Taking The Myths Out Of Pudendal Nerve Entrapment Surgery

Imagine someone with chronic pelvic pain or genital pain so severe that sitting, having sex, or holding a job becomes impossible. Unable to maintain normal relationships, this person may lose hope and fall into despair because no one understands. Finally, the patient is given a diagnosis of pudendal neuralgia due to possible pudendal nerve entrapment (PNE) that may require surgery; but for patients with PNE, making a decision about pudendal nerve decompression surgery can be very confusing. While some physicians recognize the value of PNE surgery, it is not unusual for patients with PNE to be told that surgery will not help them and that they will have to learn to live with severe pelvic pain for the rest of their lives. Many patients who are considering PNE surgery have exhausted conservative treatments such as physical therapy, medications, or nerve blocks, and are still living in serious debilitating pain. Hearing conflicting opinions from health care providers may leave a patient who has chronic genital pain wondering where to turn. More educational information is needed to dispel some of the myths related to surgical treatment of PNE.

Myth # 1

Surgery should not be considered an option for people with PNE because it is too risky and its efficacy has not been established.

There continues to be disagreement in the medical world as to whether surgery should be an option for patients with pudendal neuralgia. In some instances patients are worse after surgery, and in approximately one-third of patients, there is no improvement.(2) Naturally, these patients continue to seek medical treatment after surgery which may cause some health care providers to question the efficacy of PNE surgery. Some post-operative patients who have had ligaments cut during surgery have reported developing sacroiliac joint dysfunction, piriformis syndrome, levator ani muscle spasm, and coccyx pain after pudendal nerve surgery. Other patients have reported new problems such as penile/clitoral numbness or pain in areas they did not experience before.

Despite the risks, according to publications in peer reviewed literature and anecdotal evidence from numerous patients, surgery can often bring significant relief in a patient's pain levels, and many patients experience dramatic improvements that allow them to resume a normal life. The challenge for the diagnostician is to determine which patients are most likely to have a positive outcome, but to date (September 2011), there is no test proven to offer 100% accuracy.(3) History and physical examination remain important in the diagnosis. Traditionally, pudendal nerve blocks have been used as a tool to diagnose a possible entrapment,(4) but there are occasional reports of patients who have become permanently worse from pudendal nerve blocks. While still used by some physicians, the value of a pudendal nerve motor latency test (PNMLT) in the diagnosis of pudendal neuropathy has not been established.(5) Recently, a special type of 3 Tesla Magnetic Resonance Imaging (MRI) has shown some promise in locating specific sites of entrapment. When a patient is deemed to be a possible surgery candidate based on the clinical exam, history, PNMLT, 3 Tesla MRI, and response to nerve blocks, the patient, in consultation with physicians, then faces the decision of which type of PNE surgery to choose.


Myth #2

There is a "best" approach or protocol for pudendal nerve decompression surgery.

The pudendal nerve lies deep in the pelvis, and accessing all sites of possible entrapment presents a challenge to the surgeon. There are five basic approaches to pudendal nerve decompression surgery, but there is no consensus in the medical community as to which approach is best because there are several possible sites of entrapment. The transgluteal approach is the most widely used approach to pudendal nerve decompression because it offers the surgeon the best visualization of the nerve at the most common sites of entrapment.

1. Perineal Approach

The first pudendal nerve decompression surgeries were recorded by Shafik in 1994(6) and were performed for the treatment of erectile dysfunction (ED) using a transperineal approach in which a para-anal incision was made and the inferior rectal branch of the pudendal nerve was followed to the pudendal (Alcock's) canal. A slit was made in the canal to release the pudendal nerve, and six of the seven patients had a subsequent improvement in erectile dysfunction. In a later publication,(7) Shafik reported success in the treatment of vulvodynia, using a similar surgical approach.

Since then, Beco(8) and de Bisschop(9) have published results of perineal surgery, and both have reported that a majority of patients have significant improvement in pain levels. With the perineal approach, a small incision is made in the perineum, and part of the nerve can be accessed without ligaments being severed, although access to the ligaments at the ischial spine, a common site of entrapment, is limited and requires a rectoscope.

2. Trans-Gluteal (TG) Approach

In 1998 Robert, et al(10) published on results of 150 transgluteal surgeries in which the pudendal nerve is accessed via an incision in the gluteal muscle and the sacrotuberous ligament. He reports that 45% were cured and an additional 22% improved. Robert describes several sites of entrapment along the course of the pudendal nerve including at the "ligamentous pinch" between the sacrotuberous and sacrospinous ligaments, at the piriformis muscle, the falciform process of the sacrotuberous ligament, or in the fascia of the obturator internus muscle at the Alcock's canal.

Robert's team published the results of a randomized controlled trial in 2005,(11) reporting that after one year, 70% of the surgical group were improved versus 13% of the non-surgical group.

Popeney, et al(12) published results of 58 cases of PNE surgery in 2008, reporting that in using the transgluteal approach as described by Robert, 60% of patients had greater than 50% improvement.

Based on Vleeming's research demonstrating the importance of the sacrotuberous (ST) ligament in stabilizing the sacroiliac joint,(13) some physicians who wish to preserve the integrity of the ST ligament to prevent possible post-operative pelvic instability offer a modified TG approach that spares the ST ligament or replaces it with cadaver tendon as described by Hibner.(14) Some surgeons make a vertical instead of a horizontal cut in the ligament and suture the ligament after the nerve is decompressed.

