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The Evidence of Stoping Hair Loss by Laser Comb is Thin

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Popular hand-held laser device LaserComb might revive follicles for some men. Maybe.

Americans spend billions on hair-care products each year, a remarkable investment for a part of the body with no real function. We clean it, nourish it and style it — and we definitely mourn its loss.

Lots of products and procedures promise to restore thinning or disappearing hair. One especially intriguing option is the HairMax LaserComb, a hand-held laser device that supposedly revives hair follicles. Hailed on TV news programs as a potential “cure for baldness,” the device received FDA clearance for men in 2007. Unlike drugs, most medical devices can be approved without rigorous testing. A company must merely persuade the Food and Drug Administration that the new device is “substantially equivalent” to other products already on the market. In this case, the makers of the LaserComb told the agency that their product was roughly as safe and effective as a wide range of other laser devices, including a gadget intended to kill lice. They also claimed to be in the same league as the Evans Vacuum Cap, an early 20th century hair-growth contraption that’s pretty much what it sounds like.

The LaserComb is sold online and through the SkyMall catalog for about $500.

Users are instructed to slowly move the comb back and forth through their remaining hair for 10 to 15 minutes at a time, three days a week.

The claims
According to the HairMax website, “90% of HairMax users notice positive benefits starting in as little as 8 weeks. These results include: increased hair growth, cessation of hair loss, faster growing hair, more manageability and more vibrant color.”

David Michaels, the managing director of Lexington International, the company behind the LaserComb, says it works by “transferring light energy to cellular energy” in the follicles. The device can’t restore hair to a bald spot, he says, but it can make any remaining hair grow “faster, thicker, heavier and stronger.”

The bottom line
Lasers can undoubtedly encourage hair growth, says Dr. Marc Avram, a clinical associate professor of dermatology at Weill Cornell Medical College in New York City.

In fact, a small percentage of people who undergo laser hair removal end up with more hair than they had to start with. As Avram and colleagues noted in a 2007 issue of the Journal of Cosmetic and Laser Therapy, many hair-loss centers offer treatment with low-level laser devices, and some patients really do seem to benefit. Nobody knows why hair responds to lasers, he explains, although it’s possible that the beams somehow encourage blood flow to the follicles.

Still, according to Avram, there’s no good evidence that the LaserComb works any better than more-established treatments such as the prescription medications Rogaine or Propecia. For his patients who are unwilling or unable to use the medications, he says that the device could be worth a try. The LaserComb is safe, he says, and it just might help. “But I set low expectations for it.”

Avram recently tested the HairMax LaserComb on a handful of patients in his office over six months. (Contrary to claims made for the LaserComb, Avram says, it takes at least six months to see real results from any hair-loss treatment.)

“In 20% of the subjects, it seemed to maybe have an effect” on the appearance of hair, Avram says. The study hasn’t been published yet, and it didn’t include a control group for the sake of comparison. Avram readily admits his study “isn’t definitive,” but he hopes it might encourage more research in the future.

By contrast, Rogaine and Propecia have already been tested in multiple high-quality studies and have been shown to stop hair loss in 80% to 90% of patients, Avram says.

Uncertainty aside, the LaserComb has clearly captured the public‘s imagination. Patients ask about it “all the time,” says Dr. Paradi Mirmirani, a dermatologist with the Kaiser Permanente Vallejo Medical Center and a member of the North American Hair Research Society. Mirmirani says the device could potentially stimulate hair growth. “But I don’t have any evidence. If patients want to spend $500 on this device, it’s their choice. But I wouldn’t recommend it. They should save it for something that we know actually works.”

Last May, the FDA issued a warning letter against Lexington International for illegally marketing the device to women when it had been officially cleared only for men. The HairMax website now says that the device is intended for men only, but recorded messages for callers on hold to customer service still say that it “works equally well on both men and women” and that “anyone of any age, male or female, can benefit.”

