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Biomedical subjects

S D Silberstein

Publications and source records attributed to S D Silberstein.

At least 19 recordsLinked to original sources
PubMed2006

Botulinum toxin type A in the prophylactic treatment of chronic tension-type headache: a multicentre, double-blind, randomized, placebo-controlled, parallel-group study.

We studied the safety and efficacy of 0 U, 50 U, 100 U, 150 U (five sites), 86 Usub and 100 Usub (three sites) botulinum toxin type A (BoNTA; BOTOX); Allergan, Inc., Irvine, CA, USA) for the prophylaxis of chronic tension-type headache (CTTH). Three hundred patients (62.3% female; mean age 42.6 years) enrolled. For the primary endpoint, the mean change from baseline in the number of TTH-free days per month, there was no statistically significant difference between placebo and four BoNTA groups, but a significant difference favouring placebo vs. BoNTA 150 was observed (4.5 vs. 2.8 tension headache-free days/month; P = 0.007). All treatment groups improved at day 60. Although efficacy was not demonstrated for the primary endpoint, at day 90, more patients in three BoNTA groups had >or=50% decrease in tension headache days than did placebo (P <or= 0.024). Most treatment-related adverse events were mild or moderate, and transient. BoNTA was safe and well-tolerated in the study.

Adolescent↗
PubMed2006

New appendix criteria open for a broader concept of chronic migraine.

After the introduction of chronic migraine and medication overuse headache as diagnostic entities in The International Classification of Headache Disorders, Second Edition, ICHD-2, it has been shown that very few patients fit into the diagnostic criteria for chronic migraine (CM). The system of being able to use CM and the medication overuse headache (MOH) diagnosis only after discontinuation of overuse has proven highly unpractical and new data have suggested a much more liberal use of these diagnoses. The International Headache Classification Committee has, therefore, worked out the more inclusive criteria for CM and MOH presented in this paper. These criteria are included in the appendix of ICHD-2 and are meant primarily for further scientific evaluation but may be used already now for inclusion into drug trials, etc. It is now recommended that the MOH diagnosis should no longer request improvement after discontinuation of medication overuse but should be given to patients if they have a primary headache plus ongoing medication overuse. The latter is defined as previously, i.e. 10 days or more of intake of triptans, ergot alkaloids mixed analgesics or opioids and 15 days or more of analgesics/NSAIDs or the combined use of more than one substance. If these new criteria for CM and MOH prove useful in future testing, the plan is to include them in a future revised version of ICHD-2.

Chronic Disease↗
PubMed2006

Zonisamide for migraine prophylaxis in refractory patients.

Zonisamide is a new antiepileptic drug with multiple mechanisms of action and a favourable pharmacokinetic profile. Preliminary data suggest that zonisamide may be effective in migraine prophylaxis. We evaluated the efficacy and tolerability of zonisamide for migraine prophylaxis in refractory patients. We reviewed the charts of adult patients with International Headache Society-defined episodic migraine (EM) or with transformed migraine (TM) according to the Silberstein-Lipton criteria, who had been treated with zonisamide at our out-patient clinic for at least 60 days. Demographic data, zonisamide dosage and duration of treatment were collected and analysed. Headache frequency, attack duration, headache severity and headache-related disability before and after treatment initiation with zonisamide were compared. Thirty-three patients were included in the study (average age 43.9 +/- 8.4 years; 23 (70%) with TM and 10 (30%) with EM). The patients had failed an average of 6.2 migraine prophylactic drugs prior to zonisamide. The average zonisamide daily dose was 337.9 +/- 146.3 mg and the average duration of treatment was 186.4 +/- 174.0 days. The average number of days with headache per month was reduced in the entire study population from 20.7 +/- 9.5 before zonisamide treatment to 18.0 +/- 11.3 after its initiation (P = 0.06) [in TM from 24.7 +/- 7.3 to 21.0 +/- 10.7 (P = 0.06); in EM from 11.6 +/- 7.6 to 11.0 +/- 9.7 (P = NS)]. No significant changes in other headache parameters were found. Fourteen patients (42.4%) reported adverse events (AEs), the most common of which was fatigue. Most patients (12/14, 85.7%) rated AEs as mild or moderate. In this group of refractory migraine patients, zonisamide therapy did not result in a statistically significant beneficial effect on headache or on associated symptoms.

Adult↗
PubMed2005

An open study of botulinum-A toxin treatment of trigeminal neuralgia.

