Understanding the evidence for acupuncture and herbal nutrient medicine in the control and cure of migraine and cluster headaches
One question that keeps most patients from actually benefiting from the treatments in Complementary and Integrative Medicine (CIM) in the alleviation of migraine and cluster headaches is the question of proof of effectiveness. Since these health problems are difficult to treat, often eluding significant benefit from standard pharmaceutical protocol, and usually require a persistent course of therapy with acupuncture, herbs and nutrient medicine, which is poorly covered by standard insurance plans until voters demand that Complementary and Integrative Medicine and Traditional Chinese Medicine (CIM/TCM) coverage is mandated, as it is in Europe, the treatment course requires some commitment on the part of the patient. Today, there is finally abundant proof of effectiveness and safety for CIM/TCM in the treatment of migraine and cluster headache syndromes, despite the difficult problems of using a system of randomized controlled human clinical trials that need to somehow blind both the physician and patient to a supposedly fake or placebo insertion and manipulation of needles, which is in effect impossible by design, and that ignores the need for a holistic use of an array of therapeutic chemicals with herbal and nutrient medicine, not just single chemicals, as in synthetic pharmaceutical treatment.
In the last few years scientific study of acupuncture, herbal and nutrient medicine has blossomed, and scientific understanding of the complex mechanisms of migraine and cluster headache have also born fruit. The German 3-year human clinical trial at Essen University proved that a simple uniform acupuncture treatment reduced frequency and intensity of migraine episodes as well as an intensive course of pharmaceuticals. The combination of magnesium and potassium aspartate, CoQ10, riboflavin B2, P5P (active metabolite of Vitamin B6), and inositol hexacotinate, an active metabolite of Vitamin B3 niacin, was also proven effective in Germany for a high percentage of migraine patients if taken for a prolonged period. Each year, more and more scientific proof of a holistic therapeutic protocol is emerging, allowing patients to successfully integrate TCM/CIM for better and safer results, and preventing the medication overuse syndromes of rebound migraine.
Research has revealed that for many patients, a genetic propensity for nerve cell dysfunction in the regulatory brain stem, involving deficient function of cellular mitochondria, lies at the heart of the sequence of dysfunction allowing the migraine episode, which involves a neuro-reflex of excess vasodilation. A number of factors must be evident in most patients for the episodes to trigger, including chronic problems handling oxidative stress, chronic arterial inflammation that is poorly modulated, problems with regulation of excess histamine production, and nutritional deficiencies that keep the body from being able to produce enough niacin in the brain cells. A variety of contributing health problems may also be involved, depending on the individual case. This research has pointed to need for a more holistic approach in treatment, with restoration of normal homeostatic mechanisms needed to correct the problem. Utilizing this scientific understanding, human clinical trials with combinations of herbs and nutrients have produced very successful clinical trial results as well in the treatment of migraine and cluster headache syndromes. Utilizing a combination of proven acupuncture treatments with a course of herbal and nutrient medicine that is individualized to the patient and their particular underlying health problems and dysfunctions is very important to achieve lasting success without need for constant treatment.
As understanding of the migraine mechanisms progresses, researchers are able to refine their study to discover more effective treatment protocols in Complementary Medicine. Recent research has revealed the role of neurotransmitter and ion channel dysfunctions in the pathophysiology of migraine syndromes. For instance, fMRI and PNMRS brain studies show that migraine patients experience lowered magnesium levels in the brain (a common ion, or charged molecule) during the migraine attack, but not when the migraine was not occurring (Ramadan et al; Headache Jun 2005; Vol29(9): 590-3). This suggests a role of ion channel regulation dysfunction. Such studies have also found that glutamergic neurotransmitters (GABA regulation) were abnormal in key areas of the brain (anterior cingulate cortex and insula) during the interictal (time between migraine attacks) (Prescot et al; Molecular Pain 2009; 5:34). While the exact mechanisms of disease are still poorly understood, most experts now agree that hyperexcitability of neural membranes in the brain is central to the pathology, and that the main excitatory neurotransmitter in the brain, glutamate, is central to this dysfunction. An imbalance of glutamate receptor types, especially excess of NMDA glutamine receptors, may be central to the triggering of the neurovascular migraine chain of events. This may explain the apparent sensitivity of migraine patients to monosodium glutamate and the wide array of glutamate molecules now used in processed food to stimulate desire, or addiction, to the food. While no direct therapy can easily correct this dysfunction, a combination of specific electroacupuncture stimulations and use of herbs with effects that calm neuroexcitotoxicity, such as Huperzine A and Vinpurazine, as well as a combination of L-Glutamine, inositol hexacotinate and P5P, may eventually correct these neurotransmitter dysfunctions. Studies of the brain with fMRI have demonstrated the remarkable specific effects of certain acupoints on these key areas of the brain, demonstrating for instance that stimulation of the P6 and GB34 points resulted in considerably lowered activity of the anterior cingulate cortex, and electroacupuncture at ST36 and SP6 significantly modulated activity in the insula (JNM 2012 July; 18(3): 305-316). Such research provides more specific treatment protocols to try in the course of treatment with acupuncture, herbal and nutrient medicine.
