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Alternative Therapies

Yet another study shows that low vitamin D level predisposes to neurological problems. A report just published in a leading neurology journal, Neurology by British and American researchers shows that low levels of vitamin D are associated with a higher risk of delirium in hospitalized patients.

This study looked at 313,121 participants, 544 of whom were hospitalized with delirium. The researchers proved that there is genetic evidence supporting connection between vitamin D levels and delirium. They called for trials of correction of low vitamin D levels for the prevention of delirium.

It is a strange call to action because we already know from other large studies that vitamin D deficiency predisposes to several neurological problems. These include not only migraines, but also multiple sclerosis, stroke, and other major diseases  Why not just make sure that nobody has a deficiency? Well, one reason is that insurance companies do not want to pay for the test because we do not have proof that correcting this deficiency will prevent these neurological problems. As we know, correlation does not mean causation. However, conducting large scale studies is very expensive and it takes many years to obtain the results. And why was a normal range for vitamin D was established if not to make sure that people are not deficient.

As I mentioned in my last post on vitamin D in 2015 everyone should have their vitamin D level checked and if you are deficient, get your level up to the middle of normal range. The normal range is 30 to 100, so below 40 is definitely not optimal.

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Ginger is not only a popular spice, but a truly remarkable medicinal plant. Ginger’s proven anti-inflammatory properties may be responsible for its beneficial effects in migraine patients. Ginger may be effective for the treatment of seasickness, morning sickness of pregnancy and I recommend it for nausea of migraine as well.

A study published in the journal of the International Headache Society, Cephalalgia examined the effect of ginger, when added to an intravenous pain medication.

This was a double-blind placebo-controlled randomized clinical trial performed in the emergency room of a general hospital in Brazil. Adults who suffered from migraines with or without aura one to six times per month were included. Half of the sixty participants were given 400 mg of ginger extract (5% active ingredient) or placebo, in addition to an intravenous drug (100 mg of ketoprofen, a drug not available in the US in an injection, but it is similar to ketorolac, or Toradol) to treat an attack of migraine. Pain severity, functional status, migraine symptoms and treatment satisfaction were recorded.

Patients treated with ginger showed significantly better pain relief after 1, 1.5 and 2 hours. Ginger also significantly improved functional status and overall satisfaction.

Another double-blind study involving 100 patients compared the efficacy of ginger with sumatriptan in the treatment of an acute migraine attack. Patient satisfaction and their willingness to continue treatment was also evaluated after 1 month following intervention. Two hours after using either drug, mean headaches severity decreased significantly. Efficacy of ginger powder and sumatriptan was similar. Adverse effects of ginger powder were less than sumatriptan. Patient satisfaction was similar in two groups.

Considering that ginger has anti-inflammatory properties, it is possible taking it daily may also prevent migraines, although no preventive trials have been conducted to date.

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To be eligible for this study you have to live in NYC or its suburbs and cannot be currently receiving Botox or a CGRP monoclonal antibody, such as Aimovig, Ajovy or Emgality.

PARTICIPATE IN MIGRAINE RESEARCH
A RANDOMIZED SHAM-CONTROLLED STUDY OF HOME-DELIVERED NON-INVASIVE NEUROSTIMULATION FOR MIGRAINE

• If you have frequent headaches (on 4 days or more/month) you may be eligible to enroll in a study of non-invasive neurostimulation aiming to reduce migraines.
• Neurostimulation provides stimulation of the nerves in the human body. Frequently used neurostimulation methods are for example, acupressure, acupuncture or TENS.
• This study uses a new neurostimulation method, tDCS. tDCS is a battery-powered device that delivers stimulation via two sponge pockets placed to a simple headband. Study participants will be assigned either to a group receiving active tDCS or to a control group receiving placebo tDCS.

