Simvastatin and vitamin D for Migraines? Why not?

Statins are primarily used for high cholesterol.

Is this another use for statins? Look at outcomes.

But patients need to know to be patient.... 29% had response after 24 weeks.

Could it help prevent com-morbid stroke? No data....

Awesome news. JR

Ann Neurol. 2015 Sep 29. doi: 10.1002/ana.24534. [Epub ahead of print]

Simvastatin and Vitamin D for Migraine Prevention: A Randomized Controlled Trial.

Buettner C1, Nir RR2, Bertisch SM1, Bernstein C3, Schain A3, Mittleman MA4, Burstein R3.

Author information

Abstract

OBJECTIVE:

To assess efficacy and tolerability of simvastatin plus vitamin D for migraine prevention in adults with episodic migraine.

METHODS:

We performed a randomized, double-blind, placebo-controlled trial with a 12-week baseline period and 24-week intervention period in 57 adults with episodic migraine. Participants were randomly assigned to simvastatin 20 mg tablets twice daily plus vitamin D3 1000 international units capsules twice daily or matching placebo tablets and capsules.

RESULTS:

Compared to placebo, 

participants using simvastatin plus vitamin D3 demonstrated a greater decrease:

 in number of migraine days from the baseline period to intervention weeks 1-12: a change of -8.0 (IQR: -15.0 to -2.0) days in the active treatment group versus +1.0 (IQR: 1.0 to +6.0) days in the placebo group, P<0 .001="" and="" nbsp="" span="">

to intervention weeks 13-24: a change of -9.0 (IQR: -13 to -5) days in the active group versus +3.0 (IQR: -1.0 to +5.0) days in the placebo group, P<0 .001.="" abstracttext="" nbsp="">

In the active treatment group, 8 patients (25%) experienced 50% reduction in the number of migrainedays at 12 weeks and 9 (29%) at 24 weeks post randomization. 

In comparison, only 1 patient (3%) in the placebo group (p=0.03) experienced such reduction. Adverse events were similar in both active treatment and placebo groups.

INTERPRETATION:

The results demonstrate that simvastatin plus vitamin D is effective for prevention of headache in adults with episodic migraine. Given statins ability to repair endothelial dysfunction, this economical approach may also reduce the increased risk for vascular diseases among migraineurs. This article is protected by copyright. All rights reserved.

© 2015 American Neurological Association.

PMID:

 

26418341

 

[PubMed - as supplied by publisher]

Riluzole for treating ataxia. Ready for compassionate use?Off label use?

Riluzole is already approved for use in other neurologic conditions.  "Off-label" is different than "experimental". JR

Riluzole in patients with hereditary cerebellar ataxia: a randomised, double-blind, placebo-controlled trial

Silvia Romano, MD

,

 Giulia Coarelli, MD

,

 Christian Marcotulli, MD

,

 Luca Leonardi, MD

,

 Francesca Piccolo, MD

,

 Maria Spadaro, MD

,

 Marina Frontali, MD

,

 Michela Ferraldeschi, MD

,

 Maria Chiara Vulpiani, MD

,

 Federica Ponzelli, BPT

,

 Dr Marco Salvetti, MD

,

 Francesco Orzi, MD

,

 Antonio Petrucci, MD

,

 Nicola Vanacore, MD

,

 Carlo Casali, MD

,

 Dr Giovanni Ristori, MD

Published Online: 25 August 2015

DOI: http://dx.doi.org/10.1016/S1474-4422(15)00201-X

 |

Article Info

Publication History

Published Online:25 August 2015

© 2015 Elsevier Ltd. All rights reserved.

This article can be found in the following collections: Movement disorders

• Summary
• Full Text
• Tables and Figures
• References
• Supplementary Material

Summary

Background

Our previous study in patients with cerebellar ataxias of different causes showed significant benefit of riluzole after 8 weeks. We aimed to confirm these results in patients with spinocerebellar ataxia or Friedreich's ataxia in a 1-year trial.

