Allergic rhinitis is defined by the World Allergy Organisation as the group of nasal symptoms resulting from an IgE-mediated immune reaction to allergen exposure. According to national surveys, AR affects 5.9-29% of the general adult population and 40% of children. AR can induce psychological disorders such as fatigability, irritability, depression, sleep disorder and sexual impairment, significantly isolating the patient socially and diminishing the quality of life [1].
Despite the substantial interest in measuring several different factors of quality of life such as sleep, fatigue and sexual function in patients with CRS or AR, few studies [11-13] have evaluated various aspects of the quality of life using valid and standard questionnaires. Also, the literature is sparse to compare the quality of life in AR patients versus patients with CRSsNP. So, the present study was aimed to compare the AR patients to control groups including patients with rhinosinusitis and healthy individuals in different aspects of quality of life (sleep quality, fatigue and sexual function).
Materials and Methods
In a cross-sectional study, we enrolled three groups of adult individuals (18-45 years old) who met our inclusion criteria and visited hospitals at the Guilan University of Medical Sciences. The participants were invited to this study from October 2014 to January 2015. The informed consent was obtained from all participants.
Inclusion criteria were as follows: age 18-45 years, married, and secondary or higher education level. Liu C [14] showed that the cohabitation (living together before the marriage) had a negative effect on the satisfaction with marital sex. So, we included the participants with marital duration more than 6 months and not living together before marriage. Pregnant or lactating women, patients with active mental illness such as depression, presence of chronic diseases such as diabetes mellitus, chronic renal failure, asthma or other severe physical diseases and patients with history of pelvic surgery were excluded from the study.
Participants were classified into three groups: Group 1, patients with persistent AR (including 45 males and 45 females); Group 2, patients with Chronic Rhinosinusitis (CRSsNP); and Group 3, healthy controls. Matching for the age was performed with a tolerance range (±2 years). AR patients were eligible if they met all the following criteria: (1) exhibit atleast one positive result on the allergy skin prick reaction test, (2) meet the classification criteria of moderate to severe Persistent Allergic Rhinitis (PAR) according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines [15]. According to ARIA classification, PAR means that patients have symptoms for more than 4 days a week and for more than 4 consecutive weeks, with the understanding that patients generally suffer approximately every day [16,17]. According to the guidelines of AAO-HNS published in 2007, a combination of symptom criteria and objective findings are required for the diagnosis of CRS. A positive diagnosis of CRS was defined as complaints of 2 or more major criteria or 1 major criteria and 2 or more minor criteria lasting for 12 weeks or longer [6].
Diagnosis of CRS was confirmed with Computed Tomography (CT) of nose and para nasal sinuses. The images were obtained in axial and coronal planes. Thickness of sections was 3 mm at ostiomeatal complex and 5 mm for rest of the structures. CT scan was done for both bony and soft tissue windows. Lund-Mackay scoring system was used to assess involvement of the maxillary, anterior ethmoid, posterior ethmoid, sphenoid and frontal sinuses as follows: 0-no opacification, 1-partial opacification, 2-complete opacification. Ostiomeatal unit was scored as 0-no opacification, 2-total opacification. Each side was graded separately and the scores from each side were then added to determine the overall CT score which ranged from 0 to 24 [18]. The minimum Lund-Mackay score was 4 in this study.
In all patients, evidence of nasal polyps or purulent mucus in the middle meatus or ethmoid region were assessed with rigid nasal endoscopy and those with polyps were excluded.
After gathering demographic characteristics, the patients were asked to fill PSQI, MFI, FSFI or IIEF questionnaires for assessing sleep disorder, fatigue and sexual function, respectively. Also we assessed quality of life in our participants with Sinonasal Outcome Test 22 (SNOT 22).
The PSQI questionnaire consists of 18 items and assesses seven areas including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. Each area has a range of 0-3 points. In all cases, a score of “0” shows no difficulty, while a score of “3” means severe difficulty. The seven component scores are then added to yield one global score with a range of 0-21 points. “0” indicates no difficulty and “21” indicates severe difficulties in all areas [19]. Farrahi Moghaddam J et al., [20] showed that the psychometric properties of the Persian version of the PSQI were acceptable. Cronbach’s alpha coefficient of the PSQI was 0.52.
