New Heart Alert for Some ADHD Drugs
WebMD Health News 2006. © 2006 WebMD Inc.
Aug. 22, 2006 -- Amphetamine-based drugs for ADHD, such as Adderall and Dexedrine, now come with a new, expanded 'black box' warning for an increased risk of sudden death in patients with heart problems.
A black box warning is the most serious warning added to a drug's label information.
Earlier this year, two FDA advisory panels recommended new warnings and information for all stimulant drugs used to treat attention deficit hyperactivity disorder (ADHD). But the panels didn't quite agree on the warnings.
In February, one panel recommended a black box warning. But, in March, a separate panel stopped short of recommending the black box warnings.
Since Adderall and Dexedrine are amphetamines, they already had a black box warning about amphetamine abuse.
That black box warning for the two drugs now includes the following sentence: "Misuse of amphetamines may cause sudden death and serious cardiovascular events." Notice of the warning for Dexedrine appeared on the FDA's site yesterday.
Ritalin and Concerta, two other drugs used to treat ADHD, aren't amphetamines. So they don't bear the black box warning about amphetamine use.
However, they are stimulants and do carry warnings about the risk of sudden death in people with heart problems. The FDA has not decided these drugs need to carry a black box warning.
Ritalin is made by Novartis. Concerta is made by McNeil Pediatrics. Adderall is made by Shire. Dexedrine is made by GlaxoSmithKline. All are WebMD sponsors.
ADHD Drug Warnings
Warning information for all stimulant ADHD drugs includes the following:
Sudden death has been associated with stimulants at usual doses in children and teens with structural heart abnormalities or other serious heart problems.
Children, teens, or adults who are being considered for treatment with stimulant medicines should have a careful checkup (including family history and a physical exam) to check for heart disease.
Patients who develop symptoms such as chest pain during exertion, unexplained fainting, or other possible heart symptoms should promptly get a heart evaluation.
Sudden death, stroke, and heart attack have been reported in adults taking stimulant drugs at usual doses for ADHD.
Adults are more likely than kids to have serious structural heart abnormalities, cardiomyopathy (a disease of the heart muscle), serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems.
Adults with such heart abnormalities should also generally not be treated with stimulant drugs.
GlaxoSmithKline, maker of Dexedrine, said in a letter posted on the FDA web site that it added the warning based on recommendations from the FDA advisory committees.
WebMD contacted the makers of Ritalin, Concerta, and Adderall for their comments.
In a statement emailed to WebMD, McNeil Pediatrics spokeswoman Julie Keenan confirmed that McNeil Pediatrics has worked with the FDA to update the warnings section of the prescribing information for Concerta extended-release tablets.
The update was "based on recommendations regarding use of stimulant medications to treat ADHD from two FDA advisory committee meetings," Keenan says.
"We encourage parents whose children use Concerta to contact their physician if they have any questions," she adds.
The makers of Ritalin and Adderall didn't respond before deadline.
The ADHD drug Strattera isn't a stimulant, so it doesn't carry the same warnings. Strattera is made by Eli Lilly and Company, also a WebMD sponsor.
FDA Approves New Treatment for Insomnia
Sat Jul 23, 8:56 AM ET
The government approved a new treatment for insomnia on Friday, the first prescription sleep aid not designated as a controlled substance.
Called Rozerem, the drug works differently from its competitors.
Rozerem is chemically related to the natural hormone melatonin, which helps regulate the body's sleep-wake cycle, and is thought to work by stimulating melatonin receptors in the brain, explained Dr. Robert Meyer of the Food and Drug Administration.
"It's another option" for people with the main form of insomnia, difficulty in falling asleep, Meyer said. "By working through a different pathway, it's entirely possible that this might work for some people in ways that the other drugs do not."
Nor do studies show any sign that Rozerem, known chemically as ramelteon, causes dependence, the reason it was not designated as a controlled substance.
The main warning: Rozerem is metabolized by the liver, so people with liver problems shouldn't take it, Meyer said
Manufacturer Takeda Pharmaceuticals said Rozerem will be available in late September but would not reveal a price.
Almost a third of adults have trouble sleeping, and about 10 percent have symptoms of daytime impairment that signal true insomnia. Rozerem joins a list of newer prescription sleep pills that work without many of the side-effect concerns of older agents.
