Randomized clinical trial "olfactory dysfunction after COVID-19: olfactory rehabilitation therapy vs. intervention treatment with Palmitoylethanolamide and Luteolin": preliminary results
Randomized clinical trial "olfactory dysfunction after COVID-19: olfactory rehabilitation therapy vs. intervention treatment with Palmitoylethanolamide and Luteolin": preliminary results
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DOI：
10.26355/eurrev_202106_26059
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发表时间：
2021-01-01
影响因子：
3.3
通讯作者：
Di Stadio, A.
中科院分区：
文献类型：
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作者：
D'Ascanio, L.;Vitelli, F.;Di Stadio, A.
目的：大约30%的确诊COVID-19患者报告持续性嗅觉或味觉障碍是长期感染后遗症。严重急性呼吸道综合征冠状病毒2型（SARS-CoV-2）感染与嗅球的炎症变化相关，假设具有抗炎特性的治疗可减轻病毒损伤并促进感染后嗅觉的恢复。我们的研究调查了棕榈酰乙醇胺（PEA）和木犀草素补充剂对COVID-19患者嗅觉恢复的有效性。患者和方法：我们对有确诊COVID-19病史的门诊患者进行了一项随机对照的初步研究，这些患者在SARS-CoV-2阴性检测后持续>= 90天的感染后嗅觉障碍。患者被随机分为两组，一组每天两次单独进行嗅觉康复治疗，另一组每周进行嗅觉康复治疗，每天口服补充PEA和木犀草素。排除了既存嗅觉障碍的受试者。在基线和治疗后30天进行Sniffin' Sticks评估。关于性别、年龄的数据。和自感染以来的时间。采用Kruskal-Wallis（KW）检验比较不同时间组间Sniff评分的差异，并计算斯皮尔曼相关系数以评估Sniff评分与性别或感染持续时间之间的相关性。（n=7，补充：n=5，对照组），接受补充剂的患者在嗅觉阈值，辨别力，和识别评分与对照组相比（p=0.01）。自感染以来的时间呈负相关，与嗅Score，并没有相关性gender.CONCLUSIONS：治疗相结合的嗅觉康复与口服补充PEA和木犀草素与改善嗅觉功能的恢复。在那些长期嗅觉功能障碍的患者中最明显。进一步的研究是必要的，以复制这些发现，并确定是否早期干预，包括嗅觉康复和PEA+木犀草素口服补充剂可能会防止SARS-CoV-2相关的嗅觉障碍。
OBJECTIVE: Approximately 30% of patients with confirmed COVID-19 report persistent smell or taste disorders as long-term sequalae of infection. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection is associated with inflammatory changes to the olfactory bulb, and treatments with anti-inflammatory properties are hypothesized to attenuate viral injury and promote recovery of olfaction after infection. Our study investigated the efficacy of a supplement with Palmitoyleth-anolamide (PEA) and Luteolin to support recovery of olfaction in COVID-19 patients.PATIENTS AND METHODS: We conducted a randomized-controlled pilot study in outpatients with history of confirmed COVID-19 with post-infection olfactory impairment that persisted >= 90 days after SARS-CoV-2 negative testing. Patients were randomized to two times a day olfactory rehabilitation alone or weekly olfactory rehabilitation plus daily oral supplement with PEA and Luteolin. Subjects with preexisting olfactory disorders were excluded. Sniffin' Sticks assessments were performed at baseline and 30 days after treatment. Data on gender, age. and time since infection were collected. Kruskal-Wallis (KW) test was used to compare variances of Sniff scores between groups over time, and Spearman's correlation coefficients were calculated to assess for correlations between Sniff Score and gender or duration of infection.RESULTS: Among 12 patients enrolled (n=7, supplement: n=5, controls), patients receiving supplement had greater improvement in olfactory threshold, discrimination, and identification score versus controls (p=0.01). Time since infection was negatively correlated with Sniff Score, and there was no correlation between gender.CONCLUSIONS: Treatment combining olfactory rehabilitation with oral supplementation with PEA and Luteolin was associated with improved recovery of olfactory function. most marked in those patients with longstanding olfactory dysfunction. Further studies are necessary to replicate these findings and to determine whether early intervention including olfactory rehabilitation and PEA+Luteolin oral supplement might prevent SARS-CoV-2 associated olfactory impairment.