关键词: 中医药疗法, 饮食行为, 肥胖症, 三因素饮食问卷, 随机对照试验

Abstract: Background 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. Objective To evaluate the effects of Xiere Xingpi Yin on eating behaviors and weight-related outcomes in adults with obesity. Methods A total of 108 adults with obesity seen at the Endocrinology Department of Shanghai Municipal Hospital 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). 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. Results Baseline characteristics—including body weight, BMI, prior weight-loss history, and psychological status—were comparable between groups (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% vs 35.2%) and the proportion with ≥ 10% body-weight loss (50.5% vs 9.3%) 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). 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 groups (χ2 =0.091, P>0.05). Conclusion 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.

Key words: Traditional Chinese medicine therapy, Eating behavior, Obesity, Three-factor eating questionnaire, Randomized controlled trial