Objective

2

To investigate the clinical effectiveness and safety of

Zishen Wash Formula

（紫参洗剂，ZWF） for treatment of vulvae pruritus with the pattern of damp-heat in the liver channel.

Methods

2

A total of 180 cases of vulvae pruritus with the pattern of damp-heat in the liver channel were randomised into ZWF group，

Pifukang

group and povidone iodine group，with 60 patients in each group. The ZWF group was given ZWF，one dose daily，while the other two groups were administered with hip bath of 20 ml

Pifukang Lotion

（肤康洗液） at the ratio of 1∶20 with water， and the povidone iodine group was given hip bath with 50 ml povidone iodine added with 700 ml water. All the administrations were performed once daily，10 to 15 minutes each time for seven days. The scores of clinical symptoms including vulva score，vagina score，itching score，pain score，cracked skin score and total symptom score were assessed before treatment，3 to 7 days after treatment and 30 to 40 days after treatment. The indicators of laboratory tests including vaginal discharge test，Candida antigen detection test，bacterial vaginosis detection were assessed 3 to 7 days after treatment and 30 to 40 days after treatment to obtain the effects on traditional Chinese medicine syndromes，and the safety was evaluated.

Results

2

The effective rate of ZWF group was 98.31% at 3 to 7 days after treatment and 100% at 30 to 40 days after treatment，both significantly higher than that of

Pifukang

group （86.44% and 86.27%） and povidone iodine group （96.61% and 85.19%） （

P

＜ 0.01）. Compared to those before treatment，the scores of clinical symptoms in all groups except for cracked skin score in povidone iodine group，the proportion of cleanliness degree of Ⅲ，the proportion of positive result of Candida antigen detection test，and of bacterial vaginosis detection both at 3-7 days and 30-40 days after treatment，as well as the number of trichomonas vaginalis under microscopic test in

Pifukang

and povidone iodine group at 3-7 days after treatment significantly decreased （

P

＜ 0.05）．Compared to those results assessed at 3-7 days after treatment，the vulva score，cracked skin score，pain score and total symptom score in ZWF group，and the cracked skin score in

Pifukang

group at 30-40 days after treatment significantly decreased，while the proportion of cleanliness degree of Ⅲ and of the positive result of Candida antigen detection test in povidone iodine group，as well as the proportion of cleanliness degree of Ⅲ in

Pifukang

group significantly increased （

P

＜0.05）. Compared to those in

Pifukang

and povidone iodine group assessed at the same time point，the vulva score，itching score and total symptom score at 3-7 days after treatment，as well as vulva score，vagina score，itching score and total symptom score at 30-40 days after treatment significantly decreased in ZWF group （

P

＜0.05）； when assessed at 30-40 days after treatment，the proportion of positive result of Candida antigen detection test in ZWF group significantly decreased than that in

Pifukang

group，and the proportion of cleanliness degree of Ⅲ and of positive result of Candida antigen detection test decreased as well compared to those in povidone iodine group （

P

＜0.05）. No severe adverse events occurred in all groups.

Conclusion

2

ZWF can improve the vulva symptoms such as pruritus and pain，and has certain advantages in alleviating local skin and mucous membrane hyperemia and edema with longer effect lasting，and is safe in vulva pruritus patients with the pattern of damp-heat in the liver channel.