Health-related quality of life (HRQL) and patient-reported outcomes (PRO) in COPD patients receiving add-on-therapy with EPs® 7630

HRQL and PRO are important measures for treatment evaluation and assessment of health condition. In an RCT (ISRCTN01681733) in patients with COPD stage II/III, add-on therapy with EPs® 7630, a herbal drug preparation from Pelargonium sidoides roots (Umckaloabo®; ISO Arzneimittel, Ettlingen, GER), significantly prolonged time to exacerbations and reduced their frequency. We also investigated HRQL and further PRO parameters assessed during the trial. Patients with a standardised COPD baseline treatment according to GOLD were randomly allocated to a double-blind 24-week oral add-on therapy with 30 drops EPs® 7630 (n=99) or placebo (n=101) thrice daily. HRQL/PRO were assessed by St. George9s Respiratory Questionnaire (SGRQ), EQ-5D, Integrative Medicine Patient Satisfaction Scale (IMPSS), Integrative Medicine Outcomes Scale (IMOS), patient-reported intensity score of cough, sputum production and sternal pain while coughing, and drug tolerability. After 24 weeks, patients treated with EPs® 7630 reported a significantly more improved HRQL compared to placebo (SGRQ total score, p Conclusion: Add-on-therapy with EPs® 7630 led to a statistically significant and clinically relevant improvement of HRQL and other PRO (total score difference of SGRQ >4 points) including good long-term tolerability in patients with COPD stage II and III.