Clinical efficacy and safety of Ergoferon in flu and other acute respiratory viral infections: a critical evaluation from the standpoint of evidence-based medicine

Abstract

The review presents the results of a critical evaluation of the efficacy and safety of Ergoferon in flu and other acute respiratory viral infections (ARVI) from the standpoint of evidence-based medicine. Data of 6 registered randomized clinical trials (RCTs) can be found in an open source database (grls.ru). The statistical analysis of these RCTs was carried out, which included a pooled estimate of mean values, standard deviations, Student t-test in Welch modification, Fisher's exact test and the risk of bias. All RCTs are prospective, parallel-group, with technically correct randomization: 4 RCTs are with double-blind placebo control, 2 RCTs are open-label (compared with oseltamivir). 715 people took Ergoferon, 172 patients took oseltamivir and 554 patients took placebo. The analyzed criteria included: average duration of fever (reaching body temperature ≤37.2 °C); severity of ARVI symptoms according to the area under the curve"(AUC); proportion of patients with worsening of the disease (development of complications requiring antibiotics or hospitalization); proportion of patients with at least one adverse event. The design, methodology, quality of presentation of the results of RCTs meets modern ethical requirements and standards. The clinical efficacy and safety of Ergoferon for treatment ARVI and flu in adults and children from 6 months were proved in RCTs, among which 4 RCTs have the highest level of evidence - RCTs with double-blind placebo control.

Keywords:flu, evidence-based medicine, treatment, acute respiratory viral infections, randomized clinical trials, Ergoferon

For citation: Nikiforov V.V., Ruzhentsova T.A. Clinical efficacy and safety of Ergoferon in flu and other acute respiratory viral infections: a critical evaluation from the standpoint of evidence-based medicine. Infektsionnye bolezni: novosti, mneniya, obuchenie [Infectious Diseases: News, Opinions, Training]. 2019; 8 (4): 84-97. doi: 10.24411/2305-3496-2019-14011 (in Russian)

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CHIEF EDITOR
CHIEF EDITOR
Yushchuk Nikolay Dmitrievich
Academician of the Russian Academy of Sciences, Professor, head of the Infectious Diseases and Epidemiology Department, President of the Moscow State University of Medicine and Dentistry named after A.I. Evdokimov, Board member of the National Scientific Infectiologists? Society.
РОСМЕДОБР 2021
Вскрытие
Medicine today

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