A pilot randomized controlled trial of Kangmin Ⅰ decoction as a treatment for atopic eczema

<x>Abstract</x> <sec> <title>Background:</title> Atopic eczema is the most common type of skin disorder in both children and adults. It is characterized by erythema, pruritus, papules, xeransis, and lichenification. The Kangmin Ⅰ decoction, a Chinese herbal medicine prepared with several ingredients and used to treat eczema, was formulated according to traditional Chinese medicine theory. </sec> <sec> <title>Objectives:</title> To investigate the efficacy and safety of Kangmin Ⅰ decoction for treating atopic eczema compared to that of loratadine. </sec> <sec> <title>Methods:</title> 90 patients were enrolled at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine and randomly divided into the Kangmin Ⅰ decoction treatment group (<italic>n</italic> = 45) and loratadine control group (<italic>n</italic> = 45). Clinical efficacy was evaluated using the Eczema Area and Severity Index (EASI), Dermatology Life Quality Index(DLQI), adverse events (AEs), and recurrence rates, which were compared between the groups. </sec> <sec> <title>Results:</title> Compared to the loratadine control group (51.16%, 18.60%), the Kangmin Ⅰ decoction group (7.72%, 4.55%) displayed a significantly reduced effective rate (<italic>x</italic>² = 8.324, <italic>P</italic> = 0.040) and recurrence rate (<italic>x</italic>² = 4.225, <italic>P</italic> = 0.040). The incidence of AEs was similar between the groups (<italic>P</italic> = 0.502). </sec> <sec> <title>Conclusions:</title> These results support further development of Kangmin Ⅰ decoction for the treatment of eczema. The Kangmin Ⅰ decoction showed good efficacy with a low recurrence rate and tolerable AEs. The main limitations of this study include the small sample size and the short treatment and follow-up periods. Larger controlled studies are needed to more adequately evaluate both safety and efficacy. </sec>