***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    ***EXAMPLES*** 
    Input: Background : The BioEnterics ® Intragastric Balloon ( BIB ® ) System in association with restricted diet has been used for the short-term treatment of morbid obesity . Aim of this study was to evaluate the real , short term , efficacy of the BIB for weight reduction in morbidly obese patients by using a prospect i ve , double-blind , r and omised , sham-controlled , crossover study . Methods : Patients were recruited from January 2003 to December 2003 . After selection , they were r and omly allocated into two groups : BIB followed by sham procedure after 3 months ( Group A ) , and sham procedure followed by BIB after 3 months ( Group B ) . All endoscopic procedures were performed under unconscious intravenous sedation . The BioEnterics Intragastric Balloon ( Inamed Health ; Santa Barbara , CA , USA ) was filled by using saline ( 500 ml ) and methylene blue ( 10 ml ) . Patients were discharged with omeprazole therapy and diet ( 1000 kcal ) . Patients were followed up weekly by a physician blinded to r and omisation . In both groups mortality , complications , BMI , BMI reduction and % EWL were considered . Data were expressed as mean±s.d . , except as otherwise indicated . Statistical analysis was performed by means of Student 's t-test , Fisher 's exact test or χ 2 with Yates correction ; P<0.05 was considered significant . Results : A total of 32 patients were selected and entered the study ( 8M/24F ; mean age : 36.2±5.6 years , range 25–50 years ; mean BMI 43.7±1.5 kg/m2 , range 40–45 kg/m2 ; mean % EW : 43.1±13.1 , range : 35–65 ) . All patients completed the study . Mortality was absent . Complications related to endoscopy , balloon placement and removal were absent . Mean time of BIB positioning was 15±2 min , range 10–20 min . After the first 3 months of the study , in Group A patients the mean BMI significantly ( P<0.001 ) lowered from 43.5±1.1 to 38.0±2.6 kg/m2 , while in Group B patients the decrease was not significant ( from 43.6±1.8 to 43.1±2.8 kg/m2 ) . The mean % EWL was significantly higher in Group A than in Group B ( 34.0±4.8 vs 2.1±1 % ; P<0.001 ) . After crossover , at the end of the following 3 months , the BMI lowered from 38.0±2.6 to 37.1±3.4 kg/m2 and from 43.1±2.8 to 38.8±3.1 kg/m2 in Groups A and B , respectively . Conclusions : The results of this study show that treatment of obese patients with BioEnterics Intragastric Balloon  is a safe and effective procedure . In association with appropriate diet it is significantly effective in weight reduction when compared to sham procedure plus diet . The BIB ® procedure can play a role in weight reduction in morbidly obese patients or in the preoperative treatment of bariatric patients Background Satiety is central ly and peripherally mediated by gastrointestinal peptides and the vagal nerve . We aim ed to investigate whether intragastric balloon treatment affects satiety through effects on fasting and meal-stimulated cholecystokinin ( CCK ) and pancreatic polypeptide ( PP ) secretion . Methods Patients referred for obesity treatment were r and omised to 13 weeks of sham treatment followed by 13 weeks of balloon treatment ( group 1 ; sham/balloon ) or to twice a 13-week period of balloon treatment ( group 2 ; balloon/balloon ) . Blood sample s were taken for fasting and meal-stimulated CCK and PP levels at the start ( T0 ) and after 13 ( T1 ) and 26 ( T2 ) weeks . Patients filled out visual analogue scales ( VAS ) to assess satiety . Results Forty-two patients ( 35 females , body weight 125.1 kg , BMI 43.3 kg/m2 ) participated . In group 1 , basal CCK levels decreased but meal-stimulated response remained unchanged after 13 weeks of sham treatment . In group 2 , basal and meal-stimulated CCK levels decreased after 13 weeks of balloon treatment . At the end of the second 13-week period , when group 1 had their first balloon treatment , they duplicated the initial 13-week results of group 2 , whereas group 2 continued their balloon treatment and reduced meal-stimulated CCK release . Both groups showed reduced meal-stimulated PP secretions at T1 and T2 compared to T0 . Changes in diet composition and VAS scores