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Nonpharmacologic Management of Migraines
By Susan T. Marcolina, MD, FACP, Dr. Marcolina is a board-certified internist and geriatrician in Issaquah, WA; she reports no consultant, stockholder, speaker's bureau, research, or other financial relationships with companies having ties to this field of study.
Part 2 of a Series on Migraines
The question of whether acupuncture is effective for the treatment of migraine headaches is a complex one. The practice is variable in different countries, among different traditions, and between individual practitioners, as are the certification requirements to perform this procedure. Thus, it is difficult to generalize results of acupuncture practice from one clinical situation to others.
In Germany, a multicenter, randomized controlled trial, the Acupuncture Randomized Trial or (ART), compared acupuncture according to traditional Chinese medicine (TCM) practice (verum) to sham acupuncture (needling in areas of skin for which no TCM acupuncture points are known) and a waiting list control group for the treatment of migraine in 302 patients (88% female). The percentage of responders (persons achieving at least 50% reduction in headache days) was 51% in the verum acupuncture group, 53% in the sham acupuncture group, and 15% in the waiting list controls. Although there were no statistically significant differences between the two acupuncture groups, both acupuncture interventions were significantly more effective than the control treatment.1
The German Acupuncture study GERAC, a randomized, multicenter, parallel-group trial, involved 960 migraine patients divided into three arms. One arm received 10 TCM acupuncture sessions over eight weeks, another received 10 sham acupuncture sessions in eight weeks, and in the third arm patients were continuously treated with standard migraine prophylactic medications (beta blockers, calcium channel blockers, or anticonvulsives). After 26 weeks, 47% of the verum treatment group were responders, 39% of the sham group were responders, and 40% of the medication group were responders.1 Since there were no statistically significant differences between treatment groups, and in part due to the findings of this study, migraine is no longer a reimbursable diagnosis for acupuncture therapy in Germany.2
There is controversy regarding the interpretation of these studies, as well as methodological and design problems with blinding of patients and practitioners. Sham acupuncture is viewed by most experts not to be an inert placebo control when compared to verum acupuncture, as light touch or needling employed with this technique can stimulate C-tactile afferent nerves, which can result in analgesic effects. This may be the reason that no differences were found between acupuncture treatments.3
Vickers et al, in a primary care practice-based trial of 400 headache patients (predominantly migraine), evaluated the effect of 12 acupuncture sessions over three months vs. standard care (not explicitly defined).4 After one year, the acupuncture group experienced a statistically significant decline of 34% in headache symptoms compared with the standard care group which had a 16% decline (P = 0.0002). Additionally, the acupuncture group used 15% less medication, took 15% fewer sick days, and had 25% fewer visits to their primary care physicians.
Wonderling et al conducted a cost-benefit analysis of this randomized trial and found acupuncture to be cost effective in terms of the significant improvement in quality adjusted life years for the acupuncture vs. placebo patients. As a result of this study, the authors recommended that the National Health Service offer coverage for treatment of migraines with acupuncture.5
Mind-body or Behavioral Therapies
The Multidisciplinary U.S. Headache Consortium's recommendations regarding behavioral interventions for migraine are that relaxation training, thermal biofeedback combined with relaxation training, EMG biofeedback, and cognitive behavioral therapy (CBT) may be considered as treatment options for migraine prevention (Grade A evidence) and that behavioral therapy may be combined with preventive drug therapy to achieve enhanced clinical improvement for migraine (Grade B evidence). They also conclude that behavioral treatments may be most suitable for patients who: 1) prefer this approach; 2) cannot tolerate pharmacologic treatment secondary to side effects; 3) are currently or will imminently be pregnant or nursing; or 4) have a long history of frequent or excessive analgesic medication use, which can exacerbate headaches.6,7 A brief descriptive outline of these mind-body therapies follows.6
Relaxation Training. Relaxation techniques appear to increase control over headache-related physiologic responses and, over time, lower sympathetic arousal. Patients may practice a series of graded relaxation techniques that could include diaphragmatic breathing, progressive relaxation of isolated muscle groupings, or relaxing imagery for 20-30 minutes daily. As patients learn to differentiate between tense and relaxed states, they are encouraged to practice the techniques at intervals throughout the day, both as a preventive measure and as an abortive intervention.
