Clinical Efficacy of Weight Loss Herbal Intervention Therapy and Lifestyle Modifications on Obesity and Its Association With Distinct Gut Microbiome: A Randomized Double-Blind Phase 2 Study
Pathology, Microbiology & Immunology
GOALS: To assess the efficacy and safety of Chinese Medicine Prescription "W-LHIT" in subjects with simple obesity, and to explore its potential mechanism of action. METHODS: Thirty-seven patients aged 18 to 60 from Wei-En hospital (Weifang City, Shandong, China), participated in a double blinded, placebo-controlled study. Subjects were randomly divided into 2 groups, 18 in treatment and 19 in placebo group. The treatment group took the "W-LHIT" capsules for two months, while the control group received placebo capsules. Both groups accepted healthy lifestyle education materials. After a 2-month treatment, the placebo group transferred to open-label treatment after unblinding. RESULTS: 72.22% participants in the treatment group lost more than 5% of their body weight, compared with 36.84% in the placebo group ( < 0.001). Body weight loss and body mass index reduction of the treatment group were also significantly higher than those of the placebo group ( < 0.05). These changes were accompanied by increased abundance of and , and decreased abundance of in gut microbiota. Furthermore, the treatment group also showed improvement in obesity-related comorbidities such as hypertension and elevation of liver enzymes. No serious adverse reactions were found during the study period. Weight did not rebound at a follow-up visit 2 months after treatment. CONCLUSION: W-LHIT significantly improved body weight and comorbid conditions without obvious adverse reaction or rebound weight gain. These effects were associated with increased abundance of probiotics in gut microbiota. W-LHIT may have a potential for treating obesity in conjunction with healthy lifestyle modifications.
Cao, M., Wei, C., Wen, M., Song, Y., Srivastava, K., Yang, N., Shi, Y., Miao, M., Chung, D., & Li, X. (2023). Clinical Efficacy of Weight Loss Herbal Intervention Therapy and Lifestyle Modifications on Obesity and Its Association With Distinct Gut Microbiome: A Randomized Double-Blind Phase 2 Study. https://doi.org/10.3389/fendo.2023.1054674