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

Ethnopharmacological relevance: 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.

Keywords: Airway resistance; Asthma; Drimia maritima (L.) Stearn; Squill Oxymel; Traditional medicine.