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    Pediatric Interventional Cardiology in the United States is Dependent on the Off-label Use of Medical Devices

    CONGENITAL HEART DISEASE, Issue 1 2010
    Jamie S. Sutherell MD
    ABSTRACT Objective., A substantial unmet medical device need exists in pediatric care. As a result, the off-label use of approved devices is routine in pediatric interventional cardiology, but the extent and nature of this practice has not been previously described. The purpose of this study, therefore, is to evaluate the prevalence and nature of off-label cardiac device use in an active pediatric interventional program in the United States. Study Design., This study is a retrospective review of all interventional cardiac procedures performed at our institution from July 1, 2005 to June 30, 2008. Diagnostic (noninterventional) catheterizations, myocardial biopsies, invasive electrophysiology studies, and studies involving investigational devices were excluded. Interventions performed were compared with the manufacturer's labeled indications for each device. Results., During this 3-year period, 473 patients (median age 4.1 years) underwent 595 transcatheter interventions. An approved device was utilized for an off-label application in 63% of patients, and in 50% of all interventions performed. The most frequent off-label procedures were stent implantations (99% off-label), balloon dilations (78% off-label), and coil embolizations (29% off-label). In contrast, the off-label use of septal and ductal occluders was relatively uncommon. Conclusions., In our routine (noninvestigational) practice of pediatric interventional cardiology, 63% of patients underwent procedures utilizing medical devices for off-label indications. These data underscore the need to enhance cardiac device review and approval processes in the United States to include pediatric applications. [source]


    In Vitro Resistance to Degradation of Hyaluronic Acid Dermal Fillers by Ovine Testicular Hyaluronidase

    DERMATOLOGIC SURGERY, Issue 2010
    DEREK JONES MD
    BACKGROUND Although adverse events are uncommon with hyaluronic acid (HA) fillers, the use of hyaluronidase permits the reversal of treatment complications or overcorrection. OBJECTIVE This study sought to determine an in vitro dose-response relationship between ovine testicular hyaluronidase (OTH) and three HA dermal fillers (24-mg/mL smooth gel, 20-mg/mL particulate gel, and 5.5-mg/mL particulate gel with 0.3% lidocaine). METHODS AND MATERIALS The dose response of each was measured after incubation for 30 minutes in concentrations ranging between 5 and 40 U of OTH. Timed responses for the 24-mg/mL and 20-mg/mL HA fillers were obtained after incubation with 20 U of OTH for 15 to 120 minutes. RESULTS After all dose responses and timed-interval tests, the 24-mg/mL HA smooth gel filler exhibited more resistance against in vitro enzymatic degradation to OTH than the 20- and 5.5-mg/mL HA particulate gels. CONCLUSION This resistance to degradation in vitro may be attributed to the higher HA content of the 24-mg/mL HA smooth gel, the degree of crosslinking, and the cohesive property of the gel filler. This study was funded by a grant from Allergan, Inc., Santa Barbara, CA. Derek Jones, MD, is a consultant, investigator, advisory board member, and speaker for Allergan, Inc. He received no compensation for this study. Drs. Tezel and Borrell are employed by Allergan, Inc., Santa Barbara, CA. Editorial assistance was provided by Health Learning Systems, a part of CommonHealth, Parsippany, NJ. [source]


    Naturally Occurring Female Hairline Patterns

    DERMATOLOGIC SURGERY, Issue 6 2009
    BERNARD P. NUSBAUM MD
    BACKGROUND Hair transplantation is gaining popularity in women. Although much has been written about hairline design in male patients, more information is needed about natural female hairlines. OBJECTIVE To determine the frequency, dimensions, and location of structures that compose the female hairline. METHODS Hairline characteristics were measured in 360 female volunteers at an informal hair salon setting. RESULTS A widow's peak was present in 81%. The mean distance from the mid-eyebrow to the frontal midpoint was 5.5 cm. Lateral mounds were observed in 98%. The mean distance from the frontal midpoint to the apex of the lateral mounds was 3.74 cm on the right and 3.97 cm on the left. The mean distance from the apex of the lateral mounds to the apex of the temporal points was 3.78 cm on the right and 3.51 cm on the left. The shape of the temporal recessions was concave triangular or concave oval in 87% of the subjects. CONCLUSION This study provides proposed guidelines for designing the hairline in women. [source]


    Collagenase-Assisted Fat Dissociation for Autologous Fat Transfer

    DERMATOLOGIC SURGERY, Issue 10 2008
    DAVID K. MOSCATELLO PHD
    BACKGROUND The quality of fat for autologous transfer procedures has been a major focus of research in the past few years. The primary goal of these efforts is to improve the viability and longevity of the graft in human subjects. One possible factor in the permanence of theses transplants is the size of the adipose tissue grafts. OBJECTIVE This study evaluated the effects of collagenase digestion on the viability of human adipose tissue. MATERIALS AND METHODS Samples of fat were obtained from subjects undergoing tumescent liposuction. The tissue was digested in a variety of concentrations of collagenase using optimized methods of processing. The digested fat was also subjected to mock injections through small bore needles. RESULTS Eight subjects completed the study. The viability of the fat using the optimized methods of collagenase digestion was consistently higher than 79%. During the mock injection trials, the viability of fat was improved from approximately 17% to 84% by collagenase digestion. CONCLUSIONS Our results show increased viability of human adipose tissue when digested by collagenase. These techniques can be applied to human autologous lipoaugmentation procedures in an effort to improve longevity of the transplanted tissue. [source]


    Radiographic and Computed Tomographic Studies of Calcium Hydroxylapatite for Treatment of HIV,Associated Facial Lipoatrophy and Correction of Nasolabial Folds

