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, which I mentioned in a previous blog post, has 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”.

Nausea of migraines responds to an acupressure device, according to two German doctors who presented their findings last week at the International Headache Congress in Boston. I spoke to one of the authors, Dr. Zoltan Medgyessy about his study. The study included 41 patients, whose average age was 47 years. They had been suffering from migraines for on average 26 years and had experienced an average of 33 migraine
days over the previous three months. The average migraine pain intensity was 7 on a scale from 0 to 10; the average intensity of nausea was 6 on a 1-10 scale. Patients were instructed to use the device (Sea Band) instead of taking nausea medication during their next migraine attack and to complete and return a migraine attack diary. After using the acupressure band, 34 (83%) patients noticed a reduction of nausea and 18 (44%) reported a significant improvement in nausea. The average intensity of nausea after therapy was 3. The relief of nausea was reported after an average of 29 minutes. The average duration of the migraine attacks was 22 hours. The Sea Bands were worn on average for 18 hours. Forty patients (98%) reported that they would use Sea Band during migraine attacks again. The authors concluded that the use of an acupressure band can reduce migraine-related nausea. The advantage of this therapy is that it is drug-free and has no risks
or side-effects such as dizziness, fatigue, or restlessness seen with drugs. Its effect is rapid, and it is easy and it is inexpensive to use (in the US, $6 to $10). To prove that this method works beyond just placebo effect we need a blinded trial comparing anti-nausea medication with Sea Bands. I do recommend Sea Bands or a similar device, Psi Band for my migraine patients. A controlled trial in 60 women showed that Sea Bands relieve morning sickness of pregnancy (nausea and vomiting of pregnancy), which suggests that the relief we see in migraine patients is also real and not just due to placebo.

Art credit: JulieMauskop.com

Leeches are not pleasant to look at, but they have been used for medicinal purposes for hundreds of years. Growing up in the Ukraine in the 1960s I remember (this is hard to forget) seeing big jars with leeches in a corner pharmacy. Patients would bring in a prescription from the doctor for 4 leeches to be applied daily. The leeches would be placed into a small jar and taken home by the patient to treat swelling, high blood pressure and I don’t know what else. Leeches went out of fashion because of the advances in medicine and just because they are just disgusting. They are being used again in the US for removing extra blood around the scars after cosmetic surgery, arthritic pains, shingles, and other conditions.

British writer Emma Parker Bowles was recently in the news writing about how leeches cured her migraines. She decided on this unusual treatment because her headaches were so severe. She says, “the word headache doesn’t even begin to describe them”. She goes on with a vivid description, “Migraines are miserable with bells on – actually, the idea of listening to the sound of a bell with a migraine brings me out in a sweat. When I am suffering with one, I can’t even stand the sound of my sheets rustling. Apart from the intense throbbing, all-encompassing pain in my head, I also feel extremely nauseous and sensitive to light. I feel as if I am a vampire – a small sliver of daylight and POOF: I will spontaneously combust”.

Leeches do not hurt when they are applied because they first release a numbing substance, which along with a blood thinner and other chemicals released by the leech may be responsible for their beneficial effect. They do not have any known serious side effects. Leeches are used once and then destroyed to avoid transmitting diseases, although there is no reason why a person could not reuse them herself or himself. Several companies sell leeches to the public with instructions on how to use them. Although leeches have been used for the treatment of migraines for many years, there have been no good clinical trials or even reports of large series of cases, but someone should definitely undertake this research. Me? I am not sure I am ready.

Art credit: JulieMauskop.com

In my previous post I mentioned a TENS unit spcifically designed for the treatment of migraine headaches. It was available for a short time on Amazon.com, but no longer is. It is sold at COSTCO stores in Canada and in Europe. Howere, regular TENS units can be tried and they are less expensive.

