The Challenges of Nonpharmacological Trials: Blinding and Other Issues using Acupuncture Research as an Example

Abstract

Objective: To discuss some of the methodological challenges of nonpharmacological trials using acupuncture as an example. Summary: Challenges in nonpharmacological trials are plenty. In acupuncture trials, choosing the most credible blinding technique and selecting the appropriate treatment parameters are some of the many difficulties facing clinicians. There is no consensus about the most appropriate type of sham acupuncture. The parameters to be considered in the sham group are the location of the points (wrong points, same spinal segment as the actual points of interest, outside the spinal segment of the actual points of interest), depth of needle insertion (no insertion, superficial insertion, or regular insertion), amount of stimulation to the needles (no stimulation, minimal stimulation, or regular stimulation), or a combination of these parameters. In a review, the average number of acupuncture treatments used was six. The average frequency of treatments per week was two. The duration of treatment was between 4 to 30 minutes with the mean at 20 minutes. About an equal number of studies used electrical or manual needle stimulation. Deep needle insertions were used in the studies that reported depth of insertion. The depth was either reported as deep or between 10 to 30 mm. On average, five needles were used during treatment sessions. “De qi” was elicited in only five of the studies. It appeared that most of these high-quality trials for musculoskeletal problems used combinations of segmental and nonsegmental point locations.