Takeda Pharmaceuticals, based in Lincolnshire, Ill., is a wholly owned subsidiary of Takeda Pharmaceutical Co. Ltd., Japan's largest pharmaceutical company.
On the Net:
Takeda Pharmaceuticals North America, Inc.: http://www.tpna.com
Mobile Phones Increase Tumor Risk, Study Says Thu Oct 14, 1:38 AM ET
STOCKHOLM (Reuters) - Ten or more years of mobile phone use increases the risk of developing acoustic neuroma, a benign tumor on the auditory nerve, according to a study released on Wednesday by Sweden's Karolinska Institute.
The risk was confined to the side of the head where the phone was usually held and there were no indications of increased risk for those who have used their mobile for less than 10 years, the Karolinska Institute said in a statement.
The institute, one of Europe's largest medical universities and a clinical and biomedical research center, awards the Nobel Prize in physiology or medicine.
"At the time when the study was conducted only analog mobile phones had been in use for more than 10 years and therefore we cannot determine if there results are confined to use of analog phones or if the results would be similar also after long-term use of digital (GSM) phones," it said.
The mobile phone market is now dominated by GSM phones, which replaced the bulkier and less advanced analog phones in many markets the mid- and late-1990s.
The mobile phone industry has said there is no scientific evidence of negative health effects from use of mobile phones.
The Karolinska Institute said 150 people with acoustic neuroma and 600 healthy people participated in the study.
"The risk of acoustic neuroma was almost doubled for persons who started to use their mobile at least 10 years prior to diagnosis," the institute said.
"When the side of the head on which the phone was usually held was taken into consideration, we found that the risk of acoustic neuroma was almost four times higher on the same side as the phone was held and virtually normal on the other side."
Finland's Nokia (news - web sites) is the world's biggest mobile phone maker.
Other large producers include Motorola of the United States, South Korea (news - web sites)'s Samsung Electronics, Germany's Siemens and Swedish-Japanese joint venture Sony Ericsson (news - web sites).
Global mobile phone sales have been booming as thousands of new users sign up every day and existing subscribers replace their old handsets with new ones, capable of taking pictures or playing music.
PREVENTION AND TREATMENT OF SUNBURN
Solar ultraviolet (UV) light capable of injuring the skin is classified by wavelength into UVA I
(340-400 nm), UVA II (320-340 nm) and UVB (290-320 nm). UVB is responsible for most of the erythema
of sunburn. UVA has been implicated in the development of phototoxicity and photoaging.
The FDA permits sunscreen manufacturers to claim broad-spectrum protection if their products
block at least part of UVA II in addition to UVB.
SUN AVOIDANCE ? Avoiding exposure to direct sunlight, especially from 10 AM to 3 PM
when UV radiation from the sun is strongest, decreases but does not eliminate the risk of sunburn.
Patients should also be advised to wear protective clothing, such as wide-brimmed hats,
pants and long-sleeved shirts, and to apply sunscreen to exposed skin.
SUNSCREENS ? Topical sunscreens usually contain combinations of organic chemicals
that absorb various wavelengths of UV light. Most agents primarily absorb UVB radiation.
Avobenzone (also called Parsol 1789) also absorbs both UVA I and UVA II. Menthyl anthranilate
and oxybenzone also absorb some UVA II wavelengths. Inorganic physical sunblocks such as zinc
oxide or titanium dioxide block penetration of human skin by both UVA I and II. After application,
physical sunblocks are usually white or colored, but some newer formulations are transparent.
Sun Protection Factor ? The sun protection factor (SPF) is calculated by dividing the dose
of UV radiation needed to produce minimal erythema on skin protected by a sunscreen by the
dose that produces the same degree of erythema on unprotected skin. SPF is determined
indoors according to a standard protocol that uses artificial light sources and application of a
defined amount of sunscreen (2 mg/cm2). Applied in this thickness, a sunscreen with an SPF of
2 blocks about 50% of UVB radiation, an SPF of 10 blocks 90%, an SPF of 15 blocks 93% and an
SPF of 30 blocks 97%. The degree of protection against UVA is hard to quantify and is usually
much less than protection against UVB (RS Stern, N Engl J Med 2004; 350:1526).
