Why is it that just when we get used to evidence-based care, we now have to do value-based care? I find evidence-based care for common neurological disorders, such as epilepsy and dementia, valuable. Guidelines provide a framework and act as a reminder to maintain good quality.
But now, there is money on the table. The Medicare Access and CHIP Reauthorization Act (MACRA) was passed by Congress last year. When it comes into play, probably in 2017, physicians must choose between a Merit-Based Incentive Payment System or an Alternative Payment Model. The APM is broadly similar to the old concept of IPAs and capitation. None of us looks back at those years fondly, and this new payment model may prove to be a disaster for neurologists and their patients. Specialists will most likely participate in MIPS and not APM. There is a fixed pool of money in MIPS, so there will be winners and losers.
The American Academy of Neurology admirably has developed a “Payment Alternatives Team” and is partnering with its members to establish appropriate care for headaches and epilepsy, which I assume will be loosely based upon evidence-based guidelines.
We should applaud the AAN. For neurologists in private practice, this is truly a brave new world.
See Neurology Today, June 25, 2016, page 30.
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The mere act of being recruited into a clinical trial has clinical and biological effects. These are independent from placebo and nocebo effects. These biases are the Hawthorne effect.
Workers in a factory near Chicago, the Hawthorne Works, were observed in higher or lower amounts of light to determine which increased productivity. The conclusion was that productivity was improved only because the workers were being observed. Similarly, subjects in clinical trials often show improvement because of better attention, better observation, better care, better compliance, and better adherence. Advocates of surgical safety checklists, developed to reduce morbidity and mortality, were surprised when they learned that the mere fact that surgeons were under observation, and not any specific details of the checklist, improved performance. In clinical trials, some subjects improve between recruitment and the beginning of treatment, before any therapy has been given.
Social interaction among participants in a trial leads to more biases. Both placebo and nocebo responses can be seen. Mass psychogenic illnesses are an example of nocebo responses. They correlate with empathy scores and pain catastrophizing. These social and psychological factors may be crucial for nocebo hyperalgesia.
See Lancet Neurology, 2016, volume 15, page 736.
Many patients with migraine use “complementary and alternative medicine” and often do not discuss this with their physicians. There have been guidelines on supplements for migraine from various professional societies, and recommendations often conflict.
The greatest number of studies has been done with riboflavin, coenzyme Q10, magnesium, butterbur, feverfew, and omega-3 polyunsaturated fatty acids.
Nutraceuticals are lightly regulated by the FDA. It considers them as different from conventional foods and drugs. By contrast, in Canada, there are strict regulations. In 2015, the attorney’s office of New York State brought suit against 4 major US retailers for selling fraudulent and potentially dangerous herbal supplements and demanded that they be removed from store shelves. At a popular retail chain, 3 out of the 6 products tested negative for the herbs listed on their labels.
This is vitamin B2. Patients who take this have a yellow color in their urine. Dose is 400 mg daily. It is usually well tolerated, with minor side effects of diarrhea and increased urination. There is a compound consisting of riboflavin 400 mg daily with magnesium 300 mg and feverfew 100 mg daily. It did not show consistent benefit in one study. There is low quality evidence for use of riboflavin though there are minimal side effects.
This is widely used, and some patients think it can reduce the risk of heart disease or dementia, though these conclusions are unproven. The migraine dose is 100 mg 3 times a day, obviously less convenient than a single daily dose. There was significant benefit compared to placebo, with effect appearing after the first month and being maximal after 3 months. Side effects were minimal, with only 1 patient having a skin allergy. Some studies show that CoQ10 deficiency may be common in children and adolescents with migraine, and obtaining a serum CoQ10 level before supplementation may be a helpful guide.
The usual dose is magnesium citrate, which contains 600 mg of elemental magnesium daily. Diarrhea was seen in about 20% and gastric irritation in 5%. Similar to CoQ10, some studies show low magnesium levels in migraineurs, and checking levels prior to supplementation may be helpful.
This is derived from a shrub called Petasites hybridus. It was initially available as a particular brand, Petadolex, manufactured in Germany with a method that was said to remove toxins termed pyrrolizidine alkaloids, which have hepatotoxicity. This preparation has been widely used for years and has shown effect in placebo studies. In the last several years, cases have been recognized of significant liver damage from both the Petadolex formulation and other products. Marketing authorization for Petadolex was withdrawn in Germany in 2008. To me, the risks do not outweigh the modest benefit seen in trials.
This is derived from a daisy-like plant. A review of 5 trials covering 343 patients found mixed results and did not convincingly establish that it is effective for preventing migraine. No safety problems were found, and side effects were minimal.
The best evidence is for use of riboflavin 400 mg daily, coenzyme Q10 100 mg three times daily, and magnesium 600 mg daily.
See Headache Currents (In Headache), May 2016.
For more information visit our Headache Center’s website.