The Winter of 2011-2012 Flu Virus

The Winter of 2011-2012 Flu Virus
By Dr. Frank Ervolino

The Christmas time flu virus for 2011-2012 is not an influenza-A type virus but a different strain that is more of a pharyngitis type illness. It started showing up in Florida around November and is still spreading some two months later.
It is characterized by the following symptoms:

• Occipital (the back of the head) Headache which may last for the duration of the illness
• Slight fever and chills
• Some sweating
• Fatigue
• A nonproductive cough
• Mild laryngitis
• Duration of illness can last from as little as 48 hours to 2 weeks.

Management of this viral respiratory infection can actually be simple and effective.
To manage fever, muscle aches and cough it is suggested that you use one of the over the counter medications that contain:

• Acetaminophen which can control fevers, headaches and sore throat.
• Phenylephrine for nasal congestion
• Dextromethorphan for coughing
• Guaifenesin for coughing and to control chest congestion You can usually find all of these combined in tablet form.
  

• Gargle with alka seltzer to relieve the laryngitis.
• If coughing persists then add a guaifensin based cough syrup as well.
• Drink large amounts of warm black tea with honey and lemon in it to relieve the coughing sensation in the throat.

To take a more natural approach one can use:

• Elderberry syrup has been shown to actually kill viruses on contact when taken on a regular schedule. This therapy is especially effective as this virus resides in the laryngeal/pharyngeal area.
• The Chinese herbal pills called Jie Geng Wan to reduce the coughing sensation.
• Another useful Chinese herbal formula is Yin Qiao Jie Du Pian which is an excellent formula for warding off a viral illness.
• For the best defense against the flu and to clear it quickly from the body use an alpha glucan such as Immpower. The beta glucans are not as effective as the alpha glucans for the flu.
• NAC or n-acetyl-cysteine can be used as a mucolytic to help clear phlegm in the later stages.
• Drink large amounts of warm black tea with honey and lemon in it to relieve the coughing sensation in the throat. This is a simple and effective remedy as it also keeps the affected person hydrated.
• If traveling by air one can avoid getting ill by using a cotton swab that has been dipped in a small bottle of cooking oil to coat the insides of the nasal passages. This will prevent your nasal passages from drying out due to aggressive air conditioning used on planes. The virus usually enters your body through these cracked nasal passages.

There are many more OTC and natural remedies available. My intent was not to list them all, but to bring attention to this present viral epidemic and provide a quick working guide towards management of it.

Ave Ultra is Avemar-Don’t listen to European Whiners

Would you want a 1990 Toyota Camry made in Japan from a used car salesman or a 2011 Toyota Camry made in Kentucky? Unless you are a strange type of car collector I’ll bet you would rather have the 2011 Camry. That is the same choice you face with Avemar from Hungary of Ave Ultra which is Avemar from the United States and made in Wisconsin. You see the inventor of Avemar, a brilliant Hungarian biochemist named Mate Hidvegi originally made Avemar in Hungary, but had to make it in a form that did not follow his original design because Hungary did not have the technology or resources to make it the way he designed it. Instead of freeze drying he had to use heat spraying techniques that could damage the Avemar and he could not filter out much of the residue from manufacture so it was a heavy, poor tasting pulvis that had to be sweetened with fructose to hide the taste! Fructose is a terrible choice for a sweetener! It can give you gastric upset, raise your blood sugar levels and all sorts of other unwanted stuff. But this was Hungary, fructose? No problem.
A few years back Dr. Hidvegi was approached by some fellow Hungarian doctors with an offer he could not refuse. Let them manage his company and they would modernize production and raise revenue. He signed the operating agreement only to find out in small print that he had given up control of the company to these guys, but this is Eastern Europe....No Problem.
Once he found out that he no longer could even work at his company that he founded, he turned to the people who sold the most of the original Hungarian Avemar, a company called American BioSciences for help. They were interested in helping Dr. Hidvegi and they helped him rework the patent to include his original product design for Avemar because the United States has the technology and materials necessary to make Avemar the way Dr. Hidvegi originally envisioned it. Ave Ultra is not subjected to heat now, but freeze-dried! Ave Ultra uses stevia instead of fructose and the manufacturing is so good that one dose weighs 1/3rd of the Hungarian product. It is a better product, made the way it was originally intended and it is made in the United States!
The guys back in Hungary who stole the company from the inventor have turned into professional whiners.
So what is your choice? The 1990 Camry (or should I say Yugo) or the 2011 Camry made in the US. The old compromised Avemar or Ave Ultra?

