Comparing the efficacy and safety of atomization of traditional Chinese medicine Kai Hou Jian and budesonide suspension in adult acute laryngitis: a randomized control trial

BACKGROUND: Kai Hou Jian has an outstanding therapeutic effect and clinical use against pharyngeal infection for many years, while a few studies reported it also had an effect in laryngitis. This study aimed to evaluate the efficacy and safety of short-course oral inhalation of traditional Chinese medicine Kai Hou Jian in adults with acute laryngitis. METHODS: A total of 86 patients with acute laryngitis who met the inclusion criteria were randomly assigned according to the random number table method into a Kai Hou Jian treatment group or a budesonide control group. Patients received 2.5 mL of Kai Hou Jian via transoral atomization twice daily for 1 week, while the control group received budesonide nebulization (1 mg, bid) for 1 week. The change of symptoms scores of acute laryngitis and laryngoscopy scores before and after treatment were performed to value the effect of Kai Hou Jian and the safety was assessed by the patient's discomfort and the incidence and self-reported adverse events during treatment. RESULTS: The symptoms of acute laryngitis were significantly reduced in patients treated with Kai Hou Jian on day-3. Forty-two patients from the Kai Hou Jian and 40 patients from budesonide treated groups both experienced notable clinical improvement after 1 week. There was no difference in the two groups at the baseline. For individual symptoms, Kai Hou Jian could significantly improve sore throat [95% confidence interval (CI): –1.81 to –0.14, P=0.03], while budesonide yielded better improvement in hoarseness (95% CI: 0.67 to 0.20, P=0.001). For laryngoscopic parameters, the scores of laryngeal mucosa were significantly decreased in both groups from baseline, and there were no statistical differences in vocal cord hyperemia, edema, sputum congestion, edema, mucus adhesion, or epiglottic congestion between the groups after 1 week. We also found that the treatment of Kai Hou Jian nebulization could reduce the extent or range of vocal cord leukoplakia after 1 week. CONCLUSIONS: The short-course treatment of Kai Hou Jian atomization had significant effect in improving adult acute laryngitis and it was also possibly exhibiting a positive effect on vocal cord leukoplakia. TRIAL REGISTRATION: Chinese Clinical Trial Registry identifier: ChiCTR1900026660.