FRAMES protocol versus simple advice for medication-overuse headache: a prospective, randomized, controlled clinical trial

DOI: https://doi.org/10.1007/s13760- 021- 01758- 3

Abstract-Summary It is central to the management of patients with Medication-overuse headache that they reverse their behavior regarding the frequent use of pain medication.

The objective of this study was to compare two counseling techniques for treat-

ing patients with Medication-overuse headache (MOH).

Primary endpoints were the following: number of patients who stopped medica- tion overuse; days with acute medication use; HIT-6; the number of patients who returned for consultations.

Secondary endpoints were as follows: days per month of headache; 50% reduc- tion in monthly days with acute medication use; the number of patients with less than 15 days of headache.

There was a significant reduction in the frequency of headache and the number of days using pain medication in the first and second months of follow-up compared to baseline in both groups.

There was a significant reduction in the HIT-6 in the first and second months of follow-up compared to baseline in the FRAMES Group, but not in the control group. Patients in both counseling groups significantly decreased the use of pain medi-

cations and the frequency of their headaches.

Extended: There was a loss of follow-up in 8 weeks, respectively, of 15 (40.5%)

and 13 (40.6%) of the individuals in the intervention and control groups.

There was a significant reduction in the impact of headache (HIT-6) in the first and second months of follow-up compared to baseline in the FRAMES Group

3.5 Medication Overuse and Addiction

595

(paired t-test; p < 0.05), but not in the control group (paired t-test; Baseline vs Visit 1: p = 0.089; Baseline vs Visit 2: p = 0.453).

Introduction Many of these patients are unaware that the overuse of pain medications contributes to the chronicity of their primary headache.

To the use of prophylactic medications for primary headache, it is central to the management of patients with MOH that they reverse their behavior regarding the frequent use of pain medication [582].

Counseling seems to be less effective in more complex patients, who in addition to MOH present other associated diseases, other painful conditions, psychiatric comorbidities and use pain medications several times a day [583].

The aim of this study was to compare two counseling techniques for treating patients with MOH seen at a headache outpatient clinic, one of them structured (the FRAMES technique) and the other unstructured.

Method Consecutive patients, diagnosed with medication-overuse headache, aged over 18 years, attended for the first time (new patients) at the Headache Clinic at the Hospital Universitário Oswaldo Cruz between August 2016 and August 2018 were consid- ered eligible for the study.

Patients were excluded if they were taking medication for pain other than head- ache, presented a secondary headache hypothesis, were taking opioids or had previ- ously received treatment for MOH.

FRAMES group: 1—feedback about personal risk: Patients were initially given an explanation regarding the role of medication overuse in aggravating their head- aches and were encouraged to reflect on the negative impact of headaches on their work routine, mood and social relationships through the joint interpretation of HIT-6, answered minutes before.

Unstructured counseling group (control): Patients were given an explanation on medication overuse, how significant this is for aggravating their headache and the importance of stopping the medication overuse in order to treat it.

Number of patients who reduced the use of medications for headache by 50% or

more in days per month, and 7.

Results There was no difference in the severity of symptoms of anxiety between the two groups at follow-up (Return visit 1: FRAMES = 10.5 ± 4.6 vs 9.8 ± 4.1; p: 0.570, Mann–Whitney; Return visit 2: FRAMES  =  9.9 ± 5.2 vs 8.8 ± 5.5; p: 0.494, Mann–Whitney).

The FRAMES group presented more symptoms of depression than the controls

at return visit 1 (FRAMES = 8.8 ± 4.6 vs 6.3 ± 4.5; p: 0.048, Mann–Whitney).

There was a significant reduction in the impact of headache (HIT-6) in the first and second months of follow-up compared to baseline in the FRAMES Group (paired t-test; p < 0.05), but not in the control group (paired t-test; Baseline vs Visit 1: p = 0.089; Baseline vs Visit 2: p = 0.453).

596

3 Diagnosis

Discussion Only the FRAMES group demonstrated an improvement from the impact of head- ache during follow-up.

These findings demonstrate that counseling (structured or unstructured), even within a scenario of attending more complex patients, such as a headache clinic, is important for the treatment of MOH.

Although prophylactics for primary headaches were prescribed on the same day as counseling, an improvement in the headache and a lower use of pain medications could already be observed during the first month after intervention, when the pro- phylaxis effect was not yet significant.

Although we discovered no difference between the Frames Group and the Structured Group, there was a decrease in the impact of headache in the Frames Group during follow-up when compared to the moment before the intervention.

The sample of MOH included in this study was predominantly made up of females, of patients in the fifth decade of life, diagnosed with chronic migraine and with headaches that had a high impact on their lives and who presented symptoms of anxiety and depression.

Conclusions Patients in both counseling groups (FRAMES and unstructured counseling) signifi- cantly decreased the use of pain medications and the frequency of their headaches. There was no difference in the degree of improvement between these two groups.

Acknowledgement A machine generated summary based on the work of Moraes Alves, Anna Letícia; Silva, Izadora Karina; Paula Lemos, Pedro Henrique; Lomachinsky Torres, Victor; Crevanzi Arraes, Eric; Sampaio Rocha-Filho, Pedro Augusto. 2021  in Acta Neurologica Belgica.

Polypharmacy Among Headache Patients: A Cross-Sectional Study