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A Magic Pill? - Compound Could Mediate Noise-Induced Hearing Loss
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| HHIssues@aol.com 2005-06-11, 9:01 am |
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source: bhNEWS
The ASHA Leader, a publication of the American Speech-language-Hearing
Association
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A Magic Pill?
Compound Could Mediate Noise-Induced Hearing Loss
cite as: Shafer, D. N. (2005, June 14). A magic pill? Compound could
mediate noise-induced hearing loss. The ASHA Leader, pp. 5, 30.
by Dee Naquin Shafer
In a country that is often said to look for magic pills as health
solutions, a new treatment for hearing loss could be on the horizon: a
hearing pill.
A recently concluded double-blinded, placebo-controlled clinical trial
reviewed use of a commonly available nutritional supplement,
N-acetylcysteine or NAC. The study by the Naval Medical Center San
Diego at the Marine Corp Recruit Depot in Camp Pendleton, CA, used a
special formulation of NAC to determine its prophylactic qualities to
prevent hearing loss.
The clinical trial found that when compared to the placebo, NAC reduced
permanent hearing loss in the ear closest to the source of acoustic
trauma. NAC also shows potential in healing symptoms of acoustic
trauma, such as tinnitus and balance disorders. Another study will
tackle those issues.
Ben J. Balough, a Navy commander and otolaryngologist who directed the
study, cautioned against thinking of NAC as a one-a-day brand just yet.
"Optimal dosing for a given patient and particular noise exposure is
unknown at this point. Our goal is to provide something akin to a
nutritional supplement to provide
additional hearing protection for noise exposure over and above that
from standard ear plugs," he said.
Nearly 1,000 Marine recruits participated in the study, which lasted
about six months and ended in October 2004. Doctors requested
volunteers, who then received hearing screenings. Those who met hearing
requirements were enrolled in the study for approximately one month
during their routine recruit training. Their noise exposure was 300
rounds of M-16 fire over one week.
In addition to the standard ear plug protection that all recruits use,
nearly 600 of the participants took 900 mg of NAC three times a day
while the rest were given a placebo. Balough said the study was ideal
because noise conditions were tightly controlled. "We knew they weren't
going off to the disco at night; they weren't listening to their
Walkmans. And we knew when they were getting their [NAC] doses," he
said.
Research assistants (RAs) gave the recruits the pharmaceutical grade
formulation, a fizzy tablet that dissolved in water. Participants
received their final hearing tests 10 days after the noise exposure was
completed.
No significant differences between placebos and active agents were
present in the reported side effects of gas and bloating. Balough noted
these effects could have been due to the fizzy tablet formulation. "You
had green recruits in a hurry. Some of them were swallowing it before
it completely dissolved. When our RAs noted this and we made sure the
tabs were fully dissolved, the number of these effects declined."
The next study will focus on two already approved protocols examining
the effects of higher doses of NAC for more severe noise exposures as
well as tinnitus and balance problems. Balough said the group wants to
conduct another controlled trial to further examine NAC's prophylactic
qualities in noise injury. "It would be at a much higher dose, by a
factor of about 10. We want to
see if we can reverse or lessen an injury," he said. The higher dose is
for treatment of noise injury. Further prophylactic trials will use a
low dose but add other agents to the mix.
Finding a Gold Standard
Work on the hearing pill started about 10 years ago, Balough said. He
named a group of fellow military researchers and doctors who worked on
the project: Mike Hoffer, Ronald Jackson, and Rick Kopke. Basic science
shows that the ear has its own protective mechanism against noise. The
group discovered that protective mechanisms in the ear are mediated by
glutamate.
"For the neurotransmitters in the ear, glutathione reductase is one of
the key enzymatic pathways that helps detoxify free radicals," he said.
"The gold standard was NAC." Research and experiments with animals and
cells revealed that NAC mediated noise injuries. The next step was the
study with the Marine recruits.
Although the Navy has the patent on the NAC formulation used in the
study, the government requires that such work be made available to the
public. American BioHealth Group (ABG) bought the license from the
government and is marketing it as the "hearing pill." The Navy has a
cooperative research and development agreement with ABG. The government
will make money from the patent if ABG is
successful.
It is not considered a medication at this point. Balough said the FDA
considers it a "nutriceutical" at the lower dose. While NAC is
available at health food stores, products in such settings are not
regulated, making efficacy and dosage inconsistent.
Balough said the goal is to make the pill available for the military,
but results are premature as yet. It is the line commander's decision
whether soldiers must take it, he said. "They decide whether it's worth
enough to augment things on the field. They haven't asked for our
official opinion yet."
The Navy will continue to pursue military applications for NAC. The
substance is ripe for other areas of research though, Balough noted.
Researchers at the university of California, San Diego, are considering
a study of NAC applications in the geriatric population.
The complete study will be published in several peer-reviewed
publications in the coming months.
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| Serpent 2005-06-11, 9:01 am |
| On 11 Jun 2005 04:20:47 -0700, "HHIssues@aol.com" <HHIssues@aol.com>
wrote:
>
>source: bhNEWS
>
>The ASHA Leader, a publication of the American Speech-language-Hearing
>Association
>----------------
>A Magic Pill?
>Compound Could Mediate Noise-Induced Hearing Loss
>cite as: Shafer, D. N. (2005, June 14). A magic pill? Compound could
>mediate noise-induced hearing loss. The ASHA Leader, pp. 5, 30.
>by Dee Naquin Shafer
>
>In a country that is often said to look for magic pills as health
>solutions, a new treatment for hearing loss could be on the horizon: a
>hearing pill.
<SNIP>
After having a look at the private company's web site, it sounds
totally worthless to anybody that already has enough hearing loss, to
have already gotten hearing aids.
From their web site where you can readily plunk down your $35:
"Mechanism: The active ingredient in “The Hearing Pill” TM has been
demonstrated in laboratory studies, and along with anecdotal evidence
suggests, its ability to help protect and restorate damage from acute
(near-term) noise induced hearing loss. It has NOT been shown to
demonstrate those same capabilities for genetic, tinnitus or
autoimmune disorders.
Indications: The Hearing PillTM is indicated for helping the
remediation of the mechanisms that lead to permanent hearing loss,
either before or SHORTLY after noise trauma, after diagnosis by a
qualified physician"
"either before or SHORTLY after noise trauma" would indicate that for
us hearing aid wearers, it is most probably much to late for us.
As for those Marines firing their M-16's. Good for them, as this might
be a godsend to, at least, them! :-)
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| alf500@comcast.net 2005-06-11, 10:52 pm |
| On Sat, 11 Jun 2005 08:28:59 -0500, Serpent <ttt@none.com> wrote:
>"either before or SHORTLY after noise trauma" would indicate that for
>us hearing aid wearers, it is most probably much to late for us.
>
>As for those Marines firing their M-16's. Good for them, as this might
>be a godsend to, at least, them! :-)
Prednesone is a lot less expensive.
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