriate patient selection, coupled with rigorous evaluation of long-term outcomes, to refine its indications further.
Introduction Les myopathies inflammatoires idiopathiques sont un groupe de maladies musculaires rares dont le diagnostic repose sur l’évaluation clinique et les biomarqueurs sérologiques et histologiques. Alors que l’immunomarquage HLA-I (MHC-I) est utilisé en routine comme marqueur diagnostic de myosite, le rôle de l’immunomarquage HLA-DR (MHC-II) reste à préciser. Résultats Dans cette étude, nous avons examiné les profils d’expression d’HLA-DR par les myofibres et les capillaires, sur les biopsies musculaires de 103 patients, appartenant à cinq sous-groupes de myopathies inflammatoires idiopathiques : dermatomyosite (DM, n=31), myosite à inclusions (IBM, n=24), syndrome des anti-synthétase (ASyS, n=10), myopathie nécrosante auto-immune (MNAI, n=18) et myosite de chevauchement (OM, n=20). Une expression anormale de l’HLA-DR par les myofibres a été observée chez 63 des 103 patients (61 %), avec des profils distincts dans les différents sous-groupes : diffuse dans les IBM (96 %), négative dans les MNAI (83 %), périfasciculaire dans les ASyS (70 %), à la fois négative (61 %) et périfasciculaire (32 %) dans les DM, et groupée (40 %), périfasciculaire (30 %) ou hétérogène diffuse (15 %) dans les OM. En outre, le marquage capillaire HLA-DR a révélé des anomalies capillaires quantitatives, comme une perte en capillaires (47 sur 88, 53 %), et des anomalies qualitatives comme les capillaires dilatés et les marquages capillaires « baveux » (79 sur 98, 81 %). Conclusion Ces résultats indiquent que le marquage HLA-DR représente un outil complémentaire intéressant pour le diagnostic des sous-groupes de myopathies inflammatoires idiopathiques. Nos résultats suggèrent que l’ajout de l’immunomarquage HLA-DR dans les évaluations histologiques de routine pourrait faciliter le diagnostic entre les différents sous-types de myopathies inflammatoires idiopathiques.
BACKGROUND Whether the benefits of the robotic platform in bariatric surgery translate into superior surgical outcomes remains unclear. The aim of this retrospective study was to establish the 'best possible' outcomes for robotic bariatric surgery and compare them with the established laparoscopic benchmarks. METHODS Benchmark cut-offs were established for consecutive primary robotic bariatric surgery patients of 17 centres across four continents (13 expert centres and 4 learning phase centres) using the 75th percentile of the median outcome values until 90 days after surgery. The benchmark patients had no previous laparotomy, diabetes, sleep apnoea, cardiopathy, renal insufficiency, inflammatory bowel disease, immunosuppression, history of thromboembolic events, BMI greater than 50 kg/m2, or age greater than 65 years. RESULTS A total of 9097 patients were included, who were mainly female (75.5%) and who had a mean(s.d.) age of 44.7(11.5) years and a mean(s.d.) baseline BMI of 44.6(7.7) kg/m2. In expert centres, 13.74% of the 3020 patients who underwent primary robotic Roux-en-Y gastric bypass and 5.9% of the 4078 patients who underwent primary robotic sleeve gastrectomy presented with greater than or equal to one complication within 90 postoperative days. No patient died and 1.1% of patients had adverse events related to the robotic platform. When compared with laparoscopic benchmarks, robotic Roux-en-Y gastric bypass had lower benchmark cut-offs for hospital stay, postoperative bleeding, and marginal ulceration, but the duration of the operation was 42 min longer. For most surgical outcomes, robotic sleeve gastrectomy outperformed laparoscopic sleeve gastrectomy with a comparable duration of the operation. In robotic learning phase centres, outcomes were within the established benchmarks only for low-risk robotic Roux-en-Y gastric bypass. CONCLUSION The newly established benchmarks suggest that robotic bariatric surgery may enhance surgical safety compared with laparoscopic bariatric surgery; however, the duration of the operation for robotic Roux-en-Y gastric bypass is longer.
