Clinical Indications for Acupuncture in Chronic Post-Traumatic Headache Management

Transcription

1 MILITARY MEDICINE, 180, 2:132, 2015 Clinical Indications for Acupuncture in Chronic Post-Traumatic Headache Management Marina A. Khusid, MD, ND, MSA ABSTRACT Chronic post-traumatic headache (PTH) is one of the most common complaints after mild traumatic brain injury, yet evidence to date is insufficient to direct conventional treatment of headaches with this etiology. Therefore, the current guidelines recommend a symptomatic approach for the three patterns of PTHs: migraine-like, tension-like, and mixed symptomatology. To improve response rates and minimize the potential for polypharmacy, adverse effects, and risk of dependency, effective nonpharmacologic options should be employed to support faster and safer patient rehabilitation. Current evidence shows that acupuncture is at least as effective as drug therapy for migraine prophylaxis and neurovascular and tension-type headaches. Because of its safety, cost-effectiveness, and long-lasting benefits, adjunctive acupuncture should be offered to patients with chronic PTHs and may be a valuable primary treatment alternative for those with contraindications to pharmacotherapy. Future head-to-head, adequately powered, well-controlled randomized clinical trials are needed to investigate acupuncture efficacy for PTHs. INTRODUCTION The Centers for Disease Control and Prevention estimates that approximately 1.7 million Americans sustain traumatic brain injuries (TBIs) annually, exclusive of the U.S. service members who sustain TBIs in overseas conflicts. 1 TBI is a major cause of long-term disability in the United States and across the world. Its direct medical costs plus indirect costs, such as lost productivity, totaled an estimated $76.5 billion in the United States in Per statistical prediction, TBI will surpass many diseases as the major cause of death and disability by and is therefore a pressing public health and medical problem. About 75% of TBIs that occur each year are concussions or mild TBIs (mtbis). 1 Post-traumatic headache (PTH), also known as postconcussive headache, occurs acutely in up to 90% of all individuals who sustain a concussion or mtbi. 4 According to the International Classification of Headache Disorders, PTHs belong to a category of secondary headaches associated with head and neck trauma. 5 Symptomatically, PTHs present as migraine-like, tension-like, or a combination of the two. 4,5 A cervicogenic component may also be present as a result of traumatic damage to cervical spinal column muscles, ligaments, and peripheral nerves. Acute PTHs are defined as headaches that have an onset within 7 days of head trauma and resolve with treatment within 3 months. 4 Chronic PTHs last longer than 3 months and have a prevalence of 43%. 6 The Armed Forces Health Surveillance Center (AFHSC) recently reported on the number of visits for headache or migraine secondary to mtbi. 2.5% of male and 9.5% of female active duty service members had at least one medical visit yearly for headache or migraine; they affect about 50,000 individuals (30,000 men, 20,000 women), and result in 100,000 visits a year. 7 The 2009 Veterans Affairs (VA)/ Deployment Health Clinical Center, 8601 Georgia Avenue, 4th Floor, Silver Spring, MD doi: /MILMED-D Department of Defense (DoD) Clinical Practice Guideline for Concussion/mTBI recommends a patient-centered approach in the management of PTHs, with focus on promoting recovery and avoiding harm. 4 The emphasis is on using nonnarcotic analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), and triptans, combined with physical therapy, sleep, and relaxation education. 4 Although aggressive pain management is advised, nonpharmacologic and non-narcotic rehabilitation strategies are favored in the long term to prevent development of opioid dependence and encourage cost savings. The VA/DoD Clinical Practice Guideline states that acupuncture can be used adjunctively for rehabilitation, if requested by patients with mtbi. 4 This recommendation is further supported by Wong et al 8 in their 2013 Cochrane review showing improvement in overall functionality and motor function in individuals who received acupuncture during the rehabilitative phase of a TBI. This Cochrane review did not include investigation of acupuncture efficacy for PTHs. A 2012 systematic review demonstrated that no strong evidence is available to direct conventional treatment of PTHs or to support any clinical standards or protocols at this time. 5 Therefore, this approach for management of chronic PTH after a TBI uses symptomatic typology of postconcussive headache to guide therapy. 