Datasets:

marianna13
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litarch

+{"file": "vaespces_NBK493132/executivesummary.nxml", "text": "ABSTRACT\nBackground\nCranial electrical stimulation (CES) is increasing in popularity as a treatment, yet of uncertain clinical benefit.\nPurpose\nTo review evidence about the effectiveness and harms of CES for patients with chronic painful conditions, depression, anxiety, PTSD, and insomnia.\nData Searches\nSearches of multiple databases from inception to 10/10/2017; reference-mining of included articles; recommendations from experts.\nStudy Selection\nRandomized controlled trials of CES versus usual care or sham CES.\nData Extraction\nData extraction was performed in duplicate. The Principal Investigator performed the Strength of Evidence assessment.\nData Synthesis\n28 relevant publications from 26 RCTs met eligibility criteria. Two small RCTs compared CES to usual care, neither reported a statistically significant benefit. Four old RCTs and one modern RCT provided low strength evidence of a possible benefit of CES compared to sham in patients with anxiety and depression. RCT results were conflicting for fibromyalgia, headache, other painful conditions, depression and insomnia. There is low strength evidence that CES does not cause serious side effects. All RCTs were judged to be at high risk of bias because of the possibility of unblinding of therapy.\nLimitations\nAll RCTs were judged to be at high risk of bias; there were too few RCTs of the same patient population and intervention to support statistical pooling.\nConclusions\nThe evidence is insufficient to support conclusions that CES has clinically important effects on headache, fibromyalgia, neuromuscular pain, depression, PTSD, or insomnia. There is low-strength evidence for a possible beneficial effect of modest size in patients who have anxiety with depression. CES is probably safe, in that no serious side effects have been reported in RCTs, although reporting bias is present.", "pairs": [], "interleaved": []}
+{"file": "vaespces_NBK493132/introduction.nxml", "text": "Cranial electrical stimulation (CES) is a non-invasive method of applying low-intensity electrical current to the head. It is related to but distinct from other forms of transcranial electrical stimulation including electroconvulsive therapy, transcranial direct current stimulation (tDCS), and high-definition transcranial direct current stimulation. The different versions of transcranial electrical stimulation vary in the placement of electrodes, the intensity of the current, and the waveform of the current.1 According to Guleyupoglu and colleagues, CES evolved from the concept of \u201celectrosleep,\u201d first investigated at the beginning of the 20th century.1 Most of the early research and applications occurred in Russia. Beginning in the 1960s, the concept of electrosleep became more popular in the USA. Because of the belief that the treatment did not actually induce sleep, but rather the sleep was a side effect of the relaxing effect of the current stimulation, the name was changed from \u201celectrosleep\u201d to \u201ccranial electrical stimulation.\u201d1 Other proposed names, which have not persisted, included \u201ctranscerebral electrotherapy\u201d and \u201cNeuroElectric Therapy.\u201d The latter is noteworthy because it gave its name to an early CES device, the Neurotone 101, which was the first device approved by the FDA.1 All subsequent CES devices have been cleared for marketing by FDA based on the concept of claiming equivalency to the Neurotone 101. The status of cranial electrical stimulation devices and FDA regulation remains a matter of some controversy.