Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 Oct 29;19(21):14116.
doi: 10.3390/ijerph192114116.

A Preliminary Analysis on the Feasibility and Short-Term Efficacy of a Phase-III RCT on Mindfulness Added to Treatment as Usual for Patients with Chronic Migraine and Medication Overuse Headache

Licia Grazzi  1 , Alberto Raggi  2 , Erika Guastafierro  2 , Marco Passavanti  2 , Alessia Marcassoli  2 , Danilo Antonio Montisano  1 , Domenico D'Amico  1
Affiliations
Randomized Controlled Trial

A Preliminary Analysis on the Feasibility and Short-Term Efficacy of a Phase-III RCT on Mindfulness Added to Treatment as Usual for Patients with Chronic Migraine and Medication Overuse Headache

Licia Grazzi et al. Int J Environ Res Public Health. .

Abstract

This preliminary analysis of a single-blind phase-III RCT aims to compare the feasibility and short-term efficacy of mindfulness as an add-on to treatment as usual (TaU) in the management of patients with chronic migraine (CM) and medication overuse headache (MOH). Patients were randomized to either TaU (structured withdrawal of overused drugs, patient education and pharmacological prophylaxis) or TaU + MIND, wherein patients additionally received six 90 min weekly group sessions of mindfulness-based therapy. Repeated measures analyses were used to test whether patients in the two arms showed different course with regard to headache frequency and medication intake over a three-month period. Drop-out rates were not different between the two groups: 6/89 (6.7%) and 9/88 (10.2%) among those in TaU and TaU + MIND, respectively. A significant effect of time for all variables was shown, together with a significant effect of time by group, favoring TaU + MIND condition for headache frequency (p = 0.025) and NSAID intake (p = 0.007), controlling for age and CM duration. In total, 45/83 (54.2%) and 69/79 (75.9%) of the patients allocated to TaU and TaU + MIND, respectively, achieved 50% or more headache-day reduction (chi-squared 8.38, p = 0.004). Our preliminary analysis indicates that adding six mindfulness-based sessions to TaU was feasible and showed short-term efficacy in the treatment of patients with CM and MOH.

Trial registration: ClinicalTrials.gov NCT03671681.

Keywords: NSAIDs; chronic migraine; medication overuse headache; mindfulness; non-steroidal anti-inflammatory drugs; triptans.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1
Figure 1
Study flowchart.
See this image and copyright information in PMC

References

    1. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1–211. doi: 10.1177/0333102417738202. - DOI - PubMed
    1. GBD 2019 Diseases and Injuries Collaborators Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: A systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396:1204–1222. doi: 10.1016/S0140-6736(20)30925-9. - DOI - PMC - PubMed
    1. Raggi A., Monasta L., Beghi E., Caso V., Castelpietra G., Mondello S., Giussani G., Logroscino G., Magnani F.G., Piccininni M., et al. Incidence, prevalence and disability associated with neurological disorders in Italy between 1990 and 2019: An analysis based on the Global Burden of Disease Study 2019. J. Neurol. 2022;269:2080–2098. doi: 10.1007/s00415-021-10774-5. - DOI - PMC - PubMed
    1. Diener H.C., Dodick D., Evers S., Holle D., Jensen R.H., Lipton R.B., Porreca F., Silberstein S., Schwedt T. Pathophysiology, prevention, and treatment of medication overuse headache. Lancet Neurol. 2019;18:891–902. doi: 10.1016/S1474-4422(19)30146-2. - DOI - PubMed
    1. Linde M., Gustavsson A., Stovner L.J., Steiner T.J., Barré J., Katsarava Z., Lainez J.M., Lampl C., Lantéri-Minet M., Rastenyte D., et al. The cost of headache disorders in Europe: The Eurolight project. Eur. J. Neurol. 2012;19:703–711. doi: 10.1111/j.1468-1331.2011.03612.x. - DOI - PubMed

Publication types

Associated data