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OffLine Summer 2001

Volume 13 Number 3

A seminal article published in the New England Journal of Medicine in 1993 described the enormous impact of alternative medicine on health care in the United States. The authors reported that in 1990 Americans made 425 million visits to alternative providers, such as chiropractors, massage therapists, acupuncturists and naturopathic physicians, for charges totaling $12 billion. In the 8 years since this article appeared, complementary and alternative medical (CAM) therapies have become even more popular, a trend which is projected to continue into the foreseeable future. The number of CAM providers is expected to almost double between 1997 and 2010, meaning that a decade from now there will be one CAM provider for every six medical doctors.

What explains these statistics? For one, Americans are sometimes dissatisfied with conventional physicians' treatment of their medical conditions. Back pain, for example, is a very common condition whose diagnosis and treatment often results in frustration on the part of patients and physicians alike. Tellingly, almost one-third of Americans with a back problem in 1997 consulted a CAM provider. Additional problems commonly treated by CAM providers include other musculoskeletal conditions, menopausal symptoms, anxiety/depression, allergies and headaches.

Even though Americans are consulting CAM providers with increasing frequency, little is known about the effectiveness of most alternative treatments. And, almost nothing is known about their cost-effectiveness compared to that of conventional treatments. This represents a serious gap in knowledge. Patients would benefit from having access to scientific evidence to inform their health care choices; insurers, policymakers and managers could use such information to guide decisions related to the integration of alternative medicine into the health care system.

During the last 15 years, CHS investigator Dan Cherkin and colleagues have succeeded in filling in some of the knowledge gaps related to alternative medicine. These researchers have worked on several randomized trials evaluating the effectiveness and cost-effectiveness of various alternative methods for treating back pain. For example, in 1998 Cherkin reported in the New England Journal of Medicine that compared with a $1 educational booklet, $225–$240 worth of chiropractic or physical therapy services offered limited benefit in terms of reducing back pain-related symptoms, disability and subsequent health care use. Recently, other Center investigators have joined Cherkin in the alternative medicine research arena. Karen Sherman is a key collaborator of Cherkin's, particularly on projects related to acupuncture. And, CHS investigator Katherine Newton has received a grant from the National Institutes of Health to evaluate naturopathic remedies for treating menopausal symptoms such as hot flashes.

This issue of Off Line focuses on two randomized trials that illustrate CHS' efforts to increase knowledge related to commonly used CAM therapies. This issue concludes with results from a first-of-its-kind survey of CAM providers covering topics such as provider and patient demographics and commonly treated problems.

Alternative Therapies for Chronic Back Pain

At present, national guidelines do not recommend either massage therapy or acupuncture as treatments for back pain due to a lack of rigorous scientific studies demonstrating their effectiveness. To address this issue, Cherkin and colleagues randomized 262 chronic back pain patients aged 20 to 70 to one of 3 treatment arms: 1) therapeutic massage; 2) traditional Chinese medical (TCM) acupuncture; and 3) self-care education in the form of a book and videotapes. Subjects in the massage and acupuncture arms received up to 10 treatments over a 10-week period. Primary outcomes were back pain-related symptoms and disability. At 10 weeks (the end of treatment), massage was better than self-care on both the symptom and disability scales. Massage was also better than acupuncture on the disability scale. Outcomes observed for massage and acupuncture at 10 weeks remained relatively unchanged at one year, with massage superior to acupuncture in its effects on both symptoms and functioning. Though self-care educational materials had little early effect, by one year they were nearly as effective as massage.

While symptoms and dysfunction were the main outcomes of interest, secondary measures contribute to the positive picture of massage's role in treating chronic back pain. At 10 weeks, 50 percent were very satisfied with massage, compared to 37 percent and 13 percent for acupuncture and self-care, respectively. In addition, the massage group used fewer medications and had 40 percent lower back pain-related health care costs during the follow-up year than did the other two groups, although the latter finding was not statistically significant.

Cherkin concludes that the results of this study support that therapeutic massage is effective for chronic back pain and raise doubts about the effectiveness of TCM acupuncture. "The finding that the benefits of massage persist well beyond the last treatment and the suggestion of a possible reduction in subsequent health care costs make massage a high priority for further study," says Cherkin. The study's findings are especially noteworthy given that few conventional or CAM treatments have been found by rigorous studies to be effective for treating chronic back pain.

Although this trial demonstrated that acupuncture was ineffective relative to massage, it was not designed to assess acupuncture's effectiveness on an absolute level. That question can only be answered by comparing acupuncture to a no-treatment "placebo" group. The next issue of Off Line will describe Cherkin's and Sherman's efforts to address the issue of acupuncture's absolute effectiveness.

Alternative Therapies for Menopause
Over 20 million U.S. women will undergo menopause in the next 15 years, with up to one-third experiencing moderate to severe menopausal symptoms, such as hot flashes and night sweats. Hormone Replacement Therapy (HRT) represents one solution to these uncomfortable symptoms. But it has not proven to be a cure-all. Despite strong evidence supporting HRT's short-term use for treatment of menopausal symptoms and long-term use for osteoporosis prevention and treatment, only 12 percent of women use HRT for two years or more.