Michaels says the company has asked the FDA for approval to market the device to women and expects a decision soon.

Is there a consumer product you’d like the Healthy Skeptic to examine? E-mail the details to health@latimes.com.

Sources: Los Angles Times

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Should Statins be Available for Everyone?

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They lower cholesterol and heart attack risk and may hold promise against other diseases, including cancer. Doctors consider broadening their use.
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Should statin drugs be put in the water, or what? ¶ More than 13 million Americans are taking these medications to lower their cholesterol and hopefully stave off heart disease — a job the drugs appear to excel at. Statins can lower “bad” LDL cholesterol by 20% to 60%. Over time, this can lower the risk of having a heart attack by about the same amount. ¶ For many years, it was believed that statins worked solely by reducing blood cholesterol, which can build up in sticky plaques in the arteries that supply blood to the heart, potentially blocking blood flow and causing heart attacks. But evidence is mounting that the drugs reduce heart disease risk through more than just their cholesterol-lowering effects. New research suggests they may be beneficial even for people with cholesterol in the normal range. ¶ This has doctors and medical researchers debating whether many more people should be on statins than currently fall under treatment guidelines. Some drug companies and doctors have even argued that low doses of the drugs should be available over the counter, as they are in the United Kingdom.

At the same time, other studies are reporting that statins might help prevent or treat a number of noncardiovascular conditions — including multiple sclerosis, cancer and Alzheimer’s disease. With all this news, many may be wondering, “Should I take a statin, just in case?”

Experts, for the most part, will say only, “Maybe.”

Most of the people at high risk of cardiovascular disease “are going to be safer and live longer if they’re on a statin than if they’re not,” says Nathan Wong, director of the UC Irvine Heart Disease Prevention Program. But that doesn’t hold for people whose risk for heart attacks is very low to begin with, he adds. “I’m not saying that everyone is going to be better on a statin. They need to be used with discretion.”

All six statins available today — atorvastatin (Lipitor), rosuvastatin (Crestor), simvastatin (Zocor), lovastatin (Mevacor), pravastatin (Pravachol) and fluvastatin (Lescol) — work by blocking an enzyme called HMG-CoA reductase.

In the liver, blocking this enzyme shuts down cholesterol production and increases the amount of cholesterol the liver takes out of the bloodstream.

But statins also block HMG-CoA reductase in the cells lining blood vessels, where, among other things, they can reduce inflammation.

Dramatic results
The anti-inflammatory effect of statins has been on many heart experts’ minds since the Nov. 9 announcement of the results of a clinical trial called JUPITER. The trial showed that statin treatment can reduce the risk of heart disease in people with normal cholesterol levels but high levels of inflammation as measured by blood levels of a marker called C-reactive protein (CRP).

A team led by Dr. Paul Ridker of Brigham and Women’s Hospital in Boston and Harvard Medical School found that in 8,901 people with high blood CRP levels, rosuvastatin (Crestor) reduced the risk of a heart attack by 54% and the need for bypass surgery or angioplasty by 46% compared with an equal number of people taking a placebo.

There were 68 heart attacks and 131 bypass surgeries/angioplasties in the placebo group, but only 31 and 71, respectively, in the group taking the statin. There were 48% fewer strokes — 64 versus 33. These effects were so dramatic that regulators stopped the trial, slated to go for four years, after less than two. AstraZeneca, the company that makes Crestor, funded the JUPITER trial.

The results raise an obvious question: Are the cholesterol-lowering effects or the inflammation-reducing effects of statins more important?

Dr. Christopher Cannon, a cardiologist at Brigham and Women’s, says they both play a part: “You have to have some cholesterol get into the arteries [and cause damage]. And if you have inflammation that damages the lining of the arteries, the cholesterol gets in more easily.”

Inflammation can also encourage plaques to rupture, causing clots that block blood flow. “Both [cholesterol buildup and inflammation] are happening simultaneously, and both are inhibited simultaneously with statins,” Cannon says.

