Randomized, double-blind, placebo-controlled trial of autologous blood therapy for atopic dermatitis.

BACKGROUND

Autologous blood therapy (ABT) is used for treating atopic dermatitis (AD) in some European countries and is promoted on internet sites for this condition. However, there is little evidence from rigorous clinical trials to suggest that it is effective.

OBJECTIVES

To test the effectiveness of ABT for the symptomatic treatment of patients with AD.

METHODS

Fifty subjects responded to press advertisements, and 31 were randomized within strata of severity at recruitment. Patients were included into a double-blind, placebo-controlled trial and received ABT or placebo once weekly for 5 weeks. Assessments were performed at baseline, at weekly intervals and after a 5-week follow up. The Six Area, Six Sign AD (SASSAD) severity index was predefined as the primary outcome measure. The Dermatology Life Quality Index and patient ratings of pruritus, quality of sleep and skin appearance on 100-mm visual analogue scales were defined as secondary outcome measures. Success of patient blinding and adverse events were assessed.

RESULTS

Data were analysed on an intention-to-treat basis. Analysis of covariance suggested a significant differential change of the SASSAD score between baseline and the end of the follow-up period in favour of ABT. The mean reduction in SASSAD score was 13.5 points (95% confidence interval, CI 6.6-20.4, P < 0.001) over and above placebo; the corresponding value at the end of treatment was 9.6 (95% CI 4.2-14.9, P = 0.001). No clear significant intergroup differences in any of the secondary outcome measures were found. Six patients in the ABT group and seven in the placebo group reported minor and transient adverse events.

CONCLUSIONS

These data suggest that, according to the SASSAD score, ABT has beneficial effects in the treatment of AD, although this was not confirmed by the patient-rated assessments. The improvement in observer-rated skin condition suggested by this study needs confirmation in larger trials.