Biofeedback. The biofeedback methods of thermal hand-warming (feedback of skin temperature from an externally attached finger probe), electromyographic (EMG) feedback (feedback of electrical activity from scalp, neck, and upper body musculature), and electroencephalographic (EEG) biofeedback or neurofeedback (feedback of cortical brain wave frequencies monitored on a computer screen) all have in common subconsciously controlled body functions such as skin temperature, skeletal muscle tension, or brain wave frequency, respectively, that patients learn to impact by means of feedback with a monitoring device. The goal for patients, whether using self-regulation skills or a home biofeedback training device, is to practice for 20 minutes daily and incorporate it into their daily routine.
Cognitive Behavioral Training. Based upon the concept of stress as a common trigger factor for migraine (see Table), it logically follows that stress management training may be an effective treatment approach. CBT addresses both intellectual and affective precipitants, and teaches patients to reframe stress-generating thoughts and behavior, thus rendering them less vulnerable to stress-related headaches.
Lipton et al suggest that certain patients with cognitive impairment, comorbid psychiatric disorders, and more severe headaches may need multimodal intervention, which may include mind-body therapies, depending upon their ability to participate.8
Holroyd et al compared results reported in 25 pre-ventive drug (propranolol) therapy trials and in 35 thermal biofeedback/relaxation trials that included more than 2,400 patients. Both propranolol and thermal biofeedback training yielded a 55% reduction in migraine activity while the placebo (pill) yielded only a 12% reduction in migraine activity.1 Subsequently, Holroyd et al compared the effectiveness of limited contact thermal biofeedback training alone and with propranolol (60-180 mg/d). Propranolol significantly enhanced the effectiveness of thermal biofeedback training on measures of migraine activity, analgesic use, and quality of life.9
Nestoriuc and Martin examined the efficacy of biofeedback techniques for the treatment of migraines in a meta-analysis of 55 studies. The frequency and duration of migraine attacks were significantly reduced compared to waiting list controls. Additionally, biofeedback reduced the associated symptoms of depression and anxiety, and these treatment effects remained stable over an average follow-up interval of 17 months.10
Kaushik et al, in a comparative study of propranolol prophylaxis vs. biofeedback-assisted diaphragmatic breathing and systemic relaxation in 192 migraine patients, found that both propranolol and biofeedback groups experienced significant clinical improvements without significant intergroup differences at six months. However, during the one year post-treatment follow-up period, the biofeedback group as a whole experienced less recurrence of migraine headaches (9.37%) compared to the propranolol group, which had a recurrence rate of 38.54%.11
Adverse Effects: All Therapies
The adverse events (AEs) reported in clinical studies of feverfew were generally mild and similar in both treatment and placebo groups.12-14 Mouth ulceration is a rare AE observed in the clinical trials of Johnson et al. Such inflammation of the mucous membrane of the mouth and tongue, accompanied by swelling of the lips and taste loss, is probably a contact phenomenon, and is unlikely to be significant with encapsulated feverfew preparations.15,16 With a history of use as a folk remedy for abortions, feverfew should not be used in pregnant females. Its safety has also not been established in young children or lactating women. Because feverfew interferes with platelet aggregation, physicians should carefully consider alternative agents in persons on anticoagulation therapy.17,18
Magnesium supplements can frequently cause diarrhea; taking magnesium with food can reduce this side effect. Individuals with renal impairment should not be given supplemental magnesium as they are unable to excrete it and can build up toxic levels. ConsumerLab purchased many leading magnesium supplements sold in the United States and tested them to determine whether they: 1) possessed the claimed amount of magnesium; 2) could disintegrate properly in the digestive tract in order to be absorbed; and 3) were free of unacceptable levels of lead. Results of the Consumer Labs analysis can be viewed at www.consumerlab.com/results/magnesium.asp.19
The safety of CoQ10 has not been evaluated for pregnant or breastfeeding women and therefore should not be used in these patients.
