Medical treatment of adenoid hypertrophy with mometasone furoate monohydrate nasal spray

Background: Treatment of adenoid hypertrophy is generally planned in accordance with the degree of airway obstruction and related morbidity. If surgical treatment is indicated, the individual risk/ benefit analysis of patients should be assessed in terms of anesthetic and postoperative complications. Although there are few alternative treatment options, intranasal steroid applications may be considered as a nonsurgical approach in less serious cases and have been presented in this study. Objectives of the study: To assess the effect of mometasone furoate monohydrate nasal spray on adenoid hypertrophy and to determine how many patients will be excluded from the surgical treatment. Patients and methods: A prospective, randomized, placebo controlled study was done in Al-Sader medical city in Najaf from the period of 31 of Dec. 2012 to 31 of Dec. 2013. Patients indicated for surgery were randomly divided into two groups. The study group was treated by mometasone furoate monohydrate nasal spray (NSSnasal steroid spray) of 100 micrograms/day (50 micrograms for each nostril) for 12 weeks. The control group was treated by normal saline (NS) nasal drops in the same way. All the patients were followed-up every 4 weeks. Results: At the end of 12 weeks, statistically significant improvement (p < 0.05) was observed in the NSS treated group compared to the NS treated group in terms of nasal airway obstruction, mouth breathing, and night cough. At the end of 12 weeks, the average total symptoms score of the NSS treated group dropped from 12.82 to 4.75 while the NS treated group’s score changed from 12.53 to 12.18. After 12 weeks of NSS treatment the initial adenoid/choana (A/C) rate had dropped from 87.14 to 51.42% and a total decrease of 35.72% was observed. After 12 weeks of NS treatment the A/C rate dropped from 87.5 to 85% and a total decrease of 2.5% was observed. Conclusions: Treatment with mometasone furoate monohydrate nasal spray provides an effective alternative to surgical treatment in children with adenoid hypertrophy. With the protocol applied in this study 77.2% of the patients were excluded from the surgery and removed from the surgical waiting list. Recommendations: The reliability of nasal steroids for the pediatric population is widely recognized. Although the mechanism itself has not yet been clearly and totally explained. We recommend that it is important to determine the role of intranasal corticosteroids in treating children with adenoid hypertrophy.


Abstract
Background: Treatment of adenoid hypertrophy is generally planned in accordance with the degree of airway obstruction and related morbidity.If surgical treatment is indicated, the individual risk/ benefit analysis of patients should be assessed in terms of anesthetic and postoperative complications.Although there are few alternative treatment options, intranasal steroid applications may be considered as a nonsurgical approach in less serious cases and have been presented in this study.

Objectives of the study:
To assess the effect of mometasone furoate monohydrate nasal spray on adenoid hypertrophy and to determine how many patients will be excluded from the surgical treatment.Patients and methods: A prospective, randomized, placebo controlled study was done in Al-Sader medical city in Najaf from the period of 31 of Dec. 2012 to 31 of Dec. 2013.Patients indicated for surgery were randomly divided into two groups.The study group was treated by mometasone furoate monohydrate nasal spray (NSSnasal steroid spray) of 100 micrograms/day (50 micrograms for each nostril) for 12 weeks.The control group was treated by normal saline (NS) nasal drops in the same way.All the patients were followed-up every 4 weeks.Results: At the end of 12 weeks, statistically significant improvement (p < 0.05) was observed in the NSS treated group compared to the NS treated group in terms of nasal airway obstruction, mouth breathing, and night cough.At the end of 12 weeks, the average total symptoms score of the NSS treated group dropped from 12.82 to 4.75 while the NS treated group's score changed from 12.53 to 12.18.After 12 weeks of NSS treatment the initial adenoid/choana (A/C) rate had dropped from 87.14 to 51.42% and a total decrease of 35.72% was observed.After 12 weeks of NS treatment the A/C rate dropped from 87.5 to 85% and a total decrease of 2.5% was observed.Conclusions: Treatment with mometasone furoate monohydrate nasal spray provides an effective alternative to surgical treatment in children with adenoid hypertrophy.With the protocol applied in this study 77.2% of the patients were excluded from the surgery and removed from the surgical waiting list.Recommendations: The reliability of nasal steroids for the pediatric population is widely recognized.Although the mechanism itself has not yet been clearly and totally explained.We recommend that it is important to determine the role of intranasal corticosteroids in treating children with adenoid hypertrophy.Keywords: adenoid hypertrophy, mometasone furoate monohydrate nasal spray

INTRODUCTION
Adenoid is a lymphoid tissue located in the roof and posterior wall of the nasopharynx.Adenoid hypertrophy is a common childhood disease.An enlarged adenoid can occlude the choana, especially when sleeping in a supine position.Symptoms due to airway obstruction like mouth breathing, hyponasal speech and snoring in children are observed. [1] Adenoid hypertrophy treatment for children is determined according to the degree of airway obstruction and related morbidity.If surgical treatment is indicated, the individual risk/ benefit analysis of patients should be assessed in terms of anesthetic and postoperative complications.Although there are few alternative treatment options, these may be considered as a nonsurgical approach in less serious cases. [3]Accordingly, studies about intranasal steroid applications under various protocols have been presented in the literature .

