Warfarin for Refractory Chronic Cluster Headache

A Randomized Pilot Study

Sameh M. Hakim, MD

Disclosures

Headache. 2011;51(5):713-725. 

In This Article

Abstract and Introduction

Abstract

Objective.— To investigate the effect of low-intensity anticoagulation with warfarin on chronic cluster headache refractory to pharmacological management.
Background.— Isolated case reports on induction of remission in patients with intractable chronic cluster headache upon institution of oral anticoagulant therapy do exist. Nonetheless, evidence from randomized controlled trials on the role of oral anticoagulants in cluster headache is lacking.
Methods.— Thirty-four patients with refractory chronic cluster headache were randomized to receive warfarin or placebo for 12 weeks. Warfarin was administered to achieve an international normalized ratio between 1.5 and 1.9. After a washout period of 2 weeks, patients were crossed over from 1 treatment to the other. Status of cluster headache was assessed during both treatment periods. The primary outcome measure was the occurrence of remission lasting ≥4 weeks.
Results.— Seventeen (50%) patients underwent remission for ≥4 weeks during the warfarin period vs 4 (11.8%) patients during the placebo period (P = .004). This was associated with absolute risk reduction of 0.38 (95% CI = 0.18–0.58), and number needed to treat of 2.6 (95% CI = 1.7–5.5). The Kaplan–Meier curves for occurrence of remission had a hazard ratio of 5.26 (95% CI = 2.13–13.03, P = .0003). Frequency, duration, and intensity of cluster attacks were all significantly lower during treatment with warfarin (P < .01).
Conclusion.— In patients with refractory chronic cluster headache, low-intensity anticoagulation with warfarin was associated with significantly higher incidence of remission and less impact of headache on patients' lives compared with placebo.

Introduction

The prevalence of cluster headache (CH) has been variably reported as ranging from 56 to 326 per 100,000 in the general population,[1,2] and from 229 to 2500 per 100,000 in selected populations.[3,4] Nonetheless, a lifetime prevalence rate on the order of 279 per 100,000 seems to be the most likely figure in those aged over 14 years.[5] In contrast to time-honored notions, a progressively increasing prevalence is being reported among women.[6]

Cluster headache is perhaps the most painful of primary headache disorders, and in its chronic form, it may run a relentless course that is refractory to pharmacological treatment.[7] Intractable chronic cluster headache (CCH) could be quite incapacitating requiring interventional[8] or surgical[9,10] options be applied to management. However, such interventions may not be feasible in all patients for evident reasons.[11]

There have been isolated case reports on induction of remission in patients with CCH refractory to pharmacological treatment upon institution of oral anticoagulant therapy.[12,13] Similar reports on the efficacy of oral anticoagulants in migraineurs do exist.[14–17] Nonetheless, evidence from randomized controlled trials on the role of oral anticoagulant therapy in CH is lacking.

The aim of the present trial was to study the effect of low-intensity anticoagulation with warfarin on the occurrence of remission lasting 4 weeks or longer in patients with CCH refractory to pharmacological treatment.

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