    DERMATOLOGIC SURGERY, Issue 2008
    ALASTAIR CARRUTHERS MD
    OBJECTIVES This study sought to assess the radiographic appearance produced by calcium hydroxylapatite soft tissue filler (CaHA; Radiesse, BioForm Medical Inc.) following augmentation to correct the nasolabial folds or facial wasting associated with human immunodeficiency virus lipoatrophy. METHODS A total of 58 patients, with either lipoatrophy or pronounced nasolabial folds, were treated with CaHA. Radiographic (X-ray) and computed tomographic (CT) imaging studies were conducted pre- and posttreatment in most patients; the images were sent to an independent laboratory to be analyzed by two evaluators who were board-certified radiologists and blinded to study purpose, product, and patient condition. RESULTS While results for X-ray evaluation showed inconsistencies in visualization of CaHA, CT scans showed consistent visualization in nearly all cases in patients who were imaged immediately after treatment. In addition, the results indicated no obscuration of underlying structures by CaHA and no evidence of CaHA migration. CONCLUSIONS Earlier clinical trials established CaHA as a safe and effective soft tissue filler. This CaHA study shows no overt radiographic safety concerns. CaHA is unlikely to be confused with conventional abnormal and adverse radiographic findings. The product is not always visible on X-ray. Although usually visible on CT scans, its appearance is distinct from surrounding bony structures and does not interfere with normal analysis. In addition, the product does not obscure underlying structures on CT scans. [source]


    Hidradenitis Suppurativa: Importance of Early Treatment; Efficient Treatment with Electrosurgery

    DERMATOLOGIC SURGERY, Issue 2 2008
    A. BURHAN AKSAKAL MD
    BACKGROUND Hidradenitis suppurativa is a challenging condition, both for the physicians and for the patients. Many surgical and medical approaches with different success rates have been undertaken. Early and appropriate intervention is a factor that significantly increases the success rate of the treatment of the disease. OBJECTIVE This study was conducted to evaluate the efficiency of electrosurgery treatment in early hidradenitis suppurativa. MATERIALS AND METHODS This study comprised 12 patients aged between 29 and 38 years (mean, 34 years) with a diagnosis of hidradenitis suppurativa Grade I (n=9) or Grade II (n=3). A surgical method consisted of excision of the areas with nodules and sinuses, up to the level of subcutaneous fat tissue, and leaving the surgical defect for secondary healing. RESULTS All patients completed the study. In 10 of 12 (83%) patients, 26 of 30 (86%) lesions, cure was observed in a mean of 16 days (range 15 to 21 days). Four lesions in 2 patients with Grade II became infected and required a short course of antibiotic therapy. CONCLUSION Electrosurgery will decrease the need for other systemic treatments, owing to its high cure rates. Our results showed that electrosurgery should be considered a top alternative in the treatment algorithm of hidradenitis suppurativa. [source]


    Decision Factors and the Recognition of Medical Specialty in Patients Receiving Cosmetic Laser and Intense Pulsed Light Treatment

    DERMATOLOGIC SURGERY, Issue 12 2007
    TIEN-YI TZUNG MD
    BACKGROUND In addition to dermatologists and plastic surgeons, physicians of other medical specialties also provide cosmetic laser and light treatment. OBJECTIVE This study aimed to determine the major decision factors in patients who received cosmetic laser or intense pulsed light treatment and how they perceived different medical specialties in providing such services. METHODS The method of factor analysis was adopted to extract the common characteristics (major decision factors) from a list of 17 items patients would regard as important when they planned to receive laser and intense pulsed light treatment. In addition, the level of recognition of different medical specialties in cosmetic patients was indirectly forecast using an analytic hierarchy process. RESULTS Medical competence (0.3296) was the most important decision factor, followed by recommendation (0.2198), friendliness (0.1350), cost (0.1307), complete service (0.0984), and the physical attributes of the physician (0.0865). Dermatologists and plastic surgeons outscored cosmetic practitioners in five factors except for cost, in which the plastic surgeons were weakest. CONCLUSION Medical competence and recommendation are the core issues for cosmetic patients. Dermatologists and plastic surgeons gain better overall recognition than physicians of other medical specialties in cosmetic patients. [source]


    Making Scents: Improvement of Olfactory Profile after Botulinum Toxin-A Treatment in Healthy Individuals

    DERMATOLOGIC SURGERY, Issue 2007
    MARC HECKMANN MD
    BACKGROUND The axilla is particularly associated with body odor and putative pheromone production in humans. Although botulinum toxin type A (BT-A) is injected increasingly into the axillary skin to stop excessive sweating, its potential to control body odor is largely unexplored. OBJECTIVE The objective was to measure the impact of BT-A on human axillary odor in an objective and reproducible fashion. METHODS This study was a randomized, double-blind, placebo-controlled trial with 51 healthy volunteers receiving 50 U of BOTOX (Allergan, Inc.) in one axilla and placebo in the other. Odor quality was assessed by treated subjects (questionnaire) as well as by independent raters who were exposed to blinded T-shirt samples. RESULTS No major side effects occurred, and no subject withdrew from the study for medical reasons. Samples from the BT-A,treated side smelled less intense (p<.001) and better (p<.001) according to self-assessments. Likewise, independent raters found the BT-A,treated samples to smell less intense and better (p<.001). They preferred "to work together with the respective person" and found the odor "more erotic" (p<.001). CONCLUSION Side-by-side comparison of odor samples (T-shirt sniff test) by independent raters showed that axillary odor in healthy individuals is significantly more appealing after BT-A injection. [source]


    Lactic Acid Chemical Peels as a New Therapeutic Modality in Melasma in Comparison to Jessner's Solution Chemical Peels

