title: Adjunctive treatment with oral AKL1, a botanical nutraceutical, in chronic obstructive pulmonary disease.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Norwich Medical School, University of East Anglia, Norwich, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Brockwell
authors.affiliation: Norwich Medical School, University of East Anglia, Norwich, UK ; Norfolk and Norwich University Hospital Foundation Trust, Norwich, UK.
authors.forename: Sundari
authors.initials: S
authors.lastname: Ampikaipakan
authors.affiliation: Norwich Medical School, University of East Anglia, Norwich, UK.
authors.forename: Darren W
authors.initials: DW
authors.lastname: Sexton
authors.affiliation: Academic Primary Care, University of Aberdeen, Aberdeen, UK ; Research in Real Life, Cambridge, UK.
authors.forename: David
authors.initials: D
authors.lastname: Price
authors.affiliation: Mundesley Medical Centre, Mundesley, Norwich, UK.
authors.forename: Daryl
authors.initials: D
authors.lastname: Freeman
authors.affiliation: Primary Care Research, Aldermoor Health Centre, University of Southampton, Southampton, UK.
authors.forename: Mike
authors.initials: M
authors.lastname: Thomas
authors.affiliation: Research in Real Life, Cambridge, UK.
authors.forename: Muzammil
authors.initials: M
authors.lastname: Ali
authors.affiliation: Norwich Medical School, University of East Anglia, Norwich, UK ; Norfolk and Norwich University Hospital Foundation Trust, Norwich, UK.
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Wilson
mesh_terms: D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003371:Cough / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004739:England; D005080:Exercise Test; D005260:Female; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: C000595453:ALK1 extract; D000893:Anti-Inflammatory Agents; D010936:Plant Extracts
keywords: Ginkgo biloba; Leicester Cough Questionnaire; Picrorhiza kurroa; Zingiber officinale; anti-inflammatory