Abstract
Introduction
Hay fever is found throughout the world. Epidemiological evidence suggests considerable geographical variation in its prevalence. Symptoms are caused by an IgE-mediated type 1 hypersensitivity reaction to airborne allergens such as pollen or fungal spores, and may also cause eye, sinus, respiratory, and systemic problems.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for hay fever in adolescents and adults? We searched: Medline, Embase, The Cochrane Library, and other important databases up to April 2008 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 211 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: intranasal corticosteroids, oral antihistamines, intranasal antihistamines, oral leukotriene receptor antagonists, systemic corticosteroids, intranasal ipratropium bromide, oral decongestants, and combinations of these treatments.
Key Points
Hay fever causes sneezing, with an itchy, blocked, and/or running nose, and affects up to 25% of people in developed countries.
Symptoms are caused by an IgE-mediated type 1 hypersensitivity reaction to airborne allergens such as pollen or fungal spores, and may also cause eye, sinus, respiratory, and systemic problems.
Oral antihistamines reduce symptoms and improve quality of life compared with placebo, but they can cause drowsiness, particularly with older preparations.
CAUTION: astemizole and terfenadine may be associated with cardiac adverse effects.
Intranasal antihistamines improve symptoms compared with placebo. Intranasal azelastine seems as effective as oral antihistamines.
We don't know whether oral decongestants reduce symptoms compared with placebo, but combined treatment with pseudoephedrine plus oral antihistamines may be more effective than either treatment alone.
Intranasal corticosteroids improve symptoms compared with placebo, are more effective at improving nasal symptoms, and appear to be equally effective at improving ocular symptoms compared with oral antihistamines.
Systemic corticosteroids improve symptoms compared with placebo, and are associated with mild adverse effects when used for short periods. Long-term or repeated use of systemic corticosteroids is associated with a range of well-documented, potentially serious adverse effects.
The oral leukotriene receptor antagonist montelukast improves symptoms and quality of life compared with placebo, but combination treatment with montelukast plus loratadine may be no more effective than either treatment alone.
We don't know whether intranasal ipratropium bromide reduces symptoms, as no studies were found.
About this condition
Definition
Hay fever is a symptom complex that may affect several organ systems. Symptoms typically consist of seasonal sneezing, nasal itching, nasal blockage, and watery nasal discharge. Eye symptoms (red eyes, itchy eyes, and tearing) are also common. Other symptoms may include peak seasonal coughing, wheezing and shortness of breath, oral allergy syndrome (manifesting as an itchy, swollen oropharynx on eating stoned fruits), and systemic symptoms such as tiredness, fever, a pressure sensation in the head, and itchiness. Confirming the presence of pollen hypersensitivity using objective allergy tests, such as skin prick tests, detection of serum-specific IgE, and nasal provocation challenge testing, may improve diagnostic accuracy. This review focuses on people aged 12 years and over.
Incidence/ Prevalence
Hay fever is found throughout the world. Epidemiological evidence suggests considerable geographical variation in its prevalence. Prevalence is highest in socioeconomically developed countries, where the condition may affect as much as 25% of the population. Prevalence and severity are increasing. It is thought that improved living standards and reduced risk of childhood infections may lead to immune deviation of T helper cells in early life, which may, in turn, increase susceptibility to hay fever (the so-called "hygiene hypothesis"). Although people of all ages may be affected, the peak age of onset is adolescence.
Aetiology/ Risk factors
The symptoms of hay fever are caused by an IgE-mediated type 1 hypersensitivity reaction to grass, tree, or weed pollen. Allergy to other seasonal aeroallergens such as fungal spores may also provoke symptoms. Typically, symptoms become worse during the relevant pollen season, and outdoors when pollen exposure is increased. Risk factors include a personal or family history of atopy or other allergic disorders, male sex, birth order (increased risk being seen in first born), and small family size.
Prognosis
Hay fever may impair quality of life, interfering with work, sleep, and recreational activities. Other allergic problems such as asthma and eczema frequently coexist, adding to the impact of rhinitis.
Aims of intervention
Treatments for hay fever aim to minimise or eliminate symptoms, optimise quality of life, and reduce the risk of developing coexistent disease.
Outcomes
We extracted data on the following outcomes: quality of life; days off school/work; rhinitis symptom scores (as described in studies); medication usage and medication usage scores (as defined in studies); and adverse effects. Although most of these outcome measures have face validity, few have been formally validated. Studies using validated quality-of-life measures are the most reliable, but only a few used this outcome.
