Bach Flower Remedies: Do They Work?

You’ve probably seen Bach flower remedies at health food stores or new-agey sorts of shops. Or maybe your chiropractor or vet has recommended them. bachproducts-allThey’re recommended for all sorts of maladies, including asthma, hypertension, migraines, eczema, allergies, dyslexia. But do they work?

The story behind Bach flower remedies is pretty romantic. Dr. Edward Bach was a Welsh physician with an interest in homeopathy. He believed that many illnesses are caused by things like fear and despair–not so different from how many researchers today view the effects of stress. He also believed that we could develop a new medical system by focusing on cures found in nature. So he abandoned his London practice and headed out into the countryside to investigate the curative effects of flowers. In addition to abandoning city life, he decided to jettison the scientific method and instead use intuition to guide his work. Wandering the lanes of Oxfordshire, he developed a number of flower remedies–many of which you can still buy today.

While Dr. Bach was initially interested in the dew that collects on flowers, he realized that collecting dew drops wouldn’t be very practical if he wanted to reach the masses. So, as the closest large-scale approximation he could think up, he began to make his remedies by putting fresh flowers into water and then steeping them in the sun or boiling them. He also added brandy as a preservative. It’s highly doubtful that the flower remedies contain pharmacologically significant amounts of any flower-derived chemicals–instead, the flowers are supposed to transmit their energy to the water and then to you. So, basically, they are supposed to work via the memory-water mechanism on which homeopathy is based.

A few randomized, controlled trials have actually tested the effects of Bach flower remedies. For example, researchers tried using the Rescue Remedy or a placebo on 100 University students about to take exams. Less than half of the students completed the study, but in those who did, no effect on test anxiety was found. A similar study on test anxiety also found no difference between flower and placebo groups (although even taking a placebo helped soothe students). There is one study that has reported a significant effect of Rescue Remedy in reducing stress in a subgroup of students with very high-anxiety… but if you test enough subgroups you are bound to find a positive result eventually, due to chance alone, so I’m not sure I put much stock in these results.

In another study, researchers randomized 40 kids with ADHD to either Bach flower remedies or a placebo for three months. With only 20 kids in each group though, and with half of the kids dropping out before the three month study was complete, the power to detect any changes in behavior was pretty low. The effect of the flower remedies would have to be pretty amazing to show up. I’m fairly certain a study this small couldn’t have demonstrated a significant effect of ANY ADHD medication.

The good news is that nobody has reported any adverse effects associated with the flower remedies. Since they are essentially water, that makes sense! The bad news is there is not much evidence that they work, except for as a placebo. Some flower enthusiasts point out that so far the remedies have only been investigated for anxiety and ADHD. That’s true. It’s also true that most of the studies done so far have been so small, and getting patients to comply with treatment has been so difficult, that even if the remedies DID work, chances are that the trials wouldn’t detect an effect. Unless you buy that water can holds memories, though, it doesn’t seem likely that even a huge NIH-sponsored trial would pick up any beneficial effect of the Bach flower remedies.

That said, it’s not unusual for 30-40% of people given a placebo to report that they feel better. And Bach flower remedies appear to be harmless. So if someone’s feeling bad and they believe in the potential of these remedies to cure, maybe it’s not such a bad idea to give them a try! Since I don’t see how the placebo effect would work on pets, though, it’s hard for me to see how using the remedies on animals would be of much use. I guess that as an owner, maybe your own anxiety about your pet’s condition could be alleviated in a sort of indirect placebo effect.

