Feb 24, 2008
By: Alvaro Fernandez
(Note: neurofeedback is a form of biofeedback that measures brain waves and that, according to practitioners, provides good “brain training” for specific clinical conditions).
A few weeks ago Dr. David Rabiner wrote a great post on How Strong is the Research Support for Neurofeedback in Attention Deficits?, concluding that
– “It is for these reasons that neurofeedback is understandably regarded as an unproven treatment approach for ADHD at this time by many ADHD researchers.
– However, these studies do provide a solid basis for suggesting that if parents choose to pursue neurofeedback for their child, there is a reasonable chance that their child will benefit even though we can’t be sure that it is the specific EEG training that is responsible for the benefits. Thus, although the efficacy of neurofeedback has yet to be conclusively confirmed in a randomized, placebo-controlled trial, it is important to place this limitation in the context of the supportive research evidence that has been accumulated.
– Providing this context can help families better understand the strengths and limitations of the existing research on neurofeedback and enable them to make a better informed decision about whether to consider this treatment option for their child.”
This post prompted several good comments, one of which is reproduced below in its entirety, since it adds an interesting perspective.
Bernard writes: My wife tried EEG neurofeedback over 10 years ago in the hopes of normalizing her brain functioning to overcome lifelong epilepsy. She had a history of multiple, daily absence seizures and grand mal (tonic clonic) seizures once every two years.
After 3 and a half months of twice weekly sessions, we almost gave up on the neurofeedback. It was burning a hole in our wallet (no insurance covered it) and we were not seeing any results. However, we stuck with it (mostly because my wife refused to poison her liver with anti-epileptic drugs).
After 5 months, it was like someone had turned a switch. She stopped having seizures, was calmer, had better memory and cognitive functioning (thinking clearer). We stopped the neurofeedback sessions and she went 4 years without a single seizure event and likely would still be completely seizure free today we had not started a family (her TC seizure activity returned, but not the absence seizures, and got progressively worse with each pregnancy – but that’s a different story).
After our experience, I did as much digging as I could about EEG neurofeedback (see http://www.coping-with-epilepsy.com/forums/f22/eeg-neurofeedback-501/ ) and I’m really outraged that the medical industry continues to “poo-poo” the resounding body of evidence for it.
Snippets from my findings:”Randomized double blind placebo controlled clinical trials (RCT) are the current “gold standard” for demonstrating clinical efficacy of new drugs or therapies. It is very difficult for new therapeutic interventions to gain broad acceptance in the absence of such trials. Recent events have raised serious questions about the conditions under which placebo (sham) controls can be used. The international standards published by the World Medical Association (Declaration of Helsinki) prohibit placebo-controlled studies when known effective treatments exist. Additionally, there is new interest in identifying the mechanisms underlying the placebo response, which may challenge the “placebo” as a legitimate control condition. Both of these events should be of considerable interest to those interested in clinical psychophysiology in general and neurotherapy in particular. ”
“Recent New England Journal of Medicine reviews of research design have cast doubt on the need for placebo controlled designs. Their review has shown that when there is a preponderance of case series reports, the concordance between those results and those of the “gold standard” (double blind placebo controlled studies) was very high. Many in the field are now arguing against doing a double blind study due to the lack of proper humane treatment of those in the control group (receiving no treatment), an approach which is also now considered unethical by the World Health Organization when known treatments exist.”
“Since the first single-case study, reported over 30 years ago (Sterman & Friar, 1972), a fair number of controlled clinical studies, stemming from many different laboratories, have produced consistent data on the efficacy of SMR training in epileptic patients. It is particularly noteworthy that these results have been achieved in an extremely difficult subgroup of epilepsy patients, those with poorly controlled seizures who had proven unresponsive to pharmacological treatment. We will here provide only a cursory overview of this clinical research literature. For a more detailed treatment the interested reader is referred to Sterman (2000), while other recent summaries have also been provided by Monderer et al. (2002), and Walker and Kozlowski (2005).
In reviewing the data accumulated in these studies, Sterman (2000) found that 82% of 174 participating patients who were otherwise not controlled had shown significantly improved seizure control (defined as a minimum of 50% reduction in seizure incidence), with around 5% of these cases reporting a complete lack of seizures for up to 1 year subsequent to training cessation. …”
Because of the problems with designing a gold standard study, the Association for Applied Psychophysiology and Biofeedback (AAPB) has developed their own rating scale for measuring efficacy of neurofeedback for a given condition:
Conditions with ratings:
What really gets my goat is that EEG neurofeedback has been studied now since the 60s – almost 50 years and there have been no reports of iatrogenesis (a harmful effect produced by the healer or the healing process): “Fortunately, adverse reactions to biofeedback training are overall rare, and when they occur they are relatively transient or readily dealt with by competent practitioners (Hammond, 2001; Schwartz & Schwartz, 1995).”
So here we have a treatment option that has been studied for over 50 years, has no negative/side/adverse effects, has tons of evidence supporting it’s efficacy, but doesn’t have a single commercial entity that “owns” it in the same way that drug companies and medical device companies own their solutions. No company is pushing for FDA approval – or studies – or marketing it, because it’s not cost effective for them.
Cyberonics was able to get FDA approval, acceptance by the neurology industry and insurance coverage for their VNS medical device for epilepsy with studies showing more dubious efficacy than EEG neurofeedback and with well established, potentially serious adverse risks. It truly infuriates me to see how the commercial aspect of the medical industry drives options for patient choice in treatments.
(Note: I will now bring the few comments that followed, so it is easier to continue the conversation here).