Efficacy and safety of Chushi pellets in patients with subacute eczema of more dampness less heat type

Abstract

Objective To evaluate the clinical efficacy and safety of Chushi pellets in patients with subacute eczema of more dampness less heat type.Methods A randomized,double blind,double-dummy and positive parallel-controlled study was performed.Totally,129 patients with subacute eczema were collected at the dermatology clinic in Beijing Hospital of Traditional Chinese Medicine from May 2010 to October 2011,and classified into two groups to be treated with Chushi pellets and placebo capsules (n =66,experiment group) or Shiduqing capsules and placebo watered pills (n =63,control group) for 4 weeks.Follow-up visits were scheduled on day 1 (baseline),and 4 weeks after the beginning of treatment.Clinical endpoints included skin rash area,color,morphology,degree of pruritus and laboratory examination results.The therapeutic effect and safety of Chushi pellets were evaluated.The differences in clinical parameters were assessed by using t test and Wilcoxon rank-sum test between pre-and post-treatment,and by Pearson chi-square test or Fisher's exact test between the experiment and control group.Results Finally,the treatment outcome of 123 patients were assessed for the efficacy of Chushi pellets.At the end of the treatment,the total response rate was 69.3％ (43/62) in the experiment group,and 59.0％ (36/61) in the control group (x2 =1.43,P ＞ 0.05).The improvement in pruritus was greater in the experiment group than in the control group (x2 =4.05,P ＜ 0.05).Side effects mainly included loose stool and stomach upset,with an incidence of 13.6％ (9/66) in the experiment group,and 11.1％ (7/63) in the control group.No marked changes were observed in laboratry parameters after treatment in either of the groups.Conclusions Chushi pellets are safe and effective for the treatment of subacute eczema of more dampness less heat type.Compared with Shiduqing capsules,Chushi pellets shows an equivalent overall efficacy but a stronger antipruritic effect.