3. The Trans-Ischio-Rectal-Fossa (TIR) Approach

In the TIR approach as described by Bautrant in 2003,(15) a small (5 cm) incision is made in the posterior wall of the vagina in women or between the anus and scrotum in men. The sacrospinous ligament is accessed by dissection of the ischio-rectal trench and pushing aside the rectum. In most cases the sacrospinous ligament is sectioned to release the nerve between the ligaments at the ischial spine. With this approach, access to the sacrotuberous ligament is limited, requiring an endoscope. Bautrant reported that at 6 months, 66% were asymptomatic or satisfied with their improvement, and at one year this number increased to 86%.

4. The Laparoscopic Trans-Peritoneal Approach

Possover published results of using a laparoscopic approach for Alcock's canal decompression surgery and reports success in 15 out of 18 patients.(16) Using the laparoscopic approach as described by Possover allows neurolysis of the sacral plexus, focusing primarily on the proximal and medial portions of the pudendal nerve.

5. The Dorsal Nerve Approach
In 2005 Hubry, et al(17) described a possible site of entrapment distal to the urogenital diaphragm at the dorsal branch of the pudendal nerve. Recently, several surgeons have begun performing nerve release surgery on the dorsal nerve of the penis and clitoris, but as of September 2011, no results have been published on this approach.

Myth #3

PNE decompression surgery is like any other surgery. If you have not improved soon after surgery, the procedure should be considered a failure.

Unfortunately, it can take many months for nerves to heal, and autonomic, motor, and sensory function may never be complete.(18) During the recovery period, patients may require significant amounts of pain relief medication for an extended period of time while healing takes place. For unsuccessful surgeries, patients will require pain control for indefinite periods of time.

Considerations before Choosing PNE Surgery

It is easy to see why patients with pudendal neuralgia agonize over the decision as to whether to opt for pudendal nerve decompression surgery and which surgery approach to choose. Having spoken with hundreds of pudendal neuralgia patients, I believe there are two key considerations that must be remembered when deciding on PNE surgery.

1. Has the patient tried conservative therapies first (unsuccessfully), and has his or her illness taken away abilities to function, to enjoy life, and to have normal relationships?

2. Is the patient fully informed as to the advantages and disadvantages of each surgical approach, of the risks involved, and thereby mentally prepared for the possibility of an unsuccessful outcome?

Patients undergoing PNE surgery desperately need the non-critical support of family, friends, and health care providers. If the procedure is not successful, they don't need to hear "you should not have done that." They just need someone to give them hope and help them in their search for a way to silence the pain.

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Taking The Shame Out Of Pudendal Neuralgia

What could possibly be worse than struggling with a painful condition and feeling ashamed to discuss the problem because of its intimate nature? Such is the case for many suffering with pudendal neuralgia, a little known disease that affects one of the most sensitive areas of the body. This area is innervated by the pudendal nerve, named after the Latin word for shame.

Due to the location of the discomfort combined with inadequate knowledge, some physicians make reference to the pain as psychological. But nothing could be further from the truth. Unfortunately, discussing the condition with gynecologists, urologists and neurologists often proves fruitless since most know nothing about the condition and therefore cannot diagnose it.

What is Pudendal Neuralgia?

Pudendal neuralgia is a chronic and painful condition that occurs in both men and women, although studies reveal that about two-thirds of those with the disease are women. The primary symptom is pain in the genitals or the anal-rectal area and the immense discomfort is usually worse when sitting. The pain tends to move around in the pelvic area and can occur on one or both sides of the body. Sufferers describe the pain as burning, knife-like or aching, stabbing, pinching, twisting and even numbness.

These symptoms are usually accompanied by urinary problems, bowel problems and sexual dysfunction. Because the pudendal nerve is responsible for sexual pleasure and is one of the primary nerves related to orgasm, sexual activity is extremely painful, if not impossible for many pudendalites. When this nerve becomes damaged, irritated, or entrapped, and pudendal neuralgia sets in, life loses most of its pleasure.

Where is the pudendal nerve?

It lies deep in the pelvis and follows a path that comes from the sacral area and later separates into three branches, one going to the anal-rectal area, one to the perineum, and one to the penis or clitoris. Since there are slight anatomic variations with each person, a patient's symptoms can depend on which of the branches are affected, although often all three branches are involved. The fact that the pudendal nerve carries sensory, motor, and autonomic signals adds to the variety of symptoms that can be exhibited.

Diagnosis

Because pudendal neuralgia is uncommon and can be similar to other diseases, it is often misdiagnosed, leading some to have inappropriate and unnecessary surgery. Early in the diagnosis process, it is crucially important to undergo an MRI of the lumbar-sacral and pelvic regions to determine that no tumors or cysts are pressing on the nerve. In addition, the patient should be screened for possible infections or immune diseases, as well as having an evaluation by a pelvic floor physical therapist to determine the health of the pelvic floor muscles and to uncover whether skeletal alignment abnormalities exist. An accurate patient history is needed to assess whether there has been a trauma or an injury to the nerve from surgery, childbirth, or exercise. Tests that offer additional diagnostic clues include sensory testing, the pudendal nerve motor latency test, and electromyography. A nerve block that provides several hours of relief is another tool that helps to determine if the pudendal nerve is the source of pain.


Pudendal Neuralgia and Depression

One of the most common symptoms that accompanies pudendal neuralgia is severe depression. Some people with the disease have committed suicide due to the intractable pain. For that reason, it is important to consider antidepressants, as they can help lessen the hypersensitivity of the genital area in addition to relieving bladder problems. Certain anti-seizure drugs reportedly help to alleviate neuropathic pain while anti-anxiety drugs provide substantial relief of muscle spasms and assist with sleeping.

