Mindfulness as one component of an integrative approach to migraine treatment in clinical practice: companion editorial

1. Introduction

In this month’s publication of ‘Mindfulness in Migraine: A Narrative Review’ we described the evidence to date of mindfulness-based interventions (MBIs) for the treatment of migraine [1]. Of the eight clinical research studies conducted that were assessed, Yates Quality Rating Scale (YQRS) scores ranged from 17 to 31 (out of 35), demonstrating significant variability in study quality and design. Most studies to date have been small pilot studies (sample sizes ranging from 19 to 62 participants) and most control groups consisted of delayed treatment/wait-list or treatment as usual. While some studies have shown that both the MBI and the control group have improvements in headache frequency, no published study to date of an MBI has demonstrated a statistically significant reduction in headache frequency above and beyond the control group. MBIs appear to be most helpful for overall quality of life and headache-related disability. The data thus suggest that mindfulness may be a helpful tool for patients to use to help handle, but not cure, their headaches, and additional treatment options may be needed to fully improve all headache outcomes. Several additional studies are near-completion or ongoing that will provide additional data to understand better the role of MBIs in migraine treatment. While understanding the evidence of the research data is important to evaluate potential benefit for patients, the question still remains of how mindfulness can best be utilized in the clinical management of migraine in clinical practice.

2. Body

In order to understand mindfulness mechanisms, basic science research studies are designed to tease out the unique and specific effects that cannot be explained by factors other than mindfulness. Similarly, in clinical efficacy studies, one of the goals is to understand if the key features of the intervention (e.g., mindfulness) provide a benefit that cannot be explained otherwise by nonspecific or common factors. Unfortunately, research does not always fully guide how to best care for patients in clinical practice. For example, one of the major research challenges of Dr. Grazzi’s study that evaluated mindfulness in the setting of chronic migraine-medication overuse headache was its non-randomized approach [2]. This design in research leaves uncertainty as to rather the benefits seen compared to the control group would still be seen if the participants had been randomized. Ideally, in a randomized (and double-blinded) study, any benefits seen can only be explained by the effects of the unique qualities of the intervention. Allowing participants to choose which intervention they receive may lead to the participants being grouped by the intervention they are most interested in, likely with the most expectations for a benefit, and therefore resulting in a higher likelihood of response. While this limits the interpretation of the results of this study, this approach is most generalizable to the clinical practice of medicine and to the goals of patient care, as providers hope their patients choose interventions of interest, resulting in increased adherence and positive clinical response.

While teasing out unique benefits is important for clinical research to assess efficacy and mechanisms in order for clinicians to evaluate potential value for their patients, in the clinical practice of medicine, mindfulness does not need to be isolated as a sole intervention. Rather it may be best utilized as a part of an entire integrative approach. Many patients who are interested in mindfulness often are seeking a ‘holistic’ approach to their entire treatment plan. An integrative approach takes into account the best evidence of both traditional and integrative approaches, including an incorporation of the person’s belief system and lifestyle [3]. Complementary and integrative health options (such as mind-body treatment options like mindfulness, manualized therapies such as acupuncture, and supplements) may be discussed as treatment options alongside more traditional pharmacological options. The patient’s background, interests, and goals are discussed and accounted for when choosing treatment modalities. Given the emphasis on discussing a variety of treatment options that account for a patient’s interests and goals, resulting in shared decision-making, an integrative approach builds a strong physician–patient relationship, which can also have an important therapeutic effect [4]. An integrative approach may also target other factors, such as stress and anxiety, playing a role in headaches that may not be targeted with pharmacological treatments alone, especially since “top down regulation is not fully engaged when pain is treated with pharmacotherapy alone.“ [5,6]. Further, an integrative approach that incorporates mindfulness may enhance other healthy lifestyle approaches, such as exercise and healthy eating, which may also target headache outcomes [7–9]. Integrative approaches often empower patients to take control over their condition and treatments, increasing self-efficacy [4,10,11]. Integrative options may also increase active coping strategies and acceptance [12]. Certain populations, such as pediatric/adolescent patients, or pregnant/lactating women, may be especially amenable to such integrative treatments for headache [13]. In addition, non-pharmacological approaches may be particularly useful in patients who have challenges with medication use, such as those patients: (1) with contraindications to medications or co-morbidities limiting medication options; (2) not interested in pursuing medications; (3) refractory to pharmacological treatments (due to inefficacy and/or inadequate relief); (4) who are elderly and likely to experience medication side effects; (5) who have experienced frequent medication side effects; (6) with medication overuse headache; (7) who cannot afford medication options. While these challenges with pharmacological options may limit the use of medications, it is important to recognize that integrative treatment options can be used concurrently with medications. See Table 1 for a summary of the populations to consider integrative treatment approaches in clinical headache practice and the corresponding reasons for each consideration.