Ideas on How to Eat Healthy, Anti-aging and Lose Weight

I love food and I love to cook for people. I also like to eat, but in the past I was prone to enjoying food in a way that was not a part of the "true me" and that is where the poor dietary choices are made in everyone's life. When one loses a sense of the "true self" one makes choices that seem out of character later. In order to keep it brief I will briefly make some points that hopefully others can take to even higher ground on their own.

in the early history of mankind food was hard to come by. You had to expel calories just to forage for food. Driving to the store is not the same.

Getting enough fat in one's diet was a difficult thing to do until the 1960's. in the 1800's in England a favorite way to get fat was to pour all rendered fat from cooking into a crock jar and dip bread in it, Fat is in everything we eat today.

Most of us were designed to be active all day as opposed to sitting at a desk. our metabolisms are geared for storing fat  during harvest time to be used to survive during lean winter times. Now there are no lean winter times, Just lots of food all year round.

Foods used to be available seasonally. Now there are no seasons, We can eat what ever we want whenever we want.

We used to have more bitter foods in our diet like leafy green vegetables. Now we predominantly eat sweet and salty foods. Bitter foods satisfy the body's needs and improve our digestion making us healthier.

Our hormone balance depends on one's activity levels. Serotonin controls moods, libido, gut function and sleep patterns. It is profoundly affected by our activity levels. If we are more sedentary we will have lower levels of serotonin. If one exercises it will actually change your food preferences by changing your hormonal balance. The more you exercise the healthier your food choices. Remember serotonin levels decrease naturally after age 40 so supplementation with 5-htp can help with this.

Your lean muscle/fat deposition balance depends on your IgF1 or insulin growth factor 1 levels. This is the major component of human growth hormone. This also decreases with age but can be increased by taking certain amino acids after a vigorous workout.

Hope this sheds some light on diet and health. Its just not one problem one solution. Knowledge can help ease the frustration levels and enable better solutions towards healthy living.

Restless Leg Syndrome Management Strategies

What is a Simple Explanation of the Mechanism of Restless Leg Syndrome?
Restless Leg Syndrome or RLS is usually genetic in nature and it involves the Dopamine pathways (dopaminergic) of the brain. Dopamine is a neurotransmitter of the brain and responsible for communication related to:

• motor skills (particularly fine tuning)
• motivation
• pleasure
• euphoria
• compulsion
• perserverance

The other major brain neurotransmitter is Serotonin which is responsible for:

• sleep
• mood
• memory processing
• cognition

The pathway most likely affected in RLS is the nigrostriatal pathway which transmits dopamine from the substantia nigra to the striatum. The striatum is a major communication pathway between the cerebral cortex and the basal ganglia of the brain. The basal ganglia controls sensory-motor functions. Sensory-motor functions have to do with feelings that govern muscle movement and any impairment that causes a breakdown of communication(in the striatum) between the cerebral cortex which takes feelings and makes them into thoughts and the basal ganglia which takes feelings and turns them into motor functions will result in a set of symptoms that resembles RLS. Other conditions can also result form impairment of the striatum include schizophrenia, Parkinson's disease, chorea and hyperprolactinaemia.

