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Herbal medicine for acute management and rehabilitation of traumatic brain injury: A protocol for a systematic review.

ABSTRACT: BACKGROUND:This systematic review protocol describes the methods that will be used to evaluate the efficacy and safety of herbal medicine in treating traumatic brain injury. METHODS AND ANALYSIS:The following electronic databases will be searched up to December 2018 without language or publication status restrictions: Medline, EMBASE, the Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine Database, and Cumulative Index to Nursing and Allied Health Literature. We will also search Korean, Chinese, and Japanese databases. Any randomized controlled trials related to herbal medicine for traumatic brain injury will be included. The functional outcome, consciousness state, morbidity, and mortality will be assessed as primary outcomes. The quality of life, adverse events, and total effective rate will be evaluated as secondary outcomes. Two researchers will independently perform the study selection, data extraction, assessment of study quality, and evaluation of the quality of evidence for the main findings. Data synthesis and analysis will be performed using RevMan version 5.3. The results will be expressed as a risk ratio for the binary outcome and as the mean difference or standardized mean difference for a continuous outcome. We will synthesize the data by either fixed effects or random effects model according to a heterogeneity test or the number of studies included in the meta-analysis. The methodological quality of the included studies will be evaluated using the Cochrane Collaboration's risk of bias tool. The quality of evidence for each main outcome will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach. ETHICS AND DISSEMINATION:Ethical approval is not required because individual patient data are not included. The findings of this systematic review will be disseminated through a peer-reviewed publication or conference presentations. PROSPERO REGISTRATION NUMBER:CRD42018116559.

SUBMITTER: Lee B

PROVIDER: S-EPMC6370117 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Herbal medicine for acute management and rehabilitation of traumatic brain injury: A protocol for a systematic review.

Lee Boram B Leem Jungtae J Kim Hyunho H Jo Hee-Geun HG Yoon Sang-Hoon SH Shin Aesook A Sul Jae-Uk JU Choi Ye-Yong YY Yun Younghee Y Kwon Chan-Young CY

Medicine 20190101 3

<h4>Background</h4>This systematic review protocol describes the methods that will be used to evaluate the efficacy and safety of herbal medicine in treating traumatic brain injury.<h4>Methods and analysis</h4>The following electronic databases will be searched up to December 2018 without language or publication status restrictions: Medline, EMBASE, the Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine Database, and Cumulative Index to Nursing and Allied Health Li ...[more]

PMID: 30653148

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Project description:BackgroundComorbidity can affect health-care utilization and outcomes, and the results and interpretation of risk adjustment studies that attempt to predict rehabilitation utilization and outcomes are influenced by the choice of comorbidity measurement. Although the identification of an appropriate measurement has been conducted in some populations and outcomes, this information is currently lacking for the non-traumatic brain injury (nTBI) population in inpatient rehabilitation settings. As such, this is a systematic review protocol to survey the methods used to measure comorbidities in the rehabilitation setting for patients with nTBI.Methods/designMEDLINE, MEDLINE In-Process, Embase, The Cochrane Database of Systematic Reviews, PsycINFO, and Health and Psychosocial Instruments will be systematically searched using the concepts 'nTBI,' 'comorbidity,' and 'rehabilitation.' Grey matters and the reference list of eligible articles will also be searched. Study selection will be performed independently by two reviewers based on predetermined eligibility criteria through two rounds of screening using, first, the title and abstract, followed by full-text. Extracted information will include study purpose, design, and setting; data source and type; outcomes variables; statistical methods; comorbidity measurement method, rationale, justification, or validation; and results involving comorbidity. The data will be tabulated and narratively synthesized. Meta-analyses will be performed if appropriate.Systematic review registrationThis protocol has not been registered with PROSPERO.DiscussionThis protocol provides a systematic method for surveying current practice as well as monitoring the progress on comorbidity measurement methodology and effects of comorbidity on rehabilitation outcomes for patients with nTBI. The selection of an appropriate comorbidity measurement method has implications for the interpretation of both descriptive and risk adjustment studies, and thus, the validity of evidence used to inform planning and delivery of services.

