• 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, and Yi Zhang.
• Department of Neurology, the First Affiliated Hospital, Zhengzhou University, 1 Jianshe East R, Zhengzhou 450052, Henan Province, People's Republic of China. lianyajun840317@163.com.
• J Headache Pain. 2014 Jun 22; 15: 43.

BackgroundWe 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.MethodsA 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.ResultsTreatment 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.ConclusionLocal 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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