Question | |
Should intranasal glucocorticosteroids vs. no treatment be used for allergic rhinitis (update)? | |
Population: | Patients with allergic rhinitis |
Intervention: | intranasal glucocorticosteroids |
Comparison: | no treatment |
Main outcomes: | Nasal symptoms Ocular symptoms Quality of life Adverse events (any) Serious adverse events |
Setting: | |
Perspective: | |
Background: | Intranasal corticosteroids are one of the mainstays of the treatment of allergic rhinitis, being widely available and. Budesonide is listed in the WHO List of Essential Medicines. |
Conflict of interests: | AWMF conflict of interest declaration and management policies were applied, the assessment performed by the AWMF with guidance and help from Juan Jose Yepes Nuñez. |
Assessment
ProblemIs the problem a priority? | ||
Judgement | Research evidence | Additional considerations |
Allergic rhinitis (AR) is a common condition affecting 18.1% of the population, and its symptoms can significantly reduce the quality of life and pose a high economic burden (mainly because of indirect costs related to lost school days and workdays). [Savoure] Studies of patients consulting general practitioners for AR reported that 18–48 % had symptoms that were not controlled by pharmacotherapy. [Bousquet, Bhattacharyya, Vandenplas] Despite the bothersome nature of symptoms, AR is often trivialized by the patient - only 45% seek medical advice or treatment for their condition, which results in under-treatment and poor control of symptoms. [Linneberg] Problems related to disease Economic burden A systematic review performed to estimate the financial burden of AR in European countries [Linneberg] suggests that the GP services bore the majority of the direct costs for AR. However, the majority of the overall cost burden correspond to indirect costs caused by high absenteeism and presenteeism. In the United States, annual costs for medications for rhinitis patients can be estimated at approximately $1.3 billion. In total, direct costs are estimated to be >$4.6 billion for rhinitis management, including treatment, allergy testing, clinical visits and hospital procedures. [Roland] Similar findings were found for Asia. An analysis of the indirect costs associated with insufficiently treated AR and urticaria patients revealed an annual burden of USD 105.4 billion. This translates to a cost ranging from USD 1,137 to USD 2,195 per patient due to absenteeism and presenteeism [ Kulthanan] Clinical burden The median prevalence of allergic rhinitis was found to be 18.1%, based on a dataset that included 310 reported prevalences. The prevalence of AR ranged from as low as 1.0% to as high as 54.5%.
These statistics indicate that AR is a relatively common condition affecting a significant portion of the population, with variations in prevalence observed across different regions or studies. [Savouré] Problems related to intervention Based on a conducted rapid review, several barriers and concerns related to the feasibility of intranasal corticosteroids for patients with AR have been identified. These barriers are related to safety, knowledge, cost, and effectiveness. The extent to which these barriers pose problems in feasibility may vary depending on the specific patient population and regional differences. References:
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Desirable EffectsHow substantial are the desirable anticipated effects? | ||
Judgement | Research evidence | Additional considerations |
Nasal symptoms In a systematic review with network meta-analysis performed by Sousa-Pinto et al., the improvement of nasal symptoms was assessed in patients under intranasal corticosteroids (INCS) and compared with that registered in patients receiving placebo. For patients with seasonal allergic rhinitis, it was possible to meta-analytically pool the total nasal symptom score (TNSS; combination of four nasal symptoms and scale of 0-12) results of 73 randomised controlled trials (RCTs). INCS were associated with a significantly higher improvement in the TNSS when compared to placebo (mean difference=-1.14; 95%CI=-1.25;-1.05) [Moderate certainty of evidence]. INCS displayed a 100% probability of resulting in a clinically meaningful improvement when compared to placebo, including a 70% probability of resulting in a small