    DERMATOLOGIC SURGERY, Issue 12 2006
    KHALIFA E. SHARQUIE MBCHB
    BACKGROUND Many chemicals have been used in the skin peeling for melasma such as Jessner's solution and glycolic acid. Lactic acid is an ,-hydroxy acid that has not been used before in chemical peeling of melasma. OBJECTIVE The purpose of the present work was to evaluate the efficacy and safety of lactic acid in chemical peeling of melasma in comparison to Jessner's solution chemical peels. METHODS This study was conducted at the Department of Dermatology and Venereology, Baghdad Hospital, in the period between April 2001 and August 2002. Thirty patients with melasma were included in this study. They were mostly of skin type IV according to Fitzpatrick's classification, 26 (86.67%) were women, and 4 (13.33%) were men, with an age range from 18 and 50 years (mean±SD, 33.53±6.96 years). Full clinical examination was done to all patients including Wood's light. The severity of melasma was assessed by MASI (Melasma Area Severity Index). Pure lactic acid full strength (92%, pH 3.5) was used as a new peeling agent on the left side of the face while Jessner's solution was applied to the right side of the face. The chemical peeling sessions were done every 3 weeks until the desired response was achieved. Follow-up was carried out for 6 months after the last session. RESULTS Six patients were defaulted from the study after the first session for unknown reasons. Twenty-four patients completed the study. Twenty (83.33%) were women and four were men (16.67%). Wood's light examination showed increased contrast in all patients of mostly epidermal melasma. The number of sessions ranged from 2 to 5. All patients showed marked improvement as calculated by MASI score before and after treatment, and the response was highly statistically significant. No side effect was recorded in all treated patients. CONCLUSION Lactic acid was found to be an effective and safe peeling agent in the treatment of melasma, and it was as effective as Jessner's solution. [source]


    A Simple, Pain-Free Treatment for Ingrown Toenails Complicated with Granulation Tissue

    DERMATOLOGIC SURGERY, Issue 11 2006
    F. GÜLRU ERDOGAN MD
    BACKGROUND The treatment of ingrown toenail complicated with granulation tissue is usually partial or total nail avulsion with or without matricectomy. It costs loss of occupational power, however, because most patients cannot go to work or school for some time after surgery, and it is a costly and uncomfortable procedure for most patients. OBJECTIVE This study aimed to find an easy, painless, and inexpensive alternative. MATERIALS AND METHODS Seven patients with ingrown toenails complicated with granulation tissue are included. A small apparatus was applied on the nails, granulation tissue was chemically cauterized, and a foot bath was recommended twice daily. They were followed on a weekly basis or every other week until recovery. None of the patients received systemic treatment. RESULTS All seven patients were completely cured without requiring surgery and/or systemic treatment. The procedure did not have any effect on their daily life. The follow-up examination of the patients at 6 months revealed that they were totally cured, and there were no recurrences. CONCLUSION Patients with ingrown toenails complicated by granulation tissue might have an inexpensive and pain-free treatment alternative, although new studies with more patients are required. [source]


    Warm and Neutral Tumescent Anesthetic Solutions Are Essential Factors for a Less Painful Injection

    DERMATOLOGIC SURGERY, Issue 9 2006
    CHIH-HSUN YANG MD
    BACKGROUND Tumescent local anesthesia is widely used in dermatologic surgery. Minimizing pain associated with injections is crucial to successful surgical procedures. OBJECTIVE This study investigates the pain associated with warm and room temperatures in neutralized or nonneutralized tumescent anesthetic solutions injection. METHODS Thirty-six patients with axilla osmidrosis who underwent local anesthesia for surgery were randomly assigned to three groups. Group A received warm neutral (40°C) and room-temperature neutral (22°C) tumescent injections to each axillary region. Group B received warm neutral (pH 7.35) and warm nonneutral (pH 4.78) tumescent injections on each side of axilla. Group C received warm nonneutral and room-temperature nonneutral tumescent injections on each side of axilla. Pain associated with infiltration of anesthesia was rated on a visual analog scale (VAS). RESULTS A statistically significant decrease (p < .001) in pain sensation was reported on the warm, neutral injection side (mean rating, 32.7 mm) compared with the room-temperature, neutral injection side (mean rating, 53.3 mm). Patient-reported pain intensity was significantly lower on the side that received warm, neutral tumescent anesthesia (mean rating, 26.8 mm) than on the side receiving warm, nonneutral tumescent anesthesia (mean rating, 44.9 mm; p < .001). The difference in VAS scores between warm neutral (mean rating, 23.9 mm) and room-temperature nonneutral (mean rating, 61.2 mm) was statistically significant (p < .001). CONCLUSION The warm, neutral tumescent anesthetic preparation effectively suppressed patient pain during dermatologic surgical procedures. [source]


    Condition Known as "Dark Rings Under the Eyes" in the Japanese Population is a Kind of Dermal Melanocytosis Which can be Successfully Treatedby Q-Switched Ruby Laser

    DERMATOLOGIC SURGERY, Issue 6 2006
    SHINICHI WATANABE MD
    BACKGROUND In general, dark rings under the eyes are believed to be a phenomenon caused mainly by physiological change because of their daily fluctuation. Medically speaking, the precise cause or pathogenesis of dark rings is unknown, and this condition has not been clearly defined. In our experience, the dark rings associated with conventional nevus of Ota can be successfully treated with Q-switched ruby laser (QSRL). OBJECTIVE This study was conducted to clarify the nature of dark rings under the eyes and to determine the efficacy of QSRL. PATIENTS AND METHODS Fifty-four patients who received a biopsy for pigment macules of the face were retrieved, and of that number 12 patients with bilateral homogeneous pigment macule on suborbital regions were selected for study of the dark rings. Of those patients, the histology and the efficacy of QSRL were evaluated retrospectively. RESULTS Histologically, all 12 patients indicated dermal melanocytosis, which was confirmed by the Masson-Fontana silver stain and staining against S100. In five patients who received QSRL therapy two times or more, the clinical improvement of two patients was scored as good (40,69%), and two other patients as excellent (>70% clearance). CONCLUSIONS We speculate that so-called dark rings under the eyes in the Japanese population is a kind of dermal melanocytosis which can be successfully treated by QSRL. [source]