OBJECTIVES
To assess the effect of mometasone furoate monohydrate nasal spray on adenoid hypertrophy and to determine how many patients will be excluded from the surgical treatment.

PATIENTS AND METHODS
This is a prospective, randomized, placebo-controlled study of 65 patients with a symptomatic and surgically indicated adenoid hypertrophy.The study had been done in Al-Sader medical city in Najaf from the period of 31 of Dec. 2012 to 31 of Dec. 2013.Consent was obtained from the patients' parents after they were informed about the objectives of the study and the use of the drugs.Patients needed to meet the following inclusion criteria in order to enter the study (1)adenoid size occluding 75% of the nasopharynx, as determined with nasal endoscopy; (2) age between 5 to 15 years; (3) symptoms consistent with adenoid hypertrophy lasting for at least 6 months; (4) no previous adenoidectomy.Patients with one or more of the following criteria were excluded from the study (1)Children with concomitant tonsillar hypertrophy, (2)Positive history of allergy or atopy, (3)Upper respiratory infection within the past 2 weeks, (4)Nasal anatomic anomalies (e.g., nasal septum deviation), (5)Sinonasal diseases such as hypertrophy of inferior turbinate and/or nasal polyposis, (6)Craniofacial malformations including cleft lip/cleft palate, (7)Genetic diseases (e.g., Down syndrome), neurologic disorders, cardiovascular diseases, and immunodeficiency, (8)History of epistaxis or hypersensitivity to steroids, At the beginning, clinical history was obtained from the parents with a questionnaire and each child underwent physical evaluation and nasal endoscopy.Patient history included age, gender, history and family history of atopy or allergy, and use of drugs.Symptoms such as nasal obstruction, nasal discharge, cough, snoring, and obstructive sleep apnea were also evaluated at the first and at each subsequent visit, by using a clinical scoring system ranging from 0 to 3 (0 = absent; 1 = occasional; 2 = frequent; 3 = daytime and nighttime symptoms). [4]In this way, we gave each aforementioned symptom a score related to severity.All scores were summed to obtain an overall symptom score for each patient.
Nasal endoscopy was performed to estimate adenoid size and to identify other sinonasal disorders.After local anesthesia administration and decongestion of the nasal mucosa for 10 minutes with cotton pledgets soaked in xylocain, endoscopic examination was conducted by using a rigid (2.7-mm diameter) or flexible endoscope, according to the compliance of the child.Choanal openings from top to bottom were graded (grade 1-4) [5] , and determined as:

RESULTS
The demographic data for 65 patients is presented in Table (1), Table (2) shows that at the beginning of the treatment and at the end of the 12 weeks follow-up period, symptoms of nasal airway obstruction were assessed.By taking all the symptoms into consideration, the average total symptoms score for each group was calculated and compared, (Fig. 1).
For both NSS and NS groups, the total symptoms scores were nearly similar prior to the treatment.At the end of the 12 weeks, the average total symptoms score of the NSS treated group dropped from 12.82 to 4.75 with a statistically significant difference (t= 6.13 , p =0.004), while the NS treated group's score Figure (2) shows that the adenoid/choana (A/C) rate of the NSS treated group after 12 weeks dropped from 87.14% to 51.42% and a total decrease of 35.72% was observed.For the NS treated group the A/C rate after the 12 weeks dropped from 87.5% to 85% and a total decrease of 2.5% was observed.Table (3) shows that among the 35 patients who had NSS treatment, 27(77.2%)patients were not longer needing for surgery.Adenoidectomy was applied to 4 (11.4%)patients and the remaining 4 (11.4%) were informed of their ongoing need for surgery but their parents refused the operation.Of the 30 patients who were treated with normal saline, all of them (100%) underwent adenoidectomy.

