Article type
Abstract
IMPORTANCE Great efforts have been made to conduct clinical trials that include the use of “sham” or “placebo” acupuncture procedures, but debates and skepticism arise regarding the effectiveness of acupuncture as studies yield negative and equivocal conclusions. Summaries of current sham acupuncture designs and their theoretical and practical feasibility are needed to further promote rational and convincible clinical evidence.
OBSERCATIONS There are 601 clinical trials conducting “sham” or “placebo” acupuncture published over the past decades (from 1974 to 2019) in English, consisting of 52 735 recruited participants among 35 countries. A total of 607 pseudo-needling groups were set up involving 11 types of combinations based on four elements: Location of points (L, 61.61% used), depth of needling (D, 25.54%), needling instruments (N, 45.47%) and stimulation (S, 28.01%), but with highly heterogeneous parameters that have been rarely addressed. Given its “self-limiting” and “peak-value” property, acupuncture works via multi-component and multi-target stimulation, along with individualized dose- & time-response factors, which has differentiated it from medication and other nonpharmacologic treatment like surgery. None of the “sham” element, when interpreted from their theoretical mechanism or clinical practice, is conducted unanimously with sufficient consensus regarding irrationality and reliability, and their potential specific effects have been disregarded to a great extent due to methodological heterogeneity. The true effect size of acupuncture is likely to be underestimated and misinterpreted accordingly when compared with the current “sham” acupuncture controls. Rationality and heterogeneity between diverse “sham” designs should be verified and synthesized under pathophysiological process, and more studies are needed to optimize clinical outcomes and emerging evidence according to the characteristics of acupuncture treatment.
CONCLUSIONS AND RELEVANCE To date, sham approaches in acupuncture research have been flawed by design theoretically and practically, and are unlikely to equated with the “placebo”, hence the interpretation of clinical trials and systematic reviews (with meta-analysis) should be taken rigorously and critically. More comparative studies and pragmatic trials are encouraged, in line with clinical practice, to provide rational and robust evidence for the efficacy of acupuncture.
OBSERCATIONS There are 601 clinical trials conducting “sham” or “placebo” acupuncture published over the past decades (from 1974 to 2019) in English, consisting of 52 735 recruited participants among 35 countries. A total of 607 pseudo-needling groups were set up involving 11 types of combinations based on four elements: Location of points (L, 61.61% used), depth of needling (D, 25.54%), needling instruments (N, 45.47%) and stimulation (S, 28.01%), but with highly heterogeneous parameters that have been rarely addressed. Given its “self-limiting” and “peak-value” property, acupuncture works via multi-component and multi-target stimulation, along with individualized dose- & time-response factors, which has differentiated it from medication and other nonpharmacologic treatment like surgery. None of the “sham” element, when interpreted from their theoretical mechanism or clinical practice, is conducted unanimously with sufficient consensus regarding irrationality and reliability, and their potential specific effects have been disregarded to a great extent due to methodological heterogeneity. The true effect size of acupuncture is likely to be underestimated and misinterpreted accordingly when compared with the current “sham” acupuncture controls. Rationality and heterogeneity between diverse “sham” designs should be verified and synthesized under pathophysiological process, and more studies are needed to optimize clinical outcomes and emerging evidence according to the characteristics of acupuncture treatment.
CONCLUSIONS AND RELEVANCE To date, sham approaches in acupuncture research have been flawed by design theoretically and practically, and are unlikely to equated with the “placebo”, hence the interpretation of clinical trials and systematic reviews (with meta-analysis) should be taken rigorously and critically. More comparative studies and pragmatic trials are encouraged, in line with clinical practice, to provide rational and robust evidence for the efficacy of acupuncture.