Currently, more than 13 million people take statin drugs for elevated LDL cholesterol, and at least 47 million more have cholesterol levels high enough to make them eligible by current National Heart, Lung, and Blood Institute cholesterol guidelines.

Ridker estimates an additional 4 million to 6 million people would be added to the mix if everyone who would have qualified for the JUPITER trial (men over 50, women over 60, LDL cholesterol below 130 mg/dL and CRP above 2 mg/L) started taking a statin.

Anti-inflammatory:

Statins may be good for more than just fighting heart disease.

Very preliminary studies suggest that the anti-inflammatory effects of statins could help treat autoimmune diseases. A small, nine-month study of 36 patients with multiple sclerosis published in April in the journal PLoS One showed that statin treatment, either alone or combined with standard MS treatment, reduced the number of brain lesions characteristic of the disease by 24% and reduced their size by about 12%.

Another pilot study of just seven people, published in September 2007 in the Journal of the American Academy of Dermatology, showed that a statin reduced the severity of the skin disease psoriasis

A combined analysis of 19 studies, published in August in the International Journal of Cancer, found that statin use reduced the risk of advanced prostate cancer by 23%.

And a study published in November in the Journal of the National Cancer Institute showed that men prescribed statins had a 4.1% decline in their blood levels of prostate-specific antigen (PSA), a marker of prostate cancer.

There is some evidence that statins can lower the risk of developing Alzheimer’s disease. An October study of almost 7,000 people in Rotterdam, Netherlands, found that people taking a statin had about a 50% lower risk of Alzheimer’s compared with those who had never used cholesterol-lowering medication. Other studies, however, have failed to find an effect of statins on the risk for dementia or Alzheimer’s disease.

As the benefits of these drugs are experienced by more people, the risks will be too. Though statins are generally considered safe, they do have side effects.

Drugs’ side effects:-
The most commonly reported adverse event associated with statins is muscle pain. A 2006 analysis of seven clinical trials published in Medscape General Medicine found that 2.5% to 6% of patients taking statins reported aches and pains related to their drugs.

Rhabdomyolysis, a breakdown of skeletal muscle that can lead to kidney failure and sometimes death, has also been linked to statins. According to the 2006 Medscape report, less than 0.1% of patients taking statins reported rhabdomyolysis. There was only 0.15 death from rhabdomyolysis per 1 million prescriptions.

Liver effects are also seen in some patients taking statins. In less than 1% of patients taking moderate doses of statins, and in about 2% to 3% of those taking high doses, liver enzyme levels are abnormally high. But the enzyme changes usually subside after discontinuing statin use or switching to a different statin, says Dr. Antonio Gotto, dean of Weill Cornell Medical College in New York.

In 2007, the Food and Drug Administration conducted an investigation into whether statins increase the risk of the fatal neurodegenerative disease amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease, when the agency received a higher than expected number of reports of the disease in people taking statins. Although an analysis of 41 long-term controlled clinical trials reported in September detected no such link, the FDA has said it plans to continue studying the issue.

Dr. Scott Grundy, a professor of internal medicine and director of the Center for Human Nutrition at the University of Texas Southwestern Medical Center at Dallas, says he thinks the drugs, on balance, are safe. But he adds that caution is still warranted, especially when it comes to considering a broad expansion of their use or prescribing them earlier in people’s lives.

Statins have been in use only since the late 1980s, he notes, and so there hasn’t been enough time yet to learn what might happen if someone were to be on the drugs for 30 or 40 years. “It is possible that some of these rare side effects might turn out to be quite important if [statins are] started early in life and continued for years and years,” he says.

Whether statin use is substantially expanded may depend on how the results of the JUPITER trial and other recent research are incorporated into new cholesterol guidelines slated to be released next year by the National Heart, Lung and Blood Institute.