improvement and a 30% probability of resulting in a moderate improvement. For patients with perennial allergic rhinitis, it was possible to meta-analytically pool the four symptom TNSS results of 23 RCTs. INCS were associated with a significantly higher improvement in the TNSS when compared to placebo (mean difference=-0.76; 95%CI=-0.90;-0.63) [High certainty of evidence]. INCS displayed a 100% probability of resulting in a clinically meaningful improvement when compared to placebo (in particular, a 100% probability of resulting in a small improvement). Subgroup considerations: Asthma vs. No asthma A subsequent subgroup analysis of the network meta-analysis performed by Sousa-Pinto et al. was performed, grouping trials according to whether they had excluded patients with asthma. The following results were found:  Subgroup considerations: Children and adolescents In a systematic review with network meta-analysis performed by Sousa-Pinto et al., for patients with seasonal allergic rhinitis, it was possible to meta-analytically pool the TNSS (combination of four nasal symptoms and scale of 0-12) results of 9 RCTs. INCS were associated with a significantly higher improvement in the TNSS when compared to placebo (mean difference=-0.58; 95%CI=-0.83;-0.32). INCS displayed a 77% probability of resulting in a clinically meaningful improvement when compared to placebo (in particular, a 77% probability of resulting in a small improvement). For patients with perennial allergic rhinitis, it was possible to meta-analytically pool the four symptom TNSS results of 12 RCTs. INCS were associated with a significantly higher improvement in the TNSS when compared to placebo (mean difference=-0.54; 95%CI=-0.70;-0.38). INCS displayed a 78% probability of resulting in a clinically meaningful improvement when compared to placebo (in particular, a 78% probability of resulting in a small improvement). Ocular symptoms In a systematic review with network meta-analysis performed by Sousa-Pinto et al., the improvement of ocular symptoms was assessed in patients under INCS and compared with that registered in patients receiving placebo. For patients with seasonal allergic rhinitis, it was possible to meta-analytically pool the total ocular symptom score (TOSS; combination of three nasal symptoms and scale of 0-9) results of 21 RCTs. INCS were associated with a significantly higher improvement in the TOSS when compared to placebo (mean difference=-0.43; 95%CI=-0.50;-0.35) [High certainty of evidence]. INCS displayed a 96% probability of resulting in a clinically meaningful improvement when compared to placebo (in particular, a 96% probability of resulting in a small improvement). For patients with perennial allergic rhinitis, it was possible to meta-analytically pool the three symptom TOSS results of 3 RCTs. INCS were associated with a significantly higher improvement in the TOSS when compared to placebo (mean difference=-0.36; 95%CI=-0.66;-0.07) [Moderate certainty of evidence]. INCS displayed a 44% probability of resulting in a clinically meaningful improvement when compared to placebo, including a 29% probability of resulting in a small improvement, 10% probability of resulting in a moderate improvement and 5% probability in resulting in a large improvement. Subgroup considerations: Asthma vs. No asthma A subsequent subgroup analysis of the network meta-analysis performed by Sousa-Pinto et al. was performed, grouping trials according to whether they had excluded patients with asthma. The following results were found:  Subgroup considerations: Children and adolescents In a systematic review with network meta-analysis performed by Sousa-Pinto et al., for patients with seasonal allergic rhinitis, it was possible to meta-analytically pool the TOSS (combination of three nasal symptoms and scale of 0-9) results of 5 RCTs. INCS were not associated with a significantly higher improvement in the TOSS when compared to placebo (mean difference=0.01; 95%CI=-0.14;0.16). INCS displayed a 3% probability of resulting in a clinically meaningful improvement when compared to placebo. For patients with perennial allergic rhinitis, we did not identify primary studies assessing the TOSS in children receiving INCS. Overall symptoms In a systematic review with meta-analysis performed by Sousa-Pinto et al., the improvement of