Methods
Clinical Evidence search and appraisal April 2008. The following databases were used to identify studies for this review: Medline 1966 to April 2008, Embase 1980 to April 2008, and The Cochrane Library (all databases) 2008, Issue 1. An additional search was carried out on the NHS Centre for Reviews and Dissemination (CRD) website on all databases. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the author for additional assessment using predetermined criteria to identify relevant studies. Study design criteria for assessment in this review were: published systematic reviews and RCTs in any language, at least single blinded (where possible), and containing at least 20 individuals of whom more than 80% were followed up. The minimum length of follow-up required to include studies was 2 weeks. We excluded all studies described as "open", "open label", or not blinded unless blinding was impossible, and we also excluded RCTs that used experimental allergen challenge rather than clinical exposure to pollen. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the UK Medicines and Healthcare products Regulatory Agency (MHRA), which are added to the review as required. Many of the RCTs identified are industry funded and are methodologically suboptimal tending to suffer from selection, performance, detection, and attrition biases. Added to this, there is considerable risk of publication bias raising the possibility of overestimating treatment benefits. In this review, we did not formally conduct a sensitivity analysis of the included trials, neither did we formally assess for evidence of publication bias. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table ).
Table 1.
GRADE evaluation of interventions for hay fever in adolescents and adults
| Important outcomes | Symptom relief, quality of life, adverse effects | ||||||||
| Number of studies (participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of treatments for hay fever in adolescents and adults? | |||||||||
| 54 (at least 12,952) | Symptom relief | Intranasal corticosteroids v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 3 (1265) | Quality of life | Intranasal corticosteroids v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 18 (3316) | Symptom relief | Intranasal corticosteroids v each other | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| At least 16 RCTs (at least 2267 people) | Symptom relief | Intranasal corticosteroids v oral antihistamines | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for heterogeneity of RCTs. Directness point deducted for inclusion of people with perennial rhinitis |
| 11 (1093) | Symptom relief | Intranasal corticosteroids v intranasal antihistamines | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for incomplete reporting and heterogeneity of RCTs. Directness point deducted for inclusion of people with perennial rhinitis |
| 1 (157) | Symptom relief | Intranasal corticosteroids plus azelastine v azelastine alone | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 4 (2337) | Symptom relief | Intranasal corticosteroids v leukotriene antagonists | 4 | 0 | 0 | 0 | 0 | High | |
| 53 (22,994) | Symptom relief | Oral antihistamines v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 11 (8941) | Quality of life | Oral antihistamines v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (27) | Quality of life | Oral antihistamines plus intranasal corticosteroids v intranasal corticosteroids alone | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about clinical significance of results |
| 7 (605) | Symptom relief | Astemizole v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 14 (2997) | Symptom relief | Terfenadine v placebo | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results |
| 9 (2266) | Symptom relief | Intranasal azelastine v placebo | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results |
| 7 (1086) | Symptom relief | Intranasal azelastine v oral antihistamines | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 12 (963) | Symptom relief | Intranasal levocabastine v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 2 (1240) | Symptom relief | Intranasal olopatadine v placebo | 4 | 0 | 0 | 0 | 0 | High | |
| 1 (180) | Symptom relief | Intranasal antihistamines v each other | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 10 (7437) | Symptom relief | Montelukast v placebo | 4 | 0 | –1 | 0 | 0 | Moderate | Consistency point deducted for conflicting results |
| 5 (not reported) | Quality of life | Montelukast v placebo | 4 | 0 | 0 | 0 | 0 | High | |
| 1 (484) | Symptom relief | Pranlukast v placebo | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results |
| 6 (not reported) | Symptom relief | Montelukast v loratadine | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for incomplete reporting of results and lack of statistical comparison between groups |
| 1 (58) | Symptom relief | Montelukast v pseudoephedrine | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 4 (1507) | Symptom relief | Montelukast plus oral antihistamines v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 2 (1367) | Quality of life | Montelukast plus oral antihistamines v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 6 (1640) | Symptom relief | Oral leukotriene antagonists plus antihistamines v antihistamines alone | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results |
| 4 (1507) | Symptom relief | Oral leukotriene antagonists plus antihistamines v leukotriene antagonists alone | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results |
