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Nabilone for the treatment of medication overuse headache: results of a preliminary double-blind, active-controlled, randomized trial.
J Headache Pain. 2012 Nov; 13(8):677-84.JH

Abstract

Medication overuse headache (MOH) is a severe burden to sufferers and its treatment has few evidence-based indications. The aim of this study is to evaluate efficacy and safety of nabilone in reducing pain and frequency of headache, the number of analgesic intake and in increasing the quality of life on patients with long-standing intractable MOH. Thirty MOH patients were enrolled at the University of Modena's Interdepartmental Centre for Research on Headache and Drug Abuse (Italy) in a randomized, double-blind, active-controlled, crossover study comparing nabilone 0.5 mg/day and ibuprofen 400 mg. The patients received each treatment orally for 8 weeks (before nabilone and then ibuprofen or vice versa), with 1 week wash-out between them. Randomization and allocation (ratio 1:1) were carried out by an independent pharmacy through a central computer system. Participants, care givers, and those assessing the outcomes were blinded to treatment sequence. Twenty-six subjects completed the study. Improvements from baseline were observed with both treatments. However, nabilone was more effective than ibuprofen in reducing pain intensity and daily analgesic intake (p < 0.05); moreover, nabilone was the only drug able to reduce the level of medication dependence (-41 %, p < 0.01) and to improve the quality of life (p < 0.05). Side effects were uncommon, mild and disappeared when nabilone was discontinued. This is the first randomized controlled trial demonstrating the benefits of nabilone on headache, analgesic consumption and the quality of life in patients with intractable MOH. This drug also appears to be safe and well-tolerated. Larger scale studies are needed to confirm these preliminary findings.

Authors+Show Affiliations

Headache and Drug Abuse Interdepartmental Research Centre, University of Modena, Via del Pozzo 71, Modena, Italy. pinila@unimore.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

23070400

Citation

Pini, Luigi Alberto, et al. "Nabilone for the Treatment of Medication Overuse Headache: Results of a Preliminary Double-blind, Active-controlled, Randomized Trial." The Journal of Headache and Pain, vol. 13, no. 8, 2012, pp. 677-84.
Pini LA, Guerzoni S, Cainazzo MM, et al. Nabilone for the treatment of medication overuse headache: results of a preliminary double-blind, active-controlled, randomized trial. J Headache Pain. 2012;13(8):677-84.
Pini, L. A., Guerzoni, S., Cainazzo, M. M., Ferrari, A., Sarchielli, P., Tiraferri, I., Ciccarese, M., & Zappaterra, M. (2012). Nabilone for the treatment of medication overuse headache: results of a preliminary double-blind, active-controlled, randomized trial. The Journal of Headache and Pain, 13(8), 677-84. https://doi.org/10.1007/s10194-012-0490-1
Pini LA, et al. Nabilone for the Treatment of Medication Overuse Headache: Results of a Preliminary Double-blind, Active-controlled, Randomized Trial. J Headache Pain. 2012;13(8):677-84. PubMed PMID: 23070400.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nabilone for the treatment of medication overuse headache: results of a preliminary double-blind, active-controlled, randomized trial. AU - Pini,Luigi Alberto, AU - Guerzoni,Simona, AU - Cainazzo,Maria Michela, AU - Ferrari,Anna, AU - Sarchielli,Paola, AU - Tiraferri,Ilaria, AU - Ciccarese,Michela, AU - Zappaterra,Maurizio, Y1 - 2012/10/16/ PY - 2012/09/06/received PY - 2012/10/04/accepted PY - 2012/10/17/entrez PY - 2012/10/17/pubmed PY - 2013/4/23/medline SP - 677 EP - 84 JF - The journal of headache and pain JO - J Headache Pain VL - 13 IS - 8 N2 - Medication overuse headache (MOH) is a severe burden to sufferers and its treatment has few evidence-based indications. The aim of this study is to evaluate efficacy and safety of nabilone in reducing pain and frequency of headache, the number of analgesic intake and in increasing the quality of life on patients with long-standing intractable MOH. Thirty MOH patients were enrolled at the University of Modena's Interdepartmental Centre for Research on Headache and Drug Abuse (Italy) in a randomized, double-blind, active-controlled, crossover study comparing nabilone 0.5 mg/day and ibuprofen 400 mg. The patients received each treatment orally for 8 weeks (before nabilone and then ibuprofen or vice versa), with 1 week wash-out between them. Randomization and allocation (ratio 1:1) were carried out by an independent pharmacy through a central computer system. Participants, care givers, and those assessing the outcomes were blinded to treatment sequence. Twenty-six subjects completed the study. Improvements from baseline were observed with both treatments. However, nabilone was more effective than ibuprofen in reducing pain intensity and daily analgesic intake (p < 0.05); moreover, nabilone was the only drug able to reduce the level of medication dependence (-41 %, p < 0.01) and to improve the quality of life (p < 0.05). Side effects were uncommon, mild and disappeared when nabilone was discontinued. This is the first randomized controlled trial demonstrating the benefits of nabilone on headache, analgesic consumption and the quality of life in patients with intractable MOH. This drug also appears to be safe and well-tolerated. Larger scale studies are needed to confirm these preliminary findings. SN - 1129-2377 UR - https://www.unboundmedicine.com/medline/citation/23070400/Nabilone_for_the_treatment_of_medication_overuse_headache:_results_of_a_preliminary_double_blind_active_controlled_randomized_trial_ L2 - https://thejournalofheadacheandpain.biomedcentral.com/articles/10.1007/s10194-012-0490-1 DB - PRIME DP - Unbound Medicine ER -