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Alternative Therapies

The placebo effect is a bane of clinical trials. A drug is considered ineffective if it is only as good as a placebo. And placebo can be quite good. Intriguingly, the placebo effect in clinical trials has been getting stronger over the past few decades. Lately, placebo has been receiving a lot of attention from researchers.

A rigorous study just published in the journal Pain looked at the effect of a placebo when patients were clearly told that they are taking a placebo. These patients were compared to those who were given a placebo in a double-blind study of peppermint oil capsules for irritable bowel syndrome (IBS). These two different types of placebo were compared to a control group of patients who were not given any pills.

Participants treated with an open-label placebo and a double-blind placebo reported similar and clinically meaningful improvements in IBS symptoms. These improvements were significantly greater than in those who were not given any pills. The results were statistically significant for the primary outcome measure (IBS Symptom Severity Scale) as well as for mean global improvement scores.

Twice as many patients in the double-blind placebo group had side effects (mostly gastrointestinal, such as heartburn) than those in the open-label placebo. It is probably because the first group was told about the possible side effects of peppermint oil.

The authors concluded that an open-label placebo “could play a role in the management of patients with refractory IBS”.

Just like migraines, IBS involves central sensitization and hypersensitivity of the nervous system. And just like with migraines, placebo response in clinical trials of IBS tend to be high. This is not to suggest that these conditions are psychological. Especially with migraines, the biological basis is well documented. Psychological factors, however, cannot be ignored. About 40% of patients with chronic pain, including migraines, have a history of emotional, physical, or sexual abuse. Post-traumatic stress disorder of other types also causes hypersensitivity of the central nervous system. Psychological factors can even be the cause of such potentially deadly conditions as broken heart syndrome (Takotsubo cardiomyopathy). It is likely that the placebo effect is stronger in conditions where psychological factors are more pronounced.

It is considered unethical to prescribe a placebo to patients without telling them that they are getting a placebo. This latest study suggests that some patients may improve even if they know that they are taking a placebo.

I do prescribe herbal supplements such as feverfew and boswellia and on a rare occasion, a homeopathic remedy, all of which lack rigorous proof of their efficacy. For that matter, many drugs we prescribe for migraines lack such definitive proof. I would suggest that we should first prescribe less harmful unproven remedies rather than unproven prescription drugs.

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Migraine can be triggered by many foods, including sugar, chocolate, smoked, pickled, cured, dried, and fermented foods. There are also foods that can help with migraines. These are magnesium-rich dark leafy vegetables and whole grains. Omega-3 fatty acids that are known to have anti-inflammatory properties is another option.

The British Medical Journal just published a randomized controlled trial of omega-3 and omega-6 fatty acids in the prevention of migraines. The same group of North Carolina researchers published a similar smaller study in 2013.

The new trial included 182 participants who had migraines on 5-20 days per month. They were divided into three groups. One group was supplemented with omega-3 fatty acids (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The second group was also given the same amount of EPA and DHA but their diet also had a reduced amount of linoleic acid, an omega-6 fatty acid. The third group served as control.

Compared with the control diet, the first two diets decreased total headache hours per day, moderate to severe headache hours per day, and headache days per month. The diet that increased omega-3s and reduced omega-6 had a greater decrease in headache days per month than the diet that was only supplemented with omega-3s.

Supplementation also resulted in an improvement of inflammatory markers in the blood, a change that was not seen in the control group.

If eating more salmon or other fish rich in omega-3s is not practical, taking a good-quality supplement is a good alternative. To reduce your omega-6 intake avoid processed seed and vegetable oils and processed foods that contain them.

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Many patients with headaches are concerned about having a brain aneurysm. It is rare for an aneurysm to cause ongoing headaches. An aneurysm usually causes one very severe headache when it ruptures and causes a brain hemorrhage. Half of the patients with a ruptured aneurysm die and many of those who survive have persistent neurological problems. This is why detecting and treating an aneurysm before it ruptures is the goal. Because aneurysms have a genetic component we do angiograms in close relatives of someone with a ruptured or unruptured brain aneurysm. About 2% of the population has brain aneurysms. It would be prohibitively expensive to subject everyone to a screening angiogram.

