Efficacy and tolerability of EPs^® 7630 for children and adolescents with acute bronchitis

EPs^® 7630 (Umckaloabo^®; ISO Arzneimittel, Ettlingen, Germany) is a liquid herbal drug preparation from Pelargonium sidoides roots. EPs^® 7630 shows antiviral, antibacterial and immunomodulatory properties which account for its therapeutic effects in respiratory tract infections such as acute bronchitis (AB).

We present data from three RCTs involving 820 patients (placebo: 307, EPs^® 7630: 513) aged 1-18 years, diagnosed with AB.

In two clinical trials with 200 resp. 220 patients, changes in the total score of the BSS-ped, a short version of the physician-rated Bronchitis Severity Scale (BSS) were assessed. EPs^® 7630 solution significantly reduced the total score of the BSS-ped including three typical AB symptoms, i.e. cough, dyspnoea, rales on day 7 (main outcome measure; placebo vs EPs^® 7630: -1.2 vs -3.4 points resp. -2.9 vs -4.4 points; p<0.001). In a further study with 399 patients aged 6-18 years, EPs^® 7630 film-coated tablets (10mg/20mg/30mg/placebo t.i.d.) significantly improved the BSS-ped between day 0 and day 7 in the two higher dosages (placebo vs EPs^® 7630 (10/20/30): -3.3 vs -3.6/-4.4/-5.0 points; p<0.001 for placebo vs EPs^® 7630 (20/30)).

The EPs^® 7630 treatment group showed a significantly better outcome than placebo as assessed with the Integrative Medicine Outcome Scale (IMOS). These trials also confirm the good tolerability of EPs^® 7630. Accordingly, patients treated with EPs^® 7630 were significantly more satisfied with the treatment, as evidenced by the Integrated Medicine Patient Satisfaction Scale (IMPSS) (p<0.001).

EPs^® 7630 is an efficacious and well-tolerated herbal medicine for the treatment of AB in children and adolescents.