Cargando…
Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: a phase-III single-blind randomized-controlled trial (the MIND-CM study)
BACKGROUND: Mindfulness gained considerable attention for migraine management, but RCTs are lacking. We aimed to assess the efficacy of a six-sessions mindfulness-based treatment added to treatment as usual (TaU) in patients with Chronic Migraine (CM) and Medication Overuse Headache (MOH) on headach...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Milan
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10347788/ https://www.ncbi.nlm.nih.gov/pubmed/37452281 http://dx.doi.org/10.1186/s10194-023-01630-0 |
_version_ | 1785073598697832448 |
---|---|
author | Grazzi, Licia D’Amico, Domenico Guastafierro, Erika Demichelis, Greta Erbetta, Alessandra Fedeli, Davide Nigri, Anna Ciusani, Emilio Barbara, Corso Raggi, Alberto |
author_facet | Grazzi, Licia D’Amico, Domenico Guastafierro, Erika Demichelis, Greta Erbetta, Alessandra Fedeli, Davide Nigri, Anna Ciusani, Emilio Barbara, Corso Raggi, Alberto |
author_sort | Grazzi, Licia |
collection | PubMed |
description | BACKGROUND: Mindfulness gained considerable attention for migraine management, but RCTs are lacking. We aimed to assess the efficacy of a six-sessions mindfulness-based treatment added to treatment as usual (TaU) in patients with Chronic Migraine (CM) and Medication Overuse Headache (MOH) on headache frequency, medication intake, quality of life, disability, depression and anxiety, cutaneous allodynia, awareness of inner states, work-related difficulties, and disease cost. METHODS: In this Phase-III single-blind RCT carried out in a specialty Italian headache center, 177 patients with CM and MOH were randomized 1:1 to either TaU (withdrawal from overused drugs, education on proper medication use and lifestyle issues, and tailored prophylaxis) or mindfulness-based intervention added to TaU (TaU + MIND). The mindfulness-based intervention consisted of six group session of mindfulness practice and 7–10 min daily self-practice. The primary endpoint was the achievement of ≥ 50% headache frequency reduction at 12 months compared to baseline, and was analyzed on an intention-to-treat principle using Pearson’s Chi-Squared test. Secondary endpoints included medication intake, quality of life (QoL), disability, depression and anxiety, cutaneous allodynia, awareness of inner states, work-related difficulties, and disease cost. The secondary endpoints were analyzed using per-protocol linear mixed models. RESULTS: Out of the 177 participants 89 were randomized to TaU and 88 to TaU + MIND. Patients in the TaU + MIND group outperformed those in TaU for the primary endpoint (78.4% vs. 48.3%; p < 0.0001), and showed superior improvement in headache frequency, QoL and disability, headache impact, loss of productive time, medication intake, and in total, indirect and direct healthcare costs. CONCLUSIONS: A mindfulness-based treatment composed of six-week session and 7–10 min daily self-practice added on to TaU is superior to TaU alone for the treatment of patients with CM and MOH. TRIAL REGISTRATION: MIND-CM was registered on clinicaltrials.gov (NCT03671681) on14/09/2018. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s10194-023-01630-0. |
format | Online Article Text |
id | pubmed-10347788 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer Milan |
record_format | MEDLINE/PubMed |
spelling | pubmed-103477882023-07-15 Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: a phase-III single-blind randomized-controlled trial (the MIND-CM study) Grazzi, Licia D’Amico, Domenico Guastafierro, Erika Demichelis, Greta Erbetta, Alessandra Fedeli, Davide Nigri, Anna Ciusani, Emilio Barbara, Corso Raggi, Alberto J Headache Pain Research BACKGROUND: Mindfulness gained considerable attention for migraine management, but RCTs are lacking. We aimed to assess the efficacy of a six-sessions mindfulness-based treatment added to treatment as usual (TaU) in patients with Chronic Migraine (CM) and Medication Overuse Headache (MOH) on headache frequency, medication intake, quality of life, disability, depression and anxiety, cutaneous allodynia, awareness of inner states, work-related difficulties, and disease cost. METHODS: In this Phase-III single-blind RCT carried out in a specialty Italian headache center, 177 patients with CM and MOH were randomized 1:1 to either TaU (withdrawal from overused drugs, education on proper medication use and lifestyle issues, and tailored prophylaxis) or mindfulness-based intervention added to TaU (TaU + MIND). The mindfulness-based