Obesity is a major global public health challenge. Although intensive lifestyle intervention can induce weight loss, its effectiveness is often constrained by eating behaviors. Existing behavior-focused interventions show limited efficacy. New approaches that can improve eating behaviors are needed to enhance the weight-loss efficacy of intensive lifestyle intervention.

To evaluate the effects of Xiere Xingpi Yin on eating behaviors and weight-related outcomes in adults with obesity.

A total of 108 adults with obesity seen at the Endocrinology Department of Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, from March 2022 to March 2024 were randomized (1∶1) to an experimental group (n=54) and a control group (n=54) using simple randomization. Both groups received a 12-week intensive lifestyle intervention; in addition, the experimental group was given Xiere Xingpi Yin granules and the control group received placebo granules. At 12 weeks, between-group comparisons were made for eating behaviors—cognitive restraint, uncontrolled eating, and emotional eating; weight-related outcomes—change in body weight and BMI, and the proportions achieving≥5% and≥10% body-weight loss; body fat distribution; inflammatory markers; and glycemic and lipid indices. Adverse events were monitored throughout. Data analysis used the full analysis set (FAS) as the primary analysis set, following the intention-to-treat (ITT) principle. Sensitivity analyses for dietary behaviors and weight loss efficacy were conducted using the per-protocol set (PPS).

A total of 93 patients completed the trial, with 42 in the control group and 51 in the experimental group. There were no statistically significant differences in baseline characteristics, including body weight, BMI, prior weight-loss history, and psychological status (P>0.05). At 12 weeks, the experimental group showed better eating-behavior outcomes, with lower endpoint scores for cognitive restraint [(12.9±3.2) points vs (14.3±3.8) points] and uncontrolled eating [(16.5±4.9) points vs (18.9±6.2) points] than the control group (P<0.05). The proportion of patients with ≥5% body-weight loss in the trial group [90.7% (49/54) vs 50.0%(27/54) ] and the proportion with ≥10% body-weight loss [(35.2%(19/54) vs 9.3%(5/54) ] were higher than in the control group (P<0.05), and reductions in body weight [(8.7±3.6) kg vs (5.1±3.0) kg] and BMI [(3.1±1.2) kg/m² vs (1.8±1.0) kg/m²] were greater (P<0.05). The sensitivity analyses showed that the results from the PPS were consistent with those from the FAS for all the aforementioned endpoints. In addition, improvements in body fat distribution, inflammatory markers, glycemic and lipid indices, and TCM syndrome-factor scores were greater in the experimental group (P<0.05). The incidence of adverse events did not differ between the two groups [11.1% (6/54) vs 9.3% (5/54), χ²=0.091, P>0.05].

Xiere Xingpi Yin improved eating behaviors, and thereby enhanced the weight-loss efficacy of intensive lifestyle intervention. It also produced coordinated benefits in body fat distribution, inflammation, and glycemic and lipid indices, with a favorable safety profile. Xiere Xingpi Yin may serve as an adjunctive TCM option to improve eating behaviors and strengthen body-weight management.