Association between ivy leaves dry extract EA 575 prescriptions and antibiotic use, sick leave duration, and repeated infections in adult patients.

OBJECTIVES: The present study aimed to analyze the association between the prescription of ivy leaf dry extract EA 575 (licensed under the trade name Prospan® in Germany) and the incidence of antibiotic use, incident bacterial complications, and days of sick leave in adult patients with cold diseases. METHODS: This retrospective cohort study was based on the IQVIA Disease Analyzer database and included adult patients from 1032 general practices in Germany with a documentation of common cold between 2017 and 2020 (index date) and prescription of either EA 575 or an antibiotic drug within 3 days after index date. 1:1 propensity score matching based on age, sex, index month, physician, health insurance status, and the Charlson Comorbidity Index was carried out. Univariable regression models were used to investigate the association between EA 575 prescription and defined outcomes. RESULTS: Data of 7034 patients treated with EA 575 and 7034 matched patients receiving an antibiotic were available. EA 575 prescription was associated with significantly lower odds of an antibiotic prescription in the time periods of 4-30 days (OR: 0.83; 95% CI: 0.72-0.96) and 31-365 days (OR: 0.44; 95% CI: 0.40-0.48) after the index date. EA 575 prescription was significantly associated with a lower rate of sick leave of more than 7 days (33.0% vs. 37.7%, OR: 0.81; 95% CI: 0.73-0.90) in patients with any sick leave, as well as with lower odds of a new cough diagnosis (OR: 0.91, 95% CI: 0.85-0.98) when compared to antibiotic prescription. CONCLUSION: Our study provides further evidence that the use of phytopharmaceuticals, in particular ivy leaf dry extract EA 575, could contribute to a reduction in the number of inappropriate antibiotic prescriptions for respiratory infection with cough symptoms.

Efficacy of two dosing schemes of a liquid containing ivy leaves dry extract EA 575 versus placebo in the treatment of acute bronchitis in adults.

INTRODUCTION: The results of a clinical trial published in 2016 showed the efficacy of ivy leaves dry extract EA 575 versus placebo in the treatment of patients suffering from acute cough. A clinical trial with a very similar design was conducted to not only show the reproducibility of former results but also to investigate an alternative dosing scheme. METHODS: This randomised, placebo-controlled, multicentre, double-blind clinical trial was conducted to assess the efficacy and safety of a liquid containing EA 575 in the treatment of acute bronchitis. A total of 209 patients were treated with a liquid containing EA 575 as an active investigational medicinal product (verum) either two (7.5 mL) or three (5 mL) times a day or placebo in the respective dosing scheme for 1 week, with a total observational period of 2 weeks. The primary efficacy outcome was a change in Bronchitis Severity Score (BSS) of the pooled placebo and pooled verum groups between visits 1 and 5. Additional secondary parameters were assessed, including, for example, change in cough severity as assessed by a visual analogue scale (VAS) and the Verbal Category Descriptive (VCD) score. RESULTS: Superiority of verum over placebo was during and at the end of treatment, as measured by BSS. No significant differences between the dosing schemes were observed. VCD scores and VAS measurements also showed the superiority of verum over placebo. CONCLUSION: The existing data on the clinical efficacy of EA 575 were confirmed. Furthermore, a new dosing scheme was shown to be noninferior to the currently used scheme while maintaining the safety and tolerability of the well-established cough liquid containing EA 575.