Bethesda -- Can herbs cure warts? Does powdered shark cartilage help cancer? Can music help brain injuries, or acupuncture relieve arthritis?
These are questions that most of the conventional medical world would have ridiculed until just recently. Some experts still do.
But now they are being seriously investigated and in some cases, funded by the National Institutes of Health, through its fledging Office of Alternative Medicine.
Founded in January 1992, the office has faced charges of disorganization, ineptitude and a confused scientific mission.
Many fringe-treatment activists, particularly in the field of cancer, have alleged that the office has lagged in evaluating some treatments.
Scientific researchers say the activists want the office to abandon good science to put an NIH seal of approval on unproved treatments.
Creation of the Office of Alternative Medicine within the NIH was something of a shotgun marriage. Initiative for its creation came not from the federal agency but rather from Congress and cancer activists. Although its annual budget of $5.4 million represents less than 1 percent of the NIH's total $10 billion budget, it quickly became the most talked about, controversial office in the health conglomerate.
One of the toughest tasks for the new office was to bring together the conventional medical world and the practitioners of acupuncture, homeopathy and other fields.
Each side tends to view the other with mistrust, if not scorn. One medical establishment critic called the endeavor "the Office of Astrology." Cancer activist groups advocating unconventional treatments have contended that the mainstream medical community has refused to pursue anything but standard chemotherapy and radiation.
Activists cited a tremendous thirst for knowledge about alternative medicine. A 1992 study by Harvard Medical School researcher David Eisenberg revealed that one-third of the American population was using alternative therapies -- everything from dietary regimens to fertility treatments -- and spending $14 billion annually, most of it not reimbursed by health insurance.
Proponents of the office argued that practices used in such abundance should undergo scrutiny. If research reveals them to be ineffective, quacks should be drummed out of business; if they're legitimate, that should be made known.
In October 1992, Joe Jacobs, a former medical director of Aetna Life Insurance Co. -- a graduate of a Yale Medical School and a Mohawk Indian with an interest in native medicine -- was appointed the first permanent director.
Dr. Jacobs resigned in October after complaining that Congress was interfering in research projects. He says most of the initial year was spent inventing an office from the ground up, convening an advisory council, writing grant procedures and identifying six fields to be included under the rubric alternative.
They were: nutrition and lifestyle regimes; mind and body control, such as prayer and guided imagery; ethnic medicine, such as Native American herbs, yoga, homeopathy and acupuncture; structural manipulation such as chiropractic and massage; bioelectrical applications such as biofeedback; and pharmacological treatments such as chelation therapy and anti-oxidants.
In 1993, the office awarded its first grants, of up to $30,000 each, for 30 small, pilot studies, usually involving from 12 to 20 patients. Dr. Jacobs and his deputies were adamant that high NIH standards be brought to bear, whatever the treatment. But just writing the request for grant proposals necessitated rethinking how standard scientific methodology could be adapted to alternative medicine.
"The overwhelming majority of people practicing alternative medicine are not familiar with research methods, and certainly not as the NIH does them," explained Daniel Eskinazi, OAM's deputy director, a dentist and certified acupuncturist. "And those in the mainstream are not very familiar with alternative medicine."
Dr. Eskinazi wrote grant requirements that insist on collaboration between an academic research scientist and an alternative medicine practitioner to foster relationships between the two fields.
The first round of 30 grants was in response to 452 applications -- a record number for NIH. Initial results from the studies are expected this spring. Twelve more grants were awarded in September, including two $30,000 grants to the University of Maryland's Project for the Integration of Orthodox and Complementary Medicine.
The gold standard of scientific research has been double-blind placebo-controlled studies, where one factor at a time is isolated and then changed, and results compared with a control group.
But adapting this model was a problem: how to apply it, for instance, to Chinese herbal therapy's 5,000 different herbs, in compounds involving 50 or more substances.