Uninformed physicians are reluctant to prescribe opiates for an illness that shows no visible abnormality, yet the desperate nature of genital nerve pain requires that opiates be prescribed for these patients. While medications are not always satisfactory, they do help take the edge off of the pain for many people. Until the correct treatment is determined, it is imperative that patients with pudendal neuralgia receive adequate pain management since the pain associated with this illness can be intense.

Treatment

Treatment depends on the cause of distress to the nerve. When the cause is not obvious patients are advised to try the least invasive and least risky therapies initially.

-- Physical therapy that includes myofascial release and trigger point therapy internally through the vagina or rectum assists with relaxing of the pelvic floor, especially if pelvic floor dysfunction is the cause of nerve irritation. If no improvement is found after six to twelve sessions, nerve damage or nerve entrapment might be considered.

-- Botox is now used in medical settings to relax muscles and shows promise when injected into pelvic floor muscles; though finding a physician adept at this treatment is difficult.

-- Pudendal nerve blocks using a long-acting analgesic and a steroid can reduce the nerve inflammation and are usually given in a series of three injections four to six weeks apart.

-- If physical therapy, Botox, and nerve injections fail to provide adequate relief, some patients opt for pudendal nerve decompression surgery.

There are three published approaches to pudendal nerve decompression surgery but there is debate among members of the pudendal nerve entrapment community as to which approach is the best. Since there are advantages and disadvantages to each approach, patients face considerable confusion when deciding which type of surgery to choose. Because there are only a handful of surgeons in the world who perform these surgeries, most patients have to travel long distances for help. Moreover, the recovery period is often painful and takes anywhere from six months to several years since nerves heal very slowly. Unfortunately, early statistics indicate that only 60 to 80 percent of surgeries are successful in offering at least a 50 percent improvement. Patients whose surgeries are not successful or who do not wish to pursue surgery have the option of trying an intrathecal pain pump which delivers pain medication locally and helps to avoid some of the side effects of oral medications. Others pursue the option of a neurostimulator either to the sacral area or directly to the pudendal nerves. These are relatively new therapies for pudendal neuralgia so it is difficult to predict success rates. Some pudendalites have devised ingenious contraptions for pain relief ranging from u-shaped cushions cut from garden pads all the way to balloons filled with water, frozen, and inserted into the vagina. Most have a favorite cushion for sitting and many have special computer set-ups for home and office use in order to avoid sitting. Generally speaking, jeans are a no-no, so patients revise their wardrobes to include baggy pants and baggy underwear - if they are able to tolerate wearing underwear.

Clearly more research is required to find effective methods to better manage the pain and debilitation of pudendal neuralgia. But in the meantime, friends and family close to those who have this devastating illness play a huge role in helping patients cope, thereby maintaining the best quality of life possible. Support, love and understanding are of primary importance for those suffering with this affliction.

Ms. Violet Matthews has a Bachelor's degree in nursing and has been an active member of a Pudendal Neuralgia forum for 2 years. Having suffered with Pudendal Neuralgia, she has seen a 75% improvement in quality of life since her pudendal nerve decompression surgery in France two years ago. Married with two children, Ms. Matthews resides in Southwestern United States. You can usually find Violet at http://pudendalhope.org/forum/.

Further information is available at http://www.spuninfo.org or http://www.tipna.org/forum/index.php.

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Staph Superbug Most Common Cause Of US Skin Infections

It is known as Methicillin-resistant Staphylococcus aureus (MRSA), or the Superbug. It is resistant to most standard antibiotics and is becoming more resistant to newer ones. MRSA is now the most common cause of skin infections in the majority of American cities, says Dr. G Moran, University of California, Los Angeles, David Geffen School of Medicine. He believes doctors should be giving patients who need antibiotics only those known to effectively combat MRSA. He says things have changed over the last ten years - a different type of bacteria is now the most common cause of infections.

You can read about this in the New England Journal of Medicine (NEJM), August 17 issue.

MRSA used to be known as just the 'Hospital Superbug'. It was found just in hospitals, nursing homes and some other health care facilities. It was very rarely found in the community - what is known as 'community associated infection' with MRSA used to be extremely rare. This is not the case any more. There are more and more cases of MRSA acquired in the community - outside hospitals.

MRSA is not an uncommon bacteria. Apparently about one third of us, and maybe more, carry it around with us in our nose, on our skin and in our throat. Most of the time it is harmless. However, it can occasionally lead to serious and potentially fatal infections. Something as insignificant as a paper-cut can lead to MRSA infection.

The most common sign of Community-Associated MRSA infection is a boil or pimple on the skin. It is often swollen, red, has a discharge, and is painful.

Researchers cultured soft-tissue infections from 422 patients at emergency rooms in 11 US cities. The first time any such study had been done of so many US cities.

59% of all those patients had MRSA infection. Infection rates in those 11 cities varied from 15% to 74%. 97% of the MRSAs were of one strain, called USA-300.

The researchers had expected MRSA to be the most common infection among the 422 patients. However, they were surprised that the USA-300 strain was so common throughout the country.

The following percentages of MRSA samples could be treated with the antibiotics listed below:

-- 100% trimethoprim-sulfamethoxazole
-- 100% rifampin
-- 95% clindamycin
-- 92% tetracycline
-- 60% fluoroquinolones
-- 6% erythromycin

However, 57% of the patients had been prescribed antibiotics which were useless against the MRSA - in other words, the MRSA was resistant to 57% of the antibiotics doctors had prescribed for the 422 people. Hence, doctors should prescribe antibiotics which are known to be effective against MRSA, because MRSA infection is now the most common skin infection in the USA.

There are many steps we can take to reduce the incidence of MRSA infection in the community. It all comes down to a question of basic hygiene. Wash your hands regularly with soap. You can go even further by not sharing towels and some other toiletries.

