The Role of Montelukast Sodium in Children with Adenoid Hypertrophy - A Comparative Study

Abstract

Background Adenoid Hypertrophy (AH) results in symptoms ranging from mild nasal obstruction to the dangerous obstructive sleep apnoea. Normally for such patients Adenoidectomy with or without Tonsillectomy is carried out. However complications like haemorrhage and recurrence of adenoid tissue are common. Thus, non-surgical therapies have attracted considerable attention as an alternative strategy. The present study is aimed at evaluating the effect of oral Montelukast, a cysteinyl- leukotriene receptor antagonist, in children with AH.

Materials and Methods Sixty children aged between 6 and 12 years with adenoid hypertrophy were randomly divided into two groups of thirty each. The study group was prescribed Tablet Montelukast 5 mg daily for 12 weeks while the control group received matching placebo. A questionnaire based upon the severity of the symptoms as well as the Adenoid Nasopharynx ratio (A/N), as measured via X-ray Adenoids and the Nasal endoscopic scores done before and after treatment (at 3 months) in the two groups were taken into consideration .

Results The Mann Whitney Test which was used found no distinction in snoring, sleep discomfort and mouth breathing between the two groups before the start of treatment. But a significant difference was indeed observed between the two groups after treatment in case of snoring (P < 0.006), sleep discomfort(P < 0.001) and mouth breathing (P < 0.001).

Conclusion Oral Montelukast therapy is seen to be effective not only in the reduction of the size of adenoids but also in improvement of the overall symptoms and can thus be considered as a viable alternative .

Introduction

Adenoid hypertrophy (AH) is considered to be one of the most common causes of nasal obstruction as well as the genesis of Obstructive Sleep Apnea in the pediatric age group[1]. The adenoid or the nasopharyngeal tonsil is an important constituent of the Waldeyer’s Internal ring. As a result of its close connection to the choanae and Eustachian tube, it is also most often the site of beginning of numerous ear and nose related illness in youth. Significant AH (> 75% obstruction) may culminate in obstructive sleep apnea, ear issues like Otitis Media with effusion, pulmonary hypertension, craniofacial abnormalities and also the inability to thrive[2]. Adenoidectomy is a typical strategy employed for most of these patients but may sometimes lead to serious complications such as bleeding, postoperative respiratory compromise as well as recurrence of adenoid tissue. Levels of serum immunoglobulins have also seen to be lower in patients who had undergone adenoidectomy than in healthy control group[3]. Thus, non-surgical therapies have attracted considerable attention as an alternative strategy.

Leukotrienes, the primary inflammatory marker in the respiratory system, are actively involved with the pathogenesis of illness like asthma and adenoid hypertrophy[4]. Human cysteinyl-leukotriene receptor-1 is markedly raised in the adenotonsillar tissue of child with obstructive sleep apnea (OSA)[5, 6]. Hence, Leukotrienes anti-inflammatory agents may provide an effective interventional alternative to adeno tonsillectomy. Montelukast, an oral cysteinyl-leukotriene receptor antagonist has been in use in the treatment of asthma and allergic rhinitis since a long time and there is hardly any evidence of any drug resistance in long term studies[7, 8]. The motivation behind this study is aimed precisely at evaluating this anti-inflammatory effect of oral Montelukast in the reduction of the size of the adenoids and thus in the reduction of overall symptomatology in a child with AH.

Materials and Methods

This double-blind, randomized, placebo-controlled clinical trial was performed from October 2020 to September 2021 in our Outpatient Department. Sixty children aged between 6 and 12 years with adenoid hypertrophy were randomly divided into two groups of thirty each. The study group was prescribed Tablet Montelukast 5 mg daily for 12 weeks while the control group received matching placebo for the same period of time. A questionnaire based upon the severity of sleep discomfort, snoring, and mouth breathing was prepared and given to the parents/guardians. Diagnostic tests included a clinical evaluation, lateral neck radiography and nasal endoscopy, done at the start and end (third month) of the study period. We included children between 6 and 12 years of age with habitual snoring and grade 2 or greater nasopharyngeal obstruction on endoscopy examination and 50% (A/N > 0.67) or more in Adenoid Nasopharynx ratio (A/N) in radiographic studies.

Those excluded from the study includes obesity defined as BMI > 1.645 (95%), craniofacial, neuromuscular, syndromic, or defined genetic abnormalities, current or previous use of montelukast, acute upper respiratory tract infection, use of any corticosteroids or antibiotics within 4 weeks preceding the study, and any child having undergone adenotonsillectomy in the past.

Lateral neck radiography was performed once at the initiation and once again after the 12-weeks therapeutic course using the standard technique. The neck was extended, and the patient was instructed to breathe through the nose with the mouth closed [Fig. 1].

Fig. 1.

Lateral Neck Radiography & calculation of the A/N ratio

Adenoidal/nasopharyngeal ratio was measured according to the time-tested Fujioka method. Fujioka described the A/N ratio for measurement of the obstruction in 1979. It was calculated as the ratio of the distance between the outermost point of anterior convexity of the adenoid shadow (A) and the straight part of the anterior margin of the sphenobasiocciput (B) to the distance between sphenobasioccipital synchondrosis(B) and the posterior end of the hard palate (N). An A/N ratio > 0.67 was considered to indicate adenoidal hypertrophy.