Food sensitivities have been always suspected to be a trigger for migraine headaches. A group of Turkish neurologists published a study in the journal Headache in which they gave an elimination diet to 21 migraine sufferers who also had irritable bowel syndrome (IBS). The study was double-blind, randomized, controlled, and cross-over, which is the most reliable type of study. Depending on the results of blood tests against 270 potential food triggers each patient was given a diet that eliminated foods they tested positive for. On average, patients were sensitive to 23 items. Compared with baseline levels, elimination diet was associated with significant reductions in migraine attack count, maximum attack duration, maximum attack severity, and number of attacks requiring medication. There was a significant reduction in pain-bloating severity, pain-bloating within the last 10 days, and was a significant improvement in quality of life by the elimination diet as compared with provocation diet.
The authors concluded that food elimination based on IgG antibodies in migraine patients who suffer from concomitant IBS may effectively reduce symptoms of both disorders with a positive impact on the quality of life of patients.
A similar, but much larger double-blind study published in 2011 compared true and sham diets in 167 migraine sufferers. 84 patients received a diet that eliminated trigger foods identified by IgG testing and the other 83 a sham diet and neither the doctor nor the patients knew who received a true elimination diet and who was given a sham diet. After 12 weeks on these diets there was no difference between the true and the sham group, suggesting that IgG testing is not useful.

Photo credit: JulieMauskop.com

Marijuana seems to help some patients with migraine and cluster headaches. However a new study suggests that it has more negative effects than previously thought. We know that smoking pot causes lung problems and risks serious damage to various organs due to possible impurities. A recent report in the Proceedings of the National Academy of Sciences shows that regular cannabis use is harmful to health. Adolescents are beginning to use marijuana at younger ages, and more adolescents are using it on a daily basis. This study showed that persistent use of marijuana leads to neuropsychological decline. Researchers from Duke University, England and New Zealand examined records of 1,037 individuals who were followed from birth to age 38. Marijuana use was determined in interviews at ages 18, 21, 26, 32, and 38. Neuropsychological testing was conducted at age 13, before initiation of marijuana use, and again at age 38. Persistent use was associated with neuropsychological decline, including IQ, even after taking into account years of education. Persistent marijuana users reported noticing more cognitive problems. Impairment was strongest among those who started using marijuana in adolescence and the more persistent was the use the greater was the cognitive decline. Stopping marijuana use did not fully restore neuropsychological functioning and IQ among those who started its use in adolescence. This study suggests that cannabis has a toxic an persistent effect on the adolescent brain.

Cognitive-behavioral therapy (CBT) has been convincingly proven to help pain and headache sufferers. Many people are very skeptical about the value of psychological treatments and tell me, just get rid of my migraines and I will be fine. Unfortunately, sometimes it takes time to relieve chronic headaches and pain. So, while we are trying to find relief, it helps to learn how to function better despite pain, how not to panic and become completely paralyzed by headaches, how to inform and interact better with family, friends, and employers. Research indicates, that people who take charge of their care, get involved in working with the doctor to find relief, learn relaxation techniques, rather than just sit back and wait for doctors to “fix” the problem, do much better. CBT, which usually involves relaxation training, is one way to improve your care and it usually involves 8 to 12 structured sessions. Here is an example of what might take place during these sessions:
1. Three-component CBT model (thoughts, feelings, behaviors), pain monitoring
2. Relaxation training (diaphragmatic breathing, progressive muscle relaxation, guided imagery)
3. Migraine trigger avoidance
4. Pain-fatigue cycle, activity pacing, and pleasant event scheduling
5. Identifying and challenging negative thoughts (Activity, Belief, Consequences, Dispute model)
6. Problem-solving skills training and assertive communication
7. Review and practice
8. Review and practice
9. Relapse prevention
Another form of CBT is Acceptance Commitment Therapy (ACT) and this is what a typical schedule of sessions of ACT looks like:
1. The limits of control (short and long-term costs and benefits; finger
traps), focus on experience (body scan)
2. Values (what you care about, how you want to live your
life)
3. Cognitive defusion (observing thoughts without trying to evaluate or
change them)
4. Mindfulness (being in the moment, raisin exercise)
5. Committed action (“road map” connecting values, goals, actions,
obstacles, and strategies)
6. Review and continued action in support of values
7. Review and continued action in support of values
8. Moving forward
CBT usually is conducted by a a social worker or a psychologist and sometimes this treatment is covered by insurance. Group sessions have also been shown to be effective. However, sometimes insurance does nor cover this service or a therapist is not available. Online, web-based CBT seems to work too. Two Australian web sites offer free CBT for anxiety, depression and other problems, although they are not specifically tailored for people with headaches or pain. ThisWayUp.org.au and moodGYM.anu.edu.au are both excellent free resources for people who are looking for help, but cannot find or afford a therapist. The psychologists who developed and run these sites published results of their treatments in scientific journals, showing that self-taught CBT can be very effective. Here is a schedule of lessons for anxiety and depression on ThisWayUp website:
Lesson 1
About anxiety and depression
Learn about your own symptoms of anxiety and/or depression, and learn to tackle the physical symptoms of anxiety/depression.
Lesson 2
Identifying thoughts and tackling low activity
Learn to identify the thought symptoms of anxiety/depression, and learn to tackle the behaviours associated with anxiety/depression.
Lesson 3
Tackling thoughts
Learn to tackle the thought symptoms of anxiety/depression.
Lesson 4
Tackling avoidance
Learn to tackle avoidance behaviours associated with anxiety/depression by facing your fears.
Lesson 5
Mastering your skills
Learn to master your ability to face your fears using graded exposure, and learn to cope with the distressing emotions associated with anxiety/depression.
Lesson 6
Staying well
Learn how to avoid relapses and how to keep getting better!

