Electrical Stimulation for Nausea, Vomiting and Motion Sickness (PrimaBella and ReliefBand) and Other Selected Indications
Number: 0676
Table Of Contents
PolicyApplicable CPT / HCPCS / ICD-10 Codes
Background
References
Policy
Scope of Policy
This Clinical Policy Bulletin addresses electrical stimulation for nausea, vomiting, and motion sickness (PrimaBella and ReliefBand) and other selected indications.
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Medical Necessity
Aetna considers the following transcutaneous electrical acupoint stimulation treatments medically necessary when criteria are met:
- Prescription version ReliefBand devices for the treatment of post-operative nausea and chemotherapy-induced nausea that is unresponsive to antiemetics and other conservative therapies;
- Prescription version PrimaBella or ReliefBand devices for treatment of hyperemesis gravidarum that is unresponsive to other conservative medical therapy (e.g., change in diet, ginger capsules, vitamin B6).
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Experimental, Investigational, or Unproven
Aetna considers the following procedures experimental, investigational, or unproven for the indications below (not an all-inclusive list) because the effectiveness of these approaches has not been established:
- Transcutaneous electrical acupoint stimulation for the following indications:
- Improvement of motor functions and self-care ability in children with cerebral palsy
- Improvement of pregnancy rates in women undergoing in-vitro fertilization
- Improvement of stress response during extubation and post-operative delirium and other postoperative care
- Improvement on the quality of early recovery in patients undergoing gynecological laparoscopic surgery
- Improvement/promotion of post-operative of sleep quality and analgesic effect following video-assisted thoracoscopic surgery
- Management of dysmenorrhea
- Management of post-operative analgesia in individuals undergoing radical mastectomy
- Management of post-operative catheter-related bladder discomfort in individuals undergoing transurethral resection of the prostate
- Modulation of autonomic balance in heart transplant recipients
- Prevention of motion sickness
- Prevention of post-operative urinary retention
- Reduction of incidence and severity of etomidate-induced myoclonus
- Treatment of autism
- Treatment of cancer-induced bone pain
- Treatment of chronic fatigue syndrome
- Treatment of chronic obstructive pulmonary disease
- Treatment of hemodialysis-associated fatigue
- Treatment of hypertension
- Treatment of male infertility
- Treatment of muscle spasticity following brain injury
- Treatment of pain after total knee arthroplasty
- Treatment of post-hemorrhoidectomy-associated pain and anxiety
- Treatment of post-operative immune dysfunction in individuals with lung cancer
- Treatment of post-operative gastro-intestinal dysfunction of colorectal/gastric cancers
- Treatment of post-traumatic stress disorder
- Treatment of tinnitus;
- Transcutaneous auricular vagus nerve stimulation for the treatment of epilepsy;
- Transcutaneous neuromodulation and auricular electrostimulation for nausea, vomiting, motion sickness and other indications;
- Trans-auricular electrical stimulation for the treatment of motion sickness.
- Transcutaneous electrical acupoint stimulation for the following indications:
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Policy Limitations and Exclusions
Aetna does not cover over-the-counter disposable ReliefBand devices, which are used for the treatment of motion sickness, because they do not meet Aetna’s definition of durable medical equipment.
Background
Transcutaneous electrical acupoint stimulation, also known as acustimulation, has been proposed as a method of treating severe nausea and vomiting that does not respond to other conservative treatments. A watch-like device is placed on the wrist and provides very mild electrical impulses to stimulate the median nerve (which is an acupuncture point thought to be effective for the treatment of nausea and vomiting). Examples of devices used for this treatment include, but may not be limited to, the PrimaBella and ReliefBand.
The ReliefBand (Neurowave Medical Technologies, Chicago, IL) is a watch-like device worn on the ventral side of the wrist. When activated, the device emits a low-level electrical current across 2 small electrodes on its underside, stimulating the median nerve (an acupuncture point). The ReliefBand offers 5 stimulation levels from the rotary dial that one can control to provide maximum comfort and relief. The non-invasive and drug-free ReliefBand is available by prescription for the treatment of nausea and vomiting (NV) due to pregnancy (PrimaBella, Alaven Pharmaceutical LLC, Marietta, GA), chemotherapy-induced NV, post-operative nausea and vomiting (PONV), and over-the-counter for the treatment of motion sickness.
Studies have shown that the ReliefBand is effective in treating chemotherapy-induced NV and as effective as antiemetic medications in managing NV following surgery.
Lee and Done (1999) evaluated the effectiveness of non-pharmacologic techniques to prevent post-operative PONV by systematic review. These studies included acupuncture, electroacupuncture, transcutaneous electrical nerve stimulation, acupoint stimulation, and acupressure. The authors concluded that non-pharmacologic techniques were equivalent to commonly used antiemetic drugs in preventing vomiting after surgery. Non-pharmacologic techniques were more effective than placebo in preventing NV within 6 hours of surgery in adults, but there was no benefit in children.
- ondansetron (n = 40): 4 mg intravenous (I.V.) ondansetron and a sham ReliefBand;
- acustimulation (n = 40): 2 ml I.V. saline and an active ReliefBand; and
- combination (n = 40): 4 mg I.V. ondansetron and an active ReliefBand.
The incidences of PONV, as well as the need for "rescue" antiemetics, were determined at specific time intervals for up to 72 hours after surgery. The outcome variables assessed included recovery times, quality of recovery score, time to resumption of normal diet, and patient satisfaction with the prophylactic antiemetic therapy. Use of the ReliefBand in combination with ondansetron significantly reduced nausea (20 versus 50 %), vomiting (0 versus 20 %), and the need for rescue antiemetics (10 versus 37 %) compared with ondansetron alone at 24 hours after surgery. Furthermore, the ability to resume a normal diet (74 versus 35 %) within 24 hours after surgery was significantly improved when the ReliefBand was used to supplement ondansetron (versus ondansetron alone). Finally, the quality of recovery (90 +/- 10 versus 70 +/- 20) and patient satisfaction (94 +/- 10 versus 75 +/- 22) scores were significantly higher in the combination group than the ondansetron group. There were no significant differences between the ReliefBand and ondansetron when administered as adjuvants to droperidol for antiemetic prophylaxis. The authors concluded that the ReliefBand compared favorably to ondansetron when used for prophylaxis against PONV.
In a randomized, double-blind, placebo- and sham-controlled study, Coloma et al (2002) compared the ReliefBand with ondansetron (Zofran) for the treatment of PONV after outpatient laparoscopic surgery (n = 268). All patients received antiemetic prophylaxis with metoclopramide, 10 mg I.V. or droperidol, 0.625 mg I.V. after induction of anesthesia. A total of 90 patients developed PONV in the recovery units and were randomized to 1 of 3 treatment groups:
- the ondansetron group received 4 mg I.V. ondansetron and a sham ReliefBand;
- the acustimulation group received 2 ml I.V. saline and a ReliefBand; and
- the combination group received 4 mg I.V. ondansetron and a ReliefBand.
A rescue antiemetic (10 mg I.V. metoclopramide) was administered only if the PONV symptoms persisted for 15 minutes or longer after initiating the treatment. A blinded observer recorded the recovery times, emetic symptoms, rescue antiemetics, maximum nausea scores, complete response to study treatment, and time to achieve discharge criteria. Post-discharge side effects, as well as patient satisfaction and quality of recovery scores, were assessed at 24 and 72 hours after surgery. The combination group had a significantly higher complete response rate than the acustimulation group (73 versus 40 %). In addition, fewer patients in the combination group experienced subsequent emetic events (8 compared to 18 in the acustimulation group). However, there were no significant differences between the 3 groups with respect to patient satisfaction and quality of recovery scores. The authors concluded that acustimulation with the ReliefBand can be used as an alternative to ondansetron for the treatment of established PONV.
Habib and colleagues (2006) examined whether transcutaneous acupoint electrical stimulation with the ReliefBand can prevent NV during and after cesarean delivery under spinal anesthesia. These investigators randomized 94 patients undergoing cesarean delivery with spinal anesthesia to receive the ReliefBand at the P6 point (active group) or an active ReliefBand applied to the dorsum of the wrist (sham control group). The ReliefBand was applied 30 to 60 mins pre-operatively and left in place for 24 hours. There was no statistically significant difference between the active and sham control groups in the incidence of intra-operative/post-operative nausea (30 % versus 43 %/23 % versus 41 %), vomiting (13 % versus 9 %/26 % versus 37 %), need for rescue antiemetics (23 % versus 18 %/34 % versus 39 %), or complete response (55 % versus 57 %/51 % versus 34 %). There was also no difference between the 2 groups in nausea scores, number of vomiting episodes, or patient satisfaction with PONV management.
In a randomized controlled study (n = 105), White et al (2005) reported that acustimulation with the ReliefBand was most effective in reducing PONV and improving patients' satisfaction with their antiemetic therapy when it was administered after surgery.
However, a Cochrane review on acupuncture-point stimulation (needles, electrical stimulation, magnets, or acupressure) for chemotherapy-induced NV (Ezzo et al, 2006) reported that non-invasive electrostimulation appears unlikely to have a clinically relevant impact when patients are given state-of-the-art pharmacological antiemetic therapy.
PrimaBella™ (Alaven Pharmaceutical LLC, Marietta, GA) is a neuro-modulatory device that utilizes the same technology as the ReliefBand. It is intended for use in the treatment of NV due to pregnancy.
Slotnick (2001) evaluated the safety and effectiveness of P-6 acustimulation for the relief of NV associated with early pregnancy in 41 patients. Pre-treatment nausea severity, post-treatment nausea relief and device effectiveness were patient-rated using a 1 to 5 scale. All neonates were evaluated for congenital abnormalities. Pre-treatment nausea severity scores for treated patients averaged 4.2, with most severe and debilitating nausea rated 5. Post-treatment device effectiveness averaged 4.2, with significant or complete relief rated 5. Device ease of use averaged 4.3, with very easy to use rated 5. No congenital abnormalities were found. The authors concluded that because current pharmacologic treatments for nausea in early pregnancy are not consistent, efficacious or without un-wanted side effects or increased teratogenic risks, acustimulation of P-6 in pregnancy may prove to be a significant therapeutic alternative to current pharmacologic treatments for nausea in early pregnancy.
The American College of Obstetrics and Gynecology (ACOG, 2004) recommend a step-wise approach to alleviating NV in pregnancy, beginning with prevention at the time of conception. Two studies found that women who take a multi-vitamin at the time of conception were less likely to need medical attention for vomiting. While there is little published evidence regarding the efficacy of dietary changes for prevention or treatment of NV of pregnancy, a small study showed that protein meals were more likely to relieve NV of pregnancy than carbohydrate and fatty meals. Other conservative treatments recommended by ACOG included ginger capsules and electrical stimulation or acupressure at the P6 (or Neguian) point on the inside of the wrist. Women with more complicated NV of pregnancy may need pharmacologic therapy. While many conventional antiemetics have been used for NV of pregnancy, it is important to note that no drug has been approved by the FDA for the treatment of NV in pregnancy since Benedictine (an antiemetic no longer available in the U.S. but still widely used in Europe).
