BackgroundAllergic rhinitis is the most common of the allergic diseases. Despite improved understanding of the pathophysiology of allergic rhinitis and advances in its pharmacological treatment, its prevalence has increased worldwide. For patients whose symptoms remain uncontrolled despite medical treatment, allergen injection immunotherapy is advised. An allergen‐based treatment may reduce symptoms, the need for medication and modify the natural course of this disease.ObjectivesTo evaluate the efficacy and safety of subcutaneous specific allergen immunotherapy, compared with placebo, for reducing symptoms and medication requirements in seasonal allergic rhinitis patients.Search strategyWe searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1 2006), MEDLINE (1950 to 2006), EMBASE (1974 to 2006), Pre‐MEDLINE, KOREAMED, INDMED, LILACS, PAKMEDINET, Scisearch, mRCT and the National Research Register. The date of the last search was February 2006.Selection criteriaAll studies identified by the searches were assessed to identify randomised controlled trials involving participants with symptoms of seasonal allergic rhinitis and proven allergen sensitivity, treated with subcutaneous allergen specific immunotherapy or corresponding placebo.Data collection and analysisTwo independent authors identified all studies reporting double‐blind, placebo controlled randomised trials of specific immunotherapy in patients with seasonal allergic rhinitis due to tree, grass or weed pollens. Two authors independently performed quality assessment of studies. Data from identified studies were abstracted onto a standard extraction sheet and subsequently entered into RevMan 4.2.8. Analysis was performed using the Standardised Mean Difference (SMD) method and a random‐effects model; P values < 0.05 were considered statistically significant. The primary outcome measures were symptom scores, medication use, quality of life and adverse events.Main resultsWe retrieved 1111 publications of which 51 satisfied our inclusion criteria. In total there were 2871 participants (1645 active, 1226 placebo), each receiving on average 18 injections. Duration of immunotherapy varied from three days to three years. Symptom score data from 15 trials were suitable for meta‐analysis and showed an overall reduction in the immunotherapy group (SMD ‐0.73 (95% CI ‐0.97 to ‐0.50, P < 0.00001)). Medication score data from 13 trials showed an overall reduction in the immunotherapy group (SMD of ‐0.57 (95% CI ‐0.82 to ‐0.33, p<0.00001)). Clinical interpretation of the effect size is difficult. Adrenaline was given in 0.13% (19 of 14085 injections) of those on active treatment and in 0.01% (1 of 8278 injections) of the placebo group for treatment of adverse events. There were no fatalities.Authors' conclusionsThis review has shown that specific allergen injection immunotherapy in suitably selected patients with seasonal allergic rhinitis results in a significant reduction in symptom scores and medication use. Injection immunotherapy has a known and relatively low risk of severe adverse events. We found no long‐term consequences from adverse events.Plain Language SummaryImmunotherapy by allergen injections for seasonal allergic rhinitis ('hay fever')Seasonal allergic rhinitis ('hay fever') is a global health problem and its prevalence has increased considerably in the last two decades. Treatment includes allergen avoidance, drugs such as antihistamine tablets and nasal sprays, and immunotherapy (vaccination). For those patients whose symptoms remain uncontrolled despite drug treatment, specific allergen immunotherapy (SIT) is advised.Specific allergen immunotherapy is most commonly administered as subcutaneous (under the skin) injections by specialists requiring a building‐up period followed by a maintenance period of three to five years. Immunotherapy may also be delivered by the oral, nasal or sublingual route and these will be studied in separate Cochrane reviews, as will immunotherapy for perennial (all year round) allergic rhinitis. In this review we aimed to evaluate the efficacy and safety of injection immunotherapy, compared with placebo, for reducing symptoms and the need for medication.We identified randomised, double‐blind, placebo controlled trials of specific allergen immunotherapy in patients with seasonal allergic rhinitis due to tree, grass or weed pollens. Fifty‐one studies satisfied our inclusion criteria. In total there were 2871 participants (1645 in the treatment groups and 1226 in the placebo), each receiving on average 18 injections. The duration of treatment varied from three days to three years.This review has shown that injection immunotherapy in suitably selected patients with hay fever results in significant reductions in symptom scores and medication use. Injection immunotherapy has a known and relatively low risk of severe adverse events. We found no long‐term consequences from adverse events and no fatalities.
