Acustimulation

Acustimulation

PEP Topic 
Chemotherapy-Induced Nausea and Vomiting—Adult
Description 

Acustimulation involves electrostimulation of acupressure points (most commonly, the P6 point) by transcutaneous, electrical stimulation through a wristband device. A wristband device currently available is the Reliefband®, a class-II device approved by the U.S. Food and Drug Administration for the treatment of chemotherapy induced nausea and vomiting (CINV). The device delivers slow, weak, electrical impulses to the P6 point via two metallic electrodes. Patients can adjust the electrical output to deliver 10-35 milliamps per pulse. Reliefband® (for the indication of CINV) requires a prescription. Acustimulation has been evaluated in CINV and fatigue.

Effectiveness Not Established

Systematic Review/Meta-Analysis

Chao, L.F., Zhang, A.L., Liu, H.E., Cheng, M.H., Lam, H.B., & Lo, S.K. (2009). The efficacy of acupoint stimulation for the management of therapy-related adverse events in patients with breast cancer: A systematic review. Breast Cancer Research and Treatment, 118, 255–267.

doi: 10.1007/s10549-009-0533-8
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Purpose:

To scrutinize the evidence of using acupoint stimulation (APS) by any modality on managing adverse events related to anticancer therapies in patients with breast cancer

Search Strategy:

English databases searched were PubMed, Cochrane library, Embase, the Cumulative Index to Nursing and Allied Health, and PsycINFO.

Chinese databases searched were CNKI, CEPS, and WanFang as well as manual searching.

Search keywords were medical terms of breast cancer (e.g., breast neoplasm, breast carcinoma, breast tumor) combined separately with at least one of the following: acupuncture, acupressure, auricular acupuncture, ear acupuncture, acupuncture points, electroacupuncture, acupoint, transcutaneous electric nerve stimulation,  moxibustion.

Studies were included if they

  • Were in English or Chinese language.
  • Reported on adults diagnosed with breast cancer at any stage and undergoing treatments such as surgery, radiotherapy, chemotherapy, hormonal therapy, or palliative treatment and experiencing treatment-induced adverse events.
  • Utilized an intervention that involved stimulation of acupuncture points by any modality.
  • Had at least one clinically related outcome variable, as well as condition-specific outcomes or generic health status outcomes.

Studies were excluded if they were

  • Animal studies.
  • Case reports and anecdotal evidence.
  • Qualitative studies or descriptive surveys.
  • Reports available only in abstract form.
  • Trials that included diagnosis other than breast cancer unless separate data was available for the breast cancer group.

Literature Evaluated:

Initial review involved 843 titles and abstracts and 51 full-text articles. Of those, 26 studies were included in the report.

Study evaluation began with two independent reviewers using a modified Jadad scale, assessing 3 aspects: randomization procedure (2 points); dropout and withdrawal discussion (1 point); and blinding (2 points). Studies were classified as high quality if they attained a score of 3 or higher.

Evaluated literature included 18 randomized controlled trials (RCTs) and eight controlled clinical trials published between 1999 and 2008. Nine trials included conventional acupuncture, 6 included electroacupuncture, 5 included drug injection in acupoints, 3 included self-acupressure, and 3 included acupoint stimulation by wristbands or acumagnet. Eighteen were in English, and 8 were in Chinese.

Sample Characteristics:

  • The total sample size was 1,548.
  • Age range across across studies was 28–76 years.
  • Five studies reported the participant’s body mass index, which ranged from 23.1 to 28.8.
  • Information on participants’ education, background of acupuncturists, symptom distress before management, and measurement tool reliability was reported in too few studies to provide a meaningful summary.

Results:

Nine of the 26 studies were rated as high quality. Adverse effects (outcomes) of the APS included vasomotor syndrome, chemotherapy-induced nausea and vomiting (CINV), post-mastectomy pain, joint symptoms, lymphedema, leukopenia, and adverse events.

Eleven studies investigated CINV and APS with acupoints P6 and ST36. Ten of the CINV studies reported APS significantly improved emesis caused by breast cancer therapy.

Conclusions:

The most common outcome evaluated by APS in the studies was CINV. APS was noted to be effective in reducing acute emesis caused by breast cancer therapy. Authors reported that APS is beneficial in the management of CINV, especially in the acute phase.

Nursing Implications:

Healthcare providers should consider using APS as an option for the management of CINV.

