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Biomedical subjects

Andrew Blumenfeld

Publications and source records attributed to Andrew Blumenfeld.

10 recordsLinked to original sources
PubMed2006

A series of three sequential, randomized, controlled studies of repeated treatments with botulinum toxin type A for migraine prophylaxis.

UNLABELLED: We examined the effects of multiple treatments with low doses of botulinum toxin type A (BoNTA; BOTOX(R), Allergan Inc., Irvine, CA) versus placebo for prophylaxis of episodic migraine. This was a series of 3 sequential, randomized, controlled studies of 418 patients with a history of 4 to 8 moderate to severe migraines per month. In study I, patients were randomized to treatment with placebo or BoNTA (7.5 U, 25 U, or 50 U) in predetermined fixed injection sites on the front and sides of the head only. In study II, patients continued to receive, or were randomized to, 2 consecutive treatments with 25 U or 50 U. In study III, patients were randomized to placebo or continuation of 25 U or 50 U. Injection cycles were each 4 months long. BoNTA and placebo produced comparable decreases from baseline in the frequency of migraines at each time point examined (P >or= .201). No consistent, statistically significant differences were observed for any efficacy variable. Adverse events were similar among the groups within each study. In these exploratory studies of episodic migraine patients, repeated injections of low doses of BoNTA into fixed frontal, temporal, and glabellar sites were not more effective than placebo. BoNTA was safe and well tolerated. PERSPECTIVE: Beneficial effects of BoNTA in the treatment of migraine have been reported, but positive results are not universal, possibly because the optimal patient population and regimen are not yet definitively established. This study explores the effects of multiple injections of low BoNTA doses into fixed sites for episodic migraine.

Adolescent↗
PubMed2005

Burden of illness and satisfaction with care among patients with headache seen in a primary care setting.

OBJECTIVE: To assess the current level of headache burden and the headache management needs at three diverse clinical sites. BACKGROUND: Headache is a common disabling disorder that is costly for the patient and a management challenge for physicians. The determination of whether and how to intervene to improve headache management depends on both the burden of disease and the characteristics of patients that would likely be targeted. METHODS: Patients from three healthcare organizations were identified by administrative records as having either migraine or tension-type headache and then mailed a survey that addressed demographics, headache type, headache-related disability, depression and anxiety, satisfaction with care, general health, worry about headache, problems with headache management, and healthcare utilization. Comparisons were made across sites and between patients with more and less severe headache-related impairments. RESULTS: Of the 789 patients contacted, 385 (50%) returned a survey. While the socio-demographic characteristics of the patients were diverse, headache-related characteristics were similar. These patients have significant problems with headache management, disability, pain, worry, and dissatisfaction with care. Patients who described higher headache-related impairment experienced significantly greater problems in these areas, perceived themselves to be in worse general health, and had significantly greater use of medical services than those with lower headache severity. CONCLUSIONS: Despite various elements of heterogeneity, we observed across the sites a consistent need for improvement in headache management. Future efforts should be directed at developing and evaluating methods for effectively improving headache management.

Adult↗
PubMed2005

Clinical approaches to migraine prophylaxis.

Chronic migraine is a recognized complication of episodic migraine. A high frequency of attacks and frequent use of abortive medications are important risk factors associated with conversion to a chronic condition. Prophylaxis is therefore recommended for patients with frequent episodic migraine. The agents approved for migraine prophylaxis are the anti-epileptic agents divalproex and topiramate, and the beta-adrenergic antagonists propranolol and timolol. However, a wide range of other systemic agents and local injections of botulinum toxin have also been used in migraine prophylaxis. The anticipated benefits must be weighed against the adverse effects associated with each agent in determining the optimal preventive regimen for individual patients.

Humans↗
PubMed2004

A combination of riboflavin, magnesium, and feverfew for migraine prophylaxis: a randomized trial.

OBJECTIVE: To determine the efficacy for migraine prophylaxis of a compound containing a combination of riboflavin, magnesium, and feverfew. BACKGROUND: Previous studies of magnesium and feverfew for migraine prophylaxis have found conflicting results, and there has been only a single placebo-controlled trial of riboflavin. 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 patients had completed the trial. RESULTS: Forty-nine patients completed the 3-month trial. For the primary outcome measure, a 50% or greater reduction in migraines, there was no difference between active and "placebo" groups, achieved by 10 (42%) and 11 (44%), respectively (P=.87). Similarly, there was no significant difference in secondary outcome measures, for active versus placebo groups, respectively: 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 reduction in number of migraines, migraine days, and migraine index. This effect exceeds that reported for placebo agents in previous migraine trials. CONCLUSION: Riboflavin 25 mg showed an effect comparable to a combination of riboflavin 400 mg, magnesium 300 mg, and feverfew 100 mg. The placebo response exceeds that reported 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 scientific evidence with regard to the efficacy of these compounds for migraine prophylaxis.

Double-Blind Method↗
PubMed2003

Center of excellence for headache care: group model at Kaiser Permanente.