Nasal endoscopy (2.7-mm Karl Storz 0-degree rigid endoscope) was performed using a topical solution consisting of 4% xylocaine and 0.5% phenyl ephedrine without any sedation. The degree of obstruction by the adenoid tissue over the posterior choanae was estimated using the grading system proposed by Parikh et al. Grade 1 for adenoid tissue not in contact with adjacent structures; grade 2 for adenoid tissue in contact with torus tubarius, grade 3 for adenoid tissue in contact with vomer, and grade 4 for adenoid tissue in contact with soft palate (at rest).

The primary outcome measures were scores for snoring, mouth breathing, and sleep discomfort. Secondary outcome measures were the adenoid size estimate based on endoscopy and lateral neck radiography. Based on symptom severity, a score of 0–3 was given as follows: symptoms never existed: 0; occasional symptoms: 1; present at most times: 2; always present: 3. All numerical data was subjected to statistical analysis with Mann Whitney Test. P < 0.05 was considered significant.

Results

In total sixty children meeting the inclusion criteria were considered and there were no withdrawals, nor any side-effects observed in them. Here, the main studied symptoms were snoring, mouth breathing and sleep discomfort. The Mann Whitney Test found no distinction in snoring between the two groups (P = 0.101). But a significant difference was indeed observed between the two groups after treatment (P < 0.006) [Fig. 2]. Regarding sleep discomfort, no significant difference between the two groups was seen towards the start of study (P = 0.305). However statistically significant difference observed after treatment (P < 0.001) [Fig. 3]. In regard to mouth breathing, the trend was more or less similar to sleep discomfort with meaningful difference only after completion of the therapeutic period of 3 months or 12 weeks (P = 0.43 vs. P < 0.001) [Fig. 4].

Fig. 2.

Snoring scores before and after treatment

Fig. 3.

: Before and after treatment of Sleep discomfort score

Fig. 4.

Before and after treatment of Mouth breathing score

The patients’ symptoms were also studied by the means of nasal endoscopy and lateral neck radiography before and after the treatment course wherein a marked decrease of ≥ 25% was seen in the size of adenoids after treatment. P < 0.0001 was considered measurably significant [ Figs. 5 and 6 ].

Fig. 5.

Before and after Nasal Endoscopy score

Fig. 6.

Pre-treatment ( Left) & Post- treatment( Right) Endoscopic pics

Discussion

Adenoid Hypertrophy is a common disease affecting the pediatric population and is responsible for many morbidities like Eustachian Tube obstruction, Obstructive Sleep Apnea, recurrent upper respiratory tract infections, etc. Removal of adenoid or adenoidectomy is widely practised worldwide. However, the adenoid tissue may re-grow even after the surgery owing to chronic hypersensitive responses or infections[9]. Besides this, there are associated complications like massive bleeding, velopharyngeal insufficiency and risks of anesthesia. Hence, alternative treatment methodologies have grown over the time. This includes our study which exhibits that oral Montelukast Sodium when given to the children with AH for 3 months has effectively alleviated the severity of snoring, mouth breathing and sleep disturbances along with decrease in the size of adenoid tissue. Moreover, this treatment was all around endured by the patients with no side effects. Regardless of the troubles in performing nasal endoscopy, it has a solid connection with the clinical symptoms[10]. Shokouhi et al. observed a significant reduction in the size of adenoids (> 30%) in a group receiving Montelukast which supports our study[11]. In a study by Goldbart et al., Montelukast sodium (4 mg for age < 6 yrs and 5 mg for > 6yrs)) was utilized in the treatment of Obstructive Sleep Apnea in forty children between 4 and 12 years for 3 months[12]. A significant improvement was seen in polysomnographic parameters (> 50%) and the Adenoidal Nasopharyngeal proportion in radiography decreased from 81 to 57%. We found moderate to severe symptoms in our study while in the previously mentioned study, the manifestations were mild to moderate. Tuhanioǧlu B and Erkan SO additionally discovered reduction upto 45% in the adenoid size in the group that have taken Montelukast sodium [13]. Generally, Montelukast can be recommended as a substitute to surgical procedure to prevent post-operative complications.

Conclusion

There is an ever-increasing evidence of the role of Adenoid Hypertrophy in the various pediatric airway diseases like snoring, obstructive sleep apnea and eustachian tube dysfunction. The results of this study support the introduction of a leukotriene modifier as a novel and safe therapeutic alternative for the treatment of children with symptoms of adenoid hypertrophy. A notable decrease is observed in the size of adenoid tissue along with improvement in the clinical symptoms with Montelukast Sodium treatment. So it can safely be considered as an effective alternative to surgical procedure in children with enlarged adenoids.

Statements and Declarations

Source of financial Support

The present study did not receive any specific grant from any funding agencies. No funding agency has participated in writing or in submission of the manuscript.

Conflict of Interest and Informed Consent

The authors declare no conflicts of interest with respect to the research and publication of this article and that the procedures were conducted with the understanding and the consent of the patient and their parents.

The manuscript has been read and approved by all the authors. It has been cleared by Tata Main Hospital Ethical Committee (approval no - TMH/EC/21/151,166).