TY - JOUR
T1 - Prednisolone does not improve olfactory function after COVID-19
T2 - a randomized, double-blind, placebo-controlled trial
AU - Schepens, Emma J. A.
AU - Blijleven, Esther E.
AU - Boek, Wilbert M.
AU - Boesveldt, Sanne
AU - Stokroos, Robert J.
AU - Stegeman, Inge
AU - Kamalski, Digna M. A.
N1 - Funding Information: The COCOS study team thanks and acknowledges all patients for their participation in this study. We thank K. Krommenhoek and N. Maagdenberg for help executing tests. This publication is part of the project Sniffing Out COVID with Project Number 10430102110001 of the COVID-19 Programme which is financed by the Dutch Organization for Health Research and Development (ZonMw). Funding Information: This work was supported by the Dutch health organization ZonMW. Project Number: 10430102110001. The funder of this trial had no part in study design, data collection, analysis or interpretation, or the writing of the article. Publisher Copyright: © 2022, The Author(s).
PY - 2022/12/1
Y1 - 2022/12/1
N2 - Background: Prednisolone 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. Methods: We 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. Results: Between 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. Conclusions: This 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 registration: This trial is registered on the ISRCTN registry with trial ID ISRCTN70794078.
AB - Background: Prednisolone 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. Methods: We 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. Results: Between 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. Conclusions: This 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 registration: This trial is registered on the ISRCTN registry with trial ID ISRCTN70794078.
KW - COVID-19
KW - Olfactory function
KW - Prednisolone
KW - Smell
UR - http://www.scopus.com/inward/record.url?scp=85142037105&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s12916-022-02625-5
DO - https://doi.org/10.1186/s12916-022-02625-5
M3 - Article
C2 - 36384737
SN - 1464-2662
VL - 20
JO - BMC medicine
JF - BMC medicine
IS - 1
M1 - 445
ER -