Safety Issues Prompt FDA Changes to Psoriasis Drug Label

By Theresa TamkinsFRIDAY, Oct. 17 ( — The U.S. Food and Drug Administration (FDA) announced Thursday that it has updated the label for the psoriasis drug Raptiva to reflect the fact that the drug may increase the risk of life-threatening opportunistic infections.

Known as a boxed warning, the new label notes that Raptiva (efalizumab) can increase the risk of bacterial sepsis, an infection of the bloodstream; viral meningitis, which affects the brain; invasive fungal infections, which can damage the lungs or other areas of the body; and a condition known as progressive multifocal leukoencephalopathy (PML), a viral infection of the brain.

Several people taking Raptiva have been hospitalized and some have died due to these infections, according to the FDA.

The symptoms of PML include confusion, dizziness, vision problems, or difficulty talking or walking, the federal agency said. Other signs that require immediate medical attention include dizziness or weakness; abnormal bruising or bleeding gums; numbness or weakness in the arms, legs, or face; or worsening of psoriasis or arthritis.

In addition, animal studies have suggested that the drug may cause permanent suppression of the immune system in children. The drug is not approved for use in children under 18. The animal research was conducted in mice equivalent to ages 1 to 14 in humans.

The drug, administered as a once-a-week injection, was approved in 2003 and treats psoriasis by suppressing the immune system. Patients should receive all their vaccinations before starting treatment and they should not be given vaccines during treatment.

Raptiva is approved to treat moderate to severe plaque psoriasis in adults who would otherwise be candidates for phototherapy or systemic therapy.

“As part of FDA’s monitoring of the life cycle of approved products, the agency received reports of serious infections in some patients taking Raptiva. These reports led to our decision to highlight these risks in the drug’s labeling,” said Janet Woodcock, the FDA’s director of the Center for Drug Evaluation and Research, in a statement.

“Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks.”



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Living Well with Psoriasis on World Psoriasis Day

Even if you don’t have psoriasis and don’t know anyone with this skin condition, it’s helpful to be aware of the myths and facts, especially on World Psoriasis Day.

Between 5.8 million and 7.5 million people live with the skin disease psoriasis, yet almost half with moderate to severe cases are not getting treatment and others are receiving out-of-date treatment. How to Find a Psoriasis Treatment That Works

Why is effective treatment for psoriasis such a challege? Because the condition is still widely misunderstood—people who live with it can be subject to prejudice and discrimination—and treatments have not been very good until now. Test Your Psoriasis IQ

There are five types of psoriasis: plaque (the most common form), guttate, inverse, pustular, and erythrodermic. Psoriasis can appear anywhere on the body and up to 30% of people with psoriasis will develop psoriatic arthritis, a painful condition in which joints are inflamed and stiff. How Managing Stress May Help Your Psoriasis

Psoriasis is largely an inherited condition, but it involves multiple genes and possibly some environmental factors to bring the disease on. Common triggers include stress; skin trauma, such as sunburn or wounds; some medications, including antimalarial drugs; and, in the case of guttate psoriasis, strep infection. Can A Healthy Diet Help Psoriasis?

Though many patients find that certain diets help clear their skin, or that certain foods aggravate it, no studies have established a definitive link between nutrition and psoriasis, says Neil Korman, MD, clinical director of the Murdough Family Center for Psoriasis in Cleveland Heights, Ohio. “There’s no ‘Psoriasis Diet,’ but people with psoriasis should try to eat a healthy diet,” he says. “We do know that people who are obese are at increased risk for psoriasis, and that losing weight may help improve your psoriasis.” Psoriasis Skin-Care Product Guide

Get Flawless Skin Naturally

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The Strange Link Between Psoriasis and Depression

By Tara HaelleHealthDay Reporter

THURSDAY, Aug. 20, 2015 (HealthDay News) — People with psoriasis may be twice as likely to experience depression as those without the common skin condition, regardless of its severity, a new study suggests.

“Psoriasis in general is a pretty visible disease,” said study author Dr. Roger Ho, an assistant professor of dermatology at New York University School of Medicine in New York City. “Psoriasis patients are fearful of the public’s stigmatization of this visible disease and are worried about how people who are unfamiliar with the disease may perceive them or interact with them.”

