Do patients with sore throat benefit from penicillin? A randomized double-blind placebo-controlled clinical trial with penicillin V in general practice.
BACKGROUND
The effect of antibiotic therapy in sore throat is questionable and this dilemma has been complicated by the emergence of multiple resistant strains of micro-organisms.


OBJECTIVE
A randomized double-blind placebo-controlled clinical trial was undertaken in patients aged 4-60 years to assess the efficacy of penicillin V on the clinical course and bacteriological response in patients with sore throat in general practice.


METHODS
Two hundred and thirty-nine patients presenting with an acute sore throat to 37 general practices in the Netherlands who were clinically suspected of group A beta-haemolytic streptococci (GABHS) were randomized for treatment with penicillin V (n = 121) or placebo (n = 118). Resolution of sore throat, fever and return to daily activities were evaluated by the general practitioner 2 days after the start of treatment and by the patients keeping a diary for 7 days. The result of throat culture after 2 days was evaluated.


RESULTS
A difference in resolution of sore throat was present after 2 days in all patients, but was a result of GABHS-positive patients (n = 111; 46%) in favour of those randomized for penicillin V (adjusted odds ratio 5.3; 95% CI 1.9-15.1). An effect in the course of fever was also seen in GABHS-positive patients (adjusted odds ratio 5.3; 95% CI 1.02-27.7). A difference of 1-2 days was seen in clinical recovery. No difference was found in daily activities between the treatment groups. After 2 days, 4% of the penicillin-treated patients harboured GABHS compared with 75% of the placebo group.


CONCLUSIONS
Only GABHS-positive patients benefit from penicillin V in their clinical cure in the first few days. Therefore, rapid testing is necessary. Treatment may be beneficial with regard to the clinical course, but it is not necessary.
Dagnelie
C F
CF
Department of General Practice, University of Utrecht, The Netherlands.
van der Graaf
Y
Y
De Melker
R A
RA
D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005194:Family Practice; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010404:Penicillin V / Q000494:pharmacology / Q000627:therapeutic use*; D010406:Penicillins / Q000627:therapeutic use*; D010612:Pharyngitis / Q000188:drug therapy*; D013290:Streptococcal Infections / Q000188:drug therapy*; D013297:Streptococcus pyogenes; D016896:Treatment Outcome
D010406:Penicillins; D010404:Penicillin V