Erlichman 1981.
Methods | Double‐blind, randomised, placebo‐controlled, parallel‐group trial. No intention‐to‐treat analysis. |
|
Participants | Inclusion criteria
Exclusion criteria: if rash persisted to 8 months, diagnosis changed to infantile eczema and that participant retrospectively excluded from study. Number of participants randomised: total 20, outcome reported for 16 (7 in treatment group and 9 in comparator group) Number of dropouts: 1 lost to follow‐up, 3 excluded as diagnosis revised to infantile eczema when rash persisted to 8 months Sex: not reported Location: Jerusalem, paediatric department No topical therapy given during the trial. Age range: not reported; mean age (months): 2.1 (SD 1.3) in biotin group and 2.6 (SD 1.1) in placebo group Total 20 infants included |
|
Interventions |
Treatment (n = 10) Oral biotin 5 mg given daily for 2 weeks. Comparator (n = 10) Placebo (oral glucose) given daily for 2 weeks. Clinical outcomes reported for n = 7 in biotin group and n = 9 in placebo group. |
|
Outcomes |
Primary outcome measures
Adverse effects not reported. No quality of life outcomes reported. Outcomes assessed 2 weekly until resolution of rash or 8 months of age. |
|
Notes | Biotin supplied freely by pharmaceutical laboratory, funding from Michael and Adelaide Kennedy‐Leigh Foundation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | 1/20 participants lost to follow‐up. 3/20 participants excluded from analysis on basis of outcome, but outcome separately reported (i.e. non‐resolution of rash at age 8 months). |
Selective reporting (reporting bias) | Unclear risk | No study protocol. |
Other bias | Unclear risk | Insufficient information given in Methods section. Biotin supplied by pharmaceutical company. |