Methods

Patients with spinocerebellar ataxia or Friedreich's ataxia (2:1 ratio) from three Italian neurogenetic units were enrolled in this multicentre, double-blind, placebo-controlled trial, and randomly assigned to riluzole (50 mg orally, twice daily) or placebo for 12 months. The randomisation list was computer-generated and a centralised randomisation system was implemented. Participants and assessing neurologists were masked to treatment allocation. The primary endpoint was the proportion of patients with improved Scale for the Assessment and Rating of Ataxia (SARA) score (a drop of at least one point) at 12 months. An intention-to-treat analysis was done. This trial is registered at ClinicalTrials.gov, number NCT01104649.

Findings

Between May 22, 2010, and Feb 25, 2013, 60 patients were enrolled. Two patients in the riluzole group and three in the placebo group withdrew their consent before receiving treatment, so the intention-to-treat analysis was done on 55 patients (19 with spinocerebellar ataxia and nine with Friedreich's ataxia in the riluzole group, and 19 with spinocerebellar ataxia and eight with Friedreich's ataxia in the placebo group). The proportion with decreased SARA score was 14 (50%) of 28 patients in the riluzole group versus three (11%) of 27 in the placebo group (OR 8·00, 95% CI 1·95–32·83; p=0·002). No severe adverse events were recorded. In the riluzole group, two patients had an increase in liver enzymes (less than two times above normal limits). In two participants in the riluzole group and two participants in the placebo group, sporadic mild adverse events were reported.

Interpretation

Our findings lend support to the idea that riluzole could be a treatment for cerebellar ataxia. Longer studies and disease-specific trials are needed to confirm whether these findings can be applied in clinical practice.

Funding

Agenzia Italiana del Farmaco.

Emergency Room Use for People with Epilepsy

Using the ER when you have epilepsy? You are not alone.

How much of this has to do with access and education?

 If I get a rare call  a week from ER's about my known epilepsy patients, my practice is under 1% vs 9% in this study.

1 in 60 ER visits are for seizures?

JR

Use of emergency departments by known epileptic patients: An underestimated problem?

Marie Girot

,

 Herve Hubert

,

 Florence Richard

,

 Maxime Chochoi

,

 Dominique Deplanque

,

Philippe Derambure

,

 Patrick Girardie

,

 Nicolas Pauchet

,

 Stephanie Leblanc

,

 Alice Lim

,

 Eric Wiel

,

 Pierre Williate

,

 William Szurhaj

,

 Xavier Lenne

,

 Louise Tyvaert

Highlights

• •Epileptic seizures are associated with frequent use of emergency department (ED).
• •Little is known about the specific use by known epileptic patients (KEPs).
• •One year descriptive case series report on KEPs admitted prospectively in ED.
• •Proportion of KEPs using ED is high (9.0%), half of them concerned usual seizures.
• •Data crucial to optimize the KEPs ED care pathway.

Summary

Background and purpose

Seizure is a frequent reason of admission in emergency department (ED) but little is known about the proportion and the characteristics of known epileptic patients (KEPs) who used emergency services.

Methods

Over a 12-month period, we prospectively recruited adults admitted for seizure to a tertiary hospital ED. For KEPs, clinical epilepsy features and characteristics of the admission were collected.

Results

Of the 60,578 ED admissions, 990 were related to seizure; 580 of these admissions concerned 448 different KEPs (257 males; median age: 44); 339 were residents in the health district. Epilepsy was structural/metabolic in 268 (59.8%) patients, genetic in 44 (9.8%) and unknown/undetermined in 136 (30.3%); 218 (48.7%) patients were under a single antiepileptic drug and 135 (30.1%) were followed by an epileptologist. Of the 580 KEP admissions, 440 (75.8%) concerned patients who had called the emergency medical assistance number, 252 (43.4%) with a discharge diagnosis of usual seizure and 43 (7.4%) of a status epilepticus. Half the KEPs were discharged without hospitalization. We estimated that 9.0% of KEPs residing in the district had used the ED during the period.

