Yang 2014.
| Methods | Six‐week parallel‐group double‐blind placebo‐controlled randomised trial conducted between November 2010 and October 2011 | |
| Participants | One hundred children from 2 to 9 years of age with mild to moderate (SCORAD < 40) atopic dermatitis diagnosed according to the criteria of Hanifin and Rajka were recruited. Randomisation was done at a 1:1 ratio: 50 participants were randomised in each arm Exposure to commercial probiotic products during the 4 weeks before the study Premature children and those receiving antibiotic, systemic corticosteroid, immunosuppressive, or Chinese herbal therapies within 4 weeks before enrolment were excluded form the study. Also excluded were patients with acute gastrointestinal infection, chronic underlying disease, or baseline factors predisposing to infection (e.g. neurological disease; metabolic disease; chronic respiratory disease; congenital anomaly of the heart, gastrointestinal system, or lung; known or suspected immunodeficiency) Recruitment took place at a tertiary paediatric centre in Korea Twenty‐nine participants were lost to follow‐up |
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| Interventions | Probiotic mixture: Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium lactis in glucose anhydrous crystalline powder derived from cornstarch prepared in warm water or juice given orally immediately after meals twice daily at a dose of 1 × 10⁹ CFUs of each probiotic strain for 6 weeks Control (placebo): glucose anhydrous crystalline powder prepared in warm water or juice given orally immediately after meals twice daily for 6 weeks Instructions given to stop topical corticosteroids and calcineurin inhibitors, oral antihistamines, and any commercial probiotic‐containing products 2 weeks before study initiation Parents were trained in appropriate bathing and skin care practices and were given instructions on application of emollients |
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| Outcomes | • EASI score at baseline and end of treatment and change from baseline* • VASP score at baseline and end of treatment and change from baseline* *Denotes outcomes prespecified for this review |
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| Notes | Study sponsored by the probiotic supplier; the supplier's role in data analysis and publication is unclear | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomisation software was used to randomly allocate children..." Comment: computer‐generated and so judged as adequate for low risk of bias |
| Allocation concealment (selection bias) | Low risk | Comment: third party ‐ not involved in the trial ‐ allocated treatment. Study judged as adequate for low risk of bias |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "The probiotics mixture and placebo controls were identical in colour, taste, smell, packing and manner of administration. All formulations were dispensed by a pharmacist not associated with the study.", "both investigators and study subjects were blinded to the identity of the intervention" Comment: not clear if clinicians were blinded; patients were blinded; judged as having unclear risk of bias |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "The probiotics mixture and placebo controls were identical in colour, taste, smell, packing and manner of administration. All formulations were dispensed by a pharmacist not associated with the study" ‐ "both investigators and study subjects were blinded to the identity of the intervention" Comment: not clear if outcome assessor was blinded; judged as having unclear risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Available case analysis but high rates of loss to follow‐up (29%: 26% in probiotic group and 32% in placebo group), which were excluded from analysis Comment: effect estimate for all outcomes may have been affected; judged as having high risk of attrition bias |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
| Other bias | Unclear risk | Study sponsored by the probiotic supplier, and the supplier's role in data analysis and publication is unclear. Therefore the study was judged to be at unclear risk of bias |