If CRP testing becomes part of the standard battery of tests that guide risk assessment and statin treatment decisions, millions more Americans could find themselves filling a prescription.

Currently, most doctors use CRP testing as a sort of tie-breaker when they are on the fence as to whether a patient is at high enough risk of heart disease to warrant statin therapy. Patients might, for example, have intermediate cholesterol levels but a family history of heart attacks or some other risk factor.

Dr. Mary Malloy, co-director of the adult lipid clinic and director of the pediatric lipid clinic at the UCSF Medical Center, does not think this should change, even though she characterizes the JUPITER results as “very impressive.”

“I am personally not ready to corral everyone over 35 and do CRP testing,” she says.

Wong says it’s important that people take into account a person’s absolute risk when judging whether or not a patient needs a statin.

Of the JUPITER trial, he says, “There was a 44% reduction in cardiovascular events. This sounds very dramatic, and it is.” But the risk of heart attack in those patients was pretty tiny to begin with — 2.8%. The 44% drop took it down to 1.6%.

The bottom line is that monetary cost as well as potential side effects of statins must be weighed against the potential benefits.

Wong’s biggest concern is that people will get the idea that statins are a cure-all — and they’ll stop bothering about habits that could affect their heart health just as much.

“People think statins are magic pills,” he says. “You can’t forget about other risk factors like smoking, diabetes and blood pressure. . . . you have to make sure all these things are adequately controlled.”

Sources: Los Angles Times

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A Viral Illness That Can Be Silent and Hard to Treat but Also Cured

Hepatitis C can take decades to show up as damage to the liver.

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Chronic viral hepatitis is now the leading reason for liver transplants.

Current combination therapy can be individualized to cure chronic infections in 40 to 80 percent of cases.

The consequences of being infected with hepatitis C can take years to appear. So while new cases of the disease have fallen sharply over the past few decades, many people infected years ago are only beginning to learn they carry the virus, and to grapple with its potentially serious effects.

For many, there is good news. Half of all chronic infections can now be cured through a therapy using a combination of drugs. But hepatitis C remains a wily virus, often lying low for years and then following a course so unpredictable that doctors sometimes aren’t sure whether to recommend treatment or advise patients to watch and wait.

The biggest obstacle to effective treatment remains the fact that a majority of the estimated 3.2 million Americans who harbor chronic hepatitis C aren’t even aware they have it. In four out of five people, there are no symptoms when the infection first occurs.

“Most of the people we see discovered they have chronic hepatitis C when they went to donate blood or had a physical exam in order to get insurance,” said Dr. Bruce R. Bacon, director of the division of gastroenterology and hepatology at Saint Louis University School of Medicine.

Almost a third of those exposed to hepatitis C recover fully; their immune systems rout the virus and eliminate it. About 70 percent develop chronic infections, which carry a significant risk of cirrhosis, or scarring, of the liver and liver cancer. Paradoxically, people who become sickest soon after being infected are most likely to fight off the virus, whereas those who have few if any initial symptoms are at greatest danger of suffering persistent infection.

The treatment currently recommended for chronic hepatitis C combines ribavirin, an antiviral drug, with interferon, a substance that increases the immune system’s virus-killing power. The treatment offers a lifelong cure for more than half of patients. But because the drugs are expensive and can have serious side effects, and because the course of disease varies so much from person to person, the decision to start therapy poses tough questions.

“About one-third of people with chronic hepatitis will go on to develop cirrhosis of the liver,” said Dr. Jay H. Hoofnagle, director of the Liver Disease Research Branch at the National Institutes of Health. “Only 5 to 10 percent will develop liver cancer. In other words, many people can live perfectly well with chronic hepatitis infection and never have any problems. The trouble is we can’t tell who will do well and who will die of the disease.”

Nor can doctors predict with certainty how patients will respond to the combination therapy. In 25 to 30 percent of patients, interferon produces anxiety and depression, sometimes so extreme that sufferers have attempted suicide. It can also cause debilitating flu-like symptoms.

