Assistant Professor of Clinical Neurology, Weill Cornell Medical College

Dr. Klebanoff reports no financial relationships relevant to this field of study.

SYNOPSIS: As part of a randomized treatment trial for medication-overuse headache, a simple protocol that provided early advice on stopping excessive medications was effective in one-third of patients, even before any prophylactic medications were started.

SOURCE: Corbelli I, Sarchielli P, Eusebi P, et al; SAMOHA Study Group. Early management of patients with medication-overuse headache: Results from a multicenter clinical study. Eur J Neurol 2018;25:1027-1033.

Medication-overuse headache (MOH) is a chronic headache disorder resulting from frequent intake of pain medication, including analgesics, nonsteroidal anti-inflammatory drugs, triptans, opioids, and ergotamine. The estimated prevalence of MOH in the Western world is 1-2%, with a peak incidence of 5% in women 40-50 years of age. Patients with MOH have lower scores on quality-of-life assessment scales when compared to patients with chronic headaches without MOH, episodic headache, and healthy controls. Despite the frequency of the condition and the high burden of disability it causes, there is no established consensus on the standard of care. Withdrawal of the abused medication is advised, but recommendations regarding the methods of detoxification and administration of prophylactic medications are inconsistent. In addition, the prognosis remains poor, with approximately 30% of patients relapsing within one year of withdrawal of medication.

Patients with MOH can be divided into two subtypes, simple (Type I) and complex (Type II). Type II patients have significantly more comorbidities, including psychopathology (mood, anxiety, or substance addiction disorders), a long duration of MOH (> 1 year), a history of relapse following withdrawal, and daily use of multiple doses of symptomatic medication.

Corbelli et al reported on patients enrolled in the multicenter, placebo-controlled Sodium vAlproate in the Treatment of Medication Overuse HeadAche (SAMOHA) study. At the initial visit, patients were given simple advice regarding MOH; they were advised to stop the abused medication. After initial assessment, each patient completed a four-week observation period followed by a six-day inpatient detoxification phase during which the abused drugs were discontinued and then a 12-week, double-blind treatment period in which they were treated with valproate 800 mg/day or placebo. After the four-week observational period, patients were reassessed to see if they still met International Headache Society revised criteria for MOH, at which point they were randomized to the treatment arm of the study. The researchers screened 130 patients at the nine participating centers. Most patients (80%) were women; the mean age was 42 years; and the headaches were chronic for an average of 4.6 years, with an average of 24 days of headache per month. The most commonly abused medications were acetaminophen, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs.

After the initial observation period, 88 (67.7%) patients still met inclusion criteria and continued the study; 34 patients no longer met inclusion criteria. The patients whose headaches improved so that they no longer met inclusion criteria were significantly younger and had a significantly shorter history of chronicity when compared to those who continued to meet inclusion criteria. Since a significant proportion of patients with MOH improved after receiving simple advice, it is important to counsel patients regarding MOH early in their clinical care. In addition, when conducting studies regarding the management of MOH, it is important to have a period of observation following simple advice to ensure that the patients studied have persistent MOH.

COMMENTARY

The study, part of the SAMOHA study, suggests that simple advice given at an early clinical assessment can be helpful in the management of MOH, especially in the younger patient population with fewer years of chronic headache. In addition, when conducting research on this patient population, an observation period is needed to exclude patients who rapidly improve following simple advice. The patients with persistent MOH who failed to improve following simple advice have more psychological comorbidities and a longer duration of chronic headache and remain more challenging to treat. The management of this patient population, including recommendations regarding type of detoxification and institution of prophylactic medications, needs further study. Perhaps the results of the completed SAMOHA study will provide additional treatment recommendations.