4,5 To stay consistent with the above approach, this review aims to present pharmacotherapy and its limitations first, followed by acupuncture evidence for common symptomatic presentations of PTHs, such as migraine, tension-type, and cervicogenic headaches. Acupuncture s mechanism of action, safety, and cost-effectiveness will also be examined. METHODS MEDLINE, PubMed, and Cochrane databases were searched for articles published in English up until December Each database was searched using the key words acupuncture and headache, with search criteria restricted to selectively identify randomized clinical trials (RCTs) and systematic 132

2 TABLE I. Level of Evidence (LOE) Adopted From Ebell et al Study Quality LOE 1 Good-Quality Patient-Oriented Evidence LOE 2 Limited-Quality Patient- Oriented Evidence LOE 3 Other Evidence Description Systematic Review, Meta-Analyses, or RCTs With Consistently Replicated Findings, High-Quality Individual RCT Systematic Review, Meta-Analyses of Lower-Quality Studies With Inconsistent Results, Lower-Quality Clinical Trial, Cohort Study Consensus Guidelines, Extrapolations From Bench Research, Usual Practice, Opinion, Disease-Oriented Evidence reviews. After eliminating redundant references, this search yielded 87 citations. Articles were excluded if the studies were done in children or adolescents and did not specifically address symptoms of migraine, tension-type, neurovascular headache, or neck pain. Studies in the civilian population were included because of the paucity of clinical research in service members and veterans. Articles were included according to the criteria outlined below. Inclusion Criteria (1) Acupuncture intervention (2) Adult subjects with clinical diagnosis of mixed chronic headache, migraine, tension-type headache, neurovascular headache, cervicogenic pain, and neck pain (3) RCTs, systematic reviews, and meta-analyses (4) Studies conducted in civilians, active duty service members, and veterans (5) Study size greater than 60 subjects After systematic reviews for each type of headache were identified, subsequent RCTs were selected using the inclusion criteria defined above. Thirty-six peer-reviewed journal articles were found to be relevant and were examined for this review. Levels of evidence (LOE-1 to LOE-3; Table I) were assigned to each key study using the Strength of Recommendation Taxonomy (SORT). 9 Then, the quality, quantity, and consistency of the body of evidence were evaluated, with emphasis on patient-oriented outcomes. The strength of recommendation (SOR) level (SOR A, SOR B, SOR C; Table II) was determined using the SORT scale. 9 RESULTS POST-TRAUMATIC MIGRAINE-LIKE HEADACHES Migraine-like PTHs are often severe and debilitating, usually unilateral, and throbbing or sharp. They start after a prodrome of nausea and phono- or photophobia, last longer than 4 hours, and may be aggravated by physical activity. A therapeutic approach for migraine-like PTHs includes avoiding migraine triggers, completing a trial of triptans for abortive therapy, and assessing the need for prophylactic therapy. 5 There are three types of pharmacotherapeutic interventions that could be utilized, depending on frequency and severity of the migraine-type PTH. Abortive medications are used at the first warning signs of aura or prodrome symptoms. Rescue medications are used when acute treatment did not help, and to break the migraine cycle. Prophylactic therapy is indicated if rescue treatment is used more than once a month or migraines occur more than twice a week. 4,5 Overuse of abortive medications is common among patients and may lead to rebound headaches and make headaches refractory to abortive medications. 4 Rescue interventions for the migraine pattern of PTH may include NSAIDs, sedatives, opioids, and triptans, but their chronic use should be avoided. Divalproex sodium-extended release, topiramate, and metoprolol are the first-line prophylactic agents. 4 In their 2009 Cochrane review, Linde et al 10 (LOE-1) showed consistent evidence of acupuncture efficacy in the management of acute migraine attacks and in migraine prophylaxis. This systematic review included two reviews and 22 clinical trials with 4,419 patients, and it showed long-lasting therapeutic effect, maintained as long as 9 months. When compared to nonpharmacological routine care, acupuncture showed improved response rates and decreased headache frequency. Acupuncture was slightly more effective, with fewer side effects than pharmacotherapy, when used for migraine prophylaxis. 