Reference
Kamin W, Ilyenko L, Malek F, Kieser M. Treatment of acute bronchitis with EPs 7630: Randomized, controlled trial in children and adolescents. Pediatrics International. 2012;54:219-26.
Design
Two hundred twenty pediatric patients with acute bronchitis were randomized and given either EPs 7630, an herbal preparation of Pelargonium sidoides root (1:8–1:10 dilution of ethanolic extract), or matching placebo for 7 days. Treatment was dosed at 10 drops 3 times daily for ages 1–6, 20 drops 3 times daily for ages 6–12, and 30 drops 3 times daily for ages 12–18. The study measured a change in the total score of bronchitis specific symptoms (BSS) from day 0 to day 7.
Patients aged 1–18 were included if they were diagnosed with acute bronchitis, symptoms started less than 48 hours before the inclusion in the study, and their BSS score was ≥5 at the time of screening. Exclusion criteria included concomitant medication that could impair study results, allergic asthma, chronic obstructive pulmonary disease (COPD), bleeding disorders, immunosuppression, and chronic disease of the heart, liver, or kidney.
BSS score was determined by assessment of coughing, dyspnea, and pulmonary rales upon auscultation. Each parameter could receive a score from 0 (not present) through 4 (very severe), leading, therefore, to a maximum BSS score of 12.
Key Findings
From baseline to day 7, the mean BSS score decreased by 4.4 +/- 1.6 points in the EPs 7630 group compared to a decrease of 2.9 +/- 1.4 points in the placebo group. This represented a statistically significant difference between the treatment and placebo groups (P<0.0001). Subgroup analysis demonstrated comparable statistically significant results among the different age groups.
Additional measurements were made with respect to appetite, demonstrating that the treatment group experienced significant improvement in “lack of appetite” versus placebo, but there was no difference between the groups in headache, vomiting, and diarrhea. Patient satisfaction was also significantly higher in the treatment group versus placebo (P<0.0001).
Practice Implications
There have been at least 7 randomized, double-blind placebo-controlled studies in which EPs7630 was demonstrated to be effective for acute bronchitis, in both adults and children,1-7 as well as a systematic review and meta-analysis from 2008 which confirms its efficacy and safety for this condition.8 This study was the first randomized, double-blind, placebo-controlled study in children. Pharmacological activities of the EPs 7630 include direct antibacterial action and immune modulatory capabilities as demonstrated in vitro. These immunomodulatory activities include the release of TNF-α and nitric oxides, stimulation of interferon-β, and an increase in natural killer cell activity.9 Further in vitro studies have shown improved phagocytosis and inhibition of the interaction of group A strep with host epithelia with addition of EPs 7630.10 These mechanisms may be responsible for the beneficial response to the treatment.
Given its tolerability and efficacy, EPs 7630 should be considered for the treatment of acute bronchitis in children.
Limitations
The outcomes measured in this study are based on subjective clinical findings only, as the diagnosis of acute bronchitis is not typically obtained through standardized diagnostic signs or laboratory evaluation. The scores and scales used to measure patient outcome have not been validated, and though they appear to be associated with clinical benefit, they may or may not be clinically relevant. Further evaluation of clinical efficacy with objectively measurable outcomes would strengthen the conclusion that EPs 7630 is an effective treatment strategy for the treatment of acute bronchitis in this population.
[Editor's note: We previously wrote that “the successful treatment of acute bronchitis with EPs 7630 has been previously demonstrated in adults in 2 randomized, double-blind, placebo-controlled studies.” The article has been edited to correct the number of studies on the topic.]