How Does RLS Occur?
RLS is most likely genetic, but it can also be due to traumatic injury and kidney pathology. RLS has a relationship with iron deficiency (ID). This is because in the presence of ID glutamate receptors and adenosine receptors in the brain form connections with the dopamine receptors in the brain that decreases the dopamine receptor site function and number causing RLS symptoms. In layman's terms iron maintains proper connections between receptor sites in the striatum of the brain where important communication occurs.   Because RLS is intermittent meaning that it intially comes and goes, one can assume that there is a healthy threshold for each person. This means there is a point where full health and functionality exists and when one falls below this threshold then symptoms of RLS appear. So, when one is healthy and above the threshold there are no symptoms and conversely when one is in poor health or weak then symptoms appear. There are many factors which can bring a person's health below the healthy threshold:

• Illness
• Stress-not taking time out for you to take care of your body. Having a drink at the end of a stressful day is like pouring gas on the fire. It's ok once in a while, but try working out, taking a walk,  just sitting down for a few minutes. If you are saying to me now "oh that is easy for you to say, you don't have kids or a family like I do". Well, the turth is I do and your saying that just might be part of the problem. Make time for yourself and your family will understand.
  
• Aging
  
• Lifestyle choices which increase oxidative damage in the brain
• Smoking
• Sugar
• Processed food
• Excessive work
• Exposure to toxins
• Lack of exercise
• Alcohol consumption (too much can cause cellular damage)
  
• Menstruation
  
• Expression of genetic predisposition

Management of RLS

• Definitely keep your iron levels up by iron supplementation if you experience RLS
  
• Maintain a diet of vegetables, and whole foods
• Decrease processed foods
• Decrease fried food consumption. Frying damages the fat which is used to make your brain.
  
• Decrease consumption of flour-based products which can also increase blood glucose levels
  
• Decrease empty calories from sugar, corn syrups and high glycemic index foods
• Maintain a moderate exercise program which will encourage healthier lifestyle choices. If you are working out 5 times a week for a half hour you are more likely not to smoke or eat unhealthy foods.
• Explore the possibility that you may have a subclinical wheat intolerance
• Take R-lipoic acid, alpha is cheaper but you get what you pay for. R-lipoic acid is the most potent anti-oxidant for the brain and nervous tissue there is. 
• Supplement your diet with Omega-3 EPA and DHA oils. These are in fish oil supplements. 1-2 per day is not enough! You need to take one teaspoon of liquid or 6 gelcaps a day.
• There is a Chinese herbal formula called Yi Gan San that works on the striatum of the brain to decrease RLS symptoms. If you contact me I can help you get it.

The bottom line here is that if you have restless leg syndrome you probably have a genetic predisposition to it and your best strategy is to not encourage it with unwise lifestyle choices. Do everything you can to discourage damage to your body and your brain and the payoff could be huge. You could end up never having it seriously impacting your life. There are other strategies, but this is a good start.

Is There a Link Between Allergies to Wheat and Women's Thyroid Disease?

In my clinical practice I have seen many women with various thyroid pathology. Some of them I have been able to help and others I have not. I have seen t4/t3 conversion problems, hypothyroid, hyperthyroid, Hashimoto's thyroiditis and idopathic thyroid refractory to any treatment. Lately I have seen women who have fatigue, loss of hair, bloating after eating and constipation as part of their symptom picture. I have diligently pursued a course of action using Western medicine, Chinese medicine and Natural therapies as well as acupuncture and dietary therapy. I have had good results with some, but overall I have not been satisfied with their outcomes. Then came Elizabeth, my dear friend and patient. She had all of the symptoms and was getting the best care from all of her medical team with no real results to speak of. She was dogged in her determination to get better to the point where she was manically pursuing any lead she found on the internet of by word of mouth. This was sapping her financially and spiritually. There came a point when even her search was starting to have a negative effect on her and that is when I stepped in and did what I was trained to do. I took all the puzzle pieces of her history and started to make some order of them. I got rid of the well intentioned but incompetent internet docs who were filling her head with made up physiology and selling her hundreds of dollars of supplements to align her 'Hypothalamic/Adrenal axis". I gave her acupuncture for stress reduction and mapped out a plan to do some comprehensive testing to evaluate her thyroid, estrogen metabolism and rule out any allergies. All came back negative except her estradiol levels which were high and her thyroid which showed a high reverse T3 level. Gliadin antibody levels were negative as well but we had put Elizabeth on an elimination challenge diet and she reported that she felt much better. I also put her on an amino acid combination shown to improve Igf1 levels in research to compensate for the longstanding stress of her condition. This also was reported by her to give some improvement. Then I told her to take time for herself by walking on the beach several times a week alone and I gave her some AHCC supplementation (immpower by american biosciences) to alter her interleukin levels and optimize the functioning of her immune system with regard to her potential food sensitivities. From the elimination diet we learned that wheat was her main sensitivity even though she did not test positive for it. I urged her to try the new armour thyroid that comes from Canada because the synthroid  available in the U.S. is not performing as well as it should in women. Prior to this she had been using L-Thyronine supplementation from another physician.  Several months later she is much better and recovering nicely. She works out every day. She is not bloated anymore at night. She has an abundance of energy and feels optimistic about her future. In this case less was more and as in all cases having a focused plan with goals and objectives was more effective than a huge amount of disorganized and anecdotal advice.
I have a large amount of cases like this where women of all ages have different sets of symptoms but in the end one single cause, a sensitivity to wheat. I shake my head when I think of all the women over the deades who may have been subjected to polypharmacy and unneeded procedures plus the specter of having chronic problems that would not go away all because of an allergy to wheat. It is interesting to note that the vaunted China Study that was supposed to come out in favor of vegetables over meat consumption as the key to less disease actually showed that the strongest correlation to cancer in the food chain was wheat. Hmmm.....

