Efficacy and tolerability of combination treatment of topiramate and greater occipital nerve block versus topiramate monotherapy for the preventive treatment of chronic migraine: A randomized controlled trial

Abstract

Objective To compare the efficacy and tolerability of combination treatment of topiramate and greater occipital nerve block to topiramate monotherapy in adult chronic migraine patients. Background Options for the preventive treatment of chronic migraine are limited and costly. Combination treatments do not have an evidence base yet. Methods This was a parallel group, 3 arms with 1:1:1 allocation ratio randomized controlled study in consecutive adult chronic migraine patients attending Headache Clinic in a tertiary care hospital. Patients received either topiramate monotherapy 100 mg/day (group A), or topiramate plus greater occipital nerve block with 40 mg lidocaine (2%) and 80mg (2 ml) methylprednisolone as the first injection followed by monthly injections of lidocaine for the next 2 months (group B) or topiramate plus greater occipital nerve block with 40 mg lidocaine (2%) injections monthly for 3 months (group C). The primary endpoint was the mean change in monthly migraine days at Month 3. Multiple secondary endpoints were assessed that included among others, achievement of ≥50% reduction in mean monthly headache days compared to baseline at Month 3 and assessment for any adverse events. Results One hundred and twenty-five patients were randomized; 41 to group A, 44 to group B, and 40 to group C. Efficacy assessments were done for 121 patients. Patients receiving combination treatment of topiramate and greater occipital nerve block with steroids and lidocaine and greater occipital nerve block with only lidocaine compared to topiramate monotherapy showed greater reductions in monthly migraine days at Month 3 (−9.6 vs −7.3 days; p = 0.003) and (−10.1 vs −7.3 days; p < 0.001) respectively. Greater proportion of patients in both the combination treatment groups (added greater occipital nerve block with and without steroid) achieved ≥50% reduction in mean monthly headache days [71.4% vs 39%; OR (95% CI) 3.9(1.6–9.8); p = 0.004] and [62.4% vs 39%; OR (95% CI) 2.7(1.1–6.7); p = 0.034] respectively, compared to those receiving topiramate monotherapy. Adverse effects between the groups were comparable although patients receiving combination treatment with added greater occipital nerve block reported transient adverse effects like post-injection dizziness, local site swelling, and pain. No serious adverse event was reported. Conclusion Combination treatments of topiramate with monthly injections of greater occipital nerve block were more effective in reducing monthly migraine days in chronic migraine than topiramate monotherapy at Month 3. Combination treatments were well tolerated.

Greater occipital nerve blockade for the preventive treatment of chronic migraine: A randomized double-blind placebo-controlled study

“…There was no significant difference in mean change in AMT days between the active group and placebo. It is possible that the patients were using acute migraine treatment even for low-intensity headaches; this was noted in some previous studies as well (33,34). Medication overuse at baseline was reported by 50% of patients receiving active treatment which was adjusted in the model for efficacy analysis.…”

New migraine prophylactic drugs: Current evidence and practical suggestions for non-responders to prior therapy

“…However, there is no high-quality study comparing monotherapy and combination therapy. Nevertheless, the absence of high-quality studies does not mean futility, but it can be partly attributed to funding issues, and several case series or small-sized randomized trials have shown the potential efficacy of combination therapy, although they can provide only limited evidence (47–51). Given that patients receiving anti-CGRP(-R) mAbs or gepants are more likely to have had insufficient responses to multiple evidence-based migraine prophylactic agents, and the response rates of these new drugs are not excellent in such populations (Table 1) (6–8), combination therapy may eventually be required.…”

The pharmacotherapeutic management of episodic and chronic migraine with gepants

“…The drugs acting on CGRP pathway might be a turning point in the migraine prevention, but they are expensive in most countries [26]. Botulinum toxin type A and CGRP targeting mAbs are ratified for CM, and there are also data for topiramate [8, 21,27]. As per the AHS guideline, the goals of a migraine prophylactic treatment are to reduce attack frequency, severity, duration, and disability, to improve the patients' functioning and health-related quality of life (HR-QoL), and to reduce the intake of acute drugs and headacherelated distress.…”