Evaluation of Quality of Life and Pattern of Improvement of Bronchial Asthma in Chronic Rhinosinusitis Patients Treated by Functional Endoscopic Sinus Surgery

Abstract

Chronic inflammatory disorders of the upper airways are extremely prevalent and have a major impact on public health. Sinusitis and bronchial asthma are closely interrelated diseases and sinusitis is known to influence bronchial asthma in its severity and chronicity. Causal relationships have been proposed but not yet proved. The relationship between sinusitis and asthma is academically interesting and has important diagnostic and therapeutic implications. The present study is designed to evaluate the efficacy of functional endoscopic sinus surgery done as treatment for chronic rhinosinusitis on bronchial asthma patients, in terms of quality of life and pattern of improvement. Objectives of the study were to determine whether bronchial asthma and quality of life improved after functional endoscopic sinus surgery. This was an open labelled randomised control trial, done at ENT Department of Medical College, Thiruvananthapuram. Those in Group A underwent functional endoscopic sinus surgery and group B patients were given only medicines as per standard protocol. All of them received asthma treatment depending on asthma attacks and severity and followed up at specific intervals. Quality of life status and pattern of improvement of bronchial asthma among these patients were evaluated. Patients of chronic rhinosinusitis treated by functional endoscopic sinus surgery showed significant improvement in the mean asthma symptom score, asthma medication use score, pulmonary function test results, and quality of life assessment scores. Functional endoscopic sinus surgery could be considered early in the natural course of chronic rhinosinusitis with concomitant bronchial asthma.

Introduction

For more than 70 years, the coexistence of asthma and chronic rhinosinusitis (CRS) has been noted in medical literature. Sinusitis and asthma are closely interrelated diseases and sinusitis is known to influence bronchial asthma in its severity and chronicity. Improvements in bronchial asthma have been suggested in trials using aggressive medical or other than Functional Endoscopic Sinus Surgery (FESS) approaches or both to chronic rhinosinusitis, but it is not conclusively demonstrated [1]. There is only a few evidence exist to suggest that bronchial asthma improves after surgical correction of rhinosinusitis [2]. Even then, the effect of endoscopic sinus surgery in the treatment of chronic sinusitis and improvement of patient’s asthma is still a controversial issue [3–5]. The effects of patient variables on predicting the outcome of the surgery and pulmonary status, especially in those with a stable condition of asthma are debatable [6].

There exist only a few randomised control trials, to reveal the interrelationship of rhinosinusitis and asthma, and also to demonstrate the benefits of surgery on lower airway symptom or pulmonary function. Published data on impact of FESS on chronic rhinosinusitis and bronchial asthma in India is very much limited.

As patients often present with more than one of these diseases in concert, a comprehensive, multimodal approach with collaboration from family medicine specialist, pulmonary specialist, allergists, internist and otolaryngologist, should lead to better clinical outcomes. Thus the relationship between rhinosinusitis and asthma is not only academically interesting, but also has important diagnostic and therapeutic implications.

Objectives

1. To determine whether bronchial asthma improves after FESS done as treatment of coexisting chronic rhinosinusitis

2. To determine whether quality of life improves after FESS.

Methodology

This was a randomised controlled trial done at Department of Otorhinolaryngology, Medical College Hospital, Trivandrum done over a period of 3 years from November 2012 to October 2015. Patients having chronic rhinosinusitis with co existing bronchial asthma, and in the age group of 18–70 years were included in the study.

Inclusion Criteria

1. Adult male and female patients above 18 and below 70 years of age.

2. Patient suffering from chronic rhinosinusitis (as per working definition of CRS as; by European Position Paper on Rhinosinusitis and Nasal Polys) with coexisting bronchial asthma (as per Global Initiative for Asthma)

Exclusion Criteria

1. Previous sinus surgery.

2. Chronic rhinosinusitis caused by specific conditions such as tuberculosis, syphilis, leprosy, rhinoscleroma, and atrophic Rhinitis.

3. Anatomical deformities of nose causing severe nasal block (e.g., severe deviated nasal septum, concha bullosa) and also those with nasal polyps.