Designing clinical study trials for manual therapies along the requirements of studies meant for pharmaceutical pills has long presented overwhelming challenges. A double blinded placebo study means that both the patient and the physician administering treatment is unaware of whether placebo or actual treatment is being performed, and that a believable placebo treatment is being used. Of course, anyone can see that this works well with pills, but how do you devise a believable blinded placebo for needle stimulation or any other manual therapy? The National Institute of Health has a governmental organization devoted to health research quality assessment (AHRQ) that has determined that less than 19% of manual therapies meet these requirements in proving that they work. Of course, no surgeries meet this criteria. But acupuncture has had to meet this criteria in the West because of such amazing amounts of lobbying against the practice by big pharmaceuticals, the insurance industry and the AMA. Despite this, acupuncture has met these criteria and is adopted by the WHO and NIH as scientifically proven. In fact, when the NIH AHRQ declared that only 19 percent of manual therapies met the criteria of proof of efficacy in human clinical trials, acupuncture therapy made up the bulk of these proven studies.
In Germany, large trials in 2006 proved that acupuncture was a viable, and in fact superior, treatment for the migraine headache, performing at least as well as pharmaceutical therapies, with no adverse effects, and no risk of rebound headache syndrome (see the study link cited below). In 2013, a long-term randomized and controlled human clinical trial of 100 patients with chronic migraine syndromes was completed at the University of Padua, Italy, Department of Neurosciences, and here too, a course of simple standardized acupuncture treatment (20 sessions) outperformed pharmaceutical therapy in the long term. This study utilized what we know about acupuncture therapy for migraine syndromes, persisting with a longer course of therapy, and showing that outcomes may be better with pharmaceuticals in the short term, but at 6 months, the group receiving acupuncture consistently scored better on pain relief scales and subjective evaluation of pain intensity, and were able to reduce their use of triptan medications for migraine episodes significantly, compared to the standard protocol of daily use of a medication that included valproic acid (see study link below). In addition, the pharmaceutical course recorded adverse health effects, or side effects of medication, in nearly half of the participants, while no adverse effects of acupuncture therapy were noted. In fact, the side effects of acupuncture therapy is improved overall health and vitality. This human clinical trial clearly shows patients that a 10 week course of professional acupuncture therapy will result in an actual improvement in underlying health and causative factors, with lasting benefits. When combined with professional herbal and nutrient medicines, individualized for each patient, and taken in the proper step-by-step manner to correct the pathophysiological mechanisms responsible for these headaches, the results should be magnified greatly, insuring long-term reduction of debilitating migraine pain.
Why then did past trials of acupuncture not show demonstrative benefits? The reasons are clear when closely examining the biased study designs used in the past. When designing these placebo studies, the industry may choose so-called placebo acupuncture that is actually real acupuncture at different points than what are being studied. This so-called sham acupuncture is often found to be almost as effective as the points used in the so-called real acupuncture, and the outcome measures not the actual efficacy, but the difference between this so-called placebo acupuncture and the choice of real acupuncture in the study. The real acupuncture is often inhibited in its design effectiveness as well by not allowing manipulation of the needles, by not allowing individualized treatments, and by not allowing acupuncturists that have developed the necessary treatment repoire with the patients. Much of this biased study design was needed to achieve a double-blinded treatment protocol, meaning that the acupuncturists hired to do the treatment had to themselves be blinded to whether they were using actual acupuncture needle manipulation, or a so-called sham acupuncture stimulation. Clearly, this is a lot to overcome to make the study treatment effective, and such treatment design can be utilized to obscure the results. In addition, the outcome measures were designed to gauge short-term improvement, and lack of funding for these studies often resulted in trials utilizing only short course of acupuncture, insufficient for such a persistent and complex health problem. Since acupuncture and herbal medicine present a low-cost alternative to expensive and lucrative pharmaceutical approaches, the monetary incentive for such poor study design is evident, and much has now been written on the manipulation of study design in evaluating acupuncture.
Despite these problems, the German study on effectiveness of acupuncture for migraine patients showed that acupuncture was just as effective as standard treatment with the latest migraine medications. Of course, the so-called sham acupuncture in the study also worked quite well. This type of finding is typical of randomized trials of acupuncture, and today, government panels are created in Europe to address this problem of manipulated study design with acupuncture. Acupuncture almost always has very positive results in these clinical trials, but ultimate outcome is measured by the degree of success greater than the so-called sham acupuncture, which is actually real acupuncture with needle locations other than the ones chosen for the so-called real treatment. Study design frequently omits comparison study with standard treatment, and shows that the so-callled sham acupuncture also has very good treatment results compared to the chosen needle points. The study summary omits these details, and often states that the real acupuncture did not perform significantly better than the so-called sham acupuncture. The public has to make the decision on what information to believe when the headlines in medical journals that oppose the acupuncture industry cite the failure of these studies. Numerous studies that meet the requirements of this nearly impossible study method are, miraculously enough, showing very positive outcomes, but the funding is not great enough to allow a large patient participation, and so these study findings are usually not allowed in the journals' overall assessments.
