Positioning of the Bronchitis Severity Score (BSS) for standardised use in clinical studies

Abstract

Objective:

Diagnosis and assessment of response to treatment in acute bronchitis depends on clinical findings. We evaluated published data on the Bronchitis Severity Score (BSS) used to diagnose acute bronchitis and to evaluate the impact of treatment in clinical studies.

Methods:

We conducted a literature search using PubMed (search terms: acute bronchitis, treatment, score, and BSS; publication date April 2012 or earlier) and asked the manufacturer for relevant publications. Articles were reviewed and relevant studies were classified according to author, study design, measurements made and duration of study, study drug(s), outcome, and statistical significance.

Results:

The medication most frequently evaluated by the BSS is a herbal drug preparation from the roots of Pelargonium sidoides (EPs 7630). The BSS consistently demonstrated statistically significant differences between active treatments and placebo as well as between different doses of active treatment. The proportion of responders was considerably higher in the EPs 7630 group than in the placebo group. Because of the subjective components of the BSS, inter-individual differences in results may exist. However, the BSS outcome was supported by the results of secondary outcome measures, such as the Integrated Medicine Patient Satisfaction Scale (IMPSS), documenting that patients were more often ‘satisfied’ or ‘very satisfied’ with EPs 7630 than placebo.

Conclusions:

We recommend further use of the BSS as a reliable and convenient clinical trial tool for selecting and evaluating patients in studies of acute bronchitis. Improvement in the BSS correlates with outcomes reported by these patients.

Keywords::

• Acute bronchitis
• Bronchitis severity score
• Standardised assessment
• Symptom grading

Transparency

Declaration of funding

Financial support for the development of this manuscript was kindly provided by Dr. Willmar Schwabe GmbH & Co. KG.

Declaration of financial/other relationships

H.M. and W.K. have disclosed that they were reimbursed for their scientific services on a contractual basis by Dr. Willmar Schwabe GmbH & Co. KG. They have no other relevant financial relationships to disclose.

CMRO peer reviewers on this manuscript have received honoraria for their review work, but have no relevant financial relationships to disclose.

Acknowledgement

The authors disclose that they were assisted in the preparation of the first draft of the manuscript by professional medical writing (MediWrite GmbH) funded by Dr. Willmar Schwabe GmbH & Co. KG.

Notes

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