In the largest controlled clinical study of the Relief Band for motion sickness published to date (n = 77), Miller and Muth (2004) examined whether acupressure and acustimulation can prevent motion sickness, taking into consideration whether or not the acupressure and acustimulation are administered properly. These investigators found that neither band (the Acuband or the ReliefBand) nor placebo prevented the development of motion sickness, regardless of whether the bands were used correctly or incorrectly.
Zheng et al (2014) noted that the latest meta-analysis demonstrated that acupuncture improves pregnancy rates among women undergoing in-vitro fertilization-embryo transfer (IVF-ET), and surface acupoint stimulation, such as transcutaneous electrical acupoint stimulation (TEAS), may have the same or better potential. To explore the effect of TEAS on the clinical pregnancy rate (CPR) and live-birth rate (LBR) compared with real acupuncture and controls in women undergoing IVF, a multi-center, randomized controlled trial will be conducted. The inclusion criteria are the following: infertile women less than 40 years of age undergoing a fresh IVF or intra-cytoplasmic sperm injection cycle, and the study will be restricted to women with the potential for a lower success rate as defined by 2 or more previous unsuccessful ETs (fresh or frozen). Those who have severe illnesses possibly precluding IVF or pregnancy, have FSH levels greater than 20 IU/L, received donor eggs, had been previously randomized for this study or had undergone acupuncture (in any modality) as infertility treatment will be excluded. The subjects will be randomly assigned to the TEAS group (IVF + TEAS), the electro-acupuncture (EA) group (IVF + EA), or the control group (only IVF). A total sample size of 2,220 women is needed to detect differences in CPR among the 3 groups. Transcutaneous electrical acupoint stimulation or EA treatments will start once every 2 or 3 days from day 3 of menstruation in the ovarian stimulation cycle until the day of ET. The parameters of TEAS or EA will be the following: a frequency of 2/100 Hz, a moderate electrical current of 3 to 5 mA for TEAS and 0.8 to 1.0 mA for EA. The primary outcome is CPR; secondary outcomes are LBR, the number of oocytes aspirated and the total gonadotropin dose used in the stimulation cycle. The authors concluded that this study will provide significant evidence for using a new method (TEAS) in IVF.
Zhao et al (2015) evaluated the clinical safety and effectiveness of TEAS for the treatment of muscle spasticity after brain injury. A total of 60 patients with muscle spasticity after brain injury were randomized to the following 3 groups: 100, 2, and 0 Hz (sham) TEAS. The acupoints Hegu (LI4) -- Yuji (LU10) and Zusanli (ST36) -- Chengshan (BL57) on the injured side were stimulated at 0, 2, or 100 Hz; 5 times per week for 4 weeks. Patients were followed-up for 1 and 2 months after the treatments. The effects of the treatments on muscle spasticity at the wrist, thumb, the other 4 fingers, elbow, shoulder, knee, and ankle were evaluated by the Modified Ashworth Scale, and the effects on disability were assessed by the Disability Assessment Scale. The walking capability was evaluated by the Holden functional ambulation classification score. The overall performance was assessed by the Global Assessment Scale score and the improved Barthel Index. The safety of the treatments administered was also monitored. The wrist spasticity was significantly reduced from baseline at weeks 2, 3, and 4 of treatment and at the 1- and 2-month follow-up visits in the 100 Hz group (p < 0.01). Compared with 2 Hz or sham TEAS, 100 Hz TEAS decreased wrist spasticity at weeks 2, 3, and 4 of treatment and 1 month after treatment (p < 0.001). The other end-points were not affected by the treatments. No treatment-emergent adverse events (AEs) were reported during treatments and follow-up visits. The authors concluded that TEAS appears to be a safe and effective therapy to relieve muscle spasticity after brain injury, although large-scale studies are needed to further verify the findings.
Transdermal Neuromodulation
Transdermal neuromodulation is a variation of transcutaneous electrical acupoint stimulation. It is proposed as treatment for chemotherapy-induced nausea and vomiting. An example of a device used for this treatment is the Nomete, a watch-like device that generates a programmed pulse to stimulate the median nerve on the underside of the wrist
Auricular Electrostimulation
Auricular electrostimulation (also referred to as auricular electroacupuncture or pulsed stimulation) is the application of electrical impulses/stimulation to acupuncture points on the ear. It is theorized that stimulation of the corresponding acupuncture points will relieve pain in various locations in the body. Examples of this type of device include, but may not be limited to, the P-Stim and NIPP device which are disposable, pre-programmed units worn behind the ear and connected to acupuncture needles.
Treatment of Chronic Obstructive Pulmonary Disease
- the acu-TENS group (n = 25), who underwent acu-TENS over acupoints of bilateral EX-B-1(Dingchuan), BL-13 (Feishu), BL-23 (Shenshu), ST-36 (Zusanli), and
- the placebo acu-TENS control group (n = 25), who had the same electrode placement but no electrical output.
Treatments were performed for 40-min sessions every 2 days for 4 weeks. Lung function (forced expiratory volume in 1 second, percentage predicted (FEV(1)% predicted); forced vital capacity, percentage predicted (FVC% predicted), 6-minute walk distance (6MWD) and oxygen saturation (SpO(2)), COPD assessment test (CAT), and Dyspnea Visual Analogue Scale (DVAS) were assessed before and after the intervention. Compared to control group, FEV(1)% predicted was improved and CAT score was decreased significantly in the acu-TENS group after treatment (p < 0.05). The DVAS score decreased significantly in the acu-TENS group (p = 0.039), with a slight but insignificant improve in 6MWD, SpO(2), and FVC% predicted after treatment. The authors concluded that the Acu-TENS over acupoints of bilateral EX-B-1 (Dingchuan), BL-13 (Feishu), BL-23 (Shenshu), and ST-36 (Zusanli) improved FEV(1)% predicted and reduced DVAS and CAT scores on patients with stable COPD. They stated that this may be a novel treatment strategy in COPD.
Treatment of Post-Operative Immune Dysfunction in Individuals with Lung Cancer
Wu and colleagues (2016) noted that an imbalance in the various T lymphocytes, including T-helper (Th)1, Th2 and Th17 cells, and regulatory T (Treg) cells, has been associated with immune dysfunction, and may occur following thoracotomy of patients with lung cancer. The use of transcutaneous acupoint electrical stimulation (TAES) has previously been demonstrated to exert immune-regulatory effects; therefore, the present study aimed to examine if TAES was able to attenuate post-operative immune suppression in patients with lung cancer. Thoracic surgical patients with lung cancer (n = 27) underwent TAES (frequency, 2/100 Hz; intensity, 4 to 12 mA) at the bilateral large intestine 4, pericardium 6, small intestine 3 and San Jiao 6 acupuncture points for 30 mins, prior to incision, and at 20, 44, 68, 92 and 116 hrs following thoracotomy. The number of Th1, Th2, Th17 and Treg cells, and the protein and mRNA expression levels of related cytokines were measured by flow cytometry, ELISA and polymerase chain reaction, respectively. The balance of Th1, Th2, Th17 and Treg cells in the peripheral blood of patients with lung cancer was disrupted following thoracotomy; TAES administration increased the percentage of Th1 and Th17 cells, the protein expression levels of interleukin (IL)-2 and interferon-γ, the mRNA expression levels of T-bet and RAR-related orphan receptor-γt, and decreased the percentage of Th2 cells, IL-10 protein expression levels, and GATA binding protein 3 mRNA expression levels. The results of the present study demonstrated that TAES was able to partially attenuate the post-operative immune depression of patients with lung cancer, by regulating the balance of Th1, Th2, Th17 and Treg cells, and the expression levels of related cytokines and transcription factors; therefore, TAES may be considered to be a promising strategy for treating post-operative immune dysfunction in patients with lung cancer.
Hu and colleagues (2017) examined the effect of percutaneous electrical stimulation on chemotherapy-induced bone marrow suppression in patients with lung cancer. From December 2014 to August 2015, a total of 191 non-small cell lung cancer (NSCLC) patients with chemotherapy naive were randomly divided into control group, medication group, and TEAS group. Patients with the control group received routine nursing care, the medication group was treated by oral administration of prophylactic agents, and TEAS group received electrical stimulation of acupoints including Dazhui (DU14), Geshu (BL17), Zusanli (ST36), Sanyinjiao (SP6), and Hegu (LI4). The primary end-point was the blood routine indexes and secondary end-point was the degree of comfort. The white blood cell in the TEAS group was significantly higher than the control group on day 8 and day 14 (p < 0.05). The platelet count in the TEAS group was significantly higher than control group on day 5, day 8 and day 11 (p < 0.05). The comfort score in the TEAS group was significantly higher than control group on day 8 (p < 0.05). The authors concluded that TEAS could prevent chemotherapy-induced bone marrow suppression in patients with NSCLC and ensure a smooth continuation of chemotherapy. Moreover, they stated that a larger, multi-center study is needed to confirm the effects of TEAS.
Treatment of Tinnitus
- electrical stimulation at auricular acupoints (CO10, CO11, CO12, and TF4) innervated by the ABVN;
- electrical stimulation at auricular acupoints (CO10, CO11, CO12, and TF4) innervated by ABVN pairing tones;
- electrical stimulation at auricular acupoints innervated by non-ABVN pairing tones; and
- electrical acupuncture.
Patients will be treated for 30 minutes every other day for 8 weeks. The primary outcome measure is the Tinnitus Handicap Inventory. The secondary outcome measure combines a visual analog scale (VAS) to measure tinnitus disturbance and loudness with the Hospital Anxiety and Depression Scale. Assessment is planned at baseline (before treatment) and in the 4th and 8th week, with further follow-up visits after termination of the treatment at the 12th week. Any adverse events will be promptly documented. The authors stated that completion of this trial will help to confirm whether ABVN or the combination of ABVN and sound stimulus plays a more important role in treating tinnitus. Moreover, the result of this clinical trial will enhance our understanding of specific auricular acupoints.
Hemodialysis-Associated Fatigue
- TEAS (n = 28) and
- TEAS-Sham (n = 28).
Data were gathered through the Brief Fatigue Inventory (BFI), entered into SPSS-16 software and analyzed by descriptive and inferential statistics. Out of 56, 38 patients (67.9 %) were men and 45 (80.4 %) were married. The mean and standard deviation (SD) of age were 52.29 ± 15.26 years. The inferential tests showed no differences in the clinical and the demographic characteristics of patients among 2 groups (p > 0.05). The mean rank of fatigue score in TEAS and TEAS-Sham groups was 30.68 and 26.32, respectively (p = 0.317) at the first of study. The results of the Mann-Whitney U-test indicated that there were significant differences between the TEAS and Sham groups after intervention (p = 0.002). The authors concluded that these findings revealed that application of the TEAS on these acupoints produced a better recovery rate of fatigue in TEAS group than Sham group after a course of 10 session intervention. Furthermore, they stated that additional studies are needed to consolidate a standardized method and maximize the effectiveness of TEAS. They noted that future research should include the identification of the most effective acupoints and the mechanism behind it. In addition, other variables such as optimal electrode size, electrical power and frequency, waveform, stimulation duration should be examined.
