Montelukast As An Adjunct To Treatment of Chronic Rhinosinusitis With Polyposis: A Prospective Randomized Controlled Trial

Chronic rhinosinusitis with nasal polyposis (CRSwNP) is one of the most difficult forms of CRS to treat and exhibits frequent recurrence regardless of therapeutic modality (1). Current consensus guidelines support longterm medical treatment with intranasal corticosteroid (INCS) sprays, supplemented with short, infrequent courses of oral corticosteroids. Several reviews have systematically examined local corticosteroid use in patients with CRSwNP, showing improvements in symptom scores and polyp size via meta-analysis (2,3). Similarly, highlevel evidence supports the use of oral corticosteroids in CRSwNP patients to improve symptoms and polyp size (4); however, the effects are short lived, and long-term use is limited because of the risk of severe side effects. Despite the routine use of corticosteroid medications, a large percentage of patients with CRSwNP will continue to have ongoing symptoms requiring additional treatment, usually in the form of surgery, which provides immediate improvement but is not curative. In recent years, there has been increasing interest in the potential role of leukotrienes, potent biological mediators produced by eosinophils, mast cells, monocytes and basophils. They are derivatives of arachidonic acid via the 5-lipoxygenase pathway. There is convincing evidence for the role of leukotrienes in the pathogenesis of asthma, by causing bronchoconstriction, airway hyperresponsiveness, and airway inflammation (5). A number of drugs that selectively modify the leukotriene pathway (or antileukotrienes) have been developed (6). These use one of the two main strategies: either inhibition of the production of leukotrienes by 5-lipoxygenase (zileuton), or by antagonism of the action of the leukotriene at the Introduction Abstract In a prospective, randomized controlled trial, forty consecutive adult patients with bilateral nasal polyps were randomized into two groups. Twenty subjects in Group A were treated with oral prednisolone for 14 days and budenoside nasal spray for 8 weeks while the twenty subjects in Group B received a similar treatment with additional oral montelukast for 8 weeks. Subjects completed a modified nasal ICSD symptom score at the start of treatment and at 8 and 12 weeks after beginning the treatment. Symptom scores improved in both the groups after treatment. Subjects in Group B reported a statistically significant improvement in sense of smell (p = 0.0002), sneezing (p = 0.008) and overall score (p = 0.0006) at 8 weeks than controls. Four weeks after the completion of treatment, a statistically significant improvement was seen in the sense of smell (p = 0.0006), headache (p = 0.03) and overall score (p = 0.003) in patients in Group B when compared to Group A. Montelukast therapy may have clinical benefit as an adjunct to oral and inhaled steroid in chronic nasal polyposis.