The efficacy of botulinum toxin type-A for intractable chronic migraine patients with no pain-free time

Abstract

Aim: This is a retrospective report of the efficacy of botulinum toxin-A, Botox® (Allergan), in intractable chronic migraine patients non-responsive to previous pharmacological management and with largely no pain-free time, including those with new onset daily persistent headache. Methods: Thirty-three patients, all with severe Headache Impact Test (HIT)-6 scores at baseline, received 3-monthly injections of Botox® as per Phase III REsearch Evaluating Migraine Prophylaxis Therapy (PRE-EMPT) protocol over a maximum 33-month period. Response criteria were a sustained reduction of HIT-6 scores below 60. Results: Four patients had headache on at least 20 days a month; the remaining patients had daily headache with no pain-free time, including nine patients with new onset persistent migraine. There was a significant reduction in HIT-6 scores following Botox® therapy ( x̅ = −5.45, p = 0.000920). Twenty-one percent of the cohort exhibited a sustained reduction in HIT-6 scores below 60. The number of headache days and pain-free time did not change in five of the six responders, but disability improved. There was no difference between patients with episodic migraine evolving to chronic as opposed to those with chronic migraine from onset. Conclusion: This report suggests that Botox® treatment is efficacious in intractable chronic migraine without pain-free time. The HIT-6 is a reliable and practical parameter to assess disability in this patient group. Use of such validated parameters should be considered with greater weight in future International Classification of Headache Disorders (ICHD) guidelines for controlled clinical trials.

Comparison of Efficacy of Botulinum Toxin Injection and Conventional Oral Drugs for Treatment of Refractory Migraine

“…Although limited randomized, double-blind, placebo-controlled studies exist, our study aligns with previous research suggesting the efficacy of Botulinum toxin A in migraine prevention. In one study, 30% of patients in both botulinum toxin A treatment groups experienced a 50% or greater reduction in migraine frequency in the third month relative to baseline, compared to 25% in the placebo group (P = 0.921) (17). Our findings also align with a study evaluating headache days, migraine days, acute pain medication ingestion days, and HIT-6 score reductions in 172 patients treated with OnabotulinumtoxinA 195 U over two years.…”

New daily persistent headache: A systematic review and meta-analysis

“…A case series of 16 patients with NDPH treated with onabotulinumtoxinA injections reported that eight (50%) had an improvement in headache frequency after six months (56). In another study of onabotulinumtoxinA, which included nine patients with NDPH, two patients had an improvement of Headache Impact Test-6 score (57). Unfortunately, a previous open-label clinical trial of onabotulinumtoxinA for NDPH was terminated due to difficulty with enrolment (58).…”

Twelve-month efficacy of CGRP monoclonal antibodies and predictive value of short-term response: results of an Australian multicentre study

“…Patients with continual headaches were excluded from phase II to phase III study, presumably due to concern of reduced response to primary end points, limiting generalisability and data for these patients 7 8. Within our cohort, a significant difference was seen in the clinical efficacy of CGRP mAbs in patients who reported no headache-free days at baseline, and with the number of previously trialled preventative medications, highlighting the need for further treatment options in this cohort.…”