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By Jeff Falk
Aromatherapy—a concept that is thousands of years old—gets a boost from science and inspires the development of new products.
The U.S. Food and Drug Administration (FDA) has approved Radiesse, a cosmetic dermal filler, for the long-lasting correction of moderate to severe facial wrinkles and folds such as nasolabial folds.
Radiesse is composed of calcium hydroxylapatite microspheres in a water-based gel carrier. The product provides immediate improvement so a patient looks better the moment the product is injected. The calcium microsphere technology also enables the body to generate new collagen. Further, Radiesse provides physicians a high level of control, predictability and finesse for facial applications.
FDA approval of Radiesse for treatment of facial wrinkles and folds was based on the results of a clinical trial supporting Radiesse’s safety and effectiveness. In this study, conducted at four medical centers in the United States, 117 patients with nasolabial folds were treated with Radiesse on one side of the face and a control agent (Cosmoplast, a human collagen product) on the other. Results based on the ratings of three blinded evaluators showed that six months after treatment, Radiesse was more effective than the control on every comparative efficacy outcome (p<0.0001).
Key clinical findings include:
· 82 percent of nasolabial folds treated with Radiesse showed improvement after six months. This was significantly higher than the control, which showed improvement in only 27 percent of treated folds (p<0.0001).
· After six months, the fold treated with Radiesse was more improved in 79 percent of patients compared to the control-treated fold. The folds treated with the control rated more improved in only 5 percent of patients.
· The nasolabial folds treated with Radiesse required approximately half as much volume (1.22cc) than the folds treated with the control (2.35cc).
· Both products were safe and well tolerated, with no serious adverse events reported. In the 117 patients treated, Radiesse had zero granulomas and the same low rate of nodules as the control.
The U.S. Food and Drug Administration has approved a new treatment for moderate-to-severe frown lines, medically called nasolabial folds.
BioForm Medical issued a statement describing its Radiesse as a longer-lasting alternative to existing wrinkle fillers. The company said its calcium-based microsphere technology not only fills in facial folds and depressions, but also stimulates the body to produce collagen, the fibrous protein that gives the face its structure and fullness.
The drug was also newly approved to improve the appearance of people with AIDS-causing HIV who have significant facial fat loss (lipoatrophy), the San Mateo, Calif.-based company said.
Radiesse was first FDA approved in 2002 for use in facial reconstructive surgery.
HealthDay News, December 28, 2006
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Knees hurt? Massage may cut the pain and improve function if you have knee osteoarthritis, a new study shows.
Massage therapy "seems to be a viable option" as an addition to other treatments for osteoarthritis of the knee, write the researchers.
Osteoarthritis, the most common type of arthritis, is mainly seen in older adults. In osteoarthritis, joints are damaged as cartilage, the joints' shock absorbers, wears down.
Osteoarthritis often affects the knees, making it hard to walk. The disease can become disabling.
Massage might improve joint flexibility and circulation, note the researchers, including Adam Perlman, MD, MPH, and David Katz, MD, MPH.
Perlman works at the Institute for Complementary and Alternative Medicine at the University of Medicine and Dentistry of New Jersey. Katz is on staff at Yale University's medical school.
"Massage is free of any known side effects and, according to our results, clearly shows therapeutic promise," Katz says in a Yale news release.
The massage study focused on Swedish massage, the most widely available type in the U.S.
Swedish massage uses long strokes, kneading, and tapping techniques to target the muscles closest to the skin.
The study included 68 knee osteoarthritis patients who were at least 35 years old (average age: 66-70).
Most were white women. All lived in northern New Jersey and had X-rays confirming a knee osteoarthritis diagnosis.
First, patients rated their knee pain, stiffness, and function. Then, they were split into two similar groups.
For a month, patients in one group got two weekly Swedish massages, followed by a month of weekly Swedish massages. Each massage lasted an hour.
For comparison, patients in the other group waited two months before getting the same massage treatment.
