Thursday, August 9, 2012

FDA Approves Over The Counter Weight Loss Pills

The American Food and Drug Administration (FDA) has approved Orlistat for use as an over-the-counter weight loss drug for adults who are overweight. The drug, which was originally approved for prescription in 1999, will retain prescription status at higher doses for the medical treatment of obesity.

The FDA said that the drug on its own will not work. If you are overweight and use the drug to lose weight you need to be on a "reduced-calorie, low-fat diet, and exercise program," they said.

Dr. Douglas Throckmorton, Deputy Director at the FDA's Center for Drug Evaluation and Research said yesterday, "We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and type 2 diabetes." He said that this over the counter drug, along with "diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health."

Orlistat will be manufactured by GlaxoSmithKline as the brand Alli and will be available for adults over 18 years of age in 60 mg capsule form to be taken up to 3 times a day with meals that contain fat.

The drug works by reducing your gut's ability to absorb fat. Since this could also reduce the absorption of essential nutrients, if you take the drug you should also take a multivitamin supplement before going to bed, the FDA said.

There are contra-indications. You should not take Orlistat if you are not overweight or if you cannot absorb food properly, according to the FDA.

The National Institutes of Health define overweight as having a Body Mass Index (BMI) of 27 kg per metre squared. This is a figure where you divide your weight in kilogrammes by the square of your height in metres.

The FDA warn that if you have had an organ transplant you should not take the over the counter Orlistat because it could interfere with your other drugs. Also, if you are on blood thinners, or are receiving treatment for diabetes or thyroid disease you should talk with your doctor about whether this drug is right for you.

The side effects of over the counter Orlistat include disruption to bowel habits, such as looser stools. This effect can be reduced if you are on a low fat diet.

Orlistat is a reduced strength version of Xenical (manufactured by Roche) which is available under prescription for the treatment of obesity. It is normally prescribed by doctors in conjunction with a calorie controlled diet.

Orlistat is also known as tetrahydrolipstatin, and works by slowing down the release of lipase, a pancreatic enzyme that breaks down fatty triglycerides in the gut. Inhibition of lipase release means that a proportion of triglycerides do not get converted into fatty acids that would normally be absorbed into the bloodstream. Instead they pass through the gut into the feces, which is why this can cause looser stools.

In the prescription dose of 120 mg three times a day the drug prevents about 30 per cent of fat in the food from being absorbed.

This is the first time the FDA has approved a weight loss drug for over the counter use.
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What Is Hair Loss (Alopecia)? What Is Baldness?

The word alopecia refers to any type of hair loss, thinning hair or baldness in any hairy region of the body. Baldness tends to be a more specific term among lay people, as it usually refers to hair loss on the scalp - however, it can mean hair loss in any part of the body. Alopecia areata means "hair loss in areas". In the majority of cases hair loss is a normal process of aging, and not a disease. Because it is not seen as life-threatening to doctors it is often disregarded. This is unfortunate because hair loss can cause serious distress in some people, with some far reaching psychological effects. In some cases hair loss may be a consequence of some medical treatment, especially cancer treatment drugs - when the hair loss is generally temporary.

There are several types of alopecia, below is a list of the main types:

Alopecia areata - hair loss occurring in patches anywhere on the body. Hair is lost from some or all areas of the body, generally from the scalp. As it causes bald spots on the scalp, especially during its early phase, it is sometimes referred to as "spot baldness". A small proportion of alopecia areata cases spread to the whole scalp, or even the entire body. Approximately 0.1% to 0.2% of all humans are affected. It occurs in both men and women, but more commonly among women.

Most people who develop alopecia areata are apparently healthy and have no skin problems. When it does occur, it tends to start during the late teenage years, early childhood, or early adulthood. However, it can strike at any age.

