Evidence-Based Medicine

Research Papers

Evaluation of current post-concussion protocols

Kim, Kristin, Priefer, Ronny (2020) · Biomedicine & Pharmacotherapy = Biomedecine & Pharmacotherapie

The growing number of concussions and mild traumatic brain injuries (mTBI) with the lack of evidence-based treatment options is a continuous health concern. This creates problems when evaluating and providing efficacious symptom management to patients suffering from post-concussion syndrome (PCS). Numerous pharmacological and non-pharmacological agents have been utilized in an attempt to treat PCS. Some of these approaches include physical therapy, analgesics, antidepressants, and nutraceuticals. Although these treatments have had some success, there has been inconsistent outcomes, with some examples of patients' symptoms worsening. Among pharmaceutical agents, fluoxetine has been a popular choice for the symptom management of PCS. Although some patients have had symptom resolution with the use of fluoxetine, there is still a lack of conclusive data. Of the several biochemical changes that occur in a patient's brain following a concussion, an increase in reactive oxygen species (ROS) is of particular concern. In order to counteract the responses of the brain, antioxidants, such as ascorbic acid, have been utilized to reverse the damaging cellular effects. However, this may inadvertently cause an increase in ROS, rather than a reduction. Although there is a lack of consistency in exactly when each treatment was used in the post-injury interval, it is important that we analyze the strengths and weaknesses of the most commonly used agents due to the lack of a set protocol. The studies were chosen in a non-exhaustive manner and were not consistent in patients' post-injury intervals, in addition to other baseline characteristics. However, over-arching claims that some treatments may benefit more than others can be made. This review evaluates both the pharmaceutical and non-pharmaceutical protocols that are most commonly utilized in post-concussive patients for their efficacy in treatment of post-concussive syndrome (PCS).

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19 Channel Z-Score and LORETA Neurofeedback: Does the Evidence Support the Hype?

Coben, Robert, Hammond, D. Corydon, Arns, Martijn (2019) · Applied Psychophysiology and Biofeedback

Neurofeedback is a well-investigated treatment for ADHD and epilepsy, especially when restricted to standard protocols such as theta/beta, slow cortical potentials and sensori-motor rhythm neurofeedback. Advances in any field are welcome and other techniques are being pursued. Manufacturers and clinicians are marketing 'superior' neurofeedback approaches including 19 channel Z-score neurofeedback (ZNFB) and 3-D LORETA neurofeedback (with or without Z-scores; LNFB). We conducted a review of the empirical literature to determine if such claims were warranted. This review included the above search terms in Pubmed, Google scholar and any references that met our criteria from the ZNFB publication list and was restricted to group based studies examining improvement in a clinical population that underwent peer review (book chapters, magazine articles or conference presentations are not included since these are not peer reviewed). Fifteen relevant studies emerged with only six meeting our criterion. Based on review of these studies it was concluded that empirical validation of these approaches is sorely lacking. There is no empirical data that supports the notion that 19-channel z-score neurofeedback is effective or superior. The quality of studies for LNFB was better compared to ZNFB and some suggestion for efficacy was demonstrated for ADHD and Tinnitus distress. However, these findings need to be replicated, extended to other populations and have yet to show any "superiority." Our conclusions continue to emphasize the pervasive lack of evidence supporting these approaches to neurofeedback and the implications of this are discussed.

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Efficacy of Biofeedback for Medical Conditions: an Evidence Map

Kondo, Karli, Noonan, Katherine M., Freeman, Michele, Ayers, Chelsea, Morasco, Benjamin J., Kansagara, Devan (2019) · Journal of General Internal Medicine

BACKGROUND: Biofeedback is increasingly used to treat clinical conditions in a wide range of settings; however, evidence supporting its use remains unclear. The purpose of this evidence map is to illustrate the conditions supported by controlled trials, those that are not, and those in need of more research. METHODS: We searched multiple data sources (MEDLINE, PsycINFO, CINAHL, Epistemonikos, and EBM Reviews through September 2018) for good-quality systematic reviews examining biofeedback for clinical conditions. We included the highest quality, most recent review representing each condition and included only controlled trials from those reviews. We relied on quality ratings reported in included reviews. Outcomes of interest were condition-specific, secondary, and global health outcomes, and harms. For each review, we computed confidence ratings and categorized reported findings as no effect, unclear, or insufficient; evidence of a potential positive effect; or evidence of a positive effect. We present our findings in the form of evidence maps. RESULTS: We included 16 good-quality systematic reviews examining biofeedback alone or as an adjunctive intervention. We found clear, consistent evidence across a large number of trials that biofeedback can reduce headache pain and can provide benefit as adjunctive therapy to men experiencing urinary incontinence after a prostatectomy. Consistent evidence across fewer trials suggests biofeedback may improve fecal incontinence and stroke recovery. There is insufficient evidence to draw conclusions about effects for most conditions including bruxism, labor pain, and Raynaud's. Biofeedback was not beneficial for urinary incontinence in women, nor for hypertension management, but these conclusions are limited by small sample sizes and methodologic limitations of these studies. DISCUSSION: Available evidence suggests that biofeedback is effective for improving urinary incontinence after prostatectomy and headache, and may provide benefit for fecal incontinence and balance and stroke recovery. Further controlled trials across a wide range of conditions are indicated.

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Qualitative systemic review of randomized controlled trials on complementary and alternative medicine treatments in fibromyalgia

Baranowsky, Julia, Klose, Petra, Musial, Frauke, Häuser, Winfried, Dobos, Gustav, Langhorst, Jost (2009) · Rheumatology International

The objectives of the study were identification, quality evaluation and summary of RCTs on complementary and alternative medicine as defined by the National Institute of Health with the exception of dietary and nutritional supplements. A computerized search of databases from 1990 (year of publication of the ACR criteria for fibromyalgia) to July 2007 was performed. The RCTs were assessed by a methodological quality score. A total of 23 RCTs issued from 1992 to 2007 on acupuncture, balneotherapy, thermotherapy, magnetic therapy, homeopathy, manual manipulation, mind-body medicine, diet therapy and music therapy were identified. The RCTs had an average group size of 25 with the number of groups ranging from two to four. The quality score assessment of the RCTs yielded a mean score of 51 out of 100. The average methodological quality of the identified studies was fairly low. Best evidence was found for balneotherapy/hydrotherapy in multiple studies. Positive results were also noted for homeopathy and mild infrared hyperthermia in 1 RCT in each field. Mindfulness meditation showed mostly positive results in two trials and acupuncture mixed results in multiple trials with a tendency toward positive results. Tendencies for improvement were furthermore noted in single trials of the Mesendieck system, connective tissue massage and to some degree for osteopathy and magnet therapy. No positive evidence could be identified for Qi Gong, biofeedback, and body awareness therapy.

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