Abstract
IntroductionSham acupuncture was developed to be used as an inert control intervention in clinical trials of acupuncture. However, controversies exist regarding the validity of sham acupuncture. In this systematic review (SR) of acupuncture trials, we assessed whether serum biomarkers showed significant differences after sham and verum acupuncture treatments.MethodsAny acupuncture clinical trials that evaluated serum biomarker changes between sham acupuncture and verum acupuncture were included in this review. Relevant literature was searched in the PubMed database, EMBASE, and The Cochrane Central Register of Controlled Trials (CENTRAL) database from inception until June 2021. The Cochrane risk of bias was assessed. Summary effect estimates for each biomarker between groups were calculated with a random effect model.ResultsFrom 51 sham acupuncture trials, we found that there were no significant differences in most of the 36 serum biomarkers after sham acupuncture and verum acupuncture needling. Only VEGF, IG-E, TNF-a, NGF, GABA, NPY, and VIP serum levels were identified as being different between the groups. The overall risk of bias of the included studies and the limited numbers of studies for meta-analysis do not strongly support the results of this SR.ConclusionSham acupuncture techniques might have similar effects on biomarkers as the so-called “real acupuncture” techniques, which indicates that sham acupuncture, as an inert intervention similar to a placebo drug, needs to be reconsidered.Systematic Review PROSPERO Registrationidentifier [CRD42021260889].
Highlights
Sham acupuncture was developed to be used as an inert control intervention in clinical trials of acupuncture
From 51 sham acupuncture trials, we found that most of the 36 serum biomarkers did not suggest a significant difference between sham acupuncture and verum acupuncture needling
Sham acupuncture techniques were not developed appropriately with regard to elimination or control of potential physiological effects (Birch et al, 2021), nor did the development of sham techniques take into account the extensive physiological studies that have been conducted or the wide variety of acupuncture practices worldwide
Summary
Sham acupuncture was developed to be used as an inert control intervention in clinical trials of acupuncture. What was tested in many clinical trials (so-called “real acupuncture”) was usually one type of needling method, while other treatment techniques, seeking to avoid the sensory stimulation of that method, that may have accidentally mimicked other styles of acupuncture were used as so-called “sham acupuncture” (Wei-Xing, 2019). Empirical evidence suggests that so-called “sham acupuncture” might have physiological effects, not surprising given the confusion about what constitutes the practice of acupuncture (Wei-Xing, 2019) and predictable physiological effects of different forms of tissue stimulation (Zhang et al, 2012). These issues have sparked debate about the inadequacy of currently used sham acupuncture as a proper control intervention (Zhang et al, 2012; Birch et al, 2022). Many researchers talk about the comparison of “real” and “sham” acupuncture in their clinical trials, we do not accept this comparison as being accurate, and the term “real” is highly misleading and often inaccurate; instead, we adopt the use of “verum” vs. “sham” acupuncture, as it more accurately captures the assumptions that different research groups have made
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