Is sham acupuncture necessary in acupuncture clinical study?

Acupuncture is a therapy through physical stimulation by inserting a sharp, thin needle into the specific point on the body, with mechanical, electrical, or other physical manipulations, which stimulate nerve receptors both directly and indirectly through mechanical coupling via the connective tissue surrounding the needle. In general, the acupuncture stimulation, through the local reflex and central nervous system, induces endocrine, autonomic, and systemic behavioural responses. During past 20 years acupuncture studies have been extensively conducted worldwide, with a mean annual growth rate of 10.7%. It could be said that no other alternative medicines have been through such strict and detailed and scrutinized studies. Even though, the action mechanisms of acupuncture’s analgesic effect have been elucidated and the findings have been published on some top scientific journals.

There is a debate whether acupuncture clinical studies should be subjected to the standard drug therapy clinical trial, because acupuncture is not a medication. We know that efficacy of drug/medication can be assessed under ideal conditions of traditional randomized controlled, double-blinded, sham controlled trials. However, acupuncture is not a kind of medication therapy and is applied in routine circumstance. So the measurement of effectiveness such as comparative effectiveness research (CER), rather than efficacy used in standard drug therapy clinical trial, should be applied to acupuncture clinical studies. CER compares the benefits and harms of the best care options and produces evidence to support decision maker, which is a better option for public health. The real world evidence, more generalizable than the evidence produced by traditional randomized controlled trials, is better suited to inform real-world care decisions. With gradually understanding the nature of acupuncture, recently it was questioned whether it was necessary that sham control should be used in acupuncture clinical studies, because sham controlled study actually complicated result evidence base in some circumstance (Manheimer, 2011). Further, it has been suggested that assessment of the specific effect of acupuncture, by using sham acupuncture in an attempt to blind participants, could produce another limitation for clinical acupuncture trials by potentially attenuating the effects of ‘real’ acupuncture (Kim et al., 2017). Further discussion regarding study design and control interventions for acupuncture clinical trial is necessary.

Reference:

Manheimer E. Selecting a control for in vitro fertilization and acupuncture randomized controlled trials (RCTs): how sham controls may unnecessarily complicate the RCT evidence base. 2011, Fertil Steril. 95(8):2456-61.  https://www.ncbi.nlm.nih.gov/pubmed/21570069 

Kim TH. et al., What is lost in the acupuncture trial when using a sham intervention? Acupunct Med. 2017 Apr 29. pii: acupmed-2016-011333.   https://www.ncbi.nlm.nih.gov/pubmed/28456756