    Photoepilation Results of Axillary Hair in Dark-Skinned Patients by IPL: A Comparison Between Different Wavelength and Pulse Width

    DERMATOLOGIC SURGERY, Issue 2 2006
    JONG HEE LEE MD
    BACKGROUND Recently, intense pulsed light (IPL) sources have been shown to provide long-term hair removal. OBJECTIVE This study examined the photoepilatory effects of different wavelengths and pulse width application in the same device and compared their efficiencies in Asian skin. METHODS Twenty-eight Korean women were treated using HR (600,950 nm filter) and 27 using HR-D (645,950 nm filter) in the axillar area. Four treatments were carried out at intervals of 4 to 6 weeks; follow-ups were conducted 8 months after the last treatment. Mean energy settings were 14.9±2.0 J/cm2 for HR and 17.1±0.6 J/cm2 for HR-D. Longer pulse widths were applied in case of HR-D treatment. Hair counts and photographic evaluation of skin sites were made at baseline and at the last follow-up. Final overall evaluations were performed by patients and clinicians. RESULTS Average clearances of 52.8% and 83.4% were achieved by HR and HR-D, respectively. No significant adverse effects were reported after HR-D treatment. One case each of hypopigmentation and hyperpigmentation was reported for HR. CONCLUSION An IPL source by removing 45 nm of the emitted spectra and applying longer pulse width was found to provide a safer and more effective means of photoepilation in Asian patients. [source]


    Utility of esophageal biopsy in the diagnosis of nonerosive reflux disease

    DISEASES OF THE ESOPHAGUS, Issue 3 2003
    R. I. Narayani
    SUMMARY This study evaluated the accuracy of esophageal biopsy for the diagnosis of nonerosive reflux disease (NERD) in adults. Thirty-five patients with reflux symptoms and a normal endoscopy were prospectively evaluated using esophageal biopsies, 24-h ambulatory pH monitoring and symptomatic response 4 weeks after an increase in antireflux therapy. Biopsies were scored for the total number of typical histologic reflux features seen. Patients were considered to have NERD if both pH-metry was positive and step-up therapy was successful. Biopsies were then compared to this predefined gold standard. Biopsy was most sensitive (62%) but poorly specific (27%) when one or more histologic reflux features were seen. A threshold of three or more histologic features improved the specificity (91%) but reduced sensitivity (31%). Response to step-up therapy was associated with 100% sensitivity and 100% negative predictive value when compared to biopsy and pH-metry as an alternate combined gold standard. In conclusion, biopsy is insensitive in diagnosing NERD but reasonably specific if three or more typical histologic reflux features are present. [source]


    Limitation of nesting resources for ants in Colombian forests and coffee plantations

    ECOLOGICAL ENTOMOLOGY, Issue 5 2006
    INGE ARMBRECHT
    Abstract 1.,This study examines limitation of nesting resources for leaf-litter and twig-nesting ants as a mechanism of diversity loss across an intensification gradient of coffee production in Colombia. Twelve farms were selected and classified into four management types: forest, polygeneric shade coffee, monogeneric shade coffee, and sun coffee (unshaded coffee monocultures). 2.,At each of the farms, four treatment subplots were established at the corners of each of 10 25 m2 plots: (i) twig augmentation (adding 10 empty bamboo twigs); (ii) litter augmentation (tripling existing litter profile); (iii) twig and litter augmentation; and (iv) no manipulation control, for a total of 480 subplots. A twig addition experiment was also performed on coffee bushes. 3.,The results showed significantly more ant colonies in the forest and monogeneric shade coffee litter augmentation plots after 4 months. Litter-nesting ant species richness was higher in all three shade systems than in the sun coffee. The identities of ants nesting on coffee bushes were different from those in the soil level litter. Fewer species nested in bamboo twigs placed in litter in the most intensive systems. 4.,More ants nested in the resource addition treatments, and more ant species were found in forested habitats; however, a single mechanism cannot explain the observed patterns. It was concluded that a combination of bottom-up and top-down effects might lead to the loss of associated fauna with the intensification of these agroecosystems. [source]


    Effects of search experience in a resource-heterogeneous environment on the oviposition decisions of the seed beetle, Callosobruchus maculatus (F.)

    ECOLOGICAL ENTOMOLOGY, Issue 4 2006
    ROU-LING YANG
    Abstract 1.,This study investigates how female seed beetles, Callosobruchus maculatus, distribute their eggs on various-sized seeds when the size of seed was varied during the egg-laying period. 2.,Beetles were allowed to lay eggs on one of three arrays of 64 adzuki beans (Vigna angularis). Each array contained four size classes of seed, ranging from small (5.0,5.5 mm diameter) to large (6.5,7.0 mm), but differed in how they were distributed within the environment. In the most heterogeneous condition (the 64-patch design), the four sizes were interspersed, while in the least heterogeneous condition (the four-patch design) they were grouped into four separate blocks. Thus, a beetle exploring the 64-patch design would frequently encounter all four seed sizes, whereas a beetle exploring the four-patch design would only rarely encounter a change in bean size. 3.,Beetles experiencing greater seed size heterogeneity were more likely to lay eggs on larger seeds, whereas those in the blocked condition were more likely to oviposit on small seeds. Beetle responses to seed size heterogeneity suggest that the degree of preference for large seeds depends on a female's recent experience. 4.,Female beetles exhibited size discrimination throughout their egg-laying process; however, there was a trade-off between seed size and egg discrimination (i.e. avoiding those seeds already containing developing eggs) in response to the change in fitness gained from either laying on larger seeds or lower egg-load seeds during the egg-laying process. 5.,Our model provides the first evidence that evolving seed size discrimination ability is adaptive for the seed beetle with egg-discrimination ability. [source]