10 Subsequent RCTs support Linde s conclusion. In a single-blinded RCT (n = 140, LOE-2), Wang et al 11 showed that acupuncture was more effective than flunarizine in decreasing days of migraine attack, and as effective in reducing pain intensity and improving quality of life, immediately after TABLE II. Strength of Recommendation SOR A (Strong) SOR B (Moderate) SOR C (Weak) Strength of Recommendation Taxonomy Adopted From Ebell et al Description Recommendation Based on Consistent and Good-Quality Patient-Oriented Evidence Recommendation Based on Inconsistent or Limited-Quality Patient-Oriented Evidence Recommendation Based on Consensus, Usual Practice, Opinion, Disease-Oriented Evidence, or Case Series for Studies of Treatment 133

3 a 4-week intervention and at a 16-week follow-up. The RCT by Yang et al 12 (n = 66, LOE-2) similarly showed that 24 acupuncture treatments over 12 weeks were more effective in chronic migraine prophylaxis than topiramate titrated from 25 mg/day to a maximum of 100 mg/day over the first 4 weeks, and then maintained for 8 weeks (50% vs. 40% reduction rate). Acupuncture was also safer than topiramate, with a respective adverse event rate of 6% vs. 66%. 12 Two recent acupuncture trials (n = 480, n = 150, LOE-2) show that true acupuncture is marginally better than sham acupuncture for migraine prophylaxis, but significantly better in treatment of acute attacks and reducing use of acute medication. 13,14 Since migraines are a type of neurovascular headache, another review is worth mentioning. Zhao et al 15 showed acupuncture efficacy for neurovascular headaches in their 2011 systematic review (LOE-2). Sixteen clinical trials were included, with 535 patients in total. A meta-analysis concluded that the clinical efficacy of acupuncture was superior to pharmacotherapy (e.g., nimodipine, flunarizine, propranolol, rotundine). Acupuncture treatment showed additional advantages, such as higher safety and a lower recurrence rate of headaches. A consistent body of evidence shows that acupuncture is slightly more effective and safer than prophylactic migraine medications (SOR A). It is cost-effective with long-lasting benefits and should be offered to individuals with migraine-like PTHs who prefer a trial of acupuncture over medication, have drug contraindications, or show a poor response to standard care. Although acupuncture also shows benefit in the treatment of acute migraine attacks (SOR B), it may be less practical than abortive or rescue medications because of the time it may take to schedule, travel to, and receive acupuncture treatment. POST-TRAUMATIC TENSION-LIKE HEADACHES Tension-like PTHs are usually mild to moderate, dull, aching, or pressing. They often extend bilaterally from the neck and occiput to the temples or behind the eyes, are associated with posterior neck musculature hypertonicity, and last less than 4 hours. They have no prodrome syndrome and are not worsened by routine physical activity. 4 NSAIDs, including aspirin, ibuprofen or choline magnesium trisalicylate, and acetaminophen, are the first-line therapy in treating tension headaches. Unfortunately, postconcussive headaches with a tension-type pattern are often resistant to NSAID medication alone. 4 In addition, the NSAID side effect profile may impact patient compliance and limit their suitability for chronic use. Certain medical conditions may further restrict NSAID use. For example, acetaminophen should be avoided in patients with liver disease, as should aspirin and ibuprofen in patients with gastritis. Although combination medications can be more effective than NSAIDs alone, they often lead to rebound headaches and cause greater concern for adverse effects and dependency, especially when sedatives or opioids are included. It is recommended to avoid opioid drugs for chronic PTHs and to use other analgesics carefully to avoid rebound pain. 4,5 Physical therapy, mobilization, and coordination exercises should be strongly considered for tension and cervicogenic headaches. 