After eight weeks of massage, patients reported less knee pain and stiffness and better knee function.
"Massage therapy seems to be efficacious in the treatment of OA [osteoarthritis] of the knee," write the researchers.
They call for further studies on other types of massage and the cost-effectiveness of massage treatment.
By Miranda Hitti, WebMD Medical News, December 11, 2006
When it comes to treating the aging face, patients have their pick of numerous laser therapies for successful skin rejuvenation. But finding an effective treatment for the delicate skin of the neck can often be a real pain in the neck. Now, a retrospective review presented in a recent issue of Lasers in Surgery and Medicine, the journal of the American Society for Laser Medicine and Surgery, finds that a skilled practitioner can successfully resurface an aging and photodamaged neck using the Carbon Dioxide (CO2) laser if a series of treatment parameters are strictly followed.
In her article entitled “Safe and Effective Carbon Dioxide Laser Skin Resurfacing of the Neck,” laser expert Suzanne D. Kilmer, MD, of the Laser & Skin Surgery Center of Northern California, Sacramento, CA, outlines three key components essential to effective laser resurfacing of the neck with the CO2 laser that she and her colleagues have used to safely treat more than 1,000 patients over the past 10 years.
“We have found that for the CO2 laser to work safely and effectively on the neck, 1) the skin has to be sufficiently hydrated with a pre-operative topical anesthesia; 2) the laser has to be administered at a low density with only a single pass; and 3) the treated epidermis must not be wiped following the procedure,” explains Dr. Kilmer. “These three ingredients, in a sense, make up the ‘recipe’ for how to safely use the CO2 laser for neck resurfacing. And like all recipes, every step must be followed and all the ingredients must be added properly for the end result to turn out right.”
In order to adequately hydrate the skin prior to the laser procedure, Dr. Kilmer recommends that patients wash their entire face and neck with hot water and then immediately apply a thick layer—like frosting on a cake—of the topical anesthesia EMLA. The area is then sealed using a plastic wrap, and this process is repeated 45 minutes before the procedure. Dr. Kilmer notes that proper hydration is critical, as it “plumps up” the skin and creates a protective buffer against the laser that also aids in absorbing the laser’s energy.
During a typical laser skin resurfacing of the face with the CO2 laser, the epidermis is completely removed. For neck resurfacing, the laser energy is lowered so the epidermis is not removed and stays intact. This low density coupled with a single pass of the laser creates less trauma and less wounding on the neck. Dr. Kilmer points out that while the face would normally be wiped to remove the epidermal debris following the procedure, it is important not to wipe the treated epidermis from the neck because it serves as a natural dressing that protects the skin and aids in the healing process.
“Most of our patients that undergo CO2 laser skin resurfacing on their face also get their neck done at the same time,” says Dr. Kilmer. “Performing both procedures helps to blend the results, eliminating the noticeable line of demarcation that usually occurs when the neck is left untreated.”
While non-ablative laser treatment for skin rejuvenation has gained in popularity during the past few years, Dr. Kilmer notes that the CO2 laser produces longer-lasting results than its non-invasive counterparts and only a single treatment session is needed instead of a series of treatment sessions.
“As with any procedure, patients need to be informed of the potential risks, how much downtime is involved, and the importance of post-operative care before undergoing CO2 laser resurfacing,” adds Dr. Kilmer. “But for any single resurfacing treatment, the CO2 laser delivers the most overall improvement—hands down.”
Patients with a personal or immediate family history of vitiligo are not considered candidates for this procedure, as laser resurfacing can trigger depigmentation of the treated area consistent with this condition.
Findings from a new study confirm that tea extracts applied to the skin promote the repair of damage from radiotherapy, and shed light on the mechanisms involved in the injury...
Personal misuse of super-strength botulinum toxin caused a Florida osteopath, his girlfriend, and two of his patients to become paralyzed and hospitalized for months in 2004.
Details of the much-publicized incident—which ended in the practitioner being sentenced to three years in prison—are only now published in this week's issue of the Journal of the American Medical Association.