This study had 2 major drawbacks:
- Although, the results showed that the effects of TEAS on the improvement of fatigue in hemodialysis patients, the sample was drawn from 2 dialysis centers in Ahvaz, southwest of Iran. Generalizability of these findings to other samples of dialysis patients from other geographical areas in Iran cannot be ensured,
- non-registry in Iranian Registry of Clinical Trials (IRCT), because this project was conducted in 2009, and in that time, the registration was optional for the universities, so, this research has not been enrolled in the IRCT.
Post-Hemorrhoidectomy-Associated Pain and Anxiety
In a randomized-controlled trial (RCT) with 5 repeated measures, Yeh and colleagues (2018) examined the effects of TAES intervention on post-operative pain, anxiety, and heart rate variability (HRV) in patients who received a hemorrhoidectomy. The TAES group (n = 39) received 4 20-min sessions of electrical stimulation at chengshan (BL57) and erbai (EX-UE2) after hemorrhoidectomy, whereas the control group (n = 41) did not. Data were collected using VAS, State Anxiety Inventory (STAI), and HRV physiological signal monitor; TAES resulted in a significant group difference in pain scores, anxiety levels, and some HRV parameters. The authors concluded that these findings indicated that TAES could aid in reducing pain and anxiety associated with hemorrhoidectomy. The main drawback of this study was its relatively small sample size (n = 39 for the TAES group).
Furthermore, an UpToDate review on “Surgical treatment of hemorrhoidal disease” (Rivadeneira and Steele, 2017) does not mention transcutaneous electrical acupoint stimulation as a management tool.
Improvement of Motor Functions and Self-Care Ability in Children with Cerebral Palsy
In a preliminary, prospective, cohort, multi-center study, Zhang and colleagues (2018) examined the effects of TEAS in improving motor functions and self-care abilities in children with cerebral palsy (CP) in their early childhood (aged 2 to 6 years). A total of 23 children were included in the study and randomly assigned to a control group ([CG] n = 11) or a therapeutic group ([TG] n = 12). In the TG, children were treated with TEAS (Shousanli [LI10] and Waiguan [SJ5]) plus the exercise therapy, while in the control group, they were treated with sham TEAS plus exercise therapy. Therapies were performed 5 days per week for 8 weeks. The Gross Motor Function Measure (GMFM) and the Functional Independent Measurement for children (WeeFIM) were used to evaluate motor functions and self-care abilities before and after the therapies. Greater improvements were observed in the TG concerning all the measurements, although without statistical differences. The increments of the GMFM score and the WeeFIM motor, self-care and total scores were 36.08 ± 18.34 (26 %), 16.17 ± 8.21 (33 %), 7.67 ± 3.42 (40 %) and 20.33 ± 10.08 (28 %) in the TG, while 22.73 ± 16.54 (17 %), 9.09 ± 9.43 (19 %), 5.64 ± 6.73 (29 %) and 12.82 ± 11.77 (18 %) in the CG, respectively. No statistically significant correlations were shown between functional improvements and the demographics in the TG or the CG. The GMFM improvement was not statistically correlated with the improvements of the WeeFIM motor, self-care or total scores. However, the WeeFIM motor, self-care and total score were significantly positively correlated with one another in both groups (p < 0.01). No adverse effect was recorded during the study. The authors concluded that TEAS may be effective in improving motor functions and self-care abilities in children with CP, in addition to conventional exercise therapy. These researchers stated that larger samples are needed to confirm the efficacy of TEAS in improving motor functions and self-care abilities in children with CP.
Reduction of Incidence and Severity of Etomidate-Induced Myoclonus
Lv and colleagues (2018) stated that myoclonus is an undesirable phenomenon that occurs after induction of general anesthesia using etomidate. Opioids such as sufentanil are considered effective pre-treatment drugs for myoclonus inhibition, although high doses are needed; TAES exhibits analgesic effects, promotes anesthetic effects, decreases the dose of anesthetic drugs, and increases endogenous opioid peptide levels. In a double-blind RCT, these investigators examined the effects of TAES combined with low-dose sufentanil pre-treatment on the incidence and severity of etomidate-induced myoclonus in patients undergoing elective hysteroscopy. A total of 172 patients (American Society of Anesthesiologists [ASA] class I to II; age of 20 to 55 years) scheduled to undergo elective hysteroscopy were randomized into the following groups (n = 43 each): control (false TAES followed by saline injection after 30 mins), TAES (TAES followed by saline injection after 30 mins), sufentanil [false TAES followed by low-dose sufentanil (0.1 μg/kg) injection after 30 mins], and sufentanil plus TAES (TAES followed by low-dose sufentanil injection after 30 mins). In all groups, general anesthesia was induced by etomidate 0.3 mg/kg after sufentanil or saline injection. The incidence and severity of myoclonus were assessed for 2 mins after etomidate administration. The VAS scores for pain at 1 hour after surgery were recorded. The HR, mean arterial pressure (MAP), and peripheral capillary oxygen saturation (SPO2) were recorded before pre-medication, after etomidate injection, after uterus expansion, and after recovery from anesthesia. The incidence of myoclonus was highest in the control group (88.3 %), followed by TAES (74.4 %), sufentanil (60.4 %), and TAES plus sufentanil (48.8 %) groups. Thus, the incidence was significantly higher in the control and TAES groups than in the sufentanil and TAES plus sufentanil groups. Grade 3 myoclonus occurred in 30.2 %, 9.3 %, 11.6 %, and 9.3 % patients in the control, TAES, sufentanil, and TAES plus sufentanil groups, respectively, with significant differences between the control group and the other 3 groups. Furthermore, the post-operative VAS scores for pain were significantly lower in the TAES, sufentanil, and TAES plus sufentanil groups compared with those in the control group. There were no significant differences in any other parameters among groups. The authors concluded that these findings suggested that TAES combined with low-dose opioids such as sufentanil could decrease the incidence and severity of etomidate-induced myoclonus. The effectiveness of TAES alone for lowering the incidence and severity of etomidate-induced myoclonus needs to be further investigated in well-designed studies.
The authors stated that this study had several drawbacks. The first and the most important one was that all patients were women of child-bearing age. According to previous studies, male patients were more likely to develop myoclonus than female patients, with children aged 5 to 10 years comprising the most susceptible population (90.2 %). Second, only the incidence and severity of myoclonus was assessed in the present study, and the durations of myoclonic movements were not recorded. Third, because propofol and remifentanil were required to maintain comfortable anesthesia until 3 mins before the completion of surgery, the precise effects of TAES plus sufentanil on short-term recovery could not be assessed. These researchers stated that further studies are needed to address these drawbacks.
Treatment of Autism
Zhang and colleagues (2017) examined the efficacy of TEAS in treating children with autism spectrum disorders (ASD). A total of 41 autistic children receiving rehabilitation training were randomized into TEAS (n = 21) and control (n = 20) groups. The control group only received rehabilitation training; the TEAS group received both rehabilitation training and TEAS treatment [2 Hz/15 Hz alternating frequencies through 2 pairs of skin electrodes placed at Hegu (LI 4)-Neiguan (PC 6) on unilateral side, and Zusanli (ST 36)-Sanyinjiao (SP 6) on the contralateral side]. The treatment was given 30 mins per day for 12 weeks. The outcome assessment was quantified with a series of rating scales including Autism Behavior Checklist (ABC), Childhood Autism Rating Scale (CARS) and Parent Symptom Questionnaire (PSQ). The TEAS group showed more significant improvement than the control group in ABC (p < 0.01); 38.1 % effective rate (8/21) was observed in the TEAS group compared to 5.0 % (1/20) in the control group (p < 0.05). The CARS scores of both groups were reduced (p < 0.0001) after treatment. The TEAS group showed significantly lower score compared to the control group (p < 0.0001). There was a reduced PSQ score in both TEAS and control groups (p < 0.001) after treatment. Transcutaneous electrical acupoint stimulation showed better effect in children under age of 6 years with moderate or severe autistic symptoms. The authors concluded that TEAS intervention could improve autistic symptoms. These preliminary findings need to be validated by well-designed studies with larger sample size and long-term follow-up.
Treatment of Chronic Fatigue Syndrome
In a RCT, Li and colleagues (2017a) evaluated the clinical therapeutic effects and safety of chronic fatigue syndrome (CFS) treated with TEAS on the conception vessel and the governor vessel. A total of 89 patients with CFS were randomized into an observation group (46 cases) and a control group (43 cases). In the observation group, TEAS was applied at Dazhui (GV 14) and Mingmen (GV 4), Shenque (CV 8) and Guanyuan (CV 4) [the current intensity: (14 ± 2) mA]. In the control group, the simulated TEAS was applied at the same acupoints as the observation group (the current intensity: 1 mA). The treatment was given for 30 mins, once-daily, 5 times a week and the treatment of 4 weeks was as 1 session in the 2 groups. One session of treatment was required. Before treatment and at the end of 1 session of treatment, the fatigue severity scale (FSS) was adopted to evaluate the fatigue symptoms and the somatic and psychological health report (SPHERE) was adopted to evaluate the potential symptoms and observe the safety of TEAS therapy. At the end of treatment, FSS score and SPHERE score in the control group were not significantly different as compared with those before treatment (both p > 0.05); FSS score and SPHERE score in the observation group were reduced significantly as compared with those before treatment (both p < 0.01); FSS score and SPHERE score in the observation group were reduced apparently as compared with those in the control group (both p < 0.001). In the entire process of treatment with TEAS, no any adverse reaction occurred. The authors concluded that TEAS on the conception vessel and the governor vessel relieved fatigue symptoms and the potential symptoms in the patients with CFS; they noted that TEAS is a safe therapy. These preliminary findings need to be validated by well-designed studies with larger sample size and long-term follow-up.
