Search

Objective: To compare the safety and efficacy of isometheptene mucate, dichloralphenazone with acetaminophen to sumatriptan succinate for the treatment of mild-to-moderate migraine, with or without aura, when taken at the first sign of an attack., Background: The Food and Drug Administration approved sumatriptan succinate and the combination of isometheptene mucate, dichloralphenazone with acetaminophen for the treatment of migraine. As part of the stratified treatment of migraine, those patients whose headaches are mild or moderate may benefit from nontriptan medications. Additionally, early treatment of acute migraine before the headache has become moderate or severe may improve response to treatment., Methods: This was a multicenter, double-blind, randomized, parallel-group study to assess the safety and efficacy of the combination of isometheptene mucate, dichloralphenazone with acetaminophen and sumatriptan succinate in the early stages of a single migraine attack. Patients diagnosed with migraine, with or without aura, as defined by the International Headache Society diagnostic criteria were enrolled., Results: One hundred thirty-seven patients were enrolled in the study. Data for efficacy were available for 126 patients; safety data were available for 128 patients. No statistically significant difference between the two active agents in the patient's response to treatment was demonstrated. Headache recurrence was not significantly different over the 24-hour evaluation period for those patients responding in the first 4 hours. In those with headache recurrence, it was statistically significantly more severe in those patients treated with sumatriptan succinate. Improvement in functional disability was, in general, better among those treated with isometheptene mucate, dichloralphenazone with acetaminophen. Global analysis of efficacy was similar in the two active groups. Patients treated with sumatriptan succinate were somewhat more likely to have adverse effects than the isometheptene mucate, dichloralphenazone with acetaminophen group., Conclusions: Both isometheptene mucate, dichloralphenazone with acetaminophen and sumatriptan succinate are safe and effective when used early in the treatment of an acute migraine. Several parameters suggest that isometheptene mucate, dichloralphenazone with acetaminophen may have a slight advantage compared with sumatriptan succinate in the early treatment of mild-to-moderate migraine.

Objective: To compare gabapentin with placebo for use as a prophylactic agent in patients with migraine (with or without aura). STUDY DESIGN AND TREATMENT: After screening, a 4-week, single-blind, placebo baseline period was followed by a 12-week, double-blind, treatment period. The 12-week treatment period consisted of a 4-week titration phase and an 8-week stable-dosing phase. During the 4-week titration phase, patients were started on one 300-mg capsule of gabapentin or matching placebo. Patients were titrated weekly from 900 mg/day (end of week 1) to 2400 mg/day (end of week 4) and had to be receiving a stable dose of study medication by the end of the titration period. Study medication was to be given on a three-times-a-day dosing regimen., Methods: The study hypothesis was defined a priori as a lower 4-week migraine rate during the second stabilization period for the gabapentin-treated patients as compared with the placebo-treated patients. The analyses were performed with the 4-week migraine rate at baseline as a covariate and center as a blocking factor., Results: At seven participating centers, 143 patients with migraine were randomized in a 2:1 ratio and received either gabapentin (n = 98) or matching placebo (n = 45). Thirty-three patients (24.1%) discontinued prematurely from the study, including 24 (24.5%) of 98 gabapentin-treated patients and 9 (20.0%) of 45 placebo-treated patients; the majority of patients discontinued due to adverse events (16 [16.3%] of 98 gabapentin-treated patients; 4 [8.9%] of 45 placebo-treated patients). Patients included in the analysis were evenly balanced for age, sex, race, weight, and height. The majority of these patients were white (80 [92.0%] of 87) and women (72 [82.8%] of 87), with a mean age of approximately 39.4 years and a history of migraine episodes for a mean of about 21 years. At the end of the 12-week treatment phase, the median 4-week migraine rate was 2.7 for the gabapentin-treated patients maintained on a stable dose of 2400 mg/day and 3.5 for the placebo-treated patients (P =.006), compared with 4.2 and 4.1, respectively, during the baseline period. Additionally, 26 (46.4%) of 56 patients receiving a stable dose of 2400 mg/day gabapentin and 5 (16.1%) of 31 patients receiving placebo showed at least a 50% reduction in the 4-week migraine rate (P =.008). The average number of days per 4 weeks with migraine was also statistically significant and favored gabapentin (P =.006) during stabilization period 2. The median change in 4-week headache rate was statistically significant as well (P =.013). The most frequently reported adverse events for both treatment groups were asthenia, dizziness, somnolence, and infection. Adverse events determined by the investigator to be associated with study drug resulted in patient withdrawal in 13 (13.3%) of 98 gabapentin-treated patients and 3 (6.7%) of 45 placebo-treated patients. Somnolence and dizziness accounted for many of the premature withdrawals among those taking gabapentin., Conclusion: Gabapentin is an effective prophylactic agent for patients with migraine. In addition, gabapentin appears generally well tolerated with mild to moderate somnolence and dizziness.