MFI is a 20-item questionnaire to estimate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity and mental fatigue. This questionnaire is ranging from 1 to 7. Higher total scores correspond with more acute levels of fatigue [21]. The validity and reliability of the Persian version of MFI were showed in study done by Ghajarzadeh M et al., [22].
FSFI evaluates six main domains of sexual functions in female including sexual desire, lubrication, sexual satisfaction, sexual arousal, orgasm and sexual pain over the previous month. Total scores range from 0 to 36. A higher score indicates better performance of sexual function [23]. Persian translate of FSFI questionnaire has been previously validated in an Iranian study. Cronbach’s alpha reliability index of FSFI has been estimated at 0.85 [24].
Men completed IIEF which included 15 questions. A score of 0-5 is given to each item. This questionnaire assesses the 4 main areas of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The lower the score, the more severe sexual dysfunction [25]. Pakpour AH et al., showed that the alpha coefficients were acceptable for all sub-scales. The interclass correlation coefficients were ranging from 0.69 to 0.87 for the patient sample [26].
SNOT 22 questionnaire evaluates the nose and paranasal sinuses symptoms and their relationship with sleep, sexual function and fatigue. It is mainly used for follow-up of the sinusitis treatment. In the questionnaire, each item is rated from “0” to “5” in which “0” means no problem and “5” means worst problem. Total score of questionnaire indicates effect of disease on quality of life which could be between “0-110”, lower score indicates a better quality of life. Items pertain to specific sinonasal, ear/facial, sleep dysfunction and psychological domains [27]. Jalessi M et al., showed that Cronbach’s alpha coefficient of Iranian version of SNOT 22 was 0.90 [28].
Statistical Analysis
In this study, participants were categorised based on the gender and condition of sinus tract (AR vs. CRSsNP vs. healthy controls). The results of the Benninger MS and Benninger RM study [10] were used to perform a two-tailed sample size calculation in a level of significance of 0.05 and a power of 80, giving a required sample size of at least 45 male or female subjects in each group.
Statistical analysis of the extracted data was conducted using IBM SPSS Statistics version 22.0. All data were expressed as Mean±Standard Deviation (SD) or percentage unless otherwise stated. Comparisons between three groups were determined by ANOVA or Pearson’s chi-square test as appropriate. Bonferroni post-hoc analyses were used for the statistical comparison of more than two groups. Pearson’s test was applied to analyse correlations between improvement of the above mentioned indices and AR symptoms. Statistical significance was inferred at a two-sided p-value of <0.05.
Results
In this study, 288 participants (including 144 males and 144 females) were evaluated. There was no significant difference in demographic characteristics of participants among three groups [Table/Fig-1].
Demographic characteristic of participants among three groups.
Variable | Allergic rhinitis (n=96) | Chronic rhinosinusitis (n=96) | Healthy controls (n=96) | p-value* |
---|
Age (year, mean±SD) |
Male | 35.4±4.6 | 33.4±6.9 | 34.9±7.2 | 0.27 |
Female | 33.9±7.5 | 36.0±9.1 | 33.5±7.7 | 0.27 |
BMI (mean±SD) |
Male | 25.5±2.6 | 25.5±3.0 | 26.2±3.8 | 0.46 |
Female | 25.4±3.4 | 26.1±3.4 | 25.8±4.0 | 0.63 |
Marriage duration (month, mean±SD) |
Male | 14.8±10.9 | 11.9±6.0 | 11.4±7.9 | 0.11 |
Female | 12.4±8.1 | 13.8±9.2 | 11.7±7.9 | 0.46 |
Academic education >12 year (number, percentage) |
Male | 23 (47.9%) | 30 (62.5%) | 22 (45.8%) | 0.20 |
Female | 17 (35.4%) | 27 (56.2%) | 23 (47.9%) | 0.12 |
*with using ANOVA for age, BMI, marriage duration and chi-square for academic education
Three components of the quality life, including sleep, fatigue and sexual function, were evaluated in men and women [Table/Fig-2]. About sleep quality, analysis showed that there was a significant difference in total score of PSQI among men with AR or CRS and healthy controls (p=0.04 and p<0.001, respectively). Also, there was significant difference in sub-scales 2 (sleep latency), 4 (habitual sleep efficiency), 5 (sleep disturbances) and 6 (use of sleeping medications) in men among three groups (p<0.05). However, the difference of PSQI scores in women among three groups was not significant.