Treatment of Male Infertility
Li and co-workers (2017b) examined the feasibility, safety and clinical effect of mid-frequency TEAS combined with oral tamoxifen (TAM) in the treatment of oligoasthenozoospermia. These researchers randomly assigned 120 patients with idiopathic oligoasthenozoospermia to receive oral TAM, mid-frequency TEAS, or TAM+TEAS, all 8 weeks. Before and after treatment, these investigators recorded the semen volume, total sperm count, sperm concentration, sperm motility, percentage of progressively motile sperm (PMS), and the levels of follicle-stimulating hormone (FSH), luteotrophic hormone (LH) and testosterone (T) in the peripheral serum and compared these parameters among the 3 groups of patients. Compared with the baseline, none of the patients showed significant improvement in the semen volume (p > 0.05); but all exhibited remarkably elevated levels of serum FSH, LH and T after treatment (p < 0.05); TAM significantly improved the total sperm count (25.16 ± 2.05 versus 42.65 ± 5.78 ×106, p < 0.05) and sperm concentration (12.15 ± 2.51 versus 24.31 ± 2.59 ×10⁶/ml, p < 0.05), but not total sperm motility (21.78 ± 8.81 versus 22.61 ± 5.75 %, p > 0.05) or PMS (15.87 ± 7.81 versus 16.76 ± 5.86 %, p > 0.05); TEAS markedly increased total sperm motility (24.81 ± 8.27 versus 32.43 ± 4.97 %, p < 0.05) and PMS (19.71 ± 9.15 versus 27.17 ± 5.09 %, p < 0.05), but not the total sperm count (23.23 ± 3.14 versus 25.87 ± 4.96 x 106, p > 0.05) or sperm concentration (11.27 ± 2.24 versus 14.12 ± 2.47 ×10⁶/ml, p > 0.05); TAM+TEAS, however, improved not only the total sperm count (26.17 ± 5.05 versus 51.14 ± 3.69 ×106, p < 0.05) and sperm concentration (12.78 ± 2.41 versus 27.28 ± 1.98 ×10⁶/ml, p < 0.05), but also total sperm motility (23.89 ± 9.05 versus 37.12 ± 5.33 %, p < 0.05) and PMS (17.14 ± 8.04 versus 31.09 ± 7.12 %, p < 0.05). The total effectiveness rate was significantly higher in the TAM+TEAS group than in the TAM and TEAS groups (97.5 % versus 72.5 % and 75.0 %, p < 0.05). The authors concluded that mid-frequency TEAS combined with tamoxifen can significantly improve semen quality and increase sex hormone levels in patients with idiopathic oligoasthenozoospermia. The effectiveness of TEAS alone for the treatment of oligoasthenozoospermia needs to be further investigated in well-designed studies.
Furthermore, an UpToDate review on “Treatments for male infertility” (Anawalt and Page, 2018) does not mention transcutaneous acupoint electrical stimulation as a therapeutic option.
Transcutaneous Electrical Acupoint Stimulation for Modulation of Autonomic Balance in Heart Transplant Recipients
Moreira and colleagues (2019) stated that the increased resting heart rate (HR) in heart transplant recipients is associated with enhanced metabolic demand, the potential for fatigue, and lower quality of life (QOL). In a pilot study, these investigators hypothesized that TEAS could modulate autonomic balance and reduce resting HR in these patients. They carried out a single-arm clinical trial with patients aged greater than 18 years, at ambulatorial accompaniment following heart transplantation. Participants were submitted to a single TEAS (40 mins at PC5 and PC6 acupoints). The arterial blood pressure (BP) and RR interval were recorded from 20 minus before to 20 mins after TEAS. The RR intervals were used to calculate heart rate variability (HRV) and sympatho-vagal index. Linear mixed models were used for comparing variables before, during and after TEAS. The significance level was set as p < 0.05. TEAS acutely improved HRV in transplant recipients and enhanced the sympatho-vagal index during its application. Significant increases in systolic BP, diastolic BP and mean arterial pressure (MAP), were observed at recovery, such as a slight, but significant, decrease in HR. The authors concluded that TEAS on PC5 and PC6 acupoints acutely improved sympatho-vagal balance, reduced HR, and improved BP in heart transplantation recipients. Moreover, these researchers stated that further RCTs, with larger sample sizes, and chronic TEAS treatment trials are needed to confirm these effects.
The authors stated that this study had several drawbacks: no control group that had not received an heart transplantation was used; there was an important heterogeneity in time since surgery among the recruited participants although it had been adjusted for in the statistical analysis; and the sample size was low.
Transcutaneous Electrical Acupoint Stimulation for Prevention of Nausea and Vomiting After Breast Surgery
Sun and colleagues 92019) stated that breast disease has been a global serious health problem, among women. Surgery is the main treatment for the patients suffering from breast disease. Post-operative nausea and vomiting (PONV) are still disturbing. Acupoint stimulation has been used to reduce post-operative nausea and vomiting. Recently, non-needle acupoint stimulation becomes a new intervention. Although several clinical trials have been carried out, there is still no final conclusion on the efficacy. In a meta-analysis, these researchers examined the efficacy of non-needle acupoint stimulation for prevention of nausea and vomiting after breast surgery. Systematic searches were conducted in PubMed, Embase, Cochrane, and Wanfang Med Online databases for studies. The review period covered from the inception of databases to December 31, 2017. The outcome measures of interest were frequency of nausea, frequency of vomiting, frequency of PONV, verbal rating scale of nausea, and use of rescue anti-emetic. Data extraction and risks of bias evaluation were accomplished by 2 independent reviewers using the Cochrane Collaboration Review Manager software (RevMan 5.3.5). A total of 14 RCTs with 1,009 female subjects in the non-needle acupoint stimulation group and control group met the inclusion criteria. Although the therapeutically effect on vomiting within post-operative 2 hours was not obvious, non-needle acupoint stimulation still had an important role in reducing nausea and vomiting within post-operative 48 hours. According to Jadad scale, there was moderate quality evidence for the pooled analysis results in this study. Furthermore, stimulating acupoint by wristband acupressure was more likely to cause adverse reactions. The authors concluded that non-needle acupoint stimulation can be used for female patients undergoing breast surgery to reduce PONV. These researchers recommended transcutaneous acupoint electrical stimulation on PC6 from 30 mins before induction of anesthesia to the end of surgery for application; they stated that this non-pharmaceutical approach may be a promising approach to promote the recovery of patients after breast surgery. Moreover, these researchers stated that the comparison among various methods and different stimulating acupoints will be a meaningful topic for future studies; and although the quantity of Chinese studies regarding acupoint stimulation mounted up, more well-designed studies are needed.
The authors stated that the main methodological limitations of these included studies were the lack of description of allocation concealment, blinding of participants, and outcome assessors; which were due to the characteristic of non-needle acupoint stimulation. Due to the different publication standard, risk of bias in English trials was lower than that in Chinese trials. In addition, the inclusion criteria of patients in different studies was inconsistent, especially in age, history of nausea and vomiting, type of breast disease and surgery, the duration of surgery and use of anesthetic drug. These investigators stated that further studies with more consistent measurements and more standard data records would aid in confirming the final conclusion.
Transcutaneous Electrical Acupoint Stimulation for Treatment of Pain After Total Knee Arthroplasty
Li and colleagues (2019) noted that total knee arthroplasty (TKA) is an optimal option for patients with middle-to-end-stage knee osteoarthritis (OA). However, the management of post-operative acute pain remains inefficient; TEAS is a non-pharmacological method to manage post-operative acute pain. Different frequencies of TEAS have been tested using varying parameters, but the optimal analgesic frequency remains controversial. These researchers described the protocol of a parallel-group, randomized trial that will examine the optimal analgesic frequency of TEAS for treating acute pain after the primary unilateral TKA. This is a double-blind, RCT. A total of 156 participants will be randomly assigned to: Group 1, 5-Hz TEAS; Group 2, 10-Hz TEAS; Group 3, mixed TEAS (alternative use of daily 5-Hz and 100-Hz TEAS) and Group 4, placebo TEAS. In the G1, G2 and G3 groups, TEAS will be conducted at acupoints SP9 and GB34 of the leg that was operated on (at a wave of continuous, balanced and asymmetrical biphasic square, with a pulse width of 200 μs, and a strong but comfortable current) for 30 mins prior to a 30-minutes rehabilitation session per day for 2 weeks. In the G4 group, TEAS will be delivered at a strong but comfortable current for 30 seconds, then the current will be gradually decreased to none over the next 15 seconds. The primary outcomes are measured before surgery, at baseline (post-operative day [POD] 3, before TEAS intervention), week 1 and 2 after TEAS intervention with the Numeric Pain Rating Scale and the American Knee Society Score. The secondary outcomes will include active range of motion (ROM) of the knee that was operated on; surface electromyography (sEMG) of both quadriceps; modified 30-second sit to stand test; additional usage of analgesia; and SF-36. The additional outcomes will include patients' satisfaction rate; patient's expectation rate; and incidence of analgesia-related side effects. To test the blinding of participants and assessors, they will be asked to guess whether the subjects received active or placebo TEAS within 5 minutes after the latest intervention. The safety and financial cost of TEAS are assessed. The authors hypothesized that the mixed use of TEAS at different frequencies () can improve post-operative acute pain, the muscle performance and knee function.
Zhang et al (2024) noted that rehabilitation following TKA has become an indispensable part of the treatment strategy for degenerative joint disease. Despite some current research reporting effectiveness of TEAS for post-TKA rehabilitation, the evidence is not conclusive. In a systematic review and meta-analysis, these investigators examined the available evidence supporting TEAS for rehabilitation following TKA. They search the PubMed, Embase, The Cochrane Library, Chinese National Knowledge Infrastructure, Chinese Biomedical Literature Database, Wanfang, and Chinese Scientific Journal Data databases for relevant studies published up to October 16, 2023. Main indicators included VAS and functional scores; secondary indicators included ROM, interleukin-6 (IL-6) and C-reactive protein (CRP) levels, and analgesia-related AEs. Risk of bias was evaluated using the Cochrane Tool, and meta-analysis was carried out using Review Manager version 5.4. A total of 20 RCTs with 1,295 subjects were included; TEAS improved several outcomes compared to control groups. The TEAS group had significantly greater pain reduction at post-operative 6 hours, 12 hours, 24 ours, 48 hours, 72 hours, 7 days, and 14 days. Moreover, TEAS significantly improved the Hospital for Special Surgery Knee Score, Knee Society Score (KSS), and ROM. Patients who underwent TEAS exhibited a lower incidence of analgesia-related AEs, and lower IL-6 and CRP levels. The authors concluded that available evidence indicated that the use of TEAS in patients undergoing TKA is related to post-operative pain alleviation, functional improvement, and fewer AEs associated with analgesia. Moreover, these researchers stated that high-quality, large-sample, multi-center RCTs are needed to draw firmer conclusions.
The authors stated that this study had several drawbacks. First, the results of long-term follow-up are not known because the observation time-point in the included trials was mostly less than 28 days post-operative. Second, the acupuncture points, intervention time, and electrical stimulation parameters were inconsistent, which could have resulted in a high degree of heterogeneity and affected the results. Third, some of the studies had a small sample size and were of low quality, which had a negative impact on the strength of the evidence supporting the research findings.
Transcutaneous Electrical Acupoint Stimulation for Treatment of Hypertension
Tian and colleagues (2020) noted that hypertension is a major pathogenic factor of cardiovascular diseases. Insufficient BP control rate and sub-optimal medication adherence remain challenges for effective management of hypertension. Transcutaneous electrical acupoint stimulation has been used to treat various diseases, including hypertension, but the scientific evidence for its benefit remains insufficient. In a randomized, controlled pilot study, these researchers will examine the effects of TEAS in patients with stage-1 (systolic BP [SBP] of 140 to 159 mmHg or diastolic BP [DBP] of 90 to 99 mmHg).. Hypertension. The study will be a 2-arm parallel RCT; a total of 60 patients with stage-1 hypertension will be randomly assigned to the TEAS group and the control group in a 1:1 ratio. Subjects in the TEAS group will receive non-invasive acupoint electrical stimulation for 30 mins at 4 acupoints in the upper and lower extremities at home, 4 times weekly for 12 weeks for a total of 48 sessions. Subjects in the control group will not receive any form of acupoint stimulation. All subjects in both groups will receive lifestyle education on how to control high BP, including diet, weight control, and exercise. The primary outcome measure will be the change of the mean SBP from baseline to 12 weeks. Secondary outcomes include the change of mean DBP, QOL, body mass index (BMI), and physical activity level. The authors stated that this pilot RCT will examine the feasibility of TEAS. It will also provide potential clinical evidence for the safety and efficacy 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 RCT will inform the sample size of the subsequent trial.
