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

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 T...

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Main Authors: Meiyu Lyu, Yi Yang, Jinlian Liu, Wenting Fei, Min Fu, Yunting Hong, Hongguo Rong, Chun Wang, Linyuan Wang, Jianjun Zhang
Format: Article
Language:English
Published: Elsevier 2025-01-01
Series:Journal of Traditional Chinese Medical Sciences
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Online Access:http://www.sciencedirect.com/science/article/pii/S2095754824001078
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author Meiyu Lyu
Yi Yang
Jinlian Liu
Wenting Fei
Min Fu
Yunting Hong
Hongguo Rong
Chun Wang
Linyuan Wang
Jianjun Zhang
author_facet Meiyu Lyu
Yi Yang
Jinlian Liu
Wenting Fei
Min Fu
Yunting Hong
Hongguo Rong
Chun Wang
Linyuan Wang
Jianjun Zhang
author_sort Meiyu Lyu
collection DOAJ
description 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 mm2 (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.
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spelling doaj-art-8aada027d8f6437c8e56a27fe3fff3e22025-01-25T04:11:14ZengElsevierJournal of Traditional Chinese Medical Sciences2095-75482025-01-011217178Efficacy and safety of Lutai Danshen Baishao granules for treating female melasma: A randomized, double-blind, placebo-controlled trialMeiyu Lyu0Yi Yang1Jinlian Liu2Wenting Fei3Min Fu4Yunting Hong5Hongguo Rong6Chun Wang7Linyuan Wang8Jianjun Zhang9School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 102488, ChinaTechnology Research and Development Center, Kang'ao (Tianjin) Health Management Centre, Tianjin 300011, ChinaSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 102488, ChinaDepartment of Bioengineering, Beijing Polytechnic, Beijing 100176, ChinaThe Centre for Translational Biology, Research Institute of McGill University Health Centre, Montréal H4A 3J1, CanadaDepartment of Public Health, The Third Central Hospital of Tianjin, Tianjin 300170, ChinaCenter for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 102488, ChinaSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 102488, ChinaSchool of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, ChinaSchool of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 102488, China; Corresponding author.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 mm2 (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.http://www.sciencedirect.com/science/article/pii/S2095754824001078Female melasmaLutai danshen baishao granulesClinical trialEfficacySafetyTraditional Chinese medicine
spellingShingle Meiyu Lyu
Yi Yang
Jinlian Liu
Wenting Fei
Min Fu
Yunting Hong
Hongguo Rong
Chun Wang
Linyuan Wang
Jianjun Zhang
Efficacy and safety of Lutai Danshen Baishao granules for treating female melasma: A randomized, double-blind, placebo-controlled trial
Journal of Traditional Chinese Medical Sciences
Female melasma
Lutai danshen baishao granules
Clinical trial
Efficacy
Safety
Traditional Chinese medicine
title Efficacy and safety of Lutai Danshen Baishao granules for treating female melasma: A randomized, double-blind, placebo-controlled trial
title_full Efficacy and safety of Lutai Danshen Baishao granules for treating female melasma: A randomized, double-blind, placebo-controlled trial
title_fullStr Efficacy and safety of Lutai Danshen Baishao granules for treating female melasma: A randomized, double-blind, placebo-controlled trial
title_full_unstemmed Efficacy and safety of Lutai Danshen Baishao granules for treating female melasma: A randomized, double-blind, placebo-controlled trial
title_short Efficacy and safety of Lutai Danshen Baishao granules for treating female melasma: A randomized, double-blind, placebo-controlled trial
title_sort efficacy and safety of lutai danshen baishao granules for treating female melasma a randomized double blind placebo controlled trial
topic Female melasma
Lutai danshen baishao granules
Clinical trial
Efficacy
Safety
Traditional Chinese medicine
url http://www.sciencedirect.com/science/article/pii/S2095754824001078
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