Swallow Vioxx for your arthritis and your heart may stop. Give Prozac to your depressed teenager and he may kill himself. Pop your daily cholesterol-lowering statin pill and your muscles may fall apart.
Given the scary side effects reported for today’s drugs–and the growing mistrust by consumers of corporations that produce them–it’s no wonder the number of Americans turning to "natural" herbal remedies to cure their ailments has nearly quadrupled since 1980. Peddling the wisdom of indigenous ancients and earthy grandmothers has become a $5 billion annual business. Here in California, new, ultra-hip drugstores thrive by dispensing both standard prescriptions and herbs.
Skeptics say such stores are stocked with modern incarnations of the nineteenth-century "Lydia Pinkham’s Vegetable Tonic," but the medical establishment is taking the trend seriously. Backed by the National Institutes of Health, researchers today are subjecting herbs and other alternative therapies to the same rigorous clinical trials faced by mainstream treatments. These studies are finding what works, what doesn’t, and even what might make you sicker.
Many researchers in charge of these trials are based at centers like the Osher Center for Integrative Medicine at the University of California, San Francisco. The Osher center has a triple purpose: to study alternative treatments, to teach medical students about complementary and alternative medicine, and to offer patients complementary treatments such as acupuncture and massage.
These researchers stand at the crossroads between conventional and alternative approaches, struggling to find what to draw from each philosophy best to protect their patients' health. "This is probably the first time in history that we have large numbers of people taking both," says Jacqueline Sohn, an acupuncturist and practitioner of traditional Chinese medicine in San Francisco.
Osher Center Director Dr. Susan Folkman, a psychologist, recently served on a national panel convened by the Institute of Medicine to confront this medical fusion. "The Institute of Medicine report does a very nice job of saying, basically, there is one medicine," Folkman says, "Whether it’s acupuncture or surgery, ayurvedic psychiatry or Western psychiatry, all these treatments should be evidence-based, should be beneficial, and should be provided in a caring health system."
Sounds simple enough, but regulatory and philosophical differences between alternative and Western treatments make a seamless medical approach both challenging and controversial. Western doctors may be unwilling to yield their powers of prescription to concepts like qi and tongue examinations. They may be convinced to recommend herbal products only after controlled investigations test purified compounds in large clinical trials. But that’s exactly the problem with Western medicine, say alternative practitioners: Conventional medicine treats symptoms one at a time, rather than looking at the whole person and creating a customized treatment for the symptoms’ underlying cause. In the alternative practitioners’ view, clinical trials of one compound are useless out of the context of comprehensive care. And differences in the legal treatment of drugs and herbs deepen the division.
Regulating Herbs
In February 2003, 23-year-old Baltimore Orioles pitcher Steve Bechler fell ill during a spring training workout and died the next morning. His autopsy revealed the herbal supplement ephedra--a stimulant derived from an Asian shrub, also called ma huang--in his blood. The coroner's report concluded ephedra played a significant role in Bechler's death.
Ephedra sales were subsequently banned in the U.S. as complaints surfaced from 16,000 less famous ephedra users. A Utah judge overturned the ban for low-dose ephedra supplements in April of this year, saying that the Food and Drug Administration had not proved ephedra was unsafe at low doses.
Despite the ban, many alternative medicine practitioners point to this herb’s several-thousand-year history in traditional Chinese medicine, where practitioners prescribe it for respiratory conditions including asthma. When properly administered, such practitioners say, ma huang is safe.
The ephedra case highlights the often-different views held by traditional practitioners and the medical establishment. But, more importantly, it illustrates the difference in regulation between supplements and drugs.
Pharmaceuticals don’t reach the consumer’s medicine chest until clinical trials regulated by the FDA determine facts about the drugs’ dosage, efficacy, and side effects. Herbal remedies escape this regulation. The Dietary Supplement Health and Education Act of 1994 classifies herbs like foods: Supplement manufacturers need prove neither that their product works nor that it is safe. Only if a supplement is proven unsafe can the FDA pull it from the shelves.