were similar . Improvements in glucose homeostasis partly explained the PP results . Conclusions The reduced CCK and PP secretion after balloon positioning was unexpected and may reflect delayed gastric emptying induced by the balloon . Improved glucose metabolism partly explained the reduced PP secretion . Satiety and weight loss were not adversely influenced by these hormonal changes BACKGROUND AND STUDY AIMS Endoscopic biliary sphincterotomy in patients with sphincter of Oddi dysfunction ( SOD ) is associated with a high risk of pancreatitis after endoscopic retro grade cholangiopancreatography ( ERCP ) , which may be secondary to residual pancreatic sphincter hypertension . It was hypothesized that botulinum toxin injection could be used to reduce pancreatic sphincter hypertension temporarily in SOD patients after biliary sphincterotomy , thereby reducing the rate of procedure-induced pancreatitis . PATIENTS AND METHODS All patients undergoing ERCP with manometry due to a suspected biliary SOD were asked to participate in the study . Patients with elevated basal sphincter pressures were r and omly assigned to receive either botulinum toxin or a sham saline injection after biliary sphincterotomy . Fifty units of botulinum toxin were delivered via a sclerotherapy needle in the form of two 25-U injections of 0.25 ml each into the pancreatic sphincter . In patients in the sham arm , 0.50 ml of saline was injected into the duodenal lumen . RESULTS Between 12 February 1999 and 29 November 2000 , a total of 98 patients were referred for ERCP with manometry ; 86 consented to participate in the study , and 26 had elevated baseline pressures and underwent r and om assignment . Twelve received botulinum toxin injection and 14 were r and omly assigned to receive the sham injection . A total of six patients in the sham group ( 43 % ) developed procedure-induced pancreatitis , compared with three patients in the botulinum toxin group ( 25 % ; P = 0.34 ) . CONCLUSIONS Biliary sphincterotomy in patients with sphincter of Oddi dysfunction without pancreatic protection is risky and should no longer be carried out . This study demonstrates that botulinum toxin injection into the residual pancreatic sphincter after biliary sphincterotomy is technically feasible and safe , showing a trend toward a reduced post-ERCP pancreatitis rate in patients with sphincter of Oddi dysfunction . Further studies will need to confirm the validity of these experimental results before this technique can be used routinely OBJECTIVES : Several studies have reported symptom relief in gastro-esophageal reflux disease ( GERD ) patients treated with radiofrequency delivery ( Stretta procedure ) at the gastro-esophageal junction ( GEJ ) , but the mechanism underlying this improvement is unclear . The objective of this study was to test the hypothesis that Stretta alters GEJ resistance . METHODS : We conducted a double-blind r and omized cross-over study of Stretta and sham treatment .  Consecutive GERD patients were included in the study . The study was conducted in a tertiary care center . Patients underwent two upper gastrointestinal endoscopies with 3 months interval , during which active or sham Stretta treatment was performed in a r and omized double-blind manner . Symptom assessment , endoscopy , manometry , 24-h esophageal pH monitoring , and a distensibility test of the GEJ were done before the start of the study and after 3 months . RESULTS : Barostat distensibility test of the GEJ before and after administration of sildenafil was the main outcome measure . In all , 22 GERD patients ( 17 females , mean age 47±12 years ) participated in the study ; 11 in each group . Initial sham treatment did not affect any of the parameters studied . Three months after initial Stretta procedure , no changes were observed in esophageal acid exposure and lower esophageal sphincter ( LES ) pressure . In contrast , symptom score was significantly improved and GEJ compliance was significantly decreased . Administration of sildenafil , an esophageal smooth muscle relaxant , normalized GEJ compliance again to pre-Stretta level , arguing against GEJ fibrosis as the underlying mechanism . CONCLUSIONS : The limitation of this