title: BMI is superior to symptoms in predicting response to proton pump inhibitor: randomised trial in patients with upper gastrointestinal symptoms and normal endoscopy.
abstract: OBJECTIVE
  In most patients undergoing endoscopy for upper gastrointestinal (GI) symptoms in the Western world, no macroscopic abnormality or evidence of Helicobacter pylori infection is identified. Following this negative investigation, proton pump inhibitor (PPI) therapy is usually prescribed. The aim of this study was to assess the value of such treatment compared with placebo and to identify predictors of response.
  
  
  METHODS
  Prospective parallel randomised study.
  
  
  METHODS
  Dyspepsia Research Clinic.
  
  
  METHODS
  105 patients (49 men, median age 44 years, IQR 22) with normal endoscopy and H pylori negative with ongoing upper GI symptoms following 2-week run-in period. Intervention Full demographic symptom severity and characteristics were assessed and 24 h oesophageal pH metry and oesophageal manometry were performed prior to randomisation to 2 weeks of treatment with lansoprazole 30 mg/day or placebo (2:1), with reassessment of symptom severity during the second week of treatment.
  
  
  METHODS
  50% reduction in Glasgow Dyspepsia Severity Score (GDSS).
  
  
  RESULTS
  According to intention to treat analysis, the response was 35.7% for the active group and 5.7% for the placebo group (p < 0001). The only non-invasive independent predictor of response to PPI in multivariable analysis was the patient's body mass index (BMI) (p = 0.003). The association of BMI with response to PPI was apparent across the full range of quartiles (p values for trend=0.01). BMI had a similar predictive value to either 24 h oesophageal pH metry or manometry. Predominant symptom and symptom subgroups were unhelpful in predicting the response to PPI. Including all pretreatment assessments, only BMI (p < 0.05) and lower oesophageal sphincter pressure (p < 0.05) were independent predictors of response.
  
  
  CONCLUSIONS
  The response to PPI therapy is likely to be related to underlying acid reflux. The strong predictive value of BMI is probably due to its association with underlying reflux disease and the fact that it is a more objective and reproducible measure than symptom characteristics. It is recommended that BMI should be measured in patients with upper GI symptoms. Trial Registration Number ISRCTN 32863375.
authors.affiliation: Institute of Cardiovascular and Medical Sciences, University of Glasgow, Gardiner Institute, Glasgow G11 6NT, UK. kenneth.mccoll@glasgow.ac.uk
authors.forename: Jonathan
authors.initials: J
authors.lastname: Fletcher
authors.forename: Mohammad H
authors.initials: MH
authors.lastname: Derakhshan
authors.forename: Gareth-Rhys
authors.initials: GR
authors.lastname: Jones
authors.forename: Angela A
authors.initials: AA
authors.lastname: Wirz
authors.forename: Kenneth E L
authors.initials: KE
authors.lastname: McColl
mesh_terms: D000328:Adult; D000368:Aged; D015992:Body Mass Index; D004415:Dyspepsia / Q000188:drug therapy* / Q000209:etiology; D016099:Endoscopy, Gastrointestinal; D050782:Esophageal pH Monitoring; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D054328:Proton Pump Inhibitors