| 4 (206) | Symptom relief | Oral leukotriene antagonists plus oral antihistamines v intranasal corticosteroids | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 5 (at least 95) | Symptom relief | Systemic corticosteroids v placebo | 4 | –2 | –1 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and sparse data. Consistency point deducted for heterogeneity between studies. Directness point deducted for uncertainty about definition of outcomes or population |
| 1 (30) | Symptom relief | Intramuscular betamethasone v intranasal beclometasone | 4 | –2 | –1 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and sparse data. Consistency point deducted for heterogeneity between studies. Directness point deducted for uncertainty about definition of outcomes or population |
| 2 (101) | Symptom relief | Intramuscular betamethasone v intramuscular methylprednisolone | 4 | –2 | –1 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and sparse data. Consistency point deducted for heterogeneity between studies. Directness point deducted for uncertainty about definition of outcomes or population |
| 1 (30) | Symptom relief | Intramuscular methylprednisolone v intranasal budesonide | 4 | –2 | –1 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and sparse data. Consistency point deducted for heterogeneity between studies. Directness point deducted for uncertainty about definition of outcomes or population |
| 1 (36) | Symptom relief | Intramuscular methylprednisolone v oral prednisolone | 4 | –2 | –1 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and sparse data. Consistency point deducted for heterogeneity between studies. Directness point deducted for uncertainty about definition of outcomes or population |
| 1 (220) | Symptom relief | Intramuscular triamcinolone v intramuscular dexamethasone | 4 | –1 | –1 | –1 | 0 | Very low | Quality point deducted for incomplete reporting of results. Consistency point deducted for heterogeneity between studies. Directness point deducted for uncertainty about definition of outcomes or population |
| 1 (97) | Symptom relief | Intramuscular methylprednisolone v intramuscular betamethasone v intramuscular dexamethasone | 4 | –2 | –1 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and sparse data. Consistency point deducted for heterogeneity between studies. Directness point deducted for uncertainty about definition of outcomes or population |
| 1 (98) | Symptom relief | Oral budesonide v placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for incomplete reporting of results and sparse data |
| 1 (98) | Symptom relief | Intranasal budesonide v oral budesonide | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for incomplete reporting of results and sparse data |
| 1 (304) | Symptom relief | Oral fluticasone v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (304) | Symptom relief | Intranasal fluticasone v oral fluticasone | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (99) | Symptom relief | Oral flunisolide v placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for incomplete reporting of results and sparse data |
| 1 (99) | Symptom relief | Intranasal flunisolide v oral flunisolide | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for incomplete reporting of results and sparse data |
| 5 (2089) | Symptom relief | Pseudoephedrine plus oral antihistamines v placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 10 (6189) | Symptom relief | Pseudoephedrine plus antihistamines v antihistamines alone | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 9 (6148) | Symptom relief | Pseudoephedrine plus antihistamines v pseudoephedrine alone | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (204) | Symptom relief | Intranasal corticosteroids v oral antihistamines plus pseudoephedrine | 4 | 0 | 0 | 0 | 0 | High | |
Type of evidence: 4 = RCT; 2 = Observational; 1 = Non-analytical/expert opinion.Consistency: similarity of results across studies. Directness: generalisability of population or outcomes.Effect size: based on relative risk or odds ratio.
Glossary
- High-quality evidence
Further research is very unlikely to change our confidence in the estimate of effect.
- Low-quality evidence
Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
- Moderate-quality evidence
Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
- Rhinoconjunctivitis Quality of Life Questionnaire
This is widely used in clinical trials to evaluate problems associated with rhinoconjunctivitis, such as nose and eye symptoms in adults. It comprises 28 questions in seven domains (activity limitations, sleep problems, non-nasal/eye symptoms, practical problems, nose symptoms, eye symptoms, and emotional function), in both self-administered and interviewer-administered formats. People are asked to recall their experiences during the previous week and give their responses on a 7-point scale.
- Very low-quality evidence
Any estimate of effect is very uncertain.
Disclaimer
The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients.To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.
Contributor Information
Professor Aziz Sheikh, Allergy and Respiratory Research Group, Centre for Population Health Services, University of Edinburgh, Edinburgh, UK.
Mr Sukhmeet Singh Panesar, Allergy & Respiratory Research Group, Centre for Population Health Science, The University of Edinburgh, Edinburgh, UK.
Dr Sarah Salvilla, St. George's Hospital, London, UK.
Dr Sangeeta Dhami, , Edinburgh, UK.
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