Needling Point Location Used in Sham Acupuncture for Chronic Nonspecific Low Back Pain

Abstract

ImportanceWhen sham acupuncture is set as a control in evaluating acupuncture, the sham needling technique is usually different from acupuncture. However, the sham procedure is conducted either at the same points that are used for the acupuncture group or at nonindicated points.ObjectiveTo assess whether the outcome of sham acupuncture varies according to the needling points in sham-controlled trials of acupuncture for chronic nonspecific low back pain (CLBP) as an example.Data sourcesSearches of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and the Allied and Complementary Medicine Database were conducted on February 12, 2023.Study selectionRandomized clinical trials (RCTs) assessing the outcomes of acupuncture in sham acupuncture–controlled or waiting list–controlled trials on CLBP were included.Data extraction and synthesisTwo researchers independently extracted data on study characteristics and outcomes and assessed quality. Sham acupuncture was classified according to whether it was conducted at the same acupuncture points used in the acupuncture group, referred to as sham acupuncture therapy (verum) (SATV) or at different points, referred to as sham acupuncture therapy (sham) (SATS). Clinical similarity, transitivity, and consistency tests were conducted, followed by a random-effects frequentist network meta-analysis (NMA).Main outcomes and measuresThe primary outcome was pain, and the secondary outcome was back-specific function. The first assessment after the end of treatment was chosen for analysis. Effect sizes are reported as standardized mean differences (SMD) with 95% CIs. The risk of bias was assessed using the Cochrane risk of bias tool, and the certainty of evidence for findings was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach.ResultsTen RCTs involving 4379 participants were included. In comparison with SATS, acupuncture was significantly associated with improvements in both pain (SMD, −0.33; 95% CI, −0.52 to −0.15) and function outcomes (SMD, −0.13; 95% CI, −0.25 to −0.02); however, there were no differences between acupuncture and SATV. In comparison with SATS, SATV was significantly associated with better pain (SMD, −0.45; 95% CI, −0.88 to −0.03) and function outcomes (SMD, −0.30; 95% CI, −0.56 to −0.05). The risk of bias that could affect the interpretation of the results was usually low, and the certainty of evidence was moderate to low.Conclusions and relevanceIn this NMA, sham acupuncture needling at the same points as those in acupuncture was not a true placebo control for assessing the efficacy of acupuncture for CLBP and might underestimate the outcome of acupuncture in clinical settings.

Different Outcomes According to Needling Point Location Used in Sham Acupuncture for Cancer-Related Pain: A Systematic Review and Network Meta-Analysis

“…The statistical significance and direction of the effect size between the verum and sham acupunctures were consistent in pairwise and NMA. Interestingly, this result is consistent with our previous NMAs of CLBP and knee osteoarthritis, which were conducted with the same hypothesis [10,11]. Meanwhile, in the previous study on CLBP [10], SATV showed a significant improvement in pain and back-specific function compared to SATS.…”

“…Interestingly, this result is consistent with our previous NMAs of CLBP and knee osteoarthritis, which were conducted with the same hypothesis [10,11]. Meanwhile, in the previous study on CLBP [10], SATV showed a significant improvement in pain and back-specific function compared to SATS. However, there was no significant difference in cancer-related pain between the two groups, although SMD favored SATV.…”

“…Previous acupuncture trials for cancer-related pain have shown inconsistent results compared to sham acupuncture [23][24][25][26]; therefore, we examined whether the needling points of sham acupuncture were related to the outcome of verum and sham acupuncture, as in our previous analyses of CLBP and knee osteoarthritis [10,11]. Through a comprehensive database search, 8 RCTs involving 574 participants were included in the systematic review, and 7 RCTs comprising 527 participants were included in the pairwise meta-analysis and NMA.…”

“…Therefore, evidence for the efficacy of acupuncture derived from such clinical trials may underestimate the effect of real-world acupuncture. In our previous network meta-analyses (NMAs), we found that the comparative effect of verum acupuncture differs, depending on the needling point of sham acupuncture for chronic nonspecific low back pain (CLBP) and knee osteoarthritis, which are representative pain conditions in which acupuncture has been frequently used in clinical settings and for which many acupuncture studies have been performed [10,11]. These results raised the question of whether a similar pattern would be observed in other conditions/diseases.…”

The efficacy and safety of acupuncture and moxibustion for the management of nausea and vomiting in pregnant women: A systematic review and meta-analysis

“…In our meta-analysis, we found that acupuncture was effective in managing NVP when compared with the Chinese traditional herbs, conventional therapy, and blank control groups. In a meta-analysis conducted in patients with chronic nonspecific low back pain [ 40 ], researchers found that sham acupuncture was not a true placebo control and might underestimate the efficacy of acupuncture. In our subset analysis comparing acupuncture and sham acupuncture revealed significant heterogeneity (I 2 = 69 %).…”