If you are interested in more information about the study, please call the study personnel at 212-794-3550 or 212-440-1954 or email DrMauskop@nyheadache.com

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Cefaly is a transcutaneous electrical nerve stimulation (TENS) device designed to treat migraine headaches by stimulating supraorbital nerves. The device was cleared by the FDA in 2014 for both acute and preventive treatment of migraine headaches. The preventive indication was based on a double-blind trial involving only 67 patients, while the use of Cefaly for acute migraines was based only on an open-label trial. A study recently published in Cephalalgia examined the efficacy of this device for acute treatment of migraines in a double-blind trial of 106 patients.

The trial confirmed that Cefaly is indeed effective for abortive therapy of migraine attacks. For prevention, it is recommended to use the device for 20 minutes every day, while to treat an acute attack the device should be used for an hour. The primary outcome measure was the mean change in pain intensity at 1 hour compared to baseline. This primary outcome measure was significantly more reduced in the stimulation group compared to the sham group: 60% versus 30% reduction. No serious adverse events were reported and five minor adverse events occurred in the stimulation group. I’ve had one or two patients report that the device actually triggered a migraine, but this can also happen with any oral migraine drug.

The main reason I offer Cefaly before any other device (eNeura TMS or gammaCore) is that it is the most affordable. The price has gone up since it’s introduction and ranges from $350 to $500, however the manufacturer offers a 60-day return policy. This is long enough to see if it is effective. Cefaly is sold only with a doctor’s prescription, which is uploaded to the Cefaly website (Cefaly.us for US patients and Cefaly.com for the rest of the world).

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Several older reports have suggested an association between dry eye disease (DED) and migraine headaches. Researchers at the Univercity of North Carolina at Chapel Hill just published a large and convincing study confirming this comorbidity.

This was a retrospective study which included 72,969 patients older than 18 years seen over a period of 10 years. The study included 41,764 men and 31,205 women. Of these, 5,352 patients (7.3%) were diagnosed to have migraine headaches and 9,638 (13.2%) had the diagnosis of DED. The odds of having DED and migraine headaches was 1.4 times higher than that of patients without migraine headaches. This association was true for men and women older than 65 and women of all ages. Older age and female sex are both risk factors for the development of DED, probably due to hormonal and age-related changes.

The incidence of migraines and DED in the general population are reversed – about 12% suffer from migraines and 7% from DED, which is probably due to the fact that the study included only patients see at ophthalmology clinics.

The authors conclude that patients with migraine headaches are more likely to have comorbid DED compared with the general population, but this association may not reflect cause and effect. Both conditions do share inflammation as one of the underlying processes.

It is very likely that the eye discomfort from DED can be making migraines more frequent and severe. The diagnosis of DED should be considered in all migraine sufferers, especially in those with difficult to control attacks because effective treatment of DED could lead to an improvement in migraines.

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A study just published in Neurology by the MEGASTROKE project of the International Stroke Genetics Consortium found that “genetically higher serum magnesium concentrations are associated with a reduced risk of cardioembolic stroke…” It is an open access article, so you can download the full text. The study looked at 34,217 cases of strokes and 404,630 noncases, which makes the data highly reliable.

Here are some quotes (some modified) from the paper.

Several observational prospective studies have reported that low circulating magnesium concentrations and low magnesium intake are associated with increased risk of stroke. In the Nurses’ Health Study, low plasma magnesium concentrations were associated with an approximately 70% to 80% increased risk of embolic and thrombotic stroke.

Magnesium may in part reduce the risk of cardioembolic stroke through its antiarrhythmic effects and via atrial fibrillation. Low serum magnesium concentrations are associated with increased risk of atrial fibrillation, which is a strong risk factor for cardioembolic stroke. (My recent post mentioned that the increased risk of strokes in patients with migraines with aura is possibly related to the higher incidence of atrial fibrillation) Two of the magnesium-associated SNPs (genetic variants) were significantly associated with atrial fibrillation, with higher serum magnesium concentrations being associated with lower risk of atrial fibrillation.