Genetic or biologic factors may also play a role in the link between depression and psoriasis, which requires more research, he said. Either way, the findings mean that all individuals with psoriasis could benefit from screening for depression, Ho said, and their friends and family members should be aware of the connection as well.

The findings were scheduled for presentation Thursday at an American Academy of Dermatology meeting in New York City. They have not yet been published in a peer-reviewed journal and should be considered preliminary.

Most people with psoriasis have red, raised patches of skin covered with silvery-white scales, the researchers noted. These patches usually appear on the scalp, elbows, knees, lower back, hands and feet.

The researchers analyzed the responses of more than 12,000 U.S. adults in the 2009-2012 National Health and Nutrition Examination Survey conducted by the U.S. Centers for Disease Control and Prevention.

Overall, nearly 3 percent of responders reported that they had psoriasis, and about 8 percent had major depression based on their answers to a depression screening assessment. Among those with psoriasis, 16.5 percent had sufficient symptoms for a diagnosis of major depression.

Those with any degree of psoriasis had double the odds of having depression even after taking into account their age, sex, race, weight, physical activity level, alcohol use and history of heart attack, stroke, diabetes and smoking, the researchers said.

Depression is one of several concerns that someone with psoriasis should look out for, said Dr. Delphine Lee, a dermatologist at John Wayne Cancer Institute at Providence Saint John’s Health Center in Santa Monica, Calif.

“Patients with psoriasis should be aware that there are several other health issues associated with this condition, including cardiovascular and metabolic diseases, such as diabetes, as well as psychological or psychiatric disorders,” Lee said. “To address your health beyond your skin is critical to maximizing a person’s quality of life.”

Several aspects of dealing with psoriasis may contribute to depression, said Dr. Doris Day, a dermatologist at Lenox Hill Hospital in New York City.

What matters more than its severity is the location of flare-ups, she said. Some of her patients won’t wear shorts if it’s on their legs or won’t go on dates because they’re embarrassed about red spots on their skin, she added.

“Also, because it’s a chronic illness, you don’t know if it’s going to get worse and you don’t get to take a vacation from it either,” Day said. “You’re using topical treatments all year long, and as soon as you stop, it comes right back. It’s very depressing, and it can affect your self-esteem and your quality of life.”

Anxiety about how psoriasis and its treatment may affect your future health might also contribute to depression, Day explained.

“It’s unsightly, it can be itchy, people are worried about it spreading to other parts of their body, they worry about the side effects of medication, they worry about psoriatic arthritis, they worry about taking medications when they’re pregnant, and they worry about passing it along to their children,” she said.

Day recommended that people with psoriasis seek mental health treatment to get to the bottom of their depression.

“It’s about that emotional connection and finding out what about this condition is affecting someone in the way that it is,” Day explained.

Not seeking help can make matters worse, said Dr. Tien Nguyen, a dermatologist at Orange Coast Memorial Medical Center in Fountain Valley, Calif.

“Psoriasis can cause severe emotional distress,” he said, noting some patients may have suicidal thoughts or attempt suicide. “Stress is a known cause of exacerbation of psoriasis, so this will lead to a vicious cycle.”

Day added that it’s critically important to continue seeing a dermatologist to learn about new medications that become available.

“There are some really amazing new treatments that have a great safety profile that can have excellent clearance with lasting results,” Day said.

More information

For more about psoriasis, visit the U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases.

What Psoriasis Feels Like

Actress Ciena Rae Nelson took to Instagram last week to post a powerful message about psoriasis with a pair of side-by-side photos: On the left, her face during a flare-up, the red, scaly patches just visible beneath her makeup. On the right, the same photo, but edited to enhance the color and details—and portray what the skin disease actually feels like.

RELATED: 12 Celebrities with Psoriasis

Psoriasis is an autoimmune disease affecting an estimated 7.5 million people in the U.S. It causes skin cells to grow at a faster rate, leading to itchy lesions that can sometimes be painful. The condition is often diagnosed in early adulthood (between ages 20 and 35) and nearly one-third of those who suffer from it have a family history of the disease. There isn’t a cure, but avoiding or minimizing possible triggers—such as stress, alcohol, and exposing your skin to cold, dry air—can help keep flare-ups under control.

