RES E A R C H A R T I C L E Open Access
Single-dose botulinum toxin type a
compared with repeated-dose for
treatment of trigeminal neuralgia: a pilot
Haifeng Zhang, Yajun Lian
, Nanchang Xie, Chen Chen and Yake Zheng
Background: Several RCT studies including ours, seem to prove the role of Botulinum toxin type A (BTX-A) in the
treatment of trigeminal neuralgia (TN), but no standardized dosing regimen has been established. In our study, we
compare two different methods of administration: single-dose or repeated-dose strategy which was most
frequently applied over the years in our centre.
Methods: An open-label trail was conducted. One hundred patients with classic TN symptoms were recruited, and
randomly and equally apportioned to single- or repeated-dose group. Patients in the single-dose group received a
local BTX-A injection of 70 to 100 U. The repeated-dose group received an initial BTX-A injection of 50 to 70 U and
then another of equal volume 2 weeks later. All patients were followed for 6 months.
Results: In the single- and repeated-dose groups, 44 and 37, respectively, completed the entire study. The groups
were statistically similar in TN frequency, time between treatment and effect, time to peak effect, VAS scores, and
rates of adverse reactions (latency and duration). However, the single-dose group experienced significantly longer
duration of effect (P = 0.032).
Conclusions: The single- and repeated-dosing BTX-A regimens were largely comparable in efficacy and safety. This
study suggests that repeated dosing has no advantage over single dosing of BTX-A for TN. Dosing should be
adjusted for the individual patient.
Keywords: Botulinum toxin type a, Trigeminal neuralgia, Single dosing, Repeated dosing
Trigeminal neuralgia (TN) is severe and recurring pain
distributed unilaterally along a branch of the trigeminal
nerve. [1, 2] TN can be triggered by brushing the teeth,
washing the face, drinking liquids, or shaving. Patients
become fearful of performing these life activities, in
anticipation of long-lasting stabbing pain. TN patients
may display a haggard facial expression and depressive
mood, as their quality of life and ability to work is com-
promised. The most common treatment is anti-epileptics
such as carbamazepine and oxcarbazepine. However, these
medications may have to be discontinued due to intoler-
able side effects. Neurosurgical interventions remain
debatable for safety and efficacy concerns .
Botulinum toxin type A (BTX-A) is an exotoxin
released by the gram-positive bacterium Clostridium
botulinum. Its initial medicinal use was in the manage-
ment of blepharospasm and hemifacial spasm . In re-
cent years, BTX-A has been used for the relief of chronic
migraine and many other types of headache [5–8]. The
application of BTX-A to relieve TN was first reported in
2002, and its safety and effectiveness was later confirmed
by series studies [9–19]. These findings suggest that local
intradermal or submucosal injections of BTX-A may be a
promising therapy for TN.
* Correspondence: firstname.lastname@example.org
Department of Neurology, First Affiliated Hospital of Zhengzhou University, 1
Jianshe East R, Zhengzhou City, HeNan Province 450052, People’s Republic of
The Journal of Headache
© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made.
Zhang et al. The Journal of Headache and Pain (2017) 18:81