Tolerability Of EPs Research Articles

Tolerability and Treatment Effects of Pelargonium sidoides Preparation EPs 7630 in Adults Suffering from Acute Rhinopharyngitis – A Prospective, Open-Label Trial

Background: EPs 7630 has already been proven effective in acute rhinopharyngitis (ARP) and other acute respiratory diseases. We conducted an open-label, non-comparative, interventional multicenter study to obtain additional information on the tolerability and effectiveness of EPs 7630 in a clinical practice setting. Methods: 120 adults with clinical ARP diagnosis and at least 2 out of a set of 10 common cold symptoms received 3 × 1 film-coated 20 mg EPs 7630 tablet daily, for 10 days. Assessment of tolerability and safety was based on adverse event (AE) elicitation and safety laboratory measures. The intensity of ARP-associated symptoms was assessed daily and treatment outcome and satisfaction were evaluated. Results: At treatment end, 42% of patients were completely recovered, 42% showed major improvements. The majority of patients were satisfied with treatment. Over-all AE incidences were 0.017 (all AEs) and 0.010 (potentially related AEs) events/day of exposure. Most common events were gastrointestinal complaints and skin reactions. None of the events were serious. Conclusions: The results confirm the excellent tolerability of EPs 7630. Potentially attributable AEs were limited to the drug’s known spectrum of adverse effects. The majority of patients showed a favorable course of ARP which is unlikely to be explained by the natural course of the disease alone.

Safety and Tolerability of EPs 7630 in Clinical Trials

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 certain diseases. The controversy surrounding effective management regimes for respiratory tract infections (RTI) has made many healthcare providers reconsider current therapeutic strategies. This review presenting the available evidence from clinical trials and non-interventional studies on the safety and tolerability profile of EPs 7630 is based on publications and study reports of 29 clinical trials and post-marketing surveillance studies completed by February 2010. It includes study data from 10,026 adults and children suffering from acute or chronic RTI such as acute tonsillopharyngitis, rhinopharyngitis, sinusitis, bronchitis, or COPD and from 31 healthy subjects. In 19 double-blind, placebo-controlled trials, the type and incidence rate of adverse events under EPs 7630 were similar to those in patients treated with placebo. For gastrointestinal complaints and epistaxis, event rate differences of 2.9% and of 0.6% against EPs 7630 were determined; hypersensitivity reactions and all other system groups showed rate differences <0.5%. For liver associated events, rate differences of 0.0% for all events and of 0.1% for potentially related events were observed. Patients treated with EPs 7630 did not exhibit increased liver enzyme or bilirubin values – neither in terms of a shift in the mean, nor according to individual deviations from the reference ranges. These findings were fully supported by the data from the post-marketing surveillance studies reviewed. EPs 7630 appears to be a well-tolerated herbal medicine in the management of RTI in adults and children alike. Evidence for hepatotoxic effects in humans during routine administration was neither provided in the literature, nor by our own analyses.

Safety and tolerability of EPs® 7630 (Umckaloabo®)

Safety and tolerability of EPs® 7630 (Umckaloabo®)