Transcutaneous Electrical Acupoint Stimulation for Treatment of Post-Traumatic Stress Disorder
Feng and colleagues (2019) stated that TEAS has the potential to alleviate post-traumatic stress disorder (PTSD). In a RCT, these researchers examined if adding TEAS to sertraline or cognitive behavioral therapy (CBT) could improve the anti-PTSD efficacy. A total of 240 PTSD patients (60 in each group) were assigned to receive simulated TEAS combined with sertraline (group A) or with CBT (group B), active TEAS combined with CBT (group C), or active TEAS combined with CBT plus sertraline (group D) for 12 weeks. The outcomes were measured using the Clinician-Administered PTSD Scale, PTSD Check List-Civilian Version, and 17-item Hamilton Rating Scale for Depression. While PTSD symptoms reduced over time in all patients, groups C and D had markedly greater improvement in both PTSD and depressive measures than groups A and B in all post-baseline measurement points, with moderate-to-very large effect sizes of 0.484 to 2.244. Groups C and D also had a significantly higher rate than groups A and B on clinical response (85.0 % and 95.0 % versus 63.3 % and 60.0 %, p < 0.001) and on remission (15.0 % and 25.0 % versus 3.3 % and 1.7 %, p < 0.001). The incidence of AEs was similar between groups A and D and between groups B and C. The authors concluded that additional of TEAS augmented the anti-PTSD and anti-depressant efficacy of anti-depressants or CBT, without increasing the incidence of adverse effects. These researchers stated that TEAS could serve as an effective intervention for PTSD and co-morbid depression. The augmenting effects of TEAS may be associated with its broad modulation of multiple neurobiological systems and its reinforcement of CBT improvement in impaired sensorimotor gating.
The authors stated that this study had several drawbacks. First, these researchers did not set a group treated with simulated TEAS combined with sertraline and CBT. One pilot study, however, showed minimal benefit obtained from sertraline added to trauma‐focused CBT (TF‐CBT) in children with PTSD symptoms. Second, the average dose taken (approximately 96 mg/day) and maximum dose (100 mg/day) in this study were much lower than those previously reported, with an average dose 153 mg/day and maximum dose 200 mg/day for the treatment of PTSD. This may represent an ethnic difference in tolerability to this drug, largely due to variations in cytochrome P450 enzymes. Third, the sampling frame was mainly restricted to adults recruited from local Chinese communities that may have distinctive perceptions of acupuncture therapy. Whether TEAS treatment outcomes are related to patient expectation and whether similar treatment outcomes could be achieved in PTSD children and adolescents needs further investigation. Finally, this study did not conduct follow‐up measurements and did not examine the effects of TEAS in treatment‐resistant PTSD, which is often observed in CBT and pharmacotherapy. Whether TEAS could serve as a long‐term maintenance therapy and benefit refractory PTSD deserves further investigation.
Furthermore, UpToDate reviews on “Approach to treating posttraumatic stress disorder in adults” (Stein, 2020), and “Approach to treating posttraumatic stress disorder in children and adolescents” (Brent et al, 2020) do not mention transcutaneous electrical acupoint stimulation as a management / therapeutic option.
Transcutaneous Electrical Acupoint Stimulation for Improvement of the Quality of Early Recovery in Patients Undergoing Gynecological Laparoscopic Surgery
In a prospective, randomized, placebo-controlled trial, Yu and colleagues (2020) examined the effect of transcutaneous electrical acupoint stimulation (TEAS) on the quality of early recovery in patients undergoing gynecological laparoscopic surgery. A total of 60 patients undergoing gynecological laparoscopic surgery were randomly assigned to TEAS (TEAS group) or control group (Con group). TEAS consisted of 30 mins of stimulation (12 to 15 mA, 2/100 Hz) at the acupoints of Baihui (GV20), Yingtang (EX-HN-3), Zusanli (ST36) and Neiguan (PC6) before anesthesia. The patients in the Con group had the electrodes applied; but received no stimulation. Quality of recovery was evaluated using a 40-item questionnaire as a measure of quality of recovery (QoR-40; maximum score 200) scoring system performed on pre-operative day 1 (T0), post-operative day 1 (T1) and post-operative day 2 (T2); 100-mm VAS scores at rest, mini-mental state examination (MMSE) scores, the incidence of NV, post-operative pain medications, and anti-emetics were also recorded. QoR-40 and MMSE scores of T0 showed no difference between 2 groups (QoR-40: 197.50 ± 2.57 versus 195.83 ± 5.17), (MMSE: 26.83 ± 2.74 versus 27.53 ± 2.88). Compared with the Con group, QoR-40 and MMSE scores of T1 and T2 were higher in the TEAS group (p < 0.05) (QoR-40: T1, 166.07 ± 8.44 versus 175.33 ± 9.66; T2, 187.73 ± 5.47 versus 191.40 ± 5.74), (MMSE: T1, 24.60 ± 2.35 versus 26.10 ± 2.78; T2, 26.53 ± 2.94 versus 27.83 ± 2.73). VAS scores of T1 and T2 were lower (p < 0.05) in the TEAS group (T1, 4.73 ± 1.53 versus 3.70 ± 1.41; T2, 2.30 ± 0.95 versus 1.83 ± 0.88); the incidence of post-operative NV (PONV), remedial anti-emetics and remedial analgesia was lower in the TEAS group (p < 0.05) (PONV: 56.7 % versus 23.3 %; incidence of remedial anti-emetics: 53.3 % versus 23.3 %; incidence of remedial analgesia: 80 % versus 43.3 %). The authors concluded that the use of TEAS significantly promoted the quality of early recovery, improved MMSE scores and reduced the incidence of pain, NV in patients undergoing gynecological laparoscopic surgery. Moreover, these researchers stated that in future studies, different acupoints could be used for different types of surgery on other parts of the body. They also planned to examine the underlying mechanisms of TEAS-mediated therapy to broaden the clinical appeal of the technique.
The authors stated that this study had several drawbacks. First, the sample size of 60 was small and comprised patients classified as American Society of Anesthesiologists (ASA) I and ASA II; a more diverse sample may have provided greater power to detect the effect of TEAS on the quality of early recovery in patients undergoing gynecological laparoscopic surgery. Second, the short study duration only allowed collection of limited data, which led to an under-powered trial. Third, due to economic restrictions these researchers did not plan external monitoring and auditing; therefore, they could not prove that their data really exited or that it was error-free. However, for the sake of transparency, they stated this limitation and published these findings to the best of their understanding. Of course, before considering these results as definitive, they should be reproduced in a new trial with the highest standards for planning, monitoring, auditing and reporting.
Transcutaneous Electrical Acupoint Stimulation for Improvement/Promotion of Post-Operative Sleep Quality and Analgesic Effect Following Video-Assisted Thoracoscopic Surgery
Song et al (2020) noted that post-operative sleep disturbances have serious adverse effects on post-operative outcomes. These researchers examined the effect of TEAS on sleep quality and complications after surgery in patients undergoing selective video-assisted thoracoscopic surgery (VATS). A total of 85 patients were divided into the TEAS group or the control group randomly. Thirty minutes of TEAS treatment was performed on TEAS group at the following time points: the 1st night before surgery, at the end of surgery, and before sleeping on the 2nd and 3rd nights after surgery. The Portable Sleep Monitor (PSM) was used to determine the sleep quality of the 2 nights before the operation (Sleep preop 2 and Sleep preop 1) and the 1st and 3rd night after surgery (Sleep POD 1 and Sleep POD 3). The visual analog scale (VAS) was employed to evaluate pain scores following surgery and the Athens Insomnia Scale (AIS) was used for evaluating subjective sleep quality. Subjects in the TEAS group had a lower AIS score and higher sleep efficiency at each time point except Sleep preop 2. Subjects in the TEAS group showed significantly higher proportion of each sleep stage during Sleep-preop 1, Sleep POD 1, and Sleep POD 3. Patients in the TEAS group had significantly lower VAS scores at 2, 4, and 6 hours during the first 24 hours following surgery. The incidence of NV and dizziness in the control group was statistically higher than in the TEAS group. The authors concluded that patients undergoing VATS experienced marked post-operative sleep disturbances, characterized by higher AIS scores, lower sleep efficiency, and decreased proportions of each sleep phase. The findings of this study showed that TEAS can effectively improve post-operative sleep efficiency and subjective sleep scores, relieve post-operative complications, such as post-operative pain, as well as NV, which may further help to improve post-operative sleep quality and promote the recovery of patients.
The authors stated that this study had several drawbacks. First, these researchers only collected data on sleep quality in the short-term peri-operative period after TEAS. The effect of TEAS on long-term sleep quality after surgery needs further study. Second, although these investigators tried to reduce the confounding factors of post-operative sleep quality such as light, noise or interference due to nursing care in the study, there may be other inevitable factors that may affect post-operative sleep quality. Third, it is necessary to study the effect of TEAS on post-operative sleep quality in large-scale, multi-center studies and other types of surgery under general anesthesia in the future.
Transcutaneous Electrical Acupoint Stimulation for Management of Post-Operative Analgesia in Patients Undergoing Radical Mastectomy
Ao and colleagues (2021) stated that radical mastectomy may lead to suppression of cellular immune function in patients with malignant tumors. These researchers noted that TEAS is widely used in clinical practice; however, there have been relatively few studies on the effects of TEAS on post-operative analgesia and immune function. Ina RCT, these investigators examined the effects of TAES on post-operative pain and immune function in patients undergoing radical mastectomy. A total of 65 patients were enrolled and allocated to either receive TEAS or sham TEAS. TEAS was implemented on bilateral Hegu (LI4), Neiguan (PC6) and Zusanli (ST36) acupoints simultaneously for 30 mins before induction of anesthesia at 4, and 12 hours post-operation. The primary outcomes included VAS scores at 4 hours (T1), 12 hours T2), 24 hours (T3) and 48 hours (T4) post-operation, and serum levels of IL-2, IL-4, IFN-γ and the IL-2/IL-4 ratio at 30 mins before TEAS (T0), T1, T2, T3 and T4. Secondary outcomes included the cumulative time of rescue analgesia within 48 hours post-surgery, as well as the incidence of PONV and pruritus. Compared with the sham TEAS group, post-operative VAS scores at T2 and T3, the total consumption of opioids in the patient-controlled analgesia (PCA) pump, pressing times of the PCA pump and the incidences of PONV and headache were significantly lower in the TEAS group. The serum levels of IFN-γ at T3 and T4, and the serum levels of IL-2 and the IL-2/IL-4 ratio at T2, T3 and T4 were higher in the TEAS group compared with the sham TEAS group. In contrast, the serum levels of IL-4 were lower at T2, T3 and T4 in the TEAS group compared with the sham TEAS group. The authors concluded that the findings of this study indicated that TEAS maintained cellular immune function, alleviated post-operative pain and reduced the occurrence of opioid-related side effects, providing a novel insight for selection of post-operative analgesia. They stated that these findings may have implications for post-operative pain management in patients with cancer regarding immune function and postoperative recovery.