overall rhinitis symptoms was assessed in patients under INCS. The patient-reported outcome measure used to assess this outcome was the total symptom score (TSS), which includes nasal, ocular and other rhinitis symptoms. The TSS computing method differed among studies, and while in most it consisted of the sum of nasal and ocular symptoms, in others RCTs ear and/or palatal itching, post-nasal drip or cough were part of the TSS. Ten RCTs reported TSS values for INCS: 8 for seasonal allergic rhinitis (SAR) and 2 for perennial allergic rhinitis (PAR). Most studies found a statistically significant difference in the change from baseline TSS, favouring INCS over placebo for the treatment of SAR. Only 2 out of the 8 included RCT reported a non-significant difference between the INCS group and placebo. For PAR, a study assessing the TSS reported a significant improvement in this score for triamcinolone vs placebo while for mometasone, according to other study, the improvement did not reach statistical significance. Quality-of-life In a systematic review with network meta-analysis performed by Sousa-Pinto et al., the improvement of quality-of-life was assessed in patients under INCS and compared with that registered in patients receiving placebo. For patients with seasonal allergic rhinitis, it was possible to meta-analytically pool the rhinocojunctivitis quality of life questionnaire (RQLQ; scale of 0-6) results of 29 RCTs. INCS were associated with a significantly higher improvement in the RQLQ when compared to placebo (mean difference=-0.53; 95%CI=-0.62;-0.45) [Moderate certainty of evidence] . INCS displayed a 100% probability of resulting in a clinically meaningful improvement when compared to placebo (in particular, a 100% probability of resulting in a small improvement). For patients with perennial allergic rhinitis, it was possible to meta-analytically pool the RQLQ results of 13 RCTs. INCS were associated with a significantly higher improvement in the RQLQ when compared to placebo (mean difference=-0.35; 95%CI=-0.48;-0.23) [Moderate certainty of evidence] . INCS displayed a 91% probability of resulting in a clinically meaningful improvement when compared to placebo (in particular, a 91% probability of resulting in a small improvement). Subgroup considerations: Asthma vs. No asthma A subsequent subgroup analysis of the network meta-analysis performed by Sousa-Pinto et al. was performed, grouping trials according to whether they had excluded patients with asthma. The following results were found:  Subgroup considerations: Children and adolescents In a systematic review with network meta-analysis performed by Sousa-Pinto et al., for patients with seasonal allergic rhinitis, it was possible to meta-analytically pool the RQLQ (scale of 0-6) results of 4 RCTs. INCS were not associated with a significantly higher improvement in the RQLQ when compared to placebo (mean difference=-0.06; 95%CI=-0.19;0.07). INCS displayed a 34% probability of resulting in a clinically meaningful improvement when compared to placebo, including a 9% probability of resulting in a small improvement, a 5% probability of resulting in a moderate improvement, and a 20% probability of resulting in a large improvement. For patients with perennial allergic rhinitis, it was possible to meta-analytically pool the RQLQ results of 3 RCTs. INCS were not associated with a significantly higher improvement in the RQLQ when compared to placebo (mean difference=-0.06; 95%CI=-0.19;0.07). INCS displayed a 36% probability of resulting in a clinically meaningful improvement when compared to placebo, including a 12% probability of resulting in a small improvement, a 6% probability of resulting in a moderate improvement, and a 18% probability of resulting in a large improvement. | ||
Undesirable EffectsHow substantial are the undesirable anticipated effects? | ||
Judgement | Research evidence | Additional considerations |