Application ? Sunscreens should be applied 15-30 minutes before going out into the sun.
Most people do not apply a thick enough layer to achieve the claimed SPF. Many apply only 0.5
to 1 mg/cm2, which would give a sunscreen with a labeled SPF of 15 a true SPF of 2 to 4 (SR
Pinnell, J Am Acad Dermatol 2003; 48:1). To adequately cover all sun-exposed areas, the average
adult wearing a bathing suit would need to use about 1 oz of sunscreen.
Duration ? Wind, heat, humidity, and altitude can all decrease the effective SPF of a sunscreen.
Concomitant use of insect repellents that contain DEET also decreases SPF. Even though
newer sunscreens are more resistant to removal from the skin, to maintain protection the
American Academy of Dermatology recommends reapplication every 2 hours and after swimming
or heavy perspiration.
TREATMENT ? Once the signs and symptoms of sunburn are present no treatment,
including systemic corticosteroids, has unequivocally been shown to be effective. If started
before exposure to sun or before visible erythema, topical corticosteroids and oral nonsteroidal
anti-inflammatory drugs (NSAIDs) such as ibuprofen ( Motrin, and others) may slightly decrease
erythema during the first 24 hours. There is no evidence that an oral corticosteroid is more effective.
Emollients, antioxidants and antihistamines, taken systemically or applied topically, do not
decrease the time to healing (MS Driscoll and RF Wagner, Jr, Cutis 2000; 66:53; A Han and HI
Maibach, Am J Clin Dermatol 2004; 5:39). For symptom relief, emollients, cold compresses, topical
anesthetics and oral acetaminophen or NSAIDs may be useful.
CONCLUSION ? Prevention of sunburn requires sun avoidance, protective clothing and
generous, frequent use of broad-spectrum sunscreens with SPF of =15. No treatment has been
shown to decrease the time to healing.
Cholesterol Drugs Promising in Multiple Sclerosis
1 hour, 38 minutes ago Add Health - Reuters to My Yahoo!
By Ben Hirschler, European Pharmaceuticals Correspondent
LONDON (Reuters) - Cholesterol-lowering drugs, widely used to reduce the risk of heart attack, could also be effective in treating multiple sclerosis, according to new research published on Friday.
The news underscores the reputation of statins as potential miracle pills to rival aspirin.
Already hailed for revolutionizing the management of heart disease, the drugs -- which will soon be available over the counter in Britain -- are also being studied in the fight against Alzheimer's disease (news - web sites) and osteoporosis.
Researchers from the Medical University of South Carolina have produced the first clinical evidence that statins can help in multiple sclerosis in an article in The Lancet medical journal.
A group of 30 patients with MS given 80 mg a day of Merck & Co Inc's Zocor, or simvastatin, had a 44 percent reduction in brain lesions after three months of treatment, their study showed.
Brain lesions are areas of inflammation, and are markers of the progression and severity of MS -- a debilitating disease in which nerve cells lose their insulating sheath, leading to muscle weakness, fatigue, bladder problems and impaired vision.
Since existing MS treatments, such as interferons, are expensive injections and are only partially effective, swapping to statin pills -- which are already taken by millions of people every day -- would offer clear advantages.
But Professor Chris Polman, an MS expert at the VU Medical Center in Amsterdam, said more research was needed, including a large placebo-controlled clinical trial. The first of these trials is about to commence and could take around two years.
"It's a very good start but it's not conclusive," Polman said in a telephone interview, adding it was possible some brain lesions may have disappeared spontaneously given the relapsing-remitting nature of the disease.
The successful preliminary results recorded by Timothy Vollmer and colleagues in South Carolina follow earlier findings that statins can reverse paralysis caused by a similar condition to MS in mice.
Statins were first developed for their ability to block an enzyme involved in the liver's production of cholesterol. But researchers have since found they also counter key inflammatory processes that may be central to several chronic degenerative diseases.
Mike O'Donovan, chief executive of Britain's MS Society, said the latest findings were encouraging.
"These are early days but we must hope statins can prove to be an effective weapon in the growing armory of treatments to attack this very distressing life-long disease," he said.