Magnesium also has anticoagulant and antiplatelet properties (platelet aggregation is also implicated in migraine). Magnesium is considered to be nature’s calcium blocker as it suppresses many of the physiologic actions of calcium. For example, calcium promotes blood coagulation, whereas magnesium suppresses blood clotting and thrombus formation and reduces platelet aggregation. Antithrombotic effects may lead to reduction in risk of both cardioembolic and large artery stroke.

Other possible mechanisms whereby high serum magnesium concentrations may reduce ischemic stroke risk include improvement of endothelial function and reduction in blood pressure, atherosclerotic calcification, arterial stiffness, oxidative stress, fasting glucose concentration, insulin resistance, and risk of type 2 diabetes. Some of those beneficial e?ects may also lead to a reduction in small vessel stroke, which was not observed in this study.

Magnesium also reduces the size of a hemorrhagic stroke (bleeding into the brain), according a another recent study.

Magnesium has been my main area of research and because I never tire of promoting the role of magnesium in the treatment of migraines some colleagues call me Dr. Magnesium. The evidence is overwhelming – many studies have shown that magnesium deficiency is common in migraine sufferers and that taking magnesium can help. The American Academy of Neurology and the American Headache Society guidelines for the treatment of migraines include magnesium, but it is still underappreciated and underutilized. This is in part because there have been no large-scale (i.e. expensive) trials of magnesium which are done by pharmaceutical companies for new drugs. Another reason is that the trials that have been conducted supplemented migraine patient regardless of their magnesium status – both deficient and non-deficient patients were given magnesium, thus obscuring the great benefit obtained by the deficient cohort.

As mentioned in several previous posts, magnesium also helps asthma, palpitations, feeling cold or having cold hands and feet, muscle twitching, cramps or diffuse muscle aches (fibromyalgia), premenstrual symptoms (PMS), brain fog, and many other symptoms. If you have any of these symptoms you may want to have a blood test for magnesium. And even if you don’t have symptoms, the next time you have any kind of a routine blood test, ask your doctor to add a test for “RBC magnesium”, which is more accurate than the usual “serum magnesium”.

If you have any of the above symptoms, you can also just start taking 400 mg of magnesium glycinate, which is the daily recommended allowance for magnesium. If oral magnesium does not help and the RBC magnesium level is low we usually give monthly infusions of magnesium. They take 10 minutes to do, have no side effects and are covered by most insurance plans.

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Having conducted and published research on magnesium and seeing dramatic improvement from magnesium in many of my patients, I try to write about magnesium at least once a year. Up to half of migraine sufferers are deficient in magnesium and could greatly benefit from it.

Magnesium supplements are considered “probably effective” for the prevention of migraine headaches, according to the American Headache Society and American Academy of Neurology guidelines. The reason magnesium is listed as only probably effective is poor design of most clinical trials. There was no selection of patients – magnesium was given to all without any regard to their magnesium status. Obviously, those who did not have a deficiency did not benefit from taking magnesium and they diluted positive results seen in those who were deficient.

A study conducted by researchers at George Mason University looked at the dietary and supplement data of 2,820 American adults between 20 and 50 years old. They found that higher dietary intake of magnesium led to lower risk of migraines in both men and women. This relationship was even stronger in women, but not men who took magnesium supplements.

They also found that the average consumption of magnesium in these 2,820 Americans was only 70%-75% of the Recommended Dietary Allowance. Obviously, it is better to get your magnesium from food, such as whole grains, dark leafy vegetables, avocados, legumes, and other. However, changing your diet is not easy, so the second best choice is to take a supplement. I recommend 400 mg of magnesium glycinate, but other magnesium salts can also help.

About 10%-20% of our patients who are deficient in magnesium either do not absorb magnesium (we check their RBC magnesium levels) or do not tolerate it and get diarrhea. They do very well with a monthly intravenous infusion of magnesium.

Magnesium has many benefits besides relieving migraines, including possibly preventing Alzheimer’s disease, reducing the size of a stroke, post-concussion syndrome, fibromyalgia, palpitations, asthma, muscle cramps, “brain fog”, and other symptoms.