The authors stated that this study had several drawbacks. First, the present trial was a single-center study with a strictly defined participant population; thus, the findings might not be applicable to other centers despite high homogeneity of both groups. Second, although the sham group was treated in the same manner as the TEAS group, other than the stimulation, blinding of TEAS treatment was not possible as patients eventually knew whether they were receiving electrical stimulation. Third, it was not possible for the operators to be blinded to the grouping because the effectiveness of TEAS was determined via the sensation of de qi. Furthermore,, the present study did not detect the influences on long-term sequelae, such as tumor metastasis, recurrence and mortality, which could be associated with peri-operative immunosuppression. Moreover, the relatively small sample size (n = 65) of the present study may have partially affected the outcomes; thus, further studies with larger sample sizes and multi-indicators are needed to evaluate the potential advantages of TEAS.
Transcutaneous Electrical Acupoint Stimulation for Management of Post-Operative Catheter-Related Bladder Discomfort in Patients Undergoing Transurethral Resection of the Prostate
Liang and colleagues (2021) noted that catheter-related bladder discomfort (CRBD) is often reported in patients with transurethral resection of the prostate (TURP), post-operatively. In a prospective, randomized, controlled, double-blind study, these researchers examined the effectiveness of TEAS as a treatment for CRBD in patients undergoing TURP. A total of 70 benign prostatic hyperplasia (BPH) patients undergoing TURP under general anesthesia requiring intra-operative urinary catheterization were enrolled for the trial. An experienced acupuncturist performed TEAS for 30 mins before general anesthesia with acupoints RN7, RN6, RN5, RN4, and RN3 and bilateral BL32, BL33, and BL34. Mean arterial pressure (MAP), heart rate (HR), oxygen saturation (SPO2), body temperature (T), and blood samples were collected during the surgery. A series of assessments included the incidence and severity of CRBD, post-operative pain, NV, and physical and mental state measurements. The incidence of CRBD was significantly lower in TEAS group than in control group at the time T5 [9 (26 %) versus 28 (80 %), p < 0.001], T9 [20 (57 %) versus 28 (80 %), p = 0.039], T11 [7 (20 %) versus 31 (89 %), p < 0.001], and T12 [4 (11 %) versus 7 (20 %), p = 0.003]. The severity of CRBD was significantly lower in TEAS group than in control group at the time T5 [0 versus 10 (29 %), p < 0.001], T9 [2 (6 %) versus 10 (29 %), p = 0.011], and T11 [0 versus 0.9 (26 %), p = 0.002]. The QoR-40 total score was higher in TEAS group at time T11 [191.7 (4.4) versus 189.1 (4.3), p = 0.007] and T12 [195.3 (1.9) versus 193.3 (3.0), p < 0.001]. The post-operative analgesia requirement was higher in control group [5.0 (2.9) versus 3.8 (1.9), p = 0.045]. The authors concluded that the findings of this study suggested that TEAS had the benefits of being non-invasive, the non-pharmacological modality for peri-operative analgesia, and early post-operative recovery and can be implemented in clinical practice.
The authors stated that this trial had several drawbacks. First, this study was a clinical surgical study; thus, surgeons could not be completely unaware of the intervention, but they did not know which patients have received TEAS intervention. However, the anesthesiologist, acupuncturist, and follow-up investigator were completely blinded to the data recording and post-operative assessments. Second, invasive artery puncture may cause vascular damage to patients; however, the whole process was operated by a skilled anesthesiologist and stopped after more than 2 attempts. Despite these drawbacks, these investigators examined the status of surgery in patients using questionnaires on MMSE and QoR40, providing a steady condition for TEAS intervention by the serum biochemical parameters.
Trans-Auricular Electrical Stimulation for the Treatment of Motion Sickness
Molefi et al (2023) noted that perturbations in the autonomic nervous system (ANS) occur in individuals experiencing increasing levels of motion sickness. In a pilot study, these investigators examined the effects of trans-auricular electrical stimulation (tES) on autonomic function during visually-induced motion sickness, via the analysis of spectral and time-frequency heart rate (HR) variability. To determine the effectiveness of tES, these researchers compared sham and tES conditions in a randomized, within-subjects, cross-over design in 14 healthy subjects. They found that tES reduced motion sickness symptoms by significantly increasing normalized high-frequency (HF) power and decreasing both normalized low-frequency (LF) power and the power ratio of LF and HF components (LF/HF ratio). In addition, behavioral data recorded using the motion sickness assessment questionnaire (MSAQ) showed significant differences in decreased symptoms during tES compared to sham condition for the total MSAQ scores and, central and sopite categories of the MSAQ. The authors concluded that these preliminary findings suggested that by administering tES, parasympathetic modulation was increased, and autonomic imbalance induced by motion sickness was restored. These researchers noted that this study provided 1st evidence that tES may have potential as a non-pharmacological neuromodulation tool to keep motion sickness at bay. Therefore, these findings may have implications towards protecting individuals from becoming motion sick and possible accelerated recovery from the malady. Moreover, these researchers emphasized that the autonomic data in this preliminary study were obtained from a very small number of subjects; future large-scale studies are needed to confirm these findings.
The authors stated that this study had several drawbacks. First, the sample size in this pilot study was very small (n = 14); thus, reducing the power for statistical analysis. Second, sham sessions had no active stimulation; hence, indicating that some subjects could distinguish between tES and sham conditions. These investigators acknowledged that subjects were aware of verum (anodal and cathodal) and sham stimulation, which could potentially bias the motion sickness-related changes in this study. Future studies should replicate these findings with different sham conditions that minimize potentially confounding effects of expectations. However, these researchers noted that subject were naive to tES and sham stimulation electrode placement. Third, this study did not include a matching or sufficient number of male subjects. The participant cohort was naive to the nauseogenic stimuli and tES stimulation. Stimulation parameters employed in this study were well-tolerated by all subjects and no unexpected adverse effects were reported. While some subjects prematurely stopped the presentation of nauseogenic stimulus due to a high severe feeling of nausea, no one vomited at the end of stimulus presentation. Further investigation is needed where the findings in this trial are augmented by the assessment of physiological correlates of motion sickness (i.e., neuroendocrine hormones such as arginine vasopressin and norepinephrine). Moreover, the key questions that need to be addressed include: could one identify optimal stimulation parameters to improve effects of tES toward motion sickness reduction, and could increasing stimulation duration improve the effectiveness of tES to ameliorate motion sickness? These researchers stated that future investigations will extend to these questions and will also administer an individually adjusted electrical current intensity.
Transcutaneous Electrical Acupoint Stimulation on Pregnancy Outcomes in Women with In-Vitro Fertilization-Embryo Transfer
In a systematic review and meta-analysis, Zhu et al (2023) examined the safety and effectiveness of TEAS on pregnancy outcomes in women undergoing IVF-ET, in order to provide evidence-based medical support. These investigators searched the Cochrane Library, Embase, PubMed, Web of Science, SinoMed, and CNKI for relevant RCTs from inception to May 31, 2022, using the search terms "transcutaneous electrical acupoint stimulation", "TEAS," "in vitro fertilization-embryo transfer", "IVF-ET", "randomized controlled trial," and "clinical trials". The experimental group was treated with TEAS or combined with ovulation-inducing medication, and the control group was treated with mock TEAS (mTEAS), ovulation-inducing medication, or no intervention. The main outcome was the clinical pregnancy rate. Secondary outcomes were the embryo implantation rate, LBR, biochemical pregnancy rate, and number of oocytes retrieved. Stata15.1 software was used for data summary and analysis. This review involved 15 RCTs and 4,281 participants. TEAS were superior to the control group for improving the clinical pregnancy rate (RR: 1.29, 95 % CI: 1.19 to 1.40; p < 0.001; I2 = 23.0 %), embryo implantation rate (RR: 1.43, 95 % CI: 1.22 to 1.69; p < 0.001; I2 = 35.9 %), LBR (RR: 1.33, 95 % CI: 1.14 to 1.54; p < 0.001; I2 = 47.3 %), and biochemical pregnancy rate (RR: 1.15, 95 % CI: 1.05 to 1.26; p = 0.003; I2 = 49.1%), without significant heterogeneity. TEAS had no statistically significant effect on the number of oocytes retrieved as compared with the control group, and the heterogeneity was high (standardized mean difference [SMD]: 0.34, 95 % CI: -0.04 to 0.72; p = 0.081; I2 = 77.6 %). These investigators carried out subgroup analysis based on the sample size, interventions and intervention time-point. The results showed that the sample size had no effect on the results. There was no significant difference between TEAS and ovulation-inducing medication in the clinical pregnancy rate or the embryo implantation rate. Furthermore, TEAS did not significantly increase the embryo implantation rate or the LBR, compared with no intervention. In terms of safety, mild allergic symptoms were found in both the experimental group and the control group. The authors concluded that existing evidence supports the potential value of TEAS as an adjunctive treatment for improving pregnancy outcomes. Moreover, these researchers stated that high-quality, large-sample RCTs are needed to further support this conclusion.
Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Epilepsy
Zhang et al (2024) noted that several studies have suggested that transcutaneous VNS (tVNS) may be effective for the treatment of epilepsy; however, auricular acupoint therapy (including auricular acupuncture and auricular point-sticking therapy), a method of stimulating the vagus nerve, has been poorly reviewed. In a systematic review, these investigators categorized auricular acupoint therapy as transcutaneous auricular vagus nerve stimulation (taVNS), aiming to examine the effectiveness of taVNS in patients with epilepsy (PWE), and analyzed the results of animal experiments on the anti-epileptic effects of taVNS. They searched Medline, Embase, Web of Science, Scopus, and various Chinese databases from their inception to June 10, 2023, and found 9 clinical studies (including a total of 788 PWE) and 8 pre-clinical studies. These researchers carried out a meta-analysis and systematic review of these studies to evaluate the effectiveness of taVNS in PWE and the association between taVNS and electroencephalogram (EEG) changes. They also analyzed the effects on epileptic behavior, latency of the 1st seizure, and seizure frequency in epileptic animals. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 check-list provided by the EQUATOR Network was employed in this study. taVNS had a higher response rate in PWE than the control treatment (OR = 2.94, 95 % CI: 1.94 to 4.46, p < 0.05). The analysis showed that the taVNS group showed wider EEG changes than the control group (odds ratio [OR] = 2.17, 95 % CI: 1.03 to 4.58, p < 0.05). The pre-clinical studies analysis showed significant differences in epileptic behavior (SMD = -4.78, 95 % CI: -5.86 to -3.71, p < 0.05) and seizure frequency (SMD = -5.06, 95 % CI: -5.96 to -4.15, p < 0.05) between the taVNS and control groups. No statistical difference was observed in the latency of the 1st seizure between the 2 groups (SMD =13.54; 95 % CI: 7.76 to 19.33, p < 0.05). The authors concluded that based on the available data, PWE may benefit from the use of taVNS, which was an effective approach for improving epileptic behavior in animal models. Moreover, these researchers stated that a great deal of supplementary evidence is needed to compare left, right, and bilateral taVNS and to compare VNS and taVNS.
