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

Abstract

GoalsTo assess the efficacy and safety of Chinese Medicine Prescription “W-LHIT” in subjects with simple obesity, and to explore its potential mechanism of action.MethodsThirty-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.Results72.22% participants in the treatment group lost more than 5% of their body weight, compared with 36.84% in the placebo group (p < 0.001). Body weight loss and body mass index reduction of the treatment group were also significantly higher than those of the placebo group (p < 0.05). These changes were accompanied by increased abundance of Akkermansia muciniphila and Enterococcus faecium, and decreased abundance of Proteobacteria 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.ConclusionW-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.

Changes in the Gut Microbiota after the Use of Herbal Medicines in Overweight and Obese Individuals: A Systematic Review

“…Five studies were double-blind, parallel randomized clinical trials, and the other two had a crossover design [14][15][16][17]. They were published between 2015/2023 and carried out in three countries: China, South Korea, and Spain.…”

“…The herbal medicines studied were Moringa oleifera [16], Punica granatum [18,19], Scutellaria baicalensis [20], Schisandra chinensis [17], and weight loss herbal intervention therapy consisting of five Chinese herbal medicines: Ganoderma lucidum, Coptis chinensis, Astragalus membranaceus, Nelumbo nucifera gaertn, and Fructus aurantii (W-LHIT) [14], and white common bean extract (WCBE) [15].…”

“…The other Chinese clinical trial by Cao [14] prescribed capsules composed of five herbs (Ganoderma lucidum, Coptis chinensis, Astragalus membranaceus, Nelumbo nucifera gaertn, and Fructus aurantii). The intervention group dosage was based on individual body weight, varying from 9 to 15 capsules a day for two months.…”

“…GM research was highlighted as the main outcome in five articles [14,15,[18][19][20], while two others placed it as a secondary outcome [16,17]. Table 2 describes the main finding of microbiota analysis.…”

The Beneficial Effects of Dietary Interventions on Gut Microbiota—An Up-to-Date Critical Review and Future Perspectives

“…The relative abundance of Akkermansia muciniphila, another SCFA producer and mucindegrading bacterium, increased during different restriction programmes in five clinical trials [23,92,97,106,116]. As the level of A. muciniphila is inversely correlated with body weight and directly correlated with the weight loss observed in obese patients after CR restrictions and improvements in multiple indicators of cardio-metabolic health [128][129][130][131], it can be proposed as a prognostic tool in the context of predicting CR success. Further studies are needed to confirm this, as the effect was not consistently observed in all trials.…”