Effects of perioperative transcutaneous electrical acupoint stimulation on monocytic HLA-DR expression in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass: study protocol for a double-blind randomized controlled trial

Abstract

BackgroundCardiac surgery involving cardiopulmonary bypass (CPB) is known to be associated with a transient postoperative immunosuppression. When severe and persistent, this immune dysfunction predisposes patients to infectious complications, which contributes to a prolonged stay in the intensive care unit (ICU), and even mortality. Effective prevention and treatment methods are still lacking. Recent studies revealed that acupuncture-related techniques, such as electroacupuncture and transcutaneous electrical acupoint stimulation (TEAS), are able to produce effective cardioprotection and immunomodulation in adult and pediatric patients undergoing cardiac surgery with CPB, which leads to enhanced recovery. However, whether perioperative application of TEAS, a non-invasive technique, is able to improve immunosuppression of the patients with post-cardiosurgical conditions is unknown. Thus, as a preliminary study, the main objective is to evaluate the effects of TEAS on the postoperative expression of monocytic human leukocyte antigen (-D related) (mHLA-DR), a standardized “global” biomarker of injury or sepsis-associated immunosuppression, in patients receiving on-pump coronary artery bypass grafting (CABG).MethodsThis study is a single-center clinical trial. The 88 patients scheduled to receive CABG under CPB will be randomized into two groups: the group receiving TEAS, and the group receiving transcutaneous acupoint pseudo-electric stimulation (Sham TEAS). Expression of mHLA-DR serves as a primary endpoint, and other laboratory parameters (e.g., interleukin [IL]-6, IL-10) and clinical outcomes (e.g., postoperative infectious complications, ICU stay time, and mortality) as the secondary endpoints. In addition, immune indicators, such as high mobility group box 1 protein and regulatory T cells will also be measured.DiscussionThe current study is a preliminary monocentric clinical trial with a non-clinical primary endpoint, expression of mHLA-DR, aiming at determining whether perioperative application of TEAS has a potential to reverse CABG-associated immunosuppression. Although the immediate clinical impact of this study is limited, its results would inform further large-sample clinical trials using relevant patient-centered clinical outcomes as primary endpoints.Trial registrationClinicalTrials.gov, NCT02933996. Registered on 13 October 2016.

Transcutaneous electrical acupoint stimulation improves endometrial receptivity resulting in improved IVF-ET pregnancy outcomes in older women: a multicenter, randomized, controlled clinical trial

“…These patients had relatively normal endometrial receptivity and thus were non-responders for TEAS. The dilution of the therapeutic effects might also be responsible for the smaller effects reported in previous studies [16,17,[19][20][21][22]29]. It is well established that the incidence of diminished ovarian function and declining endometrial receptivity increase with the increasing age of women and become more critical to infertility [30].…”

“…TEAS involves no needles and has a safer profile than acupuncture. The standard procedure requires less training for physicians and can be more readily accepted by the patients [ 16 , 17 ]. It is effective in the management of various chronic conditions [ 18 ].…”

“…There is a need for more high-quality randomized controlled trials to prove or disprove the efficacy of acupuncture in infertile women [ 10 , 11 ]. Transcutaneous electrical acupoint stimulation (TEAS) is a noninvasive intervention derived from electroacupuncture as an alternative to manual or electroacupuncture [ 16 , 17 ]. Like acupuncture, TEAS has been shown to have a wide range of indications, including pain relief, treatment of digestive disorders, prevention of nausea and vomiting, management of muscular ailments, management of body weight, and treatment of depression, anxiety, addiction, and stroke, as reviewed by Jun et al [ 18 ].…”

Transcutaneous electrical acupoint stimulation for the prevention of perioperative neurocognitive disorders in geriatric patients: A systematic review and meta-analysis of randomized controlled trials

“…Since classical acupuncture is highly dependent on the skill of the acupuncturist and some people are afraid of the painful sensation of puncturing, TEAS is becoming a popular trend because of its noninvasive nature, adjustable strength, frequency and easy quantification in the clinic. And TEAS is widely used in the perioperative period, and some studies have confirmed that TEAS has gastrointestinal regulation, [36] circulatory improvement, [37] immune enhancement, [38,39] anti-inflammatory, [40] and stress-reduction effects, [41] which would lead to a shorter time of convalescence and hospitalization, improving the quality of life of patients. In terms of the prevention of PND in elderly patients, as the first comprehensive systematic review and meta-analysis after the new definition in 2018, the results may have important implications for clinicians and researchers.…”

Home‐based transcutaneous electrical acupoint stimulation for high‐normal blood pressure: A randomized controlled trial

“…[22][23][24][25][26] This approach has the advantages of being easy to use, being more "user friendly," requiring minimal training for physicians and patients and being convenient for clinical application at a health facility or at home. 27 With the miniaturization of transcutaneous nerve stimulators, the use of TEAS treatment at home has become a clinical reality and would further reduce the time and transportation costs of travel to the hospital. Although TEAS has been shown to lower BP in several studies, [22][23][24][25]…”