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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

Author

Listed:
  • Licia Grazzi

    (Centro Cefalee, Fondazione IRRCS Istituto Neurologico Carlo Besta, 20133 Milano, Italy)

  • Alberto Raggi

    (UOC Neurologia Salute Pubblica e Disabilità, Fondazione IRRCS Istituto Neurologico Carlo Besta, 20133 Milano, Italy)

  • Erika Guastafierro

    (UOC Neurologia Salute Pubblica e Disabilità, Fondazione IRRCS Istituto Neurologico Carlo Besta, 20133 Milano, Italy)

  • Marco Passavanti

    (UOC Neurologia Salute Pubblica e Disabilità, Fondazione IRRCS Istituto Neurologico Carlo Besta, 20133 Milano, Italy)

  • Alessia Marcassoli

    (UOC Neurologia Salute Pubblica e Disabilità, Fondazione IRRCS Istituto Neurologico Carlo Besta, 20133 Milano, Italy)

  • Danilo Antonio Montisano

    (Centro Cefalee, Fondazione IRRCS Istituto Neurologico Carlo Besta, 20133 Milano, Italy)

  • Domenico D’Amico

    (Centro Cefalee, Fondazione IRRCS Istituto Neurologico Carlo Besta, 20133 Milano, Italy)

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.

Suggested Citation

  • Licia Grazzi & Alberto Raggi & Erika Guastafierro & Marco Passavanti & Alessia Marcassoli & Danilo Antonio Montisano & Domenico D’Amico, 2022. "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," IJERPH, MDPI, vol. 19(21), pages 1-10, October.
    • Handle: RePEc:gam:jijerp:v:19:y:2022:i:21:p:14116-:d:957014
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    References listed on IDEAS

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    1. Licia Grazzi & Claudia Toppo & Domenico D’Amico & Matilde Leonardi & Paolo Martelletti & Alberto Raggi & Erika Guastafierro, 2021. "Non-Pharmacological Approaches to Headaches: Non-Invasive Neuromodulation, Nutraceuticals, and Behavioral Approaches," IJERPH, MDPI, vol. 18(4), pages 1-17, February.
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