title: Randomised clinical trial: the safety and efficacy of AST-120 in non-constipating irritable bowel syndrome - a double-blind, placebo-controlled study.
abstract: BACKGROUND
  There is a need for safe and effective treatment options for irritable bowel syndrome (IBS). AST-120 (spherical carbon adsorbent) is a non-absorbed, carbon-based adsorbent with extensive adsorbing capability for histamine, serotonin and other substances implicated in IBS pathogenesis.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of AST-120 in non-constipating forms of IBS.
  
  
  METHODS
  This randomised, double-blind, placebo-controlled trial conducted in the US and Belgium enrolled 115 male and female patients fulfilling Rome III criteria for IBS; individuals with predominantly constipation symptoms were excluded. Subjects were randomised to AST-120 2 g tds or placebo for an 8-week double-blind treatment period, followed by a 2-week single-blind placebo washout and 8-week single-blind active treatment. The primary efficacy endpoint was the proportion of subjects achieving at least a 50% reduction in the number of days with abdominal pain compared with baseline.
  
  
  RESULTS
  At Week 4, 26.8% of subjects treated with AST-120 responded on the primary endpoint vs. 10.2% in the placebo arm (P=0.029); at Week 8 response rates were 32.1 and 25.4% respectively (NS). More AST-120 treated subjects experienced improvement in bloating and stool consistency. These benefits abated when AST-120 was replaced by placebo, and resumed once AST-120 was restarted. The frequency of adverse events with AST-120 were less than or equal to placebo.
  
  
  CONCLUSIONS
  AST-120 is safe and well-tolerated and reduces pain and bloating in non-constipating IBS, although beneficial effects may be limited in duration. AST-120 represents a locally acting, non-absorbed, novel treatment for IBS and warrants further studies.
authors: Translational Research Center for Gastrointestinal Diseases, University of Leuven, Leuven, Belgium. jan.tack@med.kuleuven.ac.be
authors: J F
authors: JF
authors: Tack
authors: P B
authors: PB
authors: Miner
authors: L
authors: L
authors: Fischer
authors: M S
authors: MS
authors: Harris
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001530:Belgium; D002244:Carbon / Q000009:adverse effects / Q000627:therapeutic use*; D003248:Constipation / Q000188:drug therapy*; D003967:Diarrhea / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010087:Oxides / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013223:Statistics as Topic; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D005765:Gastrointestinal Agents; D010087:Oxides; D002244:Carbon; C040896:AST 120