\nAfter an initial burst of research activity in the 1970s and early 1980s, published research on CES entered a quiescent phase, but then resumed and accelerated beginning about 2005. CES has been proposed as a therapy for anxiety, pain, insomnia, depression, headache, fibromyalgia, and numerous other conditions.1 An early meta-analysis by Klawansky and colleagues2 identified 8 sham-controlled RCTs for anxiety, two RCTs for brain dysfunction, two trials for headache and two trials for insomnia. Employing an effect size approach, which pooled studies across outcomes and types of CES, the authors found a statistically significant effect size of -0.58 (95% CI -0.95, -0.22) favoring active treatment for the anxiety outcome. Pooled effects for the other conditions showed no benefit for insomnia or brain dysfunction and a small beneficial effect for headache. The authors cautioned, however, that the quality of included studies was \u201cquite low\u201d, due mostly to inadequate blinding. They concluded that larger, more rigorous studies were needed. Regarding the blinding, a more recent Cochrane review of CES in acute uncomplicated depression by Kavirajan and colleagues3 restricted their eligibility criteria to RCTs with a convincing sham, diagnosis using standardized criteria, and assessments with validated rating instruments, and reported finding no studies of subjects with depression meeting these criteria.\nThe most commonly used CES devices in the USA are the Alpha-Stim products and the Fisher-Wallace Cranial Electrical Stimulator.4 They differ in the location of the electrodes (ear clips in the former, sponge electrodes at the temples in the latter) and in the amount and type of current. Both are FDA-cleared for marketing for the treatment of anxiety, depression, and insomnia.\nOne driver for the resurgence in interest in CES has been the Department of Defense and Department of Veterans Affairs authorizing practitioners to prescribe CES for anxiety, post-traumatic stress disorder, insomnia, depression and headache. One survey of active duty service members and veterans reported on the responses from 152 subjects (a 10% response) rate, and found that 99% of respondents believed CES was effective and 99% considered CES to be safe.5 Another VA study, that included CES among a number of alternative treatments for Veterans with chronic pain, found a statistically significant decrease of 1.0 points (on a 0-10 point pain rating scale) in a pre/post study.6 Anecdotal evidence suggests that the demand for CES devices among Veterans is increasing. This systematic review was requested by VA to review the RCT evidence for effectiveness in these conditions.", "pairs": [], "interleaved": []}
+{"file": "vaespces_NBK493132/appd.nxml", "text": "", "pairs": [], "interleaved": []}
+{"file": "vaespces_NBK493132/appa.nxml", "text": "CRANIAL ELECTRIC STIMULATION \u2013 SEARCH METHODOLOGY\n________________________________________________________________________________________________________\nDATABASE SEARCHED: PubMed\n\nSEARCH STRATEGY #1:\n\nTIME PERIOD COVERED: from inception to 2/1/2016\nLANGUAGE: English\n\u201ccranial electrical stimulation\u201d(tiab) OR cranial electric stimulat*(tiab) OR electrotherap*(tiab) OR fisher wallace stimulat*(tiab) OR alpha-stim(tiab)\n\nSEARCH STRATEGY #1A (update to Search #1):\n\nTIME PERIOD COVERED: 1/1/2016-7/12/2017\nLANGUAGE: English\n\u201ccranial electrotherapy\u201d OR cranial electric stimulat* OR cranial electrical stimulat* OR alpha-stim OR fisher wallace stimulat*\n\nSEARCH STRATEGY #2:\n\nTIME PERIOD COVERED: from inception to 7/12/2017\nLANGUAGE: ALL\nElectrosleep OR \u201cTranscerebral electrotherapy\u201d OR \u201cNeuroelectric therapy\u201d\n\nSEARCH STRATEGY #3:\n\nTIME PERIOD COVERED: from inception to 7/17/2017\nLANGUAGE: English\nSimilar Article searches on the following articles:\n\nA clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression\nTimothy H.\nBarclay a,n, Raymond D.\nBarclay b, Journal of Affective Disorders\n164 (2014) 171\u201317724856571\n\n\nAlfred G.