Generic Drug for Enlarged Prostate Approved

By Kathleen Doheny
WebMD Health News

Reviewed By Louise Chang, MD

March 2, 2010 — The first generic version of Flomax, a medication to treat the signs and symptoms of an enlarged prostate gland, has won the approval of the FDA.

The generic version of Flomax, known as tamsulosin, will be made by IMPAX Laboratories of Haywood, Calif. Under FDA regulations, the generic versions must meet the same standards as the brand name drug, says Gary Buehler, director of the FDA Office of Generic Drugs, in a news release.

Enlargement of the prostate gland, a condition known as benign prostatic hyperplasia (BPH), is common among men as they age. More than half of men 60 and older and more than 90% of those 70 and older have BPH symptoms, including a weak urine stream, leaking or dribbling, frequent need to urinate at night, and urinary urgency.

The condition is not cancerous.

The prostate is a walnut-shaped gland located just below the bladder. It produces fluid for semen. But when it grows too big, the prostate puts pressure on the urine-carrying canal or urethra, which passes through the prostate, and this can result in the urinary symptoms.

According to information on the Flomax web site, the drug works by relaxing muscles in the prostate and in the neck of the bladder. Somewhat like releasing a pinched straw, it is then easier for urine to pass out of the body.

Those taking the drug are cautioned to avoid hazardous tasks or driving until they know how the drug affects them. Commonly reported side effects include a runny nose, dizziness, and a decrease in semen, although the drug is not linked with a decrease in sex drive nor impotence.

ED, Heart Disease May Be Deadly Duo

By Bill Hendrick
WebMD Health News

Reviewed by Laura J. Martin, MD
Latest Mens Health News

* ED, Heart Disease May Be Deadly Duo
* Drug for Enlarged Prostate Approved
* Discrimination May Lead to Smoking in Boys
* Men in Europe Trace Roots to Near East Migrants
* Women’s Scent Triggers Hormone Surge in Men
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March 15, 2010 — Erectile dysfunction is a major warning sign for cardiovascular disease and early death.

The finding comes from placebo-controlled studies comparing randomly selected men with ED and cardiovascular disease and men without ED.

The men with ED and cardiovascular disease were:

* 1.9 times more likely to die from cardiovascular disease
* Twice as likely to have a heart attack
* 1.2 times more likely to be hospitalized for heart failure
* 1.1 times more likely to have a stroke

The researchers say they found that medications like ramipril, an angiotensin-converting enzyme (ACE) inhibitor used to treat high blood pressure and heart failure, can reduce cardiovascular events but don’t seem to influence the course or development of ED.

“Erectile dysfunction is something that regularly should be addressed in the medical history of patients,” Michael Bohm, MD, lead author of the study and chairman of internal medicine at the University of Saarland in Germany, says in a news release. “It might be a symptom of early atherosclerosis.”

The study included 1,549 male cardiovascular patients in 13 countries. Each was asked if he had ED, and men who answered in the affirmative were then categorized as having mild, mild-to-moderate, moderate, or severe ED. The average follow-up was five years.

Patients in one trial involving 400 men were randomly assigned to take ramipril, telmisartan — an angiotensin II receptor antagonist used to treat hypertension and heart failure — or a combination.

In another, ACE inhibitor-intolerant patients were randomly assigned to take a placebo or telmisartan.

Patients with ED were older and had a higher prevalence of hypertension, stroke, diabetes, and lower urinary track surgery than men without ED. And 55% of men had ED when they entered the trials.

Researchers say deaths from all causes occurred in 11.3% of patients who had ED at the start, but in only 5.6% of people with no ED or only mild problems at baseline.

They report that 16.2% of ED patients died from cardiovascular problems, suffered heart attacks or strokes, or were hospitalized for heart failure. Only 10.3% of men with no or mild ED had similar outcomes.

As ED worsened, risk of death from all causes increased, suggesting that ED identifies men whose cardiovascular disease might be dangerously advanced.

Bohm says that ED is closely associated with conditions that occur in atherosclerosis and vascular problems, such as plaque buildup, which often precedes heart attacks and strokes.

“Men with ED going to a general practitioner or a urologist need to be referred for a cardiology workup to determine existing cardiovascular disease and proper treatment,” Bohm says. “ED is an early predictor of cardiovascular disease.”