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We’ve been prescribing medical marijuana for migraines and other painful conditions since it was legalized in the state of New York four years ago. While it does not seem to help most of our patients, it does benefit a significant minority. The benefits may include relief of pain, nausea, anxiety, and improved sleep. Various ratios of tetrahydrocannabinol (THC) and cannabidiol (CBD) produce different effects and often neither one alone is as effective as a combination of the two (so called entourage effect). Although marijuana is a very effective medicine for some patients, there is no good science to explain how it works, in what combination of ingredients and for what types of pain.

A very interesting study that sheds some light on the possible mechanism of action of THC was just published in a leading neurology journal, Neurology by Israeli researchers. They enrolled fifteen patients with chronic neuropathic pain in the leg (like sciatica) in a double-blind placebo-controlled crossover study. Nine patients were given THC in the first part of the study and placebo in the second and six were given placebo first and then THC. In addition to measuring the effect of THC on pain the researchers performed functional MRI (fMRI) scans before and after administering THC or placebo.

THC was significantly better than placebo at relieving pain and the fMRI scans showed THC-induced changes in the way pain may be processed in our brains. They found that THC produced a reduction in functional connectivity between the anterior cingulate cortex (ACC), a major pain-processing region that is rich in cannabinoid receptors and the sensorimotor cortex. This reduction correlated with the reduction in the subjective pain ratings after THC treatment, meaning that patients who did not have pain relief usually did not have a decrease in the connectivity between the two regions.

The study also showed that pretreatment functional connectivity between the ACC and the sensorimotor cortex positively correlated with the improvement in pain scores induced by THC, that is, the higher the positive functional connectivity at baseline, the more benefit was gained from THC administration.

The authors also commented that THC combined with CBD may have stronger pain-relieving properties. Hopefully, the researchers will figure out the best combination of THC and CBD, but it is possible that other ingredients in marijuana contribute to the therapeutic effects. This could be why some of our patients prefer products from one dispensary and not the other and why some find that the whole plant is more effective than THC with CBD in any ratio. Most patients also find that products made from different strains of marijuana plant (sativa vs indica) have different effects.

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Medical marijuana (MM) is now legal in 30 states. Most states approve its use for specific medical conditions and severe pain and nausea, which are symptoms of migraine, are usually on the list.

I’ve been prescribing MM since it was legalized in the State of NY four years ago. My estimate is that one out of three patients find it useful. Some take it daily for the prevention of migraine attacks, but the majority use it as needed, whenever an attack occurs. MM sometimes relieves all of the symptoms of migraine, but sometimes only pain or only nausea. Some patients find that it helps them to go to sleep and when they wake up, the headache is gone. A few patients have told me that they take it regularly for insomnia and that it often works better than prescription drugs, such as zolpidem (Ambien) and does not cause side effects. The calming effect of MM is also useful when dealing with a very upsetting and debilitating condition such as migraine.

Most states require an analysis of the amount of active ingredients in every MM product by an independent laboratory. The two main ingredients are tetrahydrocannabinol (THC) and cannabidiol (CBD). This is one of the advantages of going the legal route – you know that the product will be the same each time you buy it. However, my patients have told me that they prever products from one or another dispensary even when using products with the same concentration of THC and CBD. This can be explained by the fact that all MM products contain other supposedly inactive ingredients, which in fact may also have various positive or negative effects.

CBD oil made from hemp is legal to buy without a doctor’s prescription and is available for purchase online. For many it works well by itself to relieve pain, nausea, and inflammation. THC is responsible for the sedating and calming effect. However, even a small amount of THC often makes CBD more effective. Raphael Mechoulam, a Hebrew University professor who discovered THC, calls this the entourage effect.

Many patients take low THC/high CBD products during the day to avoid euphoric and cognitive effects, while at night they might take a high THC/low CD combination.

For faster onset of actionvaping MM is optimal, while for the prevention, taking a pill or a tincture can be more convenient. These are the three types of products that are approved in NY.

