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Biomedical subjects

J R Saper

Publications and source records attributed to J R Saper.

At least 37 records · Page 2Linked to original sources
PubMed1997

Ineffectiveness of neurokinin-1 antagonist in acute migraine: a crossover study.

Lanepitant is a high-affinity, selective neurokinin-1 receptor (NK-1) and is effective in the dural inflammation model of acute migraine. Lanepitant 30, 80, and 240 mg given orally was evaluated in a double-blind, placebo-controlled crossover study to determine its effect in reducing migraine pain and severity of associated symptoms. Outpatients treated four migraine headaches of moderate or severe pain intensity with study drug according to a randomization schedule. They recorded their pain intensity and severity of migraine-associated symptoms at 30, 60, 90, and 120 min. Although 53 patients were randomly allocated to a treatment sequence, only 40 patients completed all treatments. There was no statistically significant difference in improvement in migraine pain at any time for any of the treatments. Additionally, there was no change in severity of migraine-associated symptoms associated with lanepitant therapy. No adverse events could be attributed to lanepitant. Lanepitant was ineffective orally in treating acute migraine in this trial. This may be due to poor bioavailability during a migraine attack. Alternatively, the neurogenic inflammation hypothesis may not apply to migraine.

Acute Disease↗
PubMed1997

Clinical efficacy and tolerability of 2.5 mg zolmitriptan for the acute treatment of migraine. The 042 Clinical Trial Study Group.

Previous studies demonstrated that zolmitriptan at doses of 1 to 25 mg was highly effective in treating acute migraine attacks. The 2.5-mg dose had a favorable therapeutic effect with high efficacy and good tolerability. The objective of this study was to further evaluate the efficacy of a single 2.5-mg dose of zolmitriptan (Zomig, formerly known as 311C90) for acute treatment of a single moderate or severe migraine attack. The study was a randomized, double-blind, placebo-controlled clinical trial. Female and male patients, 12 to 65 years old, with migraine (with or without aura) for > or = 1 year, one to six migraines per month, and age at onset < 50 years were included; 327 patients were screened and randomized to receive either zolmitriptan (n = 219) or placebo (n = 108). Patients treated a single moderate or severe migraine headache with 2.5 mg zolmitriptan or placebo and recorded clinical efficacy and adverse events on a diary form. Headache response at 2 hours was 62% for zolmitriptan compared with 36% for placebo (p < 0.001); at 4 hours, headache response was 70% with zolmitriptan and 37% with placebo (p < 0.001). Headache recurrence in patients treated with 2.5 mg zolmitriptan was 22% (versus placebo 30%). The headache response at 4 hours, pain-free rate, and response rate of nonheadache symptoms favored zolmitriptan over placebo. No serious adverse events were associated with zolmitriptan treatment. A 2.5-mg dose of zolmitriptan is clinically effective and well tolerated for the acute treatment of migraine.

Acute Disease↗
PubMed1997

Diagnosis and symptomatic treatment of migraine.

Migraine is a common, complex neurophysiologic headache disorder. Most migraineurs have neither been diagnosed by physicians nor effectively treated. The clinical diagnosis of migraine is based on headache characteristics and associated symptoms, particularly nausea and vomiting. Pharmacologic symptomatic treatment is aimed at reversing, aborting, or reducing pain and the accompanying symptoms of an attack. Individualization of therapy is essential in determining whether symptomatic and/or preventive treatment for migraine attacks are needed. The presence of nausea and vomiting must be considered in developing a treatment plan. The patient's priorities and preferences regarding therapy must be taken into account. The goals of symptomatic treatment are to relieve pain and the associated symptoms and to optimize the patient's ability to function normally. Multiple treatment strategies utilizing combinations of 5-hydroxytryptamine1 (5-HT1) agonists (ergotamine tartrate [ET], sumatriptan, and dihydroergotamine [DHE]) with simple analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), and opiates provide effective treatment for most attacks of moderate to severe migraine. Treatment strategies are based on the frequency, nature, and severity of attacks. Patients with intractable, acute migraine may require hospitalization and aggressive parenteral treatment. Wider use of currently available diagnostic criteria and symptomatic medications should improve the diagnosis and treatment of migraine.

Affect↗
PubMed1996

Assessing the dimensions of pain: a multitrait-multimethod evaluation of seven measures.