Since these landmark studies that provided sound evidence that acupuncture stimulation does work to decrease migraine pain and frequency, and can be effectively used in short repeated courses within a broader holistic protocol of herbal and nutrient medicine to achieve lasting benefits, the study of specific acupuncture treatments has accelerated to provide clinical guidelines. For instance, in 2014 experts at the Chengdu University of Traditional Chinese Medicine, in Chengdu, China, used randomized controlled PET-CT studies of the brain to determine the best treatment points and meridians, and types of stimulation, for migraine patients. This study showed that a combination of electroacupuncture and manual stimulation at Shaoyang (GB/SJ) meridian points, including SJ17, SJ8, and GB33 both decreased migraine pain and increased increased brain glucose metabolism in key areas associated with migraine pathology, such as the mid-frontal gyrus, postcentral gyrus, precuneus, parahippocampus, middle cingulate gyrus and cerebellum. Non-specific points used as a control did not produce this increase in brain function in these areas, but did provide some subjective pain decrease. Such studies will help guide professional acupuncturists in clinical practice (PMID: 25496446). Such treatment should be performed in short courses with frequent treatments, at least 2-3 times per week for a few weeks per course. The frequency of these courses over time is determined by the patient schedule, the severity of the symptoms, and the progress that is seen, but this allows for an inexpensive and easy treatment protocol within a broader and more holistic treatment plan, with herbal and nutrient medicine, avoidance of triggers of the migraine, and sensible alteration of medication protocols to prevent or decrease the potential for rebound migraine syndrome.
The bottom line is that, even with this almost insurmountable problem of evidence-based study design, Europe is finding that acupuncture and Complementary Medicine is proven effective, and the European Union has mandated coverage for these therapies. The patient population continues to increase its belief in and use of Complementary Medicine, in Europe and in the U.S., with recent demographic studies showing over 80 percent of the population now utilizing some form of Complementary Medicine to help treat their migraines. The challenge for effective therapy comes in convincing patients that a professional and proven course of therapy in Complementary Medicine, with acupuncture and herbal/nutrient medicine combined, should be utilized, and not just some poor quality herbal or nutrient medicine bought online or off the shelf, or just a few treatments with acupuncture. Clearly, scientific study has demonstrated that most migraine and cluster headache syndromes are poorly controlled with standard pharmaceutical medications, prompting the rise in use of Complementary Medicine, but most of this utilization, mistakenly characterized as "alternative", has been in the form of too simple of protocols, either in response to advertising, or given to them by their medical doctors, who received virtually no training and education in this field of herbal and nutrient medicine. The intelligent patient is realizing that they need to utilize pharmacological therapy sensibly, minimizing dependency to prevent rebound headache syndromes and adverse health effects, while using professional Complementary Medicine, from the knowledgeable Licensed Acupuncturist and herbalist, in a quality individualized coures of treatment. Both fields of medicine are helpful, and should complement each other to minimize the migraine pathology, and work to achieve an eventual cure.
The German Study: Diner, Kronfeld et al, Dept of Neurology, University Essen, Essen Germany; Lancet Neurol. 2008 Jun 7(6);475: a prospective, randomized, double-blind, parallel-group, controlled, clinical trial, undertaken between April 2002 and July 2005 with 1295 migraine patients who had 2 to 6 migraines per month showed that acupuncture treatment outcomes for migraine did not differ from standard therapy using calcium channel blockers, antiseizure drugs and beta blockers, with 47 percent of the acupuncture patients showing a reduction of migraine days by at least 50 percent after 26 weeks following a course of 10 treatments in 6 weeks versus continuous prophylaxis with drugs. I repeat, 10 treatments in 6 weeks versus continuous use of 3 common expensive medications. Unlike these medications, acupuncture therapy has no risk and side effects. Acupuncture can also be combined with herbal and nutrient therapy, as well as soft tissue mobilization and myofascial release, offering the patient a number of treatment options proven effective for subsets of migraine patients. The Italian study followed 100 patients affected by migraines without aura (visual dysfunctions etc.) for over a year, showing the a course of simple acupuncture twice a week for 10 weeks resulted in a much better lasting outcome at 6 months compared to the chronic use of a Valproic acid medication such as Depakote, resulting in significantly long-term reduced pain intensity and reduction in pain-related symptoms, as well as a significant reduction in the need for a triptan medication such as Imitrex (sumatriptan), Maxalt (rizatriptan), or Zomig (zolmitriptan) for acute migraine attacks. Other acupuncture studies have also noted long-term benefits compared to different courses of pharmacological intervention, and a large list of studies prove the benefits of various herbal and nutrient combinations. The section entitled Information Resources below shows summaries of some of this study, with links to the studies themselves in government sponsored health study databases such as PubMed.