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Abstract

Objective

To measure the severity of allergic rhinitis (AR) and different types of headaches in patients with septal deviation before and after septoplasty.

Methods

This multicentre, prospective, longitudinal, observational study enrolled patients with deviated nasal septum, nasal symptoms and headaches associated with persistent AR lasting at least 2 months without resolution. The nasal obstruction evaluation (NOSE) scale, immunoglobulin-E (Ig-E) levels and visual analogue scale (VAS) for headache pain severity were evaluated before and after septoplasty using Wilcoxon signed-rank test.

Results

A total of 196 patients were enrolled in the study (102 males; 94 females). A total of 134 patients (68%) were diagnosed with severe AR and 166 (85%) experienced headaches with AR. The majority (100 of 166 patients; 60%) had sinusoidal headaches, while 25% (42 of 166 patients) reported a combination of sinusoidal headache and migraine and 14% (24 of 166 patients) experienced migraines. A comparison of preoperative and postoperative Ig-E levels, NOSE and VAS scores demonstrated that septoplasty significantly improved AR symptoms and headaches. Although there were significant improvements in headaches overall post-septoplasty, only the sinusoidal components improved, while migraine remained unaffected.

Conclusion

Septoplasty improved AR and sinusoidal headaches in patients with septal deviation, but migraines remained unaffected.

Keywords

Allergic rhinitis headache septoplasty respiratory allergy prediction (RAP) test nasal obstruction evaluation (NOSE) scale visual analogue scale (VAS)migraine

Introduction

Nasal septal deviation is the most common condition encountered worldwide in Ear, Nose and Throat (ENT) outpatient departments.¹ It is recognized as a significant global health concern, affecting approximately 90% of the population.² Due to the global prevalence of septal deviation and the increasing levels of air pollution,³ the prevalence of allergic rhinitis (AR) has been on the increase,⁴ affecting millions globally, disrupting their daily lives, work performance and productivity. AR diagnosis depends on the presence of both nasal and extra-nasal symptoms, including nasal obstruction, sneezing, rhinorrhoea or pruritus.⁵ This diagnostic process predominantly involves an exhaustive assessment of the patient history, a thorough physical examination, and confirmed through serological assessment of immunoglobulin-E (Ig-E) antibodies within the serum, radioallergosorbent test or the skin prick test.^6,7 The coexistence of septal deviation and AR can exacerbate their symptoms, often leading patients to report headaches when seeking care at otolaryngology clinics. These headaches result from contact points formed with the opposing mucosal wall, causing recurrent sinusitis attacks and intensified rhinogenic or secondary headaches, primarily via the fifth cranial nerve.⁸ This can lead to the incorrect assumption that the headaches are solely linked to these conditions, potentially obscuring any underlying causes.⁹ Septoplasty, the mainstay treatment for septal deviation,¹⁰ has shown some improvement in AR symptoms on a small scale.^11–13 However, its effectiveness for AR patients with septal deviation remains uncertain, necessitating the need for a comprehensive evaluation of long-term data. In addition, the distinction between sinusoidal headaches resulting from AR or septal deviation and chronic headaches, such as migraines or a combination of both, has not received adequate attention. To alleviate headache, the most bothersome symptom, clinicians plan surgery for AR, septal deviation, or both without identifying their nature. This ambiguity has led to cases where patients continue to experience headaches even after surgery. Observations suggest that both septal deviation and AR patients are more susceptible to migraines,^14–16 which often go undiagnosed and untreated.

To address these gaps in knowledge, the objectives of the current study were as follows: (i) to establish the severity of AR, the frequency of headaches and their types (sinusoidal, migraine or a combination) in patients with septal deviation; (ii) to assess the impact of septoplasty on AR, headaches and their types in patients with septal deviation through a multicentre prospective study in Karachi, Pakistan. These objectives aimed to determine the intricate relationship between nasal septal deviation, AR and headaches, in order to offer clinicians a more precise and cost-effective diagnostic framework during patient visits and potential treatments for these conditions.