Research Evidence Summaries

Roscoe, J.A., Morrow, G.R., Hickok, J.T., Bushunow, P., Pierce, I., Flynn, P.J., … Atkins, J.N. (2003). The efficacy of acupressure and acustimulation wrist bands for the relief of chemotherapy-induced nausea and vomiting: A University of Rochester Cancer Center Community Clinical Oncology Program multicenter study. Journal of Pain and Symptom Management, 26, 731-740.

doi: 10.1016%2FS0885-3924%2803%2900254-9
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Intervention Characteristics/Basic Study Process:

Patients were randomized to one of three study groups.

  • Acupressure bands (Sea-Bands®)
  • Acustimulation band (ReliefBand®)
  • No band control

The intervention or lack of intervention was used in combination with standard antiemetics for chemotherapy-induced nausea and vomiting.

Patients wore devices (if any) continuously for five days, and those in the acustimulation band group could adjust the intensity of stimulation.

Sample Characteristics:

  • The study consisted of 739 patients who were chemotherapy-naïve.
  • Cancer diagnoses included breast cancer (85%) and hematologic neoplasms (10%).
  • The majority of the patients were white (88%) and female (92%).
  • Patients were about to receive cancer regimens containing cisplatin or doxorubicin, without concurrent radiation therapy or interferon.
  • Patients were excluded from the study if they had pacemakers, bowel obstruction, or symptomatic brain metastases.

Setting:

The study was conducted at outpatient clinics at 17 geographically diverse member sites of the University of Rochester Clinical Oncology Program.

Study Design:

The study design was a randomized controlled trial.

Measurement Instruments/Methods:

  • Using diaries, patients reported on the severity of nausea and number of vomiting episodes in the morning, afternoon, evening, and night, on the day of treatment and the following four days on a seven-point scale.
  • Quality of life was measured using the Functional Assessment of Cancer Therapy Scale-General.
  • Demographic data, chemotherapy information, and antiemetics were recorded.
  • Efficacy reports of wristband(s) were assessed on a five-point scale prior to treatment.

Results:

  • Patients in the acupressure group experienced less nausea on the day of treatment compared to controls.
  • No significant differences were found in delayed nausea and vomiting among the three groups.
  • Pronounced gender differences existed. Men in the acustimulation group had less nausea and vomiting compared to controls. No significant differences existed in women among the three groups, although the reduction in nausea on the day of treatment in the acupressure group approached clinical significance.

Limitations:

A possible placebo effect existed.

Roscoe, J.A., Morrow, G.R., Matteson, S., Bushunow, P., & Tian, L. (2002). Acustimulation wristbands for the relief of chemotherapy-induced nausea. Alternative Therapies, 8 (4), 56-63.

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Intervention Characteristics/Basic Study Process:

This randomized controlled trial used a three-level crossover design (active acustimulation, sham acustimulation, and no acustimulation). All patients received standard antiemetics ordered by the physician. Patients wore a wristband before chemotherapy and as needed. Patients could adjust the stimulation intensity.

Sample Characteristics:

  • The study consisted of 27 patients (25 women, 2 men).
  • The mean age of patient was 49.7 years.
  • Most patients were Caucasian, one was African American, and one was Asian.
  • Cancer diagnoses were breast (81%), colorectal (11%), ovarian (4%), and lung (4%).
  • Patients who had previously experienced moderate or more severe nausea following their first chemotherapy treatment were screened for the study.
  • Patients were scheduled to receive at least three more chemotherapy treatments without radiotherapy or interferon.

Setting:

The study was conducted at three outpatient oncology clinics in the northeastern United States.

Study Design:

The study was a randomized clinical trial using a three-level crossover design (active acustimulation, sham acustimulation, and no acustimulation).

Measurement Instruments/Methods:

  • Using patient diaries, patients reported on the severity of nausea for each period (morning, afternoon, evening, night) on the day of treatment and on the following four days.
  • Severity of nausea was assessed on a seven-point rating scale.
  • Patients also reported on the type and total number of antiemetic pills taken on days 1–5.

Results:

No statistical differences in average severity of nausea were observed between the interventions. A nearly significant difference was found in the severity of delayed nausea reported during active acustimulation compared to no acustimulation.

Conclusions:

Findings were positive but not conclusive.