What is MRSA?

Staphylococcus aureus, a type of bacteria, is present in many people and generally causes no problems. If it gets inside the body, however, such as under the skin it can cause serious infections. If it gets into the lungs it can cause severe pneumonia. People who carry Staphylococcus aureus are generally healthy, and are just 'carriers'.

When Staphylococcus aureus becomes resistant to commonly used antibiotics it is called Methicillin-resistant Staphylococcus aureus (MRSA). Many years ago the most common antibiotic used to treat Staphylococcus aureus was Methicillin. Methicillin is no longer used as an antibiotic, except in identifying drug resistant Staphylococcus aureus.

Most healthy people will never get seriously ill from this bacteria. However, some people can, including children, seniors (the elderly) and people with weakened immune systems, such as people with diabetes or HIV.

Methicillin-Resistant S. aureus Infections among Patients in the Emergency Department
Gregory J. Moran, M.D., Anusha Krishnadasan, Ph.D., Rachel J. Gorwitz, M.D., M.P.H., Gregory E. Fosheim, M.P.H., Linda K. McDougal, M.S., Roberta B. Carey, Ph.D., David A. Talan, M.D., for the EMERGEncy ID Net Study Group
NEJMVolume 355:666-674 - August 17, 2006 - Number 7
Abstract

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Drinking Tea Is Better For Health Than Plain Water

If you drink three or more cups of tea a day you might be doing your health more good than drinking plain water, say researchers from King's College, London, UK. This new study found, among other things, that the urban myth that tea dehydrates could not be further from the truth - tea hydrates as well as water does, say the researchers.

You can read about this new study in the The European Journal of Clinical Nutrition.

Not only will tea rehydrate you, it may also protect you from developing heart disease, and even cancer. Apparently, three or more cups a day may also protect your teeth and strengthen your bones. The researchers say they are not sure why, but believe that flavonoids, polyphenol antioxidants, which are found in abundance in tea, may play a major role. Flavonoids help prevent cell damage.

Team leader, Dr Carrie Ruxton, a Public Health Nutritionist, said tea is better for you than water because all water does is rehydrate you. Tea rehydrates you and provides antioxidants. With tea you get two benefits.

Dr. Ruxton, in a BBC interview, said "Studies on caffeine have found very high doses dehydrate and everyone assumes that caffeine-containing beverages dehydrate. But even if you had a really, really strong cup of tea or coffee, which is quite hard to make, you would still have a net gain of fluid. Also, a cup of tea contains fluoride, which is good for the teeth."

The team found that people are drinking less tea in the UK than they used to - possibly because they are consuming more soft drinks. The biggest tea drinkers in the UK are over 40 years old.

The Research was funded by The Tea Council.

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Extensive Cell Phone Use Linked To Brain Tumors, Swedish Study

According to a Swedish study, if you spend many years using your cell phone for at least an hour a day your risk of developing a brain tumor is 240% higher than a person who never uses one. The results of this study go against another recent one carried out in the UK and published in January, 2006, which indicated that cell phone use is safe for humans.

The researchers found that even the location of the tumor, for extensive cell phone users over many years, tends to be on the side of the head where the phone is used.

You can read about this study in the International Archives of Occupational and Environmental Health.

The scientists examined cell phone use among 905 people who had a malignant brain tumor and compared them to a control group of 905 healthy people. All the volunteers were aged 20-80.

85 of the 905 people who had a malignant tumor were high users of cell phones (mobile phones) - they started using mobile phones a long time ago, and have used them a great deal, on average for about an hour a day.

According to Kjell Mild, study leader, in an interview with the Reuters news agency, the best way to reduce the risk is to use hands-free.

The team's definition of a extensive use means over 2,000 hours of cell phone use, spread over many years.

(Cell Phone = Mobile Phone. In the UK people tend to say Mobile Phone).

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Hazards Of Tongue Piercing

Body piercing is popular today in the United States and other western societies. One common type of body piercing is tongue piercing, which involves placing a "barbell"-type stud through the tongue. But wearing a tongue stud puts people at risk for chipped teeth, recessed gums, and nerve damage, warns the Academy of General Dentistry (AGD).
However, most people don't realize that getting an oral piercing also places them at risk for developing a fatal infection or, in some cases, a mini-tongue, according to a report in the January/February 2006 issue of General Dentistry, the AGD's clinical, peer-reviewed journal.

In the report, a young woman's pierced tongue developed a large, round lump adjacent to the piercing. The lump, which she called her "second tongue," didn't hurt, nor was it infected, but it was growing. This mass was determined to be a scar tissue formation. Improvement was noted after oral hygiene was increased (frequent use of mouthwash and hydrogen peroxide mouthwash) and the tongue stud was replaced with a shorter shaft.

"Keep the wound clean. Make sure the bar is short so food and bacteria won't enter the site," advises Ellis Neiburger, DDS, lead author of the study. "Replace the metal barbell heads with plastic ones."

The number of adults between ages 21 and 31 who have their tongue pierced continues to increase, notes Melvin K. Pierson, DDS, FAGD, AGD spokesperson, despite his efforts to educate his patients about the dangers.

Although this article cited an extreme case, there are some very common dangers associated with tongue piercing. Unclean piercing equipment can cause other infections, such as bloodborne hepatitis. Also, if a patient is not instructed to avoid touching the piercing, they might spread infections with their own fingers.

"I see a lot of damage caused by piercing---tooth fractures, tooth chips. Patients don't see the relation between them and piercing, which weakens the tooth. The damage is almost always in the pre-molars, the middle teeth, almost parallel to the piercing," says Dr. Pierson. "The best way to prevent damage is to not get your tongue pierced."