4. Malignant lesions of nose.

5. Pregnant female.

6. Patients having psychiatric disorders.

7. Patients not willing to be included in the study.

120 patients were selected after satisfying inclusion and exclusion criteria. Verbal and written consent of the participant in English/Malayalam language were obtained for the study. They were randomised using simple randomisation method.

Initial assessment of all participants was done; which included filling up the Performa, questionnaires, detailed examination of ENT, general and systemic examination, routine blood tests, serology, chest X-ray, ECG all leads, CT scan nose and PNS (Axial, coronal and sagittal cuts), diagnostic nasal endoscopy and sending for pulmonary function test. Based on randomisation, interventions were provided. Symbolic representation of the study is given in Fig. 1.

Fig. 1.

Symbolic representation of the study

Experimental Group

For every patient FESS was done by investigator, who is a trained endoscopic surgeon. Informed consent for functional endoscopic sinus surgery (FESS) was taken from the patient. Every patient was started on systemic antibiotic (amoxicillin 500 mg and clavulanic acid 125 mg) tablets thrice daily for 5 days, decongestant nasal drops three drops thrice daily, prednisolone tablets 30 mg in divided doses 3 days and PPI inhibitor once daily for 5 days preoperatively. FESS was done under hypotensive general anaesthesia with orotracheal intubation. After completing surgery, each side of nose was packed with merocel anterior nasal pack for 24 h. Patient started on oral feeds after complete recovery from anaesthesia; 3–4 h after surgery. Patients were instructed not to blow the nose for 7 days following surgery and to avoid any bending or heavy lifting. Systemic antibiotics, analgesics, and decongestants given for 10 days postoperatively. Endoscopic suction clearance of nose, saline douching and topical steroid nasal spray (Fluticasone propionate one puff daily to each side of nose) started from 2nd postoperative day. Nasal spray and saline douche continued for 1 month. In between, at the time of asthmatic attacks they were advised to take steroid and β2 agonist spray under care of pulmonologist. At 3, 6, 9 and 12 months patients came for review. Each time they were given Asthma Therapy Assessment Questionnaire (ATAQ), Asthma quality of Life Assessment Questionnaire (AQLQ) and Sino-Nasal Outcome Test (SNOT 20) questionnaires to fill in and Pulmonary function test (values of FEV1) was done.

Control Group

There is no standardized algorithm which can be applied to all patients of CRS. The method used in this study was to treat the patients at the time of acute exacerbations of chronic rhinosinusitis. Patients were advised to report to ENT outpatient care each time they get an acute exacerbation. Then they were given oral antibiotic (amoxicillin 500 mg + clavulanic acid 125 mg) thrice daily for 14 days, along with intranasal corticosteroid spray (Fluticasone propionate) one puff to each side of nose/day, and symptomatic management. If there were signs of wheezing, they were advised to consult pulmonologist also. At 3, 6, 9 and 12 months patients came for review. Each time they were given ATAQ, AQLQ and SNOT 20 questionnaires to fill in and pulmonary function was tested.

Results

Baseline Data

Age, Gender, Habit of smoking, Alcohol use, Usage of Snuff, Educational status, Diagnostic nasal endoscopy results and asthma control status were compared at baseline level between Group A and B. Chi Square test was used for comparison with a p value of > 0.05. It showed that p value was not significant and so both groups were homogenous and hence comparable.

Clinical Data

Effectiveness of Functional Endoscopic Sinus Surgery on Asthma Control Based on ATAQ Score

At recruitment level, mean value of ATAQ score among experimental group was 4.4 and that among control group was also 4.4. Mann–Whitney U test showed that data were homogenous (p = 0.708). So they were comparable. After FESS, 3 months ATAQ score became better in experimental group; which came down to a mean score of 1.1, but it remained at 4.2 in control group. At 6 months Mean ± SD was 0.9 ± 0.6 among cases, while that among controls were 4.2 ± 0.4. At 9 months Mean ± SD was 0.1 ± 0.4 among cases, while that among controls were 3.9 ± 0.8. One year after recruitment, Mean ± SD became 0.3 ± 1 among cases and that of the patients in the control group remained without much change; 3.8 ± 0.9. p value remained significant at 0.01 level at all the follow up period of 3, 6, 9 and 12 months. Hence there was a significant difference among both groups based on ATAQ score (Fig. 2).

Fig. 2.

