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- Patients and methods
Introduction: The Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines provide a stepwise treatment to rhinitis, which classifies the disease according to its duration and severity.
Objectives: The aim of the study was to verify whether these variables influence drug prescriptions for rhinitis and asthma.
Methods: A multi-centre cross-sectional pharmaco-epidemiological survey was carried out on 1610 allergic rhinitis patients and the relationship between the clinical features of rhinitis and drug therapy for rhinitis and asthma was evaluated.
Results: A total of 1321 adult patients were enrolled. Mild intermittent rhinitis was diagnosed in 7.7%of the patients, moderate/severe intermittent in 17.1%, mild persistent in 11.6%, and moderate/severe persistent in 63.6%. A high level of rhinitis-asthma comorbidity (616/1321 = 46.6%) was found. The majority of patients [1060 (80.24%)] were treated. Significant associations between the severity of rhinitis and the presence of therapy (P = 0.008), the use of oral antihistamines (P < 0.001), topical nasal steroids (P = 0.020) and systemic steroids (P = 0.005) were found. A weak association was found between the features of rhinitis and the therapy for asthma, and vice versa the comorbidity with asthma increases the prescription of inhalant (P < 0.001) and oral steroids (P = 0.015) to treat rhinitis.
Conclusion: The severity of rhinitis influences patient request for rhinitis therapy and the type of medication more than the duration. These features of rhinitis seem to poorly influence asthma therapy. As the ARIA classification is able to reveal a relevant impairment notwithstanding therapy, its role in treated patients merits further study.
Allergic rhinitis is a common disease whose prevalence is increasing, particularly in Western countries. A relevant impact on patient quality of life, ever-increasing evidence of comorbidity with asthma and a significant financial burden on the health service were associated with the disease (1–5). Allergic rhinitis was previously classified as seasonal, perennial and occupational, depending on the causative allergen (6–8).
In order to overcome the intrinsic limits of this classification, reviewed elsewhere (5, 9), the ARIA guidelines emphasize the unitary model of the allergic disease of the respiratory organs, underlining the link between the upper and lower airways. The parameters which the ARIA guidelines use in the classification of rhinitis are the duration of the disease (intermittent and persistent) and the severity, measured not as a nasal symptom score, but as a short assessment of the impairment in the day-to-day life of the patient (mild and moderate/severe). This allows a stepwise, evidence-based treatment for rhinitis of different degrees of severity (5). Various reports underline that this new classification represents an improvement on the previous approach (9, 10).
The aim of this study was to determine which parameters of the ARIA classification most influence the prescription of medication for rhinitis. Moreover, in view of the link between the upper and lower airways, we investigated whether the severity and duration of rhinitis play a role in the prescription of drugs for asthma.
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- Patients and methods
The study was performed in the spring of 2002, when the ARIA guidelines had just been introduced in Italy, therefore, the aim of the study was not to assess the effect of the adoption of the new guideline on the prescribing habits of physicians, but to evaluate a methodological aspect, i.e. to identify which parameter of the new ARIA guidelines used to grade rhinitis plays a role in the prescription of drugs for allergic rhinitis and asthma. Our data demonstrate that the concise ARIA evaluation of the impact on quality of life had a more relevant effect than the duration of symptoms on the treatment of rhinitis.
A significant association between the severity of the rhinitis and the percentage of patients receiving treatment and between the severity of rhinitis and the percentage of patients on oral antihistamines, topical and systemic steroids was found (Tables 4–5). These findings are consistent with those of other investigators and suggest that the impact of the disease on quality of life forms the basic motivation for seeking medical assistance and is the driving factor for the type and amount of drug therapy prescribed (9, 11, 12).
A combination of topical steroids and antihistamines was the most widespread treatment, followed by the single use of antihistamines or of topical steroids (Table 3); these findings are consistent with results of other authors (11, 13). Another noteworthy finding of our study is that more than 80% of patients had moderate-to-severe symptoms despite therapy. Consistent with studies in other countries, our results confirm that a majority of the patients with allergic rhinitis were receiving treatment when they were referred to a specialist (13).
Our study was conducted in the springtime and over half the patients were allergic to pollens (Table 1), our results in particular underline the severe impairment of the pollination period in allergic patients. Both the rhinitis responsiveness to the available treatments and the methodological issues should be considered in this finding. Regarding the first point, numerous studies have proven drug efficacy in rhinitis (5, 14), but patients remain largely unsatisfied (15). Indeed, compared with placebo, the computed effect size of different common treatments for allergic rhinitis revealed rather modest beneficial effects (16, 17); furthermore, a recent study demonstrated that the addition of levocetirizine to the treatment with fluticasone for seasonal rhinitis failed to significantly improve symptoms (18). As regards the latter point, the methodological limitations include the absence of any data recording the dosage of medication administered and patient’s adherence to therapy.
