Junfeng Liu, Xiumei Mo, Darong Wu, Aihua Ou, Suqin Xue, Chi Liu, Hongyi Li, Zehuai Wen, Dacan Chen, Liu, Junfeng, Mo, Xiumei, Wu, Darong, Ou, Aihua, Xue, Suqin, Liu, Chi, Li, Hongyi, Wen, Zehuai, and Chen, Dacan
Background: More randomised control trials are required to assess the efficacy of traditional Chinese medicine. This multi-centre, randomised, assessor-blind, controlled study assessed the efficacy of the Chinese herbal formula Pei Tu Qing Xin Tang (PTQXT) for treating patients with atopic dermatitis (AD).Methods: Patients aged 5-25 years with moderate-to-severe AD were randomised to receive a 12-week treatment involving either oral administration of PTQXT; oral administration of PTQXT combined with an external application of Chinese herbs; or oral administration of antihistamine and a placebo of PTQXT pills added to topical 1% mometasone furoate. The primary end-point measure was the change in the Scoring Atopic Dermatitis Index (SCORAD) at the end of the observation period, and secondary end-points included quality of life (QOL). The outcomes were evaluated at baseline, then every 4 weeks from week 4 to week 12 and every 8 weeks from week 12 to week 36.Results: Two hundred and seventy-five patients were recruited. During the 12-week treatment period, up to the primary end-point, the mean SCORAD decreased gradually in all three groups. At week 28 and week 36, there was a significantly greater decrease in the mean SCORAD for the Chinese herbal medicine-treated groups than for the control group (at week 28, P=0.002 and P=0.036, respectively; at week 36, P<0.001 and P=0.002, respectively). At week 36, the difference in QOL scores showed a significantly greater improvement in both Chinese herbal medicine-treated groups than in the control group (P<0.001 and P<0.001, respectively).Conclusions: PTQXT is effective in decreasing the severity of the disease and improving the QOL in patients with moderate-to-severe AD.Trial Registration: Chinese Clinical Trial Registry: ChiCTR-TRC-08000156. [ABSTRACT FROM AUTHOR]