As if the skin symptoms weren’t bad enough, nearly 30% of people with psoriasis develop psoriatic arthritis, a painful condition in which their joints become stiff and inflamed during flare-ups. Nelson mentions this additional struggle in her Instagram caption, noting that it’s an “#invisibleillness.”

Her recent post isn’t the first time the actress has spoken out about her disease. In March, she posted a selfie with red, inflamed lesions all over her face and chest. The caption begins, “This is me 2 years ago just before I went to the hospital for severe dehydration and a fever. Skin conditions are not cosmetic issues. They cause physical pain and suffering and oftentimes a feeling of being trapped in your own body, on top of the social anxiety many people face because of them.”

RELATED21 Tips and Tricks for Treating Psoriasis

Nelson goes on to explain that the adjective “itchy” doesn’t quite cut it as a description of the discomfort: “I personally struggle with sleep deprivation due to constant, widespread itchiness that feels more like I’m being stung or bitten then I am ‘itchy.'”

As Nelson’s posts portray, psoriasis doesn’t just mean having dry patches of skin. It can be debilitating, for a variety of reasons.

Her advice? “Hydrate. Get enough sleep. Eat healthy foods. Nourish your biggest organ, and all the rest while you’re at it.”

For more information about psoriasis and psoriatic arthritis, visit the National Psoriasis Foundation site.

The Many Ways Stress Can Affect Your Skin

Last week Anne Hathaway was apparently so stressed out by an upcoming appearance on The Ellen DeGeneres Show that she broke out in hives. “Proof that nerves are real,” she posted with a photo of the angry rash on Instagram.

And a few days ago actress Kirsten Storms announced she was taking a leave from her role as “Maxie” on daytime’s General Hospital due to skin issues linked to stress.

With so many celebrities succumbing to stress-related skin problems, we started to wonder which skin conditions are aggravated by stress.

The answer, it turns out, is pretty much all of them.

“Any skin condition can be made worse from stress,” says Natalie Semchyshyn, MD, a cosmetic dermatologist and assistant professor of dermatology at Saint Louis University. “Stress, especially chronic stress, changes levels of certain hormones in your body, like cortisol, which can affect your immune system.”

And that can wreak havoc with your skin.

Hives, like those proudly displayed on Anne Hathaway’s chest, can happen to anyone, even if you’re not prone to skin problems.

“One of the major jobs of our skin is to block things out that we don’t want to come in. It’s the protective wrapper of the body,” explains Dr. Semchyshyn.

RELATED: 25 Surprising Ways Stress Affects Your Health

Acne is probably the most well-known example of a skin condition exacerbated by stress: Think of a teen who has a terrible acne flare right before final exams.

Rosacea is another skin condition closely related to your mental state: Flushing, swelling, and uneven skin are hallmarks of rosacea. “One of the triggers [of flushing] is stress, if you feel embarrassed, or even good stress like working really hard on something,” says Dr. Semchyshyn. “It’s a visible response to stress going on inside your body.”

Psychological stress can also trigger a psoriasis flare-up—red, scaly patches of skin that are itchy and sometimes painful—as well as an eczema flare (an itchy rash).

RELATED: 21 Tips and Tricks for Treating Psoriasis

The silver lining in the skin-stress connection? Managing your stress can often provide the solution, or part of the solution, says Dr. Semchyshyn. She points to a growing body of research that suggests stress-relief techniques—including hypnosis, guided-imagery meditation, and mindfulness meditation—may also help calm your complexion.

This New Psoriasis Drug May Offer Long

By Amy NortonHealthDay Reporter

WEDNESDAY, June 8, 2016 (HealthDay News) — A new drug that has shown “unprecedented” effects on the skin condition psoriasis seems to work well in the longer term, too, researchers report.

The drug, called ixekizumab (Taltz), was approved in March by the U.S. Food and Drug Administration. That came after initial trials showed that over 12 weeks, the drug soundly beat standard medication for moderate-to-severe psoriasis.

The new findings show the benefits are still there after 60 weeks. At that point, about 80 percent of patients were seeing at least a 75 percent improvement in their skin symptoms, the researchers said.

So far, ixekizumab has shown “unprecedented efficacy” against more severe cases of psoriasis, said Dr. Joel Gelfand, a dermatologist who wasn’t involved in the research.

