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

NCT07646457 | Active Not Recruiting

• 1 other identifier: 115005
• Study Type: observational
• Target: 296
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity & Overweight

Outcome Measures

Primary Outcomes (1)

• Percentage change in body weight associated with Chinese herbal medicine use

  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.

  From baseline to end of follow-up (up to 14 months)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with overweight or obesity receiving weight management treatment in a hospital-based outpatient setting in Taiwan. Participants were identified from a retrospective clinical database and received pharmacologic therapy, primarily semaglutide, with or without adjunctive medications and/or traditional Chinese medicine interventions.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 12, 2026
• Study Start: April 1, 2026
• Primary Completion: April 28, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)