Chronic Lyme disease: it sounds so legit

lyme-disease-rashA lot of us are plagued with vague but unpleasant symptoms like fatigue, a sore throat, trouble sleeping, headaches, depression, or back pain. This is obviously no fun, and people want solutions. In recent years, an increasing number of people with these problems have been diagnosed with chronic Lyme disease. And they have found that getting treatment is not easy. Patients have fought their insurance carriers, trying to get them to pay for the long courses of antibiotics that they have prescribed. Lawmakers have tried to intervene: legislation to mandate coverage for chronic Lyme disease treatments has been proposed in Maryland, Pennsylvania, Connecticut, Massachusetts, Minnesota, New Hampshire, Vermont, Maine, and New York. Connecticut’s attorney general even brought an antitrust suit against the Infectious Diseases Society of America, because it refused to include extended antibiotic therapy for persistent infection in its guidelines (giving cover to insurance companies that wanted to reject claims). This is an awful but familiar story, right? Insurance carriers trying to push costs onto their customers is nothing new. But in this case, the insurance companies are probably in the right for once.

Lyme disease, of course, is real. We all know to beware of ticks when we are walking in the woods, and to watch out for the bull’s eye rash around a bite that means Lyme disease. The disease is caused by a bacterium called Borellia burgdorferi that ticks carry. A course of antibiotics, and afterwards all is fine. But what if you miss the early signs and symptoms and don’t treated? You might go on to develop a chronic infection, complete with early onset arthritis, heart problems, and Bell’s palsy. Lately, though, the concept of chronic infection has broadened. Some doctors are diagnosing patients with chronic lyme disease even if they don’t remember ever having a tick bite or a bull’s eye rash. And even if there are no signs of infection specific to Lyme disease. What is going on?

The waters around Lyme disease started to muddy in the 1980s, when a group of researchers reported that you could get Lyme disease, receive prompt treatment, and still go on to develop chronic infection. The worst thing was, these patients had no antibodies to B. burgdorferi! That means that if you tested these patients for Lyme disease, they would be seronegative–it would look like everything was fine. Although later research showed that serological tests actually were reliable for diagnosing late-stage Lyme disease, the ball was already rolling.

A relatively small number of doctors are very active in diagnosing chronic Lyme disease. They call themselves “Lyme literate.” Many of them are members of the International Lyme and Associated Diseases Society, and a number have been sanctioned, reprimanded, or even convicted of charges related to fraud and malpractice. Since they argue that you can have a longterm infection and still remain seronegative for infection, they can diagnose pretty much anyone with chronic Lyme disease. If you visit one of these doctors complaining of relatively vague and non-specific symptoms, such as pain, fatigue, or neurocognitive issues, you will probably leave with the diagnosis. Sometimes it’s even backed up by tests performed by laboratories that specialize in providing positive results by using methods that don’t adhere to official guidelines.

What are the drawbacks of getting treated for chronic Lyme disease when you don’t have it? First, of course, someone is taking your money to treat you for something you don’t have. And these treatments can get expensive! Second, and probably worse, the treatments have side effects. Serious ones. Some doctors have been infecting patients with malaria, which they say will get kill B. burgdorferi. Others are injecting them with bismuth, and sometimes the results aren’t pretty. The lucky patient will get a long course of antibiotics, but  even this is serious business. Allergic reactions to the antibiotics, infections at the site of the I.V., and other complications have resulted in the death of patients. And in one unpublished study, a fifth of the patients who received this type of treatment had serious adverse events, usually related to the I.V..

People plagued with symptoms that no one can nail down are desperate for answers. Many visit doctor after doctor with no success. Then, they read a compelling story like this one and wonder if being treated for chronic Lyme disease could transform their lives too. Or they see a documentary like Under our Skin and become convinced that Lyme disease is responsible for their symptoms. When most of us want to learn more about a topic, our first stop is the Internet. Unfortunately, many of the activist groups lobbying on behalf of chronic Lyme disease have bland names and professional-looking websites that lead people to think they are sources of unbiased information, like the Lyme Research Alliance, the Lyme Disease Association, and the California Lyme Disease Association.

One study of patients seeking help for chronic Lyme Disease found that many suffered from psychiatric problems–which probably explained their symptoms. Psychiatric problems can be treated, but most of us don’t want to hear that we have them. It’s more appealing to think a course of antibiotics is the answer. Even the suggestion of a cure is often enough to make chronic Lyme disease patients feel better; one randomized controlled trial found that roughly 40% of the patients assigned a placebo improved. Just the belief that they’ve finally identified their problem and are getting help makes a difference. In the end, chronic Lyme disease is just another example of the way we attempt to transform psychological problems into something more manageable, something with a clear external cause and a straightforward solution. It’s a shame that we can’t provide this kind of relief without made-up diseases and harmful, unnecessary treatments. If it weren’t unethical to deceive patients, this seems like a case where prescribing sugar pills could make a big difference!

