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Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial.

ABSTRACT: BACKGROUND:Hypertension is a major pathogenic factor of cardiovascular diseases. Insufficient blood pressure control rate and sub-optimal medication adherence remain challenges for effective management of hypertension. Transcutaneous electrical acupoint stimulation (TEAS) has been used to treat various diseases, including hypertension, but the scientific evidence for its benefit remains insufficient. Therefore, we will perform a randomized, controlled clinical trial in patients with stage 1 hypertension to evaluate the effect of TEAS. METHODS/DESIGN:The study will be a two-arm parallel, randomized controlled trial. Sixty patients with stage 1 hypertension will be randomly assigned to the TEAS group and the control group in a 1:1 ratio. The participants in the TEAS group will receive non-invasive acupoint electrical stimulation for 30?min at four acupoints in the upper and lower extremities at home, 4 times weekly for 12?weeks for a total of 48 sessions. Participants in the control group will not receive any form of acupoint stimulation. All participants in both groups will receive lifestyle education on how to control high blood pressure, including diet, weight control, and exercise. The primary outcome measure will be the change of the mean systolic blood pressure from baseline to 12?weeks. Secondary outcomes include the change of mean diastolic blood pressure, quality of life, body mass index, and physical activity level. DISCUSSION:This pilot, randomized, controlled trial will explore the feasibility of TEAS. It will also provide potential clinical evidence for the efficacy and safety of TEAS in the treatment of patients with stage 1 hypertension. The results of this study will be published in peer-reviewed journals. Furthermore, this pilot trial as the precursor of a large scale randomized controlled trial will inform the sample size of the subsequent trial. TRIAL REGISTRATION:Chinese clinical trial registry, ChiCTR1900025042, Registered on 8 August 2019 (http://www.chictr.org.cn/showproj.aspx?proj=41496).

SUBMITTER: Tian ZX

PROVIDER: S-EPMC7310085 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial.

Tian Zhong-Xue ZX Liu Cun-Zhi CZ Qi You-Sheng YS Tu Jian-Feng JF Lin Ying Y Wang Yu Y Yang Jing-Wen JW Shi Guang-Xia GX Liu Jun-Hong JH Wang Li-Qiong LQ

Trials 20200622 1

<h4>Background</h4>Hypertension is a major pathogenic factor of cardiovascular diseases. Insufficient blood pressure control rate and sub-optimal medication adherence remain challenges for effective management of hypertension. Transcutaneous electrical acupoint stimulation (TEAS) has been used to treat various diseases, including hypertension, but the scientific evidence for its benefit remains insufficient. Therefore, we will perform a randomized, controlled clinical trial in patients with stag ...[more]

PMID: 32571411

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Project description:Laparoscopy is performed worldwide due to its limited side effects and optimal treatment efficacy. However, it also has adverse effects, including atelectasis and ischemia-reperfusion injury, due to CO2 accumulation during ventilation in a head-down position, which may result in severe disorders and adversely affecting postoperative recovery, prolonging hospitalization. The present study was performed to assess whether transcutaneous electrical acupoint stimulation (TEAS) protects against lung injury occurring during gynecological laparoscopic surgery. Patients were randomly allocated to two groups: Control group (received no stimulation) and TEAS group (patients treated with TEAS on BL13, LI4 and LU5). The mean arterial pressure, heart rate and oxygen saturation were recorded at the time-points of arriving in the operating room (T0), immediately prior to induction of the pneumoperitoneum (T1), immediately after the end of pneumoperitoneum (T2) and on leaving the operating room (T3). Arterial blood gas analysis was performed to record the pH, determine the partial pressure of carbon dioxide and calculate the oxygenation index (OI) at T0-3. Blood samples were taken from the peripheral vein for determination of the serum concentrations of tumor necrosis factor (TNF)-? and interleukin (IL)-1? at T0 and T3. Post-operative pulmonary complications occurring during the first five days after surgery were also recorded. A total of 100 patients were initially enrolled and 80 patients were analysed. The results indicated that the OI in the control group was significantly lower than that in the TEAS group at the T2 and T3 time-points. The serum concentrations of TNF-? and IL-1? were significantly increased following surgery, while the extent of these increases was lower in the TEAS group compared with that in the control group. The incidence of post-operative pulmonary complications was significantly lower in the TEAS group. It was therefore indicated that TEAS protect against lung injury as a complication of gynecological laparoscopic surgery. The present study was registered at http://www.clinicaltrials.gov prior to enrollment of the patients (no. NCT02850471).