“I can usually get anyone through two or three months of interferon and ribavirin. Beyond that, it gets really tough,” Dr. Hoofnagle said. “At least 10 percent of patients can’t make it through the recommended course of therapy.”

Fortunately, physicians are getting better at optimizing the benefits and controlling some of the unwanted side effects, thanks in part to new insights into the virus. Researchers have discovered that hepatitis C occurs in at least six forms, called genotypes. Genotype 1 is the most common and also the hardest to treat, requiring 48 weeks of treatment. Only about 40 percent of people with this subtype get rid of the virus. Genotypes 2 and 3 can be successfully treated in just 24 weeks, eliminating the virus in about 80 percent of cases.

The more rapidly virus levels begin to fall in patients, the better the odds of a cure. By monitoring levels of the virus in blood, some doctors say, it’s now possible to individualize the course of treatment.

“I call it the accordion effect,” said Dr. Ira Jacobsen, chief of the division of gastroenterology and hepatology at Weill Cornell Medical College in New York. “If virus levels drop off very quickly, we can shorten the course of therapy. If the response is slow, we can lengthen it, sometimes to as much as 72 weeks, and improve the chances of success.”

Shortening the course of therapy remains controversial because of the risk of relapse after the treatment is stopped. Relapse occurs when lingering viruses not eradicated by the medication multiply and surge back.

Antidepressant drugs, meanwhile, are being employed to ease psychiatric side effects. And doctors are getting better at predicting who will suffer depression after starting interferon.

“Not surprisingly, people with a history of depression are at greater risk,” said Dr. Francis Lotrich, assistant professor of psychiatry at the University of Pittsburgh. He and his colleagues have also observed that people with chronic sleep problems are also more likely to have trouble with depression. The reason is not clear, but studies are under way to see if improving people’s sleep with the use of insomnia medication or other techniques can lower the risk of psychiatric side effects.

The best medicine is prevention, and it’s here that the biggest gains have been won against hepatitis C. The number of new infections per year in the United States has plummeted from 240,000 in the 1980s to about 19,000 in 2006. Experts credit a screening test that now prevents hepatitis C from spreading via blood transfusions and organ transplantation, as well as public health messages aimed at discouraging the use of shared needles, which is the leading route of transmission.

In the absence of an effective vaccine, such messages, backed up by intensified surveillance, will remain the chief defense against this virus. In 2003, chronic hepatitis B and C became notifiable diseases that must be reported to federal health officials, enabling them to track new cases nationwide. In 2004, New York State began its own enhanced viral hepatitis surveillance network.

Two years ago, the program demonstrated its usefulness when officials in the Erie County Department of Health detected a cluster of cases centered in one zip code in suburban Buffalo.

“All we had at first was a bunch of dots on a map,” said Dr. Anthony J. Billittier IV, the Erie County health commissioner. Investigators went into the community and identified about 20 young people who were injecting drugs and sometimes sharing needles. The county responded by intensifying prevention efforts, including a free needle exchange.

“We’ve made a lot of progress against hepatitis C, but there’s still a lot to do,” Dr. Billittier said. “One one thing we know about this virus is it’s not going away.”

Sources: The New York Times

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Vasectomy: Safe, Simple and Little Used

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Newer surgical techniques reduce the risk involved with having a vasectomy.
Vasectomy is a simple, painless procedure that is very effective in preventing pregnancy. Men usually have no side effects from vasectomy, and no change in sexual performance or function.

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Newer surgical techniques reduce the risk involved with having a vasectomy.

In Short:-

Vasectomies are safer and more cost-effective than tubal ligations, the sterilization technique for women, but remain relatively underused.

A new no-scalpel vasectomy technique significantly reduces complications.

The rate of unwanted pregnancies after vasectomy remains low; most of those pregnancies can be traced to patient error.