At the time of the incident, Bach McComb was an osteopathic physician who was continuing to practice in Oakland Park, Fla., after his license had been suspended. In the four cases described, McComb did not use a medical version of Allergan Inc.'s Botox.
Instead, he mistakenly gave himself and the three others four to six injections of a preparation of paralyzing botulinum toxin that was 2,800 times stronger than that typically used on patients, according to the authors of the JAMA article. This formulation was only intended for laboratory work.
The vial's labeling clearly marked the product as not being suitable for human use.
"The fact that clinical practitioners were using an unlicensed product was very disturbing," said Dr. Christopher R. Braden, a medical epidemiologist at the U.S. Centers for Disease Control and Prevention, and an author of the report. "It needed to be highlighted and the issue dealt with so that it does not recur."
"A 100-microgram vial of toxin taken from the same manufacturer's lot as the toxin administered to the case patients contained a toxin amount sufficient to kill approximately 14,286 adults if disseminated evenly," according to the JAMA report.
McComb, his two patients, Eric and Bonnie Kaplan, and McComb's girlfriend, Alma Hall, were each paralyzed by the time they were admitted to a hospital.
All of the patients eventually survived but were hospitalized for months and required assistance for basic functions such as breathing, speaking and walking. McComb was later sent to prison for three years.
The incident does not reflect on the safety of standard treatments of Botox, stressed Dr. John Canady, a professor of plastic surgery at the University of Iowa and vice president of the American Academy of Plastic Surgeons.
"This was clearly not Botox," Canady said. "More than 3 million people got Botox injections in 2005, which is the last year we have statistics on, and I don't believe any reaction such as this has been reported."
The real Botox is carefully packaged by its manufacturer, Allergan, Canady explained. "Botox comes in a vial that does not have an excessive dose, and it is reconstituted in the same vial," he said. "None of these safeguards were in place" in the Florida case, Canady added.
Basic precautions against such misuse are obvious, Canady said.
"It is important to go to a board-certified plastic surgeon," he said. "You should feel free to ask that person what his track record has been in the use of Botox. Probably the biggest take-home message is that it is important to do your homework before any medical procedure, and that includes Botox."
In addition, "It's absolutely fair to ask what material is being injected into you personally," Canady said. "I don't think it's too much to ask to see the container or the material."
And Braden cautioned consumers about bargain-hunting.
The last time he looked at the Internet, he saw advertisements for "Botox-like" medications. "I would be very suspect of those kinds of products," Braden said.
By Ed Edelson, HealthDay Reporter, November 21, 2006
Finally, there may be something duct tape can't fix: the lowly wart.
Despite claims in an earlier study, covering warts with duct tape may not make them vanish faster after all, say Dutch researchers, including Maastricht University's Marloes de Haen, MD.
The Dutch researchers had heard of a study in which duct tape showed promise as a home remedy for warts -- the skin infections caused by the human papillomavirus.
So de Haen's team conducted their own study, now published in the Archives of Pediatrics & Adolescent Medicine.
The study included 103 Dutch kids aged 4-12 who had at least one wart.
For six weeks, half the children wore duct tape over one of their warts, while the rest wore corn pads over one of theirs.
Once a week, the children uncovered the wart, soaked it in warm water for five minutes, then rubbed the wart gently with a pumice stone.
During the study, the warts covered by duct tape were only slightly more likely to heal than those covered by corn pads.
"After six weeks, the wart had disappeared in 16% of the children in the duct tape group, compared with 6% in the placebo [corn pad] group," the researchers write.
That margin was so slim that it may have been due to chance, de Haen's team says.
Most of the kids in the duct tape group -- 81% -- said the tape didn't stick well to their skin. And 15% reported skin irritations, including rashesrashes.
"Further research with longer follow-up would only be useful with a tape that is better sticking," write the researchers.
By Miranda Hitti, WebMD Medical News, November 8, 2006
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