OBJECTIVE: To evaluate the effectiveness of a disease management model for primary headache by: (1) assessing improvement in patients' quality of life, (2) decreasing headache-related visits to primary care and emergency departments, and (3) maintaining high levels of patient and physician satisfaction. BACKGROUND: Patients with headache regularly seek health care but, in general, are dissatisfied with the care they receive. Patients with primary headaches utilize resources and cost health plans more than patients with other chronic diseases. Primary care visits are time restricted, prohibiting adequate headache evaluation and management. Practice guidelines are inconsistently followed, and access to headache specialists is limited. This headache management program implemented an alternative means of delivering care to manage large volumes of patients with headache. A multidisciplinary team approach coordinated by a neurologist, utilizing education and a nurse practitioner as the main provider of care, was the central process of the program. METHODS: This was a pilot study involving a prospective cohort with defined outcome measures. Inclusion criteria were adult patients with primary headaches. Patients initially attended an educational session instructed by a neurologist and a nurse practitioner. The patient was subsequently evaluated by the nurse practitioner who developed and coordinated a comprehensive individual treatment plan. The Migraine-Specific Quality of Life and the Medical Outcomes Study 36-Item Short Form Questionnaires were completed at baseline, at follow-up visits, and 6 months after completion of the program. Subjective patient assessment of improvement in their headaches, chart review for tabulation of headache-related visits, and primary care physician satisfaction surveys were measured. RESULTS: Both the Migraine-Specific questionnaire and the Short Form-36 measurements demonstrated a statistically significant improvement at 8 weeks, and this was maintained for 6 months after completing the program. At completion of the program, 92% of patients reported subjective improvement. Patient visits for headaches to primary care and emergency departments showed a significant decrease. High levels of satisfaction for primary care physicians were achieved. CONCLUSIONS: A disease management model using a multidisciplinary team improved individualized patient care. This model increased patient/provider rapport and communication through an educational class. It empowered the patient to take control of their health care by utilizing shared decision making. Patient satisfaction improved and overall health care utilization was reduced.

Adult↗
PubMed2003

Botulinum toxin type A as an effective prophylactic treatment in primary headache disorders.

OBJECTIVE: To measure the effect of botulinum toxin type A (Botox, Allergan, Inc, Irvine, CA) treatment in 271 patients diagnosed with headache in accordance with International Headache Society (IHS) criteria. BACKGROUND: Botulinum toxin type A has shown promise for the treatment of headache in several clinical trials, but uncertainty remains as to how botulinum toxin type A optimally should be used for treating headache and which patients are best suited for this treatment. METHODS: This was a retrospective chart review of all patients who received botulinum toxin type A for the treatment of headache from January 1999 to February 2002. Patients were injected with an average dose of 63.2 U (SD, 14.5) of botulinum toxin type A on 2 or more visits, with treatments involving a "fixed-site" or a "follow-the-pain" (or a combination of both) approach. In the fixed-site approach, botulinum toxin type A was injected into the procerus, corrugator, frontalis, and temporalis muscles. In the follow-the-pain approach, botulinum toxin type A was injected into a combination of the procerus, corrugator, frontalis, temporalis, occipitalis, trapezius, and/or semispinalis capitis muscles. The primary outcomes for the trial were the reduction in headache days per month or headache intensity (0 to 3 scale) (or both) from baseline. Patients were diagnosed according to IHS criteria and subsequently classified into the following categories: chronic daily headache (more than 15 headache days per month), episodic tension-type headache, episodic migraine, and "mixed" HA (less than 15 headache days per month, combination of migraine and tension-type headache). RESULTS: Treatment period was an average of 8.6 months (SD, 6.4); patients received an average of 3.4 doses (SD, 1.6) 3 months apart. Of the 271 patients, 29 (10.7%) had episodic migraine, 17 (6.3%) had episodic tension-type headache, 71 (26.2%) had mixed headache, and 154 (56.8%) had chronic daily headache. Two-hundred fifty-six patients had data for the number of headache days per month, 117 had data for headache intensity, and all 271 had data for headache days or headache intensity. Botulinum toxin type A treatment significantly reduced the number of headache days per month from 18.9 (SD, 10.3) to 8.3 (SD, 8.9) (n=256, P<.001)--a 56% reduction. Headache intensity decreased from 2.4 points (SD, 0.6) to 1.8 points (SD, 0.8) (n=117, P<.001)--a 25% reduction. Of 263 patients surveyed, 225 (85.6%) reported improvement in headache frequency and intensity. There was no correlation of effect/lack of effect with reason for treatment, duration/number of treatments, injection technique, mean/total dose, age, gender, or comorbidity. Approximately 95% of patients did not experience medication side effects. CONCLUSION: These results suggest that botulinum toxin type A may be an effective and safe prophylactic treatment for a variety of moderate to severe chronic headache types.

Blepharoptosis↗
PubMedDate not supplied

Botulinum neurotoxin for the treatment of migraine and other primary headache disorders.

Botulinum toxin A (BoNT/A), a neurotoxin, is effective for treating a variety of disorders of involuntary muscle contraction, including cervical dystonia, blepharospasm and hemifacial spasm. It inhibits neurouscular signaling by blocking the release of acetylcholine at the neuromuscular junction. The biological effects of the toxin are transient with normal neuronal signaling returning within approximately 3-6 months post injection. Recently, clinical findings suggest that BoNT/A may inhibit pain associated with migraine and other headache types. The mechanism by which this toxin inhibits pain is under investigation, recent findings suggest that it inhibits the release of neurotransmitters from nociceptive nerve terminals and in this way may exert an analgesic effect. A number of retrospective open-label chart reviews and three placebo-controlled double-blind trials have demonstrated that localized injections of BTX-A significantly reduce migraine frequency, severity, and migraine-associated disability. The majority of patients in these studies experienced no BoNT/A mediated side effects; however, a small percentage of patients did report transient minor side effects including blepharoptosis, dipolpia, and injection-site weakness. Currently there are several large-scale randomized, placebo-controlled clinical trials in progress evaluating the efficacy, optimal dosing and side effect profile of this toxin as a novel treatment for migraine and other headache types. These studies may provide further evidence that BoNT/A is an effective option for the preventive treatment of migraine.

Botulinum Toxins, Type A↗