title: Does concomitant use of paracetamol potentiate the gastroduodenal mucosal injury associated with aspirin? A prospective, randomised, pilot study.
abstract: BACKGROUND
  Paracetamol is commonly prescribed for first-line symptomatic treatment in patients with osteoarthritis and aspirin is often co-administered for cardiovascular prophylaxis. It is not known if an interaction exists between aspirin and paracetamol in regards to gastroduodenal mucosal injury.
  
  
  OBJECTIVE
  To investigate whether or not co-administered aspirin with paracetamol results in an increased rate of endoscopic gastroduodenal mucosal injury as compared to either agent alone.
  
  
  METHODS
  In this prospective, double-blind, randomised, three-arm, placebo- and active-controlled, parallel-group pilot study healthy adult subjects (18-75 years old) with a normal baseline trans-nasal oesophagogastroduodenoscopy (TN-EGD), received oral paracetamol 4000 mg q.d.s. (n = 21), aspirin 325 mg q.d.s. (n = 19) or paracetamol 4000 mg q.d.s. and aspirin 325 mg q.d.s. (n = 20). Upper gastrointestinal mucosal injury was evaluated after 7 days of treatment with TN-EGD.
  
  
  RESULTS
  The rate of gastric ulcers in subjects receiving paracetamol (0/21, 0%) alone or aspirin (3/19, 16%) or both (2/20, 10%) was not different. There were, however, significantly more subjects with one or more lesions (erosion or ulcer) per subject in the paracetamol and aspirin (16/20, 80%) treated subjects as compared to the aspirin (8/19, 42%, P < 0.001) or the paracetamol (3/21, 14%, P < 0.01) exposed subjects. The mean number of lesions per subject was also greater (7.9 vs. 0.7, P < 0.01) in those treated with aspirin and paracetamol compared to paracetamol alone.
  
  
  CONCLUSIONS
  Co-administration of paracetamol and aspirin was not associated with a significant difference in endoscopic ulcer rates compared to either drug alone. There was a strong signal for increased endoscopic erosions and ulcers in the combined group compared to either aspirin or paracetamol alone.
authors: Department of Digestive Diseases and Nutrition, University of Illinois at Chicago, 3731 N Clifton Ave, Chicago, IL 60613, USA. justinboike@gmail.com
authors: J R
authors: JR
authors: Boike
authors: R
authors: R
authors: Kao
authors: D
authors: D
authors: Meyer
authors: B
authors: B
authors: Markle
authors: J
authors: J
authors: Rosenberg
authors: J
authors: J
authors: Niebruegge
authors: A C
authors: AC
authors: Stein
authors: J
authors: J
authors: Berkes
authors: J L
authors: JL
authors: Goldstein
mesh_terms: D000082:Acetaminophen / Q000009:adverse effects*; D000293:Adolescent; D000328:Adult; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000009:adverse effects*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D001241:Aspirin / Q000009:adverse effects*; D004311:Double-Blind Method; D004338:Drug Combinations; D004347:Drug Interactions; D004381:Duodenal Ulcer / Q000139:chemically induced*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D013223:Statistics as Topic; D013276:Stomach Ulcer / Q000139:chemically induced*; D055815:Young Adult
chemical_list: D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D000082:Acetaminophen; D001241:Aspirin