Botulinum toxin versus trihexyphenidyl in cervical dystonia: a prospective, randomized, double-blind controlled trial.
BACKGROUND
Botulinum toxin type A (BTA) is replacing trihexyphenidyl as the treatment of choice for idiopathic cervical dystonia (ICD), but there has never been a direct comparative study.


METHODS
This trial compares the effectiveness of BTA with that of trihexyphenidyl in a prospective, randomized, double-blind design. Sixty-six consecutive patients with ICD were randomized to treatment with trihexyphenidyl tablets plus placebo injection or placebo tablets plus BTA injections. Tablets were administered daily according to a fixed schedule. Dysport or saline was injected under EMG guidance at study entry and again after 8 weeks. Patients were assessed for efficacy at baseline and after 12 weeks by different clinical rating scales.


RESULTS
Sixty-four patients completed the study, 32 in each group. Mean dose of BTA was 292 mouse units (first session) and 262 mouse units (second session). Mean dose of trihexyphenidyl was 16.25 mg. The changes on the Disability section of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS-Disability) (primary outcome), Tsui Scale, and the General Health Perception Subscale were significantly in favor of BTA. More patients treated with BTA had an improvement of at least three points on the TWSTRS-Disability (14 versus 6) and on the Tsui Scale (23 versus 12). Adverse effects were significantly less frequent in the BTA group.


CONCLUSIONS
BTA is significantly more effective in the treatment of ICD, with less adverse effects.
Brans
J W
JW
Department of Neurology, Academic Medical Center, Amsterdam, The Netherlands.
Lindeboom
R
R
Snoek
J W
JW
Zwarts
M J
MJ
van Weerden
T W
TW
Brunt
E R
ER
van Hilten
J J
JJ
van der Kamp
W
W
Prins
M H
MH
Speelman
J D
JD
D000328:Adult; D001905:Botulinum Toxins / Q000009:adverse effects / Q000627:therapeutic use*; D004185:Disability Evaluation; D004311:Double-Blind Method; D004421:Dystonia / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009334:Neck Muscles / Q000503:physiopathology; D011446:Prospective Studies; D016896:Treatment Outcome; D014282:Trihexyphenidyl / Q000009:adverse effects / Q000627:therapeutic use*
D014282:Trihexyphenidyl; D001905:Botulinum Toxins