Abstract
Nasal polyposis is one of the most common chronic upper airway diseases. Management of allergic rhinosinusitis with polyps is to control the disease process and the local immune response of the nasal mucosa. This is achieved by surgical removal of polypoid mucosa of all sinuses by functional endoscopic sinus surgery (FESS) followed by suppression of local immune response by using steroids. Budesonide nasal douching was introduced recently for postoperative management of patients with allergic rhinosinusitis. The therapeutic effectiveness and safety of this procedure are becoming accepted by many physicians. Evaluation of the efficacy of budesonide nasal irrigation in the postoperative management of chronic allergic rhinosinusitis with polyps. A total of 60 postoperative chronic allergic rhinosinusitis with polyps patients were randomly divided into two groups. Both groups received routine post-FESS medication as per the institute protocol. One group of patients received budesonide nasal douching in addition to regular care. Both groups were evaluated endoscopically at 1, 2, 6 and 10 weeks after surgery. Pre and postoperative quality of life change, the patient complaints, need for revision surgery were evaluated. Endoscopic Lund–Kennedy scoring (objective measurement) and Sino-Nasal Outcome Test-22 (subjective analysis) were used to compare the two postoperative groups. The average preoperative Sino-Nasal Outcome Test 22 score was 52.2. It was reduced to an average of 29.4 in patients who used the standard postoperative regimen and to 15.8 postoperatively in patients who had budesonide added to their douching solutions. The average endoscopy score was 2.2 for patients who did receive budesonide as compared to 2.9 for patients who did not receive budesonide nasal douching. Budesonide nasal douching can offer a safe and effective tool in managing local inflammatory response in allergic rhinosinusitis. It leads to a significantly better quality of life and has an adequate response on nasal mucosa—leading to less mucosal oedema and lower incidence of polypoidal changes postoperatively.
Keywords: Chronic allergic rhinosinusitis, FESS, Steroid douching
Introduction
Chronic allergic rhinosinusitis represents a chronic inflammatory condition of the mucosa of the nose and sinuses that ultimately lead to the outgrowth of abnormal masses from the mucosa of the nasal cavity and paranasal sinuses. The characteristic features include nasal obstruction, anosmia or hyposmia and impaired quality of life.
Effective control of the disease process relieves symptoms, improves the quality of life and reduces recurrence of the disease. Management includes a regimen of oral corticosteroids, topical steroid nasal spray and isotonic saline nasal douching. Patients not responding to possible medical treatment often undergo an endoscopic sinus surgery.
While systemic antibiotics are useful to treat episodic exacerbations of CRS with infection, there is little evidence to recommend them as a long-term treatment. Nevertheless, antibiotics are often prescribed for CRS, and national surveys suggest a significant degree of over utilisation, which is associated with the development of serious adverse effects and resistant organisms [1]. In contrast, topical nasal steroid sprays are safe and effective in the long-term management of CRS [2].
Systemic steroid therapy gives better results, but it is associated with side effects like elevated blood sugar levels, hypertension, peptic ulcers, etc. Topical steroids in the form of an intranasal spray, on the other hand, act locally and are relatively free for these systemic side effects. Intranasal steroid therapy has been proven to decrease the size of the polyps and reduce recurrence rate postoperatively. However, the penetration of steroid beyond the nasal cavity and into the paranasal sinuses is limited, indicating that a better delivery method is needed to improve intra sinus corticosteroid deposition [3].
Recently, the delivery of topical steroid by way of douching has been introduced. One of the drugs used for instillation in topical forms is budesonide. Budesonide, at daily doses ranging from 250 µg to 2 mg has been used for irrigation.
Aim and Objectives
Our aim is evaluating the effectiveness of the addition of budesonide to large volume, low-pressure saline nasal irrigation as a tool for controlling local inflammation in post-FESS patients of allergic rhinosinusitis with polyps.
We use both subjective outcome measure, i.e. Sino-Nasal Outcome Test-22 and objective outcome measure, i.e. Lund–Kennedy endoscope score for the assessment.
Materials and Methods
Study Type
This study carried out at the Department of otolaryngology and head and neck surgery, Santhiram general hospital, and it was a prospective study.
Inclusion Criteria
Patients with allergic rhinosinusitis with nasal polyps irrespective age and gender.
Exclusion Criteria
Patients with co-morbid conditions like diabetes, hypertension, history of pituitary disease, morbidly obese, on oral contraception, pregnancy, chronic liver disease and chronic renal disease were excluded.
Methodology
Sixty post-FESS patients who were operated for nasal polyposis were included in this study and were divided into cases and controls. The treatment protocol at our hospital is to start the patient on oral methylprednisolone 8–16 mg/day for 1 week before surgery which is then continued till 1 week postoperatively and then gradually tapered. Patients were also started on Fluticasone nasal spray and isotonic saline nasal douching after nasal pack removal. Oral antibiotics are continued for 1 week postoperatively.
We added budesonide to isotonic saline nasal irrigation to the regimen of 30 patients that were operated. About 2 mg of budesonide was mixed in 250 mL normal saline, and the solution was used for douching—in the morning and the evening. Budesonide douching continued for 10 weeks postoperatively.