There is a long history of applying various ointments for the treatment of headaches. Widely available Tiger Balm, Head-On and other topical products can provide relief of milder headaches. There are no scientific studies proving that these treatments work beyond the placebo effect, although we do have some evidence established by Hartmut Gobel and his colleagues in Germany suggesting that the smell of peppermint can provide some pain relief. So it is possible, that the smell of herbs in Tiger Balm and possibly the cooling effect of these ointments combined with placebo effect is what accounts for the popularity of these products.
I have been using a prescription ointment for some of my patients with headaches and neck pain. This ointment has to be prepared by a compounding pharmacy and typically is not available from big chains, such as CVS or Walmart, although Walgreens does offer compounding services at some of its pharmacies. We do not have any information about the best combination of ingredients to use for the relief of headaches and pain. However, some studies indicate that topical skin application of some products does provide relief. Ketamine, which blocks the so called NMDA pain receptor can relieve pain of complex regional pain syndrome, a very serious and painful condition. Application of clonidine, a blood pressure medication has been shown to relieve pain of diabetic neuropathy – painful nerve damage due to diabetes. We also know that lidocaine is very effective when applied to the skin and it is the active ingredient in a prescription pain patch, Lidoderm. Anti-inflammatory drugs, such as aspirin or similar salicilate drugs (Aspercreme), diclofenac (Flector patch), piroxicam and other also help pain when applied to the skin. There are no studies of topical application of muscle relaxants, such as baclofen and tizanidine or an epilepsy drug gabapentin, but these drugs are often also included in compounded creams.
My usual prescription is to combine ketamine with lidocaine, piroxicam and baclofen. Unfortunately, we do not know what is the most effective combination and it would be very difficult to compare so many available ingredients in a scientific study. However, these creams are safer than oral drugs and for some patients can be as effective. Another drawback of the compounded products is that insurance often will not pay for it.

Omega-3 fatty acids (most abundantly found in fish oil) may relieve migraine headaches but only one small study found this to be the case. However, there is mounting evidence for beneficial effects of omega-3 fatty acids for various conditions, such as strokes, heart disease, dementia, and other. A just published study in the journal BMC Cancer shows that omega-3 fatty acids prevent nerve damage caused by a chemotherapy drug used to treat breast cancer. Paclitaxel (Taxol) caused peripheral neuropathy in 60% of women who received placebo and in only 30% of those who were given omega-3 fatty acids (640 mg three times a day). Using this safe and natural supplement may allow many more women receive this life-saving chemotherapy without causing crippling side effects. Considering all of the positive studies of fish oil for a variety of neurological and other conditions and, considering its safety and low cost, it is reasonable to try this supplement for the prevention of migraine headaches despite the lack of definitive studies.

Slow breathing can reduce pain, according to a recently published study in The Journal of Pain. Researchers at the University of Tulsa led by Satin Martin evaluated the effect on pain of slow breathing, normal and fast breathing in 30 healthy volunteers. Pain was induced by an electric shock to the leg. Slow breathing (50% of normal rate) significantly reduced pain perception when compared to normal or fast (at 125% of normal rate) breathing. Slow breathing has been long utilized for the reduction of pain and is usually included in biofeedback, meditation, and other relaxation methods. This study provides solid scientific support for this simple and ancient technique, which should be utilized more widely in the management of pain, including migraine and other headaches.