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Treatment of sore throat and hoarseness with Pelargonium sidoides extract EPs 7630: a meta-analysis

SUMMARY The extract EPs 7630 from the roots of Pelargonium sidoides has been proven safe and effective in the treatment of acute respiratory tract infections (aRTI). The aim of this study was to perform a meta-analysis on the efficacy of EPs 7630 in patients suffering from acute non-streptococcal tonsillopharyngitis (ATP) or common cold (CC) regarding the symptoms sore throat and hoarseness. This meta-analysis encompasses double-blind, placebo-controlled, randomized clinical trials investigating the efficacy of EPs 7630 in ATP or CC. Relevant publications were identified by searching PubMed and clinical trial registries (ISRCTN, ClinicalTrials.gov; search terms: acute tonsillopharyngitis, common cold, EPs 7630, Umckaloabo, hoarseness, and sore throat) and the assessment report on Pelargonium sidoides of the European Medicines Agency. Clinical study reports of unpublished trials were provided by the manufacturer of EPs 7630. Meta-analysis was performed separately for both indications, for formulations found, and for patient groups. Efficacy analyses were based on the change of symptom severity of ‘sore throat’ and ‘hoarseness’ as assessed by the respective indication-specific symptom scores, and on complete remission. Disease-related quality of life was also analyzed. Seven trials with a total of 1,099 participants could be included into the meta-analysis. Clinical trials investigating EPs 7630 in CC comprised adults only, whereas those in ATP only included children. Results showed EPs 7630 to be superior to placebo in reducing both symptom severity and time until complete recovery for the symptoms ‘sore throat’ and ‘hoarseness’ in the indications investigated. These findings suggest that EPs 7630 is effective in reducing severity and time to remission of the symptoms sore throat and hoarseness in ATP and CC, respectively.