In cirrhotic patients, portal hypertension increases mortality after surgery. We evaluated the impact of pre-operative transjugular intrahepatic portosystemic shunt (TIPS) on the outcomes of bariatric surgery in cirrhosis. Multicentric retrospective cohort. The decision for TIPS placement has been made according to hepatic venous pressure gradient (HVPG) values and centers’ policy. The primary outcome: 1-year decompensation-free survival; secondary outcomes: 1-year acute-on-chronic liver failure (ACLF) and survival. Fifty-three patients were included (2010–2022): 92
Background The multicentre randomised trial YOMEGA (NCT02139813) comparing the one anastomosis gastric bypass (OAGB) with the Roux -en -Y gastric bypass (RYGB) confirmed the non-inferiority of OAGB on weight loss outcomes at 24 months. We aimed to report weight loss, metabolic, and safety outcomes at 5 years. Methods YOMEGA is a prospective, open -label, non-inferiority, randomised trial conducted at nine centres in France. Inclusion criteria were BMI of 40 kg/m2 or more, or 35 kg/m2 or more with comorbidities. Key exclusion criteria were severe gastro-oesophageal reflux disease or Barrett's oesophagus and previous bariatric surgery. Patients were randomly assigned (1 :1) to OAGB (one gastrojejunal anastomosis with a 200 cm biliopancreatic limb) or RYGB (with a 150 cm alimentary limb and a 50 cm biliary limb), stratified by centre, with blocks of variable size. The primary endpoint of this extension study was percentage excess BMI loss and was analysed in the per-protocol population, including patients with data who were operated on with the technique randomly assigned to them and excluding patients with major deviations from the protocol during the follow-up (change of surgical technique, death, or withdrawal of consent). Non-inferiority was concluded for the primary endpoint if the upper bound of the CI was less than the non-inferiority limit (7 percentage points). YOMEGA is registered with ClinicalTrials.gov, NCT02139813, and the 5-year follow-up of YOMEGA is registered with ClinicalTrials.gov, NCT05549271. Findings Between May 13, 2014, and March 2, 2016, 253 patients were randomly assigned to OAGB (n=129) or RYGB (n=124), and from these patients 114 in the OAGB group and 118 in the RYGB group were included in the per-protocol analysis. In the per-protocol population, at baseline, mean age was 430 years (SD 108), mean BMI was 440 kg/m2 (56), 54 (23%) patients were male and 178 (77%) were female; 55 (27%) of 207 patients had type 2 diabetes. After 5 years, mean percentage excess BMI loss was -756% (SD 281) in the OAGB group versus -714% (SD 298) in the RYGB group, confirming non-inferiority (mean difference -41% [90% CI -120 to 37], p=00099). Remission of type 2 diabetes was similar in both groups. Nutritional status did not differ; the most common adverse event was clinical gastro-oesophageal reflux disease, occurring in 27 (41%) of 66 patients in the OAGB group versus 14 (18%) of 76 patients in the RYGB group (p=00030). Among serious adverse events, ten (8%) of 127 patients converted from OAGB to RYGB. 171 (68%) of 253 patients were followed up. Interpretation OAGB was not inferior to RYGB regarding percentage excess BMI loss at 5 years with similar metabolic outcomes. The high rate of clinical gastro-oesophageal reflux disease after OAGB raises questions about its long-term consequences, which need to be further investigated. Funding Medtronic. Copyright (c) 2024 Elsevier Ltd. All rights reserved.
BackgroundConversion of SG to Roux-en-Y gastric bypass (RYGB) is increasing. Intrathoracic migration of the sleeve (ITM) often seems associated and is increasingly reported.Material and MethodsPatients who underwent a conversion of SG to RYGB from August 2013 to December 2022 were included. Two groups were compared: patients operated on for weight loss failure (WLF gp) and those operated on for gastroesophageal reflux disease (GERD gp). Demographic data, the incidence of ITM, weight loss outcomes, resolution of symptoms, and morbidity were analyzed.ResultsFifty-nine patients were included with an average follow-up of 32 months: 46 patients in the GERD gp (78%) were compared to 13 patients (22%) in the WLF gp. Groups were comparable regarding age and gender, but BMI and commodities were significantly higher in the WLF gp. In the GERD gp, on preoperative gastroscopy, 30% had a esophagitis, 48% had an ITM which required a posterior crural closure versus no esophagitis (p=0.02) and 23% of ITM in the WLF gp (p=0.11). Conversion led to 93% of GERD symptom improvement. In the WLF gp, mean TWL% was 15.3%, significantly greater than in the GERD gp (TWL% = 4.6%, p = 0.01). The complication rate was 10% at 30 days and 3.4% after 30 days, not significantly different between groups.ConclusionThe main indication of conversion of SG to RYGB was because of GERD: in these indications, the incidence of ITM was high requiring a surgical treatment with a very good efficacy on symptoms. Weight loss results were disappointing.
