Sham Electroacupuncture Methods in Randomized Controlled Trials.

Area of Science:

• Integrative and Complementary Medicine
• Clinical Trial Methodology
• Acupuncture Research

Background:

• Sham electroacupuncture (EA) is crucial for evaluating specific EA effects in randomized-controlled trials (RCTs).
• Developing inert and concealable sham EA controls presents significant methodological challenges.
• Standardization of sham EA techniques is lacking, potentially impacting trial validity.

Purpose of the Study:

• To systematically investigate and categorize existing sham EA methods used in RCTs.
• To assess the credibility and reported efficacy of different sham EA control types.
• To identify potential improvements for future sham EA control designs.

Main Methods:

• Systematic literature search of eight electronic databases (inception to April 2015).
• Inclusion of 94 RCTs involving 6134 participants, analyzing needle location, depth, and electrical stimulation.
• Categorization of 17 identified sham EA methods, with focus on frequently used types (A, L, O) and credibility testing.

Main Results:

• Ten of 17 sham EA methods were identified across 94 RCTs.
• Sham EA types A, L, and O were most frequently employed.
• Credibility tests were reported in only 24 trials for six sham EA types (A, B, Q most common).
• Specific EA effects were reported in 56.2% of trials when compared to sham controls, with types N, F, D, and M showing higher positive rates.

Conclusions:

• Several identified sham EA types show promise for use in RCTs.
• Further research is needed to develop and validate inert and concealable sham EA control methods.
• Improved sham EA methodology is essential for enhancing the rigor of acupuncture research.