\nBracciano , Wen-Pin\nChang , Stephanie\nKokesh , Abe\nMartinez ,Melissa\nMeier & Kathleen\nMoore (2012) Cranial Electrotherapy Stimulation in the Treatment of Posttraumatic Stress Disorder: A Pilot Study of Two Military Veterans, Journal of Neurotherapy, 16:1, 60-69, DOI: 10.1080/10874208.2012.650100 \u2013 NOT IN PUBMED\n\n\nEfficacy of cranial electric stimulation for the treatment of insomnia: A randomized pilot study\nR. Gregory\nLande,*, Cynthia\nGragnanib\nComplementary Therapies in Medicine (2013) 21, 8\u20141323374200\n\nCranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia\n\nCranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia\nTaylor, A. G., Anderson, J. G.\nRiedel, S. L.\nLewis, J. E.\nKinser, P. A.\nBourguignon, C.\nPain Manag Nurs, (2013) 14(4), 327-33524315255\n\n\nSEARCH STRATEGY #4:\n\nTIME PERIOD COVERED: from inception to 10/10/17\nLANGUAGE: English\n\u201ctranscranial electrical stimulation\u201d(Title) OR \u201ctranscranial electric stimulation\u201d(Title)\n________________________________________________________________________________________________________\nDATABASE SEARCHED: PsycINFO\n\nSEARCH STRATEGY #1\n\nTIME PERIOD COVERED: from inception to 2/4/2016\nLANGUAGE: English\nS1 TI ( \u201ccranial electrotherapy\u201d OR \u201ccranial electric stimulation\u201d OR \u201ccranial electrical stimulation\u201d ) OR SU ( \u201ccranial electrotherapy\u201d OR \u201ccranial electric stimulation\u201d OR \u201ccranial electrical stimulation\u201d ) OR AB ( \u201ccranial electrotherapy\u201d OR \u201ccranial electric stimulation\u201d OR \u201ccranial electrical stimulation\u201d ) OR (SU electrical stimulation AND ( brain OR cranial OR transcranial ))\nAND\nTI ( pain OR painful OR depression OR depressive OR anxiety OR anxiety disorders(mh) OR post-traumatic stress OR posttraumatic stress OR \u201cpost traumatic stress\u201d OR ptsd OR insomnia OR sleep* OR fibromyalgia ) OR SU ( pain OR painful OR depression OR depressive OR anxiety OR anxiety disorders(mh) OR post-traumatic stress OR posttraumatic stress OR \u201cpost traumatic stress\u201d OR ptsd OR insomnia OR sleep* OR fibromyalgia ) OR AB (pain OR painful OR depression OR depressive OR anxiety OR anxiety disorders(mh) OR post-traumatic stress OR posttraumatic stress OR \u201cpost traumatic stress\u201d OR ptsd OR insomnia OR sleep* OR fibromyalgia)\nOR\nTI ( \u201cfisher wallace stimulation\u201d OR alpha-stim ) OR SU ( \u201cfisher wallace stimulation\u201d OR alpha-stim ) OR AB ( \u201cfisher wallace stimulation\u201d OR alpha-stim )\n\nSEARCH STRATEGY #1A (update to Search #1):\n\nTIME PERIOD COVERED: 1/1/2016-7/12/2017\nLANGUAGE: English\nTI ( \u201ccranial electrotherapy\u201d OR \u201ccranial electric stimulation\u201d OR \u201ccranial electrical stimulation\u201d ) OR SU ( \u201ccranial electrotherapy\u201d OR \u201ccranial electric stimulation\u201d OR \u201ccranial electrical stimulation\u201d ) OR AB ( \u201ccranial electrotherapy\u201d OR \u201ccranial electric stimulation\u201d OR \u201ccranial electrical stimulation\u201d ) OR SU (electrical stimulation AND ( brain OR cranial OR transcranial )) OR TI ( \u201cfisher wallace stimulation\u201d OR alpha-stim ) OR SU ( \u201cfisher wallace stimulation\u201d OR alpha-stim ) OR AB ( \u201cfisher wallace stimulation\u201d OR alpha-stim )\nAND\nTI ( pain OR painful OR depression OR depressive OR anxiety OR post-traumatic stress OR posttraumatic stress OR \u201cpost traumatic stress\u201d OR ptsd OR insomnia OR sleep* OR fibromyalgia ) OR SU ( pain OR painful OR depression OR depressive OR anxiety OR post-traumatic stress OR posttraumatic stress OR \u201cpost traumatic stress\u201d OR ptsd OR insomnia OR sleep* OR fibromyalgia ) OR AB (pain OR painful OR depression OR depressive OR anxiety OR post-traumatic stress OR posttraumatic stress OR \u201cpost traumatic stress\u201d OR ptsd OR insomnia OR sleep* OR fibromyalgia)\n\nSEARCH STRATEGY #2:\n\nTIME PERIOD COVERED: from inception to 7/12/2017\nLANGUAGE: ALL\nTI (Electrosleep OR \u201cTranscerebral electrotherapy\u201d OR \u201cNeuroelectric therapy\u201d) OR SU((Electrosleep OR \u201cTranscerebral electrotherapy\u201d OR \u201cNeuroelectric therapy\u201d) OR AB ((Electrosleep OR \u201cTranscerebral electrotherapy\u201d OR \u201cNeuroelectric therapy\u201d)\n\nSEARCH