Department of Surgery, College of Medicine, Tikrit University, Tikrit, 34001, Iraq.
Department of Pharmacology and Toxicology, College of Pharmacy, University of Anbar, Ramadi, 31001, Iraq.
Am J Otolaryngol. 2021 Sep-Oct;42(5):103033. doi: 10.1016/j.amjoto.2021.103033. Epub 2021 Apr 7.
Anosmia is a common debilitating symptom of the novel coronavirus disease 2019 (COVID-19). Currently, there is no satisfactory treatment of anosmia. Therefore, this study was conducted to evaluate the therapeutic effect of nasal betamethasone drops in the recovery of olfaction in COVID-19-associated anosmia.
The study was designed as a randomised, double-blind, placebo-controlled clinical trial. In total, 276 PCR-confirmed COVID-19 patients who were presented to the outpatient clinic with anosmia were enrolled in the study. In the betamethasone group, 138 participants received nasal drops of betamethasone 3 times daily until recovery for a maximum of one month. Similar dose of 9% NaCl drops was administered to 138 participants in the placebo group.
The median age of participants was 29 years (IQR 23-37). Among them, 198 (71.7%) were females. Ageusia was co-presented with anosmia in 234 (84.8%) of participants. In this study, 83% of participants had recovered from anosmia within 30 days, with a median recovery time of 13 days (IQR 8-18). Compared to placebo, nasal application of betamethasone drops has no significant effect on the recovery time of anosmia (hazard ratio 0.88; 95% CI 0.68-1.14; P = 0.31).
The use of nasal betamethasone to facilitate the recovery time of acute anosmia is not advised. In addition, age, smoking status, the duration of anosmia at presentation, and the co-presentation of ageusia with anosmia are important determinant covariates for the recovery time of anosmia. Further clinical trials, which take these covariates into account, will need to be undertaken. The trail has been registered at ClinicalTrails.gov, NCT04569825.
嗅觉丧失是新型冠状病毒病 2019（COVID-19）的一种常见致残症状。目前，对嗅觉丧失尚无满意的治疗方法。因此，本研究旨在评估鼻用倍他米松滴注治疗 COVID-19 相关嗅觉丧失恢复的疗效。
本研究设计为随机、双盲、安慰剂对照的临床试验。共纳入 276 例经 PCR 确诊的 COVID-19 门诊嗅觉丧失患者。在倍他米松组，138 例患者每天接受鼻用倍他米松 3 次滴注，直至嗅觉恢复，最长不超过 1 个月。在安慰剂组，138 例患者接受相同剂量的 9%生理盐水滴注。
参与者的中位年龄为 29 岁（IQR 23-37）。其中，198 例（71.7%）为女性。234 例（84.8%）患者同时出现味觉丧失和嗅觉丧失。在这项研究中，83%的参与者在 30 天内恢复嗅觉，中位恢复时间为 13 天（IQR 8-18）。与安慰剂相比，鼻用倍他米松滴注对嗅觉丧失的恢复时间无显著影响（风险比 0.88；95%CI 0.68-1.14；P=0.31）。
不建议使用鼻用倍他米松来促进急性嗅觉丧失的恢复时间。此外，年龄、吸烟状况、嗅觉丧失出现时的持续时间以及味觉丧失与嗅觉丧失同时出现是嗅觉丧失恢复时间的重要决定因素协变量。需要进一步开展考虑这些协变量的临床试验。该试验已在 ClinicalTrails.gov 注册，NCT04569825。