The outcome measure was a change in the quality of life based on the 22-item Sino-Nasal Outcomes Test (SNOT-22) and was a change in the Lund–Kennedy endoscopy (LK) score. A single physician measured the scores to minimise bias. An initial study was carried out before the nasal irrigation with budesonide, and this was followed-up 1, 2, 6 and 10 weeks postoperatively in the outpatient clinic. Therefore, both subjective and objective criteria were used to compare the effects of budesonide nasal douching. The data were analysed using student’s t test and Chi square tests as applicable.
Endoscopic Lund–Kennedy Score
The Lund–Kennedy endoscopic score is an objective endoscopic assessment. It has five components, each with a score of 0–2 and the total score is 10.
| 0 | 1 | 2 | |
|---|---|---|---|
| Polyp | Absent | Within middle meatus | Extending into the nasal cavity |
| Mucosal oedema | Absent | Mild/moderate | Polypoid degeneration |
| Secretion | Absent | Hyaline | Thick/mucopurulent |
| Scaring | Absent | Mild | Severe |
| Crusting | Absent | Mild | Severe |
Sino-Nasal Outcome Test
Results
The average age of the patients was 30.5 years with a male to female ratio of 1:1.5. The average preoperative SNOT-22 score was 52.2. It was reduced to an average of 29.4 in patients who used the standard postoperative regimen and to 15.8 postoperatively in patients who had budesonide added to their douching solutions. This difference was found to be statistically significant p value—0.001 (Table 1). The endoscopy score also improved from 7.4 before irrigation to 2.2 after 10 weeks (Table 2). This difference was found to be statistically significant p value—0.001.
Table 1.
SNOT-22 score pre and post operatively
| SNOT-22 score | |
|---|---|
| Preoperative | 52.2 |
| Postoperative with budesonide | 15.8 |
| Postoperative without budesonide | 29.4 |
Table 2.
Lund–Kennedy score pre and post operatively at the end of 10 weeks
| Lund–Kennedy endoscopy score | |
|---|---|
| Preoperative | 7.4 |
| Postoperative with budesonide | 2.2 |
| Postoperative without budesonide | 2.9 |
Our study showed budesonide nasal irrigation in post FESS patients who suffered from chronic allergic rhinosinusitis with polyps was effective in relieving the nasal symptoms and able to reduce the repeated use of oral steroid postoperatively. Nasal irrigation with budesonide during post-sinus surgery period is essential, especially for long-term treatment of recurrent CRS, to permit exposure of the drug to the mucosa.
Discussion
Budesonide is a potent topical corticosteroid with an approximately 1000-fold higher topical anti-inflammatory potency than cortisol. Budesonide binds the glucocorticoid receptor and exerts an anti-inflammatory effect through several mechanisms including altering the release of arachidonic acid metabolites, decreasing the vascular permeability, inhibiting the accumulation of leukocytes in the affected tissue, inhibiting neuropeptide mediated responses, and altering the secretion of glycoproteins from sub-mucosal glands.
Our study shows that constant nasal irrigation with budesonide solution twice a day can prevent worsening of the disease and so improve quality of life, and even minimise systemic steroid usage. The safety and usefulness of this method of delivering topical steroids have been studied in CRS and been accepted by many physicians [4, 5]. Various authors have used budesonide solutions of different strengths for better results in managing chronic rhinosinusitis. Seiberling et al. used 0.25 mg budesonide per day, Welch et al., used 2 mg/day while Bhalla used 1 mg/day for nasal douching by mixing respules of budesonide in normal saline [6]. All authors have achieved varying degrees of success using topical steroid douching in controlling nasal mucosal inflammation.
A recent meta-analysis showed that topical steroid is effective against sino-nasal symptoms in patients with CRS and prevents polyp recurrence in CRS with nasal polyps after FESS [7]. After FESS, delivery of the drug to sinus mucosa is difficult because the open target area is both large and deeper in the paranasal sinus cavity [8]. Large-volume, low-pressure nasal douching results in better distribution of therapeutics to the nasal cavity and sinuses than low-volume devices [9, 10]. Furthermore, these large-volume, low-pressure devices can overcome the adverse effects of head position or nasal cavity anatomy on distribution.
Limitations
There are some limitations to this study. First, the duration of the study was only 10 weeks and, given the long period of symptoms and chronic nature of the disease for many participants, this may have been an insufficient time to see the full effect of the budesonide therapy.
Compliance was assessed by patient self-report, as we did not have formal compliance assessments. Thus, we cannot be sure that participants completed the full 10 weeks of treatment.
Conclusion
In conclusion, this study shows that the use of budesonide in large-volume, low-pressure saline nasal lavage results in clinically meaningful benefits among the various postoperative treatments for this CRS with polyps patients, and it is an effective method for improving quality of life, preventing recurrence of the disease and reducing the use of the oral steroid. Further study on the appropriate dose, frequency of irrigation, and duration of treatment are needed, along with an assessment of the safety of its long-term use, to encourage extensive use of nasal irrigation with budesonide.
Funding
The authors did not receive any funding.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
Footnotes
Publisher's Note
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