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Randomized Controlled Trial Comparative Study
Single-dose botulinum toxin type a compared with repeated-dose for treatment of trigeminal neuralgia: a pilot study.
- Haifeng Zhang, Yajun Lian, Nanchang Xie, Chen Chen, and Yake Zheng.
- Department of Neurology, First Affiliated Hospital of Zhengzhou University, 1 Jianshe East R, Zhengzhou City, HeNan Province, 450052, People's Republic of China.
- J Headache Pain. 2017 Aug 10; 18 (1): 81.
BackgroundSeveral 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.MethodsAn 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.ResultsIn 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).ConclusionsThe 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.
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