Aneurysms are the result of an outpouching of a weak spot in an artery. This process is very gradual and aneurysms tend to get bigger with age. People with small aneurysms and high blood pressure are advised to control their blood pressure in the hope that this will prevent or slow down the growth of the aneurysm. Small aneurysms rarely rupture. If an aneurysm is larger than 5 millimeters in diameter, however, the risk of rupture becomes significant and surgery or non-surgical obliteration is recommended.

Until now, there have been no interventions proven to reduce the risk of aneurysm formation and rupture.

In the current issue of Neurology, a group of Swedish researchers published a rigorous study entitled, Association of Serum Magnesium Levels With Risk of Intracranial Aneurysm.

They provided evidence showing that higher serum magnesium concentrations reduce the risk of intracranial aneurysm and aneurysmal rupture. This was only partly due to the blood pressure-lowering effect of magnesium. They speculated that the additional effects were due to the improved function of the blood vessel lining (endothelium) and a reduction in oxidative stress – proven actions of magnesium.

They concluded: “These findings add to the growing body of evidence highlighting a beneficial role of higher magnesium for preventing cerebrovascular and cardiovascular diseases.” These diseases include strokes, heart attacks, cardiac arrhythmias, and certainly, migraines. Besides these diseases, magnesium is very helpful in a host of other conditions such as asthma, diabetes, osteoporosis, obesity, and many others.

In 2012, I wrote an article, Why all migraine patients should be treated with magnesium. Considering that one-third of the population is deficient in magnesium, it would not be inappropriate to say that everybody should be taking a magnesium supplement.

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The pain of cluster headaches is considered to be the worst of all headaches. Hence the moniker, suicide headaches. Thankfully, it is a rare condition. Episodic cluster headaches affect a little over 0.1% of the population or approximately 400,000 Americans. Of these, about 15% suffer from chronic cluster headaches. The division of cluster headaches into chronic and episodic is arbitrary, just like it is with migraines. Cluster headache attacks occurring for one year or longer without remission, or with remission periods lasting less than 3 months are considered to be chronic. Patients often go from episodic into chronic and back into episodic.

The term cluster comes from the fact that headaches occur daily or several times a day for a few weeks or months and then stop for a year or so. The attacks are always one-sided and the pain is localized around the eye. It can be associated with tearing, droopy eyelid, and nasal congestion on the side of pain. Some patients also have redness of the eye, sweating of the face, and tenderness in the back of the head.

These headaches are often misdiagnosed as migraine or sinus headaches. It can take several years before a patient receives the correct diagnosis and appropriate treatment.

The only FDA-approved preventive treatment is monthly injections of galcanezumab (Emgality). It came Verapamil, a calcium channel blocker used for hypertension, is another very effective drug. The dose of verapamil for cluster headaches is much higher than for hypertension – up to 960 mg a day. The only FDA-approved treatment for the treatment of individual attacks is sumatriptan (Imitrex) injections. Inhalation of pure oxygen through a mask at high flow (10-12 liters per minute) helps abort attacks in about 60% of patients. A course of steroids, such as prednisone, can sometimes stop the cluster period. These treatments are less effective for chronic cluster headaches.

Another treatment that can stop cluster attacks is an occipital nerve block. It is usually done with a steroid drug and a local anesthetic. The efficacy of this treatment led researchers to try electrical stimulation of the occipital nerve (ONS). It has been also tried in chronic migraines with mixed results.

Conducting trials of electrical stimulation presents big challenges. It requires surgical implantation of the stimulating wire next to the occipital nerve and the battery-operated device under the skin. It is impossible to disguise the sensation patients get from the electric current. They need to feel the stimulation in order for it to be effective.

A study just published in the journal Lancet compared strong and weak stimulation. The authors, led by Leopoldine Wilbrink, deserve great credit for conducting this difficult study. Despite the rarity of chronic cluster headaches, they were able to enroll 150 patients over a period of seven years. After a 12-week baseline observation, the patients were treated for 24 weeks.

The results showed that both weak and strong stimulation were equally effective. About half of the patients in each group had a 50% decrease in attack frequency. The most common side effects were local pain, impaired wound healing, neck stiffness, and hardware damage.

Another study by French researchers, Long-Term Efficacy of Occipital Nerve Stimulation for Medically Intractable Cluster Headache, was published last year in Neurosurgery. The mean duration of treatment observation was 44 months. Attack frequency was reduced by more than 50% in 69% of patients. Mean weekly attack frequency decreased from 22.5 at baseline to 10 after ONS. Functional impact, anxiety, and quality of life significantly improved after ONS. In excellent responders (59% of the patients), attack frequency decreased by 80% and quality of life dramatically improved from 38/100 to 73/100. 67 patients experienced at least one complication, 29 requiring an additional surgery: infection (6%), lead migration (12%) or lead fracture (4.5%), hardware dysfunction (8.2%), and local pain (20%).

ONS is a relatively safe treatment option for patients with chronic cluster headaches who do not respond to standard therapies. It is certainly safer than deep brain stimulation that has been reported to help some patients. Before resorting to ONS, I would also first try Botox injections, which I find to be effective in about a third of patients.

Besides ONS, vagus nerve stimulation (VNS) deserves further study. Two of my patients with severe chronic cluster headaches responded well to implanted VNS. This report led researchers to develop a non-invasive device to stimulate the vagus nerve. It was shown to be effective for episodic but not chronic cluster headaches. In my experience, however, it is only modestly effective even in episodic cluster headaches and is prohibitively expensive. The implanted VNS provides continuous stimulation. The non-invasive VNS is applied for only two minutes at a time. Future studies could compare the efficacy of ONS and implantable VNS.

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It’s been a few years since I wrote about meditation. There is little doubt that it helps migraine sufferers. Unlike drugs, meditation is harder to test in clinical trials. However, we do have many imaging studies showing the effect of meditation on the brain and specifically on pain.

Mindfulness-based stress reduction (MBSR) is based on the practice of meditation. It is more structured and usually consists of a fixed number of sessions. This makes it easier to study in research trials.

The results of such a clinical trial were recently published in JAMA Internal Medicine. The researchers compared MBSR with headache education. The study included 89 adults who experienced between 4 and 20 migraine days per month. The participants and the researchers analyzing the data were blinded as to which group patients were assigned to.

MBSR or headache education was delivered in groups that met for 2 hours each week for 8 weeks. Most participants were female and the mean number of migraine days per month was 7. They had severe migraine-related disability. The follow-up period was 36 weeks.

While MBSR did not improve migraine frequency more than headache education, it did improve disability, quality of life, self-efficacy, pain catastrophizing, and depression for up to 36 weeks.

MBSR courses are widely available online. However, you can also learn to meditate by reading a book. My favorite one is Mindfulness in Plain English by B. Gunaratana. In-person classes are also becoming again (after COVID) widely available. Tara Brach is a psychologist and a Buddhist who has a very good free meditation podcast. Many people like using apps. Headspace, Calm, and Ten Percent Happier are some of the more popular ones.

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A publication of the American Headache Society, Headache, The Journal of Head and Face Pain, has just published Dr. Allan Purdy’s most generous review of my new book, The End of Migraines: 150 Ways to Stop Your Pain.

I am very grateful to Dr. Purdy and to my many colleagues who wrote endorsements for this book.

Self-publishing allows me to set a low price of $3.95 for the ebook version. It also makes it easy for me to regularly update it. Self-publishing, however, means that, unlike my previous three books, this one does not have the promotional help of a big publisher. If you read the book, please write a review on Amazon and spread the word to other migraine sufferers.

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We know that physical emotional, and sexual abuse in childhood increases the risk of developing chronic pain and migraines later in life. Dutch researchers looked at several other potential predisposing factors. The results of their study were published in the May issue of the journal Pain.

This study was a part of the Dutch Prevention and Incidence of Asthma and Mite Allergy birth cohort study. It included 3,064 children who were evaluated at the ages of 11, 14, 17, and 20. The researchers assessed headache prevalence and incidence in girls and boys and explored associations with early life, environmental, lifestyle, health, and psychosocial factors.

From age 11 to 20 years, the prevalence of headaches increased from 9% to 20% in girls and remained in 6% to 8% range in boys. Eighty-eight percent of the girls and 76% of boys with headaches also reported at least one of the following at age 17: sleeping problems, asthma, hay fever, musculoskeletal complaints, fatigue, low mental health, or worrying. They also found that lower educational achievement, skipping breakfast on two or more days per week, and in boys, exposure to tobacco smoke in infancy, increased the risk of developing headaches. In girls, sleeping problems and musculoskeletal complaints were associated with a higher chance of having headaches. Interestingly, residential greenness reduced the chance of developing headaches.

The risk factors are usually divided into modifiable and non-modifiable. Sex, age, and genetic factors are some of the non-modifiable ones. The factors mentioned in the study, except for sex, are all theoretically modifiable. In practice, however, they are very difficult to fix. Eating breakfast every morning is probably the easiest to achieve for most families. But even that can be difficult for the very poor. Moving to suburbs for greener surroundings, improving educational opportunities, and avoiding second-hand smoke in infancy are even harder to achieve.

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Weight loss in overweight migraine sufferers – including that produced by bariatric surgery – leads to a reduction in the frequency of migraine attacks. In a previous post and in my new book I mentioned the use of metformin, a diabetes drug that helps weight loss, in migraine patients.

A study published in the February 10 issue of The New England Journal of Medicine definitively confirmed that weekly injections of another diabetes drug, semaglutide (Ozempic) can lead to an average of 15% weight loss in obese individuals. Seventy percent of participants lost at least 10% of weight. This was a double-blind, placebo-controlled trial that included 1,961 participants. Individuals in both the placebo and the active group were counseled every four weeks to encourage maintenance of a reduced calory diet and increased physical activity. Semaglutide is very similar to dulaglutide (Trulicity).

Other drugs that are used for weight loss produce an average of 4% to 6% weight loss and tend to have more side effects. Nausea and diarrhea were the most common adverse events with semaglutide. They were typically transient and mild-to-moderate in severity and subsided with time. Only 4.5% of participants on semaglutide stopped taking the drug due to side effects.

Obesity is a risk factor not only for diabetes and increased frequency of migraines but also strokes, idiopathic intracranial hypertension (pseudotumor cerebri), obstructive sleep apnea, hypertension, and others.

This trial should lead to the FDA approval of semaglutide for weight loss in obese individuals without diabetes. Hopefully, the FDA approval will compel insurance companies to pay for it. The out-of-pocket cost of 4 pen-like syringes is $735.

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Magnesium supplementation for the prevention of migraine headaches has been gaining wider acceptance. Dozens of studies, including several of our own, have shown that migraine sufferers often have a magnesium deficiency. Studies have also shown that taking an oral supplement or getting an intravenous infusion of magnesium, relieves migraines.

The causes of magnesium deficiency include genetic factors, poor absorption, stress, alcohol, and low dietary intake of foods rich in magnesium. A study just published in the journal Headache looked at the dietary intake of magnesium, including supplements, in those with migraines compared to people without migraines.

The study included 3626 participants, 20- to 50-years old. A quarter of these people suffered from migraines. People who consumed the recommended daily amount (RDA) of magnesium had a lower risk of migraine. This risk was the highest in those who were in the bottom quarter of magnesium consumption.

This was a correlational study, meaning that it does not prove that taking magnesium prevents migraines. However, common sense and our clinical experience, combined with all the previously published studies, strongly support taking magnesium to prevent migraines.

There are many other benefits of magnesium that I’ve written about in this blog – just enter “magnesium” into the search box and you will find a few dozen posts.

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My new book, The End of Migraines: 150 Ways to Stop Your Pain, was just published by Amazon. It is also available on Google Play and Kobo.
I am very grateful to all my colleagues who took the time to read the book and to provide advance praise for it.
This is a self-published book. This allows me to update it regularly and to set a very affordable price – the e-book version is only $3.95 and the paperback is $14.95. The e-book version has the advantage of having many hyperlinks to original articles and other resources.
If you read it, please write a brief review on Amazon or Google and spread the word about it.

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Nerivio device is approved by the FDA for the acute treatment of migraine attacks in adults. A study just published in the journal Headache indicates that it may be effective in the treatment of migraine in adolescents, aged 12 to 17.

This study was open-label, which means that it was not as rigorous as the one done to get FDA approval in adults. There was no placebo arm and it was not blinded.

