Discussion
obesity, BMI obesity, weight loss, slight-mild gastrointestinal adverse reactions
OBESITY, ADVERSE REACTIONS, OBESE, SEVERE OBESITY, TYPE 2 DIABETES
In recent years, China has ranked first in the world for obesity and type 2 diabetes (Unhealthy dietary habits and sedentary lifestyle are key contributing factors leading to obesity. Therefore, healthy lifestyle interventions (including healthy diet guidance and physical activity) can play a profound role in the treatment process. During the treatment, the average weight reduction of the placebo group was 4.58 kg (- 4.9%). For comparison, no healthy lifestyle intervention was performed in the open trial. The results showed that the body weight was only reduced by 3.6% in the open treatment trial, which was significantly lower than the average weight loss of the treatment group with lifestyle interventions (-7.05kg, -7.2%). Despite the insufficient sample size during open-treatment trials, we can still see the importance of healthy lifestyle interventions for obesity treatment. There was a limitation that the daily food intake calories and physical activity for each subject were not quantified during the treatment, and the healthy lifestyle intervention was tailored for each subject under the guidance of the physician. So, the difference in weight loss of subjects could have possibly been affected differently. The quality-of-life scale score did not measure changes of psychological and physiological functions before and after treatment. Improvement of the quality-of-life score could further contribute to enhancing weight loss (As a marker of obesity, the level of hs-CRP is significantly elevated in the obese individual, and positively correlated with BMI obesity (Although there has been no consensus on how changes in the composition of gut microbiota can contribute to obesity, cumulative evidences have demonstrated that the occurrence of obesity is strongly associated with gut microbiota dysbiosis, which can result in chronic, persistent low-grade inflammatory reactions and abnormal lipid metabolism (
This study still has limitations. Firstly, no lean mass subjects were enrolled in this trial, the concern should be addressed in our follow-up study. Secondly, weight loss is a long-term and arduous work for subjects with sever obesity. So, only two months treatment is insufficient, and subjects with severe obesity need to receive longer intervention duration. Thirdly, this is a single-center study, limited by the small sample size, and some efficacy indicators between the treatment and control groups are not statistically significant, including the hip circumference (In conclusion, our current study assessed the efficacy and safety of W-LHIT capsules in 37 Chinese patients with simple obesity. We found that W-LHIT significantly reduced the weight of subjects with simple obesity, by greater than 5% of body weight in 72.6% of participants, which was significantly higher than in only 36.6% of the placebo group. In addition to weight loss, subjects in the treatment group also had significant improvements in blood pressure, blood glucose, and blood lipids. During the 2-month treatment, 7 subjects reported slight-mild gastrointestinal adverse reactions. However, with taking the medicine after meal or reducing the dosage, all the adverse reactions were gradually relieved. In addition, the results of 16S gut microbiota showed that W-LHIT significantly increased the abundance of 