Medical experts recently called for this policy to change. The Institute of Medicine committee recommended in its January 2005 report that conventional treatments and alternative treatments be held to the same efficacy standards. The report called for Congress to strengthen regulations on dietary supplements to improve quality control and protect consumers. Since herbs are plants unregulated by the FDA, the dose of an active compound in herbal supplements can vary wildly: A 2001 study of 11 ginseng products measured amounts of active ingredient that varied from 11 to 328 percent of the amount printed on the bottle.
This institutional commentary comes 13 years after the government first turned its eye to complementary and alternative medicine, creating the Office of Alternative Medicine within the National Institutes of Health in 1992 to study alternative approaches using rigorous trials. The office gained clout in 1998, reopening as the National Center for Complementary and Alternative Medicine. The center’s 2005 budget exceeds $120 million. This gravy train and other private benefactors of complementary and alternative medicine research have led investigators at top medical schools to turn their attention to studying herbs and other forms of complementary and alternative medicine.
Not everybody thinks this research is a good use of money. "There’s not been one positive result that’s useful, and it’s been going on for over ten years," says Dr. Wallace Sampson, professor emeritus of medicine at Stanford University and former chief of medical oncology at Santa Clara Valley Medical Center. "Herbal medicine and most alternative medicine is a step backwards at least 200 years," Sampson adds. "It’s an extraordinary event that never has happened in the history of science."
Sampson turned his attention to alternative medicine in the 1970s when his cancer patients began disappearing to Mexico for an alternative cancer treatment called laetrile, derived from apricot pits. Since retiring, he has devoted his full attention to analyzing, and in most cases debunking, alternative therapies. He started a peer-reviewed journal called the Scientific Review of Alternative Medicine, affiliated with the Center for Scientific Investigation of Claims of the Paranormal and Skeptical Inquirer magazine, because, he says, his colleagues were having trouble getting "politically incorrect" work published that rejected alternative medicine.
Sampson’s view is that the only definitive way to prove an herbal ingredient works is to isolate a single active ingredient, identify its activity, and test it in clinical trials–as pharmacologists have done for years. And, without an accompanying hypothesis for how an herb might work, widespread consumer use of a product isn’t enough to justify clinical trials, he says.
But his outright dismissal of all things alternative hides the fact that the line dividing alternative and mainstream medicine grows blurrier all the time.
Some people define alternative medicine as "anything not taught in medical school," Folkman says. The Institute of Medicine report defines complementary and alternative medicine as ideas and practices "other than those intrinsic to the dominant health system of a particular society or culture." Especially in California, practices like yoga and massage are so common they barely seem alternative. Even Sampson trained in transcendental meditation, and he’s referred many patients for massage. "Those could be considered alternative medicine," he says of such approaches. "I’ve always considered them just adjuncts to standard medicine."
And the line shifts. "As soon as something is proved effective, it’s no longer alternative," says Dr. Stephen Bent, who studies herbal remedies at the Osher Center.
Bent points to the use of glucosamine and chondroitin in treating arthritis as an example of the changing boundary. "For a long time, people looked at it and said, ‘What is this stuff? It’s ground up shark cartilage and cow cartilage and you think it’s going to make your joints feel better?’" Now, he says, doctors regularly recommend glucosamine and chondroitin to patients.
Leaf-Popping
Bent’s office building looks to the Orient. Perched on a cliff above crashing waves outside the Golden Gate, the San Francisco Veterans Affairs Medical Center is home to Bent’s clinical trials of herbal treatments.
Many of these treatments originated thousands of years ago across the Pacific. They have settled and flourished in San Francisco like the immigrants who brought them. Immigration is one reason Bent gives for the rise in complementary and alternative medicine in the U.S.