Vaccines and Autism: A crisis of legitimacy?

photo-injectionWhat do you do when you are part of a movement, you pour your heart and soul into it, and then things start to fall apart? Like members of a religious cult the day after the world doesn’t end, eventually you have to move on. But it must be really tough. In the same way, it seems to many of us as though the vaccines-cause-autism groups are going to have to grapple with the hard truth soon. But are we silly to think that?

Years ago, organizations like the National Vaccine Information Center and SafeMinds put forth a hypothesis: that vaccines cause autism. They called for the research community to test it. Now, study after study after study after study after study after study has come out debunking any link between vaccines and autism. One of the biggest leaders in the anti-vaccine movement, Andrew Wakefield, has been disbarred and disgraced, having kicked the whole debacle off with a fraudulent scientific article in a high profile journal. Other medical experts who have lent support to anti-vaccine groups, like Dr. Mark Geier and his son David Geier,  have met similar fates. Not surprisingly, given the mountain of evidence against a link between vaccines and autism, the access of anti-vaccine groups to policy makers appears to be waning. And in the wake of falling vaccination rates, large measles epidemics have broken out in places like Swansea, demonstrating just why vaccines are so important. So what happens now? Will the members of anti-vaccine groups start to drift away? Or will the leadership abandon the vaccine-autism hypothesis and find something else to concentrate on, remain relevant somehow?

Last year, a really interesting article on exactly this question came out. It’s called The Legitimacy of Vaccine Critics: What is Left After the Autism Hypothesis? and it appeared in Journal of Health Politics, Policy and Law. The author, Anna Kirkland, wanted to know how NVIC and its supporters were responding to all of these blows to the organization’s legitimacy. Her focus was on the leadership. Why would they continue to hang on to the vaccine-autism hypothesis when it meant losing the respect of the research and policy-making worlds? Kirkland attended the 2009 NVIC meeting and gathered data about who was there and what they believed.

Activist parents turned out in a big way, of course. Parents started groups like NVIC and have  kept them going. A specialized group of health professionals and researchers were also in attendance. Some of the health providers practiced alternative medicine; others practiced traditional western medicine, but opposed state-mandated vaccinations on libertarian grounds. You might be wondering what kind of researchers were there. Apparently, they typically publish in non-peer reviewed journals, occupying a sort of shadow research-world. Nevertheless, NVIC members feel these health professionals and researchers lend credibility to the group. Donors, of course, were important attendees. NVIC donors come from the left and the right side of the political world, and many are big movers and shakers in the world of political fundraising. Finally, there was the media. Mothering magazine and the Huffington Post are apparently two sympathetic news sources for parents who choose not to vaccinate their kids. Kirkland argues that all of these constituents have joined together to create a world of internal legitimacy. The NVIC leadership needn’t change course (and in fact, it would have a very difficult time doing so), because its constituents still believe they’re on the right track. What many of us view as major setbacks to the vaccine-autism hypothesis haven’t phased the members. Want an example? Check out the part of the SafeMinds website that deals with Vaccines and Autism. It’s as if the authors are not privy to any of the recent research–or with what scientific studies can and cannot show.

I’m convinced that it’s probably hopeless to try and change the minds of hard-core vaccine critics with data. But it seems as though many new parents are probably on the fence about vaccinating. They want to do what is best for their children, and they’re not sure what that is. They try to do due diligence and research their options. Have all the studies debunking the vaccine-autism connection affected THEIR views? Apparently, as recently as a few years ago one in four Americans believed that vaccines cause autism. And between 2003 and 2008, the percentage of parents who refused or delayed vaccines for their small children rose from 22% to 39%. So I’m not getting the feeling that the results of these studies are having the effect that we’d like. What we think of as blows to the vaccine-autism hypothesis are not finding purchase in the general public.