Fibromyalgia and How To Treat It.

Fibromyalgia and How To Treat It.

I have treated fibromyalgia successfully in quite a few patients over the years. Many have gotten better and on with their lives. Many just could not overcome the challenge. Long discourses could be written about the effects the psyche has on physical health, but I am going to keep this brief and instead concentrate on explaining my views on how fibromyalgia starts in the body. I will be speaking from the perspective of Chinese Medicine because Western Medicine does not have a an explanation that goes as close to the actual cause as does Eastern Medicine's 2000 year old energetic system of Chinese Medicine. The Western Medicine system picks up it's description at the start of symptoms by explaining that there are less mitochondria in the muscles than is normal which puts the muscles into lactic acid production and therefore accounts for most of the pain felt at the 18 pressure points on the body.

In Chinese medicine there is a definite avenue of pathology that addresses the effects the Psyche has on the Soma (muscles) and Viscera (organs). This is similar to the addage that Hippocrates taught "Psche, Soma, Viscera". As we get older and move towards adulthood we realize that many of our childhood dreams will be unfulfilled.  This can manifest as extreme disappointment. In the chinese medical system the organs where anger frustration, decision making, and planning are the Liver and Gallbladder. These organs and their meridians (channels of energy flow in our bodies) govern the muscles and regulate flow of energy in our entire bodies as well. Think of the Liver and gallbladder meridians as sort of a valve like the water valve attached to a garden hose. If it is tightened down due to stress the no energy flows and pathology ensues.
Emotional stress plus poor lifestyle choices like a carbohydrate diet, poor sleep and a lack of exercise can lead to a condition called damp heat in the liver. This leads to poor overall health and makes on vulnerable to infections from viruses. In Chinese medicine the Liver is known as the general that fights for you, but when agitated in the body due to stress of life and poor lifestyle, it can stagnate the flow of Qi(chee) or energy in your body and eventually affect your bodies ability to ward off ilness which is controlled by the lungs in Chinese medicine. Stagnation of Liver Qi can also affect the digestive system and is thought to be responsible for IBS (irritable bowel syndrome), Crohn's and Colitis.
In Chinese medicine we think of the body as having multiple lines of immunological defense. Most colds and flus never get past the first line, but in a condition of damp heat in the Liver the virus can penetrate the weakened body further and this is where the major viral event happens in the patients medical history of fibromyalgia. This is where the Epstein-Barr virus titer goes high. It can actually be set off by many viruses, it does not have to be the Epstein-Barr virus. That titer is permanently high after any severe viral infection. It is a measure of the immune systems having historically dealt with a severe viral illness.

