title: Therapeutic efficacy and safety of Botulinum Toxin A Therapy in Trigeminal Neuralgia: a systematic review and meta-analysis of randomized controlled trials.
abstract: 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 %).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Faculty of Medicine, Al Azhar University, Cairo, 11884, Egypt.
authors.forename: Mostafa Ebraheem
authors.initials: ME
authors.lastname: Morra
authors.affiliation: Faculty of Medicine, Al Azhar University, Cairo, 11884, Egypt.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Elgebaly
authors.affiliation: Faculty of Medicine, Al Azhar University, Cairo, 11884, Egypt.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Elmaraezy
authors.affiliation: Faculty of Medicine, Zagazig University, Zagazig, 44519, Egypt.
authors.forename: Adham M
authors.initials: AM
authors.lastname: Khalil
authors.affiliation: Faculty of Medicine, University of Jordan, Amman, 11942, Jordan.
authors.forename: Ahmed M A
authors.initials: AM
authors.lastname: Altibi
authors.affiliation: University of California, Los Angeles, Los Angeles, CA, 90095, USA.
authors.forename: Tran Le-Huy
authors.initials: TL
authors.lastname: Vu
authors.affiliation: Faculty of Medicine, Tanta University, Tanta, 31527, Egypt.
authors.forename: Mostafa Reda
authors.initials: MR
authors.lastname: Mostafa
authors.affiliation: Department of Clinical Product Development, Institute of Tropical Medicine (NEKKEN), Leading Graduate School Program, and Graduate School of Biomedical Sciences, Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan. tienhuy@nagasaki-u.ac.jp.|Center for Molecular Bio-Medicine, University of Medicine and Pharmacy, 217 Hong Bang, District 5, Ho Chi Minh City, Ho Chi Minh, 70000, Viet Nam. tienhuy@nagasaki-u.ac.jp.
authors.forename: Nguyen Tien
authors.identifier: http://orcid.org/0000-0002-9543-9440
authors.initials: NT
authors.lastname: Huy
authors.affiliation: Department of Immunogenetics, Institute of Tropical Medicine (NEKKEN), Leading Graduate School Program, and Graduate School of Biomedical Sciences, Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan. hiraken@nagasaki-u.ac.jp.
authors.forename: Kenji
authors.initials: K
authors.lastname: Hirayama
mesh_terms: D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016208:Databases, Factual; D004487:Edema / Q000139:chemically induced; D006406:Hematoma / Q000139:chemically induced; D006801:Humans; D010147:Pain Measurement / Q000187:drug effects / Q000379:methods; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D016896:Treatment Outcome; D014277:Trigeminal Neuralgia / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology
chemical_list: D019274:Botulinum Toxins, Type A
keywords: BTX-A; Botulinum; Clinical trials; Meta-analysis; Systematic review; Trigeminal neuralgia