Have all these setbacks had any effect on the popularity of vaccine critic groups? Since NVIC and SafeMinds are nonprofits, I tried to find their annual reports. In the world of Public Health, it’s usually very easy to find an organization’s annual reports, stretching back for years. Not so for these groups. I was able to find a 2011 annual report for NVIC, but that’s all. I looked up both groups on GuideStar, which collects information about non-profits’ financials, and found a little more information there. It turns out that the loss of external legitimacy (i.e. the evaporation of respect from the research community and from the health policy world) doesn’t seem to be hurting these groups financially. In 2011, NVIC raised over $800,000–more than twice what it raised in 2009.  SafeMinds has also raised more and more money in recent years. Fundraising might not be the best measure of support for these groups, since a few big donors could contribute large amounts and mask trends in rank and file membership. But NVIC reported that in 2011, 1 million people viewed their homepage. It doesn’t seem like they are hurting for supporters.

gradusatodayAs a scientist, reading about the inner workings of the vaccine criticism movement was pretty sobering. A lot of researchers have diligently carried out research on vaccines and autism, laboring under the delusion that their data will change people’s minds. Kirkland’s research (and the ongoing epidemics of preventable infectious diseases that are taking place in the U.S. and other high income countries) makes it clear that this isn’t likely to happen anytime soon. Many vaccine critics call for research into various vaccine-autism hypotheses, but they do not trust any mainstream biomedical researchers to perform the studies. If your study is funded by the NIH (as most of our studies are), your results are not going to be taken seriously by members of these groups. I think initially it made sense to investigate the vaccine-autism hypothesis. But at this point, wasting time and money demonstrating the same thing over and over again, in hopes of converting people who will never be convinced, doesn’t seem like a good use of resources.

It seems that just as the vaccine critic movement has lost legitimacy in the eyes of the research world, we researchers have lost legitimacy in the eyes of many parents, at least when it comes to the science and epidemiology of vaccines. Groups like Generation Rescue seem to be doing a better job at communicating with nervous parents (check out their PSA above). I hope that in the future, we can find a way to bridge these two camps in order to prevent additional unnecessary outbreaks of infections like measles and mumps.

The Rise and Fall of Morgellons

MORGELLONS USAIn 2004, frustrated mother Mary Leitao coined the term “Morgellons Disease.” The name came from a 17th century source that described feverish, French children whose backs would break out in stiff hairs. When the hairs sprouted, their coughs and convulsions would disappear.

Leitao’s story started in 2003, when her 2-year-old son, Drew, developed a sore near his lip. He pointed to it and said “bugs.” When Leitao examined it, she found a fiber inside. Soon there were more sores and more fibers–strange threads of all colors. Seeking answers, she began taking the toddler to doctor after doctor. The last doctor she saw, a specialist in Infectious Disease at Johns Hopkins, concluded that what Drew suffered from was a mother with Munchausen’s by proxy. Needless to say, she was not happy.

In 2004, she created a website detailing her son’s symptoms. By 2008,  over 11,000 people had registered on the site to tell their own stories. They, too, suffered from sores and odd fibers. But they added a litany of additional complaints as well: cognitive issues, fatigue, and muscle and joint pain were some common ones. Leitao also started a research foundation devoted to Morgellons. In 2006, it collected almost $30,000 to fund small research projects and promote awareness. Celebrities like Joni Mitchell revealed that they, too, suffered from Morgellons.

People with Morgellons were angry, and the website helped them organize. The typical doctor visit for someone with Morgellons went like this: They would book an appointment, usually with a dermatologist. When the day of the visit arrived, they would bring in a Ziploc bag filled with fibers they had collected from their sores. Often, they would also bring along information they had collected about Morgellons from the web. Presented with these patients, most doctors diagnosed some variant of delusional parasitosis (a disorder in which people believe that bugs are underneath their skin). Treatment for delusional parasitosis typically involves antipsychotics or other psychiatric meds. Not surprisingly, most patients were not happy with the response they were getting from doctors. Sufferers began to demand answers. They started calling the CDC, agitating for an investigation into Morgellons, and enlisted support from politicians like Hillary Clinton, Barack Obama, John McCain, Barbara Boxer, and Tom Harkin. Eventually the CDC bowed to pressure and agreed to research the disorder.