Patients and methods

Study design and population

This multicentre, prospective, longitudinal, observational study enrolled patients at Creek General Hospital (CGH) and United Hospital (UH), both affiliated with the United Medical and Dental College, Karachi, Pakistan, under the supervision of the ENT department, between 1 June 2022 1 June 2023. The patients were sampled using a non-probability consecutive sampling technique over a 12-month time frame based on the following specific inclusion and exclusion criteria. The inclusion criteria were as follows: (i) patients aged 15–60 years; (ii) patients from the UH and CGH who exhibited a deviated nasal septum, nasal symptoms and headaches associated with persistent AR lasting at least 2 months without resolution. The exclusion criteria were as follows: (i) patients with a history of nasal surgery, such as septoplasty or submucosal resection, or those who had undergone associated surgical procedures like inferior turbinate reduction or septorhinoplasty; (ii) patients with acute or chronic rhinosinusitis, a perforated nasal septum, defective nasal valve, granulomatous nasal or sinus conditions; (iii) pregnancy; (iv) craniofacial malformations (i.e. cleft palate or cleft lip); (v) HIV infection; (vi) bleeding diathesis conditions; (vii) patients receiving systemic steroids for the treatment of AR; (viii) patients who had undergone specific immunotherapy for allergens; (ix) smokers; (x) individuals with a history of chronic obstructive pulmonary disease, psychiatric disorders, malignant tumours, severe hepatopathy, sleep apnoea or hypertension; (xi) patients presenting with headaches unrelated to rhinogenic or migraine, such as vascular headaches, tension headaches or drug-induced headaches (these patients were referred to a neurologist for further evaluation).

Ethical approval was granted by the IRB-Committee of United Medical and Dental College, Karachi, Pakistan. (no. CGH/Ethics/Retro/2022/01/06/327) and was conducted according to the ethical guidelines of the Helsinki Declaration. Written informed consent was provided by all patients for their participation during the collection process. The study was designed with complete confidentiality and only the researchers had access to the patient data. After the data collection, all patient details were de-identified. The reporting of this study conforms to STROBE guidelines.¹⁷

Study tool and data collection procedure

A self-administered evaluation form with three sections was used as follows. Part 1 consisted of the demographic data. Part 2 consisted of a respiratory allergy prediction (RAP) test based on nine questions;¹⁸ and Ig-E level measurements to screen for AR. The nasal obstruction evaluation (NOSE) scale, which consists of five components to assess AR severity (nasal congestion or stuffiness, nasal obstruction, trouble breathing through nose, trouble sleeping, unable to get enough air on exercise; scored as 0 = no symptoms, 1 = mild, 2 = moderate, 3 = fairly bad, 4 = severe), was also used.¹⁹ Part 3 consisted of a set of 12 questions for screening headache and its type along with an evaluation of its severity using a visual analogue scale (VAS) scale (mild = 0–2; moderate = 3–7; severe = 8–10).²⁰ It is crucial to note that these questions that were designed for screening types of headache were meticulously curated to constitute a modified and condensed version of the diagnostic criteria outlined in the International Classification of Headache Disorders, 3rd edition, as recommended in 2018.²¹ This specific choice was made with a deliberate alignment to the overarching objectives of the study, which sought to obtain detailed and specific insights into the realms of sinusoidal and migraine headache occurrences within the sampled population. All of the above tools were utilized due to their excellent reliability and validity.²² Three members of the IRB-committee reviewed the study tool (see supplementary materials, file 1). Before enrolment, the patients were briefed about the study's objectives and they provided written signed consent (see supplementary materials, file 2). Data collection was conducted by the authors in the ENT outpatients department following a comprehensive general physical examination and ENT examination. These data were collected both before and after the operation at 1-, 2- and 4-month intervals. The collected data included assessments using the NOSE score, Ig-E levels and VAS score to track improvements in AR symptoms and headache types from preoperation to postoperation.