Thirteen subjects with trigeminal neuralgia were treated with botulinum-A neurotoxin (BoNT/A) in an open-label pilot study. After BoNT/A, visual analog scale score, surface area of pain, and therapeutic coefficient were reduced in all patients and for all branch trigeminal nerves studied. Therefore, BoNT/A is an efficient treatment. There were no major side effects. A placebo-controlled clinical trial is needed to confirm these findings.

Aged↗
PubMed2004

Classification of primary headaches.

Given the range of disorders that produce headache, a systematic approach to classification and diagnosis is an essential prelude to clinical management. For the last 15 years, the diagnostic criteria of the International Headache Society (IHS) have been the accepted standard. The second edition of The International Classification of Headache Disorders (January 2004) reflects our improved understanding of some disorders and the identification of new disorders. Neurologists who treat headache should become familiar with the revised criteria. Like its predecessor, the second edition of the IHS classification separates headache into primary and secondary disorders. The four categories of primary headaches include migraine, tension-type headache, cluster headache and other trigeminal autonomic cephalalgias, and other primary headaches. There are eight categories of secondary headache. Important changes in the second edition include a restructuring of these criteria for migraine, a new subclassification of tension-type headache, introduction of the concept of trigeminal autonomic cephalalgias, and addition of previously unclassified primary headaches. Several disorders were eliminated or reclassified. In this article, the authors present an overview of the revised IHS classification, highlighting the primary headache disorders and their diagnostic criteria. They conclude by presenting an approach to headache diagnosis based upon these criteria.

Adult↗
PubMed2004

Migraine practice patterns among neurologists.

OBJECTIVE: To assess the attitudes, knowledge, and practice patterns of US neurologists regarding migraine management relative to the US Headache Consortium Guidelines (the Guidelines). METHODS: Two samples of 600 neurologists each were selected from the American Academy of Neurology membership database. The first group received a Migraine Attitudes, Knowledge, and Practice Patterns (MKAPP) Survey. The second group received a Clinical Vignette (CV) Survey, presenting two patient histories and correspondent questions. RESULTS: The MKAPP Survey showed that most neurologists felt that migraine was primarily a disease of the brain with a well-established neurobiological basis (69%) and an important part of their practice (60%). Most (53%) indicated that they routinely used neuroimaging in evaluating severe headache, an approach not recommended by the Guidelines. Most favored acute treatment limits, but 36% did not agree with the Guidelines that acute treatment should be limited to 2 or 3 days/week. In the CV Survey, for vignette 1, most (91%) correctly diagnosed migraine, 31% requested neuroimaging in the absence of indications, 64% appropriately recommended a triptan, and 45% recommended a preventive medication in the absence of indications. For vignette 2, 78% diagnosed migraine, 71% appropriately ordered neuroimaging, 80% appropriately recommended a preventive medication, and 38% prescribed a triptan in face of clear contraindication. CONCLUSIONS: Educational initiatives aiming to increase the awareness of the Guidelines among neurologists should highlight the full range of migraine symptoms that support the diagnosis, appropriate use of neuroimaging, indications for preventive treatments, issues of triptan cardiovascular safety, and preventing rebound headaches.

Adult↗
PubMed2004

Topiramate in migraine prevention: evidence-based medicine from clinical trials.

The importance of evidence-based medicine is often underestimated when migraine preventive treatments are chosen. Evidence from large, well-conducted, placebo-controlled trials of sufficient duration should be given particular consideration when evaluating the efficacy, tolerability and safety of a medication for a broad range of patients. Pizotifen, propranolol, flunarizine, amitriptyline, divalproex sodium and topiramate have all been evaluated for efficacy in migraine prevention in double-blind, placebo-controlled trials. The largest clinical programme in migraine prevention, studying these or any other agents, was comprised of 2 pivotal trials, as well as other studies, evaluating topiramate for preventive therapy in migraine. Results from these trials indicated that topiramate (100 mg/day) has proven safety and efficacy in migraine prevention. Response rates were high, and onset of action usually occurred within the first month of treatment. Therefore, topiramate has demonstrated safety and represents an effective option in the prevention of migraine, as supported by extensive clinical research.

Evidence-Based Medicine↗
PubMed2004

LY293558, a novel AMPA/GluR5 antagonist, is efficacious and well-tolerated in acute migraine.

