Introduction

Electroacupuncture involves the insertion of acupuncture needles into the skin at acupoints to stimulate parts of the body, followed by the application of electrical stimulation. This treatment modality is used as therapy for various conditions and, given the involvement of both acupuncture point stimulation with needling and electrical stimulation, it is thought to be more effective than traditional acupuncture. A key feature of electroacupuncture is its capacity to provide continuous stimulation to specific areas of the body at quantitatively controllable intensities during the treatment [1–3].

From the perspective of evidence-based medicine, a treatment is best validated through rigorous randomized controlled trials (RCTs) which are considered to provide the highest level of evidence [4,5]. In this context, noninvasive sham acupuncture control groups have been used in acupuncture clinical trials and electroacupuncture RCTs to determine the specific effects of the treatment [6–8]. However, there are no clear standards on the preferred method of sham electroacupuncture and this indicates the need for further research to establish an ideal sham placebo control.

To examine the methods and validity of sham electro-acupuncture this protocol study presents a method for a systematic review study of RCTs that have used sham electroacupuncture as a control. The findings of the systematic review will provide foundational data and evidence for optimal sham electroacupuncture control groups, which are essential for validating the efficacy of electroacupuncture in RCTs.

Materials and Methods

1. Information sources and search

A literature search will be conducted across major electronic databases (including PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials) with search dates through to May 2024. The search will use combinations of the following keywords: (electroacupuncture) AND (sham or placebo) AND (randomized controlled trial). This systematic review protocol was registered with PROSPERO (no.: CRD42024542514, https://www.crd.york.ac.uk).

2. Study inclusion criteria

Two reviewers will independently screen all studies identified for inclusion. The inclusion criteria will be the following: (1) original articles; (2) RCTs; and (3) studies with sham electroacupuncture as the control group. Studies will be included if they involve electroacupuncture treatment in the intervention group and sham electroacupuncture in the control group, with blinding assessments performed for patient responses. Studies with no blinding assessments will be excluded. In the first stage of selection and exclusion, titles and abstracts will be screened to exclude studies unrelated to the objectives of this review. In the second stage, full-text articles of studies will be reviewed. Any discrepancies between reviewers will be resolved through consensus.

3. Data extraction

Data extraction will be performed independently by 2 reviewers using a predefined format. The extracted data will include the following: (1) study participants (details regarding the clinical conditions and number of participants involved in the trials); (2) intervention and control groups (data on the verum and sham electroacupuncture groups, particularly the methods of sham electroacupuncture application including sham device type, needle location, and electrical stimulation); (3) blinding assessments (data on participants’ responses regarding the procedure they believed they received); (4) primary outcomes (results reported as the primary outcome in the clinical trials); and (5) adverse events (any adverse events reported in the clinical trials).

4. Data analysis

A frequency analysis will be conducted on participants’ responses in the assessment of blinding for verum and sham electroacupuncture. Where applicable, the Blinding Index [9,10] will also be calculated and reported.

5. Quality assessment

The quality of the selected RCTs will be assessed using the Cochrane Risk of Bias 2 tool [11]. This tool evaluates 5 domains: (1) randomization process; (2) deviations from the intended interventions; (3) missing outcome data; (4) measurement of the outcome; and (5) selection of the reported result. The risk of bias for each domain will be rated as low risk of bias, some concerns, or high risk of bias.

Discussion

This protocol for a systematic review aims to provide a review which will evaluate the application methods and reliability of sham electroacupuncture previously used in RCTs, thereby providing evidence for establishing optimal sham electroacupuncture placebo-controlled groups in future studies. The type of sham device, publication year, characteristic of participants, intervention and control groups, methods of sham electroacupuncture application, primary outcome and results, adverse events, and blinding assessments will be extracted from included studies. This review may provide valuable results pertaining to clinical trial design in the future where sham electroacupuncture will be used.

The review will provide insights into the latest research trends concerning electroacupuncture treatments for various conditions using sham electroacupuncture. These findings may help in the design of electroacupuncture RCTs in the future, considering specific diseases and conditions, and may validate electroacupuncture by optimizing control groups. This includes suggestions for adjusting sham electroacupuncture methods to improve application techniques and which may improve rigor of the RCT. This review may lead to practical recommendations for standardizing sham electroacupuncture practices in future trials. Additionally, the findings may lay the groundwork for developing novel, more effective sham electroacupuncture devices which could be used in double-blind interventions.

A limitation of this review will be language bias because Chinese and Japanese databases will not be used to retrieve relevant studies due to language barriers. Therefore, future research should include searches of Chinese and Japanese databases to ensure a more comprehensive analysis of the methods and reliability of sham electroacupuncture in RCTs.

Article information

Conflicts of Interest

The author has no conflicts of interest to declare.

Funding

This research was supported by a grant from the Rehabilitation Research and Development Support Program (no.: NRCRSP-24TB03), National Rehabilitation Center, Ministry of Health and Welfare, Korea.

Ethical Statement

Not applicable.

Data Availability

References

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References

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