title: Effect of Borago Officinalis Extract on Moderate Persistent Asthma: A Phase two Randomized, Double Blind, Placebo-Controlled Clinical Trial.
abstract: BACKGROUND
  Borago officinalis and its derivatives are used in folk medicine to treat asthma because of its special effect on allergic disorders. It suppresses the tumor necrosis factor-alpha (TNF-alpha) and delivers gamma-linolenic acid. The objective of this clinical trial was to determine the effect of Borago officinalis on clinical and physiological findings in moderate persistent asthma.
  
  
  METHODS
  This prospective, randomized, double blind, placebo-controlled, clinical trial was conducted on patients aged 15-90 years with moderate asthma and forced expiratory volume in one second (FEV1) of 60-79% of predicted who presented to a sub-specialty clinic of pulmonary medicine. We randomly allocated subjects to receive either Borago extract (5 mL three times a day) or a matched placebo for one month. The primary outcome was the asthma control test (ACT) score and fractional exhaled nitric oxide (FENO) test. Secondary outcomes included clinical findings, spirometry, and sputum cytology including inflammatory cells.
  
  
  RESULTS
  Thirty-eight subjects with a mean age of 46.8±15.3 years and mean duration of asthma of 71±103 months were enrolled in our study. Cough, dyspnea, wheezing, nocturnal symptoms, and airway hyper-responsiveness reduced significantly in the Borago group after the treatment and ACT scores improved significantly (10.8±5.26 before and 15.4±5.12 after the trial). Flare up of asthma and emergency department visits in the Borago group also decreased significantly (3.6±2.33 to 2±1.86 flare ups per month and 0.62±0.9 to 0.05±0.23 for emergency department visits per month). Physiological parameters including spirometry, FENO, and sputum cytology including eosinophil and neutrophil did not change significantly.
  
  
  CONCLUSIONS
  Borago improved the clinical findings of asthma, but it was not able to suppress the inflammation involved in asthma.
authors.affiliation: Department of Internal Medicine, Faculty of Medicine, Islamic Azad University- Mashhad Branch, Mashhad, Iran.
authors.forename: Majid
authors.initials: M
authors.lastname: Mirsadraee
authors.affiliation: Innovative Medical Research Center, Faculty of Medicine, Islamic Azad University- Mashhad Branch, Mashhad, Iran.
authors.forename: Sara
authors.initials: S
authors.lastname: Khashkhashi Moghaddam
authors.affiliation: Department of Pediatric Surgery and Urology, Sheyikh Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Parisa
authors.initials: P
authors.lastname: Saeedi
authors.affiliation: Shahid Hasehemi Nezhad Research Center, Ministry of Education, Mashhad, Iran.
authors.forename: Sakineh
authors.initials: S
authors.lastname: Ghaffari
keywords: Asthma; Borago officinalis; Echium amoenum; Gamma-linolenic acid; Tumor necrosis alpha