intervention consisted of six group session of mindfulness practice and 7–10 min daily self-practice. The primary endpoint was the achievement of ≥ 50% headache frequency reduction at 12 months compared to baseline, and was analyzed on an intention-to-treat principle using Pearson’s Chi-Squared test. Secondary endpoints included medication intake, quality of life (QoL), disability, depression and anxiety, cutaneous allodynia, awareness of inner states, work-related difficulties, and disease cost. The secondary endpoints were analyzed using per-protocol linear mixed models. RESULTS: Out of the 177 participants 89 were randomized to TaU and 88 to TaU + MIND. Patients in the TaU + MIND group outperformed those in TaU for the primary endpoint (78.4% vs. 48.3%; p < 0.0001), and showed superior improvement in headache frequency, QoL and disability, headache impact, loss of productive time, medication intake, and in total, indirect and direct healthcare costs. CONCLUSIONS: A mindfulness-based treatment composed of six-week session and 7–10 min daily self-practice added on to TaU is superior to TaU alone for the treatment of patients with CM and MOH. TRIAL REGISTRATION: MIND-CM was registered on clinicaltrials.gov (NCT03671681) on14/09/2018. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s10194-023-01630-0. Springer Milan 2023-07-14 /pmc/articles/PMC10347788/ /pubmed/37452281 http://dx.doi.org/10.1186/s10194-023-01630-0 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Grazzi, Licia D’Amico, Domenico Guastafierro, Erika Demichelis, Greta Erbetta, Alessandra Fedeli, Davide Nigri, Anna Ciusani, Emilio Barbara, Corso Raggi, Alberto Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: a phase-III single-blind randomized-controlled trial (the MIND-CM study) |
title | Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: a phase-III single-blind randomized-controlled trial (the MIND-CM study) |
title_full | Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: a phase-III single-blind randomized-controlled trial (the MIND-CM study) |
title_fullStr | Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: a phase-III single-blind randomized-controlled trial (the MIND-CM study) |
title_full_unstemmed | Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: a phase-III single-blind randomized-controlled trial (the MIND-CM study) |
title_short | Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: a phase-III single-blind randomized-controlled trial (the MIND-CM study) |
title_sort | efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: a phase-iii single-blind randomized-controlled trial (the mind-cm study) |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10347788/ https://www.ncbi.nlm.nih.gov/pubmed/37452281 http://dx.doi.org/10.1186/s10194-023-01630-0 |
work_keys_str_mv | AT grazzilicia efficacyofmindfulnessaddedtotreatmentasusualinpatientswithchronicmigraineandmedicationoveruseheadacheaphaseiiisingleblindrandomizedcontrolledtrialthemindcmstudy AT damicodomenico efficacyofmindfulnessaddedtotreatmentasusualinpatientswithchronicmigraineandmedicationoveruseheadacheaphaseiiisingleblindrandomizedcontrolledtrialthemindcmstudy AT guastafierroerika efficacyofmindfulnessaddedtotreatmentasusualinpatientswithchronicmigraineandmedicationoveruseheadacheaphaseiiisingleblindrandomizedcontrolledtrialthemindcmstudy AT demichelisgreta efficacyofmindfulnessaddedtotreatmentasusualinpatientswithchronicmigraineandmedicationoveruseheadacheaphaseiiisingleblindrandomizedcontrolledtrialthemindcmstudy AT erbettaalessandra efficacyofmindfulnessaddedtotreatmentasusualinpatientswithchronicmigraineandmedicationoveruseheadacheaphaseiiisingleblindrandomizedcontrolledtrialthemindcmstudy AT fedelidavide efficacyofmindfulnessaddedtotreatmentasusualinpatientswithchronicmigraineandmedicationoveruseheadacheaphaseiiisingleblindrandomizedcontrolledtrialthemindcmstudy AT nigrianna efficacyofmindfulnessaddedtotreatmentasusualinpatientswithchronicmigraineandmedicationoveruseheadacheaphaseiiisingleblindrandomizedcontrolledtrialthemindcmstudy AT ciusaniemilio efficacyofmindfulnessaddedtotreatmentasusualinpatientswithchronicmigraineandmedicationoveruseheadacheaphaseiiisingleblindrandomizedcontrolledtrialthemindcmstudy AT barbaracorso efficacyofmindfulnessaddedtotreatmentasusualinpatientswithchronicmigraineandmedicationoveruseheadacheaphaseiiisingleblindrandomizedcontrolledtrialthemindcmstudy AT raggialberto efficacyofmindfulnessaddedtotreatmentasusualinpatientswithchronicmigraineandmedicationoveruseheadacheaphaseiiisingleblindrandomizedcontrolledtrialthemindcmstudy |