Why double-blind, placebo-controlled trials for acupuncture are difficult even impossible?

Author: Dr. Richard Zeng (Chinese Med)

Double-blind, placebo-controlled trials are the golden standard for high quality of research. However, it can be very challenging to design and implement to acupuncture trials. Here are several factors affect the design of trials :

Needle insertion and sensation

Acupuncture involves the insertion of needles into specific points on the body, which creates a unique sensory experience. It can be challenging to create a placebo treatment that mimics the sensation of needle insertion convincingly. Sham acupuncture controls attempt to simulate the sensation, but it is difficult to completely mask the difference between real acupuncture and a placebo treatment.

Acupuncturist involvement

In traditional acupuncture practice, the acupuncturist plays an active role in the treatment. They may have specific training, techniques, and interactions with the patient that contribute to the therapeutic process. It can be difficult to blind the acupuncturist to the treatment being administered, which can introduce bias and affect the blinding of the study.

Expectations and beliefs

Acupuncture has a strong placebo component, and patient expectations and beliefs can significantly influence their perception of the treatment’s effectiveness. It is challenging to completely blind participants to their treatment group, as they may have prior knowledge or beliefs about acupuncture that can affect their responses.

Variability in treatment protocols

Acupuncture encompasses various techniques, styles, and individualised treatment approaches. There is significant variation in the choice of acupuncture points, needling techniques, and treatment durations among practitioners. Standardising treatment protocols for a placebo-controlled trial can be difficult due to these variations, which may limit the ability to compare results across studies.

Despite these challenges, researchers have made efforts to develop sham acupuncture controls to create placebo-like experiences. These sham controls may involve superficial needle insertion, non-penetrating needles, or non-specific needling locations. However, sham acupuncture is not real placebo. These methods may still provide some therapeutic effects or fail to fully replicate the specific physiological effects of true acupuncture.

While may be not impossible achieving complete blinding in acupuncture trials remains a complex task, and studies may still face limitations in achieving a fully placebo-controlled design.