Side effects are one explanation for the relatively low rate of use of HRT. A significant proportion of women taking HRT experience adverse effects, such as bloating, headaches and depression. Fears that HRT may increase their risk of developing breast cancer deter many women from using the hormone replacement. Current evidence suggests that HRT may increase a woman's risk of developing breast cancer by 15 to 30 percent, depending on dosage and duration of use. HRT is contraindicated in women with established heart disease, unexplained vaginal bleeding, liver disease and breast and endometrial cancer and may be inappropriate for women experiencing migraine headaches, hypertension, seizure disorders and gallbladder disease.

The decision whether or not to use HRT is complicated, whether it is being considered for short- or long-term use. To help women make up their minds, Newton worked with CHS Principal Investigator Andrea LaCroix to develop an HRT Workbook entitled "To Be Or Not To Be on Hormone Replacement Therapy: A Workbook To Help You Explore Your Options." Intended as a shared decision-making tool, the workbook guides the discussion between the provider and patients as to whether or not to take HRT. The workbook is available to all Group Health providers.

In addition to the workbook, Newton is pursuing another avenue of research designed to help women decide if, and how, to treat menopausal symptoms. According to a recent survey of Group Health women aged 45 to 65, 68 percent had tried alternative treatments for menopause including naturopathic remedies, acupuncture, chiropractic or massage therapy, increasing dietary soy and stress management. Although evidence exists supporting the effectiveness of some of these treatments, as is the case with back pain, rigorous studies are lacking. Newton and colleagues LaCroix and Susan Reed from the University of Washington are conducting a randomized trial with the primary purpose of comparing the effects of 3 alternative treatments, HRT and placebo on the frequency and intensity of menopausal symptoms.

Black cohosh, an herb commonly used by naturopathic physicians for the treatment of menopausal symptoms, is an element in each of the three alternative treatment arms. This herb, available on the drug market since 1956, is marketed as a dietary supplement for women "experiencing normal mid-life changes." The second alternative treatment is Progyne, a combination botanical formula with 10 active ingredients, one of which is black cohosh. Naturopathic physicians consider combination formulas such as Progyne to be more effective than single agent therapies (e.g., black cohosh alone). Eight of the ten ingredients in Progyne are phytoestrogens, plant constituents with a molecular structure similar to that of estrogen. Over 300 phytoestrogen-containing plants have been identified, some medicinal and some common to our diet, such as soybeans. The third alternative treatment consists of Progyne and dietary instruction to increase soy protein intake. This reflects the holistic and multi-faceted approach espoused by naturopathic physicians—that is, women are rarely treated with a single prescription.

Survey of Alternative Providers
The two trials described above are designed to answer important questions related to the role of specific alternative therapies in the treatment of chronic back pain and menopausal symptoms. In a recent survey of alternative providers, Cherkin and colleagues stepped back and addressed even more fundamental questions such as: 1) what are the characteristics of alternative providers and their patients? and 2) what types of problems do they treat? Although this type of information has been available for conventional physicians for at least two decades, prior to this survey it has only been available on a limited basis for chiropractors and not at all for other types of CAM providers.

Telephone interviews were completed with over 170 licensed providers in each of the following 4 alternative medical professions: 1) chiropractic; 2) acupuncture; 3) massage therapy; and 4) naturopathy. Data were also collected on 20 consecutive visits made to randomly sampled licensed CAM providers in the same 4 professions, resulting in information on more than 1,800 visits to each profession. The study was limited to 2 states for each profession—one western and one northeastern to enable examination of geographic diversity. The four states involved were Arizona, Washington, Massachusetts and Connecticut. Cherkin compared these survey data with similar data for conventional physicians published by the American Medical Association.

Conventional physicians and chiropractors are predominantly male (about 75 percent), while the other CAM professions are predominantly female (60–85 percent), and acupuncture and naturopathy appear to be becoming more so over time. Only 5 percent of CAM providers (excluding acupuncturists) were non-white, compared to 17 percent of conventional physicians. Interestingly, the characteristics of patients who visit CAM providers tend to mirror those of the providers themselves; that is, patients tend to be female, young or middle-aged adults and white.

Chiropractors and massage therapists primarily treated musculoskeletal problems. Acupuncturists and naturopathic physicians tended to see a broader range of conditions, often providing care for problems such as anxiety, depression, fatigue and allergies (acupuncturists) and fatigue, skin rashes and menopausal symptoms (naturopathic physicians). Most visits to chiropractors and naturopathic physicians, but less than one-third of visits to acupuncturists and massage therapists, were covered by insurance. At least two-thirds of visits to CAM providers resulted from self-referrals and only 4 percent–12 percent from conventional physician referral.

CAM providers' dependence on self-referrals brings up the issue of coordination of care. According to the survey, concurrent care between conventional and alternative providers is common, representing between ¼ and ½ of visits to acupuncturists, massage therapists and naturopathic physicians. But typically CAM providers do not discuss care for concurrent patients with conventional physicians and patients do not discuss CAM care with their medical doctors. This lack of communication could have serious implications, especially in the case of naturopathic physicians and acupuncturists who may prescribe herbs that interact with medications prescribed in a conventional medicine context.

Commenting on the significance of this survey, Cherkin says: "This study provides fundamental information about the rapidly growing numbers of CAM providers in the U.S. This information will be useful for focusing future research on CAM and for educating decision-makers whose decisions will determine the health care role CAM professionals will play in the future."

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