title: Nigella sativa Supplementation Improves Asthma Control and Biomarkers: A Randomized, Double-Blind, Placebo-Controlled Trial.
abstract: Poor compliance with conventional asthma medications remains a major problem in achieving asthma control. Nigella sativa oil (NSO) is used traditionally for many inflammatory conditions such as asthma. We aimed to investigate the benefits of NSO supplementation on clinical and inflammatory parameters of asthma. NSO capsules 500 mg twice daily for 4 weeks were used as a supplementary treatment in a randomized, double-blind, placebo-controlled trial in asthmatics (clinicaltrials.gov: NCT02407262). The primary outcome was Asthma Control Test score. The secondary outcomes were pulmonary function test, blood eosinophils and total serum Immunoglobulin E. Between 1 June and 30 December 2015, 80 asthmatics were enrolled, with 40 patients in each treatment and placebo groups. After 4 weeks, ten patients had withdrawn from each group. Compared with placebo, NSO group showed a significant improvement in mean Asthma Control Test score 21.1 (standard deviation = 2.6) versus 19.6 (standard deviation = 3.7) (p = 0.044) and a significant reduction in blood eosinophils by -50 (-155 to -1) versus 15 (-60 to 87) cells/μL (p = 0.013). NSO improved forced expiratory volume in 1 second as percentage of predicted value by 4 (-1.25 to 8.75) versus 1 (-2 to 5) but non-significant (p = 0.170). This randomized, double-blind, placebo-controlled trial demonstrated that NSO supplementation improves asthma control with a trend in pulmonary function improvement. This was associated with a remarkable normalization of blood eosinophlia. Future studies should follow asthmatics for longer periods in a multicentre trial. Copyright © 2017 John Wiley & Sons, Ltd.
authors.affiliation: Research Cluster Biodiversity and Medicines, UCL School of Pharmacy, University College London, London, UK.|Department of Natural Products & Alternative Medicine, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.
authors.forename: Abdulrahman
authors.initials: A
authors.lastname: Koshak
authors.affiliation: Department of Practice and Policy, UCL School of Pharmacy, University College London, London, UK.
authors.forename: Li
authors.initials: L
authors.lastname: Wei
authors.affiliation: Allergy and Clinical Immunology Division, Department of Internal Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
authors.forename: Emad
authors.initials: E
authors.lastname: Koshak
authors.affiliation: Respiratory Unit, Department of Internal Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
authors.forename: Siraj
authors.initials: S
authors.lastname: Wali
authors.affiliation: Respiratory Unit, Department of Internal Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
authors.forename: Omer
authors.initials: O
authors.lastname: Alamoudi
authors.affiliation: Department of Medicine, King Abdulaziz University Hospital, Jeddah, Saudi Arabia.
authors.forename: Abdulrahman
authors.initials: A
authors.lastname: Demerdash
authors.affiliation: Department of Family and Community Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
authors.forename: Majdy
authors.initials: M
authors.lastname: Qutub
authors.affiliation: Centre of Excellence in Genomic Medicine Research, Faculty of Applied Medical Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.
authors.forename: Peter Natesan
authors.initials: PN
authors.lastname: Pushparaj
authors.affiliation: Research Cluster Biodiversity and Medicines, UCL School of Pharmacy, University College London, London, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Heinrich
mesh_terms: D000328:Adult; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D015415:Biomarkers / Q000032:analysis / Q000097:blood; D003131:Combined Modality Therapy; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008168:Lung / Q000187:drug effects / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D031881:Nigella sativa / Q000737:chemistry*; D008517:Phytotherapy / Q000379:methods; D010919:Placebos; D010936:Plant Extracts / Q000008:administration & dosage*; D012129:Respiratory Function Tests; D016896:Treatment Outcome
chemical_list: D018927:Anti-Asthmatic Agents; D015415:Biomarkers; D010919:Placebos; D010936:Plant Extracts
keywords: Nigella sativa; allergy; asthma; black seed; clinical trial; eosinophils