Sistek 2006.
| Methods | Twelve‐week parallel‐group randomised controlled trial | |
| Participants | Sixty children 1 to 10 years of age with eczema diagnosed by UK Working Party criteria, SCORAD of at least 10 at recruitment, and a positive skin prick or RAST test to at least 1 common environmental or food allergen. Randomisation was done at a 1:1 ratio: 30 participants were randomised in each arm. Exclusion criteria were oral corticosteroid, immunosuppressant, or antibiotic in the previous month; previous immune deficiency or malignancy; and greater than 10‐point improvement in SCORAD during 2 weeks before the start of study treatment Setting: hospital clinic in New Zealand One participant lost to follow‐up |
|
| Interventions | Microcrystalline cellulose placebo or Lactobacillus rhamnosus and Bifidobacterium lactis given together once daily at a combined total dose of 2 × 10¹º CFUs/d. Treatment capsules administered as a powder mixed with food or drink, or taken in capsule form | |
| Outcomes | SCORAD assessed at 2 weeks before treatment, at the start of treatment, and 2, 12, and 16 weeks later* *Denotes outcomes prespecified for this review |
|
| Notes | One participant noted to be taking another non‐investigational probiotic Study was was funded by New Zealand Research Council. No conflicts of interest were declared |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Children were randomly assigned to treatment or placebo groups, using computer‐generated random numbers" Comment: judged as adequate for low risk of bias |
| Allocation concealment (selection bias) | Low risk | Adequate: treatment allocated by third party as confirmed by study authors |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quotes: "The control group received a placebo....that looked and tasted the same as the probiotic" ‐ "Both subjects and investigators were blind to the treatment groups" Comment: judged as adequate for low risk of bias |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quotes: "The control group received a placebo....that looked and tasted the same as the probiotic" ‐ "Both subjects and investigators were blind to the treatment groups" Comment: judged as adequate for low risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Available case analysis used without exclusions after randomisation and very low rates of loss to follow‐up (1/60 participants, 1.7%) Comment: low risk of attrition bias |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
| Other bias | Unclear risk | Significant differences in baseline SCORAD in the 2 groups, with more severe mean SCORAD in the placebo group. Study authors state that this could have been avoided if randomisation had been blocked Comment: uncertain how this difference could have influenced the effect estimate |