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Randomized Controlled Trial
Prednisolone does not improve olfactory function after COVID-19: a randomized, double-blind, placebo-controlled trial.
- Emma J A Schepens, Esther E Blijleven, Wilbert M Boek, Sanne Boesveldt, Robert J Stokroos, Inge Stegeman, and KamalskiDigna M ADMADepartment of Otorhinolaryngology- Head and Neck Surgery, University Medical Center Utrecht, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands.Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands..
- Department of Otorhinolaryngology- Head and Neck Surgery, University Medical Center Utrecht, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands. e.j.a.schepens-2@umcutrecht.nl.
- Bmc Med. 2022 Nov 16; 20 (1): 445445.
BackgroundPrednisolone has been suggested as a treatment for olfactory disorders after COVID-19, but evidence is scarce. Hence, we aimed to determine the efficacy of a short oral prednisolone treatment on patients with persistent olfactory disorders after COVID-19.MethodsWe performed a randomized, double-blind, placebo-controlled, single-centered trial in the Netherlands. Patients were included if they were > 18 years old and if they had persistent (> 4 weeks) olfactory disorders within 12 weeks after a confirmed COVID-19 test. The treatment group received oral prednisolone 40 mg once daily for 10 days and the placebo group received matching placebo. In addition, all patients performed olfactory training. The primary outcome was the objective olfactory function on Sniffin' Sticks Test (SST) 12 weeks after the start of treatment, measured in Threshold-Discrimination-Identification (TDI) score. Secondary outcomes were objective gustatory function assessed by the Taste Strip Test (TST) and subjective self-reported outcomes on questionnaires about olfactory, gustatory and trigeminal function, quality of life, and nasal symptoms. The CONSORT 2010 guideline was performed.ResultsBetween November 2021 and February 2022, we included 115 eligible patients, randomly assigned to the treatment (n = 58) or placebo group (n = 57). No difference in olfactory function between groups was obtained after 12 weeks. Median TDI score on SST was 26.8 (IQR 23.6-29.3) in the placebo group and 28.8 (IQR 24.0-30.9) in the prednisolone group, with a median difference of 2.0 (95% CI 0.75 to 1.5). There was similar improvement on olfactory function in both groups after 12 weeks. Furthermore, on secondary outcomes, we obtained no differences between groups.ConclusionsThis trial shows that prednisolone does not improve olfactory function after COVID-19. Therefore, we recommend not prescribing prednisolone for patients with persistent olfactory disorders after COVID-19.Trial RegistrationThis trial is registered on the ISRCTN registry with trial ID ISRCTN70794078.© 2022. The Author(s).
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