Efficacy of a benzocaine lozenge in the treatment of uncomplicated sore throat.
Author(s): Chrubasik S, Beime B, Magora F.
Affiliation(s): Institute of Forensic Medicine, University of Freiburg, Albertstr. 9, 79104,
Freiburg, Germany. sigrun.chrubasik@klinikum.uni-freiburg.de
Publication date & source: 2012, Eur Arch Otorhinolaryngol. , 269(2):571-7
Benzocaine lozenges are popular in symptomatic treatment of acute sore throat.
The aim of this study was to evaluate if sucking a benzocaine lozenge was
superior to a placebo lozenge in patients with pain while swallowing. Volunteers
with acute, uncomplicated sore throat received randomly and double-blind either a
benzocaine 8 mg or a placebo lozenge. Pain was assessed on a numerical visual
rating scale. The primary outcome measure was the sum of the pain intensity
differences (SPID) over 2 h. Secondary outcome measures included the number of
patients who reported 50% or more of their baseline pain score (responders) and
those with worthwhile and complete pain relief, the times to worthwhile/complete
pain relief and to pain recurrence and the occurrence of any adverse effects. A
predefined interim analysis after including 50 patients revealed the superiority
of benzocaine versus placebo in the SPID (p = 0.0086). At this time, a total of
165 patients had been recruited (full analysis set, FAS) and underwent
statistical analysis. In the FAS, median SPID had significantly more decreased in
patients receiving benzocaine compared to placebo (-12 vs. - 5, p = 0.001). There
were significantly more responders and patients with worthwhile pain relief in
group benzocaine. The number of patients with complete pain relief was very
small. Median time to worthwhile pain relief was 20 min (benzocaine) and >45 min
(placebo). Adverse events were not observed. Benzocaine lozenges are superior to
placebo lozenges and a useful, well-tolerated treatment option to reduce painful
pharyngeal discomfort.
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