Therapeutic efficacy and safety of Botulinum Toxin A Therapy in Trigeminal Neuralgia: a systematic review and meta-analysis of randomized controlled trials

J Headache Pain. 2016 Dec;17(1):63. doi: 10.1186/s10194-016-0651-8. Epub 2016 Jul 5.


Background: Several different interventions have been examined to alleviate pain and reduce frequency of trigeminal neuralgia (TN) paroxysms. However, some patients continue to have persistent or recurrent painful attacks. Using a systematic review and meta-analysis approach, we aimed to synthesize evidence from published randomized controlled trials (RCTs) regarding safety and efficacy of botulinum toxin type A (BTX-A) as a possible emerging choice of treatment for TN.

Methods: We conducted an electronic search in 10 databases/electronic search engines to access relevant publications. All articles in all languages reporting RCTs on the efficacy and safety of BTX-A in the treatment of TN were included for systematic review and meta-analysis.

Results: A total of four RCTs (n = 178) were identified for final meta-analysis. The overall effect favored BTX-A versus placebo in terms of proportion of responders (risk ratio RR = 2.87, 95 % confidence interval CI [1.76, 4.69], p <0.0001) with no significant detected heterogeneity (p = 0.31; I(2) = 4 %). Paroxysms frequency per day was significantly lower for BTX-A group (mean difference MD = -29.79, 95 % CI [-38.50,-21.08], p <0.00001) with no significant heterogeneity (p = 0.21; I(2) = 36 %).

Conclusion: Despite limited data, our results suggest that BTX-A may be an effective and safe treatment option for patients with TN. Further larger and well-designed RCTs are encouraged to translate these findings into better clinical outcome and better quality of life for TN patients.

Keywords: BTX-A; Botulinum; Clinical trials; Meta-analysis; Systematic review; Trigeminal neuralgia.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Botulinum Toxins, Type A / adverse effects
  • Botulinum Toxins, Type A / pharmacology
  • Botulinum Toxins, Type A / therapeutic use*
  • Databases, Factual
  • Edema / chemically induced
  • Hematoma / chemically induced
  • Humans
  • Pain Measurement / drug effects
  • Pain Measurement / methods
  • Quality of Life
  • Randomized Controlled Trials as Topic / methods*
  • Treatment Outcome
  • Trigeminal Neuralgia / diagnosis*
  • Trigeminal Neuralgia / drug therapy*
  • Trigeminal Neuralgia / epidemiology


  • Botulinum Toxins, Type A