Comment on: Setting higher standards for migraine prevention: A position statement of the International Headache Society

We are writing as the President and scientific director of Alleanza Cefalalgici (Al.Ce.), an Italian patient advocacy group dedicated to supporting people with headache disorders, regarding the article ‘Setting Higher Standards for Migraine Prevention: A Position Statement of the International Headache Society’ by Sacco et al. (1). We would like to express our appreciation for this work and offer some reflections from the patients’ perspective.

First, we commend the authors for their clarity and depth in addressing migraine prevention, prioritizing patient well-being over mere numerical outcomes. Although patients were not directly involved in the development of this position statement, the authors demonstrate remarkable sensitivity in addressing a key unmet need: the call for higher therapeutic standards that aim not only to reduce attack frequency by an arbitrary percentage, but also to achieve a state of well-being approaching migraine freedom, free from the burden of the side effects of preventive treatment as well.

We recognize that this ambitious approach, once considered visionary, is now feasible thanks to novel prophylactic medications that tend toward optimal headache control with minimal side effects. This proposal marks a significant cultural shift that we hope will permeate the entire headache community. However, patients want these new treatments to be accessible to all for whom they are indicated. In most countries, reimbursement is limited to those with more than eight headache days per month and only after previous therapeutic failures, exposing patients to unnecessary side effects, frustrations and wasted time. While this depends on national legislation or insurance policies, we believe that closer collaboration between patients’ Associations with scientific societies worldwide could help achieve broader access.

In addition, the efficacy of these new therapies frees patients from previous treatment constraints. For example, the well-known comorbidity with psychiatric disorders was often treated with tricyclic antidepressants because of their dual efficacy. Today, we may be able to overcome this limitation, although it remains unclear whether all antidepressants are equally suitable or whether tricyclics and noradrenergic-serotonergic agents should continue to be preferred. The literature is scarce, and only the commitment of an international scientific society could drive the studies needed to determine the best treatment pathways.

Finally, the article by Sacco et al. (1) encourages reflection on classification. The current International Classification of Headache Disorders, 3rd edition (ICHD-3) (2) is an evolution of the 1988 original ICHD, designed when triptans were in the pipeline and focused on identifying patients suitable for acute therapy. Today, the challenge has shifted to prevention; then, we propose to shift the focus from attack classification to patient classification, which more comprehensively captures patient complexity and disability. Beyond the above-mentioned psychiatric comorbidities, other conditions should be described and considered in diagnosis and treatment. Research is increasingly highlighting the disabling “interictal phase” (3), and episodic syndromes that may be associated with migraine (2), also known as “migraine equivalents” or “silent migraine” (attacks without headache, as migraine is not just a headache), which need to be addressed in clinical practice.

Because of this change, it is important that the ICHD partially adopt the model of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) (4), incorporating not only diagnoses, but also duration, severity (measured by more sensitive instruments) and comorbidities. Further current scales such as the Migraine Disability Assessment (MIDAS) Six-Item Headache Impact Test (HIT-6), which focus on days lost to pain, appear to lack sensitivity and may be invalidated by the daily use of symptomatic medications that many patients rely on to function. We have seen evidence of this in recent years when patients with chronic migraine have been denied prescriptions because they did not meet the minimum score required in their country by MIDAS. These scales also are unable to detect the burden of postdromal symptoms, a challenging aspect of the disease succeeding the pain (5). In addition, psychosocial and socioeconomic aspects also contribute to the global burden of disease but have not received the attention they deserve, although a biopsychosocial approach has been proposed to address the complexity of social, family and work aspects in the lives of migraineurs, in line with the International Classification of Functioning, Disability and Health (ICF) (6). In our opinion, it is crucial for the classification to consider the need for differentiation of all clinical pictures also based on attack frequency, and that two patients with identical headache days should be differentiated in terms of global (ictal and interictal) disability. The classification should go beyond “migraine with or without aura” to specify whether it is sporadic, episodic (low, moderate or high frequency) or chronic, always including disability as part of the diagnosis. For example, episodic moderate frequency migraine (e.g. six days per month) can range from low disability requiring only acute treatment to high disability with significant interictal symptoms requiring multiple preventive medications, and it further changes in the presence of important comorbidities, neurological (other pain conditions such as fibromyalgia, sleep disorders, postural orthostatic tachycardia syndrome, depression, anxiety, etc.) or non-neurological (irritable bowel syndrome, inflammatory bowel disease, obesity, polycystic ovary syndrome, endometriosis, etc.), that can share common pathophysiological features with migraine (7).

In conclusion, we hope that this position statement marks the beginning of a new era and that the patient voice will increasingly be heard alongside the scientific community in shaping the patient journey, in the spirit of the Vancouver Declaration on Global Headache Patient Advocacy 2018 (8).