Comparison of asthma control between group at different interval of time based on ATAQ Score

Effectiveness of Functional Endoscopic Sinus Surgery on Asthma Control Based on AQLQ Score

AQLQ score was compared at recruitment level and at 3, 6, 9 and 12 months follow up periods. At baseline AQLQ score showed a Mean ± SD of 28.6 ± 3.2 among experimental group and it was 29.3 ± 2.7 among control group. Mann–Whitney U test was done at recruitment and found to have a p value of 0.389, which was not significant. Hence both groups were comparable. After FESS, there was a reduction in the Mean ± SD among experimental group. From the baseline score of 28.6 ± 3.2, it reduced to 5 ± 1.9 after 3 months, 3.1 ± 1.4 after 6 months, 1.5 ± 1.6 after 9 months and became 0.8 ± 2.6 after 1 year. In the control group there was not much of a difference from basal value; mean value remained at 26.6 ± 8 after 1 year. The difference between experimental and control group was compared using Mann–Whitney U test. p value was below 0.01 and hence significant difference of AQLQ score among two groups after intervention (Fig. 3).

Fig. 3.

Effectiveness of functional endoscopic sinus surgery on asthma control based on AQLQ score

Effect of Functional Endoscopic Sinus Surgery on Asthma Control Based on FEV1

FEV1 was calculated as percentage of predicted value from pulmonary function test. At recruitment level, Mean ± SD calculated among patients of experimental group was 66.7 ± 7.2 and that among control group was 67.5 ± 6.6. Mann–Whitney U test was done. p value obtained was 0.558 which was not significant. Hence both groups were comparable. Three months after FESS, FEV1 showed group Mean ± SD among experimental group as 66.3 ± 9.1, whereas, it was 68.1 ± 5.6 among control group. Mann–Whitney U test showed p = 0.668 which was not significant. At 6 months Mean ± SD among cases was 74 ± 7.2 and 69 ± 5.2 among controls (p = 0.001). At 9 months Mean ± SD became 80.7 ± 5.7 among cases and among controls it was 68.6 ± 4.6(p = 0.000). At 12 months follow up, FEV1 Mean ± SD among experimental group was 85.1 ± 7.7 and that among control group was 69.4 ± 4.6. Mann–Whitney U test showed a significant p value at 0.01 level (Table 1).

Table 1.

Comparison of FEV1 between groups at different intervals

Time	Group	Mean ± SD	Median	Z#	p
3 months	Group A	66.3 ± 9.1	70	0.43	0.68
	Group B	68.1 ± 5.6	68
6 months	Group A	74 ± 7.2	72	3.4**	0.01
	Group B	69 ± 5.2	70
9 months	Group A	80.7 ± 5.7	80	8.39**	0.001
	Group B	68.6 ± 4.6	70
1 year	Group A	85.1 ± 7.7	80	8.43**	0.001
	Group B	69.4 ± 4.6	70

#Mann–Whitney U test; **significant at 0.01 level

Effect of FESS on Quality of Life Based on Sinonasal Outcome Test Score

All patients in both groups were having moderate to severe problem as per SNOT 20. Mean ± SD in experimental group was 76.6 ± 3.6 and that of control group was 73 ± 6.6 Mann–Whitney U test showed p value of 0.002 which was not significant. Hence both groups were homogenous and hence comparable.

Post treatment mean score was calculated. At 3 months, among the cases, mean score ± SD became 0.9 ± 1.1, 0.4 ± 0.6; 6 months, 0.6 ± 1.2; at 9 months and 0.4 ± 2.1 at 12 months follow-up. In the control group, mean score ± SD at 3 months was 69.6 ± 6.3. 67.5 ± 10.4 at 6 months 65.2 ± 16.2 at 9 months and it became 62.5 ± 20 at the end of 12 months. SNOT 20 change score was compared using Mann–Whitney U test, p value was significant at 0.01 level (Table 2). Hence there was a comparable difference of SNOT 20 score among groups.

Table 2.