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Almost everyone has an occasional pain in the upper back and shoulders, often caused by prolonged sitting in front of a computer or just by stress. The pain is due to muscle spasm and keeping those muscles in good shape helps prevent this problem. It also helps to be aware of your body through regular meditation practice or Awareness Through Movement method developed by an Israeli physicist Moshe Feldenkrais. I’ve posted Feldenkrais exercise videos for neck pain here and here. Most people are shocked at the immediate improvement in the range of movements they notice even after the first set of exercises.

I recently had a tight knot in one of my shoulders which did not go away after 90 minutes of hot yoga. Lying on the floor at the end of the yoga session I did a 5-minute Feldenkrais exercise which made the knot melt away. In this video I demonstrate this exercise that relaxes tight muscles and stops shoulder and upper back pain. Instead of watching the video you can follow these written instructions:

Lie down on your back with a thin pillow or a soft pad under your head. Spend a minute paying attention to spots where your head, shoulders, back, arms and legs touch the ground. Then, bend your knees and keep your feet flat on the floor. Stretch your arms in front of you and put your palms together with your arms forming a tall triangle. Keep your eyes on the thumbs and slowly lift the right shoulder off the ground with your head rolling to the left. Press down the left foot to make the movement easier. Keep the shoulder lift small to avoid straining and time it with exhalation. Repeat this shoulder lift and head turn five times while maintaining the gaze on the thumbs. Then, do another five of these movements in exactly the same way, except now move your eyes from the thumbs as far as you can in the opposite direction from the head roll. It may be difficult at first because your head may want to move with the eyes. When you come back to the midline, your eyes return to the thumbs. Put your arms and legs down and again spend a minute noticing the areas of pressure where various parts of your body touch the floor. Now, repeat the same two sets of 5 movements to the left side and then rest for a minute to feel your body contact the floor.
Try to maintain regular slow breathing throughout this exercise.

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The New York Headache Center participated in a large (245 patients) placebo-controlled trial of butterbur, which showed that 150 mg of butterbur is effective in the prevention of migraine headaches when compared to placebo. The results were published in Neurology and the American Academy of Neurology endorsed the use of butterbur for the prevention of migraine headaches. Because butterbur is highly toxic to the liver and can cause cancer we were very happy to have a highly purified product manufactured in Germany (sold as Petadolex), where it had to pass strict safety studies. However, Germany does not allow butterbur to be sold there because the manufacturer changed its purification process and did not repeat all of the required safety studies. Butterbur is still made in Germany and is sold in the US, but our FDA does not regulate herbal products and does not require the extensive safety tests that are required in Germany.

The manufacturer of Petadolex brand of butterbur sent me an email saying that the FDA conducted an inspection of their manufacturing plant in Germany. However, my concerns about butterbur have not been addressed. Here is my email response to the manufacturer:
“Thank you for this additional information. It is good to see that the FDA conducted a “comprehensive inspection” of the manufacturing facility in Germany. However, my concerns about the safety of Petadolex are not due to possible deficiencies in manufacturing, but are related to the extraction process. As far as I know, this is why German and UK governments still do not allow the sale of Petadolex and this is why I do not recommend Petadolex to my patients. I am also concerned that because Petadolex is fairly expensive, many patients will decide to buy a cheaper brand of butterbur, which can be truly dangerous. Once Petadolex is cleared for sale in Germany I will be happy to resume recommending it to my migraine patients”.

Some of the above text is from my previous posts a few years ago, but I still do not routinely recommend butterbur. If a patient expresses an interest in it and if other herbal treatments and supplements fail, I will provide directions for its use and will emphasise the importance of not substituting Petadolex for a cheaper brand.

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Boswellia serrata is not a drug, but a plant, but I am including herbal products as well if a serious scientific journal has published articles on it. Most of the available information on Boswellia is in mentioned in my previous post. I would only add that of all herbal products, Boswellia is the first one I recommend because it is very safe and I continue to see many patients who respond well to it. My preferred brands of Boswellia are Nature’s Way and Pure Encapsulations, although Nature’s Way is cheaper.

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