Headache Medicine 2021, 12(4):329-330 p-ISSN 2178-7468, e-ISSN 2763-6178

329

ASAA

DOI: 10.48208/HeadacheMed.2021.55

Headache Medicine

Letter to editor

The importance of considering psychosocial aspects in migraine

patients

Juliana Homem Padilha Spavieri

, Pablo Guarisco Ferreira

University of the State of São Paulo, Araraquara, São Paulo, Brazil

Federal University of Paraná, Toledo, Brazil

Recently we read the paper titled "The benecial effect of positive treatment expectations on

pharmacological migraine prophylaxis" by Katharina Schmidt and coworkers

, published in the

journal PAIN and available in 2021. We congratulate the authors for the interesting paper and

contribution on the inuence of patients' psychic conditions on migraine treatment.

In the article, patients were followed for 6 months, with surveys at study entry (T0, baseline), 1

week later after study entry (T1) by telephone, and online surveys at 1, 3, and 6 months after

baseline. The primary outcomes were the number of headache days, migraine days, and adverse

events by GASE score.

The secondary outcomes were pain intensity and duration, pain-related

impairment depression, anxiety and stress, and quality of life. The study also considered migraine

subtypes (chronic and episodic), patients' previous treatment experience, and genotype.

In general, participants showed improvement in headache and migraine symptoms during pro-

phylactic treatment, and positive expectancy was associated with fewer headache and migraine

days across all analysis time points. However, treatment efcacy was signicantly increased by

positive treatment expectancy only in chronic migraine, although expectancy was lower in this

group compared with episodic migraine.

An important factor that must be considered in clinical trials for approaches to treat migraine is

the placebo effect.

2,3

Recently, a systematic review evaluated the association between the de-

gree of response to placebo in migraine studies and the observed difference between drug and

placebo across studies of preventive treatments for migraine.

In clinical trials of preventive treat-

ments for migraine, higher placebo responses were associated with smaller placebo-subtracted

response rates, and higher sample size requirements than trials with lower placebo responses.

According to the authors, in order to control the size of the placebo effect in clinical trials, the

sample size must be increased.

Another aspect that can affect the results is the route of treatment

administration.

2,3

Studies with an oral treatment had slightly lower levels of placebo effect than

studies with an injection treatment.

Clinical trials must distinguish an effective (or non-effective)

treatment from a placebo.

Beside the placebo effect, the research team must consider the other

factors that might favor the improvement of the painful.

2,3

We can mention the Hawthorne ef-

fect (the tendency of people to change their behavior or condition simply as a consequence of

being observed or studied), the regression to the mean, the natural course of the disease, and

even a poor study design.

2,3

Some theories about clinical trials suggest that expectation should

increase the response in both treatment and placebo groups equally.

But, some studies indicate

the opposite and the study groups might be affected unevenly.

Pablo Guarisco Ferreira

pabloguarisco@ufpr.br

Submited: March 23, 2022

Accepted: March 27, 2022

Keywords:

Migraine Disorders

Mental Health

Anxiety

Depression

Edited by:

Marcelo Moraes Valença

330

ASAA

Spavieri JHP, Ferreira PG

The importance of considering psychosocial aspects in migraine patients

From our point of view, the paper was particularly inter-

esting because it considers treatment expectations and

previous treatment experience. This is especially important

considering that mental disorders such as anxiety and

depression are particularly prevalent in this population.

It is well known that psychiatric comorbidities are an im-

portant issue in the diagnosis and treatment of migraine

and require different approaches.

These conditions may

also interfere with the prophylactic treatment of migraine in

the belief that treatment is effective, even at the time of the

medical appointment. Therefore, to consider appropriate

treatment for a patient, the individual's mental health status

and expectations must be examined.

Funding: No nancial support

Conflict of interest: There is no conict of interest to de-

clare.

Authors Contribution: The authors contributed equally to the

writing of the manuscript.

Juliana Homem Padilha Spavieri

https://orcid.org/0000-0001-9653-0986

Pablo Guarisco Ferreira

https://orcid.org/0000-0002-8842-6190

References

1. Schmidt K, Berding T, Kleine-Borgmann J, Engler H,

Holle-Lee D, Gaul C and Bingel U. The beneficial effect

of positive treatment expectations on pharmacological

migraine prophylaxis.

Pain

2022;163(2):e319-e327

Doi:10.1097/j.pain.0000000000002341

2. Evans K, Romero H, Spierings EL and Katz N.

The relation between the placebo response,

observed treatment effect, and failure to meet

primary endpoint: A systematic review of clinical

trials of preventative pharmacological migraine

treatments.

Cephalalgia

2021;41(2):247-255

Doi:10.1177/0333102420960020

3. Speciali JG, Peres M and Bigal ME. Migraine

treatment and placebo effect.

Expert Rev Neurother

2010;10(3):413-419 Doi:10.1586/ern.10.8

4. Albuquerque AV, Albuquerque LHM and Filho PFM.

Ansiedade e Depressão em Pacientes Migranosos.

Rev

Neurociências

2013;21(1):22-27 Doi:10.34024/

rnc.2013.v21.8200

5. Peres MFP, Valença MM and Silva-Neto RP.

Management of psychiatric comorbidities in

migraine.

Headache Medicine

2018;9(2):61-67

Doi:10.48208/HeadacheMed.2018.13