Conclusion

Proportion of KEPs using ED is high. Most of the admissions concerned usual seizures suggesting that staff training and educational programmes for patients and for their relatives need to be improved. The organization of the prehospital and of the emergency medical services should also be adjusted to this specific need. Further research should be conducted to optimize the seizure care pathway for KEPs.

Full article here

The evidence that children with sleep disorders are at higher risk for language problems than healthy sleepers is...

Hooray for the Sleep and Language Pathologists for looking at the data linking sleep and language delay! JR

The Evidence-Based Decision

There is consistent evidence that children with sleep disorders are at higher risk for language problems than healthy sleepers. 

With the exception of expressive phonology (in a single study), these problems are subtle. 

Effect sizes were typically small and the low scores earned on standardized tests of language were still within normal limits. Although it is clear that sleep disorders do increase the risk of at least subclinical language problems, the risk is not limited to language. Children with sleep disorders also presented with poor behavior, attention, and executive function.

 The SLP should consider this evidence when taking case histories and making appropriate referrals.

If parents report that their child consistently exhibits limited sleep, poor quality sleep, snoring, or excessive daytime sleepiness, a referral to a physician is warranted. The child who presents with mild or subclinical deficits in language, along with problematic attention, executive function, or behavior, might be more accurately diagnosed with a sleep disorder than a language learning deficit. That said, given the current evidence, it is not clear that treatment for the child’s sleep disorder will remediate subclinical language problems.

Go to:

Structured Abstract

Clinical Question

Are people with sleep disorders at higher risk for language learning deficits than healthy sleepers?

Method

Scoping Review

Study Sources

PubMed, Google Scholar, Trip Database, ClinicalTrials.gov

Search Terms

sleep disorders AND language AND learning; sleep disorders language learning –deprivation –epilepsy; sleep disorders AND verbal learning

Number of Included Studies

36

Primary Results

Sleep Disorders as a Risk to Language Learning and Use

Karla K. McGregor and Rebecca M. Alper

Copyright and License information ►

Sleep Disorders as a Risk to Language Learning and Use.

McGregor KK, Alper RM.

Abstract

CLINICAL QUESTION:

Are people with sleep disorders at higher risk for language learning deficits than healthy sleepers?

METHOD:

Scoping Review.

STUDY SOURCES:

PubMed, Google Scholar, Trip Database, ClinicalTrials.gov.

SEARCH TERMS:

sleep disorders AND language AND learning; sleep disorders language learning -deprivation -epilepsy; sleep disorders AND verballearning.

NUMBER OF INCLUDED STUDIES:

36.

PRIMARY RESULTS:

Children and adults with sleep disorders were at a higher risk for language problems than healthy sleepers. The language problems typically co-occurred with problems of attention and executive function (in children and adults), behavior (in children), and visual-spatial processing (in adults). Effects were typically small. Language problems seldom rose to a level of clinical concern but there were exceptions involving phonological deficits in children with sleep-disordered breathing and verbal memory deficits among adults with sleep-disordered breathing or idiopathic REM sleep behavior disorder.

CONCLUSIONS:

Case history interviews should include questions about limited sleep, poor-quality sleep, snoring, and excessive daytime sleepiness. Medical referrals for clients with suspected sleep disorders are prudent.

CLICK HERE for MORE

What is the value of genetic testing in autism? What is the exome?

Why check an exome in children with autism and other neurologic illnesses?

This study reports molecular diagnostic yield from chromosomal microarray analysis and whole-exome sequencing performed for a population-based sample of 258 children diagnosed with autism spectrum disorder. 

The combined molecular diagnostic yield was

6.3% (95% CI, 1.7%-15.2%) in the essential group (4/64 children), 
28.6% (95% CI, 3.7%-71.0%) in the equivocal group (2/7 children), and 
37.5% (95% CI, 18.8%-59.4%) in the complex group (9/24 children; 3-group comparison, P = .001). 

The combined yield was significantly higher in the complex group when compared with the essential group (pairwise comparison, P = .002).

JAMA. 2015;314(9):895-903. doi:10.1001/jama.2015.10078.

What is the exome?

