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

• Nikiforov Vladimir V.
• Tatiana A. Ruzhentsova

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

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