Still, much work remains to be done, including discovering the optimal dose for statins in MS, since initial indications suggest it may have to be higher than for people with raised levels of LDL or "bad" cholesterol.
In the meantime, Polman urged MS sufferers not to switch from existing medications, warning that premature use of statins could develop into a "dangerous boomerang."
That risk may be heightened in countries like Britain which this week became the first in the world to approve the sale of simvastatin without prescription, although only at a low 10 mg dose.
About one in five people regularly gets bothersome canker sores, which can make eating, drinking, and even brushing your teeth a real pain. But just because they're a relatively common occurrence doesn't mean these small open sores inside the mouth should be ignored.
What Are Canker Sores?
Also known as aphthous ulcers or aphthous stomatitis, canker sores are small sores that can occur inside a person's mouth, cheeks, lips, throat, or sometimes on the tongue. But don't confuse canker sores with cold sores or fever blisters, which are sores that are caused by the herpes simplex virus
and are found outside the mouth around the lips, on the cheeks or chin, or inside the nostrils. Whereas cold sores are contagious, canker sores are not contagious - so kissing cannot spread them.
Although canker sores aren't contagious, the tendency to have outbreaks of canker sores can run in a family. If you're prone to canker sores, your children have a 90% chance of getting them as well.
Although no one knows exactly what causes canker sores, many factors are thought to put a person at risk. Diet may be a factor. People who have nutritional deficiencies of folic acid, vitamin B12, and iron
seem to develop canker sores more often, as do people who have food allergies
. Canker sores may also indicate that a person has an immune system problem. Mouth injuries, such as biting the inside of your lip or even brushing too hard and damaging the delicate lining inside your mouth, also seem to bring on canker sores. Even emotional stress seems to be a factor. One study of college students showed that they had more canker sores during stressful periods, such as around exam time, than they did during less stressful times, such as summer break.
Although anyone can get them, young people in their teens and early twenties seem to get them most often, and women are twice as likely to develop them as men. Some girls and women find that they get canker sores at the start of their menstrual periods.
Signs and Symptoms
Canker sores usually appear as painful, red spots that can be up to 1 inch (2.5 centimeters) across, although most of them are much smaller. Sometimes the area will tingle or burn before a spot actually appears. Once it does, the canker sore may swell and burst in about a day. The open sore may then have a white or yellowish coating over it as well as a red "halo" around it. Most often, canker sores pop up alone, but they can also occur in small clusters.
Although uncommon, people with canker sores can also have symptoms such as fever, swollen lymph nodes, and a lethargic or slightly ill feeling.
It takes about 2 weeks for canker sores to heal. During this time, the sores can be painful, although the first 3 to 4 days are usually the worst.
If your child develops canker sores that last longer than 2 weeks or if your child is unable to eat or drink because of the pain, contact your child's doctor. You should also call your child's doctor if the sores appear more than two or three times a year.
If your child has recurrent canker sores, your child's doctor may want to perform tests to look for possible nutritional deficiencies (which can be corrected with dietary changes or using prescription vitamin supplements), immune system deficiencies, and food or other allergies.
Often, canker sores can be easily treated with over-the-counter or even home remedies. Carbamide peroxide is a combination of peroxide and glycerin that cleans out the sore while coating it to protect the wound.
Many over-the-counter remedies have benzocaine, menthol, and eucalyptol in them. These may sting at first and need to be applied repeatedly, but they can reduce pain and shorten the duration of the sore.
You can also have your child rinse his or her mouth with a homemade solution for about a minute, four times a day, as needed. It's extremely important to remember, though, that these rinses should not be swallowed, so they shouldn't be used in children too young to understand not to swallow. Here are the rinse recipes:
2 ounces (59 milliliters) of hydrogen peroxide and 2 ounces (59 milliliters) of water
4 ounces (118 milliliters) of water mixed with 1 teaspoon (5 milliliters) of salt and 1 teaspoon (5 milliliters) of baking soda
Another option to help reduce discomfort and speed healing is dabbing a mixture of equal parts water and hydrogen peroxide directly on the sore, followed by a bit of milk of magnesia.
