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

@entity1 @entity483 @entity111 @entity14403 @entity25
BACKGROUND: Autologous blood therapy ( @entity14403 ) is used for treating @entity483 ( @entity483 ) 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 @entity14403 for the symptomatic treatment of @entity1 with @entity483 . METHODS: Fifty subjects responded to press advertisements, and 31 were randomized within strata of severity at recruitment. @entity1 were included into a double-blind, placebo-controlled trial and received @entity14403 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 @entity483 (SASSAD) severity index was predefined as the primary outcome measure. The Dermatology Life Quality Index and @entity1 ratings of @entity111 , @entity25 and skin appearance on 100-mm visual analogue scales were defined as secondary outcome measures. Success of @entity1 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 @entity14403 . 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 @entity1 in the @entity14403 group and seven in the placebo group reported minor and transient adverse events. CONCLUSIONS: These data suggest that, according to the SASSAD score, @entity14403 has beneficial effects in the treatment of @entity483 , although this was not confirmed by the @entity1 -rated assessments. The improvement in observer-rated skin condition suggested by this study needs confirmation in larger trials.