Adverse events Following the systematic review performed by Sousa-Pinto et al., the frequency of patients developing at least one adverse event was assessed in patients under intranasal corticosteroids (INCS) and compared with that registered in patients receiving placebo. The summary of fidings table is presented below. A total of 77 randomised controlled trials (RCTs) reported data on the number of patients with seasonal allergic rhinitis reporting at least one adverse event. The meta-analytical incidence rate ratio was of 0.98 (95% credible interval=0.90-1.06) [one fewer case per 1000 person-weeks; 95%CrI = 3 fewer cases to 2 more cases per 1000 person-weeks. Credible interval fully within the "trivial" category] [Moderate certainty of evidence]. A total of 29 RCTs reported data on the number of patients with perennial allergic rhinitis reporting at least one adverse event. The meta-analytical incidence rate ratio was of 1.07 (95% credible interval=0.94-1.20) [2 more cases per 1000 person-weeks; 95%CrI = 2 fewer cases to 5 more cases per 1000 person-weeks. Credible interval fully within the "trivial" category] [Moderate certainty of evidence]. Most adverse events which were considered to be related to the treatment were mild and self-limited and comprised headache, epistaxis, nasal discomfort or upper respiratory tract infection. Subgroup considerations: Asthma vs. No asthma  Subgroup considerations: Children and adolescents In a systematic review performed by Sousa-Pinto et al., a total of 11 RCTs reported data on the number of patients with seasonal allergic rhinitis reporting at least one adverse event. The meta-analytical risk ratio was of 1.07 (95%CI=0.89-1.28) [10 more cases per 1000 individuals; from 16 fewer cases to 40 more cases per 1000 individuals. These values were fully within the "trivial" category]. A total of 15 RCTs reported data on the number of patients with perennial allergic rhinitis reporting at least one adverse event. The meta-analytical risk ratio was of 0.99 (95%CI=0.94-1.05) [1 fewer case per 1000 individuals; from 9 fewer cases to 7 more cases per 1000 individuals. These values were fully within the "trivial" category]. Most adverse events which were considered to be related to the treatment were mild and self-limited and comprised headache, epistaxis, nasal discomfort or upper respiratory tract infection. Serious adverse events Following the systematic review performed by Sousa-Pinto et al., the frequency of patients developing at least one serious adverse event was assessed in patients under INCS and compared with that registered in patients receiving placebo. A total of 75 RCTs reported data on the number of patients with seasonal allergic rhinitis reporting at least one serious adverse event. The meta-analytical incidence rate ratio was of 1.55 (95% credible interval=0.45-10.33) [0 more cases per 1000 person-weeks; 95%CrI = 0 fewer cases to 3 more cases per 1000 person-weeks. Credible interval fully within the "trivial" category] [Moderate certainty of evidence]. A total of 28 RCTs reported data on the number of patients with perennial allergic rhinitis reporting at least one adverse event. The meta-analytical incidence rate ratio was of 1.03 (95% credible interval=0.93-1.14) [0 more cases per 1000 person-weeks; 95%CrI = 0 fewer cases to 0 more cases per 1000 person-weeks. Credible interval fully within the "trivial" category]. The certainty of evidence was considered moderate. Only one serious adverse event was considered likely to be related to the treatment (increased intra-ocular pressure in a patient with perennial allergic rhinitis). Subgroup considerations: Children and adolescents In a systematic review performed by Sousa-Pinto et al., a total of 7 RCTs reported data on the number of patients with seasonal allergic rhinitis reporting at least one serious adverse event. Four serious adverse events were reported in a total of 2012 children treated with INCS (this compares to 0 serious adverse events in 901 children treated with placebo). A total of 13 RCTs reported data on the number of patients with perennial allergic rhinitis reporting at least one serious adverse event. 11 serious adverse events were reported in a total of 2985 children treated with INCS (this compares to 9 serious adverse events in 1802 children treated with placebo).  | ||
Certainty of evidenceWhat is the overall certainty of the evidence of effects? | ||
Judgement | Research evidence | Additional considerations |
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ValuesIs there important uncertainty about or variability in how much people value the main outcomes? | ||
Judgement | Research evidence | Additional considerations |