Another reason is a desire for more personalized medicine. "Some of the traditional ways of using herbal medicine are a whole different concept of care," he says. "In this country, we take herbs like we take drugs." In Native American or Chinese medicine, for example, herbs are often combined with other things–walks into the woods to find a particular plant, ceremonies, acupuncture or massage, or extensive personalized consultations–all of which could be healing. "Maybe what we really need to be doing is changing the 10 to 15 minutes with the doctor that we have," he says, "and looking at how we can do a better job of taking care of patients."
At least a quarter of our pharmaceuticals’ active ingredients originally came from plants. Taxol, a widely used chemotherapy drug, comes from the Pacific yew tree. Aspirin is derived from a compound found in willow bark. These examples suggest that some herbs could cure us. Bent is working to find out.
His April 2004 review in the American Journal of Medicine collected the results from all published studies of the ten top-selling herbs in the U.S. Only four of the ten had strong evidence of efficacy: gingko, garlic, saw palmetto, and St. John’s Wort.
Of the four, ginkgo is the only herb Bent would recommend to patients. Even then, he qualifies his recommendation. Quality studies show gingko improves the cognitive function of patients with dementia, though improvements are small. Western medicine has little to offer for dementia, Bent says, so he recommends gingko for such cases. But extracts from the notched, fan-shaped leaves do not help clear-headed patients. Taking gingko to ace a test or nail an important meeting won’t help, he says.
Many doctors recommend extracts from the spiky fingers of saw palmetto leaves to ease symptoms–primarily urination problems--of benign prostate enlargement in men. Bent’s compilation showed saw palmetto likely helped, leading him to conduct a larger clinical trial of 225 men. Presenting at the American Urological Association annual meeting in May, Bent revealed that saw palmetto offered no significant benefit over a placebo in this larger trial.
Bent sees problems with garlic and St. John’s Wort. Although garlic can reduce cholesterol by 4 to 6 percent, this reduction is small compared to the 20 percent drop caused by cholesterol-lowering drugs. And, since safety trials haven’t been done on garlic supplements, Bent would recommend a pharmaceutical cholesterol drug over garlic. (Familiar and safe as garlic may seem to pesto lovers, supplements are concentrated and can thin the blood.)
The last of the "effective four" is St. John’s Wort, which probably alleviates mild to moderate–but not major–depression. But using this yellow flowering plant comes with a major caveat. St. John’s Wort increases the rate that many drugs–including oral contraceptives, chemotherapeutics, and HIV drugs--are metabolized by the liver. "It would be the rare patient--one who is on no other medications–who could safely take St. John’s Wort," Bent says.
Worse than being ineffective, some herbal supplements may cause harm. Bent points to two chemical analyses of supplements that showed unexpected ingredients. In one study, 10 to 15 percent of Chinese herbs tested contained lead, mercury or arsenic. The source of these metals is likely the metal-contaminated soils in which the herbs are grown. In other cases, manufacturers deliberately added pharmaceutical ingredients to improve the results of herbal supplements.
"The perception is that [herbs] are safer than they probably are," Bent says. People cavalierly try herbs like echinacea to treat their colds, he says, but nobody would ever pop a prescription migraine medicine without talking to their doctor, just to see if it helped their headache. "I think consumers should be very skeptical about using any kind of supplements," he says.
The Gold Standard
It may be unsettling to learn that something called "evidence-based medicine" is a new idea. In fact, this approach–advising patients based on the results of large, tightly controlled clinical trials--arose only about 20 years ago. Before that, medicine relied largely on doctors’ personal experiences and on published reports of individual cases.
"The gold standard for proving efficacy is the randomized, control trial compared to a placebo," says Bent. The key to this approach–a "double blind" trial--is that neither patient nor doctor knows who is getting the treatment and who is getting the placebo.
But developing a convincing placebo and double-blinding the trials can be challenging. For his trial of a Chinese 10-herb mixture called "longevity treasure," used to treat fatigue in the elderly, Bent developed a coating to mask the strong "herby, earthy smell" of the real herb and colored the inside of the pills so the treatment and placebo looked the same. (Longevity treasure slightly improved the moods of participants in Bent’s trial.)