Alopecia areata is not contagious. It is more commonly found among people who have close family member who have/had it. People who have a close relative with some kind of autoimmune disease are more likely to develop alopecia areata. That is why most experts believe it is an autoimmune disease - a disease where the body attacks good parts of the body as if they were foreign undesirable objects, such as some bacteria or viruses; in this case the body is attacking its own hair follicles. Studies indicate that T cell lymphocytes cluster around attacked follicles, causing inflammation and hair loss. Scientists say something, combined with hereditary factors, trigger the condition - we do not know what that something is, although some suspect it may be emotional stress or a pathogen. A pathogen is a disease-producing agent, e.g. a virus, bacterium or other microorganism. A study found that there is a close relationship between infection outbreaks on teeth and the presence of alopecia areata.

Symptoms usually appear as small, soft, bald patches. They may be of various shapes, but are generally round or oval. The scalp and beard are the most commonly affected areas; but can occur in any hairy part of the body. The patient may feel tingling, or even some slight pain in affected areas. Some parts of the body may experience hair re-growth while others will not. It can go into remission for long or short periods, and even forever (gets better and never comes back).

When the hair falls out on the scalp it tends to do so over a short period, and more so on one side than the other.

People with this type of alopecia also have "exclamation point hairs" - hairs that become narrower along the length of the strand closer to the base.

Alopecia totalis - total hair loss of the scalp. This could happen rapidly, or from progression of alopecia areata. Experts are not sure what causes it, but know that it is an autoimmune disorder. Although many believe mental stress is a contributory factor, a sizeable number of people with alopecia totalis lead relatively stress-free lives.

This type of alopecia may be an intermediary condition between Alopecia areata and Alopecia Universalis (total body hair loss). It usually emerges as a fairly sudden total scalp hair loss, or more gradual. When it is gradual it tends to be a development from alopecia areata.

The majority of sufferers are either children or young adults under 40. However alopecia totalis can affect people of any age. The patient's nails may also become ridged, pitted or brittle in appearance.

Alopecia universalis - all hair is lost throughout the body. It generally involves rapid loss of hair, including eyebrows and eyelashes. Experts consider it to be the most severe form of alopecia areata. It affects approximately 1 in every 100,000 people in North America and Western Europe. It is an autoimmune condition.

Alopecia barbae - loss of facial hear. Barbae comes from Latin and refers to the bearded area of the face. It does, in fact, affect both men and women. However, it is of more interest to men as only men are generally bothered by it.

Alopecia mucinosa - also referred to as follicular mucinosis. It is an inflammatory condition of both the hair follicle and sebaceous glands (pilosebaceous unit) which can result in scarring as well as non-scarring hair loss. Severity of scarring indicates how advanced the disease is. There is mucin around hair follicles when examined under the microscope. Mucins appear like stringy, clear or whitish gunk in the skin, and are made up mostly of hyaluronic acid - this is a normal component of the ground substance surrounding collagen of the dermis (part of the skin).

Alopecia mucinosa generally affects the face, neck, and scalp, but can affect any part of the body.

Alopecia mucinosa can be one of three types: 1. Primary and acute disorder - this affects children and teenagers (Pinkus type). 2. Primary and chronic disorder - this occurs in people over 40. 3. Secondary disorder - this is associated with benign (non-cancerous) or malignant (cancerous) skin disease.

Experts are not sure why it occurs, but it is seen as an autoimmune disease. Early signs include raised spots (follicular papules) which appear in reddened plaques or patches, about 2.5 centimeters in diameter, but they can be bigger. Some patients may start with one or more lesions, while others may have a single lesion that develops to multiple lesions over several weeks or months. The affected follicles will commonly result in hair loss.

If treated early enough it is reversible - hair will grow back. In more severe cases hair will not grow back, even after the disease has cleared up.

Androgenetic alopecia (male pattern hair loss) - this is also known as male pattern baldness. The hair gradually thins out, to an almost transparent state. It can affect both men and women. Experts say this type of alopecia is most likely to be hereditary - the person can inherit from either the mother or the father. Androgens means hormones. This type of alopecia is the type most lay people refer to when talking about balding.

Male pattern baldness usually starts with a receding hairline, and/or hair loss on the top of the head.

