RCT of the effect of berryfruit polyphenolic cultivar extract in mild steroid-naive asthma: a cross-over, placebo-controlled study

• Published in: BMJ open 2017-03, Vol.7 (3), p.e013850-e013850
• Main Authors: Power, Sharon, Williams, Mathew, Semprini, Alex, Munro, Claire, Caswell-Smith, Rachel, Pilcher, Janine, Holliday, Mark, Fingleton, James, Harper, Jacquie, Hurst, Roger, Weatherall, Mark, Beasley, Richard, Braithwaite, Irene
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Anti-Asthmatic Agents - therapeutic use; Asthma; Asthma - drug therapy; Clinical medicine; Cross-Over Studies; Double-Blind Method; Evidence-based medicine; Female; Forced Expiratory Volume; Fruit; Fruits; Humans; Hypotheses; Inflammation; Intervention; Male; Middle Aged; Nitric oxide; Pathogenesis; Phytotherapy - methods; Plant Extracts - pharmacology; Questionnaires; Respiratory Medicine; Steroids; Treatment Outcome; Trends; Young Adult
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2016-013850

ObjectiveThere is preclinical evidence that consumption of berryfruit extract may reduce chronic airways inflammation and modify airway remodelling in allergen-induced models of lung inflammation. We investigated the effect of berryfruit extract on the fractional expired nitric oxide (FeNO), a biomarker of eosinophilic airways inflammation, in adults with steroid-naïve asthma.DesignRandomised placebo-controlled cross-over double-blind trial.SettingSingle-centre community-based trial.Participants28 steroid-naïve mild asthmatics with Feno >40 ppb, of whom 25 completed both study interventions.InterventionsParticipants were randomised to receive, according to the cross-over design, 100 mg berryfruit polyphenolic extract (BFPE) or placebo for 4 weeks, with a 4-week washout period between the interventions.Primary outcome measureThe primary outcome variable was FeNO at 4 weeks, analysed by a mixed linear model, with a random effect for participant and baseline FeNo as a covariate.ResultsThe mean (SD) natural logarithm transformed (ln) FeNO after 4 weeks of treatment for the BFPE and placebo groups was 4.28 (0.47) and 4.22 (0.47), respectively. The paired change from baseline mean (SD) BFPE minus placebo ln FeNO was −0.03 (0.39), N=25. The mixed linear model estimate, with baseline covariate adjustment, difference in ln FeNO, was −0.002 (95% CI −0.15 to 0.14), p=0.98. This is equivalent to a ratio of geometric mean FeNO of 1.0 (95% CI 0.86 to 1.15).ConclusionsIn steroid-naïve participants with mild asthma and elevated FeNO, there was no effect of BFPE on FeNO, a biomarker of eosinophilic airways inflammation. Caution is required in the extrapolation of apparent benefit in murine models of lung eosinophilia to clinical efficacy in patients with asthma.Trial registration numberANZCTR: 12613000451707; Results.