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Bacteriology and treatment of purulent nasopharyngitis: a double blind, placebo-controlled evaluation
Insights
Antibiotics and decongestants did not improve purulent nasopharyngitis in children. Pseudoephedrine/triprolidine caused more side effects than placebo, indicating no routine treatment benefit without further evidence.
Area of Science:
- Pediatrics
- Infectious Diseases
- Pharmacology
Background:
- Purulent nasopharyngitis is common in children.
- The efficacy of antibiotics and decongestant/antihistamine combinations for this condition is not well-established.
- Common pathogens include Streptococcus pneumoniae and Haemophilus influenzae type b.
Purpose of the Study:
- To evaluate the therapeutic benefit of cephalexin alone or combined with pseudoephedrine/triprolidine in children with purulent nasopharyngitis.
- To assess the impact of these treatments on bacterial cultivation and clinical outcomes.
- To determine the side effect profile of the active treatments compared to placebo.
Main Methods:
- A randomized controlled trial involving 142 children with purulent nasopharyngitis.
- Four treatment groups: cephalexin alone, cephalexin with pseudoephedrine/triprolidine, and their respective placebos.
- Evaluations included clinical assessments and bacteriologic cultures after 5-6 days of therapy.
Main Results:
- No significant differences in clinical improvement (nasal discharge, complications, perceived benefit) were observed between active treatment and placebo groups.
- Cephalexin did not reduce the presence of pathogenic organisms in the nasopharynx.
- Pseudoephedrine/triprolidine was associated with a significantly higher incidence of side effects compared to placebo.
Conclusions:
- Current antibiotic and decongestant/antihistamine treatments offer no proven therapeutic benefit for purulent nasopharyngitis in children.
- The combination of pseudoephedrine/triprolidine carries a risk of increased side effects.
- Routine culture and treatment for purulent nasopharyngitis are not recommended without demonstrated clinical efficacy in further trials.
Abstract:
One hundred forty-two children with purulent nasopharyngitis were randomized to four treatment groups with an antibiotic (cephalexin) alone or combined with a decongestant/antihistamine (pseudoephedrine/triprolidine) or their corresponding placebo equivalents. Follow-up evaluations by parents and physicians and bacteriologic evaluations were performed after 5 to 6 days of therapy. Groups were comparable with regard to age, sex, race, number of patients withdrawn from the study, fever greater than 38.0 degrees C, appearance of nasal discharge, nasal crusting and number of days until follow-up. Initial cultures from patients grew: Streptococcus pneumoniae, 46%; Haemophilus influenzae type b, 21%; and Streptococcus pyogenes, 8%. Nasal crusting was significantly associated with the growth of S. pneumoniae or H. influenzae type b. There were no significant differences between active drug and placebo treatment groups for change in nasal discharge, complications or apparent drug benefit. Cephalexin therapy did not result in a decrease in cultivation of pathogenic organisms from the nasopharynx. Significantly more side effects were attributed to pseudoephedrine/triprolidine treatment than to placebo. Routine culture or treatment of purulent nasopharyngitis should not be considered unless future controlled clinical trials demonstrate some therapeutic benefit.