Is Sham Acupuncture Really Inert?

Background

To test the efficacy of acupuncture before and after embryo transfer, many studies included a control group using sham acupuncture, mostly to rule out the placebo effect. However, many researchers are questioning if the sham control is truly inert and whether it is a fair comparison alongside ‘real’ acupuncture.

Some studies aim to evaluate the influence of true versus sham acupuncture on pregnancy rates in women undergoing IVF. For example, in the case of Moy et al (2011), the overall clinical PR was 51.25% in the sham control group while that of the true acupuncture group was 45.3%. There was no significant difference clinically.

Here’s the thing. In Moy’s study, the sham group actually had needles placed in non-qi meridian lines. Likewise, Dieterle et al (2006) opted to use penetrating needles in their sham group, this time placed on acupuncture points not related to fertility. The pregnancy rates in both groups did not differ much. Though the appropriate or most suited acupoints were avoided, the the needles still pierced through the skin, achieving some form of neuro-stimulation. The sham acupuncture was meant to be physically inert, but the above two examples suggest that they may not have been.

Shallow needling cannot be considered inert. Superficial needling is often used by acupuncturists for specific conditions. In Japanese-style acupuncture, most of the needles are placed shallowly.

Needles inserted at a shallow depth have been unwittingly used by some researchers as a sham control. According to an article by Udoff et al, patients were treated with sham needles placed in non-meridian points at a shallow depth. Clinical pregnancy outcomes between acupuncture and control groups was 57.1% vs. 52.4%. In the questionnaires they all filled out after the sessions, almost all the patients in both groups believed they were in the true acupuncture group.

Example of Non-inert Sham

The following is an example of a wrong way to treat non-penetrating sham acupuncture as placebo:

So and colleagues attempted to test the use of acupuncture as an adjunctive therapy with IVF procedure back in 2009. They used the same acupoints needled in the ‘real’ acupuncture group, but applied non-penetrating sham treatment. At the end of the study, it was reported that the overall pregnancy rate was significantly higher in the placebo group than in the real group (55.1% vs 43.8%).

Quite a contrary from many studies’ conclusions. This does not mean that acupuncture was redundant when used on the day of embryo transfer. Though the information can be very misleading, it goes to show that the non-penetrating sham is possibly a highly active treatment that cannot be reduced to or labeled as placebo.

Conclusion

Sham is meant to test for placebo effect on drugs and medications. It is not a fair experiment when performed via acupuncture. No inert sham acupuncture intervention has been developed yet, if any are truly inert. Hence, many of the studies challenging the benefits of acupuncture during IVF treatment are flawed to certain extent, thus producing such varying results.

References:

  1. So EW, Ng EH, Wong YY, Lau EY, Yeung WS, Ho PC. A randomized double blind comparison of real and placebo acupuncture in IVF treatment. Hum Reprod. 2009 Feb; 24(2): 341-8.
  2. Moy, I., Milad, M.P., Barnes, R., Confino, E., Kazer, R.R., Zhang, X. Randomized controlled trial: effects of acupuncture on pregnancy rates in women undergoing in vitro fertilization. Fertil Steril. 2011;95:583–587.
  3. Dieterle, S., Ying, G., Hatzmann, W., Neuer, A. Effect of acupuncture on the outcome of in vitro fertilization and intracytoplasmic sperm injection: a randomized, prospective, controlled clinical study. Fertil Steril. 2006;85:1347–1351.
  4. Udoff, L., Zhang, G., Patwardhan, S., Wei, Z., McClamrock, H. The effect of acupuncture on outcomes in in-vitro fertilization (IVF). Fertil Steril. 2006;86:S145.
Posted by Soma Clinic

Informational content on this website was created by Soma Clinic, which provides natural and hands-on support for women going through IVF cycles, as well as other related therapies for women's reproductive health.