Project description:Background: This systematic review aimed to evaluate the effectiveness (functional outcomes and clinical symptoms) and safety (incidence of adverse events) of herbal medicine (HM) as monotherapy or adjunctive therapy to conventional treatment (CT) for traumatic brain injury (TBI). Methods: We comprehensively searched 14 databases from their inception until July 2019. Randomized controlled trials (RCTs) using HM as monotherapy or adjunctive therapy to treat TBI patients were included. The primary outcome was functional outcomes, consciousness state, morbidity, and mortality. Meta-analysis was performed to calculate a risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CIs), when appropriate data were available. Methodological quality of RCTs and the strength of evidence were also assessed. Results: Thirty-seven RCTs with 3,374 participants were included. According to meta-analysis, HM as a monotherapy (RR 1.29, 95% CI: 1.21-1.37) or an adjunctive therapy to CT (RR 1.21, 95% CI: 1.16-1.27) showed significantly better total effective rate based on clinical symptoms, compared to CT alone. Subgroup analysis showed that HM had significantly improved post-concussion syndrome, dizziness, headache, epilepsy, and mild TBI, but not traumatic brain edema, compared to CT. Moreover, HM combined with CT had significantly improved post-concussion syndrome, mental disorder, headache, epilepsy, and mild TBI-like symptoms, but not cognitive dysfunction and posttraumatic hydrocephalus, compared to CT alone. When HM was combined with CT, functional outcomes such as activities of daily living and neurological function were significantly better than in patients treated using CT alone. In terms of the incidence of adverse events, HM did not differ from either CT (RR 0.88, 95% CI: 0.33-2.30) or placebo (RR 2.29, 95% CI: 0.83-6.32). However, HM combined with CT showed better safety profile than CT alone (RR 0.64, 95% CI: 0.44-0.93). Most studies had a high risk of performance bias, and the quality of evidence was mostly rated "very low" to "moderate," mostly because the included studies had a high risk of bias and imprecise quantitative synthesis results. Conclusion: The current evidence suggests that there is insufficient evidence for recommending HM for TBI in clinical practice. Therefore, further larger, high-quality, rigorous RCTs should be conducted.

Project description:Background: Mild traumatic brain injury (mTBI) results from an external force to the head or body causing neurophysiological changes within the brain. The number and severity of symptoms can vary, with some individuals experiencing rapid recovery, and others having persistent symptoms for months to years, impacting their quality of life. Current rehabilitation is limited in its ability to treat persistent symptoms and novel approaches are being sought to improve outcomes following mTBI. Neuromodulation is one technique used to encourage adaptive neuroplasticity within the brain. Objective: To systematically review the literature on the efficacy of neuromodulation in the mTBI population. Method: A systematic review was conducted using Medline, Embase, PsycINFO, PsycARTICLES and EBM Review. Preferred Reporting Items for Systematic Reviews and the Synthesis Without Meta-analysis reporting guidelines were used and a narrative review of the selected studies was completed. Fourteen articles fulfilled the inclusion criteria which were published in English, investigating an adult sample and using a pre- and post-intervention design. Studies were excluded if they included non-mild TBI severities, pediatric or older adult populations. Results: Thirteen of fourteen studies reported positive reductions in mTBI symptomatology following neuromodulation. Specifically, improvements were reported in post-concussion symptom ratings, headaches, dizziness, depression, anxiety, sleep disturbance, general disability, cognition, return to work and quality of life. Normalization of working memory activation patterns, vestibular field potentials, hemodynamics of the dorsolateral prefrontal cortex and excessive delta wave activity were also seen. The studies reviewed had several methodological limitations including small, heterogenous samples and varied intervention protocols, limiting generalisability. Further research is required to understand the context in which neuromodulation may be beneficial. Conclusions: While these positive effects are observed, limitations included unequal representation of neuromodulation modalities in the literature, and lack of literature describing the efficacy of neuromodulation on the development or duration of persistent mTBI symptoms. Better clarity regarding neuromodulation efficacy could have a significant impact on mTBI patients, researchers, clinicians, and policy makers, facilitating a more productive post-mTBI population. Despite the limitations, the literature indicates that neuromodulation warrants further investigation. PROSPERO registration number: CRD42020161279.