Utility values Symptoms Regarding specific symptoms, in two studies, utilities (measured by VAS) were lower for severe nasal congestion and severe rhinorrhea compared to severe sneezing, severe throat itching, and severe itchy eyes (certainty of evidence: low). When utilities were elicited with the standard gamble technique, severe itchy eyes were rated by US patients as the least preferred AR symptom (certainty of evidence: low).  Studies of rating or ranking of outcomes Adults
 Children/caregivers sample Seven studies assessing children or their caregivers were included in the relative importance analysis. Most of these studies only assessed symptom-related attributes. Similarly to the adult population, a nasal symptom was frequently ranked as the most or second most important attribute (certainty of evidence: low). In particular, nasal congestion was identified as the most important attribute in five studies (certainty of evidence: low).  | ||
Balance of effectsDoes the balance between desirable and undesirable effects favor the intervention or the comparison? | ||
Judgement | Research evidence | Additional considerations |
Taking into account both benefits and harms of intranasal corticosteroids (INCS), we can consider the following:
Overall, the benefits of INCS seem to outweigh the harms. | ||
Resources requiredHow large are the resource requirements (costs)?" | ||
Judgement | Research evidence | Additional considerations |
Cost of drugs We conducted a survey, having received responses from specialists from 41 countries (mostly in Europe, America and Asia). The costs of being treated for one year with intranasal corticosteroids (INCS) ranged from 3.4 US Dollars Power Purchase Parity (PPP) [Israel] to 692.0 USD PPP [Argentina] (assuming full adherence to treatment and the choice of the least expensive INCS). This corresponds to weekly costs ranging from 0.07 USD PPP to 14.4 USD PPP. The yearly costs per country are displayed in the following map:  Evidence from direct patient data: A preliminary analysis of MASK-air data using the WPAI:AS questionnaire has identified that the overall median work impairment (including both absenteeism and presenteeism) stood at 4.6% (P25-P75: 0.8-15.1%) for well-controlled weeks, ascending to 27.7% (P25-P7512.4-46.0%) and 60.7% (P25-P75: 38.5-80.2%) for partially- and poorly-controlled weeks, respectively. In Germany, this translates into median weekly monetary losses of 42.3 USD PPPs for well-controlled weeks, 259.7 USD PPPs for partially-controlled weeks, and 554.2 USD PPPs for poorly controlled weeks (difference of 511.9 USD per week from poor to good control). For other Western European countries, the difference ranges from 200 to 695 USD. References: 1. CDR PHARMACOECONOMIC REVIEW REPORT FOR DYMISTA, https://www.cadth.ca/sites/default/files/cdr/pharmacoeconomic/SR0408_Dymista_PE_Report.pdf 2. Cardell L-O, Olsson P, Andersson M, et al. TOTALL: high cost of allergic rhinitis-a national Swedish population-based questionnaire study. NPJ primary care respiratory medicine. 2016;26:15082. 3. Fairchild CJ, Durden E, Cao Z, Smale P. Outcomes and cost comparison of three therapeutic approaches to allergic rhinitis. American journal of rhinology & allergy. 2011;25(4):257-262. 4. Smith P, Price D, Harvey R, et al. Medication-related costs of rhinitis in Australia: a NostraData cross-sectional study of pharmacy purchases. Journal of asthma and allergy. 2017;10:153-161. 5. Kulthanan K, Chusakul S, Recto MT, Gabriel MT, Aw DCW, Prepageran N, Wong A, Leong JL, Foong H, Quang VT, Zuberbier T. Economic Burden of the Inadequate Management of Allergic Rhinitis and Urticaria in Asian Countries Based on the GA²LEN Model. Allergy Asthma Immunol Res. 2018 Jul;10(4):370-378. doi: 10.4168/aair.2018.10.4.370. PMID: 29949833; PMCID: PMC6021592. | ||
Certainty of evidence of required resourcesWhat is the certainty of the evidence of resource requirements (costs)? | ||
Judgement | Research evidence | Additional considerations |
Given that intranasal steroids has been around for a long time, there is a reasonably high degree of certainty about the general costs. However, it should be noted that: 1. Available evidence comes from a survey of experts 2. There is variety in mean costs per year between studies for intranasal corticosteroids (mean costs per year range from 34$-448$). However it should be noted that some cases were calculated using worst case scenario. | ||
