Sham acupuncture improves symptoms, QoL in functional dyspepsia

Both sham manual acupuncture (MA) and sham electroacupuncture (EA) result in better symptoms and quality of life (QoL) scores among individuals with functional dyspepsia (FD) without affecting objective outcomes, a study has found. This finding underscores the importance of sham controls in acupuncture therapy clinical trials.

“[I]t is necessary that sham controls are implemented in clinical trials if possible, and noncontrolled studies should be interpreted with caution,” the researchers said.

This systematic review and meta-analysis was conducted to quantify placebo responses in clinical trials in which FD patients received sham MA or sham EA. The researchers identified randomized controlled trials (RCTs) of MA and EA in PubMed, Web of Science, Cochrane Library, and Embase databases, as well as four Chinese language databases, from inception to January 2021.

Symptom scores and QoL were pooled using the RevMan 5.20 software. Symptom scores were combined using standard (SMD) or weighted mean difference (WMD) with a 95 percent confidence interval (CI). The researchers tested the quality of studies using modified Jadad scale and the STRICTA checklist, and conducted sensitivity analyses, Egger’s, and Begg’s tests.

Thirteen RCTs were included in the systematic review, but only eight were eligible for meta-analysis. [Evid Based Complement Alternat Med 2015;2015:168252; Neurogastroenterol Motil 2018;30:e13316; Evid Based Complement Alternat Med 2015;2015:904926; Am J Gastroenterol 2012;107:1236-1247; Zhongguo Zhen Jiu 2012;32:703-708; Zhongguo Zhen Jiu 2014;34:125-129; Chong Qing Med 2015;44:1918-1920; Neurogastroenterol Motil 2008;20:1204-1211]

For subjective outcomes, the SMD of sham MA on FD symptoms was ‒0.42 (95 percent CI, ‒0.72 to ‒0.12; p=0.005), while that of sham EA was ‒0.54 (95 percent CI, ‒0.81 to ‒0.27; p<0.001). The combined effect of postsham MA on FD QoL was ‒0.32 (95 percent CI, ‒0.52 to ‒0.12; p=0.002). [J Clin Gastroenterol 2022;56:299-310]

In terms of objective outcomes, the WMD of sham EA on dominant frequency was ‒0.11 (95 percent CI, ‒0.30 to ‒0.08; p=0.24), while that of sham EA on dominant power was ‒3.35 (95 percent CI, ‒8.04 to 1.35; p=0.16).

Placebo effect

“This … is the first meta-analysis of RCTs, demonstrating that sham MA and sham EA are associated with statistical significance regarding both improvements in the symptoms and QoL of FD patients,” the researchers said. “However, dominant frequency and dominant power cannot be significantly improved for FD patients following sham EA treatment.”

The findings put forward significant implications for interpreting the results of uncontrolled acupuncture studies and other related therapies. Thus, the impact of placebo responses and effects on overall treatment response must be considered in future clinical trials, according to the researchers.

“The actual treatment efficacy of acupuncture cannot be elicited if no sham controls were implemented; so it is essential to treat nonplacebo controlled trials with cautions,” they said. [J Clin Epidemiol 2014;67:1375-1376; Neuromodulation 2020;23:1108-1116]

Previous studies reported favourable outcomes in nonsham-controlled trials following acupuncture and related therapies for FD. [J Altern Complement Med 2016;22:997-1006; J Altern Complement Med 2016;22:997-1006; World Chin J Digest 2008;16:4105-4109; World J Acupunct Moxibust 2018;28:86-90; Chin J Integr Med 2015;21:743-750]

“FD is a functional digestive disease with limited management selection,” the researchers said. “Previous studies revealed that acupuncture therapy is effective for FD.”