Forty-five participants, out of 60 who were enrolled, performed at least one treatment. There was one device-related adverse event in which a temporary feeling of pain in the arm was felt. Pain relief and pain-free status were achieved by 71% (28/39) and 35% (14/39) of participants, respectively. At 2 hours, 69% (23/33) of participants had improvement in functional ability.

Nerivio is a remote electrical neuromodulation, or REN device. It is applied to the upper arm and the current is turned up to produce a strong sensation below the pain level. It works by stimulating endogenous pain-relieving mechanisms. A recent review of various neurostimulation methods found REN to be the only one clearly proven to be effective.

Nerivio requires a prescription from a health care provider. If you don’t have one, you can consult one at a telemedicine startup, Cove (I am a consultant for Cove). It is a disposable device that costs $99 for 12 treatments. Some insurance companies pay for it.

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Feldenkrais method can appear magical but it is rooted in good science. It has withstood the test of time. Moshe Feldenkrais, a prominent Israeli physicist, developed his method over 70 years ago. You can read more about the science behind this method in my blog post from three years ago.

I continue to recommend it to patients with neck, back, and other pains. You can watch me do some of the exercises here, here and here.

You can find a local practitioner at Feldenkrais.com but these days you can see one virtually from anywhere.

What prompted this blog post is a flier I came across in my files from the now-defunct Feldenkrais Institute. From reading it you can see that anyone can practice Feldenkrais method – it requires no physical strength or major effort. And, it cannot hurt you.

Awareness Through Movement: Keys for Success

Feldenkrais exercises are called Awareness Through Movement® lessons. Awareness Through Movement® works by changing the messages that your brain sends to your musculature, creating new options for movement, health, and vitality. Contrary to popular belief, your brain and nervous system—not your muscles—determine the health of your posture, and the ease and comfort of your movement.

When you do Awareness Through Movement®, your brain has the opportunity to discover the most efficient and comfortable way to organize your movement. You will enjoy relief from pain, tension, and discomfort, and enhance your flexibility, ease of movement, relaxation, and posture.

Following these simple guidelines will ensure that each lesson is communicated effectively and will help maximize your benefits.

  1. DO ONLY WHAT IS EASY: Make each movement easy and
    comfortable. Do not strain or stretch. Doing only what is
    easy will facilitate your ability to pay attention to the
    quality of your movement.

  2. MAKE EACH MOVEMENT SMALL: Small movements, done easily, enable your body to improve most effectively. Large movements, done with effort, reduce your ability to heal and improve.

  3. GO SLOWLY: Do each movement slowly. This will give you time to sense and feel what you are doing, so that you can easily detect and reduce unnecessary effort and strain.

  4. PAUSE BETWEEN EACH MOVEMENT: Do not repeat the movements quickly, one after another. Awareness Through Movement® is most effective when you pause and relax completely for a moment after each movement, allowing your brain time to absorb new and useful sensory information.

  5. REDUCE UNNECESSARY EFFORT: Small, slow, and easy movements allow you to detect the unnecessary effort in your body. With reduced effort, your movement will automatically improve.

  6. DON’T TRY: Your improvement will be greater and quicker if you do not ‘try to succeed’. When you try, you are more likely to use more effort than necessary.

  7. TAKE RESTS: Fatigue causes unnecessary and inefficient effort in your movement, interfering with your ability to heal and improve. If at any time during a lesson you feel a need to rest, simply pause until you are ready to continue.

  8. AVOID PAIN AND DISCOMFORT: You should never experience discomfort or pain while doing Awareness Through Movement. Only do the small amount that feels comfortable and easy. If you experience pain or discomfort, use even less effort and make each movement even smaller and slower, or try doing the movements in your imagination.

  9. USE YOUR KINESTHETIC IMAGINATION: When you visualize doing a movement, your brain sends essentially the same message to your muscles as when you are actually moving. To use your imagination, close your eyes and imagine doing the movements with ease and with as much kinesthetic detail as you can.

  10. CONTINUE YOUR PROGRESS: By doing Awareness Through Movement® often, you will initiate a process of steady improvement. You can also maximize the benefits by periodically recalling the movements of a recent lesson, including your feelings and sensations.

Copyright © The Feldenkrais Institute

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