Project description:ObjectiveTo assess the incidence of, causes for, and factors associated with readmission to an acute care hospital (RTAC) during inpatient rehabilitation for traumatic brain injury (TBI).DesignProspective observational cohort.SettingInpatient rehabilitation.ParticipantsIndividuals with TBI admitted consecutively for inpatient rehabilitation (N=2130).InterventionsNot applicable.Main outcome measuresRTAC incidence, RTAC causes, rehabilitation length of stay (RLOS), and rehabilitation discharge location.ResultsA total of 183 participants (9%) experienced RTAC for a total of 210 episodes. Of 183 participants, 161 patients experienced 1 RTAC episode, 17 had 2, and 5 had 3. The mean time from rehabilitation admission to first RTAC was 22±22 days. The mean duration in acute care during RTAC was 7±8 days. Eighty-four participants (46%) had ≥1 RTAC episodes for medical reasons, 102 (56%) had ≥1 RTAC episodes for surgical reasons, and 6 (3%) participants had RTAC episodes for unknown reasons. Most common surgical RTAC reasons were neurosurgical (65%), pulmonary (9%), infection (5%), and orthopedic (5%); most common medical reasons were infection (26%), neurological (23%), and cardiac (12%). Any RTAC was predicted as more likely for patients with older age, history of coronary artery disease, history of congestive heart failure, acute care diagnosis of depression, craniotomy or craniectomy during acute care, and presence of dysphagia at rehabilitation admission. RTAC was less likely for patients with higher admission FIM motor scores and education less than high school diploma. RTAC occurrence during rehabilitation was significantly associated with longer RLOS and smaller likelihood of discharge home.ConclusionsApproximately 9% of patients with TBI experienced RTAC episodes during inpatient rehabilitation for various medical and surgical reasons. This information may help inform interventions aimed at reducing interruptions in rehabilitation for RTAC. RTACs were associated with longer RLOS and discharge to an institutional setting.

Project description:BackgroundMild traumatic brain injury (mTBI) is an acknowledged public health problem. Up to 25% of adult with mTBI present persistent symptoms. Headache, dizziness, nausea and neck pain are the most commonly reported symptoms and are frequently associated with cervical spine and vestibular impairments. The most recent international consensus statement (2017 Berlin consensus) recommends the addition of an individualized rehabilitation approach for mTBI with persistent symptoms. The addition of an individualized rehabilitation approach including the evaluation and treatment of cervical and vestibular impairments leading to symptoms such as neck pain, headache and dizziness is, however, recommended based only on limited scientific evidence. The benefit of such intervention should therefore be further investigated.ObjectiveTo compare the addition of a 6-week individualized cervicovestibular rehabilitation program to a conventional approach of gradual sub-threshold physical activation (SPA) alone in adults with persistent headache, neck pain and/or dizziness-related following a mTBI on the severity of symptoms and on other indicators of clinical recovery. We hypothesize that such a program will improve all outcomes faster than a conventional approach (between-group differences at 6-week and 12-week).MethodsIn this single-blind, parallel-group randomized controlled trial, 46 adults with subacute (3 to12 weeks post-injury) persistent mTBI symptoms will be randomly assigned to: 1) a 6-week SPA program or 2) SPA combined with a cervicovestibular rehabilitation program. The cervicovestibular rehabilitation program will include education, cervical spine manual therapy and exercises, vestibular rehabilitation and home exercises. All participants will take part in 4 evaluation sessions (baseline, week 6, 12 and 26) performed by a blinded evaluator. The primary outcome will be the Post-Concussion Symptoms Scale. The secondary outcomes will be time to clearance to return to function, number of recurrent episodes, Global Rating of Change, Numerical Pain Rating Scale, Neck Disability Index, Headache Disability Inventory and Dizziness Handicap Inventory. A 2-way ANOVA and an intention-to-treat analysis will be used.DiscussionControlled trials are needed to determine the best rehabilitation approach for mTBI with persistent symptoms such as neck pain, headache and dizziness. This RCT will be crucial to guide future clinical management recommendations.Trial registrationClinicalTrials.gov Identifier - NCT03677661, Registered on September, 15th 2018.

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Herbal medicine for acute management and rehabilitation of traumatic brain injury: A protocol for a systematic review.

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Herbal medicine for acute management and rehabilitation of traumatic brain injury: A protocol for a systematic review.

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