Objective. To determine the efficacy for migraine prophylaxis of a compound containing a combination of riboflavin, magnesium, and feverfew. Background. P revious studies of magnesium and feverfew for migraine prophyl...Objective. To determine the efficacy for migraine prophylaxis of a compound containing a combination of riboflavin, magnesium, and feverfew. Background. P revious studies of magnesium and feverfew for migraine prophylaxis have found co nflicting results, and there has been only a single placebocontrolled trial of r iboflavin. Design/Methods. Randomized double blind placebo controlled trial of a compound providing a daily dose of riboflavin 400 mg, magnesium 300 mg, and feverfew 100 mg. The placebo contained 25 mg riboflavin. The study included a 1 month run in phase and 3 month trial. The protocol allowed for 120 patients to be randomized, with a preplanned interim analysis of the data after 48 patien ts had completed the trial. Results. Forty nine patients completed the 3 mon th trial. For the primary outcome measure, a 50%or greater reduction in migrain es, there was no difference between active and “placebo”groups, achieved by 10 (42%) and 11 (44%), respectively (P = .87). Similarly, there was no significa nt difference in secondary outcome measures, for active versus placebo groups, r espectively: 50%or greater reduction in migraine days (33%and 40%, P = .63); or change in mean number of migraines, migraine days, migraine index, or triptan doses. Compared to baseline, however, both groups showed a significant reductio n in number of migraines, migraine days, and migraine index. This effect exceeds that reported for placebo agents in previous migraine trials. Conclusion. Rib oflavin 25 mg showed an effect comparable to a combi nation of riboflavin 400 m g, magnesium 300 mg, and feverfew 100 mg. The placebo response exceeds that repo rted for any other placebo in trials of migraine prophylaxis, and suggests that riboflavin 25 mg may be an active comparator. There is at present conflicting sc ientific evidence with regard to the efficacy of these compounds for migraine pr ophylaxis.展开更多
Background. - Mood disorders of anxiety and depression are well known to be comorbid with primary headache disorders. Less is known of the comorbidity of other somatic symptoms with headache. Methods. - Headache Clini...Background. - Mood disorders of anxiety and depression are well known to be comorbid with primary headache disorders. Less is known of the comorbidity of other somatic symptoms with headache. Methods. - Headache Clinic patients were screened with the Primary Care Evaluation of Mental Disorders (PRIME- MD), a multidimensional psychiatric screening tool. The prevalence of somatic symptoms was compared by headache diagnosis, frequency of severe headache, and psychiatric diagnosis. Follow- up data were obtained 6 months after consultation. Results. - Clinical diagnoses and PRIME- MD data were available for 289 patients. Associated somatic symptoms were more frequent in patients with chronic migraine (mean 5.5, P < .001) and chronic daily headache (CDH) (6.3, P = .008) compared to episodic migraine (4.0); in patients with severe headache >2 days per week compared to ≤ 2 days per week (6.15 vs. 4.15, P < .001); and in patients with a clinical diagnosis of anxiety or depression, or both, compared to no anxiety or depression, (5.7, P = .05,5.2, P < .05, and 6.8, P < .001, respectively, vs. 4.5). The most common specific symptoms were fatigue (73% ), sleep difficulty (60% ), and nausea/indigestion (55% ). Compared to a primary care sample, patients with severe headache >2 days per week had significantly higher somatic counts (P = .01). Six- month follow- up data were available for 140 patients. Associated symptoms decreased both for patients with and without decrease in severe headache frequency (mean reduction of 1.0, P = .01 and 0.8, P = .003, respectively). Conclusion. - Associated somatic symptoms are more common in patients with chronic migraine and CDH, with more frequent severe headaches, and with associated anxiety or depression. Patients with episodic migraine have similar somatic prevalence as a previously studied primary care population. The spectrum of headache disorders may be characterized as showing increasing somatic prevalence as headaches, particularly severe headaches, become more frequent.展开更多
文摘Objective. To determine the efficacy for migraine prophylaxis of a compound containing a combination of riboflavin, magnesium, and feverfew. Background. P revious studies of magnesium and feverfew for migraine prophylaxis have found co nflicting results, and there has been only a single placebocontrolled trial of r iboflavin. Design/Methods. Randomized double blind placebo controlled trial of a compound providing a daily dose of riboflavin 400 mg, magnesium 300 mg, and feverfew 100 mg. The placebo contained 25 mg riboflavin. The study included a 1 month run in phase and 3 month trial. The protocol allowed for 120 patients to be randomized, with a preplanned interim analysis of the data after 48 patien ts had completed the trial. Results. Forty nine patients completed the 3 mon th trial. For the primary outcome measure, a 50%or greater reduction in migrain es, there was no difference between active and “placebo”groups, achieved by 10 (42%) and 11 (44%), respectively (P = .87). Similarly, there was no significa nt difference in secondary outcome measures, for active versus placebo groups, r espectively: 50%or greater reduction in migraine days (33%and 40%, P = .63); or change in mean number of migraines, migraine days, migraine index, or triptan doses. Compared to baseline, however, both groups showed a significant reductio n in number of migraines, migraine days, and migraine index. This effect exceeds that reported for placebo agents in previous migraine trials. Conclusion. Rib oflavin 25 mg showed an effect comparable to a combi nation of riboflavin 400 m g, magnesium 300 mg, and feverfew 100 mg. The placebo response exceeds that repo rted for any other placebo in trials of migraine prophylaxis, and suggests that riboflavin 25 mg may be an active comparator. There is at present conflicting sc ientific evidence with regard to the efficacy of these compounds for migraine pr ophylaxis.
文摘Background. - Mood disorders of anxiety and depression are well known to be comorbid with primary headache disorders. Less is known of the comorbidity of other somatic symptoms with headache. Methods. - Headache Clinic patients were screened with the Primary Care Evaluation of Mental Disorders (PRIME- MD), a multidimensional psychiatric screening tool. The prevalence of somatic symptoms was compared by headache diagnosis, frequency of severe headache, and psychiatric diagnosis. Follow- up data were obtained 6 months after consultation. Results. - Clinical diagnoses and PRIME- MD data were available for 289 patients. Associated somatic symptoms were more frequent in patients with chronic migraine (mean 5.5, P < .001) and chronic daily headache (CDH) (6.3, P = .008) compared to episodic migraine (4.0); in patients with severe headache >2 days per week compared to ≤ 2 days per week (6.15 vs. 4.15, P < .001); and in patients with a clinical diagnosis of anxiety or depression, or both, compared to no anxiety or depression, (5.7, P = .05,5.2, P < .05, and 6.8, P < .001, respectively, vs. 4.5). The most common specific symptoms were fatigue (73% ), sleep difficulty (60% ), and nausea/indigestion (55% ). Compared to a primary care sample, patients with severe headache >2 days per week had significantly higher somatic counts (P = .01). Six- month follow- up data were available for 140 patients. Associated symptoms decreased both for patients with and without decrease in severe headache frequency (mean reduction of 1.0, P = .01 and 0.8, P = .003, respectively). Conclusion. - Associated somatic symptoms are more common in patients with chronic migraine and CDH, with more frequent severe headaches, and with associated anxiety or depression. Patients with episodic migraine have similar somatic prevalence as a previously studied primary care population. The spectrum of headache disorders may be characterized as showing increasing somatic prevalence as headaches, particularly severe headaches, become more frequent.