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Int J Chron Obstruct Pulmon Dis. 2014 Jul 9;9:715-21. doi: 10.2147/COPD.S54276. eCollection 2014.

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

Author information

1
Norwich Medical School, University of East Anglia, Norwich, UK.
2
Norwich Medical School, University of East Anglia, Norwich, UK ; Norfolk and Norwich University Hospital Foundation Trust, Norwich, UK.
3
Academic Primary Care, University of Aberdeen, Aberdeen, UK ; Research in Real Life, Cambridge, UK.
4
Mundesley Medical Centre, Mundesley, Norwich, UK.
5
Primary Care Research, Aldermoor Health Centre, University of Southampton, Southampton, UK.
6
Research in Real Life, Cambridge, UK.

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.

KEYWORDS:

Ginkgo biloba; Leicester Cough Questionnaire; Picrorhiza kurroa; Zingiber officinale; anti-inflammatory

PMID:
25031533
PMCID:
PMC4096458
DOI:
10.2147/COPD.S54276
[Indexed for MEDLINE]
Free PMC Article
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