title: Systemic corticosteroid monotherapy for clinically diagnosed acute rhinosinusitis: a randomized controlled trial.
abstract: BACKGROUND
  Patients with acute rhinosinusitis are frequently encountered in primary care. Although corticosteroids are being increasingly used for symptom control, evidence supporting their use is inconclusive. We conducted a randomized controlled trial to examine the effectiveness of systemic corticosteroid monotherapy for clinically diagnosed, uncomplicated acute rhinosinusitis.
  
  
  METHODS
  We conducted a block-randomized, double-blind, placebo-controlled clinical trial at 54 primary care practices (68 family physicians) in the Netherlands between Dec. 30, 2008, and Apr. 28, 2011. Adult patients with clinically diagnosed acute rhinosinusitis were randomly assigned to receive either prednisolone 30 mg/d or placebo for 7 days and asked to complete a symptom diary for 14 days. The primary outcome measure was the proportion of patients with resolution of facial pain or pressure on day 7.
  
  
  RESULTS
  Of the 185 patients included in the trial (93 in the treatment group, 92 in the placebo group), 2 withdrew from the study and 9 were excluded from the primary analysis because of incomplete symptom reporting. The remaining 174 patients (88 in the treatment group, 86 in the placebo group) were included in the intention-to-treat analysis. The proportions of patients with resolution of facial pain or pressure on day 7 were 62.5% (55/88) in the prednisolone group and 55.8% (48/86) in the placebo group (absolute risk difference 6.7%, 95% confidence interval -7.9% to 21.2%). The groups were similar with regard to the decrease over time in the proportion of patients with total symptoms (combined symptoms of runny nose, postnasal discharge, nasal congestion, cough and facial pain) and health-related quality of life. Adverse events were mild and did not differ significantly between the groups.
  
  
  CONCLUSIONS
  Systemic corticosteroid monotherapy had no clinically relevant beneficial effects among patients with clinically diagnosed acute rhinosinusitis. Netherlands Trial Register registration no. 1295 (www.trialregister.nl/trialreg/index.asp).
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands. r.p.venekamp@umcutrecht.nl
authors.forename: Roderick P
authors.initials: RP
authors.lastname: Venekamp
authors.forename: Marc J M
authors.initials: MJ
authors.lastname: Bonten
authors.forename: Maroeska M
authors.initials: MM
authors.lastname: Rovers
authors.forename: Theo J M
authors.initials: TJ
authors.lastname: Verheij
authors.forename: Alfred P E
authors.initials: AP
authors.lastname: Sachs
mesh_terms: D000208:Acute Disease; D000328:Adult; D004311:Double-Blind Method; D005157:Facial Pain / Q000188:drug therapy / Q000209:etiology; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D011239:Prednisolone / Q000627:therapeutic use*; D011788:Quality of Life; D012220:Rhinitis / Q000150:complications / Q000188:drug therapy*; D012852:Sinusitis / Q000150:complications / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D017211:Treatment Failure
chemical_list: D005938:Glucocorticoids; D011239:Prednisolone