Various components of participants’ quality of life among three groups.
Variable | Allergic rhinitis (n=96) | Chronic rhinosinusitis (n=96) | Healthy controls (n=96) | p-value* |
---|
PSQI (mean) |
Male | 6.9 | 7.9 | 5.5 | 0.01 |
Female | 6.0 | 6.5 | 6.5 | 0.53 |
MFI 20 (mean) |
Male | 67.4 | 71.2 | 72.4 | 0.15 |
Female | 66.6 | 60.2 | 63.0 | 0.09 |
Sexual function (mean) |
Male (IIEF) | 49.8 | 56.0 | 56.6 | <0.001 |
Female (FSFI) | 26.1 | 24.9 | 25.1 | 0.37 |
*with using ANOVA.
About fatigue, we did not find any significant difference between MFI scores in men or women among three groups.
Sexual function in men was evaluated by IIEF. ANOVA analysis revealed that men with AR had significantly weaker sexual function compared to men with CRS or healthy controls (p<0.001). Post-hoc analysis showed that the difference existed in all sub-scales among three groups. Based on the FSFI questionnaires for women, there was no significant difference among three groups.
In men with AR, there was only significant correlation between sleep quality and sexual function (p<0.01). It means patients who had higher PSQI scores had lower IIEF score. In men with CRS, correlation between sleep quality and fatigue was significant (p=0.04). However, there was no significant correlation between PSQI, MFI and IIEF in healthy controls.
On the other hand, there was only statistical correlation between sleep quality and fatigue in women with AR (p<0.001). There was no correlation in patients with rhinosinusitis and healthy controls between three components of quality of life.
We assessed the severity of AR with SNOT 22. Overall, men with AR had more severe symptoms than women with AR (SNOT 22 score 45.0 versus 39.2, respectively; [Table/Fig-3]. In men with AR, there was a significant correlation between the severity of AR and two components of quality of life including fatigue (p<0.01) and sexual function (p=0.05). In men with AR, a significant difference was observed only in sub-scale of general fatigue than the control groups.
Subset SNOT-22 Scores of Patients with allergic rhinitis (Values are mean±standard deviation).
Domain | Female | Male | p-value |
---|
Rhinologicala | 19.5±9.5 | 21.2±7.1 | 0.21 |
Psychologicalb | 9.6±7.3 | 11.1±8.0 | 0.36 |
Ear/facialc | 4.1±4.2 | 5.4±5.5 | 0.37 |
Sleep dysfunctiond | 5.9±5.6 | 7.0±5.0 | 0.24 |
Total SNOT 22 | 39.2±21.7 | 45.0±19.5 | 0.34 |
aScores range from 0 to 40. Items: need to blow nose, sneezing, cough, runny nose, postnasal discharge, thick nasal discharge, nasal obstruction, loss of smell and/or taste.
bScores range from 0 to 30. Items: fatigue, reduced productivity, reduced concentration, frustration/restlessness/irritability, sadness, embarrassment.
cScores range from 0 to 20. Items: ear fullness, dizziness, ear pain, facial pain and/or pressure.
dScores range from 0 to 20. Items: difficulty falling asleep, waking up at night, waking up tired, lack of good night’s sleep.
Post-hoc analysis showed that there were statistical relations between orgasm (p=0.05) and intercourse satisfaction (p=0.03) to severity of disease. On the other hand, in women with AR, the severity of AR was correlated with sleep quality and fatigue (p=0.03 and p=0.01, respectively). In women with AR, differences in lack of motivation, decreased activity and mental fatigue sub-scales with the control group were significant. Also, post-hoc analysis showed that women with more severe AR had more score in sleep latency sub-scale.