Table 1. Summary of populations to consider integrative treatment approaches in clinical headache medicine and reasons for consideration.

Populations to Consider Integrative Treatment Approaches	Reasons for Consideration
Patients Who May Benefit From an Integrative Approach
Potentially all patients seeking care	An integrative approach takes into account the best evidence of both traditional and integrative approaches, including an incorporation of the person’s belief system and lifestyle[3]
Patients who express interest in an integrative approach	Matching patient goals with provider recommendations increase the therapeutic relationship and increase the likelihood of adherence and positive treatment response[4]
Patients who have prior or current experience with integrative approaches	Prior experience or current use suggests interest and increases likelihood of adherence to future use
Patients who request or who need help with incorporating healthy lifestyle approaches (e.g., diet, exercise)	An integrative approach may enhance other healthy lifestyle approaches, such as exercise and healthy eating, which may also target headache outcomes.[7-9]
Patients who need or express a desire for: more control over their health, self-empowerment, coping skills, and/or acceptance	An integrative approach may increase self-management, self-efficacy, coping skills, acceptance, and/or patient empowerment.[4,10,12]
Patients experiencing other factors that may play a role in their headaches not targeted by medications	Stress, anxiety, and other factors often play a role in headache, but may not be effectively targeted with drug treatment alone[6] as “top down regulation is not fully engaged when pain is treated with pharmacotherapy alone.”[5]
Patients with Challenges with Medication Use
Pediatric/adolescent patients	Many pediatric/adolescent patients and/or their parents are interested in non-drug options to avoid chronic use of drugs with their related side effects[14]
Pregnant/lactating women	Many medications are not recommended during pregnancy or risk profiles are unsafe or uncertain, often leading to recommendations for non-pharmacological approaches first[15,16]
Older patients	Older patients are at increased risk for adverse drug reactions due to age-related changes in pharmacodynamics responses and increased risks with polypharmacy[17]
Patients with medication contraindications or co-morbidities limiting medication options	Medication use can be limited by contraindications or co-morbidities, leading to a need for non-drug options
Patients not interested in pharmacological approaches	About half of patients with headache who use complementary and alternative approaches do not use prescription or over the counter medications.[18]
Patients refractory to multiple medications (due to inefficacy and/or inadequate relief)	Approximately 2/3 of all patients who try prescription medications for headache discontinue treatment due to inadequate relief, untoward side effects, and lack of efficacy, despite 42% having moderate to severe levels of disability,[19,20] leaving a dramatic need for non-drug treatment approaches.
Patients who experience frequent side effects from medications
Patients with medication overuse headache	When pharmacological options are worsening headaches through medication overuse, non-drug options may provide acute relief in place of the offending medication
Patients who cannot afford medications	Many integrative treatment approaches are free and/or readily available

Several studies have assessed an entire integrative approach as a whole for headache care. One non-randomized study assessed a multimodal approach compared to pharmacological approach for chronic tension-type headaches in adolescents. While they found both treatments to be helpful, the multi-modal approach had a greater effect on headache frequency and intensity [21]. Cramer and colleagues have developed an ‘integrative integrated migraine care’ approach in Germany that involves inpatient, outpatient, and/or day care treatment options with mindfulness meditation as a key feature [22,23]. This intensive program includes a semi-residential day care program that could follow an inpatient stay or be applied as a sole therapy, involving six hours once/week for 10 weeks. Participants engage in mind-body therapies such as mindfulness meditation, yoga, qigong, and/or tai chi, are treated by an integrative medicine physician, and are educated about healthy lifestyle diet and exercise choices. A prospective observational study of 158 patients undergoing this approach found dramatic improvements in headache frequency, from 17 headache days/month at baseline to 11 at initial follow-up, that persisted through the six month follow-up [23]. Although this non-randomized study does not elucidate the role of the individual components of such a multi-modal approach, each therapy may have a synergistic effect on increasing adherence, interest, and outcomes of the full treatment approach. Dr. Gaul and colleagues conducted a narrative review of integrated multidisciplinary care of headache disorders and concluded that such an approach is an efficient therapeutic option for headache. Further, it may help avoid further chronification of headache and treat/prevent medication overuse. However, data on the best approach structure are limited [24].