"I don't recommend piercing," says Dr. Pierson. "Because of the risks associated with this unregulated procedure, if someone is considering an oral piercing, he or she should discuss it with their medical or dental professional."

Hazards of tongue piercing:
# Infection due to unsterile instruments.
# Pierced blood vessel or artery.
# Development of scar tissue.
# Tooth fractures and chips.

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The Academy of General Dentistry is a non-profit organization of more than 35,000 general dentists dedicated to staying up-to-date in the profession through continuing education. A general dentist is the primary care provider for patients of all ages and is responsible for the diagnosis, treatment, management and overall coordination of services related to patient's oral health needs. Learn more about AGD member dentists or find more information on dental health topics at http://www.agd.org/consumer

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Fury At Milk And Wheat In McDonalds' French Fries

When McDonalds serves its French Fries, everyone believes they contain just potatoes and cooking oil - even people who are vegan (eat no animal product at all) or allergic to wheat. We trust the company and believe everything they say. Because that is what they have been saying - that their fries are gluten-free.

It has been revealed that McDonald's fries do contain an animal product - Milk. They also contain wheat. There are thousands and thousands of people around the world who are allergic to wheat (mainly because of the gluten in wheat). Surely, out of respect for people who get ill when consuming wheat, the company could have let us know that wheat and milk were being added to its French Fries.

So far, three people in the USA are suing McDonald's because of this.

Debra Moffatt, from Chicago, has celiac disease. She cannot consume gluten, which is present in wheat. If she consumes wheat she experiences serious gastrointestinal problems.

Mark and Theresa Chimiak have a 5-year-old girl who is gluten-intolerant. The little girl, Annalise, became seriously ill after eating French fries in McDonalds. Mark and Theresa, from Florida, are also suing McDonald's.

Nadia Sugich, a vegan, is also suing McDonald's. Vegans do not eat any animal products at all (vegetarians include dairy and eggs in their diet, vegans don't). Had she known the product contained milk she would not have touched them.

What many people find incredible is that McDonald's claimed its fries were free of gluten and milk. It has just added in its web site that its fries do, in fact, contain wheat and milk ingredients - now that people are starting to take it to court.

What is the consumer to do if claims made by fast food centers are completely untrue? How can a parent protect a child if that child has a serious allergy? One minute they claim something is not present, then they say it is after lawyers start saying they are going to be sued.

Now, McDonald's Vice-President is saying that wheat and milk were added to enhance the flavour of the French Fries. There is nothing wrong with that. What is wrong is not telling people about it. Even worse, is telling people there is no gluten in a product when there is - that is dangerous.

Apparently, there is a third ingredient we knew nothing about in McDonald's French fries - a trans fat.

Here are some comments from our readers:

"I am vegan. I have eaten their vegetable burger with fries for many years. I will never do it again. I really hope their vegetable burgers were animal free."

"I really do not know where to take my children any more. I thought these companies had to work under certain rules - rules laid down to protect the public."

"I cannot believe they would deliberately add a potentially dangerous ingredient and still claim their product is free of it. I cannot eat gluten, I get very ill if I do. Each time I go out to eat now, I am going to feel uneasy."

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Non-Surgical Treatment For Leaky Heart Valves Under Investigation At UC Davis Medical Center

When Charis Bledsoe learned that her 77-year-old mother and housemate, Mattie Cooksey, was suffering from a severely leaking heart valve, it became evident why her mother had not been feeling well.

Over a period of about two months, Cooksey's breathing had been rapid and labored, and she tired quickly. Routine tasks such as taking out the garbage or picking up the mail became too taxing, and even walking from her bedroom to the kitchen weakened her. In addition, her complexion had turned to a grayish pallor, and her legs became swollen.

Currently, the only approved option for treating severely leaking heart valves is open-heart surgery with cardiopulmonary bypass. But UC Davis Medical Center is among 30 hospitals across North America that are participating in an FDA-approved clinical study of an experimental device for repairing a leaking mitral valve, (so-called mitral regurgitation), which does not require open-heart surgery. Instead, the experimental device and procedure use a catheter inserted into a vein at the groin, performed while the heart is still beating.

After having the procedure at UC Davis Medical Center, Cooksey returned home after three days, compared to the five-to-seven day hospital stay normally required after open-heart surgery. Two days later, Cooksey was "back to normal," said Bledsoe.

"She was back to fixing her own meals, and her breathing was great," Bledsoe said. "She moves around as fast as she was moving before, maybe faster. On a scale of one to 10, I'd say she's a 10."

Reginald Low and Jason Rogers are two of the UC Davis cardiologists performing this procedure, assisted by echocardiologist Bill Bommer. Cardiac surgeons Nilas Young and Royce Calhoun will perform the surgeries on patients randomly selected for the surgical comparison group.

"Patients are attracted to this procedure because it is a less invasive alternative to open-heart surgery," said Rogers. "In the future, we will likely be treating many more heart valve conditions with these catheter-based approaches.

The study that benefited Cooksey involves a minimally invasive procedure that uses a small clip to help properly close the leaflets of the mitral valve in patients with mitral regurgitation. The condition occurs when the leaflets of the heart's mitral valve do not close properly. The mitral valve is a one-way valve that separates the left atrium (a chamber in the heart that collects blood) from the left ventricle (a chamber in the heart that pumps blood out to the body).

For patients with mitral regurgitation, blood flows backward into the left atrium during the heartbeat, decreasing blood flow out to the body. When mitral regurgitation is severe, the left ventricle must pump harder to compensate. Continual backflow due to the condition places an extra burden on the heart. Eventually, the increased strain can cause other heart problems, such as ongoing damage to the heart muscle, inadequate circulation of blood in the body, stroke and, in some patients, sudden death.

