|Year : 2016 | Volume
| Issue : 3 | Page : 135-140
Effects of oral prednisolone and fluticasone nasal spray in the management of nasal polypi
Krunichuno Rino1, Mohonish N Chettri2, Niteshore Singh Moirenthem3, Rita Zoramthari4, Kalpana Devi Thongam4, M Madhumangal Singh5
1 ENT Specialist, Government of Nagaland, Nagaland, India
2 Assistant Professor of ENT, SMIMS, Gangtok, Sikkim, India
3 ENT Specialist, Government of Mizoram, Mizoram, India
4 ENT Specialist, Government of Manipur, Imphal Manipur, India
5 Professor and Head of ENT, JNIMS, Imphal Manipur, India
|Date of Web Publication||28-Sep-2016|
Mohonish N Chettri
Assistant Professor of ENT, SMIMS, Gangtok, Sikkim
Source of Support: None, Conflict of Interest: None
Background : Nasalpolyp presents a significant challenge in management due to its frequent recurrences. This study focuses on a medical model of combined local and systemic therapy for efficacy. Aims: Evaluation of a combined therapy, oral prednisolone, and fluticasone propionate nasal spray in the management of nasal polypi. Materials and Methods: This study was carried out in a tertiary care hospital in northeast India during a period of 18 months from 2010 to 2011. The recruitment of patients was done for 13 months and follow-up done for 3 months. The diagnosis made on the basis of physical examination, diagnostic nasal endoscopy, and radiological findings. The patients were evaluated for effects of combined treatment with fluticasone propionate nasal spray and oral prednisolone and followed up for 3 months. Descriptive statistics and analysis were carried out wherever applicable and P < 0.05 was considered statistically significant. Results: Altogether 67 patients were enrolled in this study. The most common presentation was observed in males in the fourth decade. With our modality, 98.5% showed a reduction in nasal obstruction score after treatment, and 83.6% showed a reduction in nasal discharge symptom score. Sixty patients (89.6%) showed a reduction in hyposmia symptom score after treatment and 68.7% showed a reduction in facial pain symptom score after treatment. Nasal polyp size was found to be significantly reduced after treatment, and no patients developed any adverse effects during or following the treatment initiation except mild burning sensation with fluticasone nasal spray (three patients) which subsided after a few days. Conclusion: We found that a 3-week course of combined oral prednisolone and fluticasone-propionate nasal spray is effective in decreasing polyp size and improving nasal symptoms for nasal polyposis, without sustained adverse effects.
Keywords: Combined therapy, fluticasone spray, medical management, nasalpolyp, oral prednisolone
|How to cite this article:|
Rino K, Chettri MN, Moirenthem NS, Zoramthari R, Thongam KD, Singh M M. Effects of oral prednisolone and fluticasone nasal spray in the management of nasal polypi. J Med Soc 2016;30:135-40
|How to cite this URL:|
Rino K, Chettri MN, Moirenthem NS, Zoramthari R, Thongam KD, Singh M M. Effects of oral prednisolone and fluticasone nasal spray in the management of nasal polypi. J Med Soc [serial online] 2016 [cited 2020 Oct 31];30:135-40. Available from: https://www.jmedsoc.org/text.asp?2016/30/3/135/191176
| Introduction|| |
Nasal polypi are one of the most commonly encountered conditions in the Otorhinolaryngology outpatients department (OPD). Nasal polypi are benign nasal masses, proliferation of the mucous membrane of the ethmoidal sinuses characterized by chronic inflammatory status. Interestingly, only man and chimpanzees are said to be affected by this condition. 
The most common symptoms are a nasal obstruction, associated with hyposmia, and clear watery secretions unless superimposed infections have occurred. Nasal examination reveals one or more round, smooth, grayish pear-shaped masses within the nose, stalked, mobile, do not bleed, and are not sensitive to manipulation. Differentiation has to be made from inverted papilloma, encephaloceles, carcinoma, sarcomas, and angiofibromas.  The etiology of this condition has remained unclear; however, the role of infection and allergy has been postulated. It represents a spectrum of disease in which both drugs and surgery play a part. However, there is no accepted treatment algorithm, and depending on their point of view, specialists have recommended observation, medical therapy, polypectomy, or sinonasal surgery. Most authors agree on the fact that management of nasal polyp should be primarily based on a medical approach to be completed by surgical procedures only in the case of drug failure.
Medical treatment of nasal polypi with glucocorticoids has met with some success, possibly due to suppression of cytokine synthesis in eosinophils and basophils. Budesonide and flunisolide have been associated with amelioration of polyposis. Systemic corticosteroids, administered in a short high burst with a rapid taper, have also been used to manage this recurrent condition. Surgical intervention is indicated when the patient's polyposis is nonresponsive to repeated steroid courses and/or when antibiotic-resistant sinusitis is present. Intranasal corticosteroids are by far the best-documented type of treatment for the condition. Systemic corticosteroids can be given as tablets (prednisolone) and as depot-injection.
