Gabapentin in the prophylaxis of chronic daily headache: A randomized, placebo-controlled study

Institute of Neurological Sciences, Prince of Wales Hospital Randwick, Australia.
Neurology (Impact Factor: 8.29). 01/2004; 61(12):1753-9. DOI: 10.1212/01.WNL.0000100121.58594.11
Source: PubMed


To compare efficacy and safety of gabapentin (GPT) versus placebo for prophylaxis of chronic daily headache (CDH) (headache at least 15 days/month of greater than 4 hours duration over preceding 6 months).
This is a multicenter randomized placebo-controlled crossover study. After 4-week baseline, subjects, aged 18 to 65, were randomized to GPT 2,400 mg/day or placebo. There was 2 weeks titration, 6-week stable dosage, and 1 week washout period between treatment arms. The primary efficacy measure was the difference between the percentage of headache-free days per treatment period. Secondary efficacy measures included headache duration and severity, degree of disability, associated symptoms, concomitant medications, Visual Analogue Scale (VAS) scores, and quality of life (QOL).
A total of 133 patients were enrolled (41 men, 92 women, mean age 43 years). All were eligible for safety analysis. Ninety-five received sufficient treatment to allow evaluation of efficacy. There was a 9.1% difference in headache-free rates favoring GPT over placebo (p = 0.0005). Benefits for GPT were also demonstrated for headache-free days/month (p = 0.0005), severity (p = 0.03), VAS (p = 0.0006), headache-associated symptoms of nausea (p = 0.03) and photophobia/phonophobia (p = 0.04), disability affecting normal activities (p = 0.02), attacks requiring bed rest (p = 0.001), and QOL related to bodily function (p = 0.01), health/vitality (p = 0.0001), social function (p = 0.006), and health transition (p = 0.0002). Reduction in headache days/month was seen across the spectrum of prerandomization headache frequencies.
Gabapentin represents a therapeutic option for chronic daily headache.

10 Reads
  • Source
    • "However, there have been few well-conducted trials examining the prophylactic treatment of CDH [10]. The previous studies indicated that some agents might have some benefits in CDH but failed to reach the main efficacy of prophylactic treatment , such as gabapentin [11], valproate [12] [13], levetiracetam [14], and antidepressants like tizanidine [15], paroxetine [16], olanzapine [17], fluoxetine [18], and amitriptyline [19]. And to date, only botulinum toxin A [20] [21] and topiramate [22] have large properly conducted placebo-controlled trials with positive outcome in subjects with chronic migraine. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Objective. To investigate the efficacy and safety of traditional Chinese medicine Duliang soft capsule (DSC) in prophylactic treatment for patients with chronic daily headache (CDH). Methods. A multicenter, double-blind, randomized, placebo-controlled clinical study was conducted at 18 Chinese clinical centers. The participants received either DSC or placebo for 4 weeks. The primary efficacy measure was headache-free rate (HFR) in a 4-week period between the pretreatment and posttreatment stages. The secondary efficacy measures were the decrease of headache days, the duration of headache attacks, the frequency of analgesic usage, quality of life, disability, and the headache severity (VAS scores). The accompanying symptoms and adverse events were also assessed. Results. Of 584 CDH patients assessed, 468 eligible patients were randomized. 338 patients received DSC, while 111 patients were assigned in the placebo group. Following treatment, there was a 16.56% difference in HFR favoring DSC over placebo ( P < 0.01 ). Significant differences were also observed between DSC and placebo groups in the secondary measures. However, no statistical difference was found between the two groups in the associated symptoms. No severe adverse effects were observed in the study. Conclusions. DSC might be an effective and well-tolerated option for the prophylactic treatment of patients with CDH.
    Full-text · Article · May 2015 · Evidence-based Complementary and Alternative Medicine
  • Source
    • "A double-blind, crossover clinical trial compared the efficacy of topiramate and sodium valproate in migraine prevention and the two drugs appear to be equivalent in efficacy and safety; a significant decrease in duration, monthly frequency and intensity of headache occurred in both groups: in valproate group the mean monthly frequency decreased from 5.4 to 4.0 and in topiramate group from 5.4 to 3.2 and headache intensity from 7.7 to 5.8 and from 6.9 to 3.7, respectively [32]. Gabapentin is among AEDs that has been evaluated for its effectiveness in migraine prevention [33] [34] [35]. In a 12-week open-label study gabapentin in dosage of 600-1800 mg was effective in episodic and chronic migraine, headache frequency decreased from 25.2 to 11.6 per month, side effects in this study were minimal [33]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: hospital Sestre milosrdnice Refference center for neurovascular disorders of the Ministry of health of Croatia Refference center for headache of the Ministry of health of Croatia 2 General Hospital Dubrovnik Summary Migraine is a common episodic headache disorder; prevalence of migraine in most western countries is 10-12%. The mechanism of migraine pain development is not fully understood. The theory of neurogenic inflammation proposes that the main event is the inflammation in the vessel wall which leads to leakage of nociceptive substances, causing thickening of the vessel wall and dilatation of vascular smooth muscles. The release of vasoactive neuropeptides causes depolarization of trigeminal perivascular axons, thus causing pain. Triptans are recommended for acute migraine attacks; studies have shown that their use increases productivity at work and improves the quality of life. Preventive therapy is recommended in migraine patients with frequent, severe, long-lasting attacks, in cases where acute therapy is not efficient, if there is a contraindi-cation to the drug, failure or unbearable side-effects from acute treatments, overuse of acute medications or in special cases such as hemiplegic migraine. Beta-blockers and tricyclic antidepressants were often used as first line therapy for migraine prevention. Other p reventive drugs include pizotifen, flunarizine, and anticonvulsives. Migraine is often associated with a number of commorbid diseases: allergies, hypotension, epilepsy, fatigue sy, gastritis, iritabile colon disease, vertigo; therefore, preventive and acute the-rapy should be tailored individually.
    Full-text · Article ·
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: To assess new treatment options for bipolar disorders. Controlled studies of new treatments for bipolar disorders were identified by computerized searches and reviews of scientific meeting proceedings, and were compiled by drug category. Two main categories of medications, newer anticonvulsants and newer antipsychotics, are yielding emerging new treatment options for bipolar disorders. Newer anticonvulsants have diverse psychotropic profiles, and although not generally effective for acute mania, may have utility for other aspects of bipolar disorders (e.g. lamotrigine for maintenance or acute bipolar depression), or for comorbid conditions (e.g. gabapentin for anxiety or pain, topiramate for obesity, bulimia, alcohol dependence, or migraine, and zonisamide for obesity). In contrast, newer antipsychotics generally appear effective for acute mania, and some may ultimately prove effective in acute depression (e.g. olanzapine combined with fluoxetine, quetiapine) and maintenance (e.g. olanzapine). Emerging research is yielding new treatment options for bipolar disorders and comorbid conditions.
    Preview · Article · Feb 2004 · Acta psychiatrica Scandinavica. Supplementum
Show more