Men with ED are often treated for impotence but not underlying cardiovascular disease, he says, thus placing “a whole segment of men” at increased risk of death.

Therefore, men and their doctors need to view ED as a risk factor, just as they do high blood pressure and cholesterol, he says.

The study is published in the March 15 issue of Circulation: Journal of the American Heart Association.

Allergic Rhinitis, Asthma, Allergic Eyes

Allergic rhinitis (“hay fever”) is the most common of the allergic diseases and refers to seasonal nasal symptoms that are due to pollens. Year round or perennial allergic rhinitis is usually due to indoor allergens, such as dust mites, animal dander, or molds. It can also be caused by pollens. Symptoms result from the inflammation of the tissues that line the inside of the nose (mucus lining or membranes) after allergens are inhaled. Adjacent areas, such as the ears, sinuses, and throat can also be involved. The most common symptoms include:

* Runny nose
* Stuffy nose
* Sneezing
* Nasal itching (rubbing)
* Itchy ears and throat
* Post nasal drip (throat clearing)

In 1819, an English physician, John Bostock, first described hay fever by detailing his own seasonal nasal symptoms, which he called “summer catarrh.” The condition was called hay fever because it was thought to be caused by “new hay.”

Asthma

Asthma is a breathing problem that results from the inflammation and spasm of the lung’s air passages (bronchial tubes). The inflammation causes a narrowing of the air passages, which limits the flow of air into and out of the lungs. Asthma is most often, but not always, related to allergies. Common symptoms include:

* Shortness of breath
* Wheezing
* Coughing
* Chest tightness

Allergic Eyes

Allergic eyes (allergic conjunctivitis) is inflammation of the tissue layers (membranes) that cover the surface of the eyeball and the undersurface of the eyelid. The inflammation occurs as a result of an allergic reaction and may produce the following symptoms:

* Redness under the lids and of the eye overall
* Watery, itchy eyes
* Swelling of the membranes

World’s largest conference on acupuncture to convene in China

Xinhua – More than 1,500 acupuncturists from nearly 30 countries and regions will gather in Beijing this October, to discuss the future of traditional Chinese medicine.

From Oct. 20 to 22, the acupuncturists will attend an academic forum for the 20th anniversary of the World Association of Acupuncture. The forum, with the theme of “acupuncture: looking back and looking forward”, will have eight sub-forums on topics like education, the evolution of acupuncture and needle therapy practise and assessment.

An exhibition of new methods and technologies in the field will also be held.

Deng Liangyue, chairman of the World Association of Acupuncture, said the association had successfully held six forums on acupuncture in China, Japan, the United States, France and the Republic of Korea over the past 20 years. With efforts from acupuncturists worldwide, needle therapy has spread to the four corners of the earth.

So far, more than 140 countries and regions have adopted acupuncture treatment. Traditional Chinese medicine represented by needle therapy is accepted and welcomed by mainstream society in many countries.

Statistics from the World Association of Acupuncture show there are about 100,000 people engaged in acupuncture services in Japan. 29 percent of Tokyo’s residents have received acupuncture treatment at least once. More than five million European patients choose needle therapy every year.

Acupuncture, one of the oldest traditional Chinese therapies, can not only help people give up smoking, but also cure sterility and even drug addiction. For poor people, it is a low-cost and easily accessible medical resource.

Acupuncture offers long lasting relief to migraines

CM NEWS – Acupuncture has been proved to provide effective and persistent relief of migraine headaches, according to a new study in Italy.

To check the effectiveness of a true acupuncture treatment according to traditional Chinese medicine (TCM) in migraine without aura, researchers of the Department of Medico-Surgical Specialities of University of Padua in Italy compared true acunpuncture to a standard mock acupuncture protocol, an accurate mock acupuncture healing ritual, and untreated controls.

“Migraine prevalence is high and affects a relevant rate of adults in the productive phase of their life,” says the study to be published in the journal Headache.

“Acupuncture has been increasingly advocated and used in Western countries for migraine treatment, but the evidence of its effectiveness still remains weak. A large variability of treatments is present in published studies and no acupoint selection according to TCM has been investigated so far; therefore, the low level of evidence of acupuncture effectiveness might partly depend on inappropriate treatment.”