STRATEGY #3:\n\nTIME PERIOD COVERED: from inception to 10/10/17\nLANGUAGE: English\nTI (\u201ctranscranial electrical stimulation\u201d OR \u201ctranscranial electric stimulation\u201d)\n________________________________________________________________________________________________________\nDATABASE SEARCHED: Cochrane databases\n\nSEARCH STRATEGY\n\nTIME PERIOD COVERED: from inception to 2/4/2016\nLANGUAGE: English\n\nSEARCH STRATEGY #1\n\n(\u201ccranial electrotherapy\u201d or \u201ccranial electric stimulation\u201d or \u201ccranial electrical stimulation\u201d:ti,ab,kw) OR (electrical stimulation and (brain or cranial or transcranial)):ti,ab,kw OR (\u201cfisher wallace stimulation\u201d or alpha-stim):ti,ab,kw (Word variations have been searched)\nAND\npain or painful or depression or depressive or anxiety or anxiety disorders (mh ) or post-traumatic stress or posttraumatic stress or \u201cpost traumatic stress\u201d or ptsd or insomnia or sleep* or fibromyalgia:ti,ab,kw (Word variations have been searched)\n\nSEARCH STRATEGY #1A (update to Search #1)\n\nDATABASE SEARCHED: Cochrane CENTRAL\nTIME PERIOD COVERED: 1/1/2016-7/12/2017\nLANGUAGE: English\n\u2018\u201ccranial electrotherapy\u201d or \u201ccranial electric stimulation\u201d or \u201ccranial electrical stimulation\u201d in Title, Abstract, Keywords\n\nSEARCH STRATEGY #2:\n\nTIME PERIOD COVERED: from inception to 10/10/17\nLANGUAGE: English\n\u201ctranscranial electrical stimulation\u201d or \u201ctranscranial electric stimulation\u201d in Record Title\n________________________________________________________________________________________________________\nDATABASE SEARCHED: Embase\n\nSEARCH STRATEGY #1:\n\nTIME PERIOD COVERED: From inception to 7/12/2017\nLANGUAGE: English\n\u2018cranial electrotherapy\u2019 OR \u2018cranial electric stimulation\u2019 OR \u2018cranial electrical stimulation\u2019 OR \u2018fisher wallace stimulation\u2019 OR \u2018alpha stim\u2019/exp OR \u2018alpha stim\u2019\nAND\n(humans)/lim\n\nSEARCH STRATEGY #2:\n\nTIME PERIOD COVERED: from inception to 7/12/2017\nLANGUAGE: ALL\n\u2018electrosleep\u2019/exp OR electrosleep OR \u2018transcerebral electrotherapy\u2019 OR \u2018neuroelectric therapy\u2019\nAND\n(humans)/lim\n\nSEARCH STRATEGY #3:\n\nTIME PERIOD COVERED: from inception to 10/10/17\nLANGUAGE: English\n\u2018transcranial electrical stimulation\u2019:ti OR \u2018transcranial electric stimulation\u2019:ti\n________________________________________________________________________________________________________\n\nNOTE: ADDITIONAL FILTERS FOR ANIMAL-ONLY STUDIES WERE APPLIED IN ENDNOTE\n", "pairs": [], "interleaved": []}
+{"file": "vaespces_NBK493132/methods.nxml", "text": "TOPIC DEVELOPMENT\nThis topic was developed in response to a nomination by Joyce Edmondson, PSAS Clinical Program Manager, Office of Rehabilitation and Prosthetic Services (10P4R) and Friedhelm Sandbrink, MD, Deputy National Director, Pain Management, National Pain Management Program, Specialty Care Services (10P4E). Key questions were then developed with input from the topic nominator, the ESP coordinating center, the review team, and the technical expert panel (TEP).\nThe Key Questions were:\nCompared to usual care, what is the effectiveness of cranial electrical stimulation (CES) for the following conditions: chronic pain, depression, anxiety, PTSD, and insomnia?\nCompared to usual care, what are the risks of cranial electrical stimulation (CES) for the following conditions: chronic pain, depression, anxiety, PTSD, and insomnia?\nThe review was registered in PROSPERO: CRD42016023951.\nSEARCH STRATEGY\nWe searched Cochrane (through 10/10/2017), PsycINFO (through 10/10/2017), and Embase (through 10/10/2017), and PubMed (through 10/10/2017) for relevant literature using key terms relating to the conditions of interest and cranial electrical stimulation intervention. We also searched for similar articles in PubMed through 10/10/2017 for three key publications.7-9 The full search strategy is available in Appendix A. In addition to these searches, we also included references from expert recommendations, and searches of manufacturer websites or other material.