| Methods |
Design: three group parallel trial
Purpose: examine the effect of antihistamine decongestant and placebo on common cold symptoms in children |
| Participants |
Patients: paediatric primary care unit out‐patients (0.5 to 5 years) with common cold symptoms
Baseline comparability: NS |
| Interventions |
Placebo: medication containing no antihistamines
Untreated: no medication
Experimental: medication containing antihistamines (brompheniramine, phenylephrine and phenylpropanolamine)
(Co‐intervention: instructions to avoid, however 9/30 in untreated group took NSAID, 0/24 in placebo group) |
| Outcomes |
Number of children with improved rhinorrhoea (parental assessment)
Individual cold symptoms (breathing problems, fever, cough, decreased appetite, crankiness, sleeping disturbance, vomiting)
General assessment |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'Neither parents and guardians nor investigators were aware of the drug‐placebo assignment' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient (parents) reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
Low risk |
N = 54 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |
