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Alternative Therapies

Two leading headache experts, Drs. Richard Lipton and Dawn Buse of the Montefiore Headache clinic gave positive comments on the report published in Pain and described in my recent post. Another headache specialist from Texas, Dr. Deborah Friedman was also quoted about this research report in Neurology Today.

“Acupuncture studies are difficult because the blinding is difficult,” Richard B. Lipton, MD, FAAN, the Edwin S. Lowe professor and vice chair of neurology at the Albert Einstein College of Medicine, said. He noted that even comparisons using sham procedures may not entirely blind the patient to whether he or she is receiving a real treatment in which needles are inserted in the “meridian” — the points where energy is said to flow.“ That said, the authors in their review show that acupuncture is very substantially better than usual care. I think in aggregate these data demonstrate that real acupuncture is very helpful to people with episodic migraine in terms of reducing the number of headache days. My longstanding practice has been to arrange acupuncture for patients who ask for it, but not to recommend it otherwise,” Dr. Lipton said. “This review is going to impact what I do. It’s 22 randomized trials, and the Cochrane review is 150 pages. I think this is an important summary of the best evidence. I think it’s quite positive. I want to make my patients better so the imperfect blinding doesn’t matter.”

Dawn C. Buse, PhD, associate professor of neurology at Albert Einstein College of Medicine of Yeshiva University, also found the review persuasive, while noting that the mechanism by which acupuncture works is unknown and may be influenced by factors other than the procedure itself. “This review demonstrates that acupuncture may be helpful in reducing the frequency of migraine attacks and is likely to be well tolerated when compared to pharmacologic treatment,” she said. “We do not know from this review how patients who incorporate both acupuncture and optimized pharmacologic approaches fare. However, we know from meta-analyses of combined behavioral and pharmacologic approaches to migraine management that the combination is superior to either approach alone both in initial and sustained response.” She added: “Evidence suggests that many additional factors unrelated to acupuncture needling including expectations, beliefs, openness to experience, and the quality of the patient-provider relationship may play important roles in the beneficial effects of acupuncture for a particular patient. In addition, it is likely that patients who participate in and as a result report benefit from acupuncture are people who are interested and open to nonpharmacologic approaches. It is likely a patient who is open to nonpharmacologic approaches may also be a patient who will take a more active role in migraine management.” Dr. Buse noted that this type of patient is likely to have better treatment outcomes, no matter what type of treatment, due to higher levels of self-efficacy and willingness to actively engage in all aspects of treatment such as following treatment recommendations for healthy lifestyle habits, exercising, managing stress and healthy sleep hygiene. “Based upon these findings, it is reasonable to suggest that a patient who is interested and motivated to try acupuncture to manage migraine may benefit,” she told Neurology Today. “There are likely to be few if any side effects or risks to acupuncture, other than time and financial expense since acupuncture may not be covered by insurance. In addition, it may be difficult to advise a patient how to find a provider with proper training, skill, and knowledge to provide successful treatment and to know exactly what successful treatment would entail. The body of literature suggests that combined pharmacologic plus behavioral approaches are superior to either one alone, Dr. Buse noted. It may be therefore wise to recommend that patients who are interested in acupuncture combine it with optimized pharmacologic and behavioral treatments for the best chance of treatment outcome with lasting benefits, she said.

Dr. Lipton echoed that comment. “Acupuncture is one of many nonpharmacologic treatments for migraine,” he said. “The nonpharmacologic interventions include education, helping people identify triggers, some vitamins and herbs that are evidence-based, cognitive-behavior therapy and biofeedback. So my broad comment is that we should not restrict what is in our toolbox and consider a range of non-pharmacologic as well as pharmacologic treatments.”

But another reviewer, Deborah I. Friedman, MD, MPH, FAAN, chief of the division of headache medicine and professor of neurology & neurotherapeutics and ophthalmology at University of Texas-Southwestern in Dallas, expressed some reservations about the quality of the data. “Acupuncture is helpful in some patients with episodic migraine, particularly as an ‘add on’ treatment, but the quality of the data from clinical trials is moderate overall. There is a lot of variability in acupuncture technique amongst practitioners,” she said. “Patients who are interested in acupuncture should be referred to reputable practitioners who have had proper training.” She added: “In general, I don’t discourage it, but I rarely suggest it as an option unless the patient asks about it, or if I get the sense that they are interested in natural remedies. I tell my patients that the clinical evidence to support acupuncture treatment for migraine is not strong, with mixed results. However, it is safe and many patients find it useful, particularly those who are attracted to ‘natural’ or non-pharmacological treatments, and those who have not tolerated conventional therapies.” Dr. Friedman said that in the program at University of Texas Southwestern Medical Center, physical therapists are trained to do dry needling. “It seems to benefit many of our patients with refractory head and neck pain,” she said. “I make it clear to my patients that this is not the same as traditional acupuncture, and encourage them to try it once to see if it helps.”

Dr. Linde, one of the authors of the original report, noted in his comments that the problem of blinding affects the study of many treatments that are not pharmacologic in nature. “While the overall quality of a number of trials is actually quite good, one has to keep in mind that apart from sham-controlled trials acupuncture studies are usually not blind. However, this applies to almost all non-pharmacological treatments.”

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Acupuncture for the treatment of migraines has been studied in dozens of clinical trials. A 2012 study mentioned in a previous blog post described a rigorous trial done in 480 patients with highly positive results. The largest, albeit uncontrolled study was done in Germany and involved over 15,000 patients. A well controlled and randomized study of 960 patients comparing acupuncture with sham acupuncture and drug therapy concluded that “…acupuncture is as effective as drug therapy, but …sham acupuncture is as effective as ‘real’ acupuncture.” and “…acupuncture should be offered to patients who do not respond to prophylactic treatment with drugs, terminate drug treatment because of adverse events or have contraindications to drug treatment.”

Most headache specialists recommend acupuncture to their patients even if they believe it works only through the placebo effect. I’ve been a licensed acupuncturist for the past 30 years, but treat a relatively small number of patients with acupuncture. The main reasons are the fact that insurance companies do not pay for it and that it is too time consuming. In the first study mentioned above, which was performed in China, patients were treated five days a week. The minimum frequency of treatments should be once a week. I often recommend that patients find a non-MD acupuncturist (whose rates are usually lower) who is closer to the patient’s home or work place. Another concern with acupuncture is that while it might help during the treatment, the effect might subside once the treatment is stopped.

A study The persistence of the effects of acupuncture after a course of treatment: A meta-analysis of patients with chronic pain, just published in the journal Pain addresses this question.

A group of researchers from the US and Europe examined a large set of information on individual patients from high quality randomized trials of acupuncture for chronic pain. The chronic pain conditions included musculoskeletal pain (low back, neck and shoulder), osteoarthritis of the knee and headache / migraine. Data on longer-term follow-up were available for 20 trials, which included 6,376 patients. In trials comparing acupuncture to no acupuncture control (wait-list, usual care, etc), the treatment effect diminished by a very small amount after treatment ended. They estimated that 90% of the benefit of acupuncture relative to controls would be sustained at 12 months. For trials comparing acupuncture to sham acupuncture, they observed a higher reduction in effect, suggesting about a 50% diminution at 12 months. They concluded that “The effects of a course of acupuncture treatment for patients with chronic pain do not appear to decrease importantly over 12 months. Patients can generally be reassured that treatment effects persist.” They also suggested that studies of the cost-effectiveness of acupuncture should take these findings into account when considering the time horizon of acupuncture effects and that further research should measure longer term outcomes of acupuncture.

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Medical marijuana was legalized in New York in February of this year. Since then, I’ve prescribed it to over 30 patients and about a third of them have found it to be effective. We are planning an observational study to determine which of the three approved types (inhaled, sublingual, oral) and what ratio of active ingredients (THC/CBD) are preferred by migraine sufferers. Doctors who prescribe medical marijuana do have to take an online training course, but the course does not teach about the optimal use because no one has researched this question. There are also regulatory issues to deal with.

Several sets of guidelines have been published by various medical organizations addressing the proper use of medical marijuana, other than dosing and route of administration. Here are some of the recommendations with my comments:

“The doctor should adhere to current standards of practice and comply with state laws, rules and regulations, which may specify conditions for which a patient may quality.”
Migraine is not one of the conditions listed specifically, but it is often accompanied by neuropathic pain, which is listed.

“The doctor’s office should not be located at a marijuana dispensary or cultivation center. The doctor should not receive financial compensation from or hold a financial interest in marijuana-related businesses or be affiliated with them in any way.”
This one is easy for us.

“The physician should not use marijuana either medicinally or recreationally while actively engaged in the practice of medicine.”
I’ve never tried it.

“There should be an established doctor-patient relationship before the doctor considers the use of medical marijuana.”
I prescribe it only to our established patients.

“The doctor should do a physical exam and gather health history, including documentation of previous therapies used by the patient and information on any personal or family history of substance abuse, mental illness or psychotic disorders. The diagnosis should justify the consideration of medical marijuana.”
All of our patients undergo a thorough evaluation.

“The doctor should review other treatment options. The known benefits and risks of marijuana should be presented, along with the warning that, unlike with FDA-approved drugs, there is variability and lack of standardization in marijuana preparation.”
We use medical marijuana only after other non-drug and drug treatments fail.

“If the medical marijuana is chosen, a specific treatment plan for a limited period of time should be agreed on, with details documented in the medical record. The doctor should instruct the patient not to drive or operate heavy machinery while using marijuana.”
Yes, I do that.

“The patient should be seen for follow-up visits to monitor for efficacy and side effects of medical marijuana.”
This is a standard practice with any treatment.

“Patients with a history of mental health problems, substance abuse or addiction should be referred for further evaluation as needed.”
I typically avoid prescribing medical marijuana to such patients.

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We are big proponents of non-drug treatments, including a variety of vitamins, minerals, and herbal supplements. However, potential liver damage by butterbur is why we do not recommend this supplement, even though I was one of the participants in the clinical trial that showed it to be effective in preventing migraines. I also cautioned about risks of some Ayurvedic medications.

A recent report in Hepatology, a journal devoted to liver diseases, suggests that 20% of all cases of liver damage are due to herbal and dietary supplements. The main culprits were anabolic steroids (these are banned in professional sports, but are widely used for muscle building), green tea extract, and supplements with multiple ingredients. Anabolic steroids cause prolonged, but not serious liver injury, which resolves when the supplement is stopped. Green tea extract and many other products cause acute liver damage, similar to that seen in hepatitis. The majority of cases of liver injury are due to products that contain multiple ingredients, which makes it difficult to figure out which of the supplements is responsible. Unfortunately, non-prescription supplements are not regulated by the government. This is mostly because it is a $37 billion dollars a year industry with a powerful lobby in Washington. The authors conclude their report by saying that “the ultimate goal should be to prohibit or more closely regulate potentially injurious ingredients and thus promote public safety.”

Until these products come under FDA’s supervision, you should buy only products made by reputable American and German companies. Germany tightly regulates their supplement industry, so if a product is sold in Germany (and none of the butterbur products are approved there or in Great Britain), it is probably safe to take. Do not buy products made in China where corruption has led to many scandals related to the quality of supplements, drugs, food, and environmental pollution.

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Medical marijuana reduces the number of prescriptions written by doctors, according to a recent study published in Health Affairs. The researchers at the University of Georgia in Athens looked at all prescriptions filled by Medicare participants over a four year period for nine conditions for which medical marijuana is used for. These included anxiety, depression, glaucoma, nausea, pain, psychosis, seizures, sleep disorders and spasticity. They compared 17 states and Washington, DC where medical marijuana was legalized with those where it was not. In states with legalized medical marijuana the number of prescriptions dropped by 0.5% providing estimated savings of $165 million a year. Of all approved indications, relief of pain was by far the most common reason medical marijuana was prescribed for. This was a much more dramatic effect than the researchers anticipated. They expected that the mostly elderly patients on Medicare would be more resistant to the idea of using marijuana than younger people.

In a February post I mentioned that I started prescribing medical marijuana to my patients with migraine headaches who also have neuropathic pain as part of their headache. While medical marijuana is not approved for migraines per se, it is approved for neuropathic (i.e nerve-related pain), which many migraine sufferers do have. Burning or stabbing pain indicates the presence of neuropathic pain. So far, I’ve prescribed medical marijuana to about two dozen patients and as expected, the results are mixed. It works well for some, but not other. Most commonly, patients who’ve had positive experience with recreational marijuana tend to request medical marijuana and they tend to do better than those who’ve never tried it.

Research on medical marijuana is complicated by the fact that there is no standard formulation, which means that there is wide variation in the strains of the plant with varying amounts of active and inactive ingredients. In New York State medical marijuana can be ingested, inhaled through a vaporizer or placed under the tongue. We also have various ratios of tetrahydrocannabinol (THC) and cannabidiol (CBD), which produce different results. Nevertheless, we do plan to do an observational study of 100 migraine sufferers who also have neuropathic pain. We hope to get an indication as to what route of administration and what THC/CBD ratio work best for migraine patients.

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Vitamin B12 was the subject of an article in the New York Times by Jane Brody entitled, Vitamin B12 as Protection for the Aging Brain. However, she mentions that “insufficient absorption of B12 from foods may even be common among adults aged 26 to 49” and that the advice to take a vitamin B12 supplement may apply to young people as well. This is particularly true for vegans and vegetarians, as well as people with stomach problems and those on PPIs – drugs for ulcers and heartburn, such as Prilosec, Nexium, Aciphex, etc.

