Yesilova 2012.
Methods | Eight‐week parallel‐group double‐blind randomised placebo‐controlled trial | |
Participants | Forty children 1 to 13 years of age with atopic dermatitis diagnosed according to Hanifin and Rajka criteria and with moderate to severe disease. Randomisation was done at a 1:1 ratio: 20 participants were randomised in each arm. Excluded were patients on medication including antihistamines and corticosteroids for 14 days before recruitment, as well as those with malabsorption. One participant was lost to follow‐up | |
Interventions | Probiotic mixture:Bifidobacterium bifidum,Lactobacillus acidophilus,Lactobacillus casei,Lactobacillus salivarius given orally at a dose of 2 × 10⁹ CFUs and a total daily dose of 4 × 10⁹ CFUs for 8 weeks Placebo: skim milk powder and dextrose |
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Outcomes | SCORAD at baseline and at 8 weeks* *Denotes outcomes prespecified for this review |
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Notes | Conflicts of interest/sponsorship not declared | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The patients were referred to a nurse who was involved in the study to receive either probiotic or placebo. The nurse randomised each patient to two different treatment groups using the closed‐envelope method" Comment: not clear how the "closed envelopes" had been created and whether the sequence generation had been random. Judged as having unclear risk of bias |
Allocation concealment (selection bias) | Low risk | Quote: "Closed envelope method" Comment: probably done; judged as adequate for low risk of bias |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "The patients were referred to a nurse who was involved in the study to receive either probiotic or placebo. The nurse randomised each patient to two different treatment groups using the closed‐envelope method. The authors had no role in the treatment decision and were blinded to the treatment groups" Comment: inadequate information provided on which parts were blinded and whether the interventions were identical. Judged as having unclear risk of bias |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "The patients were referred to a nurse who was involved in the study to receive either probiotic or placebo. The nurse randomised each patient to two different treatment groups using the closed‐envelope method. The authors had no role in the treatment decision and were blinded to the treatment groups" Comment: inadequate information on which parts were blinded and whether interventions were identical. Judged as having unclear risk of bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant from the placebo group was lost to follow‐up (2.5%). Available case analysis was used. Very few losses to follow‐up were unlikely to affect the effect estimate for any outcome |
Selective reporting (reporting bias) | Low risk | All outcomes reported. Differences between probiotic and placebo not given but reported narratively: "Our results demonstrated an improved SCORAD index in both groups, but with higher levels in the probiotic group (65%) than in the placebo group (46%). In the probiotic group, a greater decrease of SCORAD index scores was shown after treatment in patients with high SCORAD index scores. However this difference did not reach a statistically significant level" |
Other bias | Unclear risk | Conflicts of interest/sponsorship not declared Baseline characteristics of 2 groups not given. Uncertain if they were matched Judged to be at uncertain risk of other bias |