Trial of Botulinum Toxin for Isolated or Essential Head Tremor.
Adult
Humans
Botulinum Toxins, Type A
/ administration & dosage
Double-Blind Method
Essential Tremor
/ drug therapy
Head
Treatment Outcome
Tremor
/ drug therapy
Electromyography
/ methods
Injections, Intramuscular
/ methods
Headache
/ chemically induced
Neck Pain
/ chemically induced
Neuromuscular Agents
/ administration & dosage
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
09 Nov 2023
09 Nov 2023
Historique:
medline:
9
11
2023
pubmed:
8
11
2023
entrez:
8
11
2023
Statut:
ppublish
Résumé
Local injections of botulinum toxin type A have been used to treat essential head tremor but have not been extensively studied in randomized trials. In a multicenter, double-blind, randomized trial, we assigned, in a 1:1 ratio, adult patients with essential or isolated head tremor to receive botulinum toxin type A or placebo. Botulinum toxin or placebo was injected under electromyographic guidance into each splenius capitis muscle on the day of randomization (day 0) and during week 12. The primary outcome was improvement by at least 2 points on the Clinical Global Impression of Change (CGI) scale at week 6 after the second injection (week 18 after randomization). The CGI scale was used to record the patient's assessment of the degree of improvement or worsening of head tremor since baseline; scores range from 3 (very much improved) to -3 (very much worse). Secondary outcomes included changes in tremor characteristics from baseline to weeks 6, 12, and 24. A total of 120 patients were enrolled; 3 patients were excluded during screening, and 117 patients were randomly assigned to receive botulinum toxin (62 patients) or placebo (55 patients) and were included in the intention-to-treat analysis. Twelve patients in the botulinum toxin group and 2 patients in the placebo group did not receive injections during week 12. The primary outcome - improvement by at least 2 points on the CGI scale at week 18 - was met by 31% of the patients in the botulinum toxin group as compared with 9% of those in the placebo group (relative risk, 3.37; 95% confidence interval, 1.35 to 8.42; P = 0.009). Analyses of secondary outcomes at 6 and 12 weeks but not at 24 weeks were generally supportive of the primary-outcome analysis. Adverse events occurred in approximately half the patients in the botulinum toxin group and included head and neck pain, posterior cervical weakness, and dysphagia. Injection of botulinum toxin into each splenius capitis muscle on day 0 and during week 12 was more effective than placebo in reducing the severity of isolated or essential head tremor at 18 weeks but not at 24 weeks, when the effects of injection might be expected to wane, and was associated with adverse events. (Funded by the French Ministry of Health; Btx-HT ClinicalTrials.gov number, NCT02555982.).
Sections du résumé
BACKGROUND
BACKGROUND
Local injections of botulinum toxin type A have been used to treat essential head tremor but have not been extensively studied in randomized trials.
METHODS
METHODS
In a multicenter, double-blind, randomized trial, we assigned, in a 1:1 ratio, adult patients with essential or isolated head tremor to receive botulinum toxin type A or placebo. Botulinum toxin or placebo was injected under electromyographic guidance into each splenius capitis muscle on the day of randomization (day 0) and during week 12. The primary outcome was improvement by at least 2 points on the Clinical Global Impression of Change (CGI) scale at week 6 after the second injection (week 18 after randomization). The CGI scale was used to record the patient's assessment of the degree of improvement or worsening of head tremor since baseline; scores range from 3 (very much improved) to -3 (very much worse). Secondary outcomes included changes in tremor characteristics from baseline to weeks 6, 12, and 24.
RESULTS
RESULTS
A total of 120 patients were enrolled; 3 patients were excluded during screening, and 117 patients were randomly assigned to receive botulinum toxin (62 patients) or placebo (55 patients) and were included in the intention-to-treat analysis. Twelve patients in the botulinum toxin group and 2 patients in the placebo group did not receive injections during week 12. The primary outcome - improvement by at least 2 points on the CGI scale at week 18 - was met by 31% of the patients in the botulinum toxin group as compared with 9% of those in the placebo group (relative risk, 3.37; 95% confidence interval, 1.35 to 8.42; P = 0.009). Analyses of secondary outcomes at 6 and 12 weeks but not at 24 weeks were generally supportive of the primary-outcome analysis. Adverse events occurred in approximately half the patients in the botulinum toxin group and included head and neck pain, posterior cervical weakness, and dysphagia.
CONCLUSIONS
CONCLUSIONS
Injection of botulinum toxin into each splenius capitis muscle on day 0 and during week 12 was more effective than placebo in reducing the severity of isolated or essential head tremor at 18 weeks but not at 24 weeks, when the effects of injection might be expected to wane, and was associated with adverse events. (Funded by the French Ministry of Health; Btx-HT ClinicalTrials.gov number, NCT02555982.).
Identifiants
pubmed: 37937777
doi: 10.1056/NEJMoa2304192
doi:
Substances chimiques
Botulinum Toxins, Type A
EC 3.4.24.69
Neuromuscular Agents
0
Banques de données
ClinicalTrials.gov
['NCT02555982']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1753-1765Subventions
Organisme : Ministère des Affaires Sociales et de la Santé
ID : PHRC-14-0058
Investigateurs
Franck Durif
(F)
Philippe Derost
(P)
Eve Chanson
(E)
Isabelle Rieu
(I)
Elodie Durand
(E)
Stéphane Bernard
(S)
Hélène Obritin
(H)
Dihya Benghadid
(D)
Bruno Pereira
(B)
Marion Simonetta Moreau
(MS)
Galitzky Monique
(G)
Tricoire Anne Marie
(TA)
Thalamas Claire
(T)
Calvas Fabienne
(C)
Oliver Rascol
(O)
Johanne Germain
(J)
David Amarantini
(D)
Dominique Guehl
(D)
Pierre Burbaud
(P)
Olivier Branchard
(O)
Justine Pierron
(J)
Yeliz Celik
(Y)
Alexandre Kreisler
(A)
Clémence Simonin
(C)
David Devos
(D)
Valérie Santraine
(V)
Giovanni Castelnovo
(G)
Marie de Verdal
(M)
Elisabeth Llinares
(E)
Frédérique Fluchère
(F)
Jean Philippe Azulay
(JP)
Sophie Soulayrol
(S)
Manel Nouira
(M)
Sophie Sangla
(S)
Lucie Lopes
(L)
Sabrina Hammouda
(S)
Mélissa Tir
(M)
Pierre Krystkowiak
(P)
Stéphanie Blin
(S)
Chloé Laurencin
(C)
Françoise Bouhour
(F)
Hélène Merle
(H)
Elisa Météreau
(E)
Bertrand Degos
(B)
David Grabli
(D)
Raquel Guimaraes Costa
(R)
Jean Christophe Corvol
(JC)
Vanessa Brochard
(V)
Nathalie Jarry
(N)
Geneviève Fourcade Blanchet
(G)
Chbicheb Mohammed
(C)
Christine Tranchant
(C)
Ouaïd Lagha Boukbiza
(O)
Fanny Huselstein
(F)
Laurent Tatu
(L)
Matthieu Béreau
(M)
Benjamin Cuinet
(B)
Dominique Gayraud
(D)
Fabienne Zaetta
(F)
Isabelle Benatru
(I)
Jean Luc Houeto
(JL)
Solène Ansquer
(S)
Olivier Colin
(O)
Emilie Rabois
(E)
Aurelia Poujois
(A)
Nadège Girardot
(N)
Naoual Djebra
(N)
Miassa Bentifraouine
(M)
Informations de copyright
Copyright © 2023 Massachusetts Medical Society.