Statistical analyses

All statistical analyses were performed using IBM SPSS Statistics for Windows, Version 23.0 (IBM Corp., Armonk, NY, USA). Descriptive statistics were undertaken for categorical and continuous data. χ²-test/Fischer’s exact test were used to assess the relationship between sex and demographic characteristics of the study participants. For comparative analysis, Wilcoxon signed-rank test was used to analyse the NOSE score, Ig-E level and VAS score, giving mean scores and Z-values over the preoperative and postoperative time frame. An increase in mean scores or a Z-value <1.96 indicated a deterioration or no improvement in the condition, while a decrease in scores or a Z-value >1.96 suggested an improvement from the preoperative to the postoperative period. A P-value <0.05 was considered statistically significant.

Results

This multicentre, prospective, longitudinal, observational study enrolled 196 patients (102 males [52%]; 94 females [48%]) (Table 1). The largest proportion of patients were aged 26–35 years (82 of 196; 42%), followed by those aged ≤25 years (76 of 196; 39%). The majority of patients were married (114 of 196; 58%). A total of 134 of 196 patients (68%) were diagnosed with severe RA, with 166 of 196 (85%) reporting that they experienced headaches in conjunction with AR (Figure 1). Among those reporting headaches, the majority (100 of 166 patients; 60%) had sinusoidal headaches, while a subgroup (42 of 166 patients; 25%) reported a combination of sinusoidal headache and migraine. Only a minority (24 of 166 patients; 14%) experienced migraine-only headache.

Table 1.

Demographic characteristics of patients with septal deviation (n = 196) enrolled in a study designed to demonstrate the impact of septoplasty on the severity of allergic rhinitis and different headache types in patients with septal deviation.

Characteristic	Sex		Statistical analysis^a
Characteristic	Male n = 102	Femalen = 94	Statistical analysis^a
Age, years
≤25	14 (13.73%)	62 (65.96%)	P < 0.001
26–35	56 (54.90%)	26 (27.66%)
>35	32 (31.37%)	6 (6.38%)
Marital status
Married	82 (80.39%)	32 (34.04%)	P < 0.001
Unmarried	20 (19.61%)	62 (65.96%)	P < 0.001
Occupation
Student	6 (5.88%)	56 (59.57%)	P < 0.001
Housewife	0 (0.00%)	30 (31.91%)
Office/indoor work	28 (27.45%)	4 (4.26%)
Skilled labour	30 (29.41%)	2 (2.13%)
Unskilled labour	38 (37.25%)	2 (2.13%)

Data presented as n of patients (%).

χ²-test/Fischer’s exact test were used to assess the relationship between sex and the demographic characteristics.

Figure 1.

Severity of allergic rhinitis and associated headache in patients with septal deviation (n = 196) enrolled in a study designed to demonstrate the impact of septoplasty on the severity of allergic rhinitis and different headache types in patients with septal deviation.

Prior to septoplasty, the initial NOSE score showed a higher mean value of 57.60 among the patients (Table 2). The two most frequently reported AR symptoms were trouble breathing through the nose and trouble sleeping, which were reported by 57% (112 of 196) and 61% (120 of 196) of the participants, respectively. Following the surgical intervention, a consistent reduction in mean NOSE scores were observed up to 4-months postoperatively; with the mean value decreasing from 8.52 at 1-month postoperatively to 2.09 at 4-months postoperatively (Wilcoxon signed-rank test Z-value of 12.167; P < 0.001). These data indicate a steady improvement in AR symptoms as evidenced by the reduction in the mean scores, with the most significant improvement occurring at 1 month after septoplasty. Similarly, the levels of Ig-E showed a significant improvement from the preoperative to 4-month postoperative time-point (Wilcoxon signed-rank test Z-value of 12.140; P < 0.001) (Table 3).

Table 2.

Preoperative and postoperative nasal obstruction evaluation (NOSE) scores for allergic rhinitis in patients with septal deviation (n = 196) enrolled in a study designed to demonstrate the impact of septoplasty on the severity of allergic rhinitis and different headache types in patients with septal deviation.