    Perceptions about quality of life in a school-based population of adolescents with menorrhagia: implications for adolescents with bleeding disorders

    HAEMOPHILIA, Issue 3 2008
    A. PAWAR
    Summary., This study examined the effect of menorrhagia on the quality of life (QOL) of adolescents. We used data from a survey of 45 adolescents. Using the Pictorial Blood Assessment Chart (PBAC) and a PBAC score of ,100 we identified adolescents likely to have menorrhagia. Our statistical analysis indicated that menorrhagia adversely affects the QOL of adolescents. In this article we discuss the implications of our study and future research avenues. [source]


    Long-Term, Open-Label Safety Study of Oral Almotriptan 12.5 mg for the Acute Treatment of Migraine in Adolescents

    HEADACHE, Issue 5 2010
    Frank Berenson MD
    (Headache 2010;50:795-807) Objectives., This study evaluated the long-term safety of oral almotriptan 12.5 mg for the treatment of multiple migraine episodes in adolescents over a 12-month period. Efficacy outcomes were assessed as a secondary objective. Methods., Adolescent migraineurs aged 12-17 years were enrolled in this 12-month, open-label study (Study ID CR002827). Patients were instructed to record their assessments on paper headache records whenever they experienced a migraine headache that they treated with study medication. Safety was assessed descriptively and assessments included adverse event (AE) recording, change in laboratory values, vital signs, and electrocardiogram parameters. Efficacy outcomes were assessed descriptively and outcomes included rates for 2- and 24-hour pain relief and sustained pain relief, 2- and 24-hour pain-free and sustained pain-free, and presence of migraine-associated symptoms of photophobia, phonophobia, nausea and vomiting. Results., Overall, 67.1% of patients reported ,1 AE over the course of the trial, 7.6% had an AE judged by the study investigator to be related to treatment with almotriptan, 2.4% discontinued because of an AE, and 1.9% reported serious AEs. The most commonly reported treatment-related AEs (occurring in ,1% of patients) were nausea (1.4%) and somnolence (1.4%). Pain relief responses for treated migraines of moderate or severe intensity at baseline were 61.7% and 68.6%, at 2 and 24 hours, respectively; the sustained pain relief rate was 55.5%. Pain-free responses were reported for 40.5% of all treated migraines at 2 hours and 65.9% of treated migraines at 24 hours; the sustained pain-free rate was 38.4%. The proportion of migraines that achieved the pain relief, sustained pain relief, pain-free and sustained pain-free endpoints were similar in the 12- to 14-year and 15- to 17-year age groups. Treating with almotriptan 12.5 mg when headache pain was mild was associated with higher rates of pain relief and pain-free at 2 and 24 hours, and sustained pain relief and sustained pain-free, compared with treatment initiated when pain was severe. Conclusions., Almotriptan 12.5 mg was well tolerated in this adolescent population over a 12-month period. No unexpected safety or tolerability concerns were revealed over the course of this study. The results are consistent with almotriptan 12.5 mg being effective for the acute treatment of pain and symptoms associated with migraine in both younger and older adolescents. [source]


    Increased Dopamine Is Associated With the cGMP and Homocysteine Pathway in Female Migraineurs

    HEADACHE, Issue 1 2010
    Hans-Jürgen Gruber PhD
    (Headache 2010;50:109-116) Background., The group of catecholamines, which include dopamine, adrenaline, and noradrenaline, are neurotransmitters which have been considered to play a role in the pathogenesis of migraine. However, the impact of catecholamines, especially dopamine on migraine as well as the exact mechanisms is not clear to date as previous studies have yielded in part conflicting results. Objective., This study aimed to produce a comprehensive examination of dopamine in migraineurs. Methods., Catecholamines and various parameters of the homocysteine, folate, and iron metabolism as well as cyclic guanosine monophosphate (cGMP) and inflammatory markers were determined in 135 subjects. Results., We found increased dopamine levels in the headache free period in female migraineurs but not in male patients. Increased dopamine is associated with a 3.30-fold higher risk for migraine in women. We found no significant effects of aura symptoms or menstrual cycle phases on dopamine levels. Dopamine is strongly correlated with cGMP and the homocysteine,folate pathway. Conclusion., We show here that female migraineurs exhibit increased dopamine levels in the headache free period which are associated with a higher risk for migraine. [source]