A tiny puncture and a little snip, done under local anesthetic — that’s essentially all there is to a vasectomy.

“Vasectomies are the safest, simplest, most cost-effective method of contraception we have,” said Dr. Edmund Sabanegh Jr., director of the Clinic for Male Fertility at the Cleveland Clinic Foundation.

They are also strikingly little-used. About 500,000 American men have the operation each year. More than twice as many women undergo tubal ligation for permanent contraception, even though that operation costs three to four times as much, requires general anesthesia and an abdominal incision, and carries a small but real risk of serious complications.

“There’s something about having a surgeon fiddling around down there with a scalpel that makes even tough guys squeamish,” said Dr. Marc Goldstein, director of the Center for Male Reproductive Medicine and Microsurgery at the Weill Medical College of Cornell University in New York.

And then there are the misconceptions that discourage many men from having vasectomies, especially the widespread and groundless worry that the procedure will lower testosterone levels and affect sexual performance.

Whatever the reasons in the United States, the situation is not the same among men everywhere. By the time they reach their 50s, roughly half of men in New Zealand have undergone vasectomies, according to Dr. Sabanegh, compared with fewer than one in six in the United States. In Canada, vasectomies outnumber tubal ligations.

Experts hope that recent advances in vasectomy techniques will ease some of the fears.

The chief advance is the no-scalpel vasectomy, a technique pioneered in China in the 1970s that has been steadily gaining popularity in the United States. In a traditional vasectomy, doctors make two half-inch incisions on either side of the scrotum to sever the vas deferens, the two narrow tubes that carry sperm from the testicles during ejaculation. The no-scalpel approach does away with the need for incisions.

In the new technique, doctors use their fingers to locate the vas deferens by feel through the thin skin of the scrotum.

“Once we’ve located the vas, we make a tiny poke-hole over it,” said Dr. Phillip Werthman, director of the Center for Male Reproductive Medicine and Vasectomy Reversal in Los Angeles. The hole can be gently expanded in a way that pushes blood vessels aside rather than cutting through them, so there is almost no bleeding. Using a hooked instrument, surgeons pull the vas through the hole, then cut it.

“A lot of men can’t even tell where the procedure was done afterwards, the hole we make is that small,” said Dr. Goldstein, who was the first Western doctor to travel to China to learn the technique. Compared with traditional techniques, no-scalpel vasectomies result in less bleeding, less postoperative pain and quicker recovery. They also require less time to perform — a little more than 10 minutes in the hands of an experienced surgeon.

Although the traditional incision method is still more widely used, that is likely to change as more and more medical schools teach the no-scalpel approach.

In another bid to win over squeamish males, some doctors have replaced the needles used to inject anesthesia into the scrotum with high-pressure jets that deliver painkillers through the skin.

“A lot of men’s biggest fear is that needle,” Dr. Werthman said, even though the actual needle used is so narrow that most men barely feel it. “Pressure injection takes the psychological edge off that,” he said, though many patients find the loud popping sound it makes unpleasant.

In the end, the success or failure of a vasectomy depends not on how surgeons reach the vas but how they block it. Many doctors use several methods to ensure that sperm don’t find another path. Along with cutting out a small section of the tube, they may burn the inner lining of the two remaining ends, clamp them and separate them.

With current techniques, the chance of an unwanted pregnancy occurring in the first year after a vasectomy is 1 in 1,000, Dr. Sabanegh said. Some of those failures are the fault of the patient, not the procedure. Because it can take several months for sperm remaining after a vasectomy to be washed out, men are counseled to use other contraception methods until tests show that their semen is free of active sperm. Many men don’t bother. In a 2006 study of 436 vasectomies, researchers at the Cleveland Clinic Foundation found that only three out of four returned for follow-up semen analysis, and only 21 percent followed the full instructions to continue to be tested until two specimens came up negative.

Sources: The New York Times : June 29, ’08

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