Paul G. Shekelle, MD, PhD; Ian A. Cook, MD; Isomi M. Miake-Lye, PhD; Marika Suttorp Booth, MS; Jessica M. Beroes, BS; Selene Mak, MPH
Disclaimer: The findings and conclusions in this article are those of the authors, who are responsible for its contents. The findings and conclusions do not necessarily represent the views of the U.S. Department of Veterans Affairs or the U.S. government. Therefore, no statement in this article should be construed as the official position of the Department of Veterans Affairs.
Acknowledgment: The authors thank Roberta Shanman, MLS, for searches.
Financial Support: By the Veterans Affairs Quality Enhancement Research Initiative.
Disclosures: Dr. Cook reports grants from Neosync; being a consultant/advisor for Arctica Health, Cereve, and NeuroDetect; prior employment (now on leave with stock options) with NeuroSigma; and employment with the U.S. Department of Veterans Affairs and University of California, Los Angeles, outside the submitted work. In addition, Dr. Cook has patents licensed to NeuroSigma by the Regents of the University of California. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-1970.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: PROSPERO CRD42016023951. Statistical code: Not applicable. Data set: Additional data not presented in the published paper are available in the full report at http://www.hsrd.research.va.gov/publications/esp/ces.cfm.
Requests for Single Reprints: Paul G. Shekelle, MD, PhD, West Los Angeles Veterans Affairs Medical Center, 11301 Wilshire Boulevard, Los Angeles, CA 90073; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Shekelle and Miake-Lye and Ms. Beroes: West Los Angeles Veterans Affairs Medical Center, 11301 Wilshire Boulevard, Los Angeles, CA 90073.
Dr. Cook: University of California, Los Angeles, David Geffen School of Medicine, 10833 Le Conte Avenue, Los Angeles, CA 90095.
Ms. Booth: RAND Corporation, Southern California Evidence-based Practice Center, 1776 Main Street, Santa Monica, CA 90401-3208.
Ms. Mak: University of California, Los Angeles, Fielding School of Public Health, 650 Charles E. Young Drive South, Los Angeles, CA 90095.
Author Contributions: Conception and design: P.G. Shekelle, I.M. Miake-Lye.
Analysis and interpretation of the data: P.G. Shekelle, I.A. Cook, M.S. Booth, S. Mak.
Drafting of the article: P.G. Shekelle, I.A. Cook, I.M. Miake-Lye, J.M. Beroes.
Critical revision of the article for important intellectual content: P.G. Shekelle, I.A. Cook.
Final approval of the article: P.G. Shekelle, I.A. Cook, I.M. Miake-Lye, M.S. Booth, J.M. Beroes, S. Mak.
Statistical expertise: M.S. Booth.
Obtaining of funding: P.G. Shekelle.
Administrative, technical, or logistic support: J.M. Beroes, S. Mak.
Collection and assembly of data: P.G. Shekelle, I.M. Miake-Lye, M.S. Booth, S. Mak.
Cranial electrical stimulation (CES) is increasingly popular as a treatment, yet its clinical benefit is unclear.
To review evidence about the benefits and harms of CES for adult patients with chronic painful conditions, depression, anxiety, and insomnia.
Several databases from inception to 10 October 2017 without language restrictions and references from experts, prior reviews, and manufacturers.
Randomized controlled trials of CES versus usual care or sham CES that reported pain, depression, anxiety, or sleep outcomes in any language.
Single-reviewer extraction checked by another; dual independent quality assessment; strength-of-evidence grading by the first author with subsequent group discussion.
Twenty-eight articles from 26 randomized trials met eligibility criteria. The 2 trials that compared CES with usual care were small, and neither reported a statistically significant benefit in pain or anxiety outcomes for patients with fibromyalgia or anxiety, respectively. Fourteen trials with sham or placebo controls involving patients with painful conditions, such as headache, neuromuscular pain, or musculoskeletal pain, had conflicting results. Four trials done more than 40 years ago and 1 from 2014 provided low-strength evidence of a possible modest benefit compared with sham treatments in patients with anxiety and depression. Trials in patients with insomnia (n = 2), insomnia and anxiety (n = 1), or depression (n = 3) had inconclusive or conflicting results. Low-strength evidence suggested that CES does not cause serious side effects.
Most trials had small sample sizes and short durations; all had high risk of bias due to inadequate blinding.
Evidence is insufficient that CES has clinically important effects on fibromyalgia, headache, neuromusculoskeletal pain, degenerative joint pain, depression, or insomnia; low-strength evidence suggests modest benefit in patients with anxiety and depression.
Veterans Affairs Quality Enhancement Research Initiative. (PROSPERO: CRD42016023951)
Shekelle PG, Cook IA, Miake-Lye IM, et al. Benefits and Harms of Cranial Electrical Stimulation for Chronic Painful Conditions, Depression, Anxiety, and Insomnia: A Systematic Review. Ann Intern Med. [Epub ahead of print 13 February 2018]168:414–421. doi: 10.7326/M17-1970
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Published: Ann Intern Med. 2018;168(6):414-421.
Published at www.annals.org on 13 February 2018
Pulmonary/Critical Care, Sleep Disorders.
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