Efficacy and safety of Kegan Liyan oral liquid for patients with acute pharyngitis: A randomized, double-blinded, placebo-controlled, multi-center trial

Abstract

BackgroundAlleviating the sore throat caused by acute pharyngitis is a primary patient concern. However, antibiotics are not commonly recommended drugs, and abuse can lead to serious consequences such as drug resistance. Therefore, seeking alternative treatments is necessary. PurposeTo investigate the efficacy and safety of Kegan Liyan (KGLY) oral liquid for patients with acute pharyngitis. Study designRandomized, double-blinded, placebo-controlled, multi-center study. MethodsParticipants from 17 hospitals were randomly assigned 1:1 to receive KGLY oral liquid or placebo for five days. Assessments occurred at baseline, day 3, and day 6. The primary outcome was the recovery rate. Secondary outcomes included sore throat and cough visual analogue scale (VAS), the area under the curve (AUC) of sore throat VAS, time to sore throat relief and recovery, proportion of participants with sore throat relief and recovery, traditional Chinese medicine (TCM) syndrome score, single TCM manifestation score and use of acetaminophen. ResultsInvolving 239 participants (120 in KGLY and 119 in placebo group), the study found a significantly higher recovery rate on day 6 in the KGLY group (between-group difference, 27.20 % [15.00 % to 39.40 %], p < 0.001). On day 3 and 6, the KGLY group showed significantly larger reductions in sore throat (–3.02 vs –2.37, p = 0.001; –4.66 vs –3.64, p < 0.001) and cough VAS scores (–1.55 vs –1.05, p = 0.004; –2.28 vs –1.56, p < 0.001) from baseline. KGLY oral liquid lowered the AUC of sore throat VAS score (–2.33 [–4.10 to –0.56], p = 0.011), shortened time to sore throat recovery (hazard ratio, 0.42 [0.30 to 0.59], p < 0.001), increased sore throat recovery rate at day 6 (75.00 % vs 42.86 %, p < 0.001), decreased the TCM syndrome score (–2.03 [–2.69 to –1.37], p < 0.001), and improved individual TCM symptoms compared to placebo. No significant differences between the groups in acetaminophen usage. KGLY oral liquid was safe and tolerated. ConclusionKGLY oral liquid may be a beneficial and safe alternative treatment for acute pharyngitis, which can alleviate symptoms such as sore throat, swollen throat, cough, and phlegm production.