Guo 2015.
Methods | Randomised trial | |
Participants | 180 children with eczema, from 2 months to 3 years of age. No additional information provided on exact ratio of randomisation into 2 arms. Patients with other medical conditions excluded | |
Interventions | Active: routine symptomatic treatment and combination of 4 living bacterium tablets (Bifidobacterium, Lactobacillus, Enterococcus, and Bacilus cereus) taken orally at a dose of 1 tablet twice a day for 1 month Control: routine symptomatic treatment Routine symptomatic treatment: mild disease – calamine lotion and zinc oxide ointment, 3 times daily for 2 weeks Severe disease – loratadine syrup, topical mometasone and topical mupirocin to stop after disease control All participants advised to avoid washing with hot water/spa products and scratching, and to look for potential allergens and avoidance advice |
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Outcomes | IL‐4, IL‐10, IgE, IFN‐γ, and Th1:Th2 ratio Relapse rate of the 2 groups in the 3‐month follow‐up visit. Relapse is defined as recurrence of rash within the 3 months Eczema improvement: • Complete resolution: ‐ complete clearance of rash and itch; and normal eating and sleeping patterns • Good response: > 70% eczema clearance, no obvious lichenification, almost complete resolution of itch/intermittent itch, eating and daily activities not affected • Partial response: 30% to 70% clearance, symptom improvement • No response: < 30% rash clearance, no obvious reduction in itch Complete resolution, good response, and partial response make up total percentage of responding participants |
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Notes | Contact: guoyangjie829@163.com Trial was conducted in a secondary care setting at a paediatric clinic No information provided on sponsorship/conflicts of interest |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Inadequate information for a judgement |
Allocation concealment (selection bias) | Unclear risk | Inadequate information for a judgement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Inadequate information for a judgement |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Inadequate information for a judgement |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Inadequate information for a judgement |
Selective reporting (reporting bias) | Unclear risk | All outcomes reported; however dose of probiotics not given, and results reported only narratively |
Other bias | Unclear risk | No information on trial registration and sponsorship |