    Supraspinal Modulation of Trigeminal Nociception and Pain

    HEADACHE, Issue 5 2009
    Amy E. Williams MA
    Objective., This study examined modulation of trigeminal pain/nociception by 2 supraspinal mechanisms: emotional controls of nociception and diffuse noxious inhibitory controls. Background., Prior research suggests emotional picture viewing (emotional controls) and tonic noxious stimuli (diffuse noxious inhibitory controls) engage supraspinal mechanisms to modulate pain and nociceptive processes. It is currently unknown, however, whether emotional controls modulate trigeminal pain and nociception. Additionally, the influences of emotional controls and diffuse noxious inhibitory controls have not been compared in the same group of participants. Methods., Noxious electrodermal stimuli were delivered to the trigeminal nerve using a concentric electrode designed to selectively activate nociceptive fibers. Trigeminal nociception and pain were assessed (34 participants) from the nociceptive blink reflex and pain ratings, respectively. Emotional controls were engaged by presentation of standardized picture stimuli (pleasant, neutral, and unpleasant) shown to reliably evoke pleasure-induced inhibition and displeasure-induced facilitation of pain and nociception. Diffuse noxious inhibitory controls were engaged with a forearm ischemia task. Results., Trigeminal pain (self-report ratings) and nociception (blinks) were facilitated by unpleasant pictures and inhibited by pleasant pictures. Emotion induction (as assessed from trend analysis) explained 51% of the variance in trigeminal pain and 25% of the variance in trigeminal nociception. Additionally, forearm ischemia inhibited trigeminal pain but not nociception. The baseline vs ischemia comparison explained 17% of the variance in pain report and 0.1% of the variance in blinks. Supraspinal modulation by emotional controls and diffuse noxious inhibitory controls were uncorrelated. Conclusions., Emotional controls and diffuse noxious inhibitory controls modulated trigeminal pain and emotional controls modulated trigeminal nociception. These procedures can be used to study supraspinal modulation of nociceptive processing in disorders of the trigeminal pain system, including headache. [source]


    Migraine Disability Awareness Campaign in Asia: Migraine Assessment for Prophylaxis

    HEADACHE, Issue 9 2008
    Shuu-Jiun Wang MD
    Objectives., This study aimed to survey the headache diagnoses and consequences among outpatients attending neurological services in 8 Asian countries. Methods., This survey recruited patients who consulted neurologists for the first time with the chief complaint of headache. Patients suffering from headaches for 15 or more days per month were excluded. Patients answered a self-administered questionnaire, and their physicians independently completed a separate questionnaire. In this study, the migraine diagnosis given by the neurologists was used for analysis. The headache symptoms collected in the physician questionnaire were based on the diagnostic criteria of migraine proposed by the International Classification of Headache Disorders, second edition (ICHD-2). Results., A total of 2782 patients (72% females; mean age 38.1 ± 15.1 years) finished the study. Of them, 66.6% of patients were diagnosed by the neurologists to have migraine, ranging from 50.9% to 85.8% across different countries. Taken as a group, 41.4% of those patients diagnosed with migraine had not been previously diagnosed to have migraine prior to this consultation. On average, patients with migraine had 4.9 severe headaches per month with 65% of patients missing school, work, or household chores. Most (87.5%) patients with migraine took medications for acute treatment. Thirty-six percent of the patients had at least one emergency room consultation within one year. Only 29.2% were on prophylactic medications. Neurologists recommended pharmacological prophylaxis in 68.2% of patients not on preventive treatment. In comparison, migraine prevalence was the highest with ICHD-2 "any migraine" (ie, migraine with or without migraine and probable migraine) (73.3%) followed by neurologist-diagnosed migraine (66.6%) and ICHD-2 "strict migraine" (ie, migraine with or without aura only) (51.3%). About 88.6% patients with neurologist-diagnosed migraine fulfilled ICHD-2 any migraine but only 67.1% fulfilled the criteria of ICHD-2 strict migraine. Conclusions., Migraine is the most common headache diagnosis in neurological services in Asia. The prevalence of migraine was higher in countries with higher referral rates of patients to neurological services. Migraine remains under-diagnosed and under-treated in this region even though a high disability was found in patients with migraine. Probable migraine was adopted into the migraine diagnostic spectrum by neurologists in this study. [source]


    Gastric Stasis Occurs in Spontaneous, Visually Induced, and Interictal Migraine

    HEADACHE, Issue 10 2007
    Sheena Aurora MD
    Objective., To evaluate and compare gastric motility and emptying during spontaneous migraine to previous observations from induced migraine. Blackground., We have previously demonstrated a delay in gastric emptying both during the interictal period and during an induced migraine. A limitation noted in these studies was whether there are differences gastrointestinally during a visually induced migraine compared to spontaneous migraines. To address this, 9 additional studies have been performed to ascertain if there is a similar delay during spontaneous migraine Methods., Gastric scintigraphy using a standard meal was performed in 3 subjects during 3 periods: spontaneous migraine, induced migraine, and interictal period. Results., On average, the time to half emptying was delayed during spontaneous migraine (124 minutes), during induced migraine (182 minutes), and during the interictal period migraine (243 minutes) compared to normative values established at our center (112 minutes). On average, similar gastric slowing was seen in all 3 groups when the percentage of nuclear material remaining in the stomach at 2 hours was measured. Conclusions., This study provides additional evidence of gastric stasis in migraineurs interictally during induced and spontaneous migraine. [source]


    Sumatriptan Nasal Spray in Adolescent Migraineurs: A Randomized, Double-Blind, Placebo-Controlled, Acute Study