Glutamatergic hyperactivity is implicated migraine pathogenesis. Also, LY293558, an alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA)/kainate (KA) receptor antagonist, is effective in preclinical models of migraine. We therefore tested LY293558 in acute migraine. We conducted a randomized, triple-blind, parallel-group, double-dummy, multicentre trial of 1.2 mg/kg intravenous (IV) LY293558, 6 mg subcutaneous (SC) sumatriptan, or placebo in the treatment of acute migraine. The primary efficacy variable was the headache response rate, i.e. headache score improvement from moderate/severe at baseline to mild/none at 2 h. Of 45 enrolled patients, 44 patients (20M:24F; mean age +/- SD = 40 +/- 9 years) completed the study. Response rates were 69% for LY293558 (P = 0.017 vs. placebo), 86% for sumatriptan (P < 0.01 vs. placebo) and 25% for placebo. LY293558 and sumatriptan were superior to placebo (P < 0.01 for all comparisons) on all other measures of improvement in pain and migraine associated symptoms. Fifteen percent of patients who took LY293558 reported adverse events (AEs) (n = 2; one mild, one severe). Fifty-three percent of patients who took sumatriptan (n = 8; seven mild, one moderate) and 31% of those who received placebo reported AEs (n = 5; four mild, one severe). The efficacy and safety results of LY293558 in this small migraine proof of concept trial, together with supportive preclinical data, provide evidence for a potential role of nonvasoactive AMPA/KA antagonists in treating migraine. Larger trials are needed to further test the hypothesis.

Acute Disease↗
PubMed2004

Frovatriptan for the treatment of cluster headaches.

Cluster headaches both episodic and chronic are some of the most challenging headaches to treat. Although effective treatments are now available, some patients continue to be unresponsive to standard therapy. We present 17 patients from our practice whom we treated preventively with frovatriptan, a new triptan with a long half-life. The promising results suggest that this medication may be an useful addition to our ammaterium against this painful disorder.

Adult↗
PubMed2004

Migraine pathophysiology and its clinical implications.

The vascular hypothesis of migraine has now been superseded by a more integrated theory that involves both vascular and neuronal components. It has been demonstrated that the visual aura experienced by some migraineurs arises from cortical spreading depression, and that this neuronal event may also activate perivascular nerve afferents, leading to vasodilation and neurogenic inflammation of the meningeal blood vessels and, thus, throbbing pain. The involvement of the parasympathetic system supplying the meninges also causes increased vasodilation and pain. As an acute attack progresses, sensory neurones in the trigeminal nucleus caudalis become sensitized, resulting in the phenomenon of cutaneous allodynia. Triptans may act at several points during the progression of a migraine attack. However, the development of central sensitization impacts upon the effectiveness of triptan therapy.

Animals↗
PubMed2003

Why headache treatment fails.

Management of headache disorders, a leading reason for neurologic outpatient visits, is often difficult. In this article, the authors summarize and categorize the common reasons for treatment failure leading to referral to subspecialty headache centers. They have grouped these treatment failures into five broad categories: 1) the diagnosis is incomplete or incorrect; 2) important exacerbating factors have been missed; 3) pharmacotherapy has been inadequate; 4) nonpharmacologic treatment has been inadequate; 5) other factors, including unrealistic expectations and comorbidity, exist. The authors present an orderly approach to treatment failure to assist neurologists in managing difficult patients. Most refractory headache patients have a biologically determined problem and can be helped by accurate diagnosis or effective treatment. Persistence in treating these patients can be very rewarding. The authors provide a checklist intended to facilitate the management of refractory patients.

Comorbidity↗
PubMed2003

Premonitory symptoms in migraine: an electronic diary study.

BACKGROUND: Migraine is frequently associated with nonheadache symptoms before, during, and after the headache. Premonitory symptoms occurring before the attack have not been rigorously studied. Should these symptoms accurately predict headache, there are considerable implications for the pathophysiology and management of migraine. METHODS: Electronic diaries were used in a 3-month multicenter study to record nonheadache symptoms before, during, and after migraine. The authors recruited subjects who reported nonheadache symptoms in at least two of three attacks that they believed predicted headache. Symptoms were entered in the diaries by patient initiation and through prompted entries at random times daily. Entries could not be altered retrospectively. Data recorded included nonheadache symptoms occurring during all three phases of the migraine, prediction of the attack from premonitory symptoms, general state of health, and action taken to prevent the headache. RESULTS: One hundred twenty patients were recruited: 97 provided usable data. Patients correctly predicted migraine headaches from 72% of diary entries with premonitory symptoms. A range of cognitive and physical symptoms was reported at a similar rate through all three phases of the migraine. The most common premonitory symptoms were feeling tired and weary (72% of attacks with warning features), having difficulty concentrating (51%), and a stiff neck (50%). Subjects who functioned poorly in the premonitory phase were the most likely to correctly predict headache. CONCLUSIONS: Using an electronic diary system, the authors show that migraineurs who report premonitory symptoms can accurately predict the full-blown headache.

Adolescent↗