Sham manual acupuncture (MA) and sham electroacupuncture (EA) improve symptoms and quality of life (QOL) scores in patients with functional dyspepsia (FD) without affecting objective outcomes, according to a study in the Journal of Clinical Gastroenterology.
The systematic review and meta-analysis assessed placebo responses after sham MA and sham EA therapy in patients with FD. Investigators searched PubMed, Web of Science, Cochrane Library, and the Embase database, as well as 4 Chinese-language databases, from inception to June 1, 2021.
Eligible studies enrolled participants who were clinically diagnosed with FD in compliance with Rome II, III, or IV; were randomized controlled trials (RCTs) with full text published in English and Chinese; and had clearly defined observation indicators. Outcomes assessed in the meta-analysis for QOL of FD included the 36-Item Short-Form Health Survey scores and Nepean Dyspepsia Life Quality Index scores.
A total of 13 studies published from 2008 to 2021 were included in the analysis. The combined effect of sham MA treatment on FD symptoms was a standard mean difference (SMD) of -0.42 (95% CI, -0.72 to -0.12; P =.005). The combined effect of sham EA treatment on FD symptoms was a SMD of -0.54 (95% CI, -0.81 to -0.27; P <.001).
The combined effect of sham MA treatment on FD QOL was a SMD of -0.32 (95% CI, -0.52 to -0.12; P =.002). The pooled effect of sham EA on FD QOL was not calculated because only 1 study reported it.
The combined effect of sham EA on dominant frequency was a weighted mean difference (WMD) of -0.11 (95% CI, -0.30 to -0.08; P =.24). The combined effect of sham EA on dominant power was a WMD of -3.35 (95% CI, -8.04 to 1.35; P =.16).
Study limitations included the absence of a control comparison, as only sham interventions were included in the analysis. Therefore, sham acupuncture outcomes may have been influenced by confounding factors, including natural disease progression and regression to the mean. Also, although placebo responses of the trials were quantified using sham MA and sham EA for FD, it is difficult to separate placebo effects from placebo responses.
“Sham MA and sham EA remarkably improve manifestations and quality of life scores of FD without influencing objective outcomes,” the study authors commented. “So it reliably explains the treatment effect. It is necessary that sham controls are implemented in clinical trials if possible, and noncontrolled studies should be interpreted with caution. Notably, further studies should be conducted to develop a standard for the sham acupuncture clinical trial design to explore the acupuncture therapeutic effect.”
Liu J, Song G, Huang Y, et al. Placebo response rates in acupuncture therapy trials for functional dyspepsia: a systematic review and meta-analysis. J Clin Gastroenterol. 2022;56(4):299-310. doi:10.1097/MCG.0000000000001679