    HEADACHE, Issue 2 2006
    Paul Winner DO
    Objective.,To compare the efficacy and tolerability of sumatriptan nasal spray (NS) (5, 20 mg) versus placebo in the acute treatment of migraine in adolescent subjects. Background.,Currently, no triptan is approved in the United States for the treatment of migraine in adolescent subjects (12 to 17 years). In a previous randomized, placebo-controlled study of 510 adolescent subjects, sumatriptan NS at 5, 10, and 20 mg doses was well tolerated. However, the primary efficacy analysis for headache relief with 20 mg at 2 hours did not demonstrate statistical significance (P= .059). A second study was initiated to evaluate the efficacy of sumatriptan NS in this population. Methods.,This was a randomized (1:1:1), placebo-controlled, double-blind, parallel-group study. Overall, 738 adolescent subjects (mean age: 14 years) with ,6-month history of migraine (with or without aura) self-treated a single attack of moderate or severe migraine. The primary endpoints were headache relief at 1 hour and sustained relief from 1 to 24 hours. Pain-free rates, presence/absence of associated symptoms, headache recurrence, and use of rescue medications were also assessed. Tolerability was based on adverse events (AEs) and vital signs. Results.,Sumatriptan NS 20 mg provided greater headache relief than placebo at 30 minutes (42% vs. 33%, respectively; P= .046) and 2 hours (68% vs. 58%; P= .025) postdose, but did not reach statistical significance at 1 hour (61% vs. 52%; P= .087) or for sustained headache relief from 1 to 24 hours (P= .061). Significant differences (P < .05) in favor of sumatriptan NS 20 mg over placebo were observed for several secondary efficacy endpoints including sustained relief from 2 to 24 hours. In general, sumatriptan NS 5 mg percentages were slightly higher than placebo but the differences did not reach statistical significance. Both doses of sumatriptan NS were well tolerated. No AEs were serious or led to study withdrawal. The most common event was taste disturbance (2%, placebo; 19%, sumatriptan NS 5 mg; 25%, sumatriptan NS 20 mg). Conclusions.,This study suggests that sumatriptan may be beneficial to some adolescents and is generally well tolerated in the acute treatment of migraine in this population. [source]


    Assessment of Adverse Events Associated With Triptans,Methods of Assessment Influence the Results

    HEADACHE, Issue 10 2004
    Fred D. Sheftell MD
    Background.,A recent study conducted in triptan-naïve migraine patients showed that tolerability was the second most important attribute of an acute treatment. However, the proportion of patients reporting side effects after any acute treatment may vary with regard to the method of assessment. Objectives.,To contrast two methods of assessing adverse events (prompted and unprompted) in those with headache using triptans. Methods.,This study was conducted in two sites, a headache center in the United States, and a neurology office focusing on headache in Italy. We prospectively surveyed 415 adults with headache, who had been using the same triptan for at least 3 months. Participants were asked about their headache and treatment history. Subjects then completed a standardized questionnaire, assessing adverse events in two different ways. First, subjects were asked if they had any adverse events when using the triptan. After returning the first part of the questionnaire, subjects received a second form, where 49 possible adverse events were listed. We contrasted and correlated both sets of answers. Results.,Most patients (U.S. = 74.9%, Italy = 65.5%) reported no side effects in the unprompted questionnaire. However, most of them (U.S. = 62.9%, Italy = 54.1%) reported at least one side effect in the prompted questionnaire. Most patients that reported side effects in the unprompted questionnaire said they had just one adverse event, while most reported two or more side effects in the prompted questionnaire. Both in the unprompted and in the prompted questionnaires, most side effects were rated as mild or moderate. Interestingly, 31 (7.5%) subjects (pooling data from both sites together) graded their adverse events as severe in the prompted questionnaire, but had not self-reported them. Conclusions.,(1) When assessing adverse events, the method of data collection may dramatically influence the results. (2) From those subjects who did not self-report adverse events after using a triptan, most of them will report positively if presented with a list of side effects. [source]


    Epidemiology and Symptomatology of Migraine Among School Children: Denizli Urban Area in Turkey

    HEADACHE, Issue 8 2004
    Mehmet Zencir MD
    Objective.,This study was aimed at finding the prevalence, associated factors, and symptomatology of migraine among 5 to 8 grades of secondary and 9 to 11 grades of high school children (age range between 11 and 18 years old) in the Denizli urban area in the western part of Turkey. Background.,Data from the developed countries indicate that migraine is the most common cause of recurrent headaches in children. Also, childhood migraine is sufficiently severe to prevent the half of the suffering children from carrying on their usual daily activities. Methods.,A cross-sectional school-based study was conducted between May 2000 and June 2000. There were 2,490 participants selected by a multistage stratified clustered sampling procedure. A validated self-administered questionnaire designed according to the International Headache Society criteria was given to the school children of age between 11 and 18 years. Results.,Overall migraine prevalence was 8.8%; it was 6.7% in boys and 11.0% in girls (OR: 1.7; 95% CI: 1.3 to 2.3). Among girls, the highest prevalence (17.7%) occurred at 15 years of age, but among boys, the highest prevalence (11.9%) occurred at 16 years of age. Of children with migraine, 56.5% had a positive family history, and only 29.1% visited a doctor for headache. Conclusion.,Migraine is a common health problem among school children in Denizli urban area and it often goes underdiagnosed. [source]


    Validity and Reliability of the Turkish Migraine Disability Assessment (MIDAS) Questionnaire