Several headache specialists have developed integrative care programs and have published on their patients’ unique clinical benefits. For example, Dr. Bernstein in Boston, MA helped develop an integrative approach to headache care and one of her patients wrote an essay about her positive experience with the program, concluding that, ‘Since I have begun to incorporate Integrative Medicine, I have started telling myself to stop waiting until I am at 100% health to live my life. If all I have is 40%, then I make sure it is the best 40%.’ [25] This quotation highlights the importance of pain acceptance and of continuing to function despite the pain, which may be a focus of an integrative approach. Dr. Oberg in San Diego, CA writes about her experience with a patient who had dramatic improvements in headache outcomes with eight weeks of self-directed mindfulness training, but notes that ‘it may take years of encouragement from a healthcare provider before a patient is ready to adopt a mind-body practice.’ [26]

In clinical practice, one of the challenges of the integrative approach involves logistical issues that can limit mainstream adoption. For example, insurance coverage can be limiting. Even when patients prefer multi-modal treatment options, not all health insurances cover this approach. Individual treatment options, such as acupuncture and massage therapy, can be expensive [21]. Many patients, such as those in rural areas or of low-income, may have limited access to integrative approaches. Several approaches are targeting these challenges. For example, the additional research evidence to date has shifted insurance coverage for many modalities, demonstrated by the January 2020 announcement by the Centers for Medicare and Medicaid Services (CMS) of acupuncture coverage for chronic low back pain. Group acupuncture has also been developed as a model of care that increases access for many patients [27].

Additional logistical challenges include the additional time often required of an integrative approach that a busy clinician may not have, especially with the current increased non-clinical demands on a provider’s time (e.g., interfacing with the electronic medical record). Many providers may not feel well trained in the potential benefits, risks, and side effects of such treatments and may be inclined to avoid such discussions. Patients also may be hesitant to discuss all the treatment modalities they are using. Both of these reasons could explain why more than 50% of adults with migraines/severe headaches using complementary and alternative medicine do not discuss it with their provider [28]. Training providers in integrative medicine may increase provider self-efficacy and confidence of such modalities and has been one method of targeting this limitation [29]. Despite these limitations, the initial time and attention invested with an integrative approach may ultimately enhance treatment outcomes, as the patient–practitioner relationship is enhanced by such warmth, attention, and confidence [30]. Dr. Cowan in Stanford, CA points out that providers need to understand CAM in the real world, as ‘You may practice evidence-based medicine, but your patient’s don’t.’ He points out the importance of a patient-centered approach in valuing patient interests and preferences beyond pharmacological approaches [31].

Many patients who seek complementary and integrative approaches to headache have often been refractory to other treatment options and have more severe headaches [18,32], resulting in a sense of desperation. Some patients report being willing to ‘try anything that will help,’ while others are exhausted and have become hopeless. Mindfulness meditation may be of particular benefit in this case as it may help shift the mindset from one of ‘cure’ to ‘acceptance.’ However, providers need to be astutely aware and careful of promising too much relief in the setting of an overwhelmed and exhausted patient.

In summary, the research evidence to date summarized in our narrative review demonstrates the potential benefit on the overall quality of life and headache-related disability of MBIs for patients with migraine. Additional ongoing/near completed research studies will help us further assess clinical outcomes of mindfulness alone as a treatment for migraine. In addition, in clinical practice, evidence suggests that an entire integrative approach, with mindfulness as one aspect of a treatment program, may provide the most benefit. An integrative approach accounts for patients’ interests and goals with a resulting improved therapeutic patient–provider relationship and may be especially beneficial for patients with a variety of reasons that limit medication use.

Declaration of Interest

The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or conflict with the subject matter or materials discussed in this manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The author gratefully acknowledges the editorial assistance of Indra M. Newman, PhD at the Wake Forest Clinical and Translational Science Institute, funded by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through Grant Award Number UL1TR001420.

Additional information

Funding

RE Wells is supported by the National Center for Complementary & Integrative Health (NCCIH) of the National Institutes of Health under Award Number K23AT008406. The content is solely the responsibility of the author and does not necessarily represent the official views of the National Institutes of Health.