AIM: Hwang-Yeon-Hae-Dok-San (TJ-15) and Ou-Ryung-San (TJ-17) are two common herbal formulas that have been used to treat atopic dermatitis (AD), especially the Dampness-Heat pattern of AD. The aim of this study was to determine the safety and efficacy of TJ-15 plus TJ-17 for patients with the Dampness-Heat pattern of AD based on pattern identification. METHODS: This study was a parallel, randomized, active-controlled, double-blind trial. A total of 24 patients were enrolled. Either a combination of TJ-15 plus TJ-17, or TJ-15 alone was orally administered 3 times daily for 4 weeks. Of the patients enrolled, 19 patients completed the 4-week treatment course (TJ-15 plus TJ-17: n=8, TJ-15: n=11). Efficacy was assessed using the scoring atopic dermatitis (SCORAD) index; area of eczema and severity index (EASI); as well as the symptoms related to the Dampness-Heat by pattern identification. Efficacy measures were evaluated at the baseline and at 4 weeks. Safety was assessed throughout the study using ongoing laboratory tests. RESULTS: Both the SCORAD and EASI showed more improvement in the TJ-15 plus TJ-17 group than in the TJ-15 group; however, the differences were not statistically significant. The symptoms related to the Dampness-Heat pattern were reduced in both groups, and the changes were similar. There were no reported adverse events during this study, or abnormalities observed on aspartate aminotransferase, alanine aminotransferase, blood urea nitrogen, and creatinine testing. CONCLUSIONS: The results of this study suggest that both the TJ-15 plus TJ-17 and the TJ-15 provided safe and effective treatment for patients with the Dampness-Heat pattern type of AD.
RCT Entities:
AIM: Hwang-Yeon-Hae-Dok-San (TJ-15) and Ou-Ryung-San (TJ-17) are two common herbal formulas that have been used to treat atopic dermatitis (AD), especially the Dampness-Heat pattern of AD. The aim of this study was to determine the safety and efficacy of TJ-15 plus TJ-17 for patients with the Dampness-Heat pattern of AD based on pattern identification. METHODS: This study was a parallel, randomized, active-controlled, double-blind trial. A total of 24 patients were enrolled. Either a combination of TJ-15 plus TJ-17, or TJ-15 alone was orally administered 3 times daily for 4 weeks. Of the patients enrolled, 19 patients completed the 4-week treatment course (TJ-15 plus TJ-17: n=8, TJ-15: n=11). Efficacy was assessed using the scoring atopic dermatitis (SCORAD) index; area of eczema and severity index (EASI); as well as the symptoms related to the Dampness-Heat by pattern identification. Efficacy measures were evaluated at the baseline and at 4 weeks. Safety was assessed throughout the study using ongoing laboratory tests. RESULTS: Both the SCORAD and EASI showed more improvement in the TJ-15 plus TJ-17 group than in the TJ-15 group; however, the differences were not statistically significant. The symptoms related to the Dampness-Heat pattern were reduced in both groups, and the changes were similar. There were no reported adverse events during this study, or abnormalities observed on aspartate aminotransferase, alanine aminotransferase, blood ureanitrogen, and creatinine testing. CONCLUSIONS: The results of this study suggest that both the TJ-15 plus TJ-17 and the TJ-15 provided safe and effective treatment for patients with the Dampness-Heat pattern type of AD.
Authors: M P Sheehan; M H Rustin; D J Atherton; C Buckley; D W Harris; J Brostoff; L Ostlere; A Dawson; D J Harris Journal: Lancet Date: 1992-07-04 Impact factor: 79.321
Authors: K L E Hon; T F Leung; P C Ng; M C A Lam; W Y C Kam; K Y Wong; K C K Lee; Y T Sung; K F Cheng; T F Fok; K P Fung; P C Leung Journal: Br J Dermatol Date: 2007-05-14 Impact factor: 9.302