Can 2006.
| Methods | Randomised controlled trial conducted between March and July 2002 in Ege University Faculty of Medicine, Division of Pediatric Allergy and Respiratory Diseases in Turkey. The study included 7 visits. | |
| Participants | 24 patients (randomly selected from a pool of 78 patients) with moderate to severe seasonal allergic rhinitis sensitive to pollen who were followed up for at least 2 years Age (mean): 12.17 ± 2.26 years with a range of 9 to 18 years old (16 boys, 8 girls). All of the patients were only sensitive to 5 types of grass pollen (Dactylis glomerata, Anxhoxantum odoratum, Loium prenne, Phleum pratense and Poa pratensis) in the prick test. Patients with mild allergic rhinitis on local/systemic glucocorticosteroids or H1‐antihistamines patients with remarkable nose deformities or with an upper airway infection in the last month were excluded from the study. |
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| Interventions | Group 1 received oral H1‐antihistamine (loratadine syrup, 10 mg/10 mL) for children < 12 years old and loratadine, 10 mg o.d. for patients > 12 years old and intranasal glucocorticosteroid (mometasone furoate aqueous nasal spray, 100 μg, 1 puff/day) Group 2 received intranasal glucocorticosteroid alone (mometasone furoate aqueous nasal spray, 100 μg, 1 puff/day) |
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| Outcomes |
Subjective parameters: Daily rhinitis diary card to record allergic rhinitis and conjunctivitis symptoms on a 4‐point scale (0 to 3) for both daytime (completed in the evening) and night‐time (completed on awakening) Objective parameters: Nasal peak inspiratory flow Nasal smear Nasal biopsy |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | High risk | Quote (on page 249 of the article) "...the patients were randomised into two groups. Our randomisation method is based on the file's protocol numbers, odd numbers for group I and even numbers for group II". Comment: quasi‐randomised |
| Allocation concealment? | High risk | There were no attempts to conceal the allocation of patients to the 2 groups |
| Blinding? All outcomes | High risk | There were no attempts to blind the patients |
| Incomplete outcome data addressed? All outcomes | Unclear risk | The authors did not report whether there was any loss to follow up |
| Free of selective reporting? | Unclear risk | The protocol for the study was not available |
| Free of other bias? | Low risk | No indication for further concern |