\nSTUDY SELECTION\nAll titles were screened for retrieved citations by the Principal Investigator. Abstracts were then screened for relevant citations. For those abstracts deemed relevant, full-text articles were retrieved and screened against the following PICOTS framework, which describes our inclusion criteria:\nStudy design: Only randomized controlled trials were included\nPopulation(s): Adult patients with one or more of the following conditions: a chronic pain condition, depression, anxiety, insomnia, and posttraumatic stress disorder (PTSD)\nIntervention(s): Any cranial electrical stimulation (CES) device used in the home setting\nComparator(s): Usual care including appropriate known treatments\nOutcome(s): Chronic pain: pain severity, use of opioid analgesic medication, quality of life, and daily functioning; Depression and anxiety: clinical assessments, scores on standardized inventories; PTSD: symptom severity, quality-of-life measures, daily functioning; Insomnia: ability to initiate /maintain sleep, resolution of symptoms\nTiming: No restrictions\nSetting: Home setting, or office-based if needed for the conduct of the trial. Studies of hospitalized patients were excluded.\nDATA ABSTRACTION\nWe abstracted data on the following: condition, description of patients, description of CES, description of sham, sample size, duration of treatment, assessment of blinding, and results. Many studies reported outcomes in multiple domains. We only extracted primary outcomes. In other words, if the study assessed patients with a painful condition, we extracted pain outcomes. If the study assessed patients with anxiety, we extracted anxiety outcomes, etcetera.\nQUALITY ASSESSMENT\nWe assessed all included randomized controlled trials with the Cochrane Risk of Bias tool.10 Each included study was ranked Low, Unclear, or High (green, yellow, and red, respectively) on seven domains: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting, and other sources of bias. A full description of these domains is available in Appendix B. We judged that blinding was Low risk of bias only if a quantitative assessment was made of the blinding and similar proportions of subjects in each group believed they received active CES. We assessed risk of bias for the outcome assessment made nearest the end of the CES treatment.\nDATA SYNTHESIS\nFor continuous outcomes, sample size, mean change, and its standard deviation were extracted for each CES group and comparator group within each trial. If the mean change was not reported for a trial, then data at baseline and follow-up were extracted and a mean change was estimated. To estimate the standard deviation of the mean change, both the baseline and follow-up standard deviations were used and adjusted for the dependence between the two by using a correlation of 0.5 (the midpoint). A standardized mean difference (SMD) and its 95% confidence interval (CI) were estimated comparing the mean change between the CES and comparator group. A SMD less than zero suggests that the CES group performed better than the comparator group. For binary data, the sample size, number or percent of patients with an event were extracted. A risk ratio (RR) and its 95% CI was estimated comparing the CES group to the comparator group.\nA forest plot was created that included all studies with data capable of supporting an effect size analysis to facilitate visual comparison of results across studies and outcomes.\nThere were too few studies in any category of condition and specific CES device treatment to support meta-analysis. Therefore, our synthesis is narrative.\nRATING THE BODY OF EVIDENCE\nWhere possible a summary of findings and quality of evidence table was used to summarize the existing evidence. Based on the GRADE working group,11 the quality of the evidence was categorized as follows:\nHigh: We are very confident that the true effect lies close to that of the estimate of the effect.\nModerate: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.\nLow: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect.\nInsufficient: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.\nGRADE evaluates the quality of the evidence across all identified studies contributing to the outcome of interest.\nPEER REVIEW\nA draft version of the report was reviewed by technical experts and clinical leadership. Reviewer comments and our response are documented in Appendix C.", "pairs": [], "interleaved": []}