This study evaluates the effects of oral prednisolone and fluticasone nasal spray on the growth of nasal polypi and its outcome. The primary hypothesis of this study is that combined treatment with topical and systemic steroids can relieve the symptoms of nasal polypi and also reduce the size of polyp.
| Materials and methods|| |
This study was conducted on clinically, radiologically and endoscopically confirmed cases of patients with nasal polypi in the OPD during a period of 18 months after written informed consents and approval of the Institutional Ethics Committee were obtained. The sample size was calculated as 70 (seventy) based on a previous study  with an alpha error 0.05% and power 0.8.
Although 70 cases were identified and enrolled only 67 could be completed due to loss to follow up.
Patients who received medical treatment in the preceding 4 weeks, or surgery in 6 months or patients contraindicated or hypersensitive to steroid and patients below 12 years were excluded.
The patients were evaluated for the effects of the combined treatment with fluticasone propionate nasal spray and oral prednisolone. The clinical diagnosis of nasal polypi was made on the basis of clinical presentation, including facial pain or a headache, rhinorrhea, nasal obstruction, and decreased the sense of smell. The severity of each symptom was graded according to a pretested visual analog scoring system as illustrated by Yeak et al.
A thorough history and complete otorhinolaryngological examination was done and recorded. Diagnostic nasal endoscopy was performed for each patient by using a 2.7 mm 0° endoscope (Karl Storz-Endoskope, Tutlingen, Germany) with an integrated endoscopy camera system (LCH 01-D, Berlin, Germany). We used a Xenon light source from Karl-Storz, Germany. Relevant laboratory tests along with computed tomography (CT) of the paranasal sinuses with 3 mm cuts were done for each patient during the first visit. Subsequently, rigid nasal endoscopy was performed routinely at each visit during follow-up. CT of the paranasal sinuses was carried out whenever required during the follow-up period. The nasal polypi were graded according to the radiological and endoscopic Lund and MacKay's classifications.  To identify potential predictive factors that could influence therapeutic effectiveness, the presence of bronchial asthma and aspirin sensitivity was established by history.
All confirmed cases of patients with nasal polyps were given topical fluticasone propionate spray 200 mcg (two spray twice daily) for 3 weeks along with oral prednisolone 1 mg/kg in divided and tapering doses for 3 weeks. Follow-up was done at 3 weeks, 2 months and at 3 months from the baseline.
All subjects were trained in the use of the fluticasone propionate nasal spray device during the first visit. During treatment, compliance was assessed at each visit by examining the devices for use. All cases were examined and followed up by the same otorhinolaryngologist. Primary study end-point was the CT scan and endoscopic report of the nasal polypi, combined with the results of a short questionnaire used to score subjective symptoms. Results are given in the present study at baseline and at 3 months. Data were recorded using the SPSS version 16.0 Data Editor software by SPSS Inc and IBM. Descriptive statistics and analysis was carried out whenever applicable. Statistical significance was at a P < 0.05.
| Results|| |
Altogether 71 patients were identified 67 patients could be completed in this study, and the age of study group ranged from 10 to 79 years (mean being 44 years).The highest incidence of the disease was observed in the age group 13-19 years [Figure 1]. The sex distribution shows male preponderance with a male:female ratio of 1.3:1. The majority (62.7%) were unemployed, whereas 4.5% of the cases were farmers [Figure 2]. Interestingly, two cases had concomitant bronchial asthma seven had familial history whereas none had an aspirin allergy.
Pre- and post-treatment scoring for nasal obstruction, nasal discharge, hyposmia, and facial pain are as shown in [Table 1] along with Wilcoxon signed rank test. Based on the positive test, all the nasal symptoms showed a statistically significant change in the scores before treatment at the baseline and after treatment with a P < 0.05 and Z score - 5.945. Sixty-six patients (98.5%) showed a reduction in nasal obstruction score after treatment and only one patient (1.5%) showed no improvement. About 56 (83.6%) patients showed a reduction in nasal discharge symptom score and 11 patients (16.4%) showed no improvement. 60 patients (89.6%) showed a reduction in hyposmia symptom score after treatment while only seven (10.4%) showed no improvement. 46 (68.7%) patients showed a reduction in facial pain symptom score after treatment whereas only 21 (31.3%) had no reduction.
