A multicentre, randomised, double-blind, single-dose study assessing the efficacy of AMC/DCBA Warm lozenge or AMC/DCBA Cool lozenge in the relief of acute sore throat

Abstract

BackgroundClinically proven over-the-counter (OTC) treatment options are becoming increasingly important in the self-management of acute sore throat. The aim of this study was to determine the analgesic and sensorial benefits of two different amylmetacresol/2,4-dichlorobenzyl alcohol (AMC/DCBA) throat lozenge formulation variants, AMC/DCBA Warm lozenge and AMC/DCBA Cool lozenge, compared with an unflavoured, non-medicated placebo lozenge in the relief of acute sore throat due to upper respiratory tract infections.MethodsIn this multicentre, randomised, double-blind, single-dose study, 225 adult patients with acute sore throat were randomly assigned to receive either one AMC/DCBA Warm lozenge (n = 77), one AMC/DCBA Cool lozenge (n = 74) or one unflavoured, non-medicated lozenge (matched for size, shape and demulcency; n = 74). After baseline assessments, patients received their assigned lozenge and completed four rating assessments at 11 timepoints from 1 to 120 minutes post dose. Analgesic properties were assessed by comparing severity of throat soreness and sore throat relief ratings. Difficulty in swallowing, throat numbness, functional, sensorial and emotional benefits were also assessed.ResultsBoth the AMC/DCBA Warm and AMC/DCBA Cool lozenge induced significant analgesic, functional, sensorial and emotional effects compared with the unflavoured, non-medicated lozenge. Sore throat relief, improvements in throat soreness and difficulty in swallowing, and throat numbness were observed as early as 1-5 minutes, and lasted up to 2 hours post dose. Sensorial benefits of warming and cooling associated with the AMC/DCBA Warm and AMC/DCBA Cool lozenge, respectively, were experienced soon after first dose, and in the case of the latter, it lasted long after the lozenge had dissolved. Emotional benefits of feeling better, happier, less distracted and less frustrated were reported in those taking either of the AMC/DCBA throat lozenge variants, with no differences in adverse events compared with the unflavoured, non-medicated lozenge.ConclusionsAMC/DCBA Warm and AMC/DCBA Cool lozenges are well-tolerated and effective OTC treatment options, offering functional, sensorial and emotional benefits to patients with acute sore throat, over and above that of the rapid efficacy effects provided.Trial registrationISRCTN: ISRCTN00003567

Flurbiprofen microgranules for relief of sore throat: a randomised, double-blind trial

“…The outcome measures were throat soreness (11-point ordinal scale; 0 = not sore and 10 = very sore), 9 difficulty in swallowing (100 mm visual analogue scale [VAS]), 12 sore throat pain intensity (100 mm VAS), 11 and sore throat relief (7-point sore throat relief scale, 0 = no relief to 6 = complete relief). 9 These were assessed at 1 minute before the first dose (with exception of sore throat relief), at 1 minute after the first dose, at 5-minute intervals up to 15 minutes, then at 15-minute intervals up to 180 minutes and hourly up to 360 minutes after the first dose.…”

A combination of topical antiseptics for the treatment of sore throat blocks voltage-gated neuronal sodium channels

“…At a holding potential of −70 mV, the effects of AMC/DCBA are less pronounced in comparison to the effects of AMC/lidocaine. AMC/DCBA is a fixed and effective combination in overthe-counter lozenges for the treatment of acute sore throat (Wade et al 2011;McNally et al 2010). Therefore, we investigated the blocking potency of AMC/DCBA with the hypothesis that addition of DCBA to AMC might increase the local anaesthetic effects of AMC.…”

“…A randomised controlled trial on 310 patients showed a significant analgesic effect and improvements in functional impairment scores by use of these pastilles (Wade et al 2011;McNally et al 2010). Recent studies from our group have led to the theory that such pain relief was not merely as a result of an antiseptic action-a possible blocking effect of voltage-gated sodium channels was considered to be a contributing factor and a viable mechanistic pathway (Buchholz et al 2009).…”

Efficacy and safety of a triple active sore throat lozenge in the treatment of patients with acute pharyngitis: Results of a multi-centre, randomised, placebo-controlled, double-blind, parallel-group trial (DoriPha)

“…: In reviewing placebo‐controlled efficacy trials of lozenges in patients with acute pharyngitis based on a PubMed literature search for “lozenge AND pharyngitis AND randomized controlled trial” (Table 5), we conclude non‐steroidal anti‐inflammatory drugs (NSAIDs) and topical analgesics can provide short‐term pain relief within 1‐2 hours in comparison with placebo. However, these trials frequently did not address complete remission or failed in detecting superiority over placebo over the course of 3‐4 days ‐ often explained by the natural improvement in the disease in a few days 23, 24, 25…”