The drug, given by injection, targets an inflammatory protein called IL-17, said Gelfand, who directs the Psoriasis and Phototherapy Treatment Center at the University of Pennsylvania.

The FDA approved another IL-17 inhibitor, called Cosentyx, last year.

“Targeting the IL-17 pathway has proven to be yet another revolution in our ability to treat psoriasis,” Gelfand said.

That said, he added, researchers need to keep tracking the drugs’ long-term effects.

In the United States, between 5 million and 7 million people have psoriasis, according to government statistics. The disease arises from an abnormal immune response that triggers a rapid turnover of skin cells. That causes cells to pile up on the skin’s surface.

Most people have what’s called “plaque” psoriasis, says the U.S. National Institutes of Health. In that form, people periodically develop thick, scaly patches on the skin that can be itchy or painful.

Some people also suffer painful joint damage and fatigue known as psoriatic arthritis.

Skin treatments or ultraviolet light therapy can be enough to treat the symptoms of milder psoriasis. For more severe psoriasis, doctors often prescribe drugs that suppress the immune system—including injection drugs called “biologics.”

Older biologics include brands like Enbrel and Remicade, which target an immune system chemical called TNF. The new IL-17 blockers are also considered biologics, but their action appears more specific to psoriasis, said Dr. Kenneth Gordon, the lead researcher on the new study.

While the new drugs zero in on IL-17, the anti-TNF drugs seem to eventually get there, said Gordon, a professor of dermatology at Northwestern University Feinberg School of Medicine in Chicago.

The hope is that the IL-17 blockers, with their less-extensive immune effects, will also be safer, Gordon said. TNF-blockers carry a risk of sometimes-serious infections.

IL-17 blockers also dampen a portion of the immune response, so infections are still a concern. So far, Gordon said, colds and fungal infections have been the main side effect, which is “encouraging,” he noted.

However, Gordon added, there’s always the chance that more serious infections could be a problem with longer use or in vulnerable patients.

A small number of patients also developed inflammatory bowel disease, according to the report.

The findings, published online June 8 in the New England Journal of Medicine, are based on almost 4,000 patients who took part in three trials. In one trial, ixekizumab was tested against a placebo; in the other two, it was pitted against a placebo and Enbrel for the first 12 weeks, and then just the placebo from then on.

After the initial 12-week period, patients took the drug either once a month or every 12 weeks.

After 60 weeks, almost three-quarters of patients in the once-a-month group had only “minimal” psoriasis, based on doctors’ ratings. That compared with 7 percent of placebo patients.

About four out of five patients who took the drug monthly had at least a 75 percent improvement in their skin symptoms, the researchers said.

In the initial 12-week study, ixekizumab also beat Enbrel by a significant margin, the study authors said.

Gordon said IL-17 blockers are “taking (medication) responses to a whole new level. We haven’t seen rates like these before.”

That does not mean the new drugs are for everyone, Gordon stressed. “If you’re doing well on your current medication, there’s no reason to switch,” he said.

Taltz is marketed by Eli Lilly, which funded the study. The recommended dose is one injection every couple of weeks for the first three months, and then every four weeks thereafter, according to the company.

In general, biologics are very expensive, costing up to several thousand dollars per injection. Gordon acknowledged that patients could face hurdles in getting insurance coverage.

“The insurance aspect is always difficult with a new medication,” he said.

More information

The U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases has more on psoriasis.

This May Be Why Women Are Far More Likely to Get Autoimmune Diseases

Nearly 80% of people who suffer from autoimmune diseases are women, and why that’s the case has long been a medical mystery. But new research suggests the answer may have to do with differences between men’s and women’s genes—a discovery that could pave the way for better diagnostic methods and treatments in the future.

Autoimmune disorders (such as , Crohn’s disease, and ) occur when the body’s immune system attacks itself, becoming overactive and flooding the body with inflammatory proteins. Short-term, localized inflammation is useful for healing; too much or for too long, however, is harmful to cells and organ systems.

To date, most of the research on why women are so disproportionately affected by these disorders has focused on sex hormones, like estrogen and testosterone. The latest study, published in the journal Nature Immunology, took a fresh approach, which paid off: “We found a completely new angle,” said senior author Johann Gudjonsson, MD, assistant professor of dermatology at the University of Michigan, in a press release. Specifically, his team identified hundreds of gender-specific differences in how certain genes expressed themselves.

