Is acetaminophen as effective as an antihistamine-decongestant-acetaminophen combination in relieving symptoms of acute nasopharyngitis in children? A randomised, controlled trial.
OBJECTIVE
To determine the efficiency of drugs, which include antihistaminic-decongestant-acetaminophen agents versus only acetaminophen in symptomatic treatment of acute nasopharyngitis in children.


METHODS
This clinical, randomized, controlled, single blind drug efficacy comparison research was conducted in 148 patients with acute nasopharyngitis between ages 2 and 12 years. After randomization, Group-1 consisted of cases (n: 86), which used OTC drugs [acetaminophen+diphenhydramine+pseudoephedrin] and Group-2 consisted of cases (n: 62), which used only acetaminophen. After receiving nasal swab for showing the viral etiology, symptoms were scored clinically on admission and then on 10 days follow-up period, and re-evaluated on the third and fifth days of the drug therapy with the same scoring scale. Any complications were noted during the 1-month follow-up period after taking the drugs.


RESULTS
The virus isolation rate in Group-1 was 27.9% and in Group-2 was 22.6%. At the first day of study, before medication, clinic scores of the groups did not show a significant difference (Group-1 1.7 versus Group-2 2.0). Clinic scores in both groups on the third (Group-1 4.0 versus Group-2 4.1) and fifth days of therapy (Group-1 1.7 versus Group-2 2.0) were not different either. Also, the complication rate was not different during the 1-month follow-up period (Group-1 2.3% versus Group-2 8.0%, p: 0.12). The family response for the drug satisfaction in both groups was similar and positive.


CONCLUSIONS
For relieving symptoms of acute nasopharyngitis in children, acetaminophen without any combination is as effective as OTC drugs containing acetaminophen, decongestant, and antihistaminics.
Unuvar
Emin
E
Department of Pediatrics, Istanbul University, Istanbul Medical Faculty, Capa, TR-34390, Istanbul, Turkey. eunuvar@superonline.com
Yildiz
Ismail
I
Kilic
Ayse
A
Toprak
Sadik
S
Aslan
Seyhan Selvi
SS
Aydin
Salih
S
Badur
Selim
S
Oguz
Fatma
F
Sidal
Mujgan
M
D000082:Acetaminophen / Q000627:therapeutic use*; D000208:Acute Disease; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004155:Diphenhydramine / Q000627:therapeutic use*; D004338:Drug Combinations; D004809:Ephedrine / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D014663:Nasal Decongestants / Q000627:therapeutic use*; D009304:Nasopharyngitis / Q000188:drug therapy*; D004366:Nonprescription Drugs / Q000627:therapeutic use*; D014662:Vasoconstrictor Agents / Q000627:therapeutic use*
D018712:Analgesics, Non-Narcotic; D004338:Drug Combinations; D006634:Histamine H1 Antagonists; D014663:Nasal Decongestants; D004366:Nonprescription Drugs; D014662:Vasoconstrictor Agents; D000082:Acetaminophen; D004155:Diphenhydramine; D004809:Ephedrine