title: Intragastric balloon or diet alone? A retrospective evaluation.
abstract: BACKGROUND
  Very few studies have reported results of the BioEnterics Intragastric Balloon (BIB) at > or =12 months follow-up. The aim of this study is the retrospective evaluation of the results of BIB placement compared to diet regimen alone.
  
  
  METHODS
  From January 2005 to June 2006, 130 outpatients underwent a structured diet plan with simple behavioral modification at our institutions. Controls (n = 130) were selected from the charts of patients who, during the same period, underwent BIB treatment. Patients in the outpatient group were given a structured balanced diet with a caloric intake between 1,000 and 1,200. The approximate macronutrient distribution, according the "Mediterranean diet," was 25% protein (at least 60 g/day), 20-25% lipids, and 50-55% carbohydrates. In the BIB group, patients received generic counseling for eating behavior. In both groups, we considered weight loss parameters (kilograms, percentage of excess weight loss [%EWL], body mass index [BMI], percentage of excess BMI loss [%EBL]) at 6 and 24 months from baseline and comorbidities at baseline and after 24 months. Results are expressed as mean+/-standard deviation. Statistical analysis was done by Student's t-test and chi (2)-test or Fisher's exact test. p < .05 was considered significant.
  
  
  RESULTS
  At the time of BIB removal (6 months), significantly better results in terms of weight loss in kilograms (16.7 +/- 4.7 vs. 6.6 +/- 2.6; p < 0.01), BMI (35.4 +/- 11.2 vs. 38.9 +/- 12.1; p < 0.01), %EBL (38.5 +/- 16.1 Vs 18.6 +/- 14.3; p < 0.01), and %EWL (33.9 +/- 18 vs. 24.3 +/- 17.0; p < 0.01) were observed in patients treated by intragastric balloon as compared to diet-treated patients. At 24 months from baseline, patient dropout was 1/130 (0.7%) and 25/130 (19.2%) in the BIB and diet groups, respectively (p < 0.001). At this time, patients treated with intragastric balloon have tended to regain weight, whereas diet-treated patients have already regained most of lost weight.
  
  
  CONCLUSIONS
  Although the strength of this study may be limited by its retrospective design, the results indicate that, in the short-to-medium term, BIB is significantly superior to diet in terms of weight loss.
authors.affiliation: Department of Surgery Paride Sefanini, University La Sapienza, Rome, Italy. alfredogenco@uniroma1.it
authors.forename: Alfredo
authors.initials: A
authors.lastname: Genco
authors.forename: Stefano
authors.initials: S
authors.lastname: Balducci
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Bacci
authors.forename: Alberto
authors.initials: A
authors.lastname: Materia
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Cipriano
authors.forename: Giovanni
authors.initials: G
authors.lastname: Baglio
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Ribaudo
authors.forename: Roberta
authors.initials: R
authors.lastname: Maselli
authors.forename: Michele
authors.initials: M
authors.lastname: Lorenzo
authors.forename: Nicola
authors.initials: N
authors.lastname: Basso
mesh_terms: D000328:Adult; D015992:Body Mass Index; D015331:Cohort Studies; D005260:Female; D015905:Gastric Balloon; D006801:Humans; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000150:complications / Q000178:diet therapy* / Q000601:surgery*; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D015431:Weight Loss