The authors stated that based on the available evidence, they determined why the use of taVNS is limited. They noted that the correlation between the effectiveness and stimulation parameters of taVNS devices, auricular acupressure, and AA remains unclear. Choosing an appropriate stimulation method and establishing standards remains an urgent problem. Solving these questions requires more clinical trials comparing parameters, targets, and devices. The lack of rigorous trials is a key challenge. These researchers stated that future clinical designs should consider the principles of randomization, control, strict screening of subjects, as well as blinding and use relatively consistent indices to acquire high-quality evidence of the effectiveness of taVNS on PWE. These investigators noted that the mechanism of action of taVNS at the molecular, cellular, and neural circuit levels remains unclear.
Transcutaneous Electrical Acupoint Stimulation for Improvement of Stress Response During Extubation and Post-Operative Delirium
Jiang et al (2024) noted that stress response is a common complication during extubation, mainly manifested by dramatic hemodynamic fluctuations; TEAS is often used in the peri-operative period. In a systematic review and meta-analysis, these investigators examined if TEAS could relieve the stress response during extubation in non-cardiac surgery patients. They searched 6 databases (PubMed, Web of Science, Embase, Cochrane Library, China National Knowledge Infrastructure, CNKI, and Wan Fang) for relevant studies. A risk of bias assessment was conducted based on the Cochrane Criteria. These researchers applied RevMan5.4.1 software to analyze data. When the χ2 test did not show heterogeneity, they adopted the fixed-effect model. Otherwise, the random-effect model was used. A total of 12 RCTs with 1,347 subjects were included in this meta-analysis, which showed the HR and MAP of the intervention group were significantly lower than the control group at immediately, 5 mins, and 10 mins following extubation. The occurrence rate of emergency agitation (RR 0.39, 95 % CI: 0.26 to 0.60) and post-operative delirium (RR 0.40, 95 % CI: 0.22 to 0.72) were also lower in the TEAS group. The consumption of propofol (SMD 0.47, 95 % CI: -0.77 to -0.18) and remifentanil (SMD 1.49, 95 % CI: -2.01 to -0.96) of the intervention group were also significantly reduced compared with the control group. The authors concluded that TEAS was beneficial for improving stress response during extubation, emergence agitation, post-operative delirium, and reduced the consumption of intra-operative propofol and remifentanil. However, these researchers stated that more RCTs of high quality with larger sample sizes are needed to validate the findings of this study.
The authors stated that this meta-analysis had several drawbacks. First, all the studies were conducted in China; thus, the effect of TEAS on other races needs to be interpreted carefully. Second, the study mostly included studies with a small sample size. Third, the research did not analyze detailed information of TEAS, such as selection of acupoints, frequency and intensity of stimulation, as well as duration of intervention, which might influence the reliability of the conclusions.
Lay et al (2024) stated that few reviews have addressed delirium prevention among intermediate to high-risk older surgical patients. These investigators mapped pre-operative delirium prevention interventions for older surgical patients at intermediate to high-risk of developing delirium, examined outcomes and identified gaps in knowledge. They carried out a systematic narrative review of RCTs following the PRISMA guidelines. These researchers conducted a systematic search of studies published from 1990 to October 2022 in Medline, CINAHL and Ageline and of the grey literature in Google Scholar. RCTs were retrieved that assessed the effectiveness of pre-operative delirium prevention interventions for older surgical patients at intermediate to high-risk of delirium. Data were extracted using a data extraction tool, and results were tabulated. Studies were assessed for bias using the Cochrane Collaboration Risk of Bias tool. A total of 21 studies fulfilled the selection criteria entailing 5,096 participants. Two studies tested cognitive training, 2 studies tested fascia iliaca compartment block and 1 study assessed femoral nerve block. A total of 10 studies tested prophylactic medications including methylprednisolone; 5 studies examined geriatric assessment and management; and 1 study assessed TEAS. In the 2 studies testing fascia iliaca compartment block, there was a reduction in post-operative delirium for orthopedic patients. Methylprednisolone reduced post-operative delirium in orthopedic patients and in those undergoing GI surgery. Results of all other interventions on the occurrence of post-operative delirium and additional outcomes including the severity and duration of delirium were inconclusive. The authors concluded that despite the promising results for fascia iliaca compartment block and methylprednisolone, there is limited knowledge regarding evidence-based delirium prevention interventions. Most studies had small sample sizes indicating that the current evidence is exploratory. These researchers stated that there is a need for the funding and conduct of studies to test preventative interventions for older surgical patients at intermediate to high-risk of developing delirium.
The authors stated that this systematic review had several drawbacks. First, the study population included older adults aged 60 years or more and this included a wide variation in ages. Second, these researchers were unable to pool data because of the variation in participants, interventions and outcomes resulting in a narrative approach to outcomes. Third, only English language publications were included; thus, the review synthesized evidence published in English only.
Transcutaneous Electrical Acupoint Stimulation for the Management of Dysmenorrhea
Liu et al (2024) stated that primary dysmenorrhea (PD) is a common menstrual concern with significant physical and psychosocial impacts. The safety and effectiveness of TEAS in alleviating PD symptoms remain uncertain due to insufficient evidence. These researchers presented the protocol of a parallel, single-center RCT that is designed to examine the safety and effectiveness of TEAS for the management of patients with PD. A total of 60 participants aged 18 to 40 years diagnosed with moderate-to-severe PD will be recruited from Tai'an Hospital of Traditional Chinese Medicine (TCM) and randomly assigned to either a TEAS group or a TEAS-sham group (1:1). The TEAS group will undergo 12 sessions of TEAS treatment over 2 menstrual cycles, with 30 mins per session, 3 sessions weekly. Participants in the TEAS-sham group will receive TEAS stimulation using identical devices and protocols but without current output. The primary outcome is the VAS for pain assessment. Secondary outcomes are Short-Form McGill Pain Questionnaire, total effective rate, uterine artery hemodynamics, prostaglandin and β-endorphin level, mental well-being and QOL; AEs and their potential reasons and the use of analgesics will also be recorded. Furthermore, these investigators will seek to examine if TEAS therapy can ameliorate anxiety and depression in women experiencing PD.
These researchers stated that there are potential limitations in this trial. As TEAS treatment will begin 7 days before menstruation, this therapy may interfere with the menstrual periods or the different treatment times for each participant due to the slightly fluctuating menstrual cycle. Besides, the characteristics of the participants from the single-center setting are representative of the local population with PD but may limit its generalizability.
Transcutaneous Electrical Acupoint Stimulation for Prevention of Post-Operative Urinary Retention
Huang et al (2023) stated that TEAS has been proposed for preventing post-operative urinary retention (POUR). In a meta-analysis, these investigators examined the effect of TEAS in preventing POUR. Databases were searched until February 6, 2023; RCTs o the use of TEAS for preventing POUR were included. The primary concern was the incidence of POUR, with post-void residual (PVR) urine volume as a secondary outcome. A total of 14 studies with 2,865 subjects were identified. TEAS reduced the incidence of POUR (RR = 0.44, 95 % CI: 0.33 to 0.58, p < 0.00001) and decreased the PVR urine volume (MD = -75.41 ml, 95 % CI: -118.76 to -32.06, p = 0.0007). The preventive effect on POUR was found in patients receiving anorectal, gynecologic, orthopedic, and biliary surgery, but not urinary surgery. Dilatational- and continuous-wave TEAS had a great outcome in preventing POUR. Intra-operative TEAS, pre-operative and intra-operative TEAS, and post-operative TEAS were beneficial, and TEAS was more beneficial when compared with sham TEAS and blank control. However, it was nevertheless difficult to rule out publication bias. The authors concluded that TEAS could prevent POUR. Moreover, these researchers stated that due to insufficient evidence, high-quality, large-sample, multi-center RCTs should be carried out. In particular, the optimal TEAS parameters need to be tested.
The authors stated that this systematic review had several drawbacks. First, the methodological quality of the included RCTs was generally low. Only 1study emphasized allocation concealment. Approximately 28 % of the included studies implemented a blinding technique for both the subjects and operators, and the vast majority of studies didn't provide details on how outcome assessments were blinded. Only a small minority of RCTs were carried out with pre-registration. Second, all RCTs were performed in Asia, potentially resulting in publication and region bias, and may affect the validity and reliability of the systematic review. Third, acupoint selection, waveform, frequency, intensity as well as other TEAS parameters were not uniform in the included studies, which may contribute to high heterogeneity and affect the quality of evidence. Besides TEAS waveforms and TEAS timing, these investigators were unable to carry out sub-group analysis for other potential factors. Fourth, the network meta-analysis was not performed; therefore, failing to summarize the optimal TEAS regimen for preventing POUR. Considering the limited number of included RCTs and the large variation in stimulus parameters (frequency, acupoints, and treatment time) between studies, it was expected that the network meta-analysis based on existing studies would be unreliable, as they were predominantly drawn from circumstantial evidence. When more high-quality RCTs are published in the future, it will make sense to perform the network meta-analysis. Fifth, no follow-up details have been provided, and the long-term impact of TEAS is undefined.
Wang et al (2024b) noted that anesthetic drugs used in labor analgesia also paralyze the bladder muscle by blocking the sacral plexus; thus, affecting maternal post-partum spontaneous urination and increasing the risk of post-partum urinary retention (PUR). In a single-center study, these investigators examined the effect of percutaneous electrical stimulation at the Baliao point combined with biofeedback (BFB) therapy for PUR prevention. They selected 182 pregnant women who received labor analgesia in obstetrics between June 2022 and December 2023. Subjects were divided into the combined therapy group (transcutaneous electrical stimulation of the Baliao point combined with BFB) and the control group (BFB alone). The 1st spontaneous urination time, 1st post-partum urine volume, bladder residual urine volume, post-partum hemorrhage volume, pre-urination waiting time, PUR incidence, adverse reactions, and the intervention's clinical effectiveness were compared between the 2 groups. The 1st spontaneous urination time following delivery was more delayed (2.92 ± 1.04 hours versus 3.61 ± 1.13 hours, p < 0.001), with fewer initial post-partum urine (163.54 ± 24.67 ml versus 143.72 ± 23.95 ml, p < 0.001), more residual bladder urine (54.81 ± 10.78 ml versus 65.25 ± 13.52 ml, p < 0.001), more post-partum bleeding (323.15 ± 46.95 ml versus 348.12 ± 45.03 ml, p = 0.001), and longer waiting time for urination (0.94 ± 0.31 mins versus 1.29 ± 0.42 mins, p < 0.001), in the control group than in the combined therapy group. The control group also had higher PUR incidence (4.65 % versus 15.85 %, p = 0.016). Both groups had no adverse reactions; however, the clinical total effectiveness rate of the intervention was significantly higher in the combined therapy group than in the control group (95.35 % versus 84.15 %, p = 0.016). The authors concluded that percutaneous electrical stimulation of the Baliao point combined with BFB could significantly promote post-partum micturition of parturients with labor analgesia; thus, preventing PUR occurrence.