The person has a genetically determined sensitivity to the effects of DHT (dihydrotestosterone). Experts believe DHT shortens the growth phase (anagen phase) of the hair cycle, causing miniaturization of the follicles, resulting in finer hair. DHT production is regulated by 5-alpha reductase, an enzyme. DHT exists in several tissues of the body, including the scalp.

About 50% of men are affected by this type of hair loss at some time in their lives. Men of Chinese or Japanese ancestry are less likely to be affected.

A Chinese study found that men who smoked were more prone to age-related hair loss.

A study identified two genetic variants in Caucasians that together produce an astounding sevenfold increase in the risk of male pattern baldness.

Adrogenetic alopecia (female pattern hair loss) - this is also known as female pattern baldness. Women have a higher risk of female pattern baldness when they undergo hormonal changes during the menopause. The hair on the head is thinner, while facial hair may be coarser. Although new hair is not produced, the follicles are still alive. This suggests that hair regrowth is possible.

Generally, female pattern baldness is different from male pattern baldness. The woman will experience hair thinning all over the head, but will not usually lose her frontal hairline (it will not recede). Loss of hair on the crown may be moderate, but his hardly ever progresses to total or near baldness. Women can lose hair for other reasons than female pattern baldness:
  • Teologen effluvium (temporary shedding of hair)
  • The hair may breaks after styling treatments, or the twisting and pulling of hair
  • Alopecia areata
  • Some skin diseases
  • Iron deficiency
  • Hormonal problems
  • Underactive thyroid
  • Vitamin deficiency
Traction alopecia - this refers to hair loss as a result of too much pulling or tension on the hair shafts - usually the result of some hair styles. This type of alopecia is more commonly found among women. If the traction alopecia is prolonged the person's hair, where lost, may never come back.

Very tight ponytails, braids, or pigtails may cause traction alopecia if the person frequently uses them. Toy dogs whose owners use barrettes to keep hair out of their faces may also develop this type of alopecia.

Anagen effluvium - generally brought on by the use of chemotherapy or radiotherapy to treat cancer. Hair loss starts off as patchy, and then becomes total. Fortunately, in the vast majority of cases, as soon as the treatment is stopped the hair comes back within about six or so months. Some other medications can also cause hair loss. Compulsive hair pulling can also cause this type of hair loss, as well as poisoning from toxic plants, and some other diseases.

Anagen effluvium is caused by sudden, profound disturbances to the matrix cells of the hair follicles.

Telogen effluvium - more than normal amounts of hair fall out. It is characterized by excessive and early entry of hairs into the telogen phase (resting phase). This is a temporary condition - the hair comes back. It is thought to be caused by marked emotional or physiological stressful events that may result in an alteration of the normal hair cycle. The events may include childbirth, chronic illness, major surgery, anemia, crash diets, severe emotional disorders, or drugs.

What are the treatments for alopecia?

If the hair loss is caused by an infection or a condition, treating that infection/condition may prevent further hair loss, and in many cases re-growth will occur.

Male-pattern baldness treatment
  • Finasteride - this works by preventing the hormone testosterone converting to the hormone DHT (dihydrotestosterone) which causes hair follicles to shrink. Finasteride effectively brings back normal hair size (from being very fine hair). According the National Health Service, UK, two-thirds of males who are given finasteride experience some hair regrowth. However, even among the other third who experience no regrowth, most stop becoming balder. The effects of finasteride are not evident for at least four months. If the patient stops taking finasteride the balding process will resume. About 1 in every 50 men who take finasteride experiences a loss of libido (sex drive).

  • Minoxidil - this is available as a lotion. The person rubs it into the scalp on a daily basis. In the UK, and most other countries it is available over-the-counter (no prescription needed). About 15% of men who use it experience hair regrowth, while half of all men notice that the balding process stops. For about 32% of all men, minoxidil has no effect at all. It is only after four months of daily applications that those who do benefit from minoxidil notice it. If treatment is stopped the balding process will resume. Side effects are uncommon.

  • Laser phototherapy - a controlled clinical trial proved the clinical efficacy and safety of a laser phototherapy device for treating hereditary hair loss.