Discussion
Consistent with prior studies, the results of the present study showed that men with AR or CRS had significantly worse sleep quality than healthy controls. However, we could not find significant difference in sleep quality among female participants. Trikojat K et al., [11] in Germany assessed 41 patients with seasonal AR and 42 healthy subjects in terms of sleep quality. In their study, there was a significant difference between patients and healthy subjects just in sub-scale 7 (sleepiness during the day). Unlike our study, men and women were not analysed separately in Trikojat K et al., study. Stuck BA et al. [29] observed that daytime sleepiness in patients with seasonal AR was increased in the pollen season. The increase in daytime sleepiness was more pronounced in patients with moderate-to-severe AR. However, they did not find a correlation between daytime sleepiness and objective sleep patterns (eg, snoring time or AHI). They noted the daytime sleepiness to be related to the condition itself rather than to an impairment of nocturnal sleep. Colas C et al., [30] showed an inverse correlation between sleep quality (assessed by PSQI) and AR severity (measured by ARIA severity classifications, either conventional or modified). Guadin RA et al., [31] showed that there is a significant association between level of control of AR and the severity of subjectively perceived sleep quality detriment using the SNOT-22.
Assessing fatigue outcomes in participants, we found significant worse scores in male or female subjects with AR compared with CRSsNP patients or healthy controls. These results were consistent with the study by Marshal PS et al., [12]. Marshal PS et al., used MFI questionnaire to assess fatigue in patients with seasonal AR. We observed that AR patients also had a significant difference with the healthy controls in some sub-scales of MFI-20 such as reduced level of motivation, decreased activity, general fatigue and mental fatigue. It seems that allergy effects are mainly on the central nervous system. In the past, it was thought that the cause of fatigue in patients with AR, was due to the impact of symptoms particularly, effect of nasal congestion on patients’ sleep and reduced oxygenation to the central nervous system [32-34]. Sardana N and Craig TJ [35] mentioned that in addition to nasal congestion, other allergic symptoms (such as sneezing, rhinorrhea, and nasal pruritus) may contribute to reduced sleep quality and sleep disturbance in individuals with AR. Recently, however, studies show that other reasons such as allergic reactions due to release of inflammatory mediators including IL-1 and TNF-α, causing malaise, weakness, inability to concentrate and loss of interest in daily activities by affecting the central nervous system [12,35].
Regarding the effect of AR on male sexual performance, our results showed that all sub-scales of sexual function (including the erection, orgasm, sexual orientation, satisfactory intercourse and total satisfaction of sexual function) was significantly different compared with other groups. However, we could not find significant difference in women among three groups in total score or its sub-scales. In a study Kirmaz C et al., [9] used FSFI and IIEF questionnaires to assess sexual function in women and men, respectively. They found significant differences in total score and sub-scales of women or men with AR compared to control group. Also, Ozler GS et al., [13] evaluated sexual function in men with AR using the IIEF questionnaire. The results of this study showed that male patients in all sub-scales of the questionnaire had significantly weaker sexual function than the control group.
Limitation
It is worth noting some of the limitations of this study. First, some effective and uncontrollable factors such as stress, financial problems, and marital problems may be possible confounding factors in our study. Second, the severity of AR in our participants was mild to moderate. This could lessen the difference among groups. Finally, severity of CRSsNP is very important to the quality of life. Though we included only patients with Lund-Mackay score ≥4 in paranasal CT scan, little attention has been devoted to the changes in the quality of life with medical therapy of rhinosinusitis.
Conclusion
To conclude, the results of this study showed that AR could have negative effects on sleep quality and sexual function in men and women. Therefore, research to clarify reactions which induce biochemical changes of the central nervous system, is warranted.
*with using ANOVA for age, BMI, marriage duration and chi-square for academic education*with using ANOVA.aScores range from 0 to 40. Items: need to blow nose, sneezing, cough, runny nose, postnasal discharge, thick nasal discharge, nasal obstruction, loss of smell and/or taste.bScores range from 0 to 30. Items: fatigue, reduced productivity, reduced concentration, frustration/restlessness/irritability, sadness, embarrassment.cScores range from 0 to 20. Items: ear fullness, dizziness, ear pain, facial pain and/or pressure.dScores range from 0 to 20. Items: difficulty falling asleep, waking up at night, waking up tired, lack of good night’s sleep.