NOSE category	Preoperative	Postoperative
NOSE category	Preoperative	1 month	2 months	4 months
Nasal congestion or stiffness	1.77	0.65	0.36	0.22
Nasal obstruction	2.45	0.45	0.17	0.09
Trouble breathing through the nose	2.54	0.30	0.11	0.04
Trouble sleeping	2.58	0.16	0.06	0.02
Unable to get enough air on exercise	2.18	0.14	0.07	0.04
Total score (out of 20)	11.52	1.70	0.78	0.42
Total Score (out of 100)	57.60	8.52	3.88	2.09
Wilcoxon signed-rank test Z-value	12.167
Wilcoxon signed-rank test P-value	P < 0.001

Data presented as mean score.

Table 3.

Comparison of preoperative and postoperative immunoglobulin-E (Ig-E) levels in patients with septal deviation (n = 196) enrolled in a study designed to demonstrate the impact of septoplasty on the severity of allergic rhinitis and different headache types in patients with septal deviation.

Ig-E level, IU/ml	Mean	SD	SEM
Preoperative	314.59	435.91	33.14
Postoperative at 4-months	155.09	200.47	14.32
Wilcoxon signed-rank test Z-value	12.140
Wilcoxon signed-rank test P-value	P < 0.001

SD, standard deviation; SEM, standard error of the mean.

Prior to septoplasty, the participants exhibited a mean VAS severity score of 36.53 for their headache (Table 4). Following septoplasty, VAS scores demonstrated significant improvements, with the mean score declining from 19.08 at 1-month postoperatively to 12.75 at 4-months postoperatively (Wilcoxon signed-rank test Z-value of 10.545; P < 0.001). Further subgroup analyses of headaches using the Wilcoxon signed-rank test on VAS score observed that patients who experienced sinusoidal headaches exclusively, as well as those with both sinusoidal headaches and migraines, exhibited significant improvements in their headaches following septoplasty (P < 0.001 for both comparisons). However, the group consisting of individuals with migraine-only headaches did not display any discernible improvements following the surgical intervention.

Table 4.

Preoperative and postoperative visual analogue scale (VAS) scores for headache in patients with septal deviation (n = 166) enrolled in a study designed to demonstrate the impact of septoplasty on the severity of allergic rhinitis and different headache types in patients with septal deviation.

Headache type	Preoperative	Postoperative
Headache type	Preoperative	1 month	2 months	4 months
All headaches
Mean total VAS (out of 10)	3.65	1.90	1.42	1.27
Mean total VAS (out of 100)	36.53	19.08	14.28	12.75
Wilcoxon signed-rank test Z-value	10.545
Wilcoxon signed-rank test P-value	P < 0.001
Migraine + sinusoidal headache
Mean total VAS (out of 10)	6.42	3.90	2.90	2.66
Mean total VAS (out of 100)	64.28	39.05	29.05	26.66
Wilcoxon signed-rank test Z-value	5.695
Wilcoxon signed-rank test P-value	P < 0.001
Migraine headache
Mean total VAS (out of 10)	5.36	5.27	5.09	5.09
Mean total VAS (out of 100)	53.63	52.72	50.90	50.90
Wilcoxon signed-rank test Z-value	1.857
Wilcoxon signed-rank test P-value	P = 0.063
Sinusoidal headache
Mean total VAS (out of 10)	3.15	0.90	0.44	0.25
Mean total VAS (out of 100)	31.53	9.03	4.42	2.50
Wilcoxon signed-rank test Z-value	8.743
Wilcoxon signed-rank test P-value	P < 0.001

Data presented as mean score.