  • Dermabrasion gel - scientists have found a way to make the skin of laboratory mice give have fully working hair follicles complete with new hair by using a protein that stimulates follicle generating genes in skin cells under wound conditions.
Female-pattern baldness treatment

The only effective medication for women with female-pattern baldness is minoxidil. About 20% to 25% of UK women who take it experience hair regrowth, while the majority finds the treatment stops or slows the loss of hair. Other treatments include hair transplants, wigs, hair weaving, changes in hairstyle, plastic surgery (scalp reduction).

Alopecia areata treatment

There is no current reliable, safe, effective, long term treatment for alopecia areata, a study showed. Fortunately, about 80% of cases resolve themselves after a year without treatment and hair grows back. Therefore, watchful waiting may be the best initial strategy. If it does not resolve itself, some treatments are possible:
  • Steroid injections - effective when the patient has small patches. A steroid solution is injected straight into the scalp, several times. The steroid stops the immune system from attacking hair follicles. After about four weeks this treatment may stimulate regrowth. Treatment might be repeated every few months. With some patients alopecia returns some time after treatment is stopped, while with others the regrowth is permanent.

  • Topical steroids (creams and ointments) and steroid tablets - although these medications are widely prescribed for alopecia areata treatment, their long-term benefits are not clear. It seems there is a chance hair will regrow. Side effects become more common the longer the patient takes the steroid tablets or creams/ointments; they may include diabetes and stomach ulcers. Some patients experience itching, and sometimes hair growth in other areas.

  • Minoxidil - applied in lotion form to the scalp every day, this treatment can stimulate hair growth. Benefits, if they do appear, do so after about two or three months. In the UK they are not recommended for people under the age of 16.

  • Immunotherapy - this is the most effective treatment for total hair loss. DPCP (diphencyprone) is applied to the bald skin. The patient applies the chemical solution once a week, and the dosage is stronger each time. The DPCP generally causes an allergic reaction and the patient will develop mild dermatitis (mild eczema). Hair starts to regrow after about three months among patients who respond. Some patients may have a severe skin reaction. This can be dealt with by reducing the rate of dosage increase. A very small percentage of patients may develop vitiligo (patchy colored skin). Most patients find that hair continues falling out after treatment is stopped.

  • Dithranol cream - this treatment is much less popular than immunotherapy because it is less effective and there is a greater risk of causing a skin reaction and itchiness. It can also stain the scalp and hair.

  • UV light treatment - the patient is given about two to three sessions of light therapy each week. This is usually done in a hospital. After about 12 months patients may see some good results. It is not very popular as response rates are not so good.

  • Tattooing the eyebrows - this is known as dermatography.

  • Alternative therapies - alternative therapists commonly offer aromatherapy, massage, or acupuncture for alopecia treatment. Not enough studies exist to determine how effective these treatments are.
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Over-The-Counter Solution For Erectile Dysfunction

For couples worldwide, erectile dysfunction (ED) is one of the leading contributors to a man's inability to perform. As millions of men in America each year look for a solution, many seek alternative treatments to prescription medications and surgery that may have dangerous side effects. A new published study reveals that Prelox, a patented and proprietary blend of Pycnogenol, (pic-noj-en-all), an antioxidant plant extract from the bark of the French maritime pine tree, combined with L-Arginine aspartate, an amino acid, is the natural answer to enhancing erectile quality.

The study, to be published in an upcoming edition of the International Journal of Impotence Research, shows improvement in men with erectile dysfunction after just one day. The study investigated the mechanism involved in relaxation of arteries as it is required for improved blood flow in erectile function. Prelox was found to cause a markedly increased nitric oxide production, the key mediator involved in expanding arteries for elevated blood flow during erections. By the end of the study, all men taking Prelox experienced almost a 100 percent increase of orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction.

Prelox is a patented unique blend of two circulation-enhancing ingredients including Pycnogenol, which contains powerful bioflavonoids that originate from plants and help keep blood vessels dilated for optimal blood flow. L-Arginine, an amino acid found in many foods, is the other ingredient coupled with Pycnogenol that ultimately promotes blood flow.