Vitamin B12 deficiency can cause “fatigue, tingling and numbness in the hands and feet, muscle weakness and loss of reflexes, which may progress to confusion, depression, memory loss and dementia as the deficiency grows more severe”. Severe deficiency leads to peripheral and central nervous system damage (so called subacute combined degeneration), which eventually becomes irreversible and leads to death.

Jane Brody does not mention that besides Alzheimer’s, other chronic diseases, such as multiple sclerosis, diabetes, and cancer are also associated with low vitamin B12 levels. Vitamin B12 with vitamin B6 and folic acid has been shown to help some migraine sufferers

You can ask your doctor to check your vitamin B12 level, but unfortunately it is not reliable. Most laboratories cite as normal blood levels of above 200 or 250, but there are reports of rare cases where severe deficiency is present with a level of 700. I recommend taking a supplement if the level is below 500. In severe cases or in people with stomach problems, a monthly injection is a better choice. Patients can easily self-inject vitamin B12, but it does require a doctor’s prescription. Some of my patients feel the need to inject themselves with vitamin B12 more often than once a month. Whenever they start feeling tired or having other symptoms, they take a shot. Unlike some vitamins, such as B6 and A, vitamin B12 does not cause any negative effects even at high levels. As an oral supplement I usually recommend tablets of methylcobalamin, rather than cyanocobalamin form of vitamin B12 because of better absorption. The usual dose is 1 mg (or 1,000 mcg) daily. If you are deficient and stop taking the supplement, the deficiency can return within a few months.

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Intravenous magnesium relieves acute migraine attacks in patients with magnesium deficiency, which is present in half of migraine sufferers, according to the study we published in 1995 in the journal Clinical Science. Infusions not only treat an acute attack, but also prevent migraines. Oral magnesium supplementation is not as effective and helps less than 50% of patients because some patients do not absorb magnesium. Most people get enough magnesium from food, but some migraine sufferers have a genetic defect which prevents them from absorbing magnesium or a genetic defect that leads to an excessive loss of magnesium through kidneys.

Our experience with thousands of patients suggests that the majority of migraine sufferers who are magnesium deficient do improve with oral supplementation, but about 10% do not. These patients need regular infusions of magnesium and these infusions are often life-changing. Magnesium not only treats and prevents migraines, but also relieves muscle cramps, PMS, palpitations, “brain fog”, and other symptoms.

There are many mentions of magnesium on my blog and on the nyheadache.com website, so what prompted another post on this topic is a couple of patients with an unusal experience. I would occasionally see such patients but in the past few weeks, I saw several. These patients tell me that when we give them an infusion of magnesium by “slow push” over 5 minutes they get excellent relief, but when they end up in an emergency room or another doctor’s office where they receive the same amount of magnesium through an intravenous drip over a half an hour or longer, there is no relief.

A likely explanation is that a push results in a high blood level, which overcomes the blood-brain barrier and delivers magnesium into the brain, while during a drip, magnesium level does not increase to a high enough level to reach the brain. Studies have shown that migraineurs not only have a systemic magnesium deficiency, but specifically in their brains. A similar phenomenon has been described with sumatriptan (Imitrex). Researchers discovered that migraine sufferers who did not respond to sumatriptan had a much slower increase in the drug level compared to responders, even though the total amount of the drug absorbed into the blood was the same.

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Recently, a patient of mine reported that cramp bark has significantly improved her menstrual migraines. Cramp bark is a common shrub with red berries. Its bark has been used for over 100 years for muscle cramps, menstrual cramps, fluid retention, and other symptoms. Fortunately, it appears to be very safe and even though no scientific studies have been performed on it, it may be worth trying. I will start recommending it to women with menstrual migraines, menstrual cramping and patients with muscle spasms in their neck and upper back.

The two top herbs I recommend to my migraine patients are feverfew and boswellia. Feverfew has been subjected to scientific studies and seems to help some patients while causing almost no side effects. Boswellia has been reported to help even patients with cluster headaches, but no rigorous studies have been done. However, it is safe and because of its anti-inflammatory properties it can also help joint and muscle aches (see my blog post on Boswellia).

Butterbur, on the other hand is not always safe, so I haven’t been recommending it. Here is one of my blog posts on it.

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Vagus nerve stimulation (VNS) with an electrode implanted in the neck is an FDA-approved treatment for depression and epilepsy, when these conditions do not respond to medications. Since antidepressant and anti-epilepsy medications help migraines, I had six patients (four with migraines and two with cluster headaches) treated with VNS. Two of the four chronic migraine patients and both cluster patients had good relief – results that were published in the journal Cephalagia in 2005. This publication led to the development of gammaCore, a device to stimulate the vagus nerve through the skin, without the need for surgical implantation of an electrode. The New York Headache Center participated in one of the earliest studies of this device and the results were encouraging.