So how do I handle a Fibromyalgia patient? I need to tell you that I am keeping things brief in this post. The truth is each patient needs an individual approach, but this is what I do for most Fibro patients;

1. Lot's of acupuncture to move the liver qi and get rid of damp heat.
2. I use xiao chai hu tang herbal formula and modify it for each patient to rid the body of the liver damp heat.
3. I will often mix #2 with herbs to improve digestion and if there are nagging flu-like symptoms then I use Jie Geng and Isatis herbs in the formula
4. I make sure the patient is eating a higher protein diet and minimal comfort food intake which is mostly carbs made from flour like bread and chips. Minimal sugar intake. Make sure the fat consumption is high quality and lots of omega-3 fat.
5. I put the patient on an alpha-glucan (not a beta-glucan which can increase inflammation in the body) like IMMPOWER.
6. I make sure they are sleeping because if there is insomnia then there is probably low levels of serotonin (which is common in adults over 40) and there is also concomitant depression as well. For this I use a highly effective formula called SleepSolve 24/7. This is a hybrid western supplementation/Chinese herbal formula that can be used to combat insomnia in adults and children.
   
7. I try to get my Fibro patient to get moving in some way. That is the only way the brain will tell the body to make more mitochondria for those muscles. The best way for my patients is to gently ride a bicycle because it is low impact, low demand, easily accessible and can be done in their neighborhood. Riding a bike also has a remarkable positive effect on the psyche. Problems get solved and the patient gets to see the green color found in nature while riding a bike. Green is the color that soothes the LIver meridian.
8. I don't use vitamins as I prefer that my patients start cooking and getting their vitamins that way. I teach them how to cook simply and easily. I have been doing this for years. I put a hevy emphasis on complex carbs such as vegetables and I incorporate herbs into their cooking like basil, rosemary, ginger, cinnamon and astragalus.
   

There is a lot more that I do with each patient but this is the start. I hope this can be of some value to someone out there. Yours in health! Dr Frank
 

Avemar and Lymphoma

Oncol Rep. 2009 Mar;21(3):787-91.
 
    Saiko P, Ozsvar-Kozma M, Graser G, Lackner A, Grusch M, Madlener S, Krupitza G,     Jaeger W, Hidvegi M, Agarwal RP, Fritzer-Szekeres M, Szekeres T.

    Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Vienna, General Hospital of Vienna, A-1090 Vienna, Austria.

    Avemar (MSC) is a nontoxic fermented wheat germ extract, which has been shown to significantly improve the survival rate in patients suffering from various malignancies. We investigated its effects in sensitive and 5-FdUrd/Ara-C cross-resistant H9 human lymphoma cells. After 48 and 72 h of incubation, Avemar inhibited the growth of sensitive H9 cells with IC50 values of 290 and 200 microg/ml, whereas the growth of 5-FdUrd/Ara-C cross-resistant H9 cells was attenuated with IC50 values of 180 and 145 microg/ml, respectively. Treatment with 300 microg/ml MSC for 48 h caused dose-dependent induction of apoptosis in 48% of sensitive H9 cells. In cross-resistant H9 cells, incubation with 200 microg/ml Avemar for 48 h led to 41% of apoptotic tumor cells. Growth arrest of sensitive H9 cells after exposure to various concentrations of MSC occurred mainly in the S phase of the cell cycle, thereby increasing the cell population from 54 to 73% while depleting cells in the G0-G1 phase from 40 to 19%. Growth arrest in cross-resistant H9 cells occurred also mainly in the S phase, increasing the cell population from 45 to 68% while depleting cells in the G0-G1 phase from 45 to 31%. As MSC treatment likely overcomes 5-FdUrd/Ara-C resistance, further investigations to elucidate the exact mechanisms are warranted. We conclude that Avemar exerts a number of beneficial effects which could support conventional chemotherapy of human malignancies.

    PMID: 19212640 [PubMed - indexed for MEDLINE




The Cell Cycle and Cancer Drugs
Our body's cells -- both normal and cancerous -- make more cells like them through a series of four major steps often depicted as a circle, called the cell cycle.  Most cancer drugs work by interfering with a specific step in the cell cycle, because if the cell cannot make it through the first three steps of the cell cycle, it cannot divide to make two more cells just like it in the fourth step of the cell cycle -- cell division.  In that case, it usually will die, subtracting one cancer cell from the body's burden, and preventing two more from being created.
 