BACKGROUND:Weight loss trajectories after bariatric surgery vary widely between individuals, and predicting weight loss before the operation remains challenging. We aimed to develop a model using machine learning to provide individual preoperative prediction of 5-year weight loss trajectories after surgery.METHODS:In this multinational retrospective observational study we enrolled adult participants (aged ≥18 years) from ten prospective cohorts (including ABOS [NCT01129297], BAREVAL [NCT02310178], the Swedish Obese Subjects study, and a large cohort from the Dutch Obesity Clinic [Nederlandse Obesitas Kliniek]) and two randomised trials (SleevePass [NCT00793143] and SM-BOSS [NCT00356213]) in Europe, the Americas, and Asia, with a 5 year follow-up after Roux-en-Y gastric bypass, sleeve gastrectomy, or gastric band. Patients with a previous history of bariatric surgery or large delays between scheduled and actual visits were excluded. The training cohort comprised patients from two centres in France (ABOS and BAREVAL). The primary outcome was BMI at 5 years. A model was developed using least absolute shrinkage and selection operator to select variables and the classification and regression trees algorithm to build interpretable regression trees. The performances of the model were assessed through the median absolute deviation (MAD) and root mean squared error (RMSE) of BMI.FINDINGS:10 231 patients from 12 centres in ten countries were included in the analysis, corresponding to 30 602 patient-years. Among participants in all 12 cohorts, 7701 (75·3%) were female, 2530 (24·7%) were male. Among 434 baseline attributes available in the training cohort, seven variables were selected: height, weight, intervention type, age, diabetes status, diabetes duration, and smoking status. At 5 years, across external testing cohorts the overall mean MAD BMI was 2·8 kg/m2 (95% CI 2·6-3·0) and mean RMSE BMI was 4·7 kg/m2 (4·4-5·0), and the mean difference between predicted and observed BMI was -0·3 kg/m2 (SD 4·7). This model is incorporated in an easy to use and interpretable web-based prediction tool to help inform clinical decision before surgery.INTERPRETATION:We developed a machine learning-based model, which is internationally validated, for predicting individual 5-year weight loss trajectories after three common bariatric interventions.FUNDING:SOPHIA Innovative Medicines Initiative 2 Joint Undertaking, supported by the EU's Horizon 2020 research and innovation programme, the European Federation of Pharmaceutical Industries and Associations, Type 1 Diabetes Exchange, and the Juvenile Diabetes Research Foundation and Obesity Action Coalition; Métropole Européenne de Lille; Agence Nationale de la Recherche; Institut national de recherche en sciences et technologies du numérique through the Artificial Intelligence chair Apprenf; Université de Lille Nord Europe's I-SITE EXPAND as part of the Bandits For Health project; Laboratoire d'excellence European Genomic Institute for Diabetes; Soutien aux Travaux Interdisciplinaires, Multi-établissements et Exploratoires programme by Conseil Régional Hauts-de-France (volet partenarial phase 2, project PERSO-SURG).
After bariatric surgery, patients with obesity achieve sustainable weight loss, gain in mobility, quality of life and life expectancy. Bariatric surgery can lead to remission of type 2 diabetes or to long term glycaemic control for patients with type 2 diabetes, while medical treatment has a preventive efficacy on micro and macrovascular complications. This has led to the concept of metabolic surgery to treat type 2 diabetes. Despite the benefits, only a small proportion of eligible patients undergo bariatric/metabolic surgery. Powerful antidiabetic medications, self-estimated lack of knowledge by medical professionals and fear of surgical complications are some of the arguments to prefer medical treatment of type 2 diabetes obesity versus metabolic surgery. We have reviewed in this paper the barriers which explain the low referral rate to metabolic surgery. With the point of view of the diabetologist, the general practitioner and the patient, we have addressed them to help clinicians and patients model an evidenced-based patient-oriented medical plan.