So far, about 50 cases using the clip have been performed in the United States. UC Davis Medical Center is the only hospital in Northern California that has performed the procedure.

The Endovascular Valve Edge-to-Edge Repair Study (EVEREST) II is a randomized, multi-center study investigating the safety and efficacy of the MitraClip, produced by Evalve, a Menlo Park, Calif.-based company that designs, develops, manufactures and markets new devices to enable the percutaneous repair of cardiac valves. EVEREST II will compare the MitraClip process to the standard surgical mitral valve repair in patients with functional or degenerative mitral regurgitation.

During the procedure, a doctor inserts a catheter through the patient's skin in the groin area and guides it through the femoral vein into the affected area of the heart. A smaller delivery catheter that holds the MitraClip is then inserted through this tube to allow the clip to be guided into place and attached to the leaflets (the "swinging doors") of the mitral valve. After the clip is attached, it is deployed and the catheters are removed.

Mitral regurgitation is the most common type of heart valve insufficiency. An estimated four million people in the United States have significant mitral regurgitation, with an annual incidence of 250,000 newly diagnosed patients. About 50,000 of these patients under go open-heart surgery every year.

EVEREST II is a follow-up to an earlier feasibility study that enrolled 47 patients with moderately severe or severe mitral regurgitation who were experiencing symptoms or had a weakened left ventricle. Only 4 percent of those patients experienced a significant adverse event at 30 days. Ninety-three percent of the patients who had a significant reduction in mitral regurgitation at one month have maintained that improvement at one year. While all of the enrolled patients required surgery prior to the MitraClip procedure, 75 percent of those who received the clip remain free from surgery.

UC Davis Health System is an integrated, academic health system encompassing UC Davis School of Medicine, the 577-bed acute-care hospital and clinical services of UC Davis Medical Center, and the 800-member physician group known as UC Davis Medical Group.

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Exelon Patch, The First Transdermal Therapy For Alzheimer's Disease, May Provide Promising New Approach To Treatment Of Dementia

An international study of the first transdermal patch for patients with Alzheimer's - a degenerative brain disease estimated to affect more than 15 million people worldwide - has shown that it may provide a promising new treatment approach1.

The six-month IDEAL trial of 1,195 patients with Alzheimer's disease showed that the Exelon Patch provided benefits across a range of symptoms and the target dose was well tolerated. Results were presented today at the 10th International Conference on Alzheimer's Disease and Related Disorders (ICAD), presented by the Alzheimer's Association in Madrid, Spain.

Patients receiving Exelon Patch (rivastigmine transdermal patch) had significant improvements in memory and were better able to maintain everyday activities1 than those receiving placebo. They could also complete a concentration task up to 20 seconds faster compared to those taking placebo, and physicians considered Exelon Patch patients to have done better overall.

In addition, over 70% of caregivers in the IDEAL study preferred the patch to capsules as a method of drug delivery for reasons including helping them follow the treatment schedule, overall ease of use and less interference with daily life2, according to a questionnaire in the study.

"The patch represents an important new option for people with Alzheimer's disease and their families," said lead study investigator Professor Bengt Winblad of the Karolinska Institute in Stockholm, Sweden. "The target rivastigmine patch dose provided similar efficacy to that achieved at the highest doses of the capsule with three times fewer reports of nausea and vomiting. A transdermal patch may prove to be the best way to deliver rivastigmine to treat Alzheimer's."

Transdermal patches are designed to provide controlled, continuous delivery of drug through the skin. This maintains steady drug levels in the bloodstream, which may reduce side effects and consequently allow access to higher doses. In addition, patches may help caregivers to monitor treatment compliance because they provide visual reassurance that the medication has been taken.

"Although Alzheimer's disease treatments have been available in oral forms for some time, we believe a patch may offer unique advantages for patients with this condition," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "If approved, the Exelon Patch could potentially improve therapy compliance and help patients and their caregivers in reaching a better quality of life."

Exelon is a cholinesterase inhibitor already approved in many countries for the treatment of mild to moderate Alzheimer's disease and dementia associated with Parkinson's disease. The IDEAL results will support the regulatory submission of the Exelon Patch to health authorities, planned by the end of 2006.


About the IDEAL study

IDEAL (Investigation of Transdermal Exelon in Alzheimer's disease) was a 24-week, multi-center, randomized, double-blind, placebo- and active-controlled trial to compare the efficacy, safety and tolerability of the once-daily Exelon Patch with conventional twice-daily Exelon capsules in patients with moderate Alzheimer's disease. The primary outcomes measures were the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADSC-CGIC).

IDEAL was conducted in 21 countries and involved 100 centers and 1,195 patients aged 50-85 years old with a score of 10-20 in the Mini-Mental State Examination (MMSE), the most widely-used test for assessing memory problems or dementia. Patients received Exelon either in capsules (6 mg twice-daily) or patches in two sizes, namely Patch 10 (providing 9.5 mg over 24 hours) or Patch 20 (17.4 mg/24 h)1.

Both patch sizes showed superior efficacy to placebo. The target dose of Patch 10 showed similar efficacy to the highest doses of Exelon capsules with three times fewer reports of nausea (7.2 percent vs. 23.1 percent) and vomiting (6.2 percent vs. 17.0 percent), which are well-known side effects of cholinesterase inhibitors. Patch 20 showed numerically but not statistically improved cognitive scores versus capsules and similar tolerability to capsules.

