Clinical trial

Comparative Effectiveness of Western Pharmacotherapy Versus Integrative Western and Traditional Chinese Medicine for Weight Management in Central Taiwan: A Real-World Cohort Study

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07646457

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight

Full registry criteria

Inclusion Criteria: * 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) Exclusion Criteria: * 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)

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Percentage change in body weight associated with Chinese herbal medicine useFrom baseline to end of follow-up (up to 14 months)

Percentage change in body weight from baseline will be calculated and compared between participants exposed to Chinese herbal medicine and non-exposed participants during the study period.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

National Yang Ming Chiao Tung University🇹🇼 Taipei, Taiwan

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