Because the chemical structure of CoQ10 closely resembles vitamin K, it has the potential to antagonize the anticoagulant effect of warfarin, requiring dosage adjustment to achieve therapeutic International Normalized Ratios. Medications such as antidepressants, statins, antipsychotics, and beta blockers decrease the body's natural CoQ10 production; patients using these agents may require larger doses of CoQ10 than normally recommended. CoQ10 also has the potential to interact with reverse transcriptase inhibitors to exacerbate the neuropathy that can be a side effect of these medications in patients with AIDS. Information about Consumer Lab testing of CoQ10 products can be obtained at www.consumerlab.com/results/CoQ10.asp?#cautions.20
Although acupuncture is generally perceived as safe, it is a type of minimally invasive procedure and as such can result in adverse outcomes. Most experts report localized pain and bleeding as the most common complications of acupuncture.21 There have been rare reports of fatalities due to acupuncture complications published including cardiac tamponade, staphylococcal sepsis, and bilateral tension pneumothoraces. Patients who have been identified to be at increased risk of adverse events associated with acupuncture include those with emphysema and patients on chronic steroids. The complications from acupuncture are associated with inadequate hygiene practices and insufficient training and experience of the practitioner.22 In well-trained hands acupuncture is quite safe.
Nestoriuc and Martin, in their meta-analysis of 55 studies involving patients treated with behavioral therapies, noted that none of the studies reported adverse effects.10
Dosage and Administration
Clinical studies have used 6.25 mg three times daily of the MIG-99 standardized form of feverfew for migraine patients. Because this preparation is not commercially available, it is difficult to know whether available supplements will duplicate the clinical effects seen in the studies.
Although riboflavin is found in small amounts in many vegetables and nuts, much higher supplemental amounts of 400 mg/d have been suggested by clinical studies for the prevention of migraine.23
Magnesium supplementation of 360-600 mg/d has been suggested in clinical studies for the prevention of migraines.24,25
CoQ10 in a liquid gel capsule formulation and dose of 1-3 mg/kg/d for children and adolescents was successful in normalization of low serum CoQ10 levels and in significantly improving the post-supplementation Ped MIDAS headache disability assessments (P < 0.001).26 For adults, CoQ10 in a daily dose of 300 mg may help prevent migraine headaches, but does not affect the severity or duration of an acute ongoing attack. It can take up to three months to achieve the full migraine-preventing benefits of CoQ10. Products containing CoQ10 dissolved in oil or solubilized in other substances are better absorbed than products containing the dry powder.20
If a therapeutic trial of riboflavin, magnesium, or CoQ10 is to be undertaken for migraine prophylaxis, they should each be used for three continuous months. Blood levels of CoQ10 can be routinely assessed due to manufacturing differences in CoQ10 content variability, but this is rarely necessary. It generally takes up to three months of continuous supplementation of either feverfew, riboflavin, magnesium, or CoQ10 to achieve prophylactic benefits.13,14,19,23-25
Because migraine headaches reflect a chronic illness, lifestyle changes such as the implementation of regular daily aerobic exercise coupled with a daily dietary fat intake of 20-30 g may decrease the frequency, duration, and intensity of migraines, in addition to promoting improved cardiovascular and general medical health. Consideration should be given to additional supplementation with vitamin B2, magnesium, and CoQ10, especially in face of low serum levels of the latter as there is good evidence that they all can help prevent migraines. However, patients with significant renal insufficiency should not take supplemental magnesium. Feverfew, CoQ10, and migraine-preventive doses of riboflavin are not indicated for pregnant or lactating patients. Patients on systemic anticoagulation or reverse transcriptase inhibitors for AIDS should discuss CoQ10 with their doctors before initiating therapy, as concerns exist.
Food and food additive triggers can be noted by careful headache diary record keeping and can then be avoided. Mind-body therapies, when initiated and integrated into a patient's lifestyle, have been shown to be as effective as prophylactic pharmacotherapy with additional benefits for general medical and psychological health in terms of stress reduction, improved coping strategies, and self-empowerment. Indeed, pharmacotherapy has been shown to boost the effectiveness of mind-body therapies in migraine prevention. Although some studies show that acupuncture is as effective as pharmacotherapy, regional and practitioner differences in the procedure and difficulty in interpretation of the studies make it difficult to judge which patients would benefit most.
It is important for primary care physicians to utilize International Headache Society criteria to diagnose migraine headaches in their patients and promptly initiate therapeutic lifestyle interventions, including regular aerobic exercise, a low-fat diet, the avoidance of migraine triggers, and evaluation of the need for riboflavin, magnesium, or CoQ10 supplementation. Depending upon the patient's clinical situation, mind-body therapies can be considered alone or in combination with pharmacotherapy. The headache diary and Ped MIDAS or MIDAS questionnaires are important tools by which patient and physician can assess the impact of therapeutic interventions on the migraine history.
