Treatment of acute bronchitis in adults with a pelargonium sidoides preparation (EPs 7630): a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Acute bronchitis is a widespread medical problem, and, although predominantly caused by viruses, antibiotics are still prescribed unnecessarily. Therefore, it is of utmost importance to evaluate the use of alternative treatments for acute bronchitis. OBJECTIVE: To evaluate the efficacy and safety of a Pelargonium sidoides preparation (EPs 7630 is a registered trademark of Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany) compared with placebo in patients with acute bronchitis. DESIGN: Randomized, double-blind, placebo-controlled trial using a design with planned interim analyses. SETTING: Six outpatient clinics. PATIENTS: One hundred twenty-four adults with acute bronchitis present </=48 hours, Bronchitis Severity Score (BSS) >/=five points, and informed consent. INTERVENTION: EPs 7630 or placebo (30 drops three times daily) for seven days. MEASUREMENTS: The primary outcome criterion was the change of BSS on day seven. RESULTS: The decrease of BSS from baseline to day seven was 7.2 +/- 3.1 points with EPs 7630 (n = 64) and 4.9 +/- 2.7 points with placebo (n = 60). The 95% confidence interval for the difference of effects between the two treatment groups (EPs 7630 minus placebo) was calculated as (1.21, 3.56) showing a significant improvement of EPs 7630 compared with placebo on day seven (P < .0001). For each of the five individual symptoms, rates of complete recovery were considerably higher in the EPs 7630 group. Within the first four days, onset of treatment effect was recognized in 68.8% of patients in the EPs 7630 group compared with 33.3% of patients in the placebo group (P < .0001). Health-related quality of life improved more in patients treated with EPs 7630 compared with placebo-treated patients. Adverse events occurred in 25 of 124 patients (EPs 7630: 15/64 patients, placebo: 10/60 patients). All adverse events were assessed as nonserious. CONCLUSIONS: EPs 7630 was superior in efficacy compared with placebo in the treatment of adults with acute bronchitis. It may therefore offer an effective alternative for acute bronchitis unless antibiotics are clearly indicated.