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.

肥胖已成为全球性公共卫生难题。强化生活方式干预虽可实现减重，但其效果常受饮食行为的影响。现有饮食行为干预的有效性仍显不足。因此，亟须探索能够有效改善饮食行为的新方法，以提升强化生活方式干预的减重疗效。

探索泄热醒脾饮对肥胖患者饮食行为和体质量相关结局的影响。

选取2022年3月—2024年3月上海中医药大学附属市中医医院内分泌科门诊接诊的108例肥胖患者为研究对象。采用简单随机方法按1∶1比例随机分为试验组（n=54）和对照组（n=54）。两组均实施为期12周的强化生活方式干预，在此基础上试验组给予泄热醒脾饮颗粒剂，对照组给予安慰剂颗粒剂。于干预后比较两组饮食行为（认知限制性进食、非控制性进食、情绪性进食），减重疗效（体质量变化、BMI变化、体质量下降≥5%的患者比例、体质量下降≥10%的患者比例），体脂分布，炎症指标和糖脂代谢，并监测不良事件的发生率。数据分析以全分析集（FAS）为主要分析集，遵循意向性治疗原则，并采用符合方案集（PPS）对饮食行为和减重疗效的结果进行敏感性分析。

最终93例患者完成试验，其中对照组42例、试验组51例。两组体质量、BMI、既往减重史、情绪等一般资料比较，差异无统计学意义（P>0.05）。治疗后，试验组认知限制性进食[（12.9±3.2）分与（14.3±3.8）分]和非控制性进食[（16.5±4.9）分与（18.9±6.2）分]评分低于对照组（P<0.05）。试验组体质量下降≥5%的患者比例和体质量下降≥10%的患者比例高于对照组[90.7%（49/54）与50.0%（27/54）；35.2%（19/54）与9.3%（5/54），P<0.05]，体质量和BMI降幅大于对照组[（8.7±3.6）kg与（5.1±3.0）kg；（3.1±1.2）kg/m²与（1.8±1.0） kg/m²，P<0.05]。敏感性分析显示，以上指标PPS分析与FAS分析结果均一致。试验组体脂分布改善幅度、炎症指标和糖脂代谢水平及中医证素积分均优于对照组（P<0.05）。两组不良事件发生率比较[11.1%（6/54）与9.3%（5/54）]，差异无统计学意义（χ²=0.091，P>0.05）。

泄热醒脾饮可改善肥胖患者的饮食行为，进而提升强化生活方式干预的减重疗效，并在改善体脂分布、降低炎症及优化糖脂代谢等方面显示出综合获益；该方案安全性良好，可作为改善饮食行为以强化体质量管理的中医药辅助选择。