title: Ibuprofen, paracetamol, and steam for patients with respiratory tract infections in primary care: pragmatic randomised factorial trial.
abstract: OBJECTIVE
  To assess strategies for advice on analgesia and steam inhalation for respiratory tract infections.
  
  
  METHODS
  Open pragmatic parallel group factorial randomised controlled trial.
  
  
  METHODS
  Primary care in United Kingdom.
  
  
  METHODS
  Patients aged ≥ 3 with acute respiratory tract infections.
  
  
  METHODS
  889 patients were randomised with computer generated random numbers in pre-prepared sealed numbered envelopes to components of advice or comparator advice: advice on analgesia (take paracetamol, ibuprofen, or both), dosing of analgesia (take as required v regularly), and steam inhalation (no inhalation v steam inhalation).
  
  
  RESULTS
  Primary: mean symptom severity on days 2-4; symptoms rated 0 (no problem) to 7 (as bad as it can be). Secondary: temperature, antibiotic use, reconsultations.
  
  
  RESULTS
  Neither advice on dosing nor on steam inhalation was significantly associated with changes in outcomes. Compared with paracetamol, symptom severity was little different with ibuprofen (adjusted difference 0.04, 95% confidence interval -0.11 to 0.19) or the combination of ibuprofen and paracetamol (0.11, -0.04 to 0.26). There was no evidence for selective benefit with ibuprofen among most subgroups defined before analysis (presence of otalgia; previous duration of symptoms; temperature >37.5 °C; severe symptoms), but there was evidence of reduced symptoms severity benefit in the subgroup with chest infections (ibuprofen -0.40, -0.78 to -0.01; combination -0.47; -0.84 to -0.10), equivalent to almost one in two symptoms rated as a slight rather than a moderately bad problem. Children might also benefit from treatment with ibuprofen (ibuprofen: -0.47, -0.76 to -0.18; combination: -0.04, -0.31 to 0.23). Reconsultations with new/unresolved symptoms or complications were documented in 12% of those advised to take paracetamol, 20% of those advised to take ibuprofen (adjusted risk ratio 1.67, 1.12 to 2.38), and 17% of those advised to take the combination (1.49, 0.98 to 2.18). Mild thermal injury with steam was documented for four patients (2%) who returned full diaries, but no reconsultations with scalding were documented.
  
  
  CONCLUSIONS
  Overall advice to use steam inhalation, or ibuprofen rather than paracetamol, does not help control symptoms in patients with acute respiratory tract infections and must be balanced against the possible progression of symptoms during the next month for a minority of patients. Advice to use ibuprofen might help short term control of symptoms in those with chest infections and in children.
  
  
  BACKGROUND
  ISRCTN 38551726.
authors.affiliation: University of Southampton, Aldermoor Health Centre, Southampton SO16 5ST, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Little
authors.forename: Michael
authors.initials: M
authors.lastname: Moore
authors.forename: Joanne
authors.initials: J
authors.lastname: Kelly
authors.forename: Ian
authors.initials: I
authors.lastname: Williamson
authors.forename: Geraldine
authors.initials: G
authors.lastname: Leydon
authors.forename: Lisa
authors.initials: L
authors.lastname: McDermott
authors.forename: Mark
authors.initials: M
authors.lastname: Mullee
authors.forename: Beth
authors.initials: B
authors.lastname: Stuart
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance / Q000706:statistics & numerical data; D011320:Primary Health Care / Q000379:methods*; D016016:Proportional Hazards Models; D012138:Respiratory Therapy / Q000009:adverse effects / Q000379:methods*; D012141:Respiratory Tract Infections / Q000628:therapy*; D012720:Severity of Illness Index; D013227:Steam / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018712:Analgesics, Non-Narcotic; D013227:Steam; D000082:Acetaminophen; D007052:Ibuprofen