title: Squill Oxymel, a traditional formulation from Drimia Maritima (L.) Stearn, as an add-on treatment in patients with moderate to severe persistent asthma: A pilot, triple-blind, randomized clinical trial.
abstract: BACKGROUND
  In Traditional Iranian Medicine (TIM), Squill (Drimia maritima (L.) Stearn) Oxymel was utilized in the treatment of asthma. Squill has been reported to exert anti-inflammatory, anti-oxidant, anti-cholinergic, and mucus secretion modulating effects.
  
  
  OBJECTIVE
  This study aimed to make a preliminary evaluation of the efficacy and safety of an add-on Squill Oxymel treatment in patients with moderate to severe persistent asthma.
  
  
  METHODS
  In a 6-week, triple-blind, randomized, placebo-controlled trial, 60 patients with stable moderate to severe persistent asthma were randomly allocated to receive either 10ml syrup of Squill Oxymel, simple oxymel, or a placebo 2 times a day, as an add-on to their routine treatment (inhaled corticosteroids and β2 agonists). Spirometry and plethysmography were performed on patients to evaluate the effect of the treatment at baseline and end of intervention. Forced Expiratory Volume in first second (FEV1) was considered the primary outcome. St. George's respiratory questionnaire (SGRQ) was also used for the subjective evaluation of patients' responses.
  
  
  RESULTS
  Fifty-four patients completed the study. The results showed significant improvement in spirometry parameters, especially FEV1 (1.54±.38 vs. 2.11±.49l), in the Squill Oxymel group compared with the other groups. The increases in FEV1 liter, FEV1%, FEV1/FVC%, and MEF 25-75% during the intervention were significantly higher in the Squill Oxymel group than in the other groups (p<.001). However, the improvement of plethysmographic parameters showed no significant difference between the study groups (p>.05). The SGRQ scores (symptoms, activity, and total score) were significantly improved after intervention in both the Squill Oxymel and the simple honey oxymel groups (p<.001), but not in the placebo group. Nausea and vomiting was reported in 5 patients in Squill oxymel and simple oxymel groups. No other serious adverse event was observed.
  
  
  CONCLUSIONS
  The results of the current study show preliminary evidence for the efficacy and safety of the add-on treatment of Squill Oxymel in patients with moderate to severe persistent asthma.
authors.affiliation: Department of Iranian Traditional Medicine, School of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Fatemeh
authors.initials: F
authors.lastname: Nejatbakhsh
authors.affiliation: Department of Iranian Traditional Medicine, School of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Hossein
authors.initials: H
authors.lastname: Karegar-Borzi
authors.affiliation: Department of Pharmacognosy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Gholamreza
authors.initials: G
authors.lastname: Amin
authors.affiliation: Department of Pulmonary Medicine, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Alireza
authors.initials: A
authors.lastname: Eslaminejad
authors.affiliation: Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Mostafa
authors.initials: M
authors.lastname: Hosseini
authors.affiliation: Department of Traditional Pharmacy, Faculty of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Mahbubeh
authors.initials: M
authors.lastname: Bozorgi
authors.affiliation: Department of Pulmonary Medicine, Imam Khomeini Hospital, Keshavarz Boulevard, Medical Sciences/Tehran University, Tehran, Iran. Electronic address: asadi_m@tums.ac.ir.
authors.forename: Mehrnaz Asadi
authors.initials: MA
authors.lastname: Gharabaghi
mesh_terms: D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D031448:Drimia; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010865:Pilot Projects; D028321:Plant Preparations / Q000009:adverse effects / Q000627:therapeutic use*; D018517:Plant Roots
chemical_list: D018927:Anti-Asthmatic Agents; D028321:Plant Preparations
keywords: Airway resistance; Asthma; Drimia maritima (L.) Stearn; Squill Oxymel; Traditional medicine