The authors stated that this study had several drawbacks. First, it was a single-center study with a small sample size. More samples are needed in future studies to confirm the value of the results. Second, labor analgesia in each patient may have different pain properties and accompanying symptoms, which may affect the tolerance of parturients to electrical stimulation and voltage amplitude regulation; therefore, further examining the changes in electromyographic evaluation of the combined therapy on parturients is needed. Third, the application value of this combined therapy in post-partum analgesia should also be further elucidated.
Transcutaneous Electrical Acupoint Stimulation for the Treatment of Post-Operative Gastro-Intestinal Dysfunction of Colorectal/Gastric Cancers
In a systematic review and meta-analysis, Zhou et al (2024) examined the effectiveness of acupuncture in the treatment of post-operative gastro-intestinal dysfunction (POGD) of colorectal cancer (CRC). Randomized controlled trials of acupuncture in the treatment of POGD were retrieved from 7 databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, VIP Chinese Journal Service Platform, WanFang Data Knowledge Service Platform, and China Biology Medicine disc. The search period ranged from the inception of the data-bases to November 10, 2022. The quality of the included literature was assessed using the Cochrane bias risk assessment tool and the modified Jadad scale. Meta-analysis was carried out using RevMan 5.4. Regression analysis and bias risk analysis were conducted using Stata 16.0. Trial sequential analysis was performed using TSA 0.9 software. A total of 27 RCTs involving 2,629 patients were included. Intervention measures included manual acupuncture, electro-acupuncture, TEAS, warm acupuncture, and thumb-tack needle. The results showed that acupuncture treatment significantly reduced time to tolerance of liquid diet following surgery (MD = -13.70, 95 % CI: -17.94 to -9.46, p < 0.000 01), time to 1st defecation (MD = -18.20, 95 % CI: -22.62 to -13.78, p < 0.000 01), time to 1st flatus (MD = -16.31, 95 % CI: -20.32 to -12.31, p < 0.000 01), time to bowel sounds recovery (MD = -11.91, 95 % CI: -14.01 to -9.81, p < 0.000 01), and hospital length of stay (LOS) (MD = -1.49, 95 % CI: -2.27 to -0.70, p = 0.0002). Regression analysis indicated that cancer type, study quality and number of acupuncture were the main sources of heterogeneity. Bias analysis suggested potential publication bias risks. Trial sequential analysis indicated that the required number of cases had been met and the conclusion was reliable. The authors concluded that acupuncture was an effective intervention for promoting gastro-intestinal recovery in patients undergoing CRC surgery. Moreover, these researchers stated that further large-sample and well-designed clinical trials are needed to compare different acupuncture techniques.
Wang et al (2024a) noted that gastro-intestinal (GI) dysfunction is a prevalent post-operative complication in patients undergoing surgery for gastric cancer and CRC. Acupuncture holds promise as a potential therapeutic intervention. The effectiveness of acupuncture therapy for post-operative GI dysfunction has been assessed in some studies, however, the variability in results and study quality influenced practical clinical application; thus, it is necessary to summarize and analyze the published clinical research data in this field. In an umbrella review of systematic reviews and meta-analyses, these investigators synthesized evidence from systematic reviews and meta-analyses to examine the effectiveness of acupuncture therapy for post-operative GI dysfunction in patients with gastric cancer and CRC. They searched China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform (Wanfang), China Science and Technology Journal Database (VIP), Chinese biomedical literature service system (SinoMed), PubMed, Embase, Cochrane Library, and Web of Science for all systematic review/meta-analysis of acupuncture for post-operative GI dysfunction in gastric cancer and CRC from the inception of the database to July 8, 2023. Two independent reviewers carried out literature extraction and evaluation. The quality of included studies was assessed using the PRISMA 2020, the quality of the methods was assessed using a measuring tool to evaluate systematic reviews (AMSTAR 2), and the level of evidence was assessed using the grading of recommendations assessment, development, and evaluation (GRADE). The statistical analysis was performed using RevMan 5.4, and the effect size was expressed as OR, MD, and 95 % CI based on the extracted data type (test level α = 0.05). The heterogeneity was assessed using the I2 statistic and Q-test (χ2). The outcome indicators such as time to 1st defecation and time to 1st flatus were employed as endpoints to examine the effectiveness of different acupuncture therapies. A total of 6 systematic reviews/meta-analyses were included in this study, involving 12 different acupuncture therapies. PRISMA 2020 indicated that the studies all scored between 13 to 20.5. There were deficiencies in protocol and registration, assessment of the quality of evidence for outcome indicators, risk of bias, and declaration of conflict of interest. The AMSTAR 2 evaluations showed that 5 studies were very low quality and 1 was low quality. The level of evidence for various acupuncture interventions varied from very-low to moderate. For patients with GI dysfunction following gastric cancer surgery, ear acupressure (MD = -11.92, 95 % CI: -14.39 to -9.44, p < 0.00001), moxibustion (MD = -19.16, 95 % CI: -23.00 to -16.22, p < 0.00001), warm needling (MD = -12.81, 95 % CI: -17.61 to -8.01, p < 0.00001), acupoint application (MD = -6.40, 95 % CI: -10.26 to -2.54, p = 0.001), manual acupuncture (MD = -18.32, 95 % CI: -26.31 to -10.39, p < 0.00001) and TEAS (MD = -5.17, 95 % CI: -9.59 to -0.74, p = 0.02] could promote the recovery of GI function following surgery. For post-operative CRC patients, electro-acupuncture (MD = -15.17, 95 % CI: -28.81 to -1.54, p < 0.05), manual acupuncture (MD = -20.51, 95 % CI: -39.19 to -1.84, p < 0.05), warm needling (MD = -18.55, 95 % CI: -23.86 to -13.24, p < 0.05], ear acupressure (MD = -5.38, 95 % CI: -9.80 to -0.97, p < 0.05], acupoint application (MD = -26.30, 95 % CI: -32.81 to -19.79, p < 0.05), ear acupressure+acupressure (MD = -9.67, 95 % CI: -13.58 to -5.76, p < 0.05), ear acupressure+manual acupuncture (MD = -18.70, 95 % CI: -21.01 to -16.39, p < 0.05], ear acupressure+moxibustion (MD = -22.90, 95 % CI: -30.10 to -15.70, p < 0.05), moxibustion+acupressure (MD = -14.77, 95 % CI: -20.59 to -8.95, p < 0.05) improved post-operative GI function. Furthermore, the effectiveness of acupressure (MD = -12.00, 95 % CI: -31.60 to 7.60, p > 0.05) needed to be further demonstrated. The authors concluded that acupuncture therapy exhibited a positive therapeutic impact on post-operative GI dysfunction in patients with gastric cancer and CRC; however, these researchers stated that further investigation is needed to validate these findings.
The authors stated that this study had several drawbacks. First, due to the small number of included studies, this may lead to some bias in the results. furthermore, because the assessment of outcome indicators such as time to first flatus (TTFF) and time to first bowel sounds (TFBS) were influenced by subjective factors of patients and assessors, this may also lead to bias. Second, the credibility of the clinical trial results may be compromised due to deficiencies in the implementation of blinding methods in the included RCTs, potentially resulting in placebo effects and observer bias. Third, the long-term clinical effectiveness of acupuncture therapy for POGD remains to be further examined due to the lack of evaluation of the long-term effectiveness of the interventions in the included studies. Fourth, this study did not compare the effectiveness of different acupuncture interventions. These researchers hope to fill this gap by using the network meta-analysis tool in subsequent studies. Fifth, the reliability of this umbrella review depended on the quality of the included systematic evaluations/meta-analyses. Due to the low methodological quality of the included studies and the high heterogeneity, this will have an impact on their conclusions.
Transcutaneous Electrical Acupoint Stimulation for the Treatment of Cancer-Induced Bone Pain
Lyu et al (2024) stated that TEAS therapy opens up the possibility for patients with cancer-induced bone pain (CIBP) to receive a home-based, patient-controlled approach to pain management. These researchers presented the protocol of a prospective, triple-blind RCT designed to examine the effectiveness of patient-controlled TEAS (PC-TEAS) for relieving CIBP in patients with non-small cell lung cancer (NSCLC). These researchers anticipate enrolling 188 participants with NSCLC bone metastases who are also using potent opioid analgesics from 4 Chinese medical centers. These participants will be randomly assigned in a 1:1 ratio to either the true PC-TEAS or the sham PC-TEAS group. All participants will receive standard adjuvant oncology therapy. The experimental group will undergo patient-controlled TEAS intervention as needed, while the sham group will follow the same treatment schedule but with non-conductive gel patches. Each treatment course will span 7 days, with a total of 4 courses administered. There will be 4 assessment time-points: baseline, the conclusion of weeks 4, 8, and 12. The primary outcome of this study is the response rate of the average pain on the Brief Pain Inventory (BPI) scale at week 4 after treatment. Secondary outcomes include pain related indicators, QOL scale, mood scales, and routine blood counts on the assessment days. Any AEs will be promptly addressed and reported if they occur. These investigators will manage trial data using the EDC platform, with a data monitoring committee providing regular quality oversight. The authors stated that PC-TEAS interventions offer an attempt to achieve home-based acupuncture treatment and the feasibility of achieving triple blinding in acupuncture research. This study is designed to provide more rigorous trial evidence for the adjuvant treatment of cancer-related pain by acupuncture, and to examine a safe and effective integrative medicine scheme for CIBP. This trial is planned to be implemented from May 2023 to December 2025. Recruitment commenced on May 16, 2023, and is anticipated to end in December 2025. The study’s recruitment phase is currently ongoing. The study is projected to be completed by May 2026, and so far, 9 participants have been recruited into the study.
This trial has some potential limitations. First, because patient-controlled analgesia (PCA) participants generally lack a medical background, the standardization of PC-TEAS treatment heavily relies on comprehensive health education and operational training provided by investigators to the participants. Participants are required to record daily pain logs, which also required close follow-up and coaching. Second, for patients who have previously undergone TEAS treatment, distinguishing between sham PC-TEAS treatment and the actual treatment can be easy, potentially resulting in a failure in blinding. Third, studies that focus on single cancer tumors with a single type of cancer pain might require more time to complete subject recruitment. Fourth, the primary outcome indicators were designed to be too stringent, and positive results may not occur.
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