[The design, implementation, supervision and reporting of multi-centered acupunctural clinical trial]

Area of Science:

• Integrative and Complementary Medicine
• Clinical Research Methodology
• Evidence-Based Practice

Context:

• Multi-centered acupuncture clinical trials require rigorous design and execution.
• Previous research has highlighted inconsistencies in acupuncture trial quality.
• International standards are crucial for advancing acupuncture research.

Purpose:

• To provide a comprehensive overview of best practices for designing, implementing, supervising, and reporting multi-centered acupuncture clinical trials.
• To illustrate these practices using examples from major Chinese research programs.
• To emphasize key elements for ensuring research quality and validity.

Summary:

• Key design considerations include randomization, blinding, sample size calculation, and ethical approval.
• Effective implementation relies on clinical trial registration, standard operating procedures, and researcher training.
• Robust supervision involves establishing and executing a dedicated quality control system.
• Reporting must adhere to CONSORT and STRICTA guidelines for transparency and reproducibility.

Impact:

• Enhancing the quality and reliability of acupuncture clinical trial data.
• Promoting standardized methodologies in acupuncture research globally.
• Facilitating the integration of evidence-based acupuncture into mainstream healthcare.
• Improving the credibility and acceptance of acupuncture as a therapeutic intervention.