Standardized Brazilian green propolis extract (EPP-AF®) in COVID-19 outcomes: a randomized double-blind placebo-controlled trial.
Autor: | Silveira MAD; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil. marceloadsilveira@gmail.com., Menezes MA; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil., de Souza SP; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil., Galvão EBDS; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil., Berretta AA; Development and Innovation Department, Apis Flora Indl. Coml. Ltda, Rua Triunfo 945, Subsetor Sul 3, Ribeirão Preto, SP, 14020-670, Brazil., Caldas J; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil., Teixeira MB; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil., Gomes MMD; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil., Damiani LP; Academic Research Organization, Hospital Israelita Albert Einstein, Av. Albert Einstein, 627, Morumbi, São Paulo, SP, 05652-000, Brazil., Bahiense BA; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil., Cabral JB; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil., De Oliveira CWLM; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil., Mascarenhas TR; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil., Pinheiro PCG; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil., Alves MS; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil., de Melo RMV; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil.; School of Medicine, Federal University of Bahia, Rua Augusto Viana s/n, Canela, Salvador, BA, 40110-909, Brazil., Leite FM; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil., Nonaka CKV; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil.; Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ), Bahia, 40296-710, Brazil., Souza BSF; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil.; Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ), Bahia, 40296-710, Brazil., Baptista NU; Development and Innovation Department, Apis Flora Indl. Coml. Ltda, Rua Triunfo 945, Subsetor Sul 3, Ribeirão Preto, SP, 14020-670, Brazil., Teles F; School of Medicine, Federal University of Alagoas, Av. Lourival de Melo Mota S/N, Tabuleiro do Martins, Maceió, Alagoas, 57072-900, Brazil., da Guarda SF; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil.; School of Medicine, Federal University of Bahia, Rua Augusto Viana s/n, Canela, Salvador, BA, 40110-909, Brazil., Mendes AVA; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil., Passos RDH; D'Or Institute for Research and Education (IDOR), Hospital São Rafael, Avenida São Rafael 2152, São Marcos, Salvador, BA, 41253-190, Brazil. |
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Jazyk: | angličtina |
Zdroj: | Scientific reports [Sci Rep] 2023 Oct 27; Vol. 13 (1), pp. 18405. Date of Electronic Publication: 2023 Oct 27. |
DOI: | 10.1038/s41598-023-43764-w |
Abstrakt: | SARS-CoV-2 and its different variants caused a "wave and wave" pandemic pattern. During the first wave we demonstrated that standardized Brazilian green propolis extract (EPP-AF®) reduces length of hospital stay in adult patients with COVID-19. Afterwards, we decided to evaluate the impact of EPP-AF in hospitalized patients during the third wave of the pandemic. BeeCovid2 was a randomized, double-blind, placebo-controlled clinical trial in hospitalized COVID-19 adult patients. Patients were allocated to receive an oral dose of 900 mg/day of EPP-AF® or placebo for 10 days. The primary outcome was length of hospital stay. Secondary outcomes included safety, secondary infection rate, duration of oxygen therapy dependency, acute kidney injury and need for intensive care. Patients were followed up for 28 days after admission. We enrolled 188 patients; 98 were assigned to the propolis group and 90 to the placebo group. The post-intervention length of hospital stay was of 6.5 ± 6.0 days in the propolis group versus 7.7 ± 7.1 days in the control group (95% CI - 0.74 [- 1.94 to 0.42]; p = 0.22). Propolis did not have significant impact on the need for oxygen supplementation or frequency of AKI. There was a significant difference in the incidence of secondary infection between groups, with 6.1% in the propolis group versus 18.9% in the control group (95% CI - 0.28 [0.1-0.76], p = 0.01). The use of EPP-AF was considered safe and associated with a decrease in secondary infections. The drug was not associated with a significant reduction in length of hospital stay. ClinicalTrials.gov (NCT04800224). (© 2023. The Author(s).) |
Databáze: | MEDLINE |
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