In the study, the patients were divided into the following 4 groups:
(1) group TA, treated with true acupuncture (according to TCM) plus Rizatriptan; (N=32)
(2) group RMA, treated with ritualized mock acupuncture plus Rizatriptan; (N=30)
(3) group SMA, treated with standard mock acupuncture plus Rizatriptan; (N=31)
(4) group R, without prophylactic treatment with relief therapy only (Rizatriptan); (N=39)

What is Rizatriptan? Rizatriptan is used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound and light). Rizatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels in the brain, stopping pain signals from being sent to the brain, and stopping the release of certain natural substances that cause pain, nausea, and other symptoms of migraine. Rizatriptan does not prevent migraine attacks.

The MIDAS Questionnaire was administered before treatment, at 3 and 6 months from the beginning of treatment, and the MIDAS Index (MI) was calculated. Rizatriptan intake was also checked in all groups of patients at all three time intervals. All patients had moderate to severe with no significant intergroup differences before treatment.

What is MIDAS Questionnaire? MIDAS is a questionnaire that measures headache-related disability simply and easily by counting the number of days of lost and limited activity due to migraine. Activities are classed into three areas:

* Paid work and education (school / college)
* Household work (unpaid work such as housework, shopping and caring for children and others)
* Family, social and leisure activities

Migraine sufferers count the number of days on which they missed out on these activities because of their migraine in the previous 3 months. Also, they count the number of days where their productivity was at most half as normal in paid and household work. The overall MIDAS score is reached by summing the answers to these five questions, and is scored in the number of days.

Group TA and RMA were evaluated according to TCM as well; then, the former was submitted to true acupuncture and the latter to mock acupuncture treatment resembling the same as TA. The statistical analysis was conducted with factorial ANOVA and multiple tests with a Bonferroni adjustment.

Results show that the migraines improved in all patients after 3 months and 6 months of treatment. However, those treated with true acupuncture plus Rizatriptan showed a significant improvement at both 3-month and 6-month treatments than with Rizatriptan only.

The researchers thus conclude that true acupuncture was the only treatment able to provide a steady outcome improvement in comparison to the use of only Rizatriptan, while Rizatriptan plus mock acunpuncture showed a transient placebo effect after 3 months into treatment.

Garlic lowers blood glucose levels of diabetics, helps hypertension

CM NEWS – Garlic may restore some of the antioxidants damaged by free radicals in patents with vascular diseases such as diabetes and hypertension, according to a new study.

The study is recently published by the Evidence-based Complementary and Alternative Medicine. Rats induced to have diabetes and hypertension were given an an aqueous extract of garlic (500 mg/kg IP daily) for 3 weeks.

As a result, the blood antioxidant levels of these rats after 3 weeks of treatment were significantly higher (P < 0.001) than the pretreatment levels in both diabetic and hypertensive rats. The increased serum antioxidant levels were paralleled by a decrease in serum glucose in the garlic-treated diabetic rats and lowered systolic blood pressure in the garlic-treated hypertensive rats.

What is the importance of antioxidants? Oxidative stress, an excessive production of reactive oxygen species (ROS) above the body’s antioxidant capacity, has been implicated in the development of many pathophysiological conditions including hypertension, diabetes, atherosclerosis and cancer, as well as the process of aging.

ROS are normal products of cellular metabolism which are usually removed by endogenous antioxidants. However, it has become increasingly clear that overproduction of ROS can lead to a damaging cycle of lipid peroxidation, depletion of natural antioxidants such as glutathione, perturbation of nitric oxide production and disruption of normalcellular metabolism. These changes have been shown to cause damage to cell membranes and in particular can cause endothelial dysfunction.

During the last decade, it has become increasingly evident that many chronic diseases are accompanied by increased levels of oxidative stress exacerbated by decreased antioxidant levels. These observations have precipitated much interest in study of the correlations between oxidative stress, antioxidant potential and development of chronic diseases in both humans and animal models. Of particular interest are the correlations between oxidative stress and development of diabetes and hypertension.

The researchers conclude that treatment of diabetic rats with garlic resulted in significantly increased antioxidant and lowered glucose levels compared to untreated diabetic animals.

CDC – What are the symptoms of swine flu (H1N1)?