5 The Cochrane review by Linde et al 16 in 2009 included 11 clinical trials (n = 2,317, LOE-1), and in addition to a qualitative review, it employed a meta-analysis. When compared to routine care, acupuncture demonstrated statistically significant benefit in response, intensity, and number of days with acute tension headaches, lasting up to 3 months. When compared to sham acupuncture, true acupuncture showed a small but statistically significant benefit. Since postconcussive tension-like headaches have a high prevalence of concurrent neck trauma, it is important to consider acupuncture effectiveness for cervicogenic pain. In the 2009 systematic review and meta-analysis by Fu et al 17 (LOE-2), 14 RCTs of adult patients with chronic neck pain with or without radiculopathy were included. Acupuncture demonstrated short-term effectiveness and efficacy (up to 3 months) for neck pain, but it did not show benefit for longterm pain relief or disability. Acupuncture was superior to no treatment in decreasing pain intensity and improving functioning, mobility, and well-being. Acupuncture is as effective as standard care in management of chronic tension headaches (SOR A) and when used shortterm for cervicogenic pain (SOR B). It could be valuable nonpharmacologic treatment option for tension-like PTHs, especially in patients with medication contraindications. CHRONIC AND MIXED SYMPTOMATOLOGY PTHS When more than one symptomatic pattern of PTH is present, interventions for each headache type should be implemented concurrently. Such concurrent use of several medication classes often results in polypharmacy and increased adverse effects. For chronic, difficult-to-control, refractory PTHs, adjunct nonpharmacologic approaches become even more important to help achieve more effective pain control with a higher safety profile in the long-term. In 2012, researchers from the Acupuncture Trialists Collaboration published a meta-analysis of 29 clinical trials involving 17,922 patients (LOE-1). 18 They showed that adjunctive acupuncture consistently yielded greater pain reduction in chronic neck pain and chronic headaches as compared with standard care alone, such as oral medications, regular physician, and 134

4 physical therapy visits. When sham acupuncture was used as a control, the differences were significant but smaller because of nonspecific effects that both true and sham acupuncture show. 18 The 2008 systematic review by Sun and Gan 19 (LOE-2) included 31 RCTs with 4,068 study subjects and demonstrated that acupuncture is effective for chronic headache. Specifically, acupuncture was significantly superior to pharmacological therapy, waiting list, and sham acupuncture in reducing chronic headache intensity and frequency and in improving the response rate at 3- and 6-month follow-up periods. 19 Migraines and tension headaches, in particular, responded better to acupuncture compared to other headache types. 19 In addition, acupuncture might provide higher health-related quality of life than pharmacologic treatment, as demonstrated by a significant improvement of physical functioning. 19 Jena et al 20 combined an RCT (n = 3,182, LOE-1) with a nonrandomized cohort study (n = 11,874), and performed a subsequent cost-effectiveness analysis. 21 In this study, adjunctive acupuncture significantly reduced the number of days with chronic headache, reduced pain intensity, and improved healthrelated quality of life when compared to routine care alone. 20 The treatment in this landmark study consisted of 15 acupuncture sessions over 3 months, and improvement was maintained at 6-months follow-up. Although initial costs were higher in the acupuncture-plus-routine care group, adjunctive acupuncture was found to be a cost-effective treatment for chronic headaches, according to the international cost-effectiveness threshold values. 21 Adjunctive acupuncture is safe, efficacious, and cost-effective for chronic headaches of various and mixed etiologies, and it should be considered in patients with PTH as a reasonable treatment and referral option (SOR A). ANALGESIC MECHANISMS OF ACUPUNCTURE It is important to understand analgesic mechanisms of acupuncture to more skillfully combine it with conventional therapies in achieving maximum safety and efficacy. Numerous animal and human studies elucidated biochemical and neural components of acupuncture analgesia that are mediated through both peripheral and central pain pathways. 22 This review focused on specific mechanisms of acupuncture analgesia that are most relevant to PTH. They belong to one of three categories: (1) locally improving blood supply 23 and facilitating healing through increased delivery of oxygen, nutrients, immune cells, and cytokines; (2) altering metabolism of chemicals involved in ascending 24 and descending pain pathways 25 ;and(3)affecting cortical and subcortical networks responsible for sensory, emotional, and cognitive integration of pain. 26 The local analgesic effect of acupuncture is achieved through needle insertion into acupuncture points located in close proximity to the anatomical site of pain. Acupuncture stimulates local blood flow 23 through release of vasodilatory neuropeptides. Such local vasodilation may be particularly useful in PTHs with a cervicogenic component as it will help to reduce residual swelling and inflammation and assist in healing impacted peripheral nerves, deep cervical muscles, and ligaments by improving their microcirculation. The findings from animal and limited human studies support the contention that acupuncture modulates the ascending facilitatory and descending inhibitory pain pathways. 