Local skin tolerability was good. The percentage of patients who reported moderate or severe redness of the skin at any point of the study was only 7.6 percent and 6.2 percent of patients receiving Patch 10 and 20, respectively. The patch also demonstrated very good skin adhesion over 24 hours in a range of everyday situations such as bathing and in hot weather.

About Exelon

Since 1997, Exelon (rivastigmine tartrate) has been widely used to treat mild to moderate Alzheimer's disease in more than 70 countries. Exelon is the only cholinesterase inhibitor to be also approved to treat both Alzheimer's disease and dementia associated with Parkinson's disease (PDD) in Europe and US.

Exelon belongs to a class of drugs known as cholinesterase inhibitors (ChEIs) which increase the activity of the neurotransmitter acetylcholine in the brain. Among the widely-used ChEIs, Exelon is the only treatment that inhibits both enzymes involved in the breakdown of this neurotransmitter - acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE). This may offer additional benefits over treatments which inhibit AChE alone. Exelon can maintain both memory and thinking, help with behavioural problems, and affect how patients cope with the activities of daily living. It may help them communicate better, interact socially, and participate in hobbies and activities of daily living3,4.

About Alzheimer's disease

Alzheimer's disease is a progressive, degenerative disease that alters the brain, causing impaired memory, thinking and behaviour. Affecting approximately 15 million people worldwide and two to six percent of those over 65 years of age, it is the most common form of dementia and the third leading cause of death in this age group behind cardiovascular disease and cancer5. The worldwide direct costs for dementia in 2003 are estimated at $156 billion5.

This release contains certain forward-looking statements relating to the Novartis Group's business, which can be identified by the use of forward-looking terminology such as "may", "will", "could", "if approved", "planned by", or similar expressions, or by express or implied discussions regarding potential future regulatory submissions for Exelon or the Exelon Patch, or regarding potential future revenue from Exelon or the Exelon Patch. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Exelon or the Exelon Patch to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that any regulatory submissions regarding the Exelon Patch will be made as planned or, if made, will be successful. Neither can there be any guarantee regarding potential future revenue from Exelon or the Exelon Patch. In particular, management's expectations regarding commercialization of Exelon or the Exelon Patch could be affected by, among other things, additional analysis of Exelon clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays in government regulation generally; the ability of Novartis to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; as well as factors discussed in Novartis AG's Form 20-F filed with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis has been a leader in the neuroscience area for more than 50 years, having pioneered early breakthrough treatments for Alzheimer's disease, Parkinson's disease, attention deficit/hyperactivity disorder, epilepsy, schizophrenia and migraine. Novartis continues to be active in the research and development of new compounds, and is committed to addressing unmet medical needs and to supporting patients and their families affected by these disorders.

Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 96,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

References
1. Winblad B, Cummings J, et al. IDEAL: a 24 week placebo controlled study of the first transdermal patch in Alzheimer's disease - rivastigmine patch versus capsule. Oral Presentation at the 10th International Congress of Alzheimer's and Related Disorders (ICAD), Madrid, Spain, 19 July 2007.
2. Winblad B, Beusterien KM, et al. Caregivers prefer patches to capsules: results from a 24-week placebo controlled study of rivastigmine (IDEAL trial). Poster presented at the 10th International Congress of Alzheimer's and Related Disorders (ICAD), Madrid, Spain, 19 July 2007.
3. Corey-Bloom J, Anand R, Veach J. A randomized trial evaluating the efficacy and safety of ENA713 (rivastigmine tartrate), a new acetylcholinesterase inhibitor, in patients with mild to moderately severe Alzheimer's disease. Int J Geriatr Psychopharmacol 1998;1:55-65.
4. R�sler M, Anand R, Cicin-Sain A et al. Efficacy and safety of rivastigmine in patients with Alzheimer's disease: international randomized controlled trial. Br Med J 1999;318:633-40.
5. Wimo A, Jonsson L, Winblad B, An Estimate of the Worldwide Prevalence and Direct Costs of Dementia in 2003, dementia and Geriatrics Cognitive Disorders, 2006, 21: 175-181.

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Life Expectancy For Lung Cancer Patients Extended By Combined Treatment

Combining thermal ablation with radiation therapy extends average life expectancy and decreases recurrences of tumors in patients who have early stages of inoperable lung cancer, according to researchers at Rhode Island Hospital.

In a retrospective study looking at patients over seven years, the median survival rate at three years increased from 20 months after radiation alone to 42 months when thermal ablation was followed by radiation for treatment of non-small-cell lung cancer. The results are published in the July issue of the Journal of Vascular and Interventional Radiology.

"This study shows us that even patients who are not eligible for surgery can still get very good results," says senior author Damian Dupuy, MD, director of ultrasound at Rhode Island Hospital and professor of diagnostic imaging at Brown Medical School, both in Providence, RI. "By combining thermal ablation and radiation, you have a better chance of survival than with either treatment alone."

With radiation alone, overall survival rates were as follows:

one year - 57 percent
two years - 36 percent
three years - 21 percent

With thermal ablation and radiation, they were significantly higher:

one year - 87 percent
two years - 70 percent
three years - 57 percent

Surgery is the standard treatment for lung cancer. However, only one-third of patients with early stage lung cancer qualify for surgery because of other underlying medical conditions. Radiation therapy has long been used for inoperable lung cancer, and more recently, doctors have used radiofrequency ablation (RFA) and microwave ablation, processes that heat tumors to destroy them. For patients who cannot have surgery or radiation, the median survival is about one year.

