Adjunctive treatment with oral AKL1, a botanical nutraceutical, in chronic obstructive pulmonary disease

Abstract

Purpose

The objective of this pilot trial was to evaluate the safety and efficacy of AKL1, a patented botanical formulation containing extracts of Picrorhiza kurroa, Ginkgo biloba, and Zingiber officinale, as add-on therapy for patients with chronic obstructive pulmonary disease (COPD) and chronic cough.

Patients and methods

This randomized, double-blind, placebo-controlled trial enrolled male and female patients >18 years old with COPD and Leicester Cough Questionnaire (LCQ) score of <18. The 10-week study period comprised a 2-week single-blind placebo run-in period followed by add-on treatment with AKL1 or placebo twice daily for 8 weeks. The primary study endpoint was the change from week 0 to week 8 in cough-related health status, as assessed by the LCQ.

Results

Of 33 patients enrolled, 20 were randomized to AKL1 and 13 to placebo. Patients included 19 (58%) men and 14 (42%) women of mean (standard deviation [SD]) age of 67 (9.4) years; 15 (45%) patients were smokers and 16 (49%) were ex-smokers. The mean (SD) change from baseline in LCQ score at 8 weeks was 2.3 (4.9) in the AKL1 group and 0.6 (3.7) in the placebo group, with mean difference in change of 1.8 (95% confidence interval: −1.5 to 5.1; P=0.28). The St George’s Respiratory Questionnaire score improved substantially in the AKL1 treatment group by a mean (SD) of −7.7 (11.7) versus worsening in the placebo group (+1.5 [9.3]), with mean difference in change of −9.2 (95% confidence interval: −19.0 to 0.6; P=0.064). There were no significant differences between treatment groups in change from baseline to week 8 in other patient-reported measures, lung function, or the 6-minute walk distance.

Conclusion

Further study is needed with a larger patient population and over a longer duration to better assess the effects of add-on therapy with AKL1 in COPD.

Journal

Journal ID (nlm-ta): Int J Chron Obstruct Pulmon Dis

Journal ID (iso-abbrev): Int J Chron Obstruct Pulmon Dis

Journal ID (publisher-id): International Journal of COPD

Title: International Journal of Chronic Obstructive Pulmonary Disease

Publisher: Dove Medical Press

ISSN (Print): 1176-9106

ISSN (Electronic): 1178-2005

Publication date Collection: 2014

Publication date (Electronic): 09 July 2014

Volume: 9

Pages: 715-721

Affiliations

[1 ]Norwich Medical School, University of East Anglia, Norwich, UK

[2 ]Norfolk and Norwich University Hospital Foundation Trust, Norwich, UK

[3 ]Academic Primary Care, University of Aberdeen, Aberdeen, UK

[4 ]Research in Real Life, Cambridge, UK

[5 ]Mundesley Medical Centre, Mundesley, Norwich, UK

[6 ]Primary Care Research, Aldermoor Health Centre, University of Southampton, Southampton, UK

Author notes

Correspondence: Andrew M Wilson, Norwich Medical School, Medical School Building, University of East Anglia, Norwich, NR4 7TJ, UK, Tel [phone], Fax [phone], Email a.m.wilson@ 123456uea.ac.uk

Article

Publisher ID: copd-9-715

DOI: 10.2147/COPD.S54276

PMC ID: 4096458

Copyright statement: © 2014 Brockwell et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

License:

The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

Categories

Subject: Original Research