    HEADACHE, Issue 8 2004
    Mustafa Erta
    Objectives.,The aim of this study is to assess the comprehensibility, internal consistency, patient-physician reliability, test-retest reliability, and validity of Turkish version of Migraine Disability Assessment (MIDAS) questionnaire in patients with headache. Background.,MIDAS questionnaire has been developed by Stewart et al and shown to be reliable and valid to determine the degree of disability caused by migraine. Design and Methods.,This study was designed as a national multicenter study to demonstrate the reliability and validity of Turkish version of MIDAS questionnaire. Patients applying to 17 Neurology Clinics in Turkey were evaluated at the baseline (visit 1), week 4 (visit 2), and week 12 (visit 3) visits in terms of disease severity and comprehensibility, internal consistency, test-retest reliability, and validity of MIDAS. Since the severity of the disease has been found to change significantly at visit 2 compared to visit 1, test-retest reliability was assessed using the MIDAS scores of a subgroup of patients whose disease severity remained unchanged (up to ±3 days difference in the number of days with headache between visits 1 and 2). Results.,A total of 306 patients (86.2% female, mean age: 35.0 ± 9.8 years) were enrolled into the study. A total of 65.7%, 77.5%, 82.0% of patients reported that "they had fully understood the MIDAS questionnaire" in visits 1, 2, and 3, respectively. A highly positive correlation was found between physician and patient and the applied total MIDAS scores in all three visits (Spearman correlation coefficients were R= 0.87, 0.83, and 0.90, respectively, P < .001). Internal consistency of MIDAS was assessed using Cronbach's , and was found at acceptable (>0.7) or excellent (>0.8) levels in both patient and physician applied MIDAS scores, respectively. Total MIDAS score showed good test-retest reliability (R= 0.68). Both the number of days with headache and the total MIDAS scores were positively correlated at all visits with correlation coefficients between 0.47 and 0.63. There was also a moderate degree of correlation (R= 0.54) between the total MIDAS score at week 12 and the number of days with headache at visit 2 + visit 3, which quantify headache-related disability over a 3-month period similar to MIDAS questionnaire. Conclusion.,These findings demonstrated that the Turkish translation is equivalent to the English version of MIDAS in terms of internal consistency, test-retest reliability, and validity. Physicians can reliably use the Turkish translation of the MIDAS questionnaire in defining the severity of illness and its treatment strategy when applied as a self-administered report by migraine patients themselves. [source]


    Prevalence of Headache in Puerto Rico

    HEADACHE, Issue 7 2003
    Héctor Miranda MD
    Background.,Headache is one of the most frequently reported disorders in the general adult population. Despite the fact that this disorder is common, no official estimate of the prevalence of headache exists in Puerto Rico. Purpose.,To examine the prevalence of headache and migraine, specifically, in Puerto Rico. Methods.,A telephone survey of 1610 individuals was conducted. The telephone calls were distributed using the 1990 census adjusted to the population of Puerto Rico in 1998, and according to gender, geographical area, and age. Results.,The prevalence of headache in Puerto Rico was 35.9% and migraine, in particular, 13.0%. When prevalence was fractionated by age, gender, and geographical areas, the prevalence of headache was similar for all ages, with females exhibiting a 2:1 preponderance over males. In the younger population (between 20 and 50 years of age), the female-male ratio for migraine was 3:1, and the prevalence for migraine was lower in the Metropolitan area. Conclusion.,This study, the first of its type in Puerto Rico, demonstrates that headache (and migraine specifically) is a common disorder in this country. [source]


    Total Family Unit Helicobacter pylori Eradication and Pediatric Re-Infection Rates

    HELICOBACTER, Issue 4 2004
    Stephen Farrell
    ABSTRACT Background., Re-infection with Helicobacter pylori is more common in children than adults, and it is generally accepted that the family unit plays a significant role in primary childhood infection. We investigated whether the family unit plays a significant role in pediatric re-infection and if eradication of H. pylori from the entire family reduces the risk of childhood re-infection. Methods., Fifty families, each with an H. pylori -infected pediatric index case (mean age 9.48 years), were recruited. A 13carbon urea breath test was performed on all family members in the same house as the index case. Each family unit was randomized into a ,family unit treatment' group (all infected family members treated) or an ,index case treatment' group (index case only treated). Results., At long-term follow-up (mean 62.2 months), there were three re-infected children in the ,index case treatment' group compared with one in the ,family unit treatment' group. The re-infection rate was 2.4% per patient per year in the ,index case treatment' group and 0.7% per patient per year in the ,family unit treatment' group (p = .31). Conclusions., This study is the first to evaluate the effect of total family unit H. pylori eradication on pediatric re-infection rates and reports the longest period of re-infection follow-up in children. In childhood, re-infection with H. pylori is not significantly reduced by family unit H. pylori eradication. [source]


    The role of soil community biodiversity in insect biodiversity

    INSECT CONSERVATION AND DIVERSITY, Issue 3 2010
    ALISON BENNETT
    Abstract., 1.,This study demonstrates that feedback loops between plants and insects contribute to both plant and insect diversity. Synthesis of several studies reveals that both bottom-up and top-down forces are important for plant and insect communities. 2.,Feedback loops between plants and soil organisms contribute to plant and soil diversity. An analysis of multiple systems reveals that pathogens, mutualists, and a wide variety of soil fauna directly influence, and are influenced by, plant diversity. 3.,The connection of plant,insect and soil,plant feedback loops leads to the maintenance of all three groups, and the maintenance of these feedback loops crucially affects insect diversity. Examples of the influence of soil community diversity on insect diversity, and the influence of insect diversity on soil community diversity, as well as feedbacks through all three trophic levels are provided. 4.,Finally, means of conserving and restoring soil communities to influence the conservation and restoration of insect communities are discussed. [source]


    Long-term exposure to elevated CO2 in a Florida scrub-oak forest increases herbivore densities but has no effect on other arthropod guilds

    INSECT CONSERVATION AND DIVERSITY, Issue 2 2010
    PETER STILING
    Abstract., 1.,This study uses pitfall traps and sticky traps to examine the effects of elevated CO2 on the densities of insect herbivores, insectivores, and detritivores. 2.,Pitfall trapping for the last 3 years of 11 years of continuously elevated CO2 revealed increases of insect herbivore species such as Thysanoptera (thrips), Hemiptera, and Lepidoptera, but no effects on insectivores such as spiders, parasitic wasps, and ants; or on detritivores such as Diptera (flies), Psocoptera (book lice), Blattodea (cockroaches), Collembola (spring tails), Orthoptera (crickets), and Coleoptera (beetles). 3.,As the bottom-up effects of elevated CO2 are transmitted through plants to herbivores, they do not appear to reach insect natural enemies or decomposers. [source]