A multitrait-multimethod design was used to examine the convergent and discriminant validity of seven pain measures from three widely used self-report instruments designed to assess the sensory, affective and intensity dimensions of pain. The instruments were the McGill Pain Questionnaire, the Pain Perception Profile and Numerical Ratings. Three distinct factor models, each corresponding to a different hypothesis about how these pain measures are related, were tested using confirmatory factor analysis in a sample of 419 headache sufferers. A three-factor model, postulating three correlated factors defined by the three assessment instruments best explained the correlations between the pain measures. Measures of sensory, affective and intensity dimensions from the three instruments failed to exhibit convergent or discriminant validity. Rather, instrument variance obscured the pain qualities the three pain instruments were designed to assess. These findings suggest that greater attention needs to be paid to how formal characteristics of pain assessment instruments influence patients' descriptions of their pain.

Adolescent↗
PubMed1996

Self-report of cognition and objective test performance in posttraumatic headache.

The Cognitive Difficulties Scale, a self-report measure of cognitive functioning, was administered to 111 consecutive adult referrals with posttraumatic head pain subsequent to mild to moderate head and/or cervical flexion-extension injuries who were treated at a clinic specializing in head pain and neurological disorders. Factor analysis of the Cognitive Difficulties Scale yielded seven meaningful factors corresponding to the types of memory inefficiencies often associated with neurological dysfunction. Further analyses comparing the Cognitive Difficulties Scale factor scores to objective tests of mental status, memory, and depressed mood demonstrated limited relationships between specific Cognitive Difficulties Scale factor scores and these measures of cognitive performance and behavior. The Cognitive Difficulties Scale appears helpful in assisting this patient population with treatment planning and specific remediation tied to everyday situations.

Activities of Daily Living↗
PubMed1995

Migraine prophylaxis with divalproex.

OBJECTIVE: To compare the effectiveness and safety of divalproex sodium (Depakote) and placebo in the prophylaxis of migraine headache. DESIGN: Multicenter, double-blind, randomized, placebo-controlled investigation, having a 4-week, single-blind placebo baseline phase and a 12-week treatment phase (4-week dose adjustment, 8-week maintenance). SETTING: Eight headache/neurology clinics throughout the United States. PATIENTS: One hundred seven patients randomized to divalproex or placebo (2:1 ratio): 70 receiving divalproex and 37 receiving placebo. INTERVENTION: Divalproex and placebo dosages titrated in blinded fashion during dose adjustment period to achieve actual/sham trough valproate sodium concentrations of approximately 70 to 120 mg/L. MEASUREMENTS AND MAIN RESULTS: During the treatment phase, the mean migraine headache frequency per 4 weeks was 3.5 in the divalproex group and 5.7 in the placebo group (p < or = .001), compared with 6.0 and 6.4, respectively, during the baseline phase. Forty-eight percent of divalproex-treated patients and 14% of placebo-treated patients showed a 50% or greater reduction in migraine headache frequency from the baseline phase (P < .001). Among those with migraine headaches, divalproex-treated patients reported significantly less functional restriction than placebo-treated patients and used significantly less symptomatic medication per episode. No significant treatment group differences were observed in average peak severity or duration of individual migraine headaches. Treatment was stopped in 13% of divalproex-treated patients and 5% of placebo-treated patients because of intolerance (P, not significant). CONCLUSIONS: Divalproex is an effective prophylactic drug for patients with migraine headaches and is generally well tolerated.

Adolescent↗
PubMed1995

Transnasal butorphanol in the treatment of acute migraine.

We studied transnasal butorphanol (Stadol NS) for pain relief during acute migraine in a multicenter, randomized, double-blind, placebo controlled trial using ambulatory patients at 10 geographically diverse headache centers. Patients were volunteer adults diagnosed with migraine with or without aura by International Headache Society criteria. One hundred fifty-seven patients completed the study. We treated the pain of one headache in each patient with either transnasal butorphanol (n = 107) or transnasal placebo (n = 50). Pain relief, pain intensity, nausea, vomiting, and effect on function were measured periodically. Adverse experiences were documented. Global assessments were made at follow-up. With butorphanol, migraine pain was reduced from moderate, severe, or incapacitating to slight or absent for 35 patients (33%) within 30 minutes, for 50 patients (47%) within 1 hour, and for 76 (71%) within 6 hours, compared to 2 (4%), 8 (16%) and 15 (30%) respectively for placebo. Side effects were prominent, though confounded by the migraine. The most common side effects, compared to placebo, were dizziness (58% vs 4%), nausea and/or vomiting (38% vs 18%), and drowsiness (29% vs 0%). We conclude that transnasal butorphanol is a useful analgesic for the pain of acute migraine. Its prominent side effects and low self reinforcement rate may limit its usefulness in some patients, while increasing its appropriateness for others.