In this study, researchers looked retrospectively at 41 patients treated over seven years with thermal ablation (RFA or microwave ablation) and either standard radiation therapy or brachytherapy, a procedure in which a "seed" of radioactive material is implanted into the cancer or near it. Patients were diagnosed with Stage I or II lung cancer, meaning the lung cancer in most cases had not spread and was usually smaller than 3 centimeters, though not in all cases. While this study did not address the timing of combined treatment, brachytherapy radiation was typically administered within two hours of thermal ablation while external beam radiation was given within three to four weeks. Rhode Island Hospital may be the only hospital in the world to administer this combined treatment.

The recurrence rate was much lower with the combined treatment. With radiation therapy alone, about 50 percent of tumors recur within six to 12 months. By the end of this study, 24 percent of patients treated with ablation and radiation had recurrences at an average of 44 months. While there was an increased recurrence rate in larger tumors - 33 percent recurred at an average of 34 months - the overall survival rate was the same for patients with large and small tumors.

"We found that just because the tumor returns, that doesn't mean the patient lives less long," Dupuy says.

The combined treatments work because they create a "synergy," the authors write. When tumors are targeted with radiation therapy, oxygen is vital to help the radiation damage DNA and kill cancerous cells. While radiation is most effective in destroying cells around the edges of the tumor, it is less effective at targeting the center of the tumor, which tends to be a low-oxygen environment.

Thermal ablation, on the other hand, heats the tumor to kill cancerous cells - reaching the center of the tumor, but not necessarily killing all the cells at the edges. This can lead to a recurrence of the tumor, and the cancer may spread. Thermal ablation is delivered directly to cancerous cells with the guidance of a diagnostic image showing the tumor's location. However, if some cancerous cells have spread into small channels of the lung around the tumor, they tend to be small and not visible on a radiology scan. Thermal ablation, which sends electrical current into the tumor, may not penetrate far enough into the lung to kill these areas of cancer.

When the two therapies are combined, they complement each other. Thermal ablation kills the central tumor. In exchange, radiation kills the cells on the periphery of the tumor and elsewhere in the lung that are missed by thermal ablation.

While this study looked only at lung cancer, Dupuy also has pioneered the use of RFA in thyroid, kidney, adrenal and bone cancer. The combined treatment may have far-reaching effects, Dupuy says.

"You might be able to treat tumors elsewhere in the body with similar results," Dupuy says. "There are a lot of opportunities for exploring the synergy of thermal ablation and radiation."

###

Other authors on the paper are: C. Alexander Grieco, MD; Caroline J. Simon, MD, William W. Mayo-Smith, MD, Thomas A. DiPetrillo, MD; and Neal E. Ready, MD, all of Rhode Island Hospital and Brown Medical School.

This study was supported in part by grants from ValleyLab and Vivant Medical.

Founded in 1863, Rhode Island Hospital (http://www.rhodeislandhospital.org/) is a private, not-for-profit hospital and is the largest teaching hospital of Brown Medical School. A major trauma center for southeastern New England, the hospital is dedicated to being on the cutting edge of medicine and research. Rhode Island Hospital ranks 13th among independent hospitals who receive funding from the National Institutes of Health, with research awards of more than $27 million annually. Many of its physicians are recognized as leaders in their respective fields of oncology, cardiology, orthopedics and minimally invasive surgery. The hospital's pediatrics wing, Hasbro Children's Hospital, has pioneered numerous procedures and is at the forefront of fetal surgery, orthopedics and pediatric neurosurgery.

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Circumcision, Fidelity More Effective HIV Prevention Methods Than Condoms, Abstinence, Researchers Say

Promoting male circumcision and fidelity to one partner seems to be more effective at curbing the spread of HIV than promoting abstinence and condom use, USAID researcher and technical adviser Daniel Halperin said last week, the Chicago Tribune reports. As Halperin and other researchers analyze 20 years of studies on HIV/AIDS throughout Africa, they have tried to "put aside intuitions, emotions, ideologies and look at the evidence in as coldhearted a way as we can," Halperin said. During a speech at a meeting of the Southern African HIV Clinicians Society in Johannesburg, South Africa, Halperin said he and his colleagues discovered that regular sex partners rarely use condoms, and abstinence merely delays HIV infection among young people by one or two years. For example, condom use in Ghana and Senegal seems to have helped in the reduction of the spread of the HIV, which in those countries is particularly prevalent among commercial sex workers and their partners. However, condom use in South Africa and Botswana has had little effect in reducing those countries' HIV epidemics -- which have reached the general population -- because regular sex partners rarely use condoms consistently. In comparison, faithfulness to one partner has worked at reducing HIV prevalence in Uganda and Kenya, according to Halperin. Because a person is more likely to transmit HIV during the first three weeks of contracting the virus, an HIV-positive person who has just one partner during that time is likely to pass the disease to that one person. But if an HIV-positive person in the highly infectious stage has many sexual partners at a time, "the virus spreads like wildfire" as those people in turn have sex with other people, Halperin said. In addition, circumcision has been shown to reduce male-to-female HIV transmission by 60% to 75% (Goering, Chicago Tribune, 4/23). A study published in the November 2005 issue of PLoS Medicine of men living in South Africa finds that male circumcision might reduce the risk of men contracting HIV through sexual intercourse with women by about 60%. Male circumcision might also reduce the risk of HIV transmission from HIV-positive men to their female partners, according to a study of couples in Rakai, Uganda (Kaiser Daily HIV/AIDS Report, 2/9). Poverty Reduction, Status Awareness
In addition, poverty does not appear necessarily to make a person more susceptible to HIV. "[C]ontrary to popular wisdom, as income levels go up in both men and women, we see higher rates of HIV," Halperin said, adding that people who make more money tend to have more sexual partners. Other HIV prevention methods such as encouraging people to know their status and treating secondary sexually transmitted infections also have not proven effective, Halperin said (Chicago Tribune, 4/23).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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