Refractory chronic migraine: is drug withdrawal necessary before starting a therapy with onabotulinum toxin type A?

Abstract

Onabotulinum toxin A (BT-A) is now one of the authorized prophylaxis treatments for chronic migraine (CM) thanks to previous clinical trials, which usually required a pharmacologic washout as a precondition for demonstrating its efficacy. Aim of our study was to assess the efficacy in daily clinical practice of BT-A injections in refractory CM patients, regardless of medication overuse without any standardized withdrawal protocol and without stopping the ongoing prophylaxis treatment as well. We treated 44 refractory CM patients (37 females and 7 males) trimonthly without any modification in symptomatic, or prophylactic drug therapy. Main efficacy variables included number of headache, or migraine days and episodes, total cumulative headache hours, MIDAS and HIT-6 scores; all items were assessed at baseline and at the 12-, 24-, and 36-week follow-up. All variables showed a statistically significant improvement at week 36. In general, more than 50 % of patients had a good clinical outcome (including all improved patients, either partial or full responder) and that the percentage of drug abuser patients significantly decreased from 75 to 50 %, thanks to a spontaneous reduction of the symptomatic drug intake. Adverse events were uncommon and did not require treatment discontinuation. Onabotulinum toxin A treatment in refractory CM patients with unsatisfactory prophylactic drug treatments and pharmacological abuse is effective in improving clinical outcome and quality of life. This result may be achieved through a flexible pharmacologic approach tailored to each patient's needs; moreover, the patient himself can be often expected to reduce drug consumption spontaneously.

OnabotulinumtoxinA injections in chronic migraine, targeted to sites of pericranial myofascial pain: an observational, open label, real-life cohort study

“…Previous real-life studies provided conflicting results, with a ≥ 50% reduction in number of headache days achieved in a range as wide as 17.4 to 63% of patients [25–31]. With a figure of 65.1%, our results are in the higher part of this range, which may be due to the technical choice we have made.…”

“…Our study, as well as the other recently published real-world experiments addressing the same issue [25–31], has some limitations, including the small sample size and the absence of a placebo arm. Placebo effect is particularly high in headache conditions, especially when the treatment is administered by injection.…”

OnabotulinumtoxinA Is an Effective Treatment for Chronic Migraine in Patients With Comorbid Fibromyalgia

“…Indeed, MOH reduced from 90.3 to 32.3%. This finding, consistent with previous studies, confirms that OnabotA is effective in patients with MOH who do not receive withdrawal interventions ( 44 – 46 ). Thus, in patients with FM, even when reduction of acute medication use is not the short-term objective, headache frequency can be reduced without acute medication withdrawal.…”

Long-term Treatment Benefits and Prolonged Efficacy of OnabotulinumtoxinA in Patients Affected by Chronic Migraine and Medication Overuse Headache over 3 Years of Therapy

“…The reduction in AC is more relevant, showing a higher improvement than in other studies ( 24 , 25 , 28 , 30 ). The reduction in AC indicates that OnabotA could be a useful therapy to reduce the analgesics overuse, even without a detox therapy ( 31 ). This is corroborated by the fact that MOH-sufferers have a similar trend, decreasing from the 97.8% of the beginning to the 59.32% after the first year.…”