Matsumoto 2014.
Methods | Eight‐week multi‐centre randomised double‐blind placebo‐controlled parallel trial | |
Participants | Forty‐four adults with moderate to severe atopic dermatitis diagnosed according to the criteria of Hanifin and Rajka were recruited. Randomisation was done at a 1:1 ratio: 22 participants were randomised in each arm. Participants continued to use their medications as usual and did not change quantities or levels of corticosteroid medicine during the experimental period. Participants were asked to avoid probiotic supplements, fermented milk, lactic acid bacterial drinks, and fermented soybean (natto) during the experimental period Recruitment took place at 8 dermatology clinics in Japan |
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Interventions | Participants in the intervention group received capsules containing approximately 6 × 10⁹ CFUs of Bifidobacterium animalis subsp lactis and an excipient that consisted of skim milk, glucose, inulin, dextrin, and silicone dioxide for 8 weeks Control group received capsules containing the excipient only for 8 weeks |
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Outcomes | • Itch score by behavioural rating scales and by 100‐mm visual analogue scale (VAS) at baseline and at 4 and 8 weeks • Skin severity score using the reference proposed by the Research Group granted by the Japanese Ministry of Health, Labor and Welfare at baseline and at 4 and 8 weeks • Quality of life using Skindex‐29 (Japanese version) at baseline and at 4 and 8 weeks • Faecal levels of B lactis at baseline and at 4 and 8 weeks |
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Notes | Trial registration: UMIN000005695 Four of the investigators/study authors are employed by the supplier |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The 44 participants eligible for the study were randomly assigned to receive LKM512 capsule or a placebo by the masked quota director" Judgement: inadequate information on randomisation method; hence judgement of unclear risk of selection bias |
Allocation concealment (selection bias) | Unclear risk | Inadequate information for a judgement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "Double‐blind" mentioned, but trial registration shows open‐label |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "Double‐blind" mentioned, but trial registration shows open‐label |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information provided |
Selective reporting (reporting bias) | Unclear risk | All outcomes reported but not numerically, and any favourable information/outcome for probiotics particularly analysed, even if not statistically significant |
Other bias | High risk | Commercial bias: 4 investigators/study authors employed by supplier; likely that this has influenced the design and outcome of the trial |