Pycnogenol and L-Arginine work together to enhance nitric oxide, a crucial chemical for sexual arousal, said Steven Lamm MD, from New York University School of Medicine Prelox is the perfect solution for men who want the same outcome as other prescription nitric oxide enhancers, but with a natural approach.

The randomized placebo-controlled study was conducted at the Medical University of Sofia, Bulgaria. Fifty patients with moderate erectile problems were asked to take two Prelox or placebo tablets in the morning and evening. The erectile quality of men was monitored using the same methodology as applied in clinical trial with pharmaceutical drugs - in a diary consisting of a questionnaire. In addition, semen, spermatozoa and blood samples were collected to measure nitric oxide and testosterone. The study consisted of a four-week period, followed by a wash-out period, another four-week period, and a final washout.

At the end of the treatment period, patients treated with Prelox achieved high questionnaire scores, whereas the placebo group had no significant effects. The erectile function score of men (mean age 37 years) at trial start was in average 14 out of a maximum 30. After one month on Prelox, the erectile function score increased to 27, which resembles almost completely healthy values such as those found in twenty year old men. Parallel to the increase of erectile function, the mean number of intercourse more than doubled during treatment for those who took Prelox. Treatment with Prelox produced a steep increase of nitric oxide activity in most patients and no changes were indicated for the placebo group.

"This European study confirms my experience in a clinical trial with Prelox I carried out two years ago," said Lamm. "This is the third clinical study showing that men can achieve greater erectile quality with Prelox, move past their performance anxiety and get more satisfaction from their sex lives."

Blood analysis revealed an increased testosterone level during supplementation with Prelox. This is not a direct result of the supplement but is typical for men with increased sexual activity. The men in this trial reported a dramatic increased frequency of morning erections. Moreover, their partners noted a higher interest for sex as well as better performance.

Past research on Prelox scientifically demonstrated its effectiveness in increasing and enhancing sexual performance in three clinical studies in the United States and Europe. In these studies, almost 85 percent of Prelox users said it improved erectile function and more than 70 percent of Prelox users said it was easier to initiate and sustain an erection. In a study at the New York University School of Medicine, more than 80 percent of male subjects rated Prelox as effective in improving their ability to engage in sexual activity.

Furthering evidence of its effectiveness, Prelox has been awarded a U.S. patent (U.S. 6,565,851 B2) for the relief of the symptoms of erectile dysfunction. NHS and Horphag Research have granted exclusive product licenses to several companies world-wide. Horphag Research just announced a new partnership with Xion Corporation. Xion will launch Prelox to practitioners in North America.

Prelox is safe and easy to use "two tablets, twice a day for the first two weeks; then one to two tablets, twice a day to maintain and sustain enhanced pleasure and performance." Prelox is exclusively available at Purity Products, Herbalife, GVI and Xion.
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Unwanted Sex Common Among Young Married Women In India

Nearly half of young wives in the Indian states of Gujarat and West Bengal experience unwanted sex: 12% frequently and another 32% occasionally, according to "Consent and Coercion: Examining Unwanted Sex Among Married Young Women in India," which appears in the September 2007 issue of International Family Planning Perspectives.

Using survey data and in-depth interviews with 1,644 young married women, authors K.G. Santhya of the Population Council, et al., identify factors that predict a woman's likelihood of experiencing unwanted sex with her husband. They find that wealthier women, women who knew their husbands before they got married and women whose husbands support them during family conflicts are less likely than their peers to experience unwanted sex.

Frequent coerced sex is more likely to occur among recently married young women than among pregnant women or new mothers, suggesting that the pressure to have a first child leaves some young married women especially vulnerable to sexual coercion. In addition, the more circumstances in which a woman believes it is justifiable for a husband to beat his wife, the more likely she is to experience unwanted sex. Young women with lower levels of education are also at greater risk than their more educated peers.

