| Methods |
This was a randomised controlled trial (single centre, UK). D = parallel AC = clear ‐ randomisation schedule supervised by the Director of Pharmacy RS = random number tables using blocks of 4 B = outcome assessor |
| Participants |
Inclusion criteria of the trial
48 children (T1: 24; T2: 24) older than 12 months (age range 2 to 15 years) who had not received oral corticosteroids in the last 2 months. 41 were evaluable (T1:19, T2: 22)
Setting = outpatients
SAE = moderate or severe
Dig = Hanifin and Rajka
Co‐T = all participants were receiving conventional topical treatment with emollients and corticosteroids of milk or moderate potency
Exclusion criteria of the trial
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| Interventions |
T1: pyridoxine hydrochloride (n = 24) T2: placebo tablet (n = 24) T1 vs T2 ‐ 1 tablet (50 mg) per day for 4 weeks |
| Outcomes |
FU at baseline and after 4 weeks of treatment
Parents recorded in a diary the amount of nocturnal sleep disturbances due to scratching, and the amount of daytime scratching on a numeric scale from 0 (none) to 10 (the worst you could imagine)
The percentage surface area of the body affected by dermatitis was determined using charts that divided the body into 32 separate zones. Skin severity for each of the 32 zones assessed by extent of area affected. The total of all 32 zones summated to give total extent of skin involvement
Overall degree of erythema graded on an arbitrary scale: 0 (none) to 5 (severe)
After 4 weeks parents recorded if eczema was 'better', 'worse', or 'no change'
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| Notes |
A per‐protocol analysis was undertaken.
7 participants were lost to FU ‐ 3 from the treatment group, 2 from the placebo group (3 because of eczema flare up due to bacterial infection requiring antibiotics, and 2 due to exacerbations of coexistent asthma requiring oral prednisolone treatment), 1 stopped taking the tablets suspecting food allergy, and 1 failed to return for the 4‐week assessment.
Randomisation led to differences in sex distribution, with 79% men in the treatment group and 68% women in the placebo group.
The scoring of the degree of erythema was semi‐objective. The dosage was the same regardless of the age or size of the child.
There was no table of results.
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| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random number tables using blocks of 4 were used. |
| Allocation concealment (selection bias) |
Low risk |
Randomisation schedule were supervised by the Director of Pharmacy. |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
The outcome assessor was blinded. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
7 participants were lost to FU ‐ 3 from the treatment group, 2 from the placebo group (3 because of eczema flare up due to bacterial infection requiring antibiotics, and 2 due to exacerbations of coexistent asthma requiring oral prednisolone treatment), 1 stopped taking the tablets suspecting food allergy, and 1 failed to return for the 4‐week assessment. |
| Certainty of AD |
Low risk |
This was measured using criteria by Hanifin and Rajka. |
| Baseline comparability |
High risk |
Randomisation led to differences in sex distribution with 79% men in the treatment group versus 32% men in the placebo group. |
| Compliance |
Unclear risk |
This was not described. |
| Severity of AD |
Low risk |
This was rated as moderate and severe. |
| Conflict of interest |
Unclear risk |
No details were given. |