ObjectiveTo observe the effects of Xiere Xingpi Yin （XRXPY） on the body mass and body fat distribution in patients with simple obesity， and to preliminarily explore whether the mechanism involves the regulation of specific obesity-related microRNAs （miRNAs）. MethodsA randomized controlled trial design was employed to recruit patients with simple obesity diagnosed with the traditional Chinese medicine （TCM） syndrome of dampness-heat accumulating in the spleen. Using a randomized controlled trial design， 95 patients with simple obesity of dampness-heat encumbering the Spleen syndrome were recruited， after 3 were excluded， 92 were randomly assigned in a 1∶1 ratio by means of a random number table. On the basis of lifestyle intervention， the observation group received XRXPY granules， while the control group received a placebo. Serum samples and TCM symptom scores were collected before and after the 12-week observation period. Differences in body mass loss， body composition， lipid metabolism， and TCM symptom scores were compared between the groups. An obesity-related miRNA dataset was constructed by searching the Human MicroRNA Disease Database. Library construction， sequencing， and quality control were performed on 6 selected patients from each group to screen the differentially expressed miRNAs. The intersection of these miRNAs with the obesity-related miRNAs was verified by bioinformatics and correlation analysis. ResultsBaseline characteristics were comparable between the two groups before treatment. A total of 86 patients completed the study （42 cases in the observation group and 44 cases in the control group）. The proportion of patients achieving ≥5% body weight reduction was significantly higher in the observation group than in the control group 81.0% （34/42） vs. 43.2% （19/44） （χ²=12.963， P<0.01）. Compared with baseline within the observation group， body weight， waist circumference， and TCM syndrome score were significantly decreased （P<0.01）， as were body fat percentage （P<0.01） and serum triglyceride level （P<0.05）. Compared with the control group after treatment， waist circumference and TCM syndrome score were significantly lower in the observation group （P<0.01）， and body weight showed a trend toward reduction. When changes from baseline were compared between the two groups， the magnitudes of decrease in body weight， waist circumference， and TCM syndrome score were all significantly greater in the observation group than in the control group （P<0.01）. With respect to safety， no serious adverse events occurred in either group and no participant discontinued the study because of adverse events. Compared with baseline， alanine aminotransferase levels decreased significantly in both the control and observation groups （P<0.01）， and urea decreased significantly in the observation group （P<0.01）， indicating a favorable safety profile. Sequencing identified nine differentially expressed miRNAs. After intersecting with the obesity-related miRNA dataset （187 miRNAs）， 3 miRNAs were identified： miR-221 （log₂FC=-6.62， P=0.009）， miR-29a （log₂FC=6.33， P=0.016）， and miR-10b （log₂FC=-5.91， P=0.029）. A total of 262 target genes of the 3 miRNAs were identified， which were significantly enriched in 67 pathways， including the lysine degradation pathway （P=0.001）. Correlation analysis revealed a positive correlation between miR-221 and triglycerides （r=0.46， P=0.027）， a negative correlation between miR-29a and waist-to-hip ratio （r=-0.41， P=0.047）， and positive correlations of miR-10b with body fat percentage （r=0.49， P=0.014） and waist circumference （r=0.44， P=0.032）. ConclusionXRXPY combined with lifestyle intervention can effectively reduce the body mass and improve body composition. The underlying mechanism may involve the regulation of the lysine degradation pathway via miR-221， miR-29a， and miR-10b， though further verification is required.

ObjectiveTo observe the effects of Xiere Xingpi Yin （XRXPY） on the body mass and body fat distribution in patients with simple obesity， and to preliminarily explore whether the mechanism involves the regulation of specific obesity-related microRNAs （miRNAs）. MethodsA randomized controlled trial design was employed to recruit patients with simple obesity diagnosed with the traditional Chinese medicine （TCM） syndrome of dampness-heat accumulating in the spleen. Using a randomized controlled trial design， 95 patients with simple obesity of dampness-heat encumbering the Spleen syndrome were recruited， after 3 were excluded， 92 were randomly assigned in a 1∶1 ratio by means of a random number table. On the basis of lifestyle intervention， the observation group received XRXPY granules， while the control group received a placebo. Serum samples and TCM symptom scores were collected before and after the 12-week observation period. Differences in body mass loss， body composition， lipid metabolism， and TCM symptom scores were compared between the groups. An obesity-related miRNA dataset was constructed by searching the Human MicroRNA Disease Database. Library construction， sequencing， and quality control were performed on 6 selected patients from each group to screen the differentially expressed miRNAs. The intersection of these miRNAs with the obesity-related miRNAs was verified by bioinformatics and correlation analysis. ResultsBaseline characteristics were comparable between the two groups before treatment. A total of 86 patients completed the study （42 cases in the observation group and 44 cases in the control group）. The proportion of patients achieving ≥5% body weight reduction was significantly higher in the observation group than in the control group 81.0% （34/42） vs. 43.2% （19/44） （χ²=12.963， P<0.01）. Compared with baseline within the observation group， body weight， waist circumference， and TCM syndrome score were significantly decreased （P<0.01）， as were body fat percentage （P<0.01） and serum triglyceride level （P<0.05）. Compared with the control group after treatment， waist circumference and TCM syndrome score were significantly lower in the observation group （P<0.01）， and body weight showed a trend toward reduction. When changes from baseline were compared between the two groups， the magnitudes of decrease in body weight， waist circumference， and TCM syndrome score were all significantly greater in the observation group than in the control group （P<0.01）. With respect to safety， no serious adverse events occurred in either group and no participant discontinued the study because of adverse events. Compared with baseline， alanine aminotransferase levels decreased significantly in both the control and observation groups （P<0.01）， and urea decreased significantly in the observation group （P<0.01）， indicating a favorable safety profile. Sequencing identified nine differentially expressed miRNAs. After intersecting with the obesity-related miRNA dataset （187 miRNAs）， 3 miRNAs were identified： miR-221 （log₂FC=-6.62， P=0.009）， miR-29a （log₂FC=6.33， P=0.016）， and miR-10b （log₂FC=-5.91， P=0.029）. A total of 262 target genes of the 3 miRNAs were identified， which were significantly enriched in 67 pathways， including the lysine degradation pathway （P=0.001）. Correlation analysis revealed a positive correlation between miR-221 and triglycerides （r=0.46， P=0.027）， a negative correlation between miR-29a and waist-to-hip ratio （r=-0.41， P=0.047）， and positive correlations of miR-10b with body fat percentage （r=0.49， P=0.014） and waist circumference （r=0.44， P=0.032）. ConclusionXRXPY combined with lifestyle intervention can effectively reduce the body mass and improve body composition. The underlying mechanism may involve the regulation of the lysine degradation pathway via miR-221， miR-29a， and miR-10b， though further verification is required.