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Brockwell, C, Ampikaipakan, S, Sexton, DW, Price, D, Freeman, D, Thomas, M, Ali, M and Wilson, AM (2014) Adjunctive treatment with oral AKL1, a botanical nutraceutical, in chronic obstructive pulmonary disease. International Journal of Chronic Obstructive Pulmonary Disease, 9. pp. 715-721. ISSN 1178-2005
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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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | 1102 Cardiovascular Medicine And Haematology |
| Subjects: | R Medicine > RS Pharmacy and materia medica |
| Divisions: | Pharmacy and Biomolecular Sciences |
| Publisher: | Dove Medical Press Ltd |
| Related URLs: | |
| Date of first compliant Open Access: | 11 January 2016 |
| Date Deposited: | 19 Mar 2015 11:48 |
| Last Modified: | 04 Sep 2021 14:34 |
| DOI or ID number: | 10.2147/COPD.S54276 |
| URI: | https://researchonline.ljmu.ac.uk/id/eprint/744 |
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