Some doctors suggest applying wet black tea bags to the sore. Black tea contains tannin, an astringent that can help relieve pain. You can also get tannin in over-the-counter medications. Ask the pharmacist for more information.
If your child's doctor prescribes a medicine that should be applied directly to the canker sore, first dry the area with a tissue. Use a cotton swab to apply a small amount of the medication. Finally, avoid eating or drinking for at least 30 minutes to make sure that the medicine isn't immediately washed away and has time to work.
In some cases of severe mouth sores, your child's doctor may prescribe treatments such as immunosuppressive drugs or mouth rinses or gels that contain steroids.
Caring for Your Child
Help make canker sores less painful and prevent them from recurring by encouraging your child to:
avoid eating abrasive foods, such as potato chips and nuts, which can irritate gums and other delicate mouth tissues
use only soft bristle toothbrushes and be careful not to brush so hard that they do damage
avoid any foods he or she is allergic to
avoid spicy, salty, and acidic foods (such as lemons and tomatoes), which can aggravate tender mouth sores
Although they can certainly be a pain, canker sores aren't that big of a deal. Plenty of people have learned to deal with them - and your child can, too.
House OKs Importation of Lower-Cost Drugs
56 minutes ago Add Health - AP to My Yahoo!
By DAVID ESPO, AP Special Correspondent
WASHINGTON - The House approved legislation early Friday to allow the importation of lower-cost prescription drugs from industrialized nations, brushing aside opposition from the Bush administration and a fierce lobbying campaign by the pharmaceutical industry.
The vote was 243-186, and sent the measure to the Senate, where it faced an uncertain fate.
"I was not sent here by drug companies and I will not stand here and see American seniors take a back seat to the pharmaceutical industry," said Rep. Jo Ann Emerson (news, bio, voting record), R-Missouri.
"A bottle of tamoxifen, used to fight breast cancer (news - web sites), costs $360 in the United States. It costs $60 in Germany," she added.
But critics argued the bill, while it held out the hope of lower prices, would sacrifice patient safety.
"The country is going to be flooded with unsafe pharmaceutical counterfeits, over-age pharmaceuticals, pharmaceuticals that don't preserve and protect the safety of our citizens," said Rep. John Dingell (news, bio, voting record), a Michigan Democrat who has worked across the decades for patient safety legislation.
The bill was brought to the floor under unusual circumstances. Republican leaders oppose it, but Speaker Dennis Hastert, R-Ill., agreed to allow a vote last month as part of an agreement for Emerson to vote for Medicare prescription drug legislation.
Congress has approved legislation twice before dealing with the drug importation issue, but both times said the secretary of the Department of Health and Human Services (news - web sites) would first have to certify that the drugs would be safe. Neither Donna Shalala, who served under former President Clinton (news - web sites), nor Tommy Thompson, who holds office under President Bush (news - web sites), was willing to do so.
The vote was designed to force House and Senate bargainers to accept the legislation as part of a Medicare prescription drug bill.
But even as it was passing, 53 senators declared their opposition to any change in law that would remove deny the secretary of HHS the ability to decide whether importation was safe.
The House bill, backed by Republican Reps. Gil Gutknecht of Minnesota and Emerson, as well as Rep. Rahm Emanuel of Illinois, ordered HHS to set up a system to allow importation of FDA (news - web sites)-approved drugs from FDA-approved facilities in Canada, the European Union (news - web sites) and seven other nations.
The measure also would require imported medicine to be shipped in anti-tampering and anti-counterfeiting packaging.
But the Bush administration issued a statement calling the bill "dangerous legislation."
And FDA Commissioner Mark McClellan said the measure "creates a wide channel for large volumes of unapproved drugs and other products to enter the United States that are potentially injurious to public health and pose a threat to the security of our nation's drug supply."
The measure had wide appeal to consumers — thousands of whom have ridden in buses to Canada in recent years to buy lower-cost drugs. And several lawmakers accused the drug industry of merely trying to protect its own profits. Liberal Rep. Bernard Sanders (news, bio, voting record), I-Vt., saying it had spread "lies, lies, and lies again" in an effort to kill the bill, while conservative Rep. Dan Burton (news, bio, voting record), R-Ind., said, "it's not about safety, it's about money."
