Roessler 2007.
Methods | Twenty‐week cross‐over randomised double‐blind placebo‐controlled trial | |
Participants | Sixteen adults between 18 and 40 years of age with eczema diagnosed based on Erlangen score > 10 (atopic score of Diepgen) and SCORAD severity score 5 to 30 were recruited. Only patients who were willing to apply cosmetic products and the Class II topical corticosteroid Advantan were recruited. Exclusion criteria were disease necessitating medication with systemic corticosteroids, immunosuppression, or cytostatics within 4 weeks before the start of the study; phototherapy or systemic treatments within 4 weeks before the start of the study; long‐acting antihistamines, antibiotics, long‐term systemic corticosteroids, depot steroids, tranquillisers, and psychopharmaceuticals with antihistamine effect or within 7 days from skin prick test; or astemizole intake within 4 weeks before prick testing. Also excluded were patients with active skin infection; asthma needing treatment with corticosteroids; indigestibility/allergy to milk components (including skin prick test); lactose intolerance; acute or chronic symptomatic heart disease or severe internistic disease; autoimmune disease; immune deficiency (including immune suppressive treatment); immune complex‐induced immunopathy or malignant tumour; or abuse of alcohol, drugs, or medicaments, as well as pregnant and breastfeeding women Recruitment was done at a secondary care centre in Germany One participant withdrew after randomisation and before treatment started |
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Interventions | Probiotic yoghurt drink containing Streptococcus thermophilus enriched with Lactobacillus paracasei Lpc‐37 (3.9 × 10⁸ CFUs/g), Lactobacillus acidophilus 74‐2 (2.9 × 10⁴ CFUs/g), Bifidobacterium lactis DGCC 420 (5.9 × 10⁴ CFUs/g) taken as 100 mL twice daily for 8 weeks Total daily dose was Lpc‐37: 7.8 × 10¹º CFUs/d, 74‐2: 5.8 × 10⁶ CFUs/d, and DGCC 420: 1.2 × 10⁷ CFUs/d Placebo drink not otherwise specified given as 100 mL twice daily Crossing over from one to the other intervention involved a washout period of 2 weeks Instructions were given for elimination of other probiotic and prebiotic products for 3 weeks before the start of treatment and during the 20 weeks of intervention |
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Outcomes | Total SCORAD and SCORAD part C at baseline and after 8 weeks of each intervention* *Denotes outcomes prespecified for this review |
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Notes | Study was sponsored by a grant from Zott Dairy GmbH (not the probiotic supplier). It was declared that Zott had no involvement in study design, data analysis, and publication, and study authors declared no conflict of interest | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "all subjects were randomly assigned to 2 treatment groups (1:1) according to a computer generated blocked randomisation list (blocked randomisation)" Comment: judged as adequate for low risk of bias |
Allocation concealment (selection bias) | Unclear risk | Comment: not clear whether treatment allocation was concealed |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The placebo drink had an identical composition except for the probiotic cultures and had the same appearance, taste and smell as the probiotic drink" ‐ "Enrollment and assignment to interventions were performed by the trial physician and AR. All involved persons (trial physician and scientific staff) were blinded. In addition study products were blinded and labelled with a numerical code by the production dairy" Comment: judged as adequate for low risk of bias |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The placebo drink had an identical composition except for the probiotic cultures and had the same appearance, taste and smell as the probiotic drink" ‐ "Enrollment and assignment to interventions were performed by the trial physician and AR. All involved persons (trial physician and scientific staff) were blinded. In addition study products were blinded and labelled with a numerical code by the production dairy" Comment: judged as adequate for low risk of bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant (6.6%) withdrew after randomisation and before the start of treatment and was excluded from analysis. All other participants were analysed in the group to which they had been randomised. Low rates of loss to follow‐up were unlikely to have a significant influence on effect estimates |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | No other bias found |