The solution has been something of an innovation. In one project, Linda Gooding, a viral immunologist at the Emory University School of Medicine in Atlanta, and Chinese herbalist Cindy Xu received a $29,070 grant to study the effect of herbs on warts. Four core herbs are tested at a time, with another group of six prescribed for the individual's overall constitution, as is customary in Chinese medicine.
Like many researchers, Dr. Gooding delved into alternative medicine after a personal experience: her 12-year-old son had warts on his hands burned off with liquid nitrogen -- the standard wart treatment -- seven times, without success.
Finally she went to Ms. Xu, who prescribed a bag of herbs. Dr. Gooding boiled them for 20 minutes, and her son soaked one hand in the solution for 20 minutes a day, for nine days. The warts never reappeared on the hand soaked in herbs; on the other hand, new growth sprouted from the burned-off stubs.
The alternative medicine office helped the project researchers cut red tape at the Food and Drug Administration to obtain Investigative New Drug status. Similarly, an acupuncture conference in July produced a ground-breaking application to the FDA to reclassify acupuncture needles from experimental devices, which could lead to health insurance reimbursement.
The September grants to the University of Maryland were for two acupuncture studies. The first will test acupuncture as a treatment for osteoarthritis; the second will examine acupuncture as a treatment for post-operative oral surgery pain.
But cancer activists want faster action, investigation into therapies already in use.
After much debate and conflict, the alternative medicine office this year approved protocols for four field investigations into the work of doctors who have become celebrated causes for cancer activists.
They are: a study by Houston doctor Stanislaw Burzynski of brain tumors in children treated by antineoplastons, a substance originally derived from urine, but now manufactured synthetically; a study of the effect of bee pollen on asthma by Royden Brown (the study was suspended after the doctor's death); a retrospective review of cases of New York cancer doctor Emanuel Revici, who advocates giving patients a mixture of lipids and selenium compounds; and treatment of solid tumors by former National Cancer Institute oncologist Charles Simone of Lawrenceville, N.J., who administers milk mixed with powdered shark cartilage.
In the case of Dr. Burzynski, trials are being performed by the Mayo Clinic and the Memorial Sloan Kettering Cancer Center -- two establishment centers that Ralph Moss, editor of the Cancer Chronicles newsletter, criticizes as "the locus of resistance to alternative medicine."
Several of these investigations (which get NIH advice, but no funding) are having difficulty recruiting subjects for the new protocols.
Dr. Simone says in the last year, 30 to 35 of 150 patients with advanced tumors who adopted his regime of low-fat, exercise, no smoking, no alcohol and three doses a day of shark cartilage showed a reduction in tumor mass and inflammation. Shark cartilage is a folk remedy that has been around for centuries, but rTC Dr. Simone argues that the science behind it is sound: Proteins in the cartilage inhibit newly forming blood vessels.
"Theoretically, the tumor should shrivel up and die because it can't be fed or get oxygen," he says.
But most of his patients elect the shark cartilage and lifestyle changes in conjunction with conventional chemo or radiation therapies -- so far, he has signed up only four patients for a study to take the shark cartilage alone.
Despite the controversy surrounding the alternative medicine office, one of the most lasting effects on science might turn out to be a re-evaluation of the relationship between the mind and the body and the placebo effect -- the scientific phenomenon in which no matter how a group of patients is treated, one-third of them will improve.
"When someone receives an alternative treatment and gets better, what is going on between patient and the doctor? Or the patients' supposed expectation of an outcome -- does that play a part?" asked Jack Spencer, deputy director of the alternative medicine office in charge of research.
Already just the very existence of the office has conferred some legitimacy on practices that once were laughed at. Alan Trachtenberg, a doctor from the NIH's National Institute on Drug Abuse with an interest in acupuncture, recounts how when he was a research fellow just out of medical school, he wanted to study Chinese herbs for HIV-positive patients. He was called an idiot by a colleague.
"Now we're willing to look at things that at first blush look a little crazy," he says.