Skip to main content
. 2010 Jul 7;2010(7):CD006989. doi: 10.1002/14651858.CD006989.pub2

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.
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)
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
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