These findings offer valuable insights for programs and policies aimed at protecting young women from unwanted sex within marriage. Such programs should target newly married couples to foster supportive relationships which protect against unwanted sex. HIV and unintended pregnancy prevention programs should incorporate counseling and education on sexual coercion. In addition, programs are needed to address men's sense of entitlement when it comes to sex within marriage.

Also in the September 2007 issue of International Family Planning Perspectives:

"Changes in Contraceptive Method Mix in Developing Countries," by Eric E. Seiber of Ohio State University, et al.

"HIV Risk Perceptions and First Sexual Intercourse Among Youth in Cape Town, South Africa," by Kermyt G. Anderson of the University of Oklahoma, et al.

"Legal Abortion Worldwide: Incidence and Recent Trends," by Gilda Sedgh of the Guttmacher Institute, et al.

The Guttmacher sexual and reproductive health worldwide through research, policy analysis and public education.
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Warning Signs For Appendicitis In Children

A 5-year-old with abdominal pain, nausea and fever may have appendicitis or any of a number of other problems. But how does the child's doctor decide whether to schedule an emergency appendectomy to surgically remove a presumably inflamed appendix -- a procedure that carries its own risks like any surgery -- or wait and observe what could be a ticking time bomb that could rupture and kill the patient in a matter of hours" It's a classic physician's dilemma, but a new study led by the Johns Hopkins Children's Center may ease the pediatrician's problem-solving and parents' anxiety.

Reporting on their review of the frequency of the most common symptoms of actual appendicitis in children, the researchers concluded that beyond fever, the most telltale signs are 'rebound' tenderness or pain that occurs after pressure is removed abruptly from the lower right part of the abdomen; abdominal pain that starts around the belly button and migrates down and to the right; and an elevated white blood cell count (10,000 or more per microliter), which is a marker of infection in the body.

Notably, loss of appetite, nausea and vomiting, hallmark appendicitis symptoms in adults, were NOT predictive of appendicitis in children.

"These signs don't give you an absolute diagnosis, but they should prompt the doctor to refer the child to a surgeon for evaluation," said study lead author David Bundy, M.D., M.P.H., a pediatrician at the Johns Hopkins Children's Center.

Appendicitis is most common in teens and young adults in their early 20s. However, children younger than 4 years are at the highest risk for a rupture. Up to 80 percent of appendicitis cases in this age group end in rupture, partly because young children have fewer of the classic symptoms of nausea, vomiting and pain localized in the lower right portion of the abdomen than do teenagers and young adults, making the diagnosis easy to miss or delay. In the study report, published in the July 25 issue of the Journal of the American Medical Association, the researchers said ultrasound and CT scan images can be helpful, but are not always conclusive, even if they are available on an emergency basis. And CT scans in particular expose young children to radiation, which should be avoided if possible.

"In a very young child, the presentation of symptoms associated with appendicitis tends to be different from adults, so when trying to decide between fast-track surgery versus watchful observation, you're often damned if you do and damned if you don't," Bundy said. "In our analysis, we've identified some of the more powerful telltale signs that should help residents, general pediatricians and ER doctors narrow down what is seldom a clear-cut diagnosis."

The appendix is a small tube extending from the large intestine, and infections and inflammation of the organ can be dangerous. The only absolute way to diagnose the condition is surgery, and each year, appendicitis sends 77,000 American children to the hospital. An estimated one-third of them suffer a ruptured appendix, a life-threatening complication, before they reach the OR.

In their analysis of previous research, investigators searched hundreds of studies, weeding out weak from solid science. The 25 studies that made the final cut examined symptoms and outcomes in children who presented with abdominal pain and in whom appendicitis was considered a possible diagnosis. Abdominal pain in children is one of the most common and vaguest symptoms, and can suggest anything from innocent constipation to serious infections or blockages of the intestines. Doctors advise parents that any abdominal pain should be evaluated for appendicitis. "We really want parents to keep in mind that children with appendicitis don't always show up with the classic story that we see in adults," Bundy says. "There isn't a perfect formula, but we think the signs we've identified can help."
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