Pelargonium sidoides preparation EPs 7630 in COPD: health-related quality-of-life and other patient-reported outcomes in adults receiving add-on therapy

Abstract

Objective: Patient-reported outcomes (PRO) such as health-related quality-of-life (HRQoL) belong to the most important criteria for the evaluation of medical therapies in clinical trials or practice-based benefit assessments. This study, therefore, revisited results of an earlier published clinical trial investigating the effects of the herbal drug preparation from the roots of Pelargonium sidoides EPs 7630, administered as add-on therapy in patients suffering from chronic obstructive pulmonary disease (COPD), with respect to HRQoL and other PRO.

Methods: A total of 199 adults diagnosed with COPD stages II/III and receiving standard treatment according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) were randomly assigned to add-on therapy with EPs 7630 or placebo for 24 weeks. HRQoL (disease-specific St. George’s Respiratory Questionnaire, SGRQ; current HRQoL state according to the EuroQuol visual analog scale, EQ VAS) and PRO (Integrative Medicine Outcomes Scale, IMOS; Integrative Medicine Patient Satisfaction Scale, IMPSS; symptom severity score of cough, sputum production and sternal pain while coughing; duration of inability to work) were assessed at each study visit or documented daily by the patient in a patient diary, respectively.

Results: At week 24, all HRQoL and PRO measures showed a more pronounced improvement under EPs 7630 than under placebo (EQ VAS, p < .001; SGRQ total score, p < .001; symptom severity score of cough, sputum production, and sternal pain while coughing, p = .021; duration of inability to work, p = .004; two-sided t-test each; IMOS, p < .001, IMPSS, p < .001, two-sided Mantel-Haenszel test each). Moreover, the difference seen for the SGRQ exceeded the SGRQ minimal clinically important difference (MCID) threshold of 4 points.

Conclusions: Add-on therapy with EPs 7630 led to an improvement in HRQoL and other PRO in adult patients with COPD compared to placebo while showing a good long-term tolerability.

Keywords:

• Clinical trial
• COPD
• EPs 7630
• health-related quality-of-life

Transparency

Declaration of funding

The trial was funded by Dr Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.

Declaration of financial/other relationships

HM was reimbursed by the sponsor according to contract for scientific services associated with this clinical trial. PF is an employee of Dr Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgment

We thank all patients, investigators, and study nurses who participated in this study, and Dr Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany for providing formerly unpublished data.

Note

Notes

*EPs^® 7630 is the active ingredient of the product Umckaloabo^® (ISO Arzneimittel, Ettlingen, Germany).