Although uncomplicated influenza-like illness (fever, cough or sore throat) has been reported in many cases, mild respiratory illness (nasal congestion, rhinorrhea) without fever and occasional severe disease also has been reported. Other symptoms reported with swine influenza A virus infection include vomiting, diarrhea, myalgia, headache, chills, fatigue, and dyspnea. Conjunctivitis is rare, but has been reported. Severe disease (pneumonia, respiratory failure) and fatal outcomes have been reported with swine influenza A virus infection. The potential for exacerbation of underlying chronic medical conditions or invasive bacterial infection with swine influenza A virus infection should be considered.

Medicine Wheel Model For Nutrition Shows Promise For Control Of Type 2 Diabetes

American Indian populations experience significant nutrition-related health disparities compared to other racial and ethnic groups within the US. American Indian adults have the highest age-adjusted rates for cardiovascular disease, diabetes and obesity of any racial or ethnic group. Age-adjusted rates of diabetes among Native people vary from 14% to 72%, which are 2.4 to more than 6 times the rate of the general US population.

In a study published in the September 2009 issue of the Journal of the American Dietetic Association, researchers from the South Dakota State University, Brookings, report that a culturally-sensitive educational program based on the Medicine Wheel Model for Nutrition shows promise in changing dietary patterns in an American Indian population and impacting glycemic control.

During a 6-month period from January 2005 through December 2005, participants from the Cheyenne River Sioux Reservation were randomized to an education intervention or to a usual care control group. The education group received six nutrition lessons based on the Medicine Wheel Model for Nutrition, a diet patterned after the traditional consumption of macronutrients for Northern Plains Indians: protein (25% of energy), moderate in carbohydrate (45% to 50% of energy) and low in fat (25% to 30% of energy). The usual care group received the usual dietary education from their personal providers.

The education group experienced a significant weight loss and decrease in body mass index (BMI) from baseline to completion. The usual care group had no change in weight or BMI. There were no between group differences due to intervention in energy, carbohydrate, protein and fat intake and physical activity.

Writing in the article, Kendra K. Kattelmann, PhD, RD, Professor and Director, Didactic Program in Dietetics, Nutrition, Food Science and Hospitality Department, South Dakota State University, Brookings, states, “A diet patterned after the historical hunter-gatherer type diet, or even the early reservation diet (with the higher proportion of energy being supplied from protein), may provide better blood glucose control and lower the circulating insulin levels in Northern Plains Indians with type 2 diabetes. Tribal leaders are interested in preserving the history of their food patterns and embrace the development of educational tools depicting their historical consumption patterns. This trial is one of the first studies reported that attempts to measure the influence of the traditional Northern Plains Indians diet on control of type 2 diabetes.”

In a commentary, Jamie Stang, PhD, MPH, RD, LN, Chair of the Public Health Nutrition Program at the University of Minnesota, School of Public Health, cites some of the dietary challenges faced by the American Indian population. “Limited access to grocery stores that offer low fat, low sugar or whole grain food products and a variety of fruits and vegetables is the most frequently cited barrier to healthy eating…The loss of hunting and fishing rights, unavailability of traditional foods such as wild game, loss of traditional agriculture due to water scarcity and poor soil condition and loss of traditional ways of procuring and preparing foods have also been identified as reasons for poor food choices. Many urban American Indians live in neighborhoods that lack large, well-stocked grocery stores which limits their availability of healthful foods…Even the most culturally competent, evidence-based programs cannot improve eating behaviors among individuals or populations who live and work in an environment that does not support or provide healthy food choices.”

The article is “The Medicine Wheel Nutrition Intervention: A Diabetes Education Study with the Cheyenne River Sioux Tribe” by Kendra K. Kattelmann, PhD, RD; Kibbe Conti, MS, RD; Cuirong Ren, PhD. The commentary is “Improving Health among American Indians through Environmentally-focused Nutrition Interventions” by Jamie Stang, PhD, MPH, RD, LN. Both appear in the Journal of the American Dietetic Association, Volume 109 Issue 9 (September 2009), published by Elsevier.

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Journal references:

1. Kendra K. Kattelmann, Kibbe Conti, Cuirong Ren. The Medicine Wheel Nutrition Intervention: A Diabetes Education Study with the Cheyenne River Sioux Tribe. Journal of the American Dietetic Association, 2009; 109 (9): 1532 DOI: 10.1016/j.jada.2009.06.362
2. Jamie Stang. Improving Health among American Indians through Environmentally-Focused Nutrition Interventions. Journal of the American Dietetic Association, 2009; 109 (9): 1528 DOI: 10.1016/j.jada.2009.06.371

Aderans Research Institute Inc. (ARI) announced it has launched Phase 2 of its clinical study on cell-based hair regeneration for men and women.