22 It alters the metabolites involved in the ascending pain pathways, such as interleukin-1 and N-methyl-D-aspartate receptors, which contribute to inflammatory pain hypersensitivity, and substance P, which is involved in the transmission of pain information to the central nervous system. Acupuncture also alters the metabolism of biochemical intermediates of the descending inhibitory pain pathway, such as endogenous opioids, serotonin, and norepinephrine. Napadow et al 26 used fmri to show that acupuncture deactivates the amygdala and activates the hypothalamus in patients with chronic pain. The amygdala is often sensitized and hyperactivated in response to chronic pain, which may translate into exaggerated fear and anxiety in anticipation of pain. By deactivating the amygdala, acupuncture ameliorates the affective component of chronic pain. Simultaneous activation of hypothalamic activity via acupuncture may result in upregulation of the endogenous opioid pain control system and downregulation of the cholinergic anti-inflammatory pathway. 26 Although further mechanistic research in humans is necessary, these findings illuminate the synergistic interference of acupuncture with the biochemistry of pain response and its neural and emotional processing. SAFETY AND COST Multiple systematic reviews report acupuncture to be relatively safe when performed by qualified acupuncturists. Only minor side effects related to the local insertion of needles, such as transient redness, spot bleeding, minor bruising, and local discomfort, have been reported. 19,27,28 The total number of adverse effects and dropout rates are significantly lower in the acupuncture groups compared with medication treatment. 19 Acupuncture appears to be a cost-effective treatment of chronic headaches according to a large RCT 21 and a recent systematic review of economic evaluations. 29 Acupuncture was also more cost-effective compared to usual care or no treatment for chronic neck pain, according to another systematic review. 30 CONCLUSION Although acupuncture has not yet been sufficiently investigated in PTHs specifically, it shows safety, efficacy, costeffectiveness, and long-lasting benefits for primary migraine, tension-type headaches, and cervicogenic pain. Since symptomatic PTH typology is currently used to guide therapy, it is reasonable to consider acupuncture for chronic PTHs with migraine-like, tension-like, cervicogenic, or mixed symptomatology. A referral for adjunctive acupuncture should be offered to patients with chronic or refractory PTHs and to increase mobility and compliance with physical therapy. Acupuncture 135

5 may also be valuable as a primary treatment for those with contraindications to pharmacotherapy or a history of opioid addiction or dependency, and during the analgesic washout period in patients with an abortive migraine medication-overuse history. Acupuncture is most effective when administered as a course of treatment consisting of 6 to 10 weekly or twiceweekly acupuncture visits, each contributing to a cumulative long-lasting analgesic effect. Future head-to-head, well-controlled, adequately powered RCTs investigating acupuncture efficacy and its comparative effectiveness to medications in the management of chronic PTHs are necessary. Studies incorporating acupuncture techniques as part of a multimodal conventional treatment regimen are likely to be more clinically relevant than those using a single modality. Health-related quality of life, regarded as a clinically significant measurement for headache, should be assessed using a well-validated instrument. Further studies are need to establish the optimal timing of acupuncture administration, the points used, and the ideal frequency and duration of treatment. ACKNOWLEDGMENTS I thank Chris M Crowe, PhD, Deputy Director, Deployment Health Clinical Center, Defense Centers of Excellence for Psychological Health and TBI and Richard Isaac, Editor, Rich Text Editing. REFERENCES 1. Faul M, Xu L, Wald M, Coronado V. Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations, and Deaths. Atlanta, GA, Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, Available at accessed September 2, Finkelstein E, Corso P, Miller TAA. The Incidence and Economic Burden of Injuries in the United States. New York, Oxford University Press, Humphreys I, Wood RL, Phillips CJ, Macey S: The costs of traumatic brain injury: a literature review. Clinicoecon Outcomes Res 2013; 5: Department of Defense: VA/DoD Clinical Practice Guideline for Management of Concussion/mild Traumatic Brain Injury. Washington, DC, Department of Veterans Affairs, Department of Defense, Available at mtbi_full_1_0.pdf; accessed September 2, Watanabe TK, Bell KR, Walker WC, Schomer K: Systematic review of interventions for post-traumatic headache. PM R 2012; 4(2): Nampiaparampil DE: Prevalence of chronic pain after traumatic brain injury: a systematic review. JAMA 2008; 300(6): Armed Forces Health Surveillance Center: Risk factors for migraine after OEF/OIF deployment, active components, U.S. Armed Forces. MSMR 2009; 16(12): Wong V, Cheuk DK, Lee S, Chu V: Acupuncture for acute management and rehabilitation of traumatic brain injury. Cochrane Database Syst Rev 2013; 3: CD Ebell MH, Siwek J, Weiss BD, et al: Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. J Am Board Fam Pract 2004; 17(1): Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A, White AR: Acupuncture for migraine prophylaxis. Cochrane Database Syst Rev 2009; 1: CD Wang LP, Zhang XZ, Guo J, et al: Efficacy of acupuncture for migraine prophylaxis: a single-blinded, double-dummy, randomized controlled trial. Pain 2011; 152(8): Yang CP, Chang MH, Liu PE, et al: Acupuncture versus topiramate in chronic migraine prophylaxis: a randomized clinical trial. Cephalalgia 2011; 31(15): Li Y, Zheng H, Witt CM, et al: Acupuncture for migraine prophylaxis: a randomized controlled trial. CMAJ 2012; 184(4): Wang LP, Zhang XZ, Guo J, et al: Efficacy of acupuncture for acute migraine attack: a multicenter single blinded, randomized controlled trial. Pain Med 2012; 13(5): Zhao L, Guo Y, Wang W, Yan LJ: Systematic review on randomized controlled clinical trials of acupuncture therapy for neurovascular headache. Chin J Integr Med 2011; 17(8): Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A, White AR: Acupuncture for tension-type headache. Cochrane Database Syst Rev 2009; 1: CD Fu LM, Li JT, Wu WS: Randomized controlled trials of acupuncture for neck pain: systematic review and meta-analysis. J Altern Complement Med 2009; 15(2): Vickers A, Cronin A, Maschino A, et al Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med 2012; 172(19): Sun Y, Gan TJ: Acupuncture for the management of chronic headache: a systematic review. Anesth Analg 2008; 107(6): Jena S, Witt CM, Brinkhaus B, Wegscheider K, Willich SN: Acupuncture in patients with headache. Cephalalgia 2008; 28(9): Witt CM, Reinhold T, Jena S, Brinkhaus B, Willich SN: Cost-effectiveness of acupuncture treatment in patients with headache. Cephalalgia 2008; 28(4): Kong JT, Schnyer RN, Johnson KA, Mackey S: Understanding central mechanisms of acupuncture analgesia using dynamic quantitative sensory testing: a review. Evid Based Complement Alternat Med 2013; 2013: Sandberg M, Lundeberg T, Lindberg L, Gerdle B: Effects of acupuncture on skin and muscle blood flow in healthy subjects. Eur J Appl Physiol 2003; 90(1-2): Zhang RX, Wang L, Wang X, Ren K, Berman B, Lao L: Electroacupuncture combined with MK-801 prolongs anti-hyperalgesia in rats with peripheral inflammation. Pharmacol Biochem Behav 2005; 81(1): Han J: Acupuncture and endorphins. Neurosci Lett 2004; 361(1-3): Napadow V, Kettner N, Liu J, et al: Hypothalamus and amygdala response to acupuncture stimuli in Carpal Tunnel Syndrome. Pain 2007; 130(3): Wong V, Cheuk DK, Lee S, Chu V: Acupuncture for acute management and rehabilitation of traumatic brain injury. Eur J Phys Rehabil Med 2012; 48(1): Witt CM, Pach D, Reinhold T, et al: Treatment of the adverse effects from acupuncture and their economic impact: a prospective study in 73,406 patients with low back or neck pain. Eur J Pain 2011; 15(2): Ambrósio EM, Bloor K, MacPherson H: Costs and consequences of acupuncture as a treatment for chronic pain: a systematic review of economic evaluations conducted alongside randomised controlled trials. Complement Ther Med 2012; 20(5): Furlan AD, van Tulder M, Cherkin D, et al: Acupuncture and dryneedling for low back pain: an updated systematic review within the framework of the cochrane collaboration. Spine 2005; 30(8):