These differences, they found, were not influenced by changes in sex hormones. Yet, they appeared to make women more susceptible to developing an overactive immune system.

RELATED: 7 Women’s Health Problems Doctors Miss

Dr. Gudjonsson’s lab focuses on autoimmune diseases of the skin, including and lupus. (While lupus often affects the whole body, four of the 11 criteria for diagnosis relate to the skin.) For this study, however, they analyzed genetic material from skin samples of 82 healthy men and women.

None of the participants had autoimmune diseases. Nevertheless, they did have some “striking differences in gene expression,” said first author Yun Liang, PhD, a dermatology research investigator, in the statement. In total, the researchers discovered 661 genes that were expressed differently in women versus men. Many were already known to be involved in immune function, Liang added, and some have even been linked to autoimmune disease.

“This finding suggested that these sex-biased genes contributed to not only increased disease susceptibility but possibly also heightened disease activity,” the researchers wrote in their paper. “In this context, we note that being female is the strongest risk factor for the development of autoimmunity, and it dwarfs the identified autoimmune genetic risk variants.”

RELATED: 21 Tips and Tricks for Treating Psoriasis

The team was even was able to identify one protein, called VGLL3, as a “master regulator” of inflammation and autoimmunity. In their analysis of healthy skin samples, VGLL3 was only active in women. But when the researchers looked at biopsies from patients with autoimmune diseases, they saw it activated in men with lupus, as well.

The findings provide new insight into how gender contributes to autoimmune disease, the authors wrote, and highlight the importance of studying men and women separately. They also suggest that these genes and proteins may one day be useful as biomarkers for assessing who’s most at risk, or as targets for new medications.

“Learning more about these disease processes in each gender will provide opportunities for therapeutic interventions we did not imagine before,” said Dr. Gudjonsson, “including both prevention and treatment.”

Did Stress Trigger Kim Kardashian West's Psoriasis Flare

After a three-month hiatus, Kim Kardashian West returned to social media this week with a series of adorable photos of North and Saint. But a recent tweet has fans concerned about the reality star’s well-being. 

Kardashian West, 36, suffers from , an autoimmune disease that causes raised red, white, or silvery patches on the skin. On Thursday night, Kardashian West revealed she’s experiencing a flare in a new location: “Wait why am I now getting psoriasis on my face,” she wrote on Twitter.

It’s been a difficult three months for Kardashian West, who was robbed at gunpoint in her hotel room in Paris on October 3. In November, her husband, Kanye West, was hospitalized for exhaustion after canceling his tour; People reported that the rapper then lived apart from his family while undergoing outpatient treatment for undisclosed mental health issues.

Experts say it’s possible all that stress could have aggravated Kardashian West’s psoriasis. “There has always been a theoretical connection with stress and [the] worsening of many skin conditions,” Kally Papantoniou, MD, a New York City-based dermatologist, explained to Health via email. (Dr. Papantoniou has not treated Kardashian West.)

While there isn’t research that proves a cause-and-effect relationship, many patients claim that reducing stress helps ease their symptoms. And in one Scandinavian survey, more than two-thirds of respondents said that their psoriasis was exacerbated by stress. According to the National Psoriasis Foundation, women may be particularly susceptible to stress-related flares.

RELATED: 21 Tips and Tricks for Treating Psoriasis

“There are a number of pathways related to how stress can worsen psoriasis, and the nervous system has been shown to have a significant role in this phenomenon,” Dr. Papantoniou said. “The impact of sympathetic nerves in the skin can lead to a series of immune and inflammatory changes in the skin, which flare skin diseases such as psoriasis.”

Angela Lamb, MD, a dermatologist at Mount Sinai Hospital in New York City (who also has not treated Kardashian West), reminds her psoriasis patients that the skin is the largest organ: “Any time you have stress and anxiety in your life, it will impact you by changing your body chemistry and that immune balance. It only makes sense when that changes you will have flares of psoriasis,” she wrote in an email.

“The best thing would be for [a psoriasis patient] to come up with good stress and anxiety coping strategies,” Dr. Lamb added. Such strategies might include attending a support group, working with a therapist, or learning meditation.

