Yoshida 2010.
Methods | Eight‐week parallel‐group placebo‐controlled trial | |
Participants | Twenty‐four adults with atopic dermatitis diagnosed according to the Guideline for Management of AD by the Japanese Dermatological Association were recruited and randomised at a 2:1 ratio of intervention:control (16 participants in intervention arm/8 participants in control arm) Recruitment took place in a centre in Japan No participants were lost to follow‐up |
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Interventions | Probiotic: Bifidobacterium breve (lyophilised powder of live B breve YY) in a capsule preparation at a dose of 1.0 × 10¹º CFUs/capsule taken twice daily after breakfast and after dinner for 8 weeks Placebo not described |
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Outcomes | • SCORAD: total, objective, subjective* • Japanese version of Skindex‐29* *Denotes outcomes prespecified for this review |
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Notes | Sponsorship was not declared, but 2 of the authors of the report are linked to the supplier of the probiotic | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Test meals for 24 subjects were randomly allocated..." Comment: no other information provided; judged as having unclear risk |
Allocation concealment (selection bias) | Unclear risk | No information given |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information given |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information given |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up. All participants analysed |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
Other bias | High risk | Selection bias: baseline SCORAD scores not matched between the 2 groups Commercial bias: sponsorship not declared but 2 of the authors of the report linked to the supplier of the probiotic; this may have affected the outcome Study was judged to have high risk of other bias |
AD: atopic dermatitis. AEDS: atopic eczema‐dermatitis syndrome. BPD: bronchopulmonary dysplasia. CDLQI: Children's Dermatology Life Quality Index. CFU: colony‐forming unit. cGMP: cyclic guanosine monophosphate. DFI: Dermatology Family Impact. DLQI: Dermatology Life Quality Index. EASI: Eczema Area Severity Index. FDLQI: Family Dermatology Life Quality Index. IDQoL: Infant Dermatitis Quality of Life. IFN: interferon. IgE: immunoglobulin E. IL: interleukin. LF: Lactobacillus fermentum. LP: Lactobacillus paracasei. RAST: radioallergosorbent test. RSV: respiratory syncytial virus. SCORAD: Severity Scoring of Atopic Dermatitis. TCS: topical corticosteroid. TS: topical steroid. VAS: visual analogue scale. VASP: Visual Analogue Scale of Pruritus.