study was reflux evaluation did not include impedance monitoring . In this sham-controlled study , Stretta improved GERD symptoms and decreased GEJ compliance . Decreased GEJ compliance , which reflects altered LES neuromuscular function , may contribute to symptomatic benefit by decreasing refluxate volume A r and omized controlled double-blind study was undertaken to assess the efficacy and safety of endoscopic neodymium : yttrium aluminum garnet ( Nd : YAG ) laser therapy for  active esophageal variceal bleeding . Ten patients were r and omized to the laser treatment group and 10 to a control group that received sham endoscopy and st and ard medical therapy .  Initial hemostasis was achieved in seven laser-treated patients but in 0 of 10 controls receiving sham treatment ( p less than 0.002 ) . However , four of the seven who were initially controlled with laser therapy had rebleeding 12 to 48 hours later ; thus , three of 10 laser patients had lasting hemostasis . The mean blood transfusion requirements were similar in both groups ( laser = 7.3 units ; control = 7.8 units ) . Six of the 10 laser-treated patients were discharged from the hospital and four died . There were seven hospital deaths in the control group and three patients were discharged ( p = 0.22 ) . In two patients in the treatment group , laser therapy  increased bleeding . There were no perforations Background / Aims : In obesity , many gastro-oesophageal reflux promoting factors are present . Weight reduction is advised to symptomatic overweight subjects . The aim of the present study was to investigate the influences of untreated obesity , weight loss , and chronic gastric balloon distension on the lower oesophageal sphincter ( LOS ) function . Methods : Patients entering a r and omized , double-blind , sham-controlled study of balloon treatment  , consisting of 4 months of either sham balloon or balloon treatment  followed by 4 months of balloon treatment .  Manometry and 24-hour pH measurements were performed at the start of the study and after 13 and 26 weeks . Results : Before treatment , LOS dysfunction was present in 7 of 32 patients ( 21.9 % ) . Increased upright and supine reflux was present in 8 patients ( 25 % ) . Sham treatment result ed in a weight loss of 9.7 % with improved LOS function ( a significant 0.6-cm increase in LOS length and a non-significant 2.6 mm Hg higher LOS pressure ) and in a significantly decreased upright reflux ( acid reflux time decreasing from 8.0 to 5.5 % and number of meal-related and postpr and ial reflux episodes decreasing from 49 to 32 ) . These improved values deteriorated after 4 months of balloon placement , with significantly increasing total , upright , and supine reflux to 7.5 , 7.6 , and 6.7 % of the time , respectively , with oesophageal lesions after an overall 17.8 % weight loss . Four months of balloon treatment induced a similar weight loss ( 9.9 % ) with significantly increased supine reflux from 1.6 to 6.7 % of the time . After a second 4-month balloon period and an overall 13.8 % weight loss , LOS and reflux values returned towards baseline values . A comparison of both groups demonstrated the adverse effects of balloon positioning after a period of substantial sham-induced weight loss . Conclusions : Impaired LOS function and increased gastro-oesophageal reflux were observed in one quarter of the untreated obese subjects .  Weight loss ameliorated manometry and pH values , but subsequent balloon positioning tended to counteract these beneficial changes . In patients on balloon treatment from the start , adverse effects seemed to wear off with prolonged treatment Background : Endoscopic treatment for gastro-oesophageal reflux disease ( GORD ) is rapidly emerging , but there is a great need for r and omised controlled trials to evaluate the efficacy . Design and setting : A single-centre , double-blind , r and omised , sham-controlled trial of endoscopic gastroplication by the Endocinch suturing system . Patients and interventions : 60 patients with GORD were r and omly assigned to three endoscop 
    Output:
    
The frequency of AEs in endoscopic sham procedures is substantial , and patients are subjected to considerable morbidity .