|Table 1: Wilcoxon signed ranks test for the difference between various nasal symptom score ranks before and after treatment|
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The difference between the endoscopic and CT scan scores before treatment at the baseline and after treatment was found to be statistically significant withP> 0.05 and Z score - 6.002 [Table 2]. Fifty-five patients (82%) showed improvement in endoscopic score whereas 12 (17.9%) showed no improvement. The mean endoscopic score before treatment is 1.88 while after treatment is 0.82 with a standard deviation of 0.89 and 0.77, respectively. Forty patients showed a reduction in CT scan score while 24 patients (35.8%) showed no improvement. Mean CT scan score before treatment [Figure 3] was 3.3 while after treatment [Figure 4] is 2.49 with a standard deviation of 3.17 and 3.21, respectively.
|Figure 3: Computed tomography picture (axial view) of patient with nasal polyposis before treatment|
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|Figure 4: Computed tomography picture (axial view) of patient with nasal polyposis 3 months after treatment|
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|Table 2: Mean, standard deviation and Wilcoxon signed ranks test endoscopic and computed tomography scoring|
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| Discussion|| |
The characteristics of the population are close to those found in the literature, in reference to age (mean age, 44 years), sex ratio (1.3:1), and association with asthma (3%). ,,,,
In this study, the most commonly affected age group was be 13-19 years (31.3%) with a mean age of 44 years. However, most of the literature state that nasal polyps affect an older age group reaching a peak in those aged 50 years and older.  Interestingly, a study on two hundred and forty patients conducted in our country by Zafar et al.,  have also found nasal polyps affecting younger age group ranging from first decade onwards, with the peak seen in second and third decade of life. Kausha et al.,  in their prospective study also have also found similar younger age presentation ranging from 7 to 35 years with a mean of 17.5 years. An observational study done in the same center also showed the occurrence of nasal polyps in lower age groups which were in the second and third decade of life.  The difference in slightly younger age of presentation among the patients could be due to better diagnostic facilities, better access to medical facilities or could be attributed to hereditary and ethnic variations.
Large cohort studies have revealed a strong association between asthma and nasal polyp. ,,, It is said that up to 50% of aspirin-insensitive patients have nasal polyp and up to 36% of patients with nasal polyp may have some form of analgesic insensitivity.  However, this study found only 3% of the patients with nasal polyp had associated bronchial asthma, and only 7% had positive family history of asthma. In a study done on the epidemiology of nasal polyp among the Asian group, only 2 (2.9%) out of thirty patients were found to have asthma.  These findings are comparable with those in the present study. As the exact mechanism of nasal polyp formation remains a topic of investigation, the ethnic and geographic variation has emerged as a potential modifier in the pathophysiology. The present study also found that none of the patients had a history of aspirin intolerance. This could be attributed to the ethnic variation or could also be due to error arising from hospital based data.
The study demonstrates a parallel and sustained improvement in both polyp size and the four nasal symptoms visual analog scale score, as seen in the short-term study by other authors. ,
We determined the severity of each symptom by calculating the mean value and found two nasal symptoms (nasal obstruction and hyposmia) towering over the others. This finding is comparable to the study on the corticosteroid treatment in nasal polyposis with a 3-year follow-up period done by Bonfils et al. 
A Wilcoxon signed ranks test showed that 3 weeks, steroid treatment course with oral prednisolone and fluticasone nasal spray elicited a statistically significant change in all the four nasal symptoms in individuals with nasal polyposis with a P < 0.05. Hissaria et al.  compared 50 mg prednisolone daily for 14 days with placebo and found a significant difference was found in nasal symptoms and endoscopic findings.
The difference between the endoscopic and CT scan scores before treatment at the baseline and after treatment was found to be statistically significant with P > 0.05 and with Z score −6.773 and −6.002, respectively. These findings show that nasal polyp size was reduced after 3 weeks of steroid treatment. This complements the findings of Hissaria et al.  who found a significant reduction in polyp size, as noted with endoscopy (P < 0.001) in the steroid group. Van Zele et al.  also found that nasal polyp size was reduced in the steroid group when compared to placebo, with maximal reduction after 2 weeks.
In this study, following the treatment initiation three patients complained of mild burning sensation with fluticasone propionate nasal spray which subsided after few days and one patient complained of malaise. The remaining sixty-three patients did not have any complaints during the whole course of treatment. Vaidyanathan et al.  observed no clinical adverse events after oral steroid therapy in their study, except for a slight reduction in HPA (Hypothalamic-Pituitary-Adrenal) axis and bone metabolism markers after 2 weeks of oral steroid therapy which subsequently returned to normal. Although Vaidyanathan et al. trial was not large, it was a carefully executed study of the effects of combined oral and nasal corticosteroids. Previous studies provided less direct evidence in support of this approach.
The therapeutic strategy used in this study closely approximated that commonly given in clinical practice. Assessment of both subjective (nasal symptoms including sense of smell) and objective (polyp size, nasal patency) outcomes are the strength of this study.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2]