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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07646457

Enrollment

296

Registered

2026-06-12

Start date

2026-04-01

Completion date

2026-06-30

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity & Overweight

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Percentage change in body weight associated with Chinese herbal medicine use	From 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.

Countries

Taiwan

Outcome results