Limitations:

  • The sample size was small, and data were missing.
  • The study did not account for medication changes (antiemetics).
  • The wristband may have caused a placebo effect. Mood elevation may be possible with nerve stimulation and the release of endorphins.

Nursing Implications:

Caution should be used in patients with pacemakers.

Roscoe, J.A., Matteson, S.E., Morrow, G.R., Hickok, J.T., Bushunow, P., Griggs, J., … Smith, J. (2005). Acustimulation wrist bands are not effective for the control of chemotherapy-induced nausea in women with breast cancer. Journal of Pain and Symptom Management, 29, 376-384.

doi: 10.1016%2Fj.jpainsymman.2004.07.007
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Intervention Characteristics/Basic Study Process:

Patients receiving doxorubicin and cyclophosphamide were randomized to one of three arms.

  • Active acustimulation
  • Sham acustimulation
  • No acustimulation

Participants were told to wear the assigned band and adjust the acustimulation dial to increase or decrease the acustimulation; they could wear the band as frequently as desired over five days.

Sample Characteristics:

  • The study consisted of 96 patients.
  • All patients were women with breast cancer on the second cycle of chemotherapy.
  • Patients’ mean age was 49.5 years.
  • The majority of patients were white (n = 87).
  • The majority of patients (93%) took some type of antiemetic following treatment.

Setting:

All participants were treated at outpatient centers at one of four Rochester, NY, area cancer centers.

Study Design:

The study design was a randomized, three-arm trial.

Measurement Instruments/Methods:

  • Demographic information and details of prior nausea and vomiting experience were recorded.
  • Five-point Likert-type questions were assessed at the time of randomization following a one-minute trial of the band.
  • Patient report diaries were used to measure nausea and emesis over the five-day period.
  • The severity of nausea and vomiting episodes, as well as antiemetics, were recorded.
  • Quality of life was measured with the Functional Assessment of Cancer Therapy Scale-General.

Results:

No significant differences were found in any study measures among the three treatment conditions.

Conclusions:

The study does not support the use of acustimulation bands as an adjunct to antiemetics in female patients with breast cancer.

Limitations:

  • Only women were included in the study.
  • The band could be viewed as a reinforcer (negative conditioning effect) and reminder of an unpleasant state.
  • Patients with brain metastases, bowel obstructions, or cardiac pacemakers, or those undergoing concurrent radiation therapy or interferon therapy were excluded.

Treish, I., Shord, S., Valgus, J., Harvey, D., Nagy, J., Stegal, J., & Lindley, C. (2003). Randomized double-blind study of the Reliefband as an adjunct to standard antiemetics in patients receiving moderately-high to highly emetogenic chemotherapy. Supportive Care in Cancer, 11, 516-521.

doi: 10.1007%2Fs00520-003-0467-3
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Intervention Characteristics/Basic Study Process:

Adult cancer patients receiving moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) were randomized to receive the active ReliefBand® or an inactive device. All patients received scheduled and as-needed antiemetics. Patients wore devices continuously for five days, except during showering and hand washing.

Sample Characteristics:

  • The study consisted of 49 patients.
  • Mean age was 45 years.
  • Diagnoses included leukemia, non-Hodgkin lymphoma, sarcoma, breast, head and neck, and lung cancer.
  • A variety of chemotherapy regimens were reported that met criteria for MEC or HEC. Many subjects had three to four prior chemotherapy cycles. All received single- or multiday chemotherapy, including myeloablative chemotherapy, for bone marrow transplant.

Setting:

All participants in this single-site study were inpatients at the University of North Carolina Hospitals.

Study Design:

The study design was a randomized, prospective, double-blind, placebo-controlled trial.

Measurement Instruments/Methods:

  • Patients recorded nausea, vomiting, retching episodes, and antiemetic medications use in diaries daily.
  • The Functional Living Index Emesis and tolerability survey were completed at the conclusion of the study.

Results:

Patients wearing the ReliefBand experienced less vomiting, retching, and nausea severity over the five-day period than patients wearing the inactive device. Vomiting was statistically and significantly reduced during the delayed period, and nausea was significantly reduced during the acute and delayed periods. Functional Living Index Emesis scores did not differ between the two groups.

Limitations:

  • Differences existed in risk factors for emesis, chemotherapy, and antiemetic regimens.
  • The sample size was small.
  • Patients with pacemakers, low life expectancy, and poor performance status (greater than three) were excluded.

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