Abstract Introduction Sleeve gastrectomy (SG) represents more than 60% of bariatric procedures worldwide. Conversion of SG to Roux-en-Y gastric bypass (RYGB) for weight loss failure (WLF) or gastro-oesophageal reflux disease (GERD) is increasing. Intrathoracic migration of the sleeve often seems associated. Aim The aim of our study was to analyse the relevance of the indications, the prevalence of an associated de novo hiatal hernia, and the outcomes of the conversion of SG to RYGB. Methods This is a retrospective study of prospectively collected data including all the patients who underwent a conversion of SG to RYGB from August 2013 to December 2022. 2 groups were compared: patients operated on because of weight loss failure (WLF group) and those operated on for GERD (GERD group). Results We analysed in both groups demographic data, the incidence of an associated hiatal hernia, morbidity, weight loss outcomes and resolution of symptoms. 59 patients were included with an average follow-up of 30.5 months: 46 patients in the GERD group (78%) were compared to 13 patients (22%) in the WLF group. Groups were comparable regarding age (47) and gender (women: 74%); BMI at conversion and prevalence of comorbidities were significantly higher in the WLF group (41.8 kg/m² vs 33.3, p=0.0001). In the GERD group: on preoperative gastroscopy, 30% (14/46) had a grade B esophagitis, 48% (22/46) had a significant hiatal hernia which required a posterior crural closure versus 23% (3/13) in the WLF group, not requiring a surgical treatment (p = 0.02). Conversion was very effective on GERD symptoms (93% of improvement), 52% of the patients stopped proton pump inhibitor treatment. In the WLF group, mean percentage total weight loss (% TWL) was 15.3%, significantly greater than in the GERD group (% TWL=4.6%, p = 0.01). The complication rate was 10% at 30 days and 3.4% after 30 days, not significantly different between groups (p = 1 and 1 respectively). Conclusions The main indication of conversion of SG to RYGB was because of GERD: in these indications, the incidence of intrathoracic migration of the sleeve is high requiring a surgical treatment with a very good efficacy on resolution of symptoms. Weight loss results were disappointing.
Les résultats de la chirurgie bariatrique, bien que souvent impressionnants, ne sont pas universels et varient d’un patient à l’autre et d’une intervention chirurgicale à l’autre. Entre 20 et 30 % des patients atteignent une perte de poids sous-optimale ou présentent une reprise de poids significative au cours des premières années postopératoires. Face à cette maladie qui reste une pathologie chronique et face à des échecs qui sont difficiles à prendre en charge, il apparaît essentiel de mieux caractériser l’obésité en préopératoire et d’aller au-delà de l’indice de masse corporelle (IMC) pour sélectionner les bons candidats à la chirurgie et optimiser la balance bénéfices–risques. L’objectif de cette mise au point est, à partir des données des études les plus récentes sur la chirurgie bariatrique, d’identifier les facteurs prédictifs de la perte de poids ainsi que les facteurs de risque d’échec pondéral. Les résultats colligés montrent que le choix de la technique chirurgicale, l’âge, l’IMC initial, l’origine ethnique, les troubles du comportement alimentaire et des facteurs métaboliques ont un impact sur les résultats métaboliques et pondéraux après une chirurgie bariatrique. On comprend ainsi l’importance de bien sélectionner les patients en préopératoire au cours d’une discussion pluridisciplinaire afin d’optimiser les résultats pondéraux et métaboliques de la chirurgie.
Abstract Introduction Sleeve gastrectomy (SG) represents more than 60% of bariatric procedures worldwide. Conversion of SG to Roux-en-Y gastric bypass (RYGB) for weight loss failure (WLF) or gastro-oesophageal reflux disease (GERD) is increasing. Intrathoracic migration of the sleeve often seems associated. Aim The aim of our study was to analyse the relevance of the indications, the prevalence of an associated de novo hiatal hernia, and the outcomes of the conversion of SG to RYGB. Methods This is a retrospective study of prospectively collected data including all the patients who underwent a conversion of SG to RYGB from August 2013 to December 2022. 2 groups were compared: patients operated on because of weight loss failure (WLF group) and those operated on for GERD (GERD group). Results We analysed in both groups demographic data, the incidence of an associated hiatal hernia, morbidity, weight loss outcomes and resolution of symptoms. 59 patients were included with an average follow-up of 30.5 months: 46 patients in the GERD group (78%) were compared to 13 patients (22%) in the WLF group. Groups were comparable regarding age (47) and gender (women: 74%); BMI at conversion and prevalence of comorbidities were significantly higher in the WLF group (41.8 kg/m² vs 33.3, p=0.0001). In the GERD group: on preoperative gastroscopy, 30% (14/46) had a grade B esophagitis, 48% (22/46) had a significant hiatal hernia which required a posterior crural closure versus 23% (3/13) in the WLF group, not requiring a surgical treatment (p = 0.02). Conversion was very effective on GERD symptoms (93% of improvement), 52% of the patients stopped proton pump inhibitor treatment. In the WLF group, mean percentage total weight loss (% TWL) was 15.3%, significantly greater than in the GERD group (% TWL=4.6%, p = 0.01). The complication rate was 10% at 30 days and 3.4% after 30 days, not significantly different between groups (p = 1 and 1 respectively). Conclusions The main indication of conversion of SG to RYGB was because of GERD: in these indications, the incidence of intrathoracic migration of the sleeve is high requiring a surgical treatment with a very good efficacy on resolution of symptoms. Weight loss results were disappointing.