Table 2.
Clinical studies on BoNT-A efficiency in migraines.
| Author, Reference | Study Design | No. of Patients | Type of Migraine | Dose of BoNT-A | Results | Follow-Up Period |
|---|---|---|---|---|---|---|
| Saper et al., 2007 [142] | Randomized, Double-Blind, placebo-control study | 232 patients (45 placebo) | EM | 25 U BoNT-A | Both BoNT-A and placebo had similar efficiency, and showed greater reduction of migraine severity | 3 months |
| Evers et al., 2004 [143] | Randomized, Double-Blind, placebo-control study | 60 patients (20 placebo) | EM | 16 U or 100 U BoNT-A | Both BoNT-A and placebo decreased the number of migraine days and the frequency of the attacks | 3 months |
| Vo et al., 2007 [144] | Randomized, Double-Blind, placebo-control study | 32 patients (17 placebo) | EM | 205 U BoNT-A | No significant reduction of migraine frequency and severity was registered The headache pattern index indicated a protective effect for BoNT-A against attacks severity |
3 months |
| Petri et al., 2009 [145] | Randomized, Double-Blind, placebo-control study | 127 patients (63 placebo) | EM | 80–120 U BoNT-A into cervical and pericranial muscles | BoNT-A was not useful as a prophylactic treatment; the reduction of headache did not reach statistically significance | 3 months |
| Chankrachang et al., 2011 [146] | Randomized, Double-Blind, placebo-control study | 128 patients (37 placebo) | EM | 120–240 U BoNT-A | BoNT-A was significantly useful over placebo | 8–12 weeks |
| Anand et al., 2006 [147] | Randomized, Double-Blind, placebo-control study | 32 patients (16 placebo) |
EM | 50 U BoNT-A | 75% of patients reported a complete relief of the symptoms | 3 months |
| Relja et al., 2007 [148] | Randomized, Double-Blind, placebo-control study | 515 patients | EM | 75–225 U BoNT-A | Similar results in both groups | 9 months |
| Silberstein et al., 2000 [135] | Randomized, Double-Blind, placebo-control study | 123 (41 placebo) | EM | 25 U or 75 U BoNT-A | Greater results in both groups | 3 months |
| Elkind et al., 2006 [149] | Randomized, Double-Blind, placebo-control study | 182 patients (100 placebo) | EM | 7.5 U–50 U BoNT-A | No improvements in headache were noted, no differences between BoNT-A and placebo | 120 days |
| Barrientos and Chana, 2003 [150] | Randomized, Double-Blind, placebo-control study | 30 patients (15 placebo) | EM | 50 U BoNT-A | The number of attacks per day and headache frequencies were significantly reduced on day 90 | 3 months |
| Freitag et al., 2008 [151] | Randomized, Double-Blind, placebo-control study | 86 patients | CM | 100 U BoNT-A | BoNT-A was superior to placebo for both endpoints | 4 months |
| Cady et al., 2011 [133] | Randomized, Double-Blind, placebo-control study | 59 patients (30 topiramate) | CM | 300 U BoNT-A | Similar results for both BoNT-A and Topiramate | 26 weeks |
| Diener et al., 2010 [131] | Randomized, Double-Blind, placebo-control study | 679 patients (338 placebo) | CM | 155–195 U BoNT-A | All the secondary endpoints were favoured | 32 weeks |
| Binder et al., 2000 [134] | Non-randomized, open-label | 106 patients | CM | −51% of cases—complete response −38% of cases—partial response −70% of cases—improvements were observed after one hour of injection |
3 months | |
| Magalhaes et al., 2010 [152] | Randomized, Double-Blind, placebo-control study | 72 patients (23 amytriptiline) | CM | 250 U BoNT-A | No difference was observed between BoNT-A and amytriptiline effects | 90 days |
| Mathew et al., 2009 [153] | Randomized, Double-Blind, placebo-control study | 60 patients (29 topiramate) | CM | 200 U BoNT-A | Similar results for both groups. BoNT-A and Topiramate showed similar efficiency | 9 months |
| Aurora et al., 2011 [154] | Randomized, Double-Blind, placebo-control study | 1384 patients (696 placebo) | CM | 155–195 U BoNT-A | BoNT-A was efficient in improvement of the total headache days number | 56 weeks |
| Aurora et al., 2010 [130] | Randomized, Double-Blind, placebo-control study | 679 patients (338 placebo) | CM | 155–195 U BoNT-A | BoNT-A was efficient in improvement of the headache days number but no reduction in the migraine episodes was recorded | 24 weeks |
| Lipton et al., 2011 [138] | Randomized, Double-Blind, placebo-control study | 1384 patients (696 placebo) | CM | 155 U BoNT-A | Significantly reduction in headache compared to placebo | 56 weeks |
| Mathew et al., 2005 [136] | Prospective Study | 571 patients | CM | 105–260 U | 50% or more decrease in the frequency of headache days was registered at 180 days | 11 months |
| Dodick et al., 2009 [119] | Randomized, placebo-control study | 1384 patients | CM | 155–195 U | BoNT-A considerable decreased the number of pain days in comparison to placebo. | 24 weeks |