+{"file": "vaespces_NBK493132/summary.nxml", "text": "The principal conclusions of this systematic review are that the evidence is insufficient to support conclusions that CES has clinically important effects on headache, fibromyalgia, neuromuscular pain, depression, PTSD, or insomnia. There is low-strength evidence for a possible beneficial effect of modest size in patients who have anxiety with depression. CES is probably safe, in that no serious side effects have been reported, although reporting bias is present.\nSUMMARY OF EVIDENCE BY KEY QUESTION\nCompared to usual care, what is the effectiveness of cranial electrical stimulation (CES) for the following conditions: chronic pain, depression, anxiety, PTSD, and insomnia?\nCES may have a modest beneficial effect on symptoms of anxiety and depression in selected patients (SOE = LOW).\nCompared to usual care, what are the risks of cranial electrical stimulation (CES) for the following conditions: chronic pain, depression, anxiety, PTSD, and insomnia?\nCES does not cause serious adverse events but does cause certain minor symptoms (SOE = LOW).\nLIMITATIONS\nPublication Bias\nWe were not able to test for publication bias and can make no conclusions about its possible existence.\nStudy Quality\nThe principal limitation to this review is the quality of the original RCTs. With all RCTs at high risk of bias, even the few signals of benefits are suspect.\nHeterogeneity\nHeterogeneity is a limitation of this review as there were too few studies of the same patient and treatment to support statistical pooling.\nApplicability of Findings to the VA Population\nSeveral studies were specifically of VA populations and for those studies the applicability of findings is direct. Many other studies, however enrolled populations that differ from VA in gender and probably comorbidities (probably fewer comorbidities than VA populations) rendering their applicability to VA only moderate.\nRESEARCH GAPS/FUTURE RESEARCH\nThe biggest research gap and need for future research is adequately blinded studies of sufficient size to detect clinical benefits of moderate size. While the sample size depends on the specific outcome being assessed, a reasonable rule-of-thumb would be 60 patients per group. Given that VA has many patients with pain, depression, anxiety, PTSD, and insomnia, and given that these studies may be relatively short in duration (6 months), it should be very feasible for VA to mount a program of research to answer the questions about effectiveness and safety, and answer these questions within a few years (2 \u2013 4 years). As part of this evaluation, it would also be useful to understand whether any possible benefit persists after treatment discontinuation, or whether relapse in symptoms occur, and the timing of relapse. If CES is shown to have benefit compared to sham, then comparative effectiveness studies that assess CES compared to other proven active therapies for these conditions is warranted. Finally, long-term studies of safety may be needed.\nCONCLUSIONS\nThe evidence for the effectiveness and safety of CES is sparse. There is low strength evidence of a modest benefit in patients with anxiety and depression. CES is probably safe, but strength of evidence is low since few RCTs report adverse events. It should be feasible for VA to obtain better quality data to answer these questions through a series of RCTs with adequate blinding.", "pairs": [], "interleaved": []}