But the lobbying seemed one-sided.
Rep. Elijah Cummings (news, bio, voting record) of Maryland, a liberal Democrat and head of the Congressional Black Caucus (news - web sites), said only one outside group had contacted him, the pharmaceutical industry.
And in Indiana, Eli Lilly & Co. ran newspaper advertisements in GOP Rep. Dan Burton's district attacking the bill that he supporters. Burton, a conservative Republican, ran radio advertisements in response.
"We do believe there is a safety problem," said Mark Grayson, a spokesman for the Pharmaceutical Research and Manufacturers of America, known as PhRMA. He also said the legislation would import the system of price controls that foreign government impose on drugs.
He said he didn't know how much the group was spending the defeat the bill, adding, "We don't discuss that."
The pharmaceutical industry made more than $20 million in political contributions in the past election, with roughly $8 of every $10 going to Republicans, according to an analysis by the Center for Responsive Politics.
PhRMA itself gave more than $3 million and spent more than $14 million lobbying Congress on various issues last year. In addition, the organization gave millions last year to an organization that aired television commercials on behalf of candidates who backed a GOP-written prescription drug bill.
Individuals who rarely agreed on anything worked to defeat the measure.
They included the Traditional Values Coalition (news - web sites) and the Rev. Jerry Falwell, both warning that the bill could allow importation of the morning-after abortion drug RU-486 (news - web sites); and Rep. Bobby Rush (news, bio, voting record), D-Ill., a liberal Democrat who represents an inner-city Chicago district.
In a letter to all House members, he warned the bill could divide the country into two groups: one, middle class and suburban "will be able to pay higher prices for the medicines they need." The other, he said will be "economically disadvantaged ... including a significant portion of the minority community." Those Americans, he said, won't be able to afford what American drugs cost and will wind up with "cheap, reimported, cut-rate medications sold through knockoff drugstores."
Also opposed to the bill was the National Medical Association, an organization of black physicians, which cited concern about safety issues. The association also receives support from PhRMA, which was a corporate sponsor at the group's 2002 annual convention.
Given the circumstances, the customary party lobbying was suspended.
Antioxidant Shows Promise in Staving Off Parkinson's
Mon Oct 14, 7:07 PM ET
By Jennifer Thomas
MONDAY, Oct. 14 (HealthScoutNews) -- A natural compound often used as an antioxidant is showing promise in slowing the progression of Parkinson's disease (news - web sites).
Researchers in 10 hospitals across the United States tested the compound, called coenzyme Q10, in 80 patients who were in the early stages of Parkinson's.
After 16 months, the study found patients taking the highest dose of coenzyme Q10 had 44 percent less decline in their ability to carry out activities of daily living, including dressing, bathing and walking.
However, doctors caution it's too soon to recommend coenzyme Q10 to patients with Parkinson's.
"While it is tremendously encouraging that our results indicate that it is likely that coenzyme Q10 slows the progression of Parkinson's disease, our study did not have sufficient numbers of patients to unequivocally prove that it does," says Dr. Clifford Shults, the study's principal investigator and a professor of neurosciences at the University of California, San Diego. "It would be premature to recommend that patients with Parkinson's disease take high doses of coenzyme Q10."
Dr. Joel Perlmutter, a Parkinson's expert and professor of neurology, radiology and neurobiology at Washington University in St. Louis, made that point even more strongly.
"My father has Parkinson's, and I'm telling him not to take it," says Perlmutter, whose hospital was one of the centers involved with the study. "The findings are suggestive but not conclusive. Larger studies may demonstrate an unexpected result. There could be an adverse effect, although we haven't seen any evidence of that yet."
Coenzyme Q10 is classified as a dietary supplement and is therefore not regulated by the U.S. Food and Drug Administration (news - web sites). It's sold in various forms, including as a toothpaste additive, at health food stores.
However, the versions of the coenzyme Q10 sold in stores may differ and might not contain beneficial amounts of the compound, Shults says. Furthermore, it's very costly, he adds.
Another consideration: The people in the study had early-stage Parkinson's. None of the patients were taking any other Parkinson's medication, and nothing says coenzyme Q10 is beneficial for people with later stages of Parkinson's, he says.