Objective: We conducted the first nonclinic, Internet-based survey of cluster headache to investigate this population with regard to diagnostic problems encountered, effective and ineffective medications, problems obtaining medications through third-party payers, and symptoms as they relate to International Headache Society criteria., Background: Previous cluster headache surveys have been at specialty centers. These patients might be different from cluster headache sufferers in the general population. An Internet-based population of cluster headache sufferers who connected to a Web site responded to the questionnaire, and e-mailed it back to our site to be analyzed. We analyzed a total of 789 respondents, 76% men and 28% women., Results: Eighty-seven percent of respondents qualified as having cluster headache according to International Headache Society criteria. However, diagnosis was delayed an average of 6.6 years from the onset of symptoms. The average number of physicians seen before the correct diagnosis was made was 4.3, and the average number of incorrect diagnoses was 3.9. Seventy-one percent of respondents had undergone unnecessary magnetic resonance or computed tomography scans, and 4% had unnecessary sinus or deviated septum surgery. We found that many inappropriate medications such as propranolol, amitriptyline, and antibiotics were prescribed and that successful medications for clusters such as sumatriptan and oxygen were often denied due to a failure to understand the nature of this disorder. Seventy-seven percent of respondents were smokers. Seventy-four percent stopped smoking in an attempt to improve their condition; however, only 3% experienced relief., Conclusions: The most alarming finding was the delay in diagnosing cluster headache in this population--an average of 6.6 years. The selection of medications demonstrated to be successful in the treatment of clusters proved effective for the majority of this population. Many respondents reported being denied some of these effective medications by their physicians or third-party payers. Using International Headache Society criteria for cluster headache, 87% of the respondents should have been correctly diagnosed by the first physician seen.

Purpose: The demographics of patients who attend public awareness seminars relating to headache have not been studied. In order to improve the presentations at these meetings, it was felt that the meeting planners should know as much as possible about the audience., Methods: Attendees at a public awareness seminar entitled Help for Headaches were asked to respond to a series of questions using an audience response system., Results: The majority of the 212 responders were women (90%) and were over the age of 50 (53%). Most felt that they had more than one type of headache (64%), were treated by a family practitioner or internist (58%), and had been denied important diagnostic or therapeutic modalities (42%). The majority were dissatisfied with current treatment (87%) and attended the meeting to find out more about new treatments (64%). Fifty-eight percent felt their physicians did not know enough about headaches. Forty-nine percent felt they had rebound headaches., Conclusions: Public awareness seminars for headache should be designed with the realization that most attendees will be women who have more than one type of headache. The majority will be interested in new and alternative therapies, and approximately half will have rebound headaches.

Inpatient treatment with intravenous dihydroergotamine has been remarkably successful in managing chronic daily headaches due to excessive use of analgesics or ergotamine tartrate. Recently we have been denied authorization in appropriate patients for this procedure by third party payers on the grounds that it was "not medically necessary," "based on anecdotal information," or is "an outpatient procedure." Three cases are described in which the insurer's decision was either contested as an issue of substandard care, or the patient elected to pay for the procedure. The outcome in two cases was dramatically favorable, at least from the patient's and the physician's point of view. The third case is currently being appealed. Time and energy spent on combating the position of the third party payer on issues of standards of specialist care should be unnecessary. Publication of standards of care by specialists, and a requirement that these care standards must be provided by third party payers are needed in order that quality medical care can continue in this society.

Based on reports of headache in arteriovenous malformations and epilepsy, one would predict that the prevalence of migraine headache in the Sturge-Weber syndrome would be higher than in the general population. A questionnaire designed to determine the prevalence and type of headache by IHS criteria was sent to the 500 members of the Sturge-Weber Foundation. The average age of the patients in this sample (71 patients) was 15 years. The sex ratio was approximately one to one. Headache meeting IHS criteria for migraine occurred in 28% (equally among males and females) compared to 17% in females and 5% in males in the general population. Neurologic deficits occurred in 58% during migraine. The prevalence of migraine in children under the age of 10 (31%) was higher than that reported in the general population (5%) and the age of onset was younger. The mechanism of migraine headache in Sturge-Weber syndrome may be similar to that found in epilepsy and vascular malformations.

Objective: To compare the efficacy of the combination of meperidine and hydroxyzine IM, versus dihydroergotamine and metoclopramide IV in the treatment of severe migraine headaches., Design: This was a randomized double-blind, double-dummy study., Setting: Established patients, whose headache had failed to respond to their usual abortive agent, were invited to an out-patient headache clinic for the study., Patients: Twenty-eight patients, diagnosed as suffering from either migraine headache or chronic daily headache, were screened on arrival to exclude life-threatening causes., Intervention: Group A (14 patients) received dihydroergotamine 1mg and metoclopramide 10mg IV and a placebo injection IM, and Group B (14 patients) received meperidine 75mg and hydroxyzine 75mg IM and a placebo injection IV., Main Outcome Measures: Patients rated their headaches on a scale of 0-3 prior to treatment and again at 30 and 60 minutes., Results: Both groups experienced improvement in headache severity. (Group A P = 0.001 and Group B P = 0.003). Improvement in pain scale score was greater for Group A than Group B. (P = 0.006). The number of patients having a mild or no headache in Group A (13/14) was significantly greater than Group B (3/14). (P < 0.001), Conclusions: The combination of dihydroergotamine and metoclopramide IV should replace the standard IM narcotic and anti-emetic as the parenteral treatment of choice for severe migraine headache.

Ketorolac IM was compared to DHE and metoclopramide IV in migraine patients whose regular abortive medication had failed and who presented to a headache clinic for acute treatment. Pain scale ratings and ratings of ability to function were recorded before and after injection. Ketorolac provided moderate relief in headache in six of nine patients compared to eight of nine given DHE and metoclopramide. The average improvement in patients receiving DHE and metoclopramide was greater in pain (p = .031) and disability scores (p = .057), than in those patients given ketorolac.