DISCUSSION
Adenoid hypertrophy is probably the most frequent pathologic condition occurring in the pediatric age group.It leads to different clinical manifestations according to adenoid size.Bilateral nasal obstruction is a primary complaint that can be associated with different sleep disorders, ranging from snoring to OSAS [6] .In such a situation, patients typically complain of both nighttime and daytime behavioral illnesses (i.e., intermittent sleep, sleepwalking, morning headaches, difficulty concentrating, daytime sleepiness, enuresis, slow feeding, and poor growth), which may lead to cardiorespiratory syndromes such as cor pulmonale in extreme cases. [7]Rhinorrhea, mouth-breathing, hyponasal speech, and cough can also be observed in patients with adenoid hypertrophy.At present, adenoid hypertrophy is one of the most frequent indications for surgery in childhood, and adenoidectomy commonly is considered definitive treatment for nasopharyngeal obstruction. [8]Nevertheless, this surgical technique has been the subject of some criticism.Paulussen et al [9] hypothesized that the removal of adenoid lymphatic tissue could have a negative impact on the systemic immunologic system.Moreover, immediate postoperative or late bleeding is observed in 1% of children who undergo adenoidectomy.Furthermore, it is well demonstrated that adenoids may recur after surgery in 10% to 20% of cases. [10]n our study, the effect of mometasone furoate monohydrate nasal spray on adenoid hypertrophy was assessed to determine how many patients will be excluded from the surgical treatment.In 2005, Brouillette et al [11] tested the efficacy of another intranasal steroid treatment for OSAS in a randomized, placebo-controlled clinical study by studying the use of fluticasone propionate nasal spray versus placebo for 25 children affected by OSAS, as demonstrated with polysomnography.After treatment, the mixed/obstructive apnea/ hypopnea index, frequency of hemoglobin desaturation, and respiratory movement/arousals decreased more in the fluticasone-treated group, compared with the placebo-treated group.Moreover, improvements in symptom scores were observed for 69% of children who received fluticasone.
In 2003, Criscuoli et al [12] by studying 53 children, they reported on the longterm outcomes of treatment with aqueous nasal beclomethasone for patients with adenotonsillar hypertrophy.Twenty four patients exhibited improvement after 2 weeks of steroid treatment, and an additional 24 weeks of therapy at a lower steroid dose maintained clinical improvement for 45.8% of those patients.Recently, Cengel and Akyol [13] assessed the efficacy of Mometasone furoate monohydrate in the treatment of adenoid hypertrophy, in a prospective, controlled, randomized, clinical trial.Of 122 patients enrolled, 67 received intranasal Mometasone furoate monohydrate (100 mcg/day) therapy for 6 weeks, whereas 55 patients were assigned to the control group.After treatment, a significant decrease of the adenoid mass was observed for 67.2% of the study group, whereas the clinical situation was unchanged in the control group.They reported that the A/C rate decreased by 50%.Ciprandi et al [4] showed significant decrease (p < 0.05) in average adenoid size after 8 weeks of Flunisolide treatment compared to normal saline treatment.Berlucchi et al [14] in a placebo-controlled study observed that the average symptoms score dropped from 11 to 3 in the group treated by Mometasone furoate spray and from 10 to 9 in the placebo treated control group.They also observed a 20% decrease in average choanal obstruction in the Mometasone group and 0.0% in the placebo group Lepcha et al [15] reported, on the contrary to other studies, that although there was a decrease in symptom scores after 12 weeks with Beclomethasone treatment , it did not constitute a statistically significant difference comparing to placebo control group's scores .
Brouillette et al [11] also reported that reduction in adenotonsillar hypertrophy caused by Fluticasone spray did not show statistically significant difference compared to placebo.
Regarding the need for surgery after the nasal steroid treatment of the adenoid hypertrophy, our study showed that among the 35 patients who had NSS treatment, 27(77.2%)patients were not longer needing for surgery.Adenoidectomy was applied to 4 (11.4%)patients and the remaining 4 (11.4%) were informed of their ongoing need for surgery but their parents refused the operation.Of the 30 patients who were treated with normal saline, all of them (100%) underwent adenoidectomy.Criscuoli et al [12] reported in their first long-term study that out of a total 24 patients who responded well to the initial treatment, 13 patients (54%) were still in need of surgery.Berlucchi et al [14] informed that after Mometasone furoate treatment only 2 of 39 patients who were indicated for adenoidectomy underwent the surgery.Corticosteroids are generally well tolerated in children.In our study, for each nostril a maximum dose of 50 microgram/day, and for each patient total dose of 100 micrograms/day, was used for 12 weeks.We have not observed any side effects in our patients.

CONCLUSION
This study provides an effective alternative to surgical treatment in children with adenoid hypertrophy.With the protocol applied in this study 77.2 % of the patients were no longer needing the surgery therefore they were removed from the surgical waiting list.Intranasal corticosteroids are well tolerated by children; however, the most appropriate drug, the most efficient dose and optimal treatment duration continue to be investigated and determined by way of further prospective and randomized studies.

Fig ( 2 )
Fig (2): A/C rate before and after treatment

Table (
Among the 30 patients (control group) who were treated by the nasal saline drops(NS), their age ranging from 5 to 13 years with mean age equal to 8.5 years.
This table shows that among the total 65 patients, 30 patients were males and 35 were females.Also it shows that 35 patients were treated by the nasal steroid spray(NSS).Their age ranging from 5 to 14 years with mean age equal to 8.6 years.

Table ( 3) Surgical need among the two groups
At the end of 12 weeks treatment, a statistically significant improvement in nasal airway obstruction symptoms was observed in the nasal steroid spray( NSS) treated group compared to the normal saline drops(NS) control group (p < 0.05).Patients' average total symptoms score dropped from 12.82to 4.75 in the NSS group and from 12.53 to 12.18 in the control group.The average total symptom score of the NSS treated group decreased by 63%.Regarding the adenoid size, after 12 weeks of treatment, the decrease in the A/C rate was 35.72% in the NSS group and only 2.5% in the NS group.