Efficacy and tolerability of EPs 7630 tablets in patients with acute bronchitis: a randomised, double-blind, placebo-controlled dose-finding study with a herbal drug preparation from Pelargonium sidoides

Abstract

Objective:

Acute bronchitis is one of the most frequent health complaints for which patients seek medical advice. Although viral infections prevail, antibiotics are commonly prescribed. In this study, the efficacy and tolerability of EPs 7630 tablets, a herbal drug preparation from the roots of Pelargonium sidoides, were investigated in adults with acute bronchitis outside the strict indication for antibiotics.

Research design and methods:

In this randomised, double-blind, placebo-controlled, multicentre dose-finding trial using an adaptive group-sequential design, 406 patients were randomly assigned to one of four parallel treatment groups (10 mg EPs 7630 tablets three times a day (30-mg group), 20 mg EPs 7630 tablets three times a day (60-mg group), 30 mg EPs 7630 tablets three times a day (90-mg group) or placebo three times a day) for a treatment period of 7 days. Primary endpoint was the change in the total score of bronchitis-specific symptoms (BSS) from baseline to day 7.

Results:

Between day 0 and day 7, the mean BSS score decreased by 2.7 ± 2.3 (placebo), 4.3 ± 1.9 (30-mg group), 6.1 ± 2.1 (60-mg group), and 6.3 ± 2.0 points (90-mg group), respectively. The differences between the EPs 7630 groups and placebo were statistically significant (p < 0.0001, each). The secondary endpoints showed comparable results. EPs 7630 was well-tolerated. All documented adverse events were of mild to moderate intensity; their frequency was dose-dependent. No serious adverse events were reported.

Conclusion:

This study demonstrated statistically significant and clinically relevant superiority of all three tested dosages of EPs 7630 over placebo. All dosages of EPs 7630 were well-tolerated. Taking into account both efficacy and safety, the results of this study indicate that the 20 mg tablets of EPs 7630 taken three times daily constitute the optimal dose with respect to the benefit-risk ratio.

Keywords::

• Acute bronchitis
• Bronchitis specific symptoms
• EPs 7630
• Herbal drug preparation

Declaration of funding

The study and the medical writing services were sponsored and study medication was provided by Dr Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany. The study was designed by the corresponding author in collaboration with colleagues at the study sponsor. The corresponding author had full access to all the data and final responsibility for the decision to submit for publication. All logistical aspects of the study were managed by the study sponsor. The sponsor entrusted an independent clinical research organisation with carrying out the statistical analysis and was involved in the writing of the report. The CADQEC was also entrusted by the sponsor.

Declaration of financial/other relationships

H.M. and V.G.L. declare that they have no conflict of interest. H.M. and V.G.L. were reimbursed for their scientific services for this study on a contractual basis by the sponsor. F.A.M. is an employee of the sponsor. M.K. was an employee of the sponsor from 1992 to 2007.

Peer reviewers may receive honoraria from CMRO for their review work. Peer Reviewer 1 has disclosed no relevant financial relationships. Peer Reviewer 2 has disclosed that he/she is a stock shareholder in AstraZeneca and GlaxoSmithKline.

Acknowledgements

The authors thank all the patients, physicians, nurses, and clinical research associates who collaborated in this study, and Friedhelm Achenbach, medicaltext.de, for medical writing and editing services.

Transparency

The main results of this study were previously presented at several meetings as both an oral and a poster presentation, and published as an abstract:

Matthys H. (2007) Efficacy and tolerability of EPs® 7630 tablets in adult patients with acute bronchitis – a randomised, placebo-controlled, double-blind, dose-finding study. Foc Altern Complement Ther 12 (1): 35–36 (Abstract; Oral presentation, 14th Annual Symposium on Complementary Health Care, 11–13th December 2007, Exeter, UK)

Matthys H. (2008) Wirksamkeit und Verträglichkeit der EPs® 7630 Tablette bei Erwachsenen mit akuter Bronchitis – eine randomisierte, placebokontrollierte, doppelblinde Dosisfindungsstudie. Z Phytother 29 (1): S13 (Abstract; Oral presentation, Annual Congress on Phytopharmaceuticals and Phytotherapy, 14–16th February 2008, Berlin, Germany)

Matthys H. (2008) Wirksamkeit und Verträglichkeit der EPs®-7630-Tablette bei erwachsenen Patienten mit akuter Bronchitis – eine randomisierte, placebokontrollierte, doppelblinde Dosisfindungsstudie. Pneumologie 62 (2): S67 (Abstract; Oral presentation, 49th Congress of the German Society for Pneumology, 9–12th April 2008, Lübeck, Germany)

Matthys H. (2008) Efficacy and tolerability of the EPs® 7630 tablets in adult patients with acute bronchitis – a randomised, placebo controlled, double-blind, dose-finding study. Swiss Med Weekly 138 (16): 32S (Abstract; Poster presentation, Annual Joint Meeting of the Swiss Societies for Pneumology, Paediatric Pneumology, Allergology and Immunology, Thoracic Surgery, 17–18th April 2008, Fribourg, Switzerland).

Notes

*EPs 7630 is the active ingredient of the product Umckaloabo (ISO Arzneimittel, Ettlingen, Germany). EPs and Umckaloabo are registered trade marks of Dr. Willmar Schwabe GmbH & Co. KG, Germany.