[Sample size estimation in acupuncture and moxibustion clinical trials]

Area of Science:

• Clinical Trials Methodology
• Biostatistics
• Traditional Chinese Medicine Research

Background:

• Appropriate sample size estimation is vital for clinical trial validity.
• Published acupuncture and moxibustion trials frequently suffer from insufficient or incorrect sample size calculations.
• Superiority, non-inferiority, and equivalence tests are commonly employed in these trials.

Purpose of the Study:

• To detail the application and calculation methods for superiority, non-inferiority, and equivalence tests.
• To demonstrate the use of PASS11 software for sample size calculations.
• To address specific challenges in sample size estimation for acupuncture and moxibustion research.

Main Methods:

• Focus on the application and calculation of three hypothesis test types: superiority, non-inferiority, and equivalence.
• Utilize PASS11 software for sample size calculation examples.
• Analyze particularities of sample size estimation in acupuncture and moxibustion.

Main Results:

• Discussion of parameter setting considerations for sample size.
• Analysis of the impact of intervention and control group ratios.
• Guidance on sample size for multi-group comparisons in acupuncture trials.

Conclusions:

• Provides practical guidance for acupuncture researchers on correct sample size estimation.
• Highlights the importance of appropriate statistical methods and software in clinical trial design.
• Aims to improve the quality and reliability of acupuncture and moxibustion clinical trials through better sample size planning.