Comparative Effectiveness of Western Pharmacotherapy Versus Integrative Western and Traditional Chinese Medicine for Weight Management in Central Taiwan: A Real-World Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 296
- 试验地点
- 1
研究概览
简要总结
Obesity is a major public health issue. While modern Western pharmacotherapies (e.g., GLP-1 receptor agonists) and Traditional Chinese Medicine (TCM) are utilized for weight management, the comparative effectiveness of their integration remains unclear. This study aims to compare the effects of Western medicine (WM) alone versus integrative WM and TCM on body weight and composition. A retrospective cohort study design will be employed, aiming to enroll approximately 500 patients (BMI ≥ 27) receiving treatment at a regional hospital in Central Taiwan. Participants will be categorized into the WM-only or WM+TCM groups. The primary outcome is the percentage of total body weight loss (%TBWL) at 6 and 12 months. Secondary outcomes include changes in body composition, including fat percentage and the muscle-to-fat ratio (MFR). Statistical analysis will utilize Propensity Score Matching (PSM) or Inverse Probability of Treatment Weighting (IPTW) to balance baseline differences and Mixed-Effects Models for Repeated Measures (MMRM) for longitudinal data analysis. Interaction effects between different WM modalities and TCM will be explored (sub-analysis). Preliminary analysis indicated that individualized treatment significantly reduced body fat and increased MFR. This study anticipates further clarifying the advantages of integrative WM+TCM and identifying the optimal synergistic combinations, providing crucial real-world evidence for clinical weight management strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥20 years
- •Obesity defined by Health Promotion Administration, Taiwan: BMI ≥27 kg/m², or BMI ≥24 kg/m² with metabolic comorbidities
- •Received weight management treatment
- •Primary pharmacologic therapy with: Rybelsus® (oral semaglutide), or Ozempic® (subcutaneous semaglutide)
- •May have received adjunctive weight-loss medications, including: Mounjaro® (tirzepatide), SGLT2 inhibitors, Contrave® (naltrexone/bupropion)
排除标准
- •Incomplete data, including missing baseline measurements or absence of follow-up records, precluding assessment of treatment effectiveness
- •Pregnancy or breastfeeding
- •History of bariatric surgery during the study period (e.g., gastric bypass, gastric banding)
- •Presence of major medical conditions that may significantly affect body weight independent of obesity treatment (e.g., active malignancy, end-stage organ failure)
- •Patients deemed unsuitable for inclusion by the investigators (e.g., poor treatment adherence or unreliable data)