Direct Comparison of Treatment Outcome Between the Botulinum Toxin and Calcitonin Gene-Related Peptide Monoclonal Antibody in Migraine Patients.

Abstract

Background: Migraine is a genetic disorder characterized by recurrent episodes of headache that are throbbing in nature. The objective of this study was to directly compare the efficacy and safety of anti-calcitonin gene-related peptide (anti-CGRP) and botulinum neurotoxin (BoNT) for the preventive treatment of chronic migraine.

Methods: This quasi-experimental comparative study was conducted on 80 "chronic migraine patients" at King Fahad University Hospital, Dammam, KSA. Chronic migraineurs were divided into two groups (40 patients/group) and were treated with the standard doses of BoNT (group I) and anti-CGRP (group II). All the patients filled out the migraine pain scale, migraine disability assessment score, headache impact test (HIT-6), and adverse drug event questionnaire before the start and at the end of 9 months of treatment.

Results: Most of the patients were females (76.3% vs. 23.8%) and were suffering from migraine for more than 24 months (66%). The mean age of the participants was 39.07 ± 10.01 years. Both BoNT and anti-CGRP groups showed a statistically significant decrease in mean HIT-6 and pain scores after 9 months of intervention. A direct comparison between the two treatment groups showed that the anti-CGRP drug caused a higher decrease in HIT-6 and pain scores as compared to the botulinum drug, but the difference was not statistically significant (P = 0.075 and 0.07, respectively). The most common adverse effect was "headache", reported by 45% and 40% of patients, followed by "pain at the site of injection" reported by 27.5% and 32.5% of BoNT and anti-CGRP groups, respectively. The two groups did not differ significantly in the frequency of adverse effects such as nausea, vomiting, visual problems, etc., except "joint stiffness". A significantly higher number of anti-CGRP patients experienced joint stiffness as compared to the BoNT group (17.5% vs. 0%, P = 0.006).

Conclusion: A direct comparison between the two treatments indicated that neither of the two interventions is statistically superior to the other in terms of efficacy and both are equally effective in the management of migraine. However, BoNT can be preferred over anti-CGRP because of its cost-effectiveness.