Risk that 'nobody will have access to pediatric specialty care'

What is going on in pediatric specialty care? High Deductible Plans? Narrow Network health Plans? HMO? Learn more below.  - JR

Risk that 'nobody will have access  to pediatric specialty care'

By Modern Healthcare  | July 18, 2015

Since 1999, Christopher Dawes has served as president and CEO of Lucile Packard Children's Hospital at Stanford, a 300-bed hospital in Palo Alto, Calif., affiliated with Stanford University that has 47 outpatient sites throughout the Greater San Francisco Bay Area....

Modern Healthcare: Has California's Medicaid expansion increased the number of patients at Lucile Packard and Stanford Children's Health who are on Medi-Cal?

Christopher Dawes: The number has not increased very much. About 42% of the patients we see are covered by Medi-Cal. The big issue for us and other children's hospitals in California is that, according to a recent Kaiser Family Foundation report, providers treating Medi-Cal patients are only paid about 53% of Medicare rates. California ranks 48th among the states in terms of what it pays for Medi-Cal recipients. So our challenge is that we're not paid by the state the full cost of providing care to these children. We have a significant deficit on that population, and we have to make up that deficit through our commercial patients, which represent about 55% of our patients.

This is a very big issue in California because over the next few years, they're estimating that about 50% of kids will be covered by Medi-Cal, and access becomes an increasing issue. We accept anybody regardless of their ability to pay, but that's not true across the whole state.

MH: Has your organization had problems with narrow-network health plans excluding your children's hospital?

Dawes: The trouble with narrow networks is that they're basically built around price and a limited number of providers. For routine adult care, that may or may not work. But when you're looking at kids with cancers and prematurity and so forth, it's a huge issue. If we simply have networks defined by low price and a thin cohort of providers, virtually nobody will have access to pediatric specialty care.

MH: Have there been any networks that Stanford has been excluded from?

Dawes: We have not been excluded yet. We have been put in different tiers. We negotiate pretty hard with payers to ensure that we're always in tier 1. That hasn't always happened. What that means is that kids whose parents are covered by a particular insurance product may be denied access to us. We follow up on those vigorously. But as of today, there hasn't been a narrow network created that we've been excluded from. Still, we're anticipating that to be the case over the next few months or years, because narrow networks are picking up some popularity.

We're kind of in a unique spot because we're in Silicon Valley, and the high-tech firms are trying to attract and retain a limited resource of engineers. So they have a tendency to offer more robust benefit packages than you would find in other industries. They are very interested in offering benefit plans that include us. If you look at other children's hospitals in California and other states, it's become a much bigger issue for them.

WEB EXTRAListen to the full interview with Christopher Dawes atmodernhealthcare.com/podcasts.

MH: What are you and other children's hospitals doing about this narrow-network issue?

Dawes: The California Children's Hospital Association has legislation pending, both at the state level and federal level, to create geographically based networks of care for kids with complex and chronic illnesses. The children's hospital would be a key component of that, but in addition, you'd have rehab and other services that these kids with special needs require. The networks would go at risk for managing a population of kids with special-care needs. We would have within that network all the resources required to care for these kids. On the federal level, we would accept a rate of increase on an annual basis that will be lower than the current rate of increase for Medicaid. So the government would save money, the kids would be better served, and the providers would have assurance that they would receive a sufficient revenue stream to support the needs of these kids.

MH: Have you noticed any pickup in high-deductible plans?

Dawes: We're seeing a lot more benefit plans that have much higher deductibles. It's making the consumer much more aware of costs. From a macro perspective, I think that's a good thing. A lot of the population we serve is fairly sophisticated, and many of the companies are providing tools to their employees to help them determine quality and cost for various providers.

We're seeing consumers get a lot more sophisticated in making their choices. They're getting a lot pickier, they're asking more questions, and that is definitely impacting us, and we're responding. We're looking carefully at our prices, particularly for ancillary services, so we can be more competitive.

One of the issues is we're an academic medical center, and we price our services based on our cost structure, which is quite extensive given that we're doing training and research and delivering services to very complex patients. 