Moreover, our results may have been affected by a selection bias – only those patients poorly responding to the usual treatments were referred to a specialist, even though, similar results were found in a survey performed in a general practice setting (9). However, the most important methodological objection concerns the use of the ARIA classification in treated patients. According to the guidelines, this classification should be used on nontreated patients to provide an evidence-based and stepwise treatment for rhinitis, but several studies, both in the specialist and the primary care setting, document that a majority of the patients were already being treated when they contacted the doctor (9, 13, 19).
The persistence of a significant impairment evaluated by the ARIA classification despite therapy in most of the patients consulting a GP has already been documented in another large survey (9). As the non-orthodox use of the ARIA classification in an epidemiological study is almost inevitable, the issue requires comment.
Currently, classification relies on a single dimension: the patient’s perspective (perceived symptoms). As our findings seem to suggest that the ARIA classification incorporates the effects of treatment, the assessment of a second dimension: the doctor’s perspective (therapy), should also be taken into account. This change shifts the classification from the simple measurement of the severity of the disease (in untreated patients), to a more complex measurement which takes into account the responsiveness to the therapy, i.e. the control of the disease (20).
The relevance of this issue was confirmed by the absence of any difference in rhinitis severity between patients with and without asthma comorbidity (Table 7), notwithstanding a significant greater intake of inhalant and oral steroids to treat rhinitis in the first group was found (Table 8). In order to extend the use of the ARIA guidelines to epidemiological or follow-up studies, this point should be examined at the next ARIA guidelines update. Also for the GINA guidelines for asthma, the role of treatment in the grading of the disease was added after the first version (1995), which has been proposed in untreated patients (21). An analysis of the relationship between rhinitis and asthma through the assessment of the ARIA categories and the drug treatments essentially produces two results:
An overall most severe rhinitis is associated with the asthma comorbidity (Table 7
The ARIA categories of rhinitis have a weak effect on the treatment for asthma in the subgroup of patients with comorbidity (Table 6
The first result is consistent with the hypothesis suggesting that rhinitis and asthma are manifestations of a single chronic inflammatory syndrome, in which the mildest and earliest forms primarily affect the upper airway (3). Indeed, in our survey, the interplay between the ARIA classification and the therapy demonstrates that rhinitis is milder in non-treated than in treated patients (Table 2). In treated patients, the interference of therapy prevents the ARIA classification from revealing any difference between patients with and without asthma, but a significant greater use of inhalant and oral steroids for rhinitis in the subgroup with comorbidity (Table 8) indirectly demonstrates that the most severe rhinitis is associated with the presence of asthma.
The second result could be related to two different interpretations: the first is that the asthma therapy was prescribed independently from the clinical features of rhinitis; such behaviour is consistent with the organ-related management of patients with comorbidities, which occurs when different specialists treat the same patient (22). On the other hand, the weak effect of the ARIA categories on asthma treatment could be caused by the complexity of the interference between the rhinitis therapy and the symptomatic features of the upper and the lower airways. This is particularly evident with drugs like oral steroids, which are able to treat acute asthma.
The significant association between oral steroids and persistent rhinitis suggests that the control of bronchial symptoms can be achieved much more easily in patients with intermittent, rather than persistent rhinitis. The involvement of the lower airways in patients with intermittent rhinitis has been reported (10, 23), but the bronchial impairment in these patients is milder than in patients with persistent rhinitis (23). The surprising absence of an association between the severity of rhinitis and the use of oral steroids to treat asthma (Table 6) could be related to a significant association between the use of oral steroids and severe rhinitis (Tables 4–5). The use of oral steroids for severe rhinitis can reduce the need of this therapy for asthma, thus undermining the association between the severity of rhinitis and the use of oral steroids for asthma. Indeed, worsening of the upper airway disease affects the lower airway (3), but numerous findings reveal that the treatment of rhinitis can improve asthma symptoms (24, 25). In our survey, the interplay between upper and lower airways treatment is less evident for the long lasting therapy of asthma. The significant association between the severity of rhinitis and prescription of antileukotrienes could be indicative of the intention to treat, with a single drug, patients with severe rhinitis and asthma (26), but the absence of further association weakens the strength of such a relationship. In this finding, a methodological issue, concerning the absence of a record of the therapeutic doses administered into the treatment of asthma played an important role. This was particularly relevant for the inhalant steroids, whose dosage is related to the severity of asthma.
In conclusion, our findings reveal certain methodological issues of the ARIA classification. A direct correlation between the severity of rhinitis and the amount and the type of drug prescribed for rhinitis was found, whereas the association between the ARIA categories of rhinitis and asthma therapy was weak. In epidemiological surveys, a vast majority of the patients are treated, and the ARIA classification is able to detect a relevant impairment notwithstanding therapy. Further studies will be necessary to better understand the interplay between the ARIA classification and the therapy of upper and lower airways.