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MEASURE
Brought to you by DyAnsys India Pvt. Ltd., For private circulation only
When you can measure what you are
speaking about, and express it in
numbers, you know something about it;
but when you cannot measure it, when
you cannot express it in numbers, your
knowledge is of a meager and
unsatisfactory kind.
- Lord Kelvin (1883)
Director's corner
Greetings!
Narcotics are finally
being recognized for
what they are. They
cause
addiction,
damage to the brain
and a host of other complications. A
reliable, non-narcotic treatment for chronic
pain is the need of the hour.
DyAnsys got involved in neurostimulation
about 4 years ago via our ANSiscope. We
found that chronic pain, almost always
causes an imbalance in the Autonomic
Nervous System, which of course we
measure. It made sense to ally the
ANSiscope with treatments to provide a
monitoring/treatment solution.
Subsequently, we became involved with a
device for auricular neurostimulation called
the P-Stim. The results achieved were
excellent. It provided pain relief in a
majority of the patients that it was put on.
We made a significant commitment to this
business and designed our version of this
device called the ANSiStim.
We are now involved in developing this
business, initially in the USA and then in
other parts of the world. We expect to
publicize successes via this newsletter,
clinical studies, patient testimonials and
other marketing activities.
This is the first of our Measure issues that is
devoted to one of the diseases associated
with Chronic Pain Migraine. We have
known Dr. Meenakshisunderam for many
years through his diabetology practice. The
main application for the ANSiscope was
diabetic autonomic neuropathy.
In this issue he talks about treating his wife
for Migraine that had been dogging her for
over 15 years. It was completely resistant to
any treatment.
Enter the ANSiStim. She is now finally
able to have a majority of pain free days.
More importantly she is able to live a
normal life. She expresses her feelings on
her own words.
The default treatment for migraines in the
US seems to be Botox. We would hope that
US physicians would treat their patients first
April 16
Doc Talk
The patient
Discussion
https://www.botoxchronicmigraine.com/
New nerve drugs may finally prevent
migraine headaches - David Noonan,
Scientific American Health Nov 17, 2015
The nerve supply of the human auricle Elmar
T.Peuker & Timm J. Fuller Clin Anatomy 15,
35-37
DyAnsys application note #44
Faced with an all-time national high of opioid-induced overdoses, the Food and Drug
Administration (FDA) rolled out strict new guidelines for labeling addictive painkillers Tuesday
afternoon. These new rules will require fast-acting opioid-based drugs, like OxyContin, Demerol,
Percocet, and Vicodin, to come with a new warning about the serious risks of abuse, addiction,
overdose, and deaths linked to the painkiller.
These quick-release forms of opioid drugs represent about 90 percent of painkiller products on
the market. And while they are meant to diffuse temporary pain, like a broken bone, wisdom tooth
removal, or surgery, these opioids have quickly become the nations top drug of choice for people
struggling with addiction.
Opioid addiction and overdose have reached epidemic levels over the past decade, and the
FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of
the misuse and abuse of prescription opioids, said Robert Califf, FDA commissioner, in a press
release. Califf said the new regulations are just a part of the FDAs comprehensive action plan
to attack the crisis in 2016.
This sweeping update is just one of the new ways federal organizations and Congress are
expressing their interest in reversing drug addiction. The FDAs announcement comes a week after
the Centers for Disease Control and Prevention (CDC) released new voluntary guidelines that
suggest primary care physicians limit the dosage of opioid painkillers for patients or offer
alternative treatments for chronic pain before prescribing. Days before, the U.S. Senate swiftly
passed a bipartisan bill that would fund addiction prevention and recovery programs.
The new FDA labels will also include the dangers of using these types of drugs while pregnant.
Over the past decade, more than 130,000 newborns have entered the world addicted to drugs
and facing a painful withdrawal process. Regardless, many pregnant women have been
prescribed opioid painkillers.
But will updating the warning labels on addictive drugs be enough? Some legislators dont
think so.
Shortly after the FDAs announcement, Senator Ed Markey (D-MA) told the New York Times that
the changes have done little to prevent prescription drug opioid addiction, and that it has taken
the F.D.A. far too long to address the grave risks of these drugs that have claimed the lives of
thousands this year alone.
This action failed to address a petition signed by 41 city and state health department heads in
February, which asked for labeling that warned users of the risk of mixing a painkiller with another
type of drug. In its press release, the FDA said it is currently reviewing this risk.
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APPLICATION NOTE
Date: Fe b 22 nd 2016 No. IN 0044
Current Treatment
BOTOX is currently used as a preventive medicine if patients have chronic
migraine i.e. >15 headache days a month. The FDA has approved BOTOX
treatments once every 90 days.
