Lin 2015.
Methods | Four‐week randomised parallel controlled trial | |
Participants | Forty‐four infants of both genders with newly diagnosed eczema based on the diagnostic criteria for eczema up to 3 years of age were recruited. Randomisation was done at 1:2 ratio: 22 participants were randomised in each group. Infants who had been treated with antibiotics, probiotics, or other drugs and food at least 2 weeks before the start of the study were excluded. Also excluded were children suffering from pneumonia, capillary bronchitis, and other diseases, or who had been treated with antibiotics or hormones during the experimental process Infants were treated with antiallergic therapy and dietary guidance Recruitment took place in a secondary paediatric setting in China between December 2010 and March 2011 |
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Interventions | Intervention group received triple viable capsules containing Bifidobacterium bifidum 3 times daily for 4 weeks Control group received no treatment |
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Outcomes | • Total SCORAD index at baseline and after 4 weeks of intervention • Bifidobacterium bifidum stool levels at baseline and after 4 weeks of treatment |
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Notes | Sponsorship of the trial not declared. Not clear what role the supplier of the probiotic played in the study | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The 40 infants were randomly divided into treatment and control groups" Judgement: inadequate information on randomisation method; risk of bias judged as unclear |
Allocation concealment (selection bias) | Unclear risk | Inadequate information for a judgement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The control group … did not receive any special treatment and were not administered a placebo drug" Judgement: unlikely to be done adequately with no treatment and no placebo in the control group |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "The control group … did not receive any special treatment and were not administered a placebo drug" Otherwise no information on blinding of outcome assessors; hence risk of detection bias judged to be unclear |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information provided on losses to follow‐up and missing outcome data Judgement: unclear risk of bias |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Unclear risk | Not clear what role the supplier of the probiotic played in the study. Sponsorship of the trial not declared Judgement: unclear risk of commercial bias |