Han 2012.
| Methods | Sixteen‐week parallel‐group double‐blind placebo‐controlled randomised trial | |
| Participants | One hundred eighteen children between 1 and 13 years of age with atopic dermatitis diagnosed according to Hanifin and Rajka criteria with SCORAD between 20 and 50 Randomisation was done at a 1:1 ratio: 58 participants were randomised in the intervention arm, and 60 in the control arm. After selection, participants went through a 2‐week washout period, when both groups were administered placebo only. Patients who had taken systemic corticosteroids, probiotics, or phototherapy within a month before enrolment, with systemic immunosuppression within 3 months before enrolment, with SCORAD < 20 after a 2‐week washout period, or with other concomitant skin disease or systemic illness were excluded from the study. One recruiting centre was located in Korea. Thirty‐five participants were lost to follow‐up | |
| Interventions | Probiotic: Lactobacillus plantarum CJLP 133 given orally twice daily at a dose of 0.5 × 10¹º CFUs for 12 weeks Placebo: maltodextrin and anhydrous glucose twice daily for 2 weeks as a washout period by both groups, and then for 12 weeks by the control group |
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| Outcomes | • Total SCORAD at baseline, after 2‐week washout period, and at 8, 14, and 16 weeks, and changes from week 2 (start of intervention) to week 14 (end of intervention) and week 16 (2‐week follow‐up after end of intervention)* • Amount in weight of topical corticosteroids used during the whole study and during intervention only* • Number of participants using topical corticosteroids during the study* *Denotes outcomes prespecified for this review |
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| Notes | Trial sponsored by probiotic supplier; 2 investigators are employed by this company. No other information on conflicts of interest | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "...using a computer‐generated list of random numbers" Comment: judged as adequate for low risk |
| Allocation concealment (selection bias) | Low risk | Quote: "The random number list was prepared and posted on the fronts of the bags containing the materials by an investigator who was not involved clinically in the trial", "...placebo preparation with identical appearance and taste" Comment: probably done and judged as adequate for low risk. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Intervention and placebo identical in appearance and taste Also quote from correspondence with study author: "clinicians and outcome assessors had been blinded during the study period" Comment: judged as adequate for low risk |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote from correspondence with study author: "clinicians and outcome assessors had been blinded during the study period" Comment: judged as adequate for low risk |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Intention‐to‐treat analysis used but high rates of losses to follow‐up (30%). 14/58 (24%) participants from probiotic group and 21/60 (35%) from placebo group lost to follow‐up. Reasons for losses to follow‐up given and similar in both groups Incomplete data likely to have an impact on the effect estimate; judged as high risk |
| Selective reporting (reporting bias) | High risk | Symptom scores (i.e. for pruritus, sleep loss, and SCORAD part C) after intervention not reported |
| Other bias | High risk | Commercial bias: trial sponsored by probiotic supplier, and 2 of the investigators employed by the company. It is likely that the sponsor had an influence on the outcome and on selective reporting Selection bias: power calculation and final numbers of participants suggest that study did not meet the target According to publication: "Study discontinued after the second interim analysis showed statistically significant differences between the groups" Study assessed to be at high risk of bias |