Fig: Pharyngotonsillitis
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OBJECTIVE
To determine whether total
exposure to penicillin V can be reduced while maintaining adequate clinical
efficacy when treating pharyngotonsillitis caused by group A streptococci.
DESIGN
Open label, randomised controlled
non-inferiority study.
SETTING
17 primary healthcare centres in
Sweden between September 2015 and February 2018.
PARTICIPANTS
Patients aged 6 years and over
with pharyngotonsillitis caused by group A streptococci and three or four
Centor criteria (fever ≥38.5°C, tender lymph nodes, coatings of the tonsils,
and absence of cough).
INTERVENTIONS
Penicillin V 800 mg four times
daily for five days (total 16 g) compared with the current recommended dose of
1000 mg three times daily for 10 days (total 30 g).
MAIN OUTCOME MEASURES
Primary outcome was clinical cure
five to seven days after the end of antibiotic treatment. The non-inferiority
margin was prespecified to 10 percentage points. Secondary outcomes were
bacteriological eradication, time to relief of symptoms, frequency of relapses,
complications and new tonsillitis, and patterns of adverse events.
RESULTS
Patients (n=433) were randomly
allocated to the five day (n=215) or 10 day (n=218) regimen. Clinical cure in
the per protocol population was 89.6% (n=181/202) in the five day group and
93.3% (n=182/195) in the 10 day group (95% confidence interval -9.7 to 2.2).
Bacteriological eradication was
80.4% (n=156/194) in the five day group and 90.7% (n=165/182) in the 10 day
group. Eight and seven patients had relapses, no patients and four patients had
complications, and six and 13 patients had new tonsillitis in the five day and
10 day groups, respectively.
Time to relief of symptoms was
shorter in the five day group. Adverse events were mainly diarrhoea, nausea,
and vulvovaginal disorders; the 10 day group had higher incidence and longer
duration of adverse events.
CONCLUSIONS
Penicillin V four times daily for
five days was non-inferior in clinical outcome to penicillin V three times
daily for 10 days in patients with pharyngotonsillitis caused by group A
streptococci. The number of relapses and complications did not differ between
the two intervention groups.
Five day treatment with
penicillin V four times daily might be an alternative to the currently recommended
10 day regimen.
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