How Cancer Drugs Work -- Or Don't
 
The reason one cancer drug may work well on a particular cancer while a different drug may not is because drugs each typically have different ways of killing cancer cells, referred to as a drug's mechanism of action, and various cancers are more or less vulnerable to being attacked in any particular way.
 
If a patient's cancer doesn't respond to treatment with a particular drug, the cancer is said to be resistant to that drug, and doctors will usually select another drug that may work better.
 
The cancer drug 5-FdUrd is an improved version of the cancer drug 5-FU.  It makes a sort of "counterfeit" uracil, a substance needed to make new RNA necessary for cell division. When cells try to use the counterfeit uracil, it doesn't work, so the cells can't make RNA.  The cell quits moving through the cell cycle, and so it dies.
 
Ara-C is a cancer drug made to resemble a protein cells need to make DNA, but which won't work for that purpose.  When cells take it up, they can't make DNA.  Unable to make DNA, they can't move further through the cell cycle, and they die.
 
Sometimes, a patient's cancer will be resistant to not one, but two different cancer drugs that work in two different ways.  Such a cancer is said to be "cross-resistant", meaning neither drug works, alone or in combination. A cancer like that can be very difficult to treat successfully.
 
Lymphoma is a cancer that starts in lymphocytes, white blood cells of the immune system.  Among lymphoma cell types, some called H9 human lymphoma cells can be killed by FdUrd or Ara-C.  But if they are cross-resistant to both drugs, the H9 lymphoma cells are an example of cancer cells very hard to kill.
 
However, in a recent research study of H9 cells cross-resistant to both drugs, an international team of cancer scientists working together from universities in the US and Europe found that a natural substance earlier shown effective against several other kinds of cancer killed cross-resistant H9 lymhoma cells when neither of the two conventional cancer drugs used against them in the study could do so. 

DHEA and Vaginal Atrophy

The use of Intravaginal DHEA as a suitable treatment for women who suffer from vaginal atrophy and have a history of cancer. These women typically cannot use estrogen-related hormones to provide relief from a very uncomfortable condition that affects about 5% of menopausal women. Besides hampering intercourse vaginal atrophy can progress as to cause pain with common activities such as walking. This group studied the effect that DHEA had on vaginal tissue integrity when applied intravaginally. They found that it improved vaginal skin tone by causing a dramatic increase in Parabasal cells, an increase in superficial  cells and an impressive lowering of ph. Further study showed that the intravaginal DHEA was able to” improve sexual function and caused no or minimal changes in serum sex steroid levels”. This is important because changes in serum sex steroid levels are the concern of women who have had cancer and it is these changes in serum sex steroid levels that prevents women with a history of cancer from using estrogen.




Menopause. 2009 May 8. [Epub ahead of print]
    Intravaginal dehydroepiandrosterone (Prasterone), the physiological and a highly efficient treatment of vaginal atrophy.
    Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dubé R, Côté I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J.

    From the 1Laval University Hospital Research Center and Laval University, Quebec, Canada; 2Endoceutics Inc., Quebec City, QC, Canada;3Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA; 4Clinique de Recherche en Santé des Femmes, Quebec City, Canada; 5Diex Recherche Inc., Sherbrooke, QC, Canada; 6Rapid Medical Research Inc., Cleveland, OH;7Clinique Gynécologique, Shawinigan, Canada; 8Montreal Clinical Study Center, Montreal, Canada; 9Centre Hospitalier affilié Universitaire de Québec, Quebec City, Canada; 10McGill University Health Center, Royal Victoria Hospital, Montreal, QC, Canada; and 11Veristat Inc., Boston, MA.