Discussion

In rhinology, two of the most prevalent complaints are difficulty in nasal breathing and headaches. These symptoms are often associated with nasal septal deviation and AR. When faced with patients suffering from both conditions, clinicians encounter therapeutic challenges. In such circumstances, they frequently recommend septoplasty to address problems such as nasal breathing and headaches.^11,23 Although septoplasty is an effective surgical procedure for nasal obstruction and deviation, there currently exist no evidence-based guidelines to determine which patients should undergo the surgery or who will benefit the most when nasal deviation co-occurs with AR and headaches. This current study is the first to examine a prevalent but understudied health issue associated with AR and headaches in patients with septal deviation. This is particularly relevant in nations with high air pollution rankings, such as Pakistan. This study aimed to elaborate on the severity of AR, frequency of headache, and its type, as well as to demonstrate septoplasty’s impact on AR, headache, and its types in patients with septal deviation through a multicentre prospective study in Karachi, Pakistan, whilst simultaneously providing a standard screening procedure for them. This current study reveals demonstrated that 68% of patient with septal deviation suffered from severe AR; and 85% also complained of headaches. In contrast, the worldwide prevalence of mild-to-moderate AR is 20%–40%;⁵ and 34% of AR patients experienced headaches.²⁴ The discrepancy between these previous findings and the current research can be attributed to the specific focus on patients with septal deviation who were experiencing both AR and headaches in the current study, which is a combination of symptoms that presents unique challenges in terms of management and diagnosis. Another reason for the disparity is the 90% worldwide prevalence of septal deviation² and the drastic increase in air pollution in recent years,³ contributing to AR globally.⁴ The higher proportion of severe AR in the current study can be attributed to Pakistan's status as one of the most air-polluted countries.²⁵ The increased incidence of headaches results from the misdiagnosis between sinusoidal headaches and migraine,^9,15 as the majority of the current patients presented with sinusoidal headaches and combinations of sinusoidal and migraine headaches, often caused by contact points with the opposite mucosal wall. These contact points disrupt ciliary activity and cause the accumulation of secretions in the sinuses, leading to recurrent sinusitis and rhinogenic headaches or secondary headaches by stimulating the fifth cranial nerve, which supplies sensory nerves to the face and neck.⁴

Furthermore, the current study demonstrated a significant impact of septoplasty on improving the symptoms of AR in patients with septal deviation. This was assessed using the NOSE scale, with a mean score decreasing from 57.60 preoperatively to 2.09 at 4 months postoperative. There was also a significant improvement in the Ig-E levels, which decreased from a mean of 314.59 IU/ml preoperatively to 155.09 IU/ml at 4 months postoperative. In contrast, previous research found that septoplasty improved AR symptoms in two-thirds of patients, with one-third experiencing no effect or a worsening of the condition.^12,13 While these previous findings partially agree with the current study, they differ with regard to demonstrating the outstanding efficacy of septoplasty on AR symptoms in patients with septal deviation, a factor not previously accounted for in earlier studies. The efficacy of septoplasty can be attributed to the relief of nasal symptoms caused by septal deviation, which AR exacerbates. This suggests that septoplasty is most beneficial for patients with both conditions simultaneously, especially those residing in air-polluted countries.

In addition, this current study demonstrated that septoplasty improved headache, with the mean VAS score decreasing from 36.53 preoperatively to 12.75 at 4 months postoperatively, which agrees with previous findings.²⁶ However, this current study demonstrated an improvement only in patients with AR and septal deviation who had sinusoidal headaches, or a combination of sinusoidal headaches and migraine,^27–35 but no improvement was seen in migraine-only patients.^27,35 The improvement was attributable to alleviating nasal obstruction symptoms and contact or pressure points that cause sinusoidal headaches, which may contribute to the activation and aggravation of secondary headaches, i.e. migraines. These current findings were significant because they highlight the need for screening the type of headache instead of administering septoplasty for AR and septal deviation to alleviate the symptoms of headache, which is only beneficial for rhinological headaches alone^5,24–33,35 or when they occur in combination with migraines.³⁴ While migraine-only patients complain of headaches even after the surgery,^27,35 which was not taken into account by previous studies, as numerous studies show that patients with AR and septal deviation tend to suffer from migraines too,^14–16 and migraine responds best to medication rather than surgery. Nasal surgeries can alleviate headache severity, addressing sinusoidal, rhinological or migraine types by relieving contact points or obstructions. However, it is essential to clarify that nasal surgery is not a curative treatment for migraines in patients with both AR and septal deviation. In such cases, nerve decompression surgery is recommended, as it has demonstrated effectiveness in reducing migraine symptoms.³⁶