Dr. Papantoniou also recommends that stressed-out psoriasis patients add more anti-inflammatory foods to their diets, and limit dairy and refined carbohydrates, which are among the worst foods for psoriasis.

“It’s important to eat healthy and take care of yourself,” she said. “Psoriasis can improve with diet modification for many patients. It’s also linked to and other risk factors, which makes it that much more important to eat right.”

This isn’t the first time Kardashian West has talked publicly about her autoimmune disease. She was first diagnosed in 2010, after her mom, Kris Jenner (who also has psoriasis), recognized the rash on her daughter’s legs. In September, Kardashian West shared some of her strategies for managing the condition on her app, such as applying a topical cortisone ointment at night, and avoiding acidic foods like tomatoes and eggplants.

“After this many years, I’ve really learned to live with it,” she wrote. “I’m always hoping for a cure, of course, but in the meantime, I’m learning to just accept it as part of who I am.”

Cyndi Lauper on Her Psoriasis Treatment

I found out I had psoriasis when…

I had this kind of buildup on my scalp, which, because my son played hockey at the time, I thought Oh, it might be bugs [from the hockey players]. I’d never had bugs. Then I went to the doctor and he said, “No, no, no, that’s .” He gave me some shampoo, and it kept it at bay a little bit, and then it started to spread. In 2012, it was really, really not good. By 2014, I was covered head to toe except for my face. I was able to hide it. But it took my strength.

The hardest thing about my diagnosis was…

I always had pretty skin when I was young. I thought I’d never be able to feel my skin again. I gave up hope. I did every kind of treatment. I didn’t realize that the cortisone cream was going to thin my skin out so much. I rubbed up against a cab one time and a piece of skin on my arm came off.

You’re tired. It’s an inflammatory disease so it kind of zaps your strength. And trying to sing, work out, and have all this [clothing] on, and then taking it off, your skin comes with it. It’s awful. Emotionally, honestly, at the height of being that sick you feel very much alone. Actually, I’m one of 7.5 million people in this country with psoriasis. When it flairs, it’s real bad. People who suffer with it on their knees or elbows, it gets bad, it hurts. I still worked, but it was difficult. I had to get up in front of people acting like a big, strong woman and really you’re just feeling your mortality.

RELATED: The Different Types of Psoriasis

I finally got help when…

I came upon, through the National Psoriasis Foundation, a doctor who gave me options. The problem sometimes is you feel like you don’t have options.

I tried a lot of lifestyle changes, I really did. They didn’t work for me. That’s what pissed me off so much. I thought I’d be gluten-free, I wouldn’t drink alcohol, or do this or that, and it was so stressful that I figured it wasn’t changing anything. After five years, I went on traditional medicine. At first I tried cortisone and realized those side effects were too much for me. So I talked about the options with my doctors. I chose the option I thought I could live with and that’s how I’m sustaining myself now. Now I can get back to the things I like to do, like singing and going on tour.

After I started the medicine, the psoriasis started to go away, and I couldn’t even believe it. I was always on eggshells. I still lather up with cream and am nervous because I don’t want to go back to that.

I advocate for psoriasis awareness because…

One person told me, “You’re so famous, you can bring a voice to this like nobody else.” [Psoriasis] is one of those things that no one wants to talk about, which makes it something I want to talk about. I just think in the world, for me, there are only unpopular causes. The popular causes will be taken care of, but the unpopular causes and the people who don’t have a voice, those are the ones you should speak for.

One misconception I wish people didn’t have about psoriasis is…

That it’s contagious. It’s a very unattractive disease because you shed everywhere.

Also, there is hope. I want to write a song for the people who have gone through this and what they inspired in me, which was hope.

I want someone who was just diagnosed with psoriasis to know…

It’s not just a rash. Cream helps at first, and I hope it always helps, but it’s something you should research right away. Don’t let it go. Get information. Knowledge is power.

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To keep my mental health in check, I…

Call the doctor. When you get the information and find a treatment for yourself, well, then you can meditate. You can take an Epsom salt bath. But don’t go without treatment. It’s an inflammatory disease that can lead to other things. Get treatment for your peace of mind. You’re hurting inside because you feel powerless and information is power. Help yourself. Don’t just sit in the dark.