Interestingly, BOTOX prevents up to 9 headache days a month compared
to up to 7 days a month for a placebo injection!
It is injected into 7 key areas of the head and neck at a recommended
dosage of 155 units per treatment session.
BOTOX has side effects that can be serious
1. Problems swallowing, speaking or breathing
2. Spread of toxin effects causing problems in other areas of the body
i. Loss of strength and overall muscle weakness
ii. Double or blurred vision
iii. Hoarseness or change or loss of voice
iv. Loss of bladder control
Recent Insights
Recent developments have identified the trigeminal nerve as the most likely
source of these migraines. (See review article attached).
Migraine has been treated with various methodologies
1. Forehead and eyelid surgery to decompress branches of the trigeminal
nerve system
2. As well as transcranial magnetic stimulation (TMS - a noninvasive
technique to alter nerve cell activity).
TMS has shown some good results.
TMS actually induces currents in areas of the brain causing cranial
electrostimulation.
APPLICATION NOTE
Date: Fe b 22 nd 2016 No. IN 0044
References
1. https://www.botoxchronicmigraine.com/
2. New nerve drugs may finally prevent migraine headaches David
Noonan Scientific American Health Nov 17, 2015
3. The nerve supply of the human auricle Elmar T.Peuker & Timm J. Fuller
Clin Anatomy 15, 35-37
Julia Yellow
People take them to stop attacks after they start, and they
have become a reliable frontline treatment for millions.
What triptans cannot doand what Peter Goadsby, director
of the Headache Center at the University of California, San
Francisco, has dreamed about doing for more than 30
yearsis prevent migraine attacks from happening in the
first place. In the 1980s, in pursuit of this goal, Goadsby
focused on the trigeminal nerve system, long known to be the
brain's primary pain pathway. It was there, he suspected,
that migraine did its dirty work. Studies in animals indicated
that in branches of the nerve that exit from the back of the
brain and wrap around various parts of the face and head,
overactive cells would respond to typically benign lights,
sounds and smells by releasing chemicals that transmit pain
signals and cause migraine. The heightened sensitivity of
these cells may be inherited; 80 percent of migraine sufferers
have a family history of the disorder.
Goadsby co-authored his first paper on the subject in 1988,
and other researchers, including Dodick, joined the effort.
Their goal was to find a way to block the pain signals. One of
the chemicals found in high levels in the blood of people
experiencing migraine is calcitonin gene-related peptide
(CGRP), a neurotransmitter that is released from one nerve
cell and activates the next one in a nerve tract during an
attack. Zeroing in on CGRP and interfering with it was hard.
It was difficult to find a molecule that worked on that
neurotransmitter and left other essential chemicals alone.
As biotech engineers' ability to control and design proteins
improved, several pharmaceutical companies developed
migraine-fighting monoclonal antibodies. These designer
proteins bind tightly to CGRP molecules or their receptors
on trigeminal nerve cells, preventing cell activation. The new
drugs are like precision-guided missiles, Dodick says.
They go straight to their targets.
It is that specificity, and the fact that scientists actually know
how the drugs work, that has Dodick, Goadsby and others
excited. In two placebo-controlled trials with a total of 380
people who had severe migraines up to 14 days per month, a
single dose of a CGRP drug decreased headache days by
more than 60 percent (63 percent in one study and 66
percent in the other). In addition, in the first study, 16
percent of the patients remained totally migraine-free 12
weeks into the 24-week trial. Larger clinical trials to confirm
those findings are currently under way. So far the CGRP
drugs work better at prevention than any of the borrowed
heart or epilepsy drugs and have far fewer side effects. They
are given to patients in a single monthly injection.
Migraine specialists are also exploring other treatments,
including forehead and eyelid surgery to decompress
branches of the trigeminal nerve, as well as transcranial
magnetic stimulation (TMS), a noninvasive way of altering
nerve cell activity.
Lipton says he has had some good results with TMS. He has
also referred patients for surgical interventions but says the
experience has been disappointing, and he is not
recommending it. For his part, Goadsby views surgeries and
high-tech efforts as a kind of desperation: They strike me as
a cry for help. If we better understood migraine, we'd know
better what to do.
Even though the cause now appears rooted in the trigeminal
nerve system, the origin of its overactive cells is still a
mystery, Goadsby says. What's the nature of what you
inherit when you inherit migraine? he asks. Why you, and
why not me? If researchers untangle the genetics of
migraine, Jefferson's periodical head-ach may loosen its
painful modern grip.