Project description:BackgroundAcupuncture-balanced anesthesia has been found to offer protective benefits. Electrical stimulation at certain acupoints can potentially promote perioperative gastrointestinal function recovery. The purpose of this study is to explore the effects of acupuncture-balanced anesthesia on the postoperative recovery of gastrointestinal function, on anesthesia strategies for abdominal surgery, on postoperative pain treatment, and on any associated complications or alterations in immune function. We further seek to verify the protective effects of transcutaneous electrical acupoint stimulation (TEAS), to explore possible underlying neuroimmune-endocrine mechanisms, and to thereby develop an optimized acupuncture-balanced anesthesia strategy suitable for abdominal surgery. Together, these findings will provide a scientific basis for the clinical utilization of acupuncture-balanced anesthesia in the context of abdominal surgery.Methods/designThis study is a multicenter, large-sample, randomized placebo-controlled trial. All subjects will be patients undergoing elective gastric or colorectal surgery. In Part 1, these patients will be stratified according to surgical site (gastric or colorectal), and randomly divided into four groups based on different perioperative interventions: Con group, which will undergo sham TEAS before, during, and after surgery; T1 group, which will receive TEAS during the preoperative and intraoperative periods, and sham TEAS during the postoperative period; T2 group, which will receive TEAS during the preoperative period, sham TEAS during the intraoperative period, and TEAS during the postoperative period; and T3 group, which will receive TEAS before, during, and after operation. Part 2 of this study will focus solely on colorectal surgery patients. All patients will receive TEAS during the preoperative and intraoperative periods, and they will be randomized into four groups according to different postoperative treatments: Con' group, which will not receive TEAS; T1' group, which will receive sham TEAS; T2' group, which will receive 5-Hz TEAS; and T3' group, which will receive 100-Hz TEAS. Venous blood (5 ml) will be used to measure immunological and inflammatory indexes both at the preoperative stage prior to TEAS and 4-5 days after operation. The primary outcome will be the time to first bowel sounds after surgery. Secondary outcomes will include gastrointestinal functional recovery, analgesic efficacy during the postoperative period, acupuncture-balanced anesthesia efficacy, postoperative nausea and vomiting, and postoperative complications.DiscussionThis study is designed to investigate the clinical value of TEAS during various perioperative periods in those undergoing abdominal surgery, with the overall goal of evaluating the clinical value and advantages of acupuncture-balanced anesthesia, and of providing new strategies for improving patient prognoses.Trial registrationChinese Clinical Trial Registry, ChiCTR-TRC-14004435. Registered on 26 March 2014.

Project description:BackgroundCraniotomy aneurysm clipping is one of the main treatments for intracranial aneurysm (IA). Endotracheal intubation and intraoperative operation may induce dramatic hemodynamic fluctuations and increase the risk of aneurysm rupture. Intraoperative high-dose opioid use is the main measure to reduce the intraoperative stress response, but it increases the incidence of complications such as postoperative vomiting and delayed awakening. Transcutaneous electrical acupoint stimulation (TEAS) stimulates β-endorphin expression levels and reduces opioid requirements. In this study, we aimed to assess the effects of TEAS on remifentanil dosage and oxidative stress (OS) in craniotomy aneurysm clipping.MethodForty-two patients with craniotomy aneurysm clipping were randomized into two groups: the TEAS group (T group) and the sham TEAS group (S group). "Hegu" (LI4), "Neiguan" (PC6) and "Zusanli" points (ST36) were selected, and a "HANS" percutaneous acupoint electrical stimulator was used for intervention 30 min before anesthesia induction until the end of the operation. The primary outcome was intraoperative remifentanil dosage. The secondary outcomes were intraoperative propofol dosage, mean arterial pressure (MAP) and heart rate (HR) 5 min before the TEAS intervention (T0), 5 min before head holder pinning (T1), immediately after pinning (T2), 5 min before craniotomy (T3), immediately after craniotomy (T4), at craniotomy (T5), and at the end of surgery (T6), as well as serum β-endorphin levels at T1, T2 and T6 and neuron-specific enolase (NSE), S100β, superoxide dismutase (SOD) and malondialdehyde (MDA) levels at T1, T2 and 24 h after surgery (T7).ResultsThe dosage of remifentanil in the T group was reduced compared to that in the S group (P < 0.05). At T2, T4 and T5, the MAP and HR in the T group were lower than those in the S group (P < 0.05). At T2 and T7, the levels of NSE, S100β and MDA in group T were lower than those in group S (P < 0.05), while the SOD levels in group T were higher than those in group S (P < 0.05).ConclusionsThe use of TEAS can reduce the dosage of remifentanil and reduce hemodynamic fluctuations during craniotomy aneurysm clipping. It reduces the occurrence of OS and central nervous system damage during surgery and has a certain brain protective effect.Trial registrationChiCTR2100052353. https://www.chictr.org.cn/about.html .

Project description:BackgroundThis study aimed to evaluate the effect of perioperative transcutaneous electrical acupoint stimulation (TEAS) on postoperative cognitive dysfunction (POCD) in older patients who were diagnosed with gastrointestinal tumor and received radical resection of gastrointestinal tumors under general anesthesia.MethodsA total of 68 patients who received radical resection of gastrointestinal tumors under general anesthesia were randomly divided into two groups. TEAS group patients received TEAS treatment. The treatment time was 30 min before the induction of anesthesia until the end of the surgery, 1 day before operation and from the first day to the third day after the operation. Except on the day of surgery, we treated the patients for 30 min once a day. In the sham TEAS group, the electronic stimulation was not applied and the treatment was the same as the TEAS group. The primary outcome was perioperative cognition evaluated by the Mini-Mental State Examination (MMSE) and secondary outcomes were the perioperative level of interleukin-6 (IL-6), S100 calcium-binding protein β (S100β), and C-reactive protein (CRP).ResultsThe postoperative score of MMSE, orientation, memory, and short-term recall in the sham TEAS group was significantly lower than the preoperative and TEAS group (P < 0.05). The incidence of POCD in the TEAS group (21.88%) was lower than those in the sham TEAS group (40.63%). S100β, IL-6, and CRP in the TEAS group were significantly lower than those in the sham TEAS group on the third day after the operation (P< 0.05). Postoperative S100β, IL-6, and CRP in two groups were significantly higher than those before operation except for S100β on the third day after the operation in the TEAS group (P < 0.05).ConclusionsPerioperative TEAS treatment reduced the postoperative inflammatory response and increased the postoperative cognitive function score and decrease the incidence of POCD in geriatric patients with gastrointestinal tumor.Trial registrationClinicalTrials.gov NCT04606888 . Registered on 27 October 2020. https://register.clinicaltrials.gov .

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Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial.

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Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial.

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