Efficacy and safety of Lutai Danshen Baishao granules for treating female melasma:A randomized,double-blind,placebo-controlled trial  

作　　者：Meiyu Lyu Yi Yang Jinlian Liu Wenting Fei Min Fu Yunting Hong Hongguo Rong Chun Wang Linyuan Wang Jianjun Zhang 

机构地区：[1]School of Traditional Chinese Medicine,Beijing University of Chinese Medicine,Beijing 102488,China [2]Technology Research and Development Center,Kang'ao(Tianjin)Health Management Centre,Tianjin 300011,China [3]Department of Bioengineering,Beijing Polytechnic,Beijing 100176,China [4]The Centre for Translational Biology,Research Institute of McGill University Health Centre,Montreal H4A 3J1,Canada [5]Department of Public Health,The Third Central Hospital of Tianjin,Tianjin 300170,China [6]Center for Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing 102488,China [7]School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China

出　　处：《Journal of Traditional Chinese Medical Sciences》2025年第1期71-78,共8页中医科学杂志(英文)

基　　金：funded by the National Key Research and Development Plan of the Traditional Chinese Medicine Modernization Research Key Project(2018YFC1706800).

摘　　要：Objective:To investigate the potential efficacy and safety of Lutai Danshen Baishao granules(LDBG)for treating female melasma associated with kidney deficiency and blood stasis patterns.Methods:A randomized,double-blind,placebo-controlled trial was conducted at the Third Central Hospital of Tianjin,China from March to December 2023.A total of 110 female patients with melasma linked to kidney deficiency and blood stasis were enrolled and treated with either LDBG or a placebo twice daily for 60 days.Efficacy was assessed through measures such as the total melasma area,reduced melasma area,reduction rate of melasma area,melasma color score,Melasma Area and Severity Index(MASI)score,and traditional Chinese medicine(TCM)symptom score scale.Safety assessments included routine blood and biochemical tests.Results:Participants in both groups were aged 52-63 years,with no significant differences.After the 2-month intervention,the total melasma area decreased in both groups;however,a greater reduction was observed in the test group[462.50 mm^(2)(12.81%)vs.100.00 mm2(3.11%),P<.001].Moreover,LDBG treatment significantly reduced the MASI and melasma color scores in the test group(P<.05).The total TCM symptom evaluation score significantly decreased(test group:6.00 vs.placebo group:7.00,P=.001),with significant relief in symptoms such as improvement in dark lips,nails,and waist soreness in the test group,compared with that in the placebo group(P<.05).Within-group comparisons revealed that TCM syndrome was significantly alleviated in the test group(P<.05).Conclusion:LDBG intervention shows promising effectiveness in reducing female melasma and alleviating TCM syndromes.

关 键 词：Female melasma Lutai danshen baishao granules Clinical trial Efficacy Safety Traditional Chinese medicine Kidney deficiency Blood stasis 

分 类 号：R275[医药卫生—中医皮科]