NIMH Cautiously Exploring Realm of Alternative Medicine

Quietly, almost shyly, the National Institute of Mental Health (NIMH) is supporting research into religious healing in Puerto Rico, Navajo healing rituals, the use of acupuncture in the treatment of depression and laser acupuncture for attention-deficit/hyperactivity disorder (ADHD). Recently it sent a team of researchers to India for a conference on Ayurvedic medicine.

More well-known, though, is research of the antidepressant capabilities of a European wildflower known as St. John's wort (PT February).

NIMH information officers generally avoid reporters who have questions about alternative medicine, and top institute staff members are reluctant to discuss out-of-mainstream investigations. Despite numerous requests, no one at the institute can provide a list of alternative projects or the amount of funding available.

"We're looking for what works, regardless of whether it's technically considered a nutritional substance, a botanical or a new pharmaceutical," said David Shore, M.D., NIMH's associate director for clinical research.

The total NIMH budget for alternative medicine research-based on documents available through the Internet-is well under $2 million, including $1.5 million allocated for a hastily-arranged study of St. John's wort (Hypericum perforatum). A search of the National Institutes of Health (NIH) CRISP database turns up only a handful of NIMH grants for alternative or traditional medicine.

The issue came into sharp focus last August after the British Medical Journal carried a research review of 23 European studies that appear to support the use of Hypericum in treating some cases of mild depression.

In announcing the NIMH study, the NIH issued a statement that said, in part, "The completed studies are important, but data are limited. The doses in the European studies were not standardized and the trial lengths not sufficiently long to yield definitive evidence that St. John's wort is superior to placebo. The inclusion criteria for patients also varied. NIMH concluded that studies should also assess the risk of relapse and the occurrence of side effects that may occur with long-term use."

"The European studies were not designed the way we would have done them," Shore said. "There were some questions as to whether or not [St. John's wort] was ready for prime time in this country, especially since you can buy it in most health food stores.

"Our concern was that, since it was getting a lot of press, we wanted to design a study that would have a large enough sample size and be well-controlled enough-with standardized assessments, and specific diagnostic criteria for depression-and compare a standard extract of 900 mg per day with placebo and an selective serotonin reuptake inhibitor. We especially wanted to address the issue of placebo response, which in depression may be as high as 30%," he added.

The three-year Hypericum study will be conducted at 10 research centers around the country, under the direction of Jonathan Davidson, M.D., of Duke University.

"The major principle as far as I'm concerned is if we hear what seems to be intriguing evidence that something works, it's worth looking into," Shore said. "Most of the time we find that the evidence is not as strong as initially claimed. In the case of Hypericum, we think the evidence was convincing."

Convincing or not, the St. John's wort study reflects a response by the research community to an increasing amount of pressure from Congress to explore alternative therapies. An Office of Alternative Medicine (OAM) was created within NIH in 1991 to coordinate grants among various NIH institutes. In fiscal year 1997, its funding was increased to $12 million.

There is a substantial constituency for alternative medicine. The OAM estimates that worldwide, 70% to 90% of all health care "ranges from self-care according to folk principles, to care given in an organized health care system based on an alternative tradition or practice." As many as one-third of all Americans are reported to have some belief in alternative medicine or to be actively using nonmainstream remedies.

A source close to the NIH said, "We created an office that evaluates the broad spectrum, but that will bring with it the rigor of scientific peer review, so we wind up funding only the best of those studies. Even some of the mainstream medical schools are starting to look at some of the alternative approaches, so it is reasonable for the NIH to do so as well."

Congress knows how to gauge popular interest. This year, Rep. Peter DeFazio (D-Ore.) is sponsoring legislation that would authorize patients to seek "nonconventional, nonharmful" therapies without losing health insurance coverage. "As we confront escalating medical costs and struggle to protect the Medicare program, alternative medicine offers affordable and often effective treatments for chronic illnesses when conventional treatments fail," DeFazio said. "There's no reason to deny people access to the broadest possible range of medical treatments."

One Washington observer, who asked not to be identified, noted, "There are some people in the current Congress who are convinced of the value of alternative approaches. They may have a personal or family experience that they believe has been helpful and they question why the NIH has not pursued more vigorously some of the evidence that these products may do some of the things that their proponents claim."

Most of the OAM grants are made through the National Center for Research Resources (NCRR), which focuses on biomedical technology, comparative medicine, clinical research and research infrastructure.

Among NCRR-funded projects are "Intercessory Prayer-a Pilot Investigation" and "Acupuncture Treatment for Unipolar Depression."

