Wu 2012.
| Methods | Ten‐week parallel‐group double‐blind randomised placebo‐controlled trial | |
| Participants | Sixty children from 2 to 14 years of age with eczema diagnosed by Hanifin and Rajka criteria and moderate to severe disease (SCORAD > 25) who had eczema symptoms for at least 4 days before diagnosis. Randomisation was done at a 1:1 ratio: 30 children were randomised in each arm Setting: secondary care with 1 recruiting centre in Taiwan Six participants were excluded post randomisation but before treatment started |
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| Interventions | Synbiotic: Lactobacillus salivarius PM‐A0006 2 × 10⁹ CFUs/25 mgr and fructo‐oligosaccharide 475 mgr in a capsule preparation twice daily Control: corn starch 25 mgr and fructo‐oligosaccharide 475 mgr in a capsule twice daily |
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| Outcomes | • SCORAD* • 13‐item quality of life daily diary • Global eczema severity • SCORAD parameters for pruritus and sleep loss* • Frequency of use of topical corticosteroid or calcineurin inhibitor (times/month)* *Denotes outcomes prespecified for this review |
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| Notes | Two probiotic‐treated participants initially had mild diarrhoea but overall tolerated treatment well Sponsorship declared and no conflicts of interest reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The children were randomised into two groups...in a double‐blind manner using a computer‐generated blocked randomisation list provided by ProMD Biotech Co., Taiwan. A block size of four was used and stratified according to sex, age and diagnosis of moderate to severe AD" Comment: judged as adequate for low risk of bias |
| Allocation concealment (selection bias) | Low risk | Quote: "The code was opened only after all data were analysed." Comment: probably done, so judged as adequate for low risk of bias |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The synbiotic and prebiotic products, which were identical in appearance, odour and taste, were delivered in numbered packages directly to the parents according to randomisation list. The code was opened only after all data were analysed" ‐ "the same investigator (KGW), who was blinded to group assignment, enrolled patients and performed all SCORAD assessments at weeks 0, 4, 8 and 10" Comment: judged as adequate for low risk of bias |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The synbiotic and prebiotic products, which were identical in appearance, odour and taste, were delivered in numbered packages directly to the parents according to randomisation list. The code was opened only after all data were analysed" ‐ "the same investigator (KGW), who was blinded to group assignment, enrolled patients and performed all SCORAD assessments at weeks 0, 4, 8 and 10" Comment: judged as adequate for low risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Six participants (10% in total and in each group) withdrew after randomisation but before treatment initiation and were excluded from analysis. Reasons for withdrawal given and similar in both groups Comment: low rates of excluded patients unlikely to have a significant impact on effect estimate; hence low risk of attrition bias |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
| Other bias | Low risk | No other bias found |