Cost effectivenessDoes the cost-effectiveness of the intervention favor the intervention or the comparison? | ||
Judgement | Research evidence | Additional considerations |
No published cost-utility or cost-effectiveness analyses for nasal corticosteroids were identified in the literature databases. However, through a supplementary search conducted on the INAHTA database and the HTA agency website, one reimbursement recommendation (specifically for Azelastine/Fluticasone) was found on the CADTH website, which included cost-effectiveness data for Fluticasone Propionate (FP) compared wih placebo. The manufacturer’s economic submission for Azelastine-Fluticasone reported that, based on a cost-utility analysis, FP (comparator in submission dossier) had an ICUR of $12,223 per QALY compared with placebo. The manufacturer's submission had several limitations, that were noted in CDR PHARMACOECONOMIC REVIEW REPORT such as the source of input data (efficacy data), the time horizon of the analysis, the assessment of adverse events' impact on quality of life, and adjustments of QALY. However there are no difference in ICUR values between base case scenario [submission model] and re-analysis [CDR multi-way reanalysis]. Considering the costs reported in the survey alongside the differences in QALYs reported in the CDR Pharmacoeconomic Review Report, INCS would be cost-effective for all countries at a willingness to pay threshold of $50,000/QALY gained (only direct costs with medication being considered). Considering the conservative willingness to pay threshold of 1 time the GDP per capita, INCS would only not be cost-effective in three countries (Argentina, Paraguay and Syria). 1. CDR PHARMACOECONOMIC REVIEW REPORT FOR DYMISTA, https://www.cadth.ca/sites/default/files/cdr/pharmacoeconomic/SR0408_Dymista_PE_Report.pdf | ||
EquityWhat would be the impact on health equity? | ||
Judgement | Research evidence | Additional considerations |
Availability We conducted a survey, having received responses from specialists from 41 countries (mostly in Europe, America and Asia). Intranasal corticosteroids (INCS) are available in all assessed countries. All respondents reported availability of at least three different INCS in their respective country. Other equity-related aspects  For equity, we included 2 records, from South Korea (Lee) and South America (Naclerio). We analysed health equities for specific populations exposed to inequalities according to the acronym PROGRESS-Plus and other variables found relevant during the data analysis process. Each domain could be analysed in terms of effect modifiers for disadvantaged populations, baseline risk and utilisation and access to care, according to the available evidence. We summarized the equity-related issue for patients with allergic rhinitis treated with intranasal corticosteroides. We have not found studies on the effect modifiers for disadvantaged populations, as they should be conducted as a part of an effectiveness review (subgroup analysis). Socioeconomic status (1 study included)
Other domains (1 study included)
References:
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AcceptabilityIs the intervention acceptable to key interest-holders? | ||
Judgement | Research evidence | Additional considerations |
We have included 7 studies that provide data on the acceptability of intranasal steroids (INCS). The majority of these studies were surveys while the rest comprised randomized controlled trials (RCTs), database analyses, other observational studies , and 1 evidence synthesis study. All the studies included in the analysis were published between 2004 and 2023. These studies encompassed data related to INCS acceptability from various regions. Dropouts A network meta-analysis [Soe] assessed acceptability of INCS (including mometasone furoate, fluticasone furoate, ciclesonide, fluticasone propionate, and triamcinolone acetonide) through study dropout or discontinuation in RCTs of patients with moderate-severe allergic rhinitis (AR). The acceptability of all assessed INCS was found to be comparable to that of the placebo in both seasonal and perennial AR.  *From Soe Compliance (patient) In an Allergies in America survey [Naclerio], 61% of patients AR indicated that they ceased using an INCS due to an attribute of the medication itself rather than a change in their condition. In a cross-sectional study involving 400 users of INCS in northern South Arabia, 36.5% participants reported poor scores in adherence to the prescribed INCS treatment and their compliance with recommended doctor follow-ups. Evidence from direct patient data: In complete weeks of MASK-air reporting during the pollen season, there were 36.0% in which INCS were used for 6 or 7 days. This compares with 38.5% for OAH and 31.7% for fixed combinations of INAH+INCS. Satisfaction Based on data from 5 studies from Asia pacific region, America, Middle East [Katelaris, Naclerio, Gross, Fromer, Abdulrahman] satisfaction rates range from 35%-82%. Evidence from direct patient data: In the MASK-air dataset, there were 6174 days in which INCS were used in monotherapy and for which patients provided information on how satisfied they were with their treatments. The median results of the visual analogue scale were of 86 (higher values indicating higher satisfaction) [IQR=26]. Switching rate Evidence from direct patient data: In the MASK-air dataset, in 56.2% of the days in which INCS have been used, they have been used in comedication. This compares with 50.1% for oral AH, 51.0% for the fixed combination of intranasal AH+INCS, 83.0% for LTRAs, and 84.8% for intranasal AH. Compared to other rhinitis medication classes, INCS was associated with lower odds of being used in co-medication (OR=0.90; 95%CI=0.86-0.93) in a study using multivariable mixed-effects logistic regression models [Sousa-Pinto]. Days of INCS monotherapy were associated with worse symptoms than those in co-medication. In 6.2% of days with INCS use, more than one INCS was used (that is, patients tried at least two INCS on the same day). This compares to 54.8% of days with intranasal AH use, 4.1% of days with oral AH use, 0.3% of days with fixed combination of intranasal AH+INCS use, and 0.4% of days with LTRAs use. Willingness to continue treatment In a conjoint analysis [Mahadevia] using data from 120 American users of INCS the patient's willingness to adhere to the therapy was associated with the varying intensity levels of sensory attributes. Onset of action In a rapid review of the literature, the median (min-max) onset of action of INCS was found to be 720 min (12 hrs) [120-3600 min (2-60 hrs)]
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FeasibilityIs the intervention feasible to implement? | ||
Judgement | Research evidence | Additional considerations |
We have included 11 studies that provide data on the feasibility of intranasal steroids (INCS). All included studies were published between 2007 and 2023. Barriers - safety-related Asia-Pacific In two Asia-Pacific studies [Zheng, Abdullah], 30% of pediatric physicians noted parents refusing to use INCS for allergic rhinitis due to child development concerns. Around 90% of Asia-Pacific physicians reported adult patients being hesitant to use INCS due to potential side effects. In Southeast Asian Nations, 72.6% of pharmacists and 62.5% of general practitioners cited patient concerns about corticosteroids as a significant factor in compliance issues. Europe/North America In two studies from European region [Hellings, Cingi], 36-48% of INCS users express their concern related to safety issue. Middle East 75.2% of primary healthcare physicians considered INCS as safe medication for AR [Almousa] Barriers - knowledge In two studies from the Asia-Pacific and Middle East region, barriers related to patients' knowledge about INCS were identified. 39.3-67% of patients using INCS displayed inadequate knowledge [Al-Rasheedi, Katelaris] Barriers-related to effectiveness In two studies conducted in the USA and Turkey, both patients and specialists voiced their concerns regarding the effectiveness of INCS. None of the specialists believed that INCS provided complete symptom relief in patients with AR. [Naclerio] In survey study involving 100 Turkish patients with AR, only 19% stated the INCS as being an effective treatment [Cingi] Ease of use Patients generally found INCS easy to use in the three provided studies. [Fromer 2008, Fromer 2014, Gross 2013] 78-98% of INCS users declare that INCS are easy to use or feel confident that they correctly use INCS.
