title: Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlled trial.
abstract: BACKGROUND
  The common cold and other viral airway infections are highly prevalent in the population, and their treatment often requires the use of medications for symptomatic relief. Paracetamol is as an analgesic and antipyretic; chlorphenamine is an antihistamine; and phenylephrine, a vasoconstrictor and decongestant. This randomized, double-blind, placebo-controlled trial sought to evaluate the efficacy and safety of a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine in the symptomatic treatment of the common cold and flu-like syndrome in adults.
  
  
  METHODS
  This study enrolled 146 individuals aged 18 to 60 years who had moderate to severe flu-like syndrome or common cold. After clinical examination and laboratory tests, individuals were randomly assigned to receive the fixed-dose combination (73) or placebo (73), five capsules per day for 48 to 72 hours. The primary efficacy endpoint was the sum of the scores of 10 symptoms on a four-point Likert-type scale. To evaluate treatment safety, the occurrence of adverse events was also measured.
  
  
  RESULTS
  Mean age was 33.5 (±9.5) years in the placebo group and 33.8 (±11.5) in the treatment group. There were 55 women and 18 men in the placebo group, and 46 women and 27 men in the treatment group. Comparison of overall symptom scores in the two groups revealed a significantly greater reduction in the treatment group than in the placebo group (p = 0.015). Analysis at the first 13 dose intervals (± 66 h of treatment) showed a greater reduction of symptom scores in the treatment group than in the placebo group (p < 0.05). The number and distribution of adverse events were similar in both groups.
  
  
  CONCLUSIONS
  A fixed-dose combination of paracetamol, chlorphenamine and phenylephrine was safe and more effective than placebo in the symptomatic treatment of the common cold or flu-like syndrome in adults.
  
  
  BACKGROUND
  NCT01389518.
authors.affiliation: Department of Internal Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil. paulopicon@gmail.com.
authors.forename: Paulo Dornelles
authors.initials: PD
authors.lastname: Picon
authors.forename: Marisa Boff
authors.initials: MB
authors.lastname: Costa
authors.forename: Rafael
authors.initials: R
authors.lastname: da Veiga Picon
authors.forename: Lucia Costa Cabral
authors.initials: LC
authors.lastname: Fendt
authors.forename: Maurício Leichter
authors.initials: ML
authors.lastname: Suksteris
authors.forename: Indara Carmanim
authors.initials: IC
authors.lastname: Saccilotto
authors.forename: Alicia Dorneles
authors.initials: AD
authors.lastname: Dornelles
authors.forename: Luis Felipe Carissimi
authors.initials: LF
authors.lastname: Schmidt
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D002744:Chlorpheniramine / Q000008:administration & dosage*; D003139:Common Cold / Q000188:drug therapy*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010656:Phenylephrine / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D010656:Phenylephrine; D000082:Acetaminophen; D002744:Chlorpheniramine