This current study had several limitations. First, it used the consecutive sampling technique and no randomization, which was mitigated by enrolling a sufficient sample size compared with previous studies. Secondly, the study was conducted at two specific hospitals in Karachi, Pakistan. This limited geographical area might affect the generalizability of the findings to different healthcare settings in diverse geographical locations. Thirdly, the exclusion criteria used in the study might lead to selection bias, as patients with certain conditions or characteristics were excluded. This could impact the generalizability of the findings to a broader patient population. Fourthly, the use of subjective methods can introduce recall bias, which was limited by measuring the Ig-E level and conducting an ENT examination of the nose before and after surgery. Finally, the lack of observance of the anatomical type of septal deviation was a limitation. The strengths of the study include a large sample size, a combination of subjective and laboratory screening methods, and a 4-month follow-up period, which provided sufficient time to measure the postoperative outcomes and establish a standard screening procedure for the aforementioned conditions. Another strength of this study is that it was conducted in the second most air-polluted country in the world, which adequately demonstrates the efficiency of septoplasty in the above-mentioned circumstances. In addition, the study was undertaken in two institutions where surgery and consultation are provided at minimal or no cost, thus reducing the risk of patients being lost to follow-up due to financial constraints.

In conclusion, this current study demonstrated a significant improvement in the symptoms of AR and relieving sinusoidal headaches following septoplasty among patients with septal deviation. This observation suggests that this surgical intervention holds substantial promise for benefiting this specific patient population. However, these current findings underscore the necessity of distinguishing between different headache types before opting for surgical intervention to alleviate symptoms. Notably, migraines do not exhibit similar benefits from this procedure. Consequently, careful patient selection is pivotal and surgical candidates must receive comprehensive counselling regarding the surgery's potential advantages, disadvantages and implications on their headache symptoms. This holistic approach will likely enhance patient satisfaction and facilitate targeted symptom management. Furthermore, this current investigation has yielded a streamlined screening methodology promising nationwide adoption among ENT clinicians. This method may effectively assess pertinent conditions and evaluate treatment outcomes in clinical settings. Further research, intervention and adoption are warranted to elaborate more in this field to increase patient satisfaction and treatment options for particular conditions. Considering individual symptoms and underlying causes will result in more effective and patient-specific treatment, contributing to a greater understanding and management of these common rhinological issues.

Supplemental Material

sj-pdf-1-imr-10.1177_03000605231215168 - Supplemental material for A longitudinal prospective study of septoplasty impact on headache and allergic rhinitis in patients with septal deviation

Supplemental material, sj-pdf-1-imr-10.1177_03000605231215168 for A longitudinal prospective study of septoplasty impact on headache and allergic rhinitis in patients with septal deviation by Shanila Feroz, Muhammad Hamza Dawood, Sheza Sohail, Muhammad Daniyal, Ayesha Zafar, Ukashah Bin Shahid and Shamim Ahmed in Journal of International Medical Research

Supplemental Material

sj-pdf-2-imr-10.1177_03000605231215168 - Supplemental material for A longitudinal prospective study of septoplasty impact on headache and allergic rhinitis in patients with septal deviation

Supplemental material, sj-pdf-2-imr-10.1177_03000605231215168 for A longitudinal prospective study of septoplasty impact on headache and allergic rhinitis in patients with septal deviation by Shanila Feroz, Muhammad Hamza Dawood, Sheza Sohail, Muhammad Daniyal, Ayesha Zafar, Ukashah Bin Shahid and Shamim Ahmed in Journal of International Medical Research

Footnotes

Authors contributions

S.F. is the guarantor of the study. S.F. and M.H.D. are first authors. The contributions of each author are as follows: S.F.: research proposal, study design, surgery, drafting and supervision; M.H.D.: research proposal, study design, drafting, data collection, analysis, critical revision; S.S., M.D., A.Z. and U.B.S. were involved in data collection, interpretation, visualization, writing – review & editing; S.A.: surgery, critically revising article and proof reading. All authors have approved the final version of the article.

Declaration of conflicting interests

The authors declare that there are no conflicts of interest.

Funding

This research received no specific grant from funding agency in the public, commercial, or not-for-profit sectors.

ORCID iD

Muhammad Hamza Dawood

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