An article published in the current issue of Neurology presents the results of another study of gammaCore. In this first double-blind study 59 adults with chronic migraines (15 or more headache days each month) were given either real VNS or sham treatment for two months. After two months they were all given the real treatment for 6 months. The main goal of the study was to examine the safety and tolerability of this treatment, but the researchers also looked at the efficacy by measuring the change in the number of headache days per 28 days and acute medication use.

Both sham and real treatment were well tolerated with most adverse events being mild or moderate and transient. The number of headache days were reduced by 1.4 days in the real and 0.2 days in the sham group. Twenty-seven participants completed the open-label 6-month phase, which suggests that this treatment might work for half of the patients. However, larger sham-controlled studies are needed to prove that this treatment really works. GammaCore is also being tested for the treatment of cluster headaches. Although it has not been definitively proven to be effective, it is already being sold in some European countries.
gammaCore_sites_device_large_tile1

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If you are interested in learning to meditate, but don’t know how to get started, go to Dr. Tara Brach’s website for help. It offers her free weekly podcasts that will guide you through the process. Tara Brach is a psychologist and a buddhist, who after college spent 10 years in an ashram studying yoga and meditation. She has a pleasant voice and her podcasts are full of stories, funny anecdotes and short poems that are sure to inspire you.

My wife and I recently attended Tara Brach’s workshop on “Radical Acceptance” at the Omega Institute in Rhinebeck, NY. There were frequent sessions of guided meditation as well as exercises and Q & A sessions. Many participants had listened to her podcasts for years and came to hear her in person. One of the questions was, how do you maintain a regular meditation practice? Tara’s answer was to meditate daily. If you do not have time for a 20 or 30-minute session, do it for a minute or two. I would also recommend reading books such as Living Fully by Shyalpa Tenzin Rinpoche, Mindfulness by Joseph Goldstein, Peace is Every Step by Thich Nhat Hanh, and Tara’s two excellent books, Radical Acceptance and True Refuge.

Meditation can bring you relief of anxiety, migraine headaches, and many medical conditions that are made worse by stress. It can also make your life more enjoyable.

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A new report presented at the last annual scientific meeting of the American Headache Society in San Diego showed that post-concussion symptoms can be helped by an intravenous infusion of magnesium.

Doctors at the department of neurology at UCLA described six patients with a post-concussion syndrome, who were given an infusion of 2 grams of magnesium sulfate. Three out of six had a significant improvement of their headaches and all had improvement in at least one of the following symptoms: concentration, mood, insomnia, memory, and dizziness.

This was a small study, but it is consistent with other studies that show a drop in the magnesium level following a concussion and also studies in animals that show beneficial effects of magnesium following a head trauma.

Our studies have shown that intravenous magnesium can relieve migraine and cluster headaches in a significant proportion of patients.

Considering how safe intravenous magnesium is and how devastating the effect of a concussion can be, it makes sense to give all patients with a post-concussion syndrome if not an intravenous infusion, at least an oral supplement. I usually recommend 400 mg of magnesium glycinate, which should be taken with food. For faster and more reliable effect, we routinely give patients with migraines, cluster, and post-concussion headaches an infusion of magnesium. Patients who do not absorb or do not tolerate (it can cause diarrhea) oral magnesium, come in to for monthly infusions.

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Should you sleep on the right or on the left side? Researchers led by Dr. Helene Benveniste of Stony Brook University discovered that sleeping on the right side provides better drainage of toxins out of the brain, at least in rats. She presented their findings at the meeting of the American Headache Society in San Diego earlier this month.

The lymphatic system, which has been long known to exist throughout the body, was only recently discovered in the brain. It is called a glymphatic system because brain’s glial cells form this network of draining channels. According to the latest studies, our brain does housekeeping by removing waste products when we are asleep. Insomnia has been associated not only with more frequent migraine headaches, but also with an increased risk for Alzheimer’s disease, which is thought to be at least in part due to accumulation of waste products in brain cells.

When you google sleep positions, many sites recommend sleeping on the left side, but no scientific studies have been done to see which position is more beneficial. The rat study mentioned above suggests that sleeping on either side is better than sleeping on your back or on the stomach. Hopefully, Dr. Benveniste and her colleagues will conduct studies in humans, so that we know how to sleep. For now, whatever position you sleep in, try to get enough sleep every night.

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