Aderans Research Institute Inc. (ARI) announced it has launched Phase 2 of its clinical study on cell-based hair regeneration for men and women.

Structured around the findings of the recently completed Phase 1 of the study, this second phase will continue to evaluate the impact of its novel cell treatment process on pattern hair loss, also known as androgenetic alopecia. Phase 2 of the study is being conducted in six U.S. cities: Atlanta, Boston, New York, Raleigh, Houston, and Washington DC. Phase 1 was conducted exclusively in the United Kingdom.

“The second phase of this study is another step in our efforts to truly understand the impact of regenerative cell therapy on pattern hair loss. It’s a tremendous opportunity,” says Kurt Stenn, MD, Vice President and Chief Scientific Officer. The company’s research is focused on developing a state-of-the-art tissue engineering solution to the regeneration of hair, taking actual hair cells— fibroblasts and keratinocytes, the two primary cell types within hair follicles—and promoting their growth in controlled laboratory environments. The research teams then recombine them and these “combined hair cells” are then placed in the patient’s skin, where they are expected to elicit hair growth. “This is research the industry has always wanted to do, and ARI has combined the support, the market, and the scientific wherewithal to do it,” says Vern Liebmann, Vice President.

TransEnterix Announces Positive First-in-Man Results With New Laparoscopic Surgical Platform

Officials with TransEnterix announce that surgeons from the United States and Paraguay have successfully performed first-in-man studies of its revolutionary single-incision, single-port, four-channel laparoscopic surgical platform called the SPIDER™ System.

The SPIDER System – short for Single Port Instrument Delivery Extended Reach – allows surgeons to perform minimally invasive abdominal surgeries entirely through the umbilicus, leaving no visible scar. It’s the first single-port system to offer surgeons true triangulation and other critical techniques common in multi-port laparoscopy.

Fewer complications, faster full recovery, less post-surgical pain and an improved aesthetic result are potential benefits of single-port technology. Conventional laparoscopic surgery typically involves three to five incisions, which leave small scars in a patient’s abdomen. Surgeons in the United States perform more than 2.5 million laparoscopic procedures each year. TransEnterix expects to market its platform early next year.

In the TransEnterix first-in-man studies, surgeons successfully used the SPIDER System to perform cholecystectomies – gallbladder removals – on seven patients in Paraguay. One of the surgeons was American; the other surgeon was Paraguayan. The patients were Paraguayans who previously had received medical diagnoses requiring surgical removal of their gallbladders.

Todd M. Pope, president and CEO, said the procedures went extremely well, adding that surgeons confirmed that cholecystectomies performed with the SPIDER System took approximately the same amount of time as standard laparoscopic procedures.

“And that’s a critical point to make because surgeons won’t be interested in new technology that requires that they spend more time in the operating room – technological advances should make their jobs easier, not harder,” Pope said. “As we knew from having worked so closely with TransEnterix’s expert surgeon advisers, the SPIDER System is extremely user friendly. Surgeons who are comfortable with current laparoscopic techniques will adapt easily to our new platform.”

Dr. Aurora Pryor, a surgeon who serves on the TransEnterix Scientific Advisory Board, oversaw the first-in-man studies in Paraguay. She said the SPIDER System performed exactly as expected.

“I was pleased with how straightforward the system was to set up and use,” she said. “Two of the patients had acute inflammation and with the SPIDER System, I was able to complete their procedures safely and efficiently. The post-operative results were excellent – the patients’ scars were hidden and the patients reported less pain than is typical with standard laparoscopic approaches.”

Dr. Héctor Rolando Herrera Cabral is the Paraguayan surgeon who performed two of the cholecystectomies during the first-in-man studies. Despite never having seen the SPIDER System before participating in the TransEnterix first-in-man cases, the surgeon said he was quickly able to use it.

“My experience was very positive,” he said. “What was most impressive is how patients who had a cholecystectomy with the SPIDER System did not report any pain the day after the surgery or said their pain was minimal, whereas patients who undergo conventional laparoscopic surgery typically report mild pain. The aesthetic result is fantastic – the wound heals without leaving marks on the abdomen – and patients report total satisfaction.”

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