Comparison of Sino-Nasal outcome between group at different interval of time

Time	Group	Mean ± SD	Median	Z#	p
3 months	Group A	0.9 ± 1.1	0.0	9.18**	0.001
	Group B	69.6 ± 6.3	70.0
6 months	Group A	0.4 ± 0.6	0.0	9.1**	0.001
	Group B	67.5 ± 10.4	70.0
9 months	Group A	0.6 ± 1.2	0.0	8.94**	0.001
	Group B	65.2 ± 16.2	70.0
1 year	Group A	0.4 ± 2.1	0.0	9.17**	0.001
	Group B	62.5 ± 20	70.0

#Mann–Whitney U test; **significant at 0.01 level

Discussion

In the present study, most of the patients were aged between 41 and 50 years. Minimum number of patients were in the age group of 21–30 years in both groups. In a similar prospective study conducted by Ehnhage et al. [7] mean age affected was 50 years. It is evident that in majority of studies, the commonest age group affected was in their third to fourth decade [8, 9].

In this study, males were more in both groups compared to females, which simulates the study of Kamal et al. [10], with male predominance and differs from results of Michael et al. [11], where females outnumbered. In almost all the studies, age and sex did not have any significant relationships with other variables.

Smoking, alcoholism and usage of snuff were among the medical co morbidities that might allow outcome prediction. In the present study, the influence of this on outcome prediction and QOL was not done.

In this study, the effect of FESS on bronchial asthma was evaluated based on changes in the mean scores of ATAQ, AQLQ, SNOT 20 and values of FEVI.

At recruitment level, mean value of ATAQ score among experimental group and control group was 4.4. After FESS, there was a progressive reduction in mean scores of ATAQ in experimental group; which came down to 0.3 after 12 months. In control group, there was no significant change in the mean score; it remained at a score of 3.8 after 1 year follow up.

Asthma quality of life questionnaire score was compared at recruitment level and at 3, 6, 9 and 12 months follow up periods. At baseline AQLQ mean score was comparable among both groups. After FESS, the quality of life found to be improved progressively till the end of 1 year, among experimental group. In the control group there was not much of a difference from basal value after 1 year.

At recruitment level, all patients in both groups were having a FEV1 value below the standard normal range; of 80–120%. At the end of 1 year, there was significant improvement in the FEV1 values in those cases that have undergone FESS. In them it became normal; mean value of 85% of the predicted FEV1. But among controls, the value of FEV1 remained in the range of moderate obstruction (60–69% of predicted) even at the end of 1 year.

All patients in both groups were having moderate to severe problem as per pre-treatment SNOT 20 score. Post treatment mean score was calculated at 3, 6, 9 and 12 months. All cases gave a very good response to FESS; change in score showed a mean of about 75; having no problem to mild problems. In the control group, mean post treatment score remained almost the same as that of pre-treatment score. There was a comparable difference of SNOT 20 change-score among both groups.

As per these subjective and objective outcome measures, it showed that the alternate hypothesis was proved; functional endoscopic sinus surgery improved quality of life and bronchial asthma, in chronic rhinosinusitis patients.

Clinical studies with co existent sinusitis and asthma at St Louis University Health Sciences centre (St Louis MO) showed that more than 80% of the patients had experienced moderate or greatly improved nasal symptoms and 60% felt that their asthma symptoms had improved. They also noted that FESS had an important role in indicated cases. Prospective 21 week study conducted by Ehnhage et al. [7] showed results consistent with our study. Batra et al. [12] and Ragab et al. [13] reported that FESS had a subjective and objective tendency for asthma improvement, however, statistically non significant. Mark F conducted a retrospective analysis with same objective as our present study. They evaluated improvement in asthma based on mean changes in asthma symptom score, asthma medication use score, PFT results and emergency department visits or hospital admissions for asthma before and after operation. No statistically significant postoperative improvements were observed.

Results of a retrospective analysis by Shivakumar and Sambandan [14] also gave results showing improvement in quality of life after FESS.

Conclusion

The alternate hypothesis is accepted based on the study findings; quality of life and bronchial asthma improved after functional endoscopic sinus surgery, done as treatment of chronic rhinosinusitis patients with co-existing bronchial asthma. Proper surgical management of CRS in asthmatic patients, can result in both improved sinonasal and asthmatic symptoms with fewer physician visits and decreased need for medication. This can be a cost effective treatment plan. This should be discussed with pulmonologist, allergist, general practitioners’ and otolaryngologist and initiation should be taken for successful implementation of programmes for treatment of sinusitis and bronchial asthma.