CPS Research, Glasgow, UK.
BMC Fam Pract. 2011 Feb 18;12:6. doi: 10.1186/1471-2296-12-6.
Clinically 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.
In 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.
Both 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.
AMC/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.
ISRCTN: ISRCTN00003567.
在急性咽痛的自我管理中，经过临床验证的非处方（OTC）治疗选择变得越来越重要。本研究的目的是确定两种不同的邻甲氨基酚/2,4-二氯苯甲醇（AMC/DCBA）润喉片制剂变体，即 AMC/DCBA 温喉片和 AMC/DCBA 凉喉片，与无味、非药物的安慰剂喉片相比，在缓解上呼吸道感染引起的急性咽痛方面的镇痛和感官益处。
在这项多中心、随机、双盲、单次剂量研究中，225 名患有急性咽痛的成年患者被随机分配接受一种 AMC/DCBA 温喉片（n = 77）、一种 AMC/DCBA 凉喉片（n = 74）或一种无味、非药物的喉片（大小、形状和消泡剂匹配；n = 74）。在基线评估后，患者接受他们分配的含片，并在给药后 1 至 120 分钟内的 11 个时间点完成 4 次评分评估。通过比较咽喉疼痛严重程度和咽喉疼痛缓解评分来评估镇痛特性。还评估了吞咽困难、咽喉麻木、功能、感官和情感益处。
与无味、非药物的含片相比，AMC/DCBA 温喉片和 AMC/DCBA 凉喉片均能显著缓解疼痛、改善功能、感官和情感。在 1-5 分钟内观察到咽喉疼痛缓解、咽喉疼痛改善和吞咽困难减轻以及咽喉麻木，并且在给药后长达 2 小时内仍能观察到这些效果。与 AMC/DCBA 温喉片相关的温暖感觉和与 AMC/DCBA 凉喉片相关的凉爽感觉的感官益处，在首次服用后即可立即感受到，而对于后者，在含片溶解后很长时间仍能感受到。服用任何一种 AMC/DCBA 润喉片变体的患者均报告感觉更好、更快乐、注意力不那么分散和不那么沮丧的情感益处，与无味、非药物的含片相比，不良反应无差异。
AMC/DCBA 温喉片和 AMC/DCBA 凉喉片是耐受良好且有效的 OTC 治疗选择，为急性咽痛患者提供了功能、感官和情感益处，超过了快速疗效的作用。
ISRCTN：ISRCTN00003567。