<p><b>SCIENTIFIC AMERICAN ONLINE</b> <br
/>COMMENT ON THIS ARTICLE AT <a
href="http://ScientificAmerican.com/dec2015">ScientificAmerica
n.com/dec2015</a></p>
AND
TIMM J. FILLER
Knowledge of the innervation of the outer ear is crucial for surgery in this region. The aim
of this study was to describe the system of the auricular nerve supply. On 14 ears of seven
cadavers the complete course of the nerve supply was exposed and categorized. A heterogeneous distribution of two cranial branchial nerves and two somatic cervical nerves was
found. At the lateral as well as the medial surface the great auricular nerve prevails. No region
with triple innervation was found. Clin. Anat. 15:3537, 2002. 2002 Wiley-Liss, Inc.
Key words: innervation; external ear; cadaveric study; variation
INTRODUCTION
A detailed knowledge on vascularization and innervation of the outer ear is crucial for reconstructive and
plastic surgery in this region. Moreover, the innervation of the auricle is the theoretical basis of different
reflex therapies (e.g., ear acupuncture). However, data
on the innervation as provided by scientific publications are scarce, incomplete, and inconsistent. The
aim of this study is to describe the system of the
auricular nerve supply.
RESULTS
A heterogeneous distribution of cranial branchial
nerves and somatic cervical nerves was found.
At the lateral surface the GAN (great auricular
nerve) prevails. In 73% of cases the ABVN (auricular
branch of vagus nerve) and in 18% the GAN was
found on the antihelix solely, and 9% showed a double
2002 Wiley-Liss, Inc.
DOI 10.1002/ca.1089
innervation. The lobule and the antitragus were supplied by the GAN in all cases. The tragus was innervated by GAN in 45% solely, in 9% by the ATN
(auriculotemporal nerve), and in all other cases by
both of them. The tail of helix and the scapha were
always supplied by the GAN, the spine of helix in
91% by the ATN (9% GAN). The ATN was found in
80% at the crus helicis; in 20% the ABVN branched on
this part. In 9% the ABVN provided ramification for
the crura antihelices (91% GAN), in 45% of the specimen for the cavity of conchae, and in 100% for the
cymba conchae. In 55% two nerves were found on the
cavity of conchae (GAN and ABVN). No region with
triple innervation was found. For an overview see
Table 1 and Figure 1A.
At the medial surface of the auricle the LON (lesser occipital nerve) participated in 55% of the innervation of the upper third (in 37% solely). The GAN
participated in 63% (in 27% solely); in 36% double
innervation was found. The supply of the middle third
was provided in 64% by the GAN (18% solely), in 73%
by the ABVN (27% solely), and in 18% by the LON
(in no case solely). Double innervation was seen in
55% of the middle third. At the lower third, in 91% of
the cases GAN was found (73% solely), and in 27%
the ABVN (9% solely). No region with triple innervation was found at the medial surface of the auricle as
*Correspondence to: Dr. Elmar T. Peuker, Institute of Anatomy,
Vesaliusweg 2-4, D-48149 Muenster, Germany.
E-mail: peuker@uni-muenster.de
Received 16 August 2000; Revised 19 January 2001
36
20%
9%
73%
45%
100%
45%
GAN
ATN
9%
100%
100%
91%
9%
100%
46%
80%
91%
18%
9%
55%
100%
DISCUSSION
37
nervation with both origins of the nerves. The overlapping was seen on the lateral site only within the
middle third (tragus, inferior concha, and antihelix),
whereas the medial surface revealed overlapping in all
parts.
Other studies imply that the sensory innervation is
provided by the cranial and cervical nerves (Satomi
and Takahashi, 1991). Labeling of the central projections shows a remarkable ipsilateral distribution (Nomura and Mizuno, 1984). However, the respective
studies have been performed mainly on cat auricles,
and no suggestions were made on the function of this
extensive innervation. Regulation of temperature
might be a possible explanation, control of ear formation could be another. Nonetheless, to our knowledge,
there are no related studies available.
Depending on the technique, complications of otoplasty and auricular reconstruction are quite common.
Cutaneous problems, residual pain, hypesthesia, sensitivity to cold or touch, and delayed wound healing
are mentioned in scientific publications (Calder and
Naasan, 1994; Caouette-Laberge et al., 2000; Weerda
and Siegert, 1994). Most of the surgical techniques do
not consider the innervation pattern (Heppt and
Trautmann, 1999). However, disturbances of the
nerve supply of the vessels and therefore of the tissue
nutrition may be responsible for the considerable
postoperative problems.
REFERENCES