    OBJECTIVE:: Because the secretion of dehydroepiandrosterone (DHEA), the exclusive source of sex steroids in postmenopausal women, is already decreased by 60% and continues to decline at the time of menopause, the objective of this study was to examine the effect of intravaginal DHEA on the symptoms and signs of vaginal atrophy. METHODS:: This prospective, randomized, double-blind and placebo-controlled phase III clinical trial studied the effect of Prasterone (DHEA) applied locally in the vagina on the signs and symptoms of vaginal atrophy in 216 postmenopausal women. RESULTS:: All three doses (0.25%, 0.5%, and 1.0%) of DHEA ovules applied daily intravaginally induced a highly significant beneficial change in the percentage of vaginal parabasal and superficial cells and pH as well as in the most bothersome symptom at 2 weeks. At the standard 12-week time interval, 0.5% DHEA caused a 45.9 +/- 5.31 (P < 0.0001 vs placebo) decrease in the percentage of parabasal cells, a 6.8 +/- 1.29% (P < 0.0001) increase in superficial cells, a 1.3 +/- 0.13 unit (P < 0.0001) decrease in vaginal pH, and a 1.5 +/- 0.14 score unit (P < 0.0001) decrease in the severity of the most bothersome symptom. Similar changes were seen on vaginal secretions, color, epithelial surface thickness, and epithelial integrity. Comparable effects were observed at the 0.25% and 1.0% DHEA doses. CONCLUSIONS:: Local Prasterone, through local androgen and estrogen formation, causes a rapid and efficient reversal of all the symptoms and signs of vaginal atrophy with no or minimal changes in serum steroids, which remain well within the normal postmenopausal range. This approach avoids the fear of systemic effects common to all presently available estrogen formulations and adds a novel physiological androgenic component to therapy.

    PMID: 19436225 [PubMed - as supplied by publisher













Menopause. 2009 May 8. [Epub ahead of print]
    Serum steroid levels during 12-week intravaginal dehydroepiandrosterone administration.
    Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dubé R, Côté I, Labrie C, Lavoie L, Bérubé R, Bélanger P, Berger L, Gilbert L, Martel C, Balser J.

    From the 1Laval University Hospital Research Center and Laval University, Quebec, Canada; 2Endoceutics Inc., Quebec City, QC, Canada; 3Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA; 4Clinique de Recherche en Santé des Femmes, Quebec City, Canada; 5Diex Recherche Inc., Sherbrooke, QC, Canada; 6Rapid Medical Research Inc.,Cleveland, OH; 7Clinique Gynécologique, Shawinigan, Canada; 8Montreal Clinical Study Center, Montreal, Canada; 9Centre Hospitalier Affilié Universitaire de Québec, Quebec City, Canada; 10McGill University Health Center, Royal Victoria Hospital, Montreal, QC, Canada; and 11Veristat Inc., Boston, MA.

    OBJECTIVE:: Because a previous 1-week study has shown no or minimal changes in the serum levels of dehydroepiandrosterone (DHEA) and its metabolites after up to daily 1.8% (23.4 mg) intravaginal DHEA, the objective of the present study was to investigate the serum steroid levels during a 12-week daily intravaginal administration of 0%, 0.25%, 0.5%, and 1.0% DHEA (Prasterone) 1.3 mL ovules. METHODS:: In a double-blind, placebo-controlled phase III study, 218 postmenopausal women (age range, 42-74 y) were randomized to receive daily one of four DHEA concentrations intravaginally. Serum steroids were measured by a Good Laboratory Practice-validated mass spectrometry technology in samples obtained at time of visit. RESULTS:: The serum levels of DHEA and 11 of its metabolites measured at screening, day 1, and weeks 2, 4, 8, and 12 in women showed no or minimal changes during the whole observation period, with all values remaining well within the limits of normal postmenopausal women. No accumulation of the steroid metabolites nor change in DHEA bioavailability was detected. CONCLUSIONS:: The present data show that local daily intravaginal DHEA administration at DHEA doses of 3.25-13 mg was able to rapidly and efficiently achieve correction of all the signs and symptoms of vaginal atrophy and improve sexual function and caused no or minimal changes in serum sex steroid levels, which all remain within the normal postmenopausal range, thus avoiding the risks of all estrogen formulations.

    PMID: 19436226 [PubMed - as supplied by publisher]