1. Linde K, et al. Acupuncture for patients with migraine: A randomized controlled trial. JAMA 2005;293:2118-2125.
2. Diener HC, et al. The GERAC Migraine Study Group. Efficacy of acupuncture for the prophylaxis of migraine: A multicentre randomised, controlled clinical trial. Lancet Neurol 2006;5:310-316.
3. Birch S. Reflections on the German Acupuncture studies. J Chin Med 2007;83:12-17.
4. Vickers AJ, et al. Acupuncture for chronic headache in primary care: Large, pragmatic, randomised trial. BMJ 2004;328:744-747. Epub 2004 Mar 15.
5. Wonderling D, et al. Cost effectiveness analysis of a randomized trial of acupuncture for chronic headache in primary care. BMJ 2004;328:747-749.
6. Penzien DB, et al. Behavioral management of recurrent headache: Three decades of experience and empiricism. Applied Psychophysiol Biofeedback 2002;27:163-181.
7. The American Academy of Neurology. Behavioral and Physical Treatments for Migraine: Encounter Kit for Migraine Headache. Available at: www.aan.com/go/practice/quality/headache. Accessed Feb. 22, 2007.
8. Lipton RB, et al. Disease management of migraine and the importance of stratified care. Dis Manage Health Outcomes 2003;11:379-388.
9. Holroyd KA, et al. Enhancing the effectiveness of relaxation-thermal biofeedback training with propranolol hydrochloride. J Consult Clin Psychol 1995;63:327-330.
10. Nestoriuc Y, Martin A. Efficacy of biofeedback for migraine: A meta-analysis. Pain 2007;128:111-127.
11. Kaushik R, et al. Biofeedback assisted diaphragmatic breathing and systemic relaxation versus propranolol in long term prophylaxis of migraine. Complement Ther Med 2005;13:165-174.
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13. Pfaffenrath V, et al. The efficacy and safety of Tanacetum parthenium (feverfew) in migraine prophylaxis—a double-blind, multicentre, randomized placebo-controlled dose-response study. Cephalalgia 2002;22:523-532.
14. Diener HC, et al. Efficacy and safety of 6.24 mg t.i.d. feverfew CO2-extract (MIG-99) in migraine prevention—a randomized, double-blind, multicenter, placebo-controlled study. Cephalalgia 2005;25:1031-1041.
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16. Paulsen E, et al. Do monoterpenes released from feverfew plants cause airborne Compositae dermatitis? Contact Derm 2002;47:14-18.
17. European Scientific Cooperative on Phytotherapy. Tanaceti parthenii herba/folium (feverfew). Exeter UK: ESCOP; 1996. Monographs on the Medicinal Uses of Plant Drugs, Fascicule 2. Feverfew Monograph.
18. Feverfew Monograph. Consumer Lab. Available at: www.consumerlab.com/tnp.asp?chunkiid=21713#ref1. Accessed April 1, 2007.
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20. Consumer Lab Product Review: CoEnzymeQ10. Available at: www.consumerlab.com/results/CoQ10.asp?#cautions. Accessed Feb. 7, 2007.
21. Ernst E, White AR. Prospective studies of the safety of acupuncture: A systemic review. Am J Med 2001;110:481-485.
22. Su JW, et al. Bilateral pneumothoraces as a complication of acupuncture. Available at: www.sma.org.sg/smj/4801/4801cr10.pdf. Accessed March 25, 2005.
23. Schoenen J, et al. Effectiveness of high-dose riboflavin in migraine prophylaxis. A randomized controlled trial. Neurology 1998;50:466-470.
24. Piekert A, et al. Prophylaxis of migraine with oral magnesium: Results from a prospective multicenter, placebo-controlled and double-blind randomized study. Cephalalgia 1996;16:257-263.
25. Facchinetti F, et al. Magnesium prophylaxis of menstrual migraine: Effects on intracellular magnesium. Headache 1991;31:298-301.
26. Hershey AD, et al. Coenzyme Q10 deficiency and response to supplementation in pediatric and adolescent migraine. Headache 2007;47:73-80.