With these tricks, herb and supplement tests are among the easiest trials to do right. Conceiving of a placebo massage is much harder. Dr. Brian Berman at the University of Maryland used a placebo acupuncture technique using fake needles in his study published December 2004 in the Annals of Internal Medicine, which showed acupuncture reduced knee pain better than "sham" acupuncture treatment in arthritic patients.
Such tests may not matter when patients make decisions about their own treatments, says Dr. Dawn Motyka, a family practitioner in Scotts Valley, Calif., "I don’t honestly believe that an infinite number of double blind placebo studies will convince the believer. People’s minds are made up. Generally, when people convert, it’s because of personal experience and not because of research."
In the Trenches
Practicing doctors like Motyka are faced with advising their patients about how to use complementary and alternative therapies. Though many people are trying alternative approaches, a 1997 survey estimated that only 40 percent of patients who use alternative therapies tell their doctors about it.
Motyka recommends five to 10 herbs to patients instead of pharmaceuticals. Among them are echinacea, saw palmetto, glucosamine, gingko and black cohosh (used to treat menopausal symptoms). She feels another 20 herbs also work, but not as well as drugs. Beyond that, hundreds are dangerous in her view. "But they’re dangerous for different reasons," she says, including harmful impurities in the herbs, patients using herbs instead of life-saving pharmaceuticals, and side effects. "Most problems I worry about are interactions," Motyka notes. "We have minimal research on drug-herb interactions."
"One thing that scares me as a prescribing physician is these things aren’t controlled by the FDA," says Dr. Kara Nance, an internist in Arlington Heights, Ill. "I am hesitant to endorse herbal products."
But, she says, for mild conditions she’s happy to let the patient decide. "I have no problem with people pursuing complementary and alternative medicines when what they’re pursuing is not a life-threatening problem," she says.
And, she says, complementary and alternative medicine has a role in diseases that traditional medicine does not treat well. Number one on Nance’s list is chronic pain, including back pain, arthritis and fibromyalgia. "With fibromyalgia, people just hurt all over. You can’t find anything wrong with the person. But they can be really disabled by this pain that they clearly perceive." She thinks acupuncture and parts of chiropractic therapy may help such patients.
Do No Harm
Regulatory concerns and drug interactions may make physicians nervous about herbs and dietary supplements, especially in the treatment of very serious illnesses. But other complementary and alternative medicines make it easier for such doctors to comply with their primary pledge, "Do no harm."
Acupuncture is perhaps the most widely hailed recent success in alternative medicine. Following studies like Berman's that looked at arthritis and acupuncture, the treatment is coming into the mainstream. Insurance companies are beginning to cover acupuncture treatments.
The Osher Center’s recent efforts focus on mind-body treatments, such as yoga, massage and meditation. Folkman says the time is right to study such methods now that brain-imaging technology is mature. "It’s going to allow us to look at the effect of meditation on the brain," she says. Also, these approaches may be useful for treating conditions like chronic pain or cancer-treatment side effects not managed well by Western medicine. She, Bent, and the Institute report highlight this criterion in prioritizing research.
"These are all low cost, non-invasive treatments that are accessible by the general public here and in other countries," Folkman adds. "If they work, it will be a nice contribution to the public health."
Bent notes that acupuncture, exercise, meditation and yoga don’t carry the risk of interacting with drugs. And, they might have other benefits in moving patients and doctors away from medicine-based treatments to making lifestyle changes. "If we can get people to stop watching television, to exercise more, to eat better, to live less stressful lives and not commute an hour and a half in crazy traffic every day, I think we can do a lot of positive health care change through what might be considered alternative things, but really are just common sense."
Still, consumers seek drugs and herbs, because it’s easier to pop a
pill or a plant than to change one’s routine. And whatever common
sense dictates, the debate over what’s safest to swallow continues.
"I’ve seen people present slides that say, ‘We started by
taking plants and leeches,’" Bent says, "‘and then we
developed antibiotics and genetic therapies, and now we’re back to
plants and leeches again.’" 
