Safety and tolerability of EPs® 7630 (Umckaloabo®)

Herbal medicines play an increasingly important role in the perception of physicians and patients looking for equally effective, albeit safer approaches to conventional management of respiratory tract infections (RTIs). This review systematically presents the available evidence on the safety and tolerability profile of EPs® 7630. EPs® 7630 is a herbal drug preparation from the roots of Pelargonium sidoides (1:8–10), extraction solvent: ethanol 11% (w/w), and is widely used in several countries for RTI treatment. Based upon the study reports of all 25 clinical trials as well as post-marketing surveillance studies with EPs® 7630 completed by 2006, this review includes data from 9218 patients with acute or chronic RTIs such as tonsillopharyngitis, sinusitis or bronchitis and from 31 healthy subjects. EPs® 7630 was well tolerated and its safety is underlined by the fact that no serious adverse drug reactions were reported in this large patient population. Comparing EPs® 7630 and placebo groups, adverse events were similar with regard to quality and quantity throughout almost all organ systems and symptoms. The only differences were a slightly higher incidence of gastrointestinal disorders, namely epigastric pain, nausea and diarrhoea, and of hypersensitivity reactions (mostly skin reactions), as well as gingival bleeding and epistaxis associated with EPs® 7630 treatment compared to placebo. Data on treatment-emergent changes in liver enzymes from placebo-controlled trials gave no indication of an unfavourable influence of EPs® 7630. EPs® 7630 therefore is a well-tolerated herbal medicine in the management of RTIs in children from 1 year of age and adults alike.