Acute Disease↗
PubMed1994

Double-blind trial of fluoxetine: chronic daily headache and migraine.

This study is the first double-blind placebo-controlled trial of fluoxetine for chronic daily headache (CDH) and migraine. After a one month single-blind baseline on placebo, subjects with CDH (n = 64) and migraine (n = 58) were randomly assigned to a three month trial of fluoxetine (20 mg) or an identical placebo. Fluoxetine and placebo were increased to 40 mg in the second month, depending on patient response. Patients kept daily headache records, and completed 100 mm visual analogue scales (VAS) of headache and mood each month. For the group of CDH patients on fluoxetine, overall headache status (VAS) after three months compared to the end of the single-blind placebo baseline improved a mean of 50% vs. 11% for those receiving the double-blind placebo (P = .029), with 47% vs. 23% improving at least 50% (P = .097, n.s.). Fluoxetine patients showed significant improvement in monthly mood ratings compared to placebo (.001 by the end of the study), and modest but significant improvement in daily records of headache frequency (P = .019) but not pain severity. Significant mood improvements preceded improvement in headache, reaching significance by the end of the second month on fluoxetine (P = .013), while headache improvement emerged only during the third month (P = .001). Double-blind investigator judgement identified more headache improvement in fluoxetine than placebo recipients (40% vs. 22%, P = .032).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1993

Comprehensive inpatient treatment for intractable migraine: a prospective long-term outcome study.

This paper describes outcome data for 100 patients with severe, intractable, persistent migraine (chronic daily headache), who were admitted to a comprehensive inpatient Head-Pain Treatment Unit for a mean of 8.5 days. Headache, pain-related behavior, depression, sleep disturbance, functional performance, work status, and medication use were assessed at admission, post-discharge (mean = 2.3 weeks) and long-term follow-up (mean = 8.3 months). Significant improvement noted two weeks after discharge was maintained over time. Long-term results revealed a 64% reduction in the mean number of days in a 2-week period with severe to incapacitating headache (6.29 to 2.26), with a corresponding increase in pain-free days (1.03 to 5.40). At follow-up, the frequency of severe headaches was reduced by at least 50% for 75% of the patients. The mean rating of overall improvement was 74%. Patients on work-leave due to pain dropped from 24% to 4%, while the number of working patients rose from 31% to 53%. The data showed statistically significant reductions in days lost to pain, depression, sleep disturbance, and use of symptomatic medication. All the above analyses were significant at P = .000. These results demonstrate the efficacy of the inpatient headache program intervention for this group of patients.

Adolescent↗
PubMed1990

Daily chronic headache.

Headache is a disabling condition, and medical science has not, until recently, begun to address it in a fashion consistent with its widespread impact. Despite the limitations in our current understanding, as well as the historical prejudice directed toward patients with this condition, current understanding and treatment approaches can provide hope and relief for most patients who have these disorders.

Analgesics↗
PubMed1989

Migraine, migraine variants, and related headaches.

The perspectives on migraine are changing rapidly. Many of the recent findings on migraine are examined. The overlap between migraine and tension headache, which has led to a reappraisal of the treatment of this disorder, is reviewed. Both pharmacologic and non-pharmacologic methods of treating migraine are discussed.

Adrenergic beta-Antagonists↗
PubMed1989

Chronic headache syndromes.

This article reviews the changing perspectives on migraine and other chronic headache syndromes. It addresses the current interest in "central" (brain) pathogenetic mechanisms and various aspects of the diagnostic evaluation, classification, and treatment. Specific treatment regimens are detailed, including approaches to overuse of medication and dependency in patients with headache. The use of inpatient treatment units for refractory syndromes are considered. Post-traumatic headache conditions and those arising as a consequence of dental pathology are addressed.

Adult↗