Medicine Full Circle
The Elephant Pharmacy, at a busy Berkeley intersection, benefits from
bustling foot traffic among coffee shops, boutiques, and gourmet
restaurants. Inside, you’ll find Band-Aids and toothbrushes, but also
yoga mats and a surprisingly large selection of Buddha statues. In the back
corner is a typical pharmacy, manned by white-coat-clad pharmacists ready
to fill your prescription.
Walk along the back wall, though, and you reach the herbal pharmacy. Medicinal herbs in rectangular glass jars with brushed stainless steel lids line the wall, floor to ceiling. Labels on the jars begin with "agrimony" and end with "zi su ye." Herbalists from various traditions staff the pharmacy every afternoon, offering free advice in personalized, 20-minute consultations. On a Sunday afternoon, the place is packed. Customers wait–lounging in easy chairs in the health reading room--for perhaps an hour to talk with a practitioner.
Jacqueline Sohn, a traditional Chinese medicine practitioner and acupuncturist, spends Sunday afternoons at the store. The Elephant Pharmacy’s founder hired her to stock the herbal department with the goal of making it the best in the Bay Area. Sohn filled the herbal pharmacy with more than 500 herbs. "It was a dream job," she says.
Sohn comes from family of Western medical doctors who expected she would join their ranks. But after volunteering at a local hospital in New York, she knew conventional medicine was not for her. She graduated from the Massachusetts Institute of Technology in art and design, but was still interested in health. While working at a holistic learning center, Sohn was drawn to acupuncture. She went to acupuncture school and trained in traditional Chinese medicine. "I realized that though everyone in my family is a medical doctor, if we trace back, I’m actually taking my family back to its roots," says Sohn, a Korean-American.
The difference for Sohn was the holistic approach. "If someone has a condition, the goal in Western medicine is just to get rid of it. In a more holistic approach, the symptoms are a manifestation of an underlying problem. Instead of thinking of the thing as a problem that needs to be gotten rid of, you can embrace it and use it on your path to improvement."
Sohn acknowledges that Western surgical techniques are "unsurpassed," and that Western medicine has a deeper understanding of physiology. "We do need the technology and the information," she says. But Western approaches to "validating" Chinese medicine often miss the point. "If you just try to isolate the compounds, that’s tunnel vision. Just giving one thing to one person won’t work. There’s no way we can find out the other 200 components."
Would a study showing that whole traditional Chinese herbs don’t work
change her view? "I would question the way the study was done," Sohn
states. "For me it would be about believing the study’s results versus
6,000 years of evidence. How can you discount that?"
ABOUT THE WRITER
Jessica Marshall
B.S.E. (chemical engineering), Princeton University
M.S. (chemical engineering), UC Berkeley
Ph.D. (chemical engineering), UC Berkeley
ABOUT THE ILLUSTRATORS
Mary J. Lai graduated from
the University of California, Santa Cruz with a B.A. in Art. As an
undergrad, she favored zoological subjects (particularly birds) and
rendered them in bold inks and charcoal. While working at the UCSC
Arboretum pulling weeds, the director re-directed her efforts to
interpretive panel work and encouraged her to look into the Science
Illustration program. Currently, Mary freelances in a wide variety of
mediums and works in addition to scientific illustrations, including
character and website design, and comic art.
Melissa Garden Streblow
was born and raised on a ranch in the Napa Valley. She is a natural
science, editorial and commercial illustrator. Her primary passion is in
the exploration of natural and organic forms as a life science illustrator.
This interest is a direct result of the environment in which she was
raised. The images and sensations that she absorbed have developed and
informed her aesthetic vocabulary. Melissa finds herself comfortable in a
wide range of media and eagerly adapts to any challenge. Skills include
comprehension in both traditional and digital media. Her strengths are in
her level of involvement, her command of her materials and versatility as
an artist. Melissa has recently completed the graduate program in Natural
Science Illustration at UC Santa Cruz and is accepting assignments and
commissions. You are invited to visit her work and contact her through her
website www.melissagarden.com