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Botulinum toxin type A in the prophylactic treatment of chronic tension-type headache: a multicentre, double-blind, randomized, placebo-controlled, parallel-group study.
Cephalalgia. 2006 Jul; 26(7):790-800.C

Abstract

We studied the safety and efficacy of 0 U, 50 U, 100 U, 150 U (five sites), 86 Usub and 100 Usub (three sites) botulinum toxin type A (BoNTA; BOTOX); Allergan, Inc., Irvine, CA, USA) for the prophylaxis of chronic tension-type headache (CTTH). Three hundred patients (62.3% female; mean age 42.6 years) enrolled. For the primary endpoint, the mean change from baseline in the number of TTH-free days per month, there was no statistically significant difference between placebo and four BoNTA groups, but a significant difference favouring placebo vs. BoNTA 150 was observed (4.5 vs. 2.8 tension headache-free days/month; P = 0.007). All treatment groups improved at day 60. Although efficacy was not demonstrated for the primary endpoint, at day 90, more patients in three BoNTA groups had >or=50% decrease in tension headache days than did placebo (P <or= 0.024). Most treatment-related adverse events were mild or moderate, and transient. BoNTA was safe and well-tolerated in the study.

Authors+Show Affiliations

Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA 19107, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

16776693

Citation

Silberstein, S D., et al. "Botulinum Toxin Type a in the Prophylactic Treatment of Chronic Tension-type Headache: a Multicentre, Double-blind, Randomized, Placebo-controlled, Parallel-group Study." Cephalalgia : an International Journal of Headache, vol. 26, no. 7, 2006, pp. 790-800.
Silberstein SD, Göbel H, Jensen R, et al. Botulinum toxin type A in the prophylactic treatment of chronic tension-type headache: a multicentre, double-blind, randomized, placebo-controlled, parallel-group study. Cephalalgia. 2006;26(7):790-800.
Silberstein, S. D., Göbel, H., Jensen, R., Elkind, A. H., Degryse, R., Walcott, J. M., & Turkel, C. (2006). Botulinum toxin type A in the prophylactic treatment of chronic tension-type headache: a multicentre, double-blind, randomized, placebo-controlled, parallel-group study. Cephalalgia : an International Journal of Headache, 26(7), 790-800.
Silberstein SD, et al. Botulinum Toxin Type a in the Prophylactic Treatment of Chronic Tension-type Headache: a Multicentre, Double-blind, Randomized, Placebo-controlled, Parallel-group Study. Cephalalgia. 2006;26(7):790-800. PubMed PMID: 16776693.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Botulinum toxin type A in the prophylactic treatment of chronic tension-type headache: a multicentre, double-blind, randomized, placebo-controlled, parallel-group study. AU - Silberstein,S D, AU - Göbel,H, AU - Jensen,R, AU - Elkind,A H, AU - Degryse,R, AU - Walcott,J M C M, AU - Turkel,C, PY - 2006/6/17/pubmed PY - 2006/9/6/medline PY - 2006/6/17/entrez SP - 790 EP - 800 JF - Cephalalgia : an international journal of headache JO - Cephalalgia VL - 26 IS - 7 N2 - We studied the safety and efficacy of 0 U, 50 U, 100 U, 150 U (five sites), 86 Usub and 100 Usub (three sites) botulinum toxin type A (BoNTA; BOTOX); Allergan, Inc., Irvine, CA, USA) for the prophylaxis of chronic tension-type headache (CTTH). Three hundred patients (62.3% female; mean age 42.6 years) enrolled. For the primary endpoint, the mean change from baseline in the number of TTH-free days per month, there was no statistically significant difference between placebo and four BoNTA groups, but a significant difference favouring placebo vs. BoNTA 150 was observed (4.5 vs. 2.8 tension headache-free days/month; P = 0.007). All treatment groups improved at day 60. Although efficacy was not demonstrated for the primary endpoint, at day 90, more patients in three BoNTA groups had >or=50% decrease in tension headache days than did placebo (P <or= 0.024). Most treatment-related adverse events were mild or moderate, and transient. BoNTA was safe and well-tolerated in the study. SN - 0333-1024 UR - https://www.unboundmedicine.com/medline/citation/16776693/Botulinum_toxin_type_A_in_the_prophylactic_treatment_of_chronic_tension_type_headache:_a_multicentre_double_blind_randomized_placebo_controlled_parallel_group_study_ L2 - http://journals.sagepub.com/doi/full/10.1111/j.1468-2982.2006.01114.x?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -