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Notes From the Underground

November 1997


The Ball's in Your Court: Testosterone 101

By Sally Cooper and Tim Horn

Testosterone, usually seen as a male hormone, is something we all have. How much depends upon a lot of things, including gender, time of day, age, menstrual cycle, menopause, stress, and medications. In men, testosterone is produced in the testes, or balls, in a daily cycle. In women, ovaries and the adrenal glands produce testosterone. For both, levels decline with age. Exactly how testosterone works is not well understood. It's strange that something so central to our sex lives would be so little understood, but like much of life, research on testosterone is pretty skewed by cultural beliefs about masculinity and femininity.

Studies have found that testosterone can get very low in men and women with HIV/AIDS. Doctors have started offering replacement therapy to men but not yet to women for treating weight loss and low levels. Here's a brief update. Testosterone is a hormone. Hormones are substances made in one place in the body, which travel around affecting how other parts work. In medical terms, we're talking the endocrine system, which, like the immune system, is really complicated, not well understood, and deeply affected by HIV. Testosterone plays at least four important roles in the body:

  • it's critical for nutrition,
  • it helps sex drive (desire for sex, libido),
  • it regulates moods and builds energy, and,
  • high levels shape masculine traits.

Studies suggest that testosterone directly affects muscle development, fat levels, bone mass, many different parts of the brain, moods, depression, energy levels, ability to have orgasms, and ability to sleep. Big stuff here -- but bear in mind that other hormones, diet, exercise, medications, chemokines and much of life also affects most of these things.

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Testosterone, Muscles and Weight Loss

Weight loss in people with HIV and AIDS is a serious problem, even with super-combo therapy. Much of AIDS weight loss is a specific shortage of muscle, and in women, fat as well. With low T cells, the body often burns up muscle, instead of the usual fat and carbohydrates. This is why some PWAs get skinny legs and bulging stomachs without losing weight.

Muscles need protein. Hormones, like testosterone, IGF (insulin-like growth factor) and HGH (human growth hormone), help proteins find their way to muscles and stay there. They also help maintain muscle once it has been made, and help the body burn fat instead of muscle. If it wasn't for these hormones, protein from food would not be used to make muscles, and existing muscles would get quickly burned up. Studies of low testosterone in HIV-negative people show that protein fails to build muscle, and old muscle is broken down by the body to fuel itself. Low testosterone levels lead to muscle loss.


Testosterone and HIV

Testosterone can get very low in men and women with HIV/AIDS, especially free testosterone. In the blood, testosterone exists in two forms, an active kind called free testosterone, and an inactive kind. "Total testosterone" is the total of both. Being HIV+ can increase SHBG, a protein in the blood. SHBG attaches to free testosterone and makes it inactive. The more SHBG you have, the less useful (free) testosterone you have. SHBG levels increase with AIDS and both men and women lose free testosterone. Some researchers suggest that HIV may directly damage the testes. Others believe that the immune system's response to HIV upsets all hormone production.

A 1988 study found that 25% of HIV+ men with no symptoms had low testosterone, and this increased among men with AIDS. Many studies in men have confirmed this. A study of 31 HIV+ women found low testosterone levels, even in women without any weight loss. Women with wasting had very low total testosterone. A different study of 54 HIV+ women found that almost half had low testosterone and 25% low DHEA (a testosterone precursor.)

In an 8-week study of 81 HIV+ men taking testosterone shots, 85% (of the 72 who finished) reported improvement in sexual desire and function. 64% of those with depression felt better. There were no significant changes in T-cells in any of the PWAs. There have been no testosterone replacement studies in women with HIV and AIDS. A number of studies involving a scrotal testosterone patch have been completed. The patch, which you place directly on shaved testicles (careful!), has been heavily marketed as a great, safe way to treat low testosterone and sex drive, and, possibly, reverse wasting. Two randomized studies in men using the patch found that the patch (called Testoderm) does not reverse wasting. The studies did show that testosterone became normal and that libido and energy levels (although not aspects of the study) improved.


Testosterone or Anabolics?

Testosterone contains two parts; an anabolic part (for building muscle), and an androgenic part (for developing masculine traits and libido). Anabolic steroids are prescription drugs that mimic testosterone's muscle-building properties. They're often better for building muscles than testosterone, with exercise. Taking testosterone is not the same as taking an anabolic, but it may help how they work and offer other benefits. Anabolics are used by some body-builders to look like Mr. Universe. Most physicians distrust them, and the federal government regulates them, thanks to some big-time Olympic fiascoes. Research on the use and safety of anabolics in AIDS is tiny, but promising.

There are lots of opinions about anabolics, making it difficult to figure out what and how much to take. PWAs usually take less than body-builders, so there's less risk of liver damage. Most are injection drugs. The one oral anabolic (overpriced!), Oxandrin, has been around since 1963 and may cause fewer masculine side effects in women. Studies are going on to figure out the best dose (20, 40 or 80 mg/day) for AIDS weight loss. Call us for referrals to community groups specializing in anabolics, and keep close track of your liver enzymes whether you're on testosterone or anabolics.


Taking testosterone

Low testosterone can be treated with prescription testosterone, available by shots, patches, cream or small micronized amounts in pills (1.5-3 mg/day) for women. A lozenge form for men and a patch for women are being studied. A big question is how much to take. As with most supplements, there are two strategies. You can take just enough to bring your level back to normal. This is called "physiologic replacement." This strategy causes less side effects since you're just taking what your body is already used to. Or you can take more, in order to have a therapeutic effect, just like some people take high doses of vitamins. This is called "pharmacologic replacement." Taking more means there's a greater chance of side effects.

For men, 50mg to 600mg a week has been shown to be safe for the liver. Many AIDS doctors report that 100mg or 200mg every week with intramuscular (IM) injections is enough for men to restore testosterone levels, achieve weight and muscle gain, and increase libido. If you take it with anabolic steroids (such as deca-durabolin or oxandrin), you may want to use a lower dose and spread out the injection times (i.e., testosterone injections on Monday and steroids on Thursday). For women, a useful replacement dose is unknown. A national testosterone trial (ACTG #313) is offering women 100 mg every two weeks, which seems high. Since no one has enrolled, it's difficult to evaluate this dose for safety or efficacy.

No one knows how long you should take testosterone. Some recommend that PWAs with very low levels (hypogonadism) stay on indefinitely. Others suggest "cycling off" every 12 weeks. Some PWAs can re-start their own testosterone production after stopping, especially with a booster shot of HCG (human chorionic gonadtropin). Others can't, and lose weight and libido soon after stopping. They may require prolonged therapy.


Patch or Injection?

There are several injectable forms (the generic is fine and much cheaper,) and two patches for men. Patches are time-release, so that blood levels stay consistent with normal, daily levels. They're very thin (like Saran Wrap), require changing every day, and are, of course, visible. One is applied directly to the scrotum. The other is a double patch system that is less well absorbed, but can be stuck on any part of your skin. Some argue that patches are safer, because they only raise testosterone levels back to normal.

Shots are taken once a week or every other week. To get an average daily dose, each shot is a high dose that gets lower in the blood as the days pass until the next shot. This means that right after the shot, blood levels of testosterone are pretty high. Some PWAs report that these high levels cause side effects: hair loss, irregular moods, and acne. Others believe that injections offer more bang for the buck -- the initial high dose is better for building muscles than just replacing what's missing. An on-going study comparing the patch to injectable testosterone for weight loss will help sort this out.

Even though testosterone is available, getting it may take some work. Some physicians won't prescribe testosterone because of bad press from a few star athletes who used high doses of hormones for long periods, and then claimed that the drugs gave them brain tumors or heart disease. Many doctors are simply unaware that testosterone and anabolic steroids can be safely offered to men and women with HIV/AIDS for weight loss.

It's often really hard for women to get a doctor to treat weight loss at all. Research now suggests a possible role for testosterone replacement in HIV+ women. If you think testosterone is right for you, make sure that you tell your doctor. Your doctor may be able to read laboratory results, but he or she can't read your mind. It is totally within your rights to question anything your doctor says is right or wrong for you.


Side Effects from Testosterone

The various side effects are not fully understood. In men, reversible side effects have been seen at all doses, including: enlarged breasts (gynomastia), hair loss, water retention, irritability, acne, head-aches, muscle soreness at the injection site, joint stiffness and increased liver enzymes. Many of these are probably from excess testosterone, which may be more of an issue with shots than patches.

There's not much information about side effects in women. Anecdotal reports suggest that excess testosterone can lower your voice and cause an enlarged clitoris and increased facial and shoulder hair. However, case reports from post-menopausal women taking small amounts found none of these effects. This makes sense, since simply replacing normal amounts should be what the body is used to. Hormones are pretty powerful, and it's likely that some people will be more sensitive than others.

Once you start taking testosterone, the body shuts down its own natural production to compensate for excess levels in the blood. The endocrine system is a fantastic balanced system with exquisite feedback controls. Add testosterone, and the body promptly cuts back. In men, as time passes, the testicles can shrink as a result. Some doctors prescribe regular shots of HCG to offset this. There are worries that long-term testosterone therapy might be immunosuppressive and cause cancer. There is no data about this. Larger and longer studies are needed to address these very important concerns.


What does this add up to?

  1. Men and women with HIV often have low free testosterone and low DHEA. These get lower with AIDS, weight loss, and if menstruation stops. Get baseline levels of your hormones.

  2. Doctors routinely offer men shots or a patch -- even if it's not clear that their levels are really low for them. Treating weight loss may require higher doses, which may mean coping with side effects.

  3. Bringing testosterone levels back to normal can boost energy, sexual desire and performance, lessen depression and can help as part of a package of interventions to fight wasting.

  4. Taking testosterone (or any medication) for weight loss without regular exercise and enough calories may be worthless. Exercise directly stimulates how the body builds muscle, significantly boosting the effect of testosterone and anabolic steroids. In one testosterone study, men who exercised gained almost 4 lbs. of muscle compared to only 1/4 lb. in those who didn't.

  5. Testosterone may help HIV+ women fighting weight loss or low sexual desire. Small studies suggest that women lose muscle, similarly to men, but also lose fat. Based on what we know about testosterone and wasting, and the growing experience of post-menopausal women with testosterone replacement therapy, there is no biological reason why women should not try testosterone therapy.

What's normal testosterone?

This is a bit tricky. What's considered normal is really broad, because levels vary a lot from person to person. What's low for one person can be quite normal for someone else. Since most of us have no idea what our usual testosterone level is (who gets a testosterone baseline?), trying to figure out if you're low can be difficult, unless you're super low. For women, even what's low is debatable. The research is minimal. For example, a big national lab, Metpath, used to state that under 20 ng/dl was low. Under new management, they just switched to saying that under 15 ng/dl is low. Other doctors argue that 30-60 ng/dl is a much healthier range for women, particularly after menopause.

Low testosterone is called hypogonadism. Since testosterone is produced in daily cycles, levels vary by time of day, stage of menstruation/menopause, and age. Studies of men in combat show that severe stress and fear strongly lower testosterone. Coping with an opportunistic infection or a diagnosis of AIDS might bottom out anyone's testosterone. Some medications directly lower testosterone, such as Megace, ganciclovir, Nizoral and progesterone (some birth control pills), and others can wipe out your sex drive, like Prozac. Symptoms of low testosterone: low sex drive and desire, depression, loss of bone mass, low energy, moodiness, weakness, and muscle loss.

In sum, low testosterone might be temporary, or even normal for you. Figuring out what's really going on means paying close attention to how you feel, including weight, muscle mass and sexual desire and finding out both your total and your free testosterone levels with an Age-Corrected Free Testosterone Test. Getting testosterone levels checked is not a big deal -- it's a small blood test. The most common test is an "androgen panel," which reports your total testosterone and DHEA levels. With HIV and AIDS, you need to get an Age-Corrected Free Testosterone Test to check free testosterone levels. Prices in NYC range from $79-150, and both tests are covered by insurance and Medicaid. Usually the biggest problem is getting your doctor to order them.


Normal Testosterone

  • Men: 450-900ng/dl
  • Women: 6-86 ng/dl (Grinspoon et al) 30-60ng/dl (Vliet, 1995) >15ng/dl (Metpath)

These are general -- not age-corrected. Keep in mind that there's been little research and the interpretation of test results may change. Get a baseline and check your levels regularly.


Announcements

A terrific new nutritional guide for pregnant women, infants, and toddlers is available from God's Love We Deliver: 212/294-8100.

Nutrition Access Project -- bringing vital nutritional information into the hands of people living with HIV/AIDS. Call for a copy of Nutrition for Life -- a guide to healthful living with HIV. Learn how appropriate nutritional interventions may help combat wasting, counter nutrient deficits, support other healing modalities, and improve overall health. (718)727 2752. Sponsored by The Healing Well, a Goddess Outreach Project.

HIV University!
Lorna Gottesman and Susan Rodriguez, of our Women's Treatment Project, are headed to San Francisco in December for the fantastic HIV University training offered by WORLD. Congratulations and thank you to Rebecca Denison for her vision and support.

Methotrexate for lymphoma in the CNS
7 of 15 PWAs with Primary Central Nervous System Lymphoma (PCNSL) had complete improvement of symptoms with intravenous methotrexate (IV 3g/m2 every 14 days with a maximum of 6 shots). 10 of the 15 had mild side-effects, including upset stomach, skin rash, and fever. No one required a dose reduction. Methotrexate may be an alternative to radiation therapy. Call for a copy of the article.

Ribavirin & Hepatitis C
The results of two phase III trials of ribavirin plus alpha-interferon for treating hepatitis C are in. The combination, with 1200 mg/day ribavirin, is 10 times more effective in reducing HCV viral load to below detectable for people in whom prior solo therapy with alpha-interferon did not work. Schering-Plough is releasing full study results at a liver conference in November.

Neupogen & Neutropenia
A recent study of 201 PWAs taking Neupogen to prevent neutropenia and bacterial infections found that yes, having more bacteria-fighting white blood cells is good for PWAs. Neutropenia is when you have low numbers of neutrophils, white blood cells that fight bacteria. Neupogen is a synthetic version of what your body uses to make more neutrophils. In the study, one group took Neupogen daily, for a 12.8% reduction in illness and death. The next group took it intermittently, for a 8% reduction and the third group got a placebo. Main side effect reported: bone pain. Too bad it's so expensive. Neupogen is usually used to help maintain white blood counts for people taking chemo or other meds that bring them down. (Like ribavirin -- where's that trial, Schering Plough?)

Isoniazid & TB prevention
A Ugandan study enrolled 2,736 HIV+ adults (who were PPD positive) to assess three drug regimens versus placebo in preventing TB: isoniazid alone; isoniazid plus rifampin; isoniazid, rifampin and pyrazinamide; or placebo. After six months, people on isoniazid alone had a 67% reduction in TB compared to placebo. The combinations lowered this risk slightly more, after over three years of treatment. 43 people left the study due to side effects like rash, nausea, vomiting, numbness, tingling, and joint pain. The pyrazinamide combination caused the most side effects.


What's L-A-C got to Do with It?

By Sally Cooper

The PWA Health Group will soon be carrying a quality-controlled brand of L-acetyl-carnitine. There are lots of different kinds of carnitines in the body, often used by muscles and nerves. Medicines that lower carnitines cause muscle and nerve damage. For example, taking AZT for years causes muscle weakness, because a side effect of AZT is that it drains L-carnitine out of muscles. L-acetyl-carnitine (LAC) is different from L-carnitine.

It may be that d4T and ddI cause neuropathy by lowering L-acetyl-carnitine in the nerves. An Italian study of 24 PWAs taking ddI found that those with neuropathy had low L-acetyl-carnitine in their nerves, but regular levels of L-carnitine. The 12 PWAs without neuropathy had normal L-acetyl-carnitine and L-carnitine levels.

Does taking L-acetyl-carnitine help neuropathy? We have no idea -- there haven't been any studies. Does taking oral L-acetyl-carnitine get into the nerves? No idea. It's been studied in dementia in the elderly with some results, so maybe. Can you measure L-acetyl-carnitine levels to see if this is the cause of your neuropathy? Not that we know of. What's a good dose? Since there hasn't been a study, it's impossible to know.

So why would we carry it? One, there are several studies of the elderly, looking at mood, short-term memory, and thinking ability (cognitive function) in which L-A-C offered significant help. Two, it doesn't seem to have caused any particular side effects at the doses used in the dementia studies, and three, given how severe neuropathy can be, why not offer something safe that might help? If you've tried it or are taking it -- please let us know what you think so we can let others know.

[PS: About L-carnitine: health food brands of L-Carnitine vary a lot, and are sometimes really weak. It's better to get the prescription form called L-Carnitor. Hate to recommend an overpriced pharmaceutical, but this is an important supplement for neuropathy and muscle strength, so better not to mess around.]


Expanded Access

Sustiva (DMP 266)

DuPont Merck Co. has opened expanded access for Sustiva (also called DMP-266), a new NNRTI. PWAs with 50 T cells or less, and failing other antivirals can apply. There's no viral load restrictions. It sounds like it will be a big program, so if you're interested, it's worth pushing your doctor about it. [NNRTI is the improbable name of the third family of anti-AIDS drugs: the non-nucleosides. They work where AZT and its cousins (ddI, ddC, d4T, 3TC) work, but in a different way. Nevirapine and delavirdine are NNRTIs.]

DMP-266 is a once-a-day dose, and it seems fairly powerful. One real big virtue may be how it works with Crixivan. It lowers the Crixivan punch, but extends it. Taking high dose Crixivan (3000-3600 mg/day) and DMP-266 might put the shine back in the Crixivan combo. Side effects so far: rash, dizziness and feeling "out of sorts", The fact is there's too little data in people to know how safe it is yet. There's no clear information about whether there's cross-resistance with nevirapine, but it looks like cross resistance with delavirdine is real. To get the drug, call (800) 998-6854, 8am-6pm EST.


Adefovir (new name: Preveon)

Gilead has opened unlimited expanded access for adefovir for PWAs with less than 50 T cells, viral load greater than 30,000, failing other drugs. and progression. Adefovir is a nucleoTide analogue, of low-moderate antiviral strength. This is not an improved nuclear-powered laundry detergent. It's a whole new class of antivirals (just when you were getting used to NNRTIs). It appears to hit several viruses, like CMV, herpes, and HPV. Early reports suggest major side effects, including serious kidney damage. Be careful!!! It comes from a powerful class of drugs with a bad history of ruining kidneys. For information call (800) 445-3235.


Gym Dandy

By Halley Low

Exercise is something I have actively tried to avoid my entire adult life. The very word fills my head with images of cold-hearted gym teachers forcing me to do somersaults on the parallel bars, when I couldn't even do one on the floor. Where do they get those people anyway?

All joking aside, exercise is important to stay healthy. For people with HIV exercise may be treatment. When we speak of treatment, we usually think of pills or medicines -- something we take, not something we do. Perhaps it's time to re-evaluate how to view exercise. Results from a number of studies indicate that exercise helps you gain muscle, boosts some parts of the immune system, improves mood/attitude, and enhances sex. I knew that would get your attention.

What is exercise? According to the dictionary, it's activity that causes "bodily or mental exertion, for the sake of training or improvement of health". Basically, exercise falls into two groups: aerobic (or cardiovascular exercise), and anabolic (also called resistance) exercise.

Aerobic exercise is all the rage, with Jane Fonda and a host of Hollywood beauties dancing to the oldies for only $19.95. Aerobic exercise can improve heart health. Several studies suggest that regular aerobic exercise can help PWAs reduce stress and dispel the blues. This is partly due to the release of brain chemicals that occurs during exercise. Depression could seriously affect your health, and exercise may be one non-drug way for dealing with this demon.

In a 1993 study, small and temporary increases in T-cells were seen after an aerobic work-out. In another study, aerobic exercise was shown to temporarily increase the number of natural killer and CD8 cells. The clinical benefit from this is unclear. It would be interesting to see a study comparing people on anti-viral combinations who exercise and those that don't exercise, to see who achieves higher T-cell counts. Of course, you can try this on your own.

Anabolic exercise has been studied for HIV-related weight loss, a slow process of muscle loss that may begin early in infection. Michael Youssouf, a medical exercise specialist, strongly recommends beginning an exercise program early in infection for maximum benefit. Dr. Mary Romeyn, author of "Nutrition and HIV," says that, "We now know you can add to your energy bank by building your muscle mass." The theory is to take full advantage of "well" time to build up a defense to protect you during possible "sick" time, by preventing loss of lean body mass (muscle). Prevent wasting, prolong life. Exercise is also good for people with AIDS. In a 1990 study, 24 PWAs who had recently recovered from PCP were divided into two groups. One group did resistance exercise with machines three times a week, and the other group watched soap operas (not exactly a blinded study). Everyone in the exercise group experienced small increases in strength, endurance, and muscle at the end of six weeks. The soap opera group got no such benefit, though they were fully informed as to Erica Kane's most recent divorce. The researchers do not recommend exercising when you're sick. "A time to work, a time to rest." Listen to your body--it will tell you what you need.

One person's testimonial to the benefits of exercise: an HIV+ man in his forties who weighed 185, had dropped to 150 pounds. He was wasting and had low testosterone. He started taking testosterone, doing regular resistance exercise and a high calorie/high protein diet, and now weighs 200 lbs. HIV changes the body so that it saves fat and burns protein instead of the other way around, so a high protein diet may help compensate for lost protein.

In a recent testosterone study, half of the participants regularly exercised. They gained 4 1/2 lbs, most of which was muscle. People who didn't exercise gained less than 2 lbs, and only 1/4 lb of muscle. This is an impressive benefit from combining therapies. No specific exercise program was designed for the study. People were simply asked if they did some form of exercise. I wonder what the results would have been if they included a systematic resistance exercise program? Many people with HIV/AIDS have an increased need for calories, due to changes in metabolism, or for fighting an active infection. Some people with a high viral load may need to eat as much as 6,000 calories a day. If you exercise, it's very important to get all the calories you need. Check with a nutritionist or dietitian, they can do the calculations and guide you.

Exercise needs to be tailored to individual need and ability. Youssouf gave this example: "if you are having trouble holding water, then a treadmill would not be practical at that time." This is where the help of a physical therapist or trainer with a lot of experience working with PWAs can be very useful. Exercise trainers are great, though often expensive. New York City's recreation centers have trainers available for $50 a month. Some AIDS agencies offer exercise programs. Does yours? If not, then it's time to advocate for one!

For many, motivation remains a problem. Sometimes just knowing something is good for you isn't enough. Find an exercise that you like doing, and find someone to exercise with. It's a lot easier staying committed to something you enjoy. Doing it with someone you like can make it more fun. Also it gets much harder to say: "not today" when someone is there ready to go. Don't get discouraged -- think of exercise as something that just might save your life. Exercise is not just recreation. Exercise is treatment.


The Best Kept Secret in NYC?

By Halley Low

New York City has a living memorial to people who have died of AIDS, and it's a lovely rose garden in Battery Park called the Hope Garden. Millions of people visit the garden each year. Shame they go away unaware of what they saw. The Parks Department won't acknowledge it with a sign. There used to be a small sign under the "Hope Garden" sign that read: "this is a living memorial to those who have died of AIDS," but it's been missing over a year. Calls to the Parks Department are not returned or offer contradictory information. First I was told that a replacement sign was on order (heard that before) and a "tpriority." Then I was told that the plain "Hope Garden" sign was enough recognition. It isn't, because nowhere is it even implied that this is an AIDS memorial garden. The garden is next to a statue honoring immigrants, and it's easy for people to assume it's part of that tribute. This is NYC's only public memorial to people who have died of AIDS, and they deserve to have one that remembers them without shame. Demand a sign that clearly states who the garden is in memory of. Please call Henry Stern, Park Commissioner, at (212) 360-1305, or the mayor: (212) 788-9600. Don't leave this for tomorrow, please call TODAY!!! Be a voice for those who have been silenced. If you think this AIDS memorial is important, and would like to join a citizen's committee to keep an eye on the garden, please call me here. Thank you.


NOTES FROM THE UNDERGROUND is published six times a year by People With AIDS Working for Health, Inc., a non-profit buyer's club doing business as the PWA Health Group, and reports on issues pertaining to underground AIDS treatment and access.

Articles in this publication are for informational purposes only, and in no way constitute an endorsement of any particular treatment regimen or strategy. We do not consider ourselves qualified to offer medical advice, and encourage people to consult with their physician prior to taking any medications.

copyright 1997 by People With AIDS Working For Health, Inc.
REPRODUCTION IS HEARTILY ENCOURAGED.




  
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