Electrical Stimulation for Nausea, Vomiting and Motion Sickness (PrimaBella and ReliefBand) and Other Selected Indications

Number: 0676

Policy

Aetna considers transcutaneous electrical acupoint stimulation (prescription version ReliefBand devices) medically necessary for the treatment of post-operative nausea and chemotherapy-induced nausea that is unresponsive to antiemetics and other conservative therapies.  

Aetna considers transcutaneous electrical acupoint stimulation (prescription version PrimaBella or ReliefBand devices) medically necessary for the treatment of hyperemesis gravidarum that is unresponsive to other conservative medical therapy (e.g., change in diet, ginger capsules, vitamin B6).

Aetna considers transcutaneous electrical acupoint stimulation experimental and investigational for the following indications because its effectiveness for these indications (not an all-inclusive list) has not been established:

  • Improvement of motor functions and self-care ability in children with cerebral palsy
  • Improvement of pregnancy rates in women undergoing in-vitro fertilization
  • Modulation of autonomic balance in heart transplant recipients
  • Prevention of motion sickness
  • Reduction of incidence and severity of etomidate-induced myoclonus
  • Treatment of autism
  • 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-traumatic stress disorder
  • Treatment of tinnitus.

Aetna considers transcutaneous neuromodulation and auricular electrostimulation experimental and investigational for nausea, vomiting, motion sickness and other indications because of insufficient evidence of effectiveness.

Note: 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.

In a single-center, randomized, double-blind, placebo- and sham-controlled study, White et al (2002) compared the effectiveness of the ReliefBand to ondansetron when utilized alone or in combination for preventing PONV following plastic surgery (n = 120).  Patients were randomly assigned to 3 prophylactic antiemetic treatment regimens with routine low-dose droperidol prophylaxis:
  1. ondansetron (n = 40): 4 mg intravenous (I.V.) ondansetron and a sham ReliefBand;
  2. acustimulation (n = 40): 2 ml I.V. saline and an active ReliefBand; and
  3. 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:
  1. the ondansetron group received 4 mg I.V. ondansetron and a sham ReliefBand;
  2. the acustimulation group received 2 ml I.V. saline and a ReliefBand; and
  3. 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 neuromodulatory 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

In a prospective, single-blind, randomized, placebo-controlled study, Liu and associates (2015) evaluated the clinical effect of transcutaneous electrical nerve stimulation over acupoints (acu-TENS) on patients with stable chronic obstructive pulmonary disease (COPD). A total of 50 patients with stable COPD enrolled in the study.  Patients were randomly assigned to 1 of 2 groups:
  1. 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
  2. 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

Li and co-workers (2015) noted that subjective tinnitus is a phantom sensation experienced in the absence of any source of sound. Its mechanism remains unclear, and no approved drugs are available.  Vagus nerve stimulation (VNS) is an exciting new method to treat tinnitus, but direct electrical stimulation of the cervical vagus has disadvantages.  This randomized controlled clinical trial aims to overcome these limitations by stimulating the auricular branch of vagus nerve (ABVN) on the outer ear.  Since the ABVN is the only peripheral branch of the vagus nerve distributed on the ear's surface, it should be possible to achieve analogous efficacy to VNS by activating the central vagal pathways.  However, researches have indicated that the curative effect lies in a combination of auditory and vagal nerve stimulation.  Moreover, from traditional Chinese theory, auricular acupoints used to treat tinnitus are mainly in the regions supplied by the ABVN.  Whether stimulation at the auricular acupoints is due to unintentional stimulation of vagal afferent fibers also needs evidence.  A total of 120 subjects with subjective tinnitus are randomized equally into 4 groups:
  1. electrical stimulation at auricular acupoints (CO10, CO11, CO12, and TF4) innervated by the ABVN;
  2. electrical stimulation at auricular acupoints (CO10, CO11, CO12, and TF4) innervated by ABVN pairing tones;
  3. electrical stimulation at auricular acupoints innervated by non-ABVN pairing tones; and
  4. 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

In a randomized control trial (RCT), Hadadian and associates (2016) evaluated the effects of TEAS on fatigue among end-stage renal disease (ESRD) patients receiving hemodialysis treatment.  This study was conducted over a 5- month period in 2009.  A total of 56 patients who had undergone hemodialysis and meeting the inclusion criteria, were divided into 2 groups by simple random sampling:
  1. TEAS (n = 28) and
  2. 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:

  1. 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,
  2. 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.

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.

Table: CPT Codes / HCPCS Codes / ICD-10 Codes
Code Code Description

Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":

CPT codes not covered for indications listed in the CPB:

97813 Acupuncture, 1 or more needles; with electrical stimulation, initial 15 minutes of personal one-on-one contact with patient
+97814     with electrical stimulation, each additional 15 minutes of personal one-on-one contact with the patient, with re-insertion of needle(s) (List separately in addition to code for primary procedure)

Other CPT codes related to the CPB:

97014 Application of a modality to one or more areas; electrical stimulation (unattended)
97032 Application of a modality to one or more areas; electrical stimulation (manual), each 15 minutes

HCPCS codes covered if selection criteria are met:

E0765 FDA approved nerve stimulator, with replaceable batteries, for treatment of nausea and vomiting

HCPCS codes not covered for indications listed in the CPB:

S8930 Electrical stimulation of auricular acupuncture points; each 15 minutes of personal one-on-one contact with the patient

Other HCPCS codes related to the CPB:

G0283 Electrical stimulation (unattended), to one or more areas for indication(s) other than wound care, as part of a therapy plan of care

ICD-10 codes covered if selection criteria are met:

K91.0 Vomiting following gastrointestinal surgery
O21.0 - O21.9 Excessive vomiting in pregnancy
R11.0 - R11.2 Nausea and vomiting
T45.1X5+ Adverse effect of antineoplastic and immunosuppressive drugs [post-operative nausea and chemotherapy-induced nausea]

ICD-10 codes not covered for indications listed in the CPB:

C34.00 - C34.92 Malignant neoplasm of bronchus and lung
D02.20 - D02.22 Carcinoma in situ of bronchus and lung
F43.10 - F43.12 Post-traumatic stress disorder (PTSD)
F84.0 - F84.9 Pervasive developmental disorders
G25.3 Myoclonus [etomidate-induced]
G80.0 - G80.9 Cerebral palsy
H93.11 - H93.19 Tinnitus
H93.A1 - H93.A9 Pulstile tinnitus
I10 - I16.9 Hypertensive diseases
J44.0 - J44.9 Other chronic obstructive pulmonary disease
M25.561 – M25.569 Pain in knee [pain after total knee arthroplasty]
M62.40 - M62.49 Contracture of muscle
N46.01 - N46.9 Male infertility
N97.0 - N97.9 Female infertility
R53.82 Chronic fatigue, unspecified [hemodialysis-associated]
R53.83 Other fatigue [hemodialysis-associated]
S02.0XX+ - S02.92X+ Fracture of skull and facial bones
S06.0X0+ - 06.9X9+ Intracranial injury
T75.3XX+ Motion sickness
Z31.83 Encounter for assisted reproductive fertility procedure cycle
Z31.89 Encounter for other procreative management
Z94.0 Heart transplant status [modulation of autonomic balance in heart transplant recipients]
Z96.651 – Z96.659 Presence of artificial knee joint [knee pain]

The above policy is based on the following references:

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