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Planetary healthWhat would be the impact on planetary health? | ||
Judgement | Research evidence | Additional considerations |
To assess planetary health, it is usual to perform lifecycle assessment studies, that is, studies assessing the environmental impact of interventions from cradle-to-grave. In a rapid review of the literature, we were unable to find LCA studies assessing intranasal corticosteroids. The following table presents a qualitative summary of topics which may be considered for the assessment of the planetary impact of intranasal corticosteroids across the medication lifecycle.  A key consideration is the effectiveness of intranasal corticosteroids, compared to no treatment, in reducing healthcare resource utilization. | Uncertainty among members of the impact - possibility of no impact (as the environmental impact of the medication could be covered by the reduced emissions in lower healthcare use and lower OTC medications) | |
Summary of judgements
Judgement | |||||||
|---|---|---|---|---|---|---|---|
Problem | No | Probably no | Probably yes | Yes | Varies | Don't know | |
Desirable Effects | Trivial | Small | Moderate | Large | Varies | Don't know | |
Undesirable Effects | Trivial | Small | Moderate | Large | Varies | Don't know | |
Certainty of evidence | Very low | Low | Moderate | High | No included studies | ||
Values | Important uncertainty or variability | Possibly important uncertainty or variability | Probably no important uncertainty or variability | No important uncertainty or variability | |||
Balance of effects | Favors the comparison | Probably favors the comparison | Does not favor either the intervention or the comparison | Probably favors the intervention | Favors the intervention | Varies | Don't know |
Resources required | Large costs | Moderate costs | Negligible costs and savings | Moderate savings | Large savings | Varies | Don't know |
Certainty of evidence of required resources | Very low | Low | Moderate | High | No included studies | ||
Cost effectiveness | Favors the comparison | Probably favors the comparison | Does not favor either the intervention or the comparison | Probably favors the intervention | Favors the intervention | Varies | No included studies |
Equity | Reduced | Probably reduced | Probably no impact | Probably increased | Increased | Varies | Don't know |
Acceptability | No | Probably no | Probably yes | Yes | Varies | Don't know | |
Feasibility | No | Probably no | Probably yes | Yes | Varies | Don't know | |
Planetary health | Reduced | Probably reduced | Probably no impact | Probably increased | Increased | Varies | Don't know |
Type of recommendation
Conclusions
Recommendation |
In patients with allergic rhinitis, the ARIA guideline panel recommends using intranasal corticosteroids over no treatment (strong recommendation based on moderate certainty of evidence). |
Justification |
This recommendation is mostly grounded (i) on a favourable balance of effects, (ii) large savings and cost-effectiveness, and (iii) acceptability of the intervention. |
Subgroup considerations |
Considerations for children and adolescents: This recommendation is also applicable for children and adolescents. A subgroup analysis of studies in children and adolescents was performed, showing that INCS were associated with a significantly higher improvement in the TNSS when compared to placebo both in PAR and SAR patients. INCS displayed a 77 to 78% probability of resulting in a clinically meaningful improvement of the TNSS when compared to placebo. While no studies assessed the improvement in TOSS in patients with PAR under INCS treatment, for the remaining outcome measures, INCS were not associated with a significant improvement versus placebo in patients with either PAR or SAR. The subgroup analysis of the network meta-analysis performed by Sousa-Pinto et al., grouping trials according to whether they had excluded patients with asthma, showed a significant improvement in all the assessed outcomes in both subgroups. However, INCS displayed a higher probability of a clinically meaningful improvement in TOSS (94% vs 71%) and RQLQ (100% vs 78%) in the subgroup of patients with SAR without asthma and in TNSS (100% vs 74%) in patients with PAR without asthma. |
Implementation considerations |
Monitoring and evaluation |
Research priorities |
- Need for studies in specific subgroups of participants or presentation of results by subgroup. Such subgroups include: older patients, patients with multimorbidity (asthma and conjunctivitis), and patients from ethnic minorities. - Need for studies - particularly randomised controlled trials - evaluating participants with mild allergic rhinitis. In perennial allergic rhinitis, there is lack of evidence on ocular symptoms. - Need for studies evaluating the planetary impact of the intervention. |