More Here

Changing Insurances? What are considerations for specialty care? Does Texas have rules for HMO Access? Parents..Know the language and laws of Texas!

"You chose a managed care organization (MCO) because your primary doctor is in the plan's network, but later you learn that you don't have access to your longstanding specialists, who may be more important to your health care - Before selecting a plan, look at the MCO's network of providers. 

Consider whether the MCO offers you access to your specialists (such as psychiatrists or rehabilitation specialists) as well as your PCP. 

For people with disabilities, access to a specialist can be more important than access to their regular doctor. If you ask for a list of specialists, the MCO is required to give it to you."

It appears that we are going through a cycle where families may experience difficulty with specialty access.  Please learn the language health care insurance and review your rights. 

Your primary care, employer (or even the health plan) may not be aware of the difficulties that you face with access. Let them know. They can help. 

Cook Childrens' in Fort Worth compiled an excellent review.  Read More Here

Texas law provides protections by requiring
 that HMOs....

• have adequate personnel and facilities
• make covered health care services available within a certain distance of your home or workplace
• allow referrals to out-of-network doctors and hospitals when medically necessary services aren't available within the network
• allow members to change a PCP up to four times a year
• allow members with chronic, disabling, or life-threatening illnesses to use specialists as their PCPs under certain circumstances
• allow members with terminal illness, disability, life-threatening condition, or pregnancy to temporarily continue seeing doctors no longer with the network if the doctor agrees to continue treatment at the HMO's contracted rate
• pay for emergency care if not getting immediate medical care could place your health - or the health of your unborn child if you're pregnant - in serious jeopardy. If you get emergency treatment at a hospital outside the HMO's network, you may be transferred to a network doctor or hospital after your condition is stabilized.

Referrals for Specialty Care - Its your primary care providers' responsibility for managing your care.

In most HMO plans the enrollee's primary care physician (PCP) is responsible for managing the enrollee's primary, preventative, acute and chronic health care needs and for initiating any required specialist referrals.

HMO-contracted specialists are also responsible for providing covered health care services and for coordinating the enrollee's health care, which may include the reporting of the enrollee's medical status to the referring healthcare provider and/or the HMO.

From Texas Department of Insurance......

Network Availability

Q. How does an HMO deliver care?
A. An HMO delivers care by providing or arranging for health care services directly or indirectly through contracts and subcontracts with physicians, providers, and/or other HMOs.

Back to top

Q. What determines whether an HMO has an adequate health care delivery system?
A. All covered health care services that are offered by the HMO shall be sufficient in number and location to be readily available and accessible within the geographical service area to all enrollees. The HMO must have a sufficient number of primary care physicians and specialists with hospital admitting privileges at participating facilities who are available and accessible 24 hours per day, seven days per week, within the HMO's geographical service area. Additionally, an HMO shall make emergency care available and accessible 24 hours per day, seven days per week, without restrictions as to where the services are rendered.

Back to top

Q. What are the accessibility and availability requirements for an HMO?
A. An HMO is required to provide an adequate network which would consist of contracted physicians and providers for its entire geographical service area.* All covered health care services must be accessible and available to enrollees within certain travel distances. The distance from any point in the HMOs service area to a point of service can be no greater than:

• 30 miles for primary care and general hospital care; and
• 75 miles for specialty care, specialty hospitals, and single healthcare service plan physicians or providers.

An HMO must arrange and make available urgent care within:

• 24 hours for medical and dental conditions; and
• 24 hours for behavioral health conditions.

An HMO must arrange and make available routine care within:

• 3 weeks for medical conditions;
• 8 weeks for non-emergent dental conditions; and
• 2 weeks for behavioral health conditions

An HMO must arrange and make available preventive care within:

• 2 months for a child;
• 3 months for an adult; and
• 4 months for dental services.

*Geographic Service Area is defined as a geographic area within which direct service benefits are available and accessible to HMO enrollees who live, reside, or work within that geographic area.

http://www.tdi.texas.gov/hmo/mcqa/hmofaq.html#17