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South African Herbal Extract Effectively Treats Acute Bronchitis

Matthis H, Eisebitt R, Seith B, Heger M. Efficacy and safety of an extract of Pelargonium sidoides (EPs 7630) in adults with acute bronchitis. Phytomedicine. 2003;10(Supp 4):7-17. Acute bronchitis is one of the most commonly encountered infections in medical practice. Although bronchitis often results from a viral infection, it is often treated with antibiotics. Because antibiotic therapy is associated with a host of side effects (e.g., gastrointestinal disorders and allergic reactions), can lead to the development of resistant bacteria, and does not shorten the duration of the disease substantially, other more efficacious treatments are desirable. Physicians and patients alike have become increasingly interested in the use of herbal medicines to treat acute bronchitis. An extract of Pelargonium sidoides, otherwise known as EPs 7630 (Schwabe Pharmaceuticals, Karlsruhe, Germany), is popularly used in Germany, Mexico, and other countries to treat respiratory infections. Although the mechanism of action of EPs 7630 is only partially understood, its immunomodulatory activities are mediated primarily by the release of tumor necrosis factor alpha and nitric oxide, the stimulation of interferon beta, and an increase in the activity of natural killer cells. The current clinical trial was conducted to evaluate the efficacy and safety of EPs 7630 relative to that of a placebo in adult patients with acute bronchitis. Four hundred sixty-eight patients (over 18 years) were randomly assigned in a double-blind manner to receive either EPs 7630 (4.5 mL/d in three doses; n = 233) or a placebo (n = 235), before or after meals, for 7 days. The main outcome measure was the change in the Bronchitis Severity Score (BSS), which is rated on a 5-point scale in which 0 = the absence of symptoms and 5 = very severe symptoms. Secondary outcome measures were individual symptoms scores and quality-of-life indicators. BSS values were not significantly different between the two groups at baseline. However, by day 7, the BSS decreased by 5.9 plus/minus 2.9 points in the EPs 7630 group and by 3.2 plus/minus 4.1 points in the placebo group (p < 0.0001). The greatest recovery rates were observed for fever, which had disappeared in 96.9% of patients in the EPs 7630 group and in 58.4% of the patients in the placebo group by day 7 (p < 0.0001). The weakest recovery rates were for fatigue/exhaustion, which had disappeared in 65.1% of the patients in the EPs 7630 group but in only 39.3% of the placebo group by day 7 (p < 0.0001). The duration of illness was significantly shorter in the EPs 7630 group than in the placebo group (p < 0.001). The onset of the treatment effect occurred earlier in the EPs 7630 group than in the placebo group; by day 4, 53.6% of the EPs 7630 group and 36.2% of the placebo group had recognized a treatment effect (p < 0.0002). Adverse events associated with treatment were reported by 20 patients in the EPs 7630 group and by 16 patients in the placebo group; however, none of these adverse events were considered serious. EPs 7630ĘCtreated patients returned to work nearly 2 days earlier than did placebo-treated patients (p < 0.0001). The authors concluded that EPs 7630 was superior in efficacy to the placebo treatment. Despite some limitations of the current clinical trial, the authors indicate that it is safe to prescribe EPs 7630 as initial therapy for physician-diagnosed acute bronchitis. In the event that symptoms have not improved after 4 days of EPs 7630 treatment, they recommend that antibiotics then be prescribed. -Brenda Milot, ELS

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