Since 1993, NIMH has funded at least four studies through OAM, including the St. John's wort project. The others include:

• A project at Santa Clara Valley Medical Center in San Jose, Calif., studying the use of laser acupuncture treatment for ADHD-$27,900;
  
• A study at the University of Tucson in Arizona of the use of acupuncture in the treatment of depression-$289,598;
  
• A University of Iowa study on nonpharmacologic analgesia for invasive procedures-$100,000.In addition, a search of the CRISP database found two other NIMH grants for alternative medicine bot at Case Western Reserve University:
  
• Communication and experience in Navajo healing-no amount reported;
  
• Religious healing and identity in Puerto Rico-no amount reported.
  The St. John's wort study represents, by far, the largest commitment of NIMH money to alternative medicine, and it naturally attracted researchers who believe strongly in the efficacy of nonconventional treatments, according to one observer. But, this same source added, when it came to making the hard choices in designing the study, the researchers made "all the right decisions. It was as if they knew how much their credibility depends on the outcome of this study," the source said.

In an announcement from the NIMH, the OAM and the Office of Dietary Supplements, which is cooperating in the study, Wayne B. Jonas, M.D., director of OAM, said, "The interest and collaboration among these three NIH components in this clinical trial will provide the scientific expertise and clinical guidance to rigorously investigate this herb's benefit or risk in the treatment of depression."

Shortly after the announcement of the Hypericumstudy, the spotlight was again focused on NIMH when Richard Allan Shweder, chairman of the University of Chicago's Committee on Human Development, wrote an essay for The New York Times on an NIMH-sponsored trip to India for a conference on Ayurvedic medicine and mental health.

According to Shweder's article, "There is even a curiosity among some NIMH scientists, who are concerned about the high cost of drug development and who acknowledge the prevalence of psychosomatic illness. They are reevaluating alternative medicine as a body of knowledge rather than dismissing it as quackery."

Shweder wrote that "Lotions, potions, massages and purges are used by the hundreds of millions of Hindus, for everything from wrinkles, backaches, asthma and hair loss to impotency, senility, diabetes and schizophrenia."

In an Ayurvedic clinic in Kerala, he added, "Hysteria and chronic headaches are treated by streaming medicated milk onto the patient's forehead."

"It is a bet of some of the neuropharm-acologists at NIMH that Ayurvedic practitioners know something about barks, roots, leaves and other botanical provisions for human beings that they can no longer afford to overlook," he wrote.

Stephen H. Koslow, M.D., the NIMH director of neuroscience and behavior, who Shweder said led the expedition, declined to be interviewed about it. Shweder, however, agreed to discuss the importance of the conference.

"This trip to India was not part of the alternative medicine project," he said. "It is part of our scientific trade with India, which paid for U.S. grain in the '70s by setting aside funds for scientific and cultural exchanges. Most of the people on the trip were in pharmacology, not alternative medicine."

Despite the tone of his New York Times article, Shweder said the meetings were conducted on a very high, scientific level. "It was a spectacular conference. One of co-organizers was one of their star neurochemists. There were very serious presentations in an atmosphere that permitted critical debate. It was one of the more stimulating academic meetings I've attended.

"There also are skeptics within the Indian tradition," he added. "People at the NIMH are as familiar with DSM-III and DSM-IV as anyone in the West. Ayurvedic medicine is tied up with the whole anti-British movement in the 20th century, which revived it. It was not full-blown all through Indian history. It was an ancient system the nationalists returned to in opposition to British dominance. People view the two systems as complementary."

Shweder said the goal of the meetings was not research.

"This wasn't a research enterprise. It had two purposes: It was a joint workshop on mental health that featured a very good bunch of papers. People on the American delegation were talking about the way research is done here.

"There were presentations on their classifications of plants, presentations on how research is done, on Ayurvedic analysis and therapy, and its degrees of effectiveness. There was a visit to a major health center to educate us on how this happens in practice," he said.

The conference also underscored the diversity of approaches to medicine and healing-a diversity that this country may just be beginning to understand.

"The Ayurvedic healers' responses were that India's not homogeneous," Shweder said. "The beliefs vary all the way from thinking 'This really works!' to people who see the opportunity to bring together the technology and know-how of the West and linking it to their traditions of medicine to make them more sophisticated.

"One of the key issues was trials," he added. "There are some Ayurvedics who are totally accepting scientific methodology, and others who are thinking, 'This works and its a waste of time to do double-blind trials.' For the most part this was a very sophisticated group of people on both sides and there was enormous good will toward some kind of cooperation.

"What Steve Koslow did was a very good thing," Shweder said. "If you believe that, as I do, different cultures are all aspects of the human experience, this was in that spirit."