The study appears in tomorrow's issue of the Archives of Neurology, and the researchers made a presentation today at the annual meeting of the American Neurological Association in New York City.
Parkinson's is a degenerative brain disease that affects about 1 percent of Americans over age 65. Symptoms include tremors, slowness of movement and muscle stiffness to the point of paralysis. Some patients also develop problems with sleeping, swallowing, depression and a decline in mental function.
Certain drugs, including levodopa, can reduce symptoms of Parkinson's disease, but no drug has been shown to slow the progressive deterioration in function.
The exact cause of Parkinson's in unknown, although it results from a loss of brain cells that produce the neurotransmitter dopamine.
What does coenzyme Q10 have to do with it?
Coenzyme Q10 is a molecular compound found in the mitochondria, a long, oval-shaped part of cells that convert nutrients into energy. Coenzyme Q10 is also a potent antioxidant.
Previous research by Shults and his colleagues has shown that people with Parkinson's have low levels of coenzyme Q10 and that the function of mitochondria is impaired.
In the current study, 80 patients were randomly assigned to one of four groups: those taking four doses of coenzyme Q10 that added up to 300, 600, or 1,200 milligrams a day, and those taking a placebo.
Study participants had a thorough physical exam and medical history taken before taking the coenzyme Q10.
They were then re-examined at regular intervals for up to 16 months, or until it was determined they needed to begin taking medication such as levodopa for the treatment of symptoms.
The eight-month exam was when the differences between the groups really began to show. Those on the highest dosage of coenzyme Q10 showed fewer declines in their physical abilities, mental function and mood. Those taking lower doses of coenzyme Q10 didn't do as well, but they did better than those on the placebo.
The benefit was seen throughout the 16 months of the study.
Shults believes coenzyme Q10 was doing more than just relieving the symptoms. If that was the case, he says, the groups taking the coenzyme Q10 would have shown improvement at the first check-up, one month into the study.
Since it wasn't until eight months into the study that the differences in the groups became apparent, Shults believes the coenzyme Q10 could be stopping Parkinson's march. "It suggests it may be possible to actually slow the progression of the disease rather than just treat the symptoms," he says.
Researchers are now seeking funding for a larger clinical trial to study the effects of dosages of 1,200 milligrams a day of coenzyme Q10 and greater.
"The value of this study is to lay the foundation for a subsequent larger study," Perlmutter says. "It's exciting. I'm enthusiastic about doing a real trial now to really find out if this stuff has benefit. It's a big step, but it's not the final step."
New Compound Said to Stop HIV, Aid Immune Response
Fri Sep 27, 5:41 PM ET By Deena Beasley
LOS ANGELES (Reuters) - Scientists have created compounds that may be able to block the virus that causes AIDS ( news - web sites) and at the same time keep the body from sabotaging its own immune response, according to early-stage research unveiled on Friday.
Mymetics Corp. said test tube studies show that one of its experimental compounds is seven times as potent as the most promising "fusion inhibitor" of HIV ( news - web sites). The results were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy in San Diego.
So-called fusion inhibitors, designed to stop the virus from getting into cells in the first place, are the most advanced new HIV drug class in development. Currently approved AIDS medicines attack HIV only after it has entered a cell.
Annapolis, Maryland-based Mymetics is developing compounds that block the virus before it fuses with the host cell while disrupting a phenomenon dubbed "molecular mimicry"--the existence of similarities between viral and host cell proteins that undermine the body's immune system, making it easier for the viral infection to progress.
"They have tailor-made peptides (short chains of amino acids) that prevent viral entry without affecting IL-2 (a naturally occurring protein involved in immune system regulation)," said Dr. Ronald Gray, professor of epidemiology at Johns Hopkins Bloomberg School of Public Health in Baltimore.
The theory is that mimicry allows gp41, a protein on the surface of HIV cells, to bind to the host cell's receptor for IL-2, which provokes the body's own immune system to attack IL-2 and may explain why HIV infection leads to AIDS and, ultimately, the fatal breakdown of the body's immune system.
"Patients who have AIDS actually have antibodies against IL-2. We think we've come up with an explanation for why," said Peter McCann, chief executive of Mymetics.