Now all of this may sound crazy. But some responses from bona fide scientists gave credibility to the idea that this disease wasn’t simply about delusions. Randy Wymore, at Oklahoma State university, got interested in Morgellons after reading about it online. People started sending him samples of fiber. He maintained that even though these shipments came from all over the U.S., the blue and red fibers they contained resembled one another. He passed 20 samples on to the forensics team in the Tulsa police department. The forensic lab reported that they were unable to match the chemical structure of the fibers to any of the hundreds in their database, and when they heated the fibers to the  highest temperature possible in their lab (700 degrees Fahrenheit), nothing happened. Wymore and his forensic colleagues were baffled. What could these unearthly fibers be? Wymore also referred some Morgellon contacts to a doctor at Oklahoma State named Rhonda Casey. She professed that she found the fibers embedded under the patients’ unbroken skin. Moreover, she felt the people she saw seemed genuinely ill, presenting with a host of neurological symptoms.

None of that stuff got published. But Leitao teamed up with some colleagues who specialized in treating Lyme Disease and wrote a paper on Morgellons that appeared in the American Journal of Clinical Dermatology. They reported that 79 of 80 Moregellons patients were infected with the bacterium responsible for Lyme disease, and hypothesized that Morgellons could be related. (It should be noted that long term sequelae of Lyme Disease are controversial in their own right.)

So what did the CDC investigation find? In a 4 year collaboration with Kaiser Permanente that cost $600,000, they identified 115 cases. Their analysis was published in PLoS ONE in 2012. The patients were primarily white, middle-aged females. Half of the hair samples tested came back positive for drugs like amphetamines and cocaine. The women presented with a number of neurological complaints (chronic fatigue, cognitive deficits, etc.). But not parasites or mycobacteria were detected in biopsies of their lesions. And those fibers? They appeared to come from cotton.

If this is true, how can we explain the former findings, the ones from the Tulsa PD, for example? What about those strange fibers that were heated to 700 degrees Fahrenheit and remained unscathed? The ones that didn’t match any known fiber? It seems as though they may have resulted from a strange day in the lab. They sort of defy belief, and it makes you wonder about the forensics team there.

After the CDC study was released, the furor surrounding Morgellons seems to have died down. The website Mary Leitao founded has shut down, and the Morgellons Research Foundation has been shuttered. Apparently Wymore and Leitao fell out, and Wymore started his own foundation at Oklahoma State. His research continues, and people who suffer from Morgellons can still register on his website. The Lyme Disease group also continues to publish papers on Morgellons, linking it to infection with spirochetes.

journal.pone.0029908.g004It’s interesting to look at Morgellons as a powerful example of an internent meme, a disease that exploded after a website was created and then began to wane a few years later when the tide of evidence turned against it. After reading about its history, I just ended up feeling terrible for the people involved, though. You can check out pictures of the lesions. Even if they are self-inflicted or the result of bug bites, they don’t look pleasant. One woman reported day after day of agony as her body released red fibers, culminating in a pink worm coming out of her eye and coughing up a fly. Another reported waking up in the psych ward multiple times and becoming addicted to cocaine, driven to desperation by her disease. Moregellons patients try crazy and expensive cures–liquid silver, diatomaceous earth, deworming medication meant for farm animals, high dose antibiotics. These are sad stories. Since we began with Mary Leitao’s tale, you may be wondering how her family is doing. After a while, she reported that her older children began to exhibit signs of Morgellons. Her teenage daughter quit going to school as a result. Since the CDC study, it appears that she has more or less bowed out of the Morgellons community. I hope this family is doing better.