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01.12.2014 | Research article | Ausgabe 1/2014 Open Access

The Journal of Headache and Pain 1/2014

Therapeutic effect of Botulinum toxin-A in 88 patients with Trigeminal Neuralgia with 14-month follow-up

The Journal of Headache and Pain > Ausgabe 1/2014
Shuang Li, Ya-Jun Lian, Yuan Chen, Hai-Feng Zhang, Yun-Qing Ma, Cai-Hong He, Chuan-Jie Wu, Nan-Chang Xie, Ya-Ke Zheng, Yi Zhang
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1129-2377-15-43) contains supplementary material, which is available to authorized users.
Shuang Li, Yuan Chen, Hai-Feng Zhang contributed equally to this work.

Competing interests

The authors declare that they have no competing interest.

Authors’ contributions

YJL study concept and design. SL acquisition of data. HFZ carried out the treatment and studies, drafted the manuscript. YC participated in the sequence alignment, analysis and interpretation. YQM, CHH, CJW revise the manuscript. NCX, YKZ, YC study supervision. All authors read and approved the final manuscript.



We investigated the long-term effects and safety of botulinum toxin-A (BTX-A) for treating trigeminal neuralgia (TN). We also studied long-term maintenance of this therapeutic effect.


A visual analog scale (VAS) score, pain attack frequency per day, patient’s overall response to treatment and side effects during 14-month follow-up were evaluated in 88 patients with TN receiving BTX-A. The primary endpoints were pain severity (assessed by VAS) and pain attack frequency per day. The secondary endpoint was the patient’s overall response to treatment, assessed using the Patient Global Impression of Change. The influence of different doses (≤50, 50–100 and ≥100 U) on the therapeutic effect was evaluated.


Treatment was deemed “effective” within 1 month in 81 patients and at 2 months in 88 patients (100%). The shortest period of effective treatment was 3 months, and complete control of pain was observed in a maximum of 46 patients. The therapeutic effect decreased gradually after 3 months, and the prevalence of effective treatment at 14 months was 38.6%, with complete control of pain seen in 22 patients (25%). There was no significant difference in the prevalence of effective treatment between different dose groups at identical time points (p > 0.05). Three patients showed swelling at injection sites and 10 patients showed facial asymmetry, both of which disappeared spontaneously without special treatment.


Local subcutaneous injection of BTX-A for TN treatment has considerable therapeutic effects lasting several months and is safe for this indication. At least one-quarter of patients maintained complete analgesia. The maintenance period of the therapeutic effect may be related to the reduction in the VAS score after the first injection of BTX-A.
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