He cautioned that the work is still very early-stage--the peptides have yet to be tested in animals--and permission for trials in humans will be sought within two years.
According to the in vitro results, Mymetics' candidate compounds, S291 and N36E, cut viral levels in a commonly tested HIV strain to 0.37 micrograms per milliliter (ml) and 0.02 micrograms per ml, respectively. By comparison, a peptide similar to the most clinically advanced fusion inhibitor, Trimeris Inc.'s T-20, measured 0.15 micrograms per ml.
The compounds have been designed to adhere to gp41 without interfering with the IL-2 receptor, thus inhibiting HIV without suppressing the immune system's response.
The company said it is testing the peptide candidates against a variety of mutated HIV strains and intends to begin animal testing within the next nine months.
Mymetics is also planning to test a model peptide against a feline leukemia virus in order to iron out details before beginning more advanced studies of its HIV peptides. "We can work through formulations and dosage levels in cats," said Joseph Mosca, Mymetics' vice president of development.
The company is also looking at using its molecular mimicry platform to combat retroviruses associated with diseases that include certain leukemias and multiple sclerosis.
Chewing Gum Speeds Recovery After Colon Surgery
Fri Jul 26, 5:37 PM ET
NEW YORK (Reuters Health) - Chewing gum may help patients recover normal intestinal function more quickly after major abdominal surgery, according to the results of a small study.
Patients who have major abdominal surgery usually suffer temporary bowel problems, stomach discomfort, nausea and vomiting afterward--a condition known as ileus. The sooner a patient recovers normal bowel function after surgery, the earlier he or she can leave the hospital.
In the report, published in the July issue of the Journal of the American College of Surgeons, lead author Dr. Takayuki Asao of Gunma University School of Medicine in Maebashi, Japan, and colleagues point out that chewing, or "sham feeding," has been reported to stimulate intestinal activity in humans.
To investigate whether chewing gum might have this effect on patients after abdominal surgery, Asao's team studied a group of 19 patients who underwent operations to remove a portion of their colon to treat colon cancer. Ten of the patients chewed gum three times daily from the first morning after their surgery until they were able to eat, while the other patients did not chew gum.
According to the findings, the gum-chewing patients recovered normal bowel function more quickly than those who did not chew gum. They passed gas for the first time about 2 days after their surgery, compared with about 3 days after the operation for the patients who did not chew gum. And the gum-chewing patients had their first bowel movement about 2.7 days earlier than the patients who did not chew gum.
The researchers hypothesize that chewing gum might have this effect by stimulating reflexes involved in digestion, and also triggering the release of saliva and other digestive juices.
"Gum-chewing should be added as an adjunct treatment in postoperative care because it might contribute to shorter hospital stays," Asao and colleagues conclude.
SOURCE: Journal of the American College of Surgeons 2002;195:30-32.
Decade-Long "Benign" MS Predicts Continuing Stable Disease
NEW YORK (Reuters Health) Sept 01 - A long-term follow-up study of patients with multiple sclerosis suggests that for those who have minimal disability for more than 10 years, the likelihood that their disease will remain stable is very high.
The findings are reported in the August issue of Annals of Neurology. The authors note that "benign MS" has been used to denote "MS patients who are doing well," but whether such patients should be treated with immunomodulatory drugs remains a question.
At the Mayo Clinic in Rochester, Minnesota, Dr. Sean J. Pittock and colleagues analyzed the course of disease in 162 patients who comprised the 1991 Olmsted County Multiple Sclerosis prevalence cohort. In particular, the researchers studied 49 patients who in 1991 had benign disease.
The investigators point out that by the time of the latest follow-up, their subjects had a minimum disease duration of more than 20 years.
The team reports that "the longer the duration of multiple sclerosis and the lower the disability, the more likely a patient is to remain stable and not progress."
They add, "This is particularly powerful for patients with benign multiple sclerosis with Expanded Disability Status Scale scores of 2 or lower for 10 years or longer." In such patients, the chance of remaining stable is greater than 90%.
"This is important because these patients represent 17% of the entire prevalence cohort," the authors conclude. "These data should assist in the shared therapeutic decision-making process of whether to start immunomodulatory medications."
Ann Neurol 2004;56:303-306.