Complementary and Alternative

The Permanente Journal PRSRT STD 500 NE Multnomah St, Suite 100 US POSTAGE Portland, Oregon 97232 PAID Portland OR Change Service Requested Permit No 1452 Fall 2002 Volume 6 No. 4

THE PERMANENTE JOURN

LVOLUME 6 NO. 4 — F AL

Complementary and Alternative Medicine

2 National Institutes of Health “Oregon Center for Complementary and Alternative Medicine”: Value to Permanente Medical Groups and to Kaiser Foundation Health Plan and Hospitals

22 The Herbal Medicine Pharmacy Update

28 Jimson Weed Poisoning—A Case Report

34 The Macrobiotic Diet as Treatment for Cancer: Review of the Evidence

44 Symposium on Complementary and Alternative Medicine: In the Era of Evidence-Based Medicine, What’s a Physician to Do?

ALL 2002

The Permanente Journal Printed on Fall 2002 recycled paper. Volume 6 No. 4 www.kp.org/permanentejournal Fall 2002/ Volume 6 No. 4 PermanenteThe Journal EDITORIAL COMMENTS 22 The Herbal Medicine 2 National Institutes of Health Pharmacy Update. “Oregon Center for Complemen- Philip J Tuso, MD, FACP tary and Alternative Medicine”: Because of continued use of Mission: The Permanente Journal is Value to Permanente Medical over-the-counter therapy and written and published by the clinicians Groups and to Kaiser Foundation the lack of routine screening of the Permanente Medical Groups and Health Plan and Hospitals. for drug interaction, it is impor- KFHP to promote the delivery of superior Tom Janisse, MD, Editor-In-Chief tant for physicians to under- health care through the principles and stand risks and benefits of benefits of Permanente Medicine. COMMENTARY herbal treatment. This article is a partial review of selected 8Views and Use of Complementary herbal medicines with potential and Alternative Medicine by to harm patients. Mid-Atlantic Permanente Medical Group Health Care Providers. 27 The 79-Year Illness.

Lydia S Segal, MD, MPH David Clarke, MD ○○○○○○○○○○○○ ○○○○○○○○○○○○○○ Psychosocial stress is respon- SOUL OF THE HEALER sible for many primary care of- On the cover: fice visits. A case study is pre- “Teardrop Arch” by 6 “Glade Creek Grist Mill” sented with positive outcomes. Ahmad Abdalla, MD, Ahmad Abdalla, MD is a photograph of this 28 Jimson Weed Poisoning— beautiful arch tucked deep 38 “A Gathering of Crabs” A Case Report. Kit Chan, MD in Monument Valley, Utah, Ahmad Abdalla, MD far from the eyes of the 43 “Tools of the Trade” The hallucinogenic effects of casual passerby. It required John J Kuiper, MD, FACP this common plant have been a long desert drive and a known for many centuries, and short hike for Dr Abdalla 64 “Spider Web” it is widely used by young to arrive when the light Suzanne Ackley, MD people. The atropine, scopola- was perfect for this mid- morning shot. 69 You Can’t Go Home. mine, and hyoscyamine content Calvin Weisberger, MD can produce profound anticho- Dr Abdalla has been a Head and Neck Surgeon linergic effects; recognition and with SCPMG since 1978. He is a graduate of 72 In Memory of Carol management are discussed. the New York Institute of Photography and has Abramowski, RN, NP, MS. been designated a “Master Photographer.” Winnie Star, RNP 31 Corridor Consult: More art by Dr Abdalla can be seen on pages 77 “Portland Head Light” 6, 38, and 77. How Can We Integrate Ahmad Abdalla, MD Alternative Approaches and Mainstream Medicine to Treat CLINICAL CONTRIBUTIONS Chronic Low Back Pain? Lydia S Segal, MD, MPH 17 Immediate Hypersensitivity to Methylparaben Causing Using a case history as an ex- False-Positive Results of Local ample, this article outlines Anesthetic Skin Testing or lifestyle, biosocial, and alterna- Provocative Dose Testing. tive measures available to treat Eric Macy, MD; Michael Schatz, this common condition. Skillful MD, MS; Robert S Zeiger, MD, PhD integration of alternative mea- 7 LETTERS TO THE EDITOR sures can bring about distinct Parabens are commonly used 13 PERMANENTE ABSTRACTS benefit for these patients. preservatives in multidose vials 81 ANNOUNCEMENTS of local anesthetics but rarely 34 The Macrobiotic Diet as Treatment 81 THE LIGHTER SIDE OF MEDICINE cause immediate hypersensitiv- for Cancer: Review of the ity reactions. Data confirms Evidence. Joellyn Horowitz, MD; 82 BOOK REVIEWS the rarity of these reactions. Mitsuo Tomita, MD 87 CME EVALUATION FORM Because of the possibility of In this Independent Study false reactions, provocative Project by a medical student positive sensitivity tests should mentored by a KP physician, be repeated. potential risks and benefits of a macrobiotic diet as treatment are explored.

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The Permanente Journal/ Fall 2002/ Volume 6 No. 4 HEALTH SYSTEMS 73 Physicians as Leaders: SPECIAL FEATURE 39 Successful Practices in the Roundtable Discussion — Complementary & Physician Work Environment: Human Resource Leaders from Alternative Medicine We Work Together. Karen Tallman, the Permanente Medical Groups Symposium PhD; Jill Steinbruegge, MD; Lee Jacobs, MD, Moderator Michelle Hatzis, PhD A panel of Permanente human In May 2002, The Southeast The Physician Work Environ- resource experts, called to- Permanente Medical Group’s ment Workgroup conducted gether in a roundtable discus- Spring CME Program was held in focus groups to identify suc- sion, discusses the important Georgia. A panel of speakers: Paul cessful practices in the physi- informal leadership role physi- Wallace, MD; Tieraona Low Dog, cian work environment. This cians play in the work unit. MD; Lee Ballance, MD; and Charles article explores the practices Elder, MD, joined Lee Jacobs, MD, that discriminate “highly rated” in presenting the Symposium on teams from “medium-rated” MEDICAL ETHICS Complementary and Alternative or “low-rated” teams. 78 To Be or Not to Be— Medicine. Each presenter spoke Preimplantation Genetic from their area of expertise and 65 Clinical Information System Diagnosis. Kate Scannell, MD, shared their thoughts on the inte- (CIS) Baselets Help Standardize Editor; Commentary by Jeffrey R gration of CAM into practice. The Evaluation of ADHD in the KP Botkin, MD, MPH edited transcripts of each speaker Colorado Region. along with the transcript of the Mark Groshek, MD The rapid development of panel discussion with questions One powerful tool of CIS is reproductive technologies from the audience conducted at the baselet, a module contain- has given birth to formidable the end of the symposium are ing a set of prewritten items ethical questions. A case study excerpted in this special feature. that can be inserted into a of the biologic construction clinical progress note. This of a child is presented with 44 Symposium on Complementary article discusses the successful commentary addressing the and Alternative Medicine: In the use of these baselets in the KP physician’s, the patients’, and Era of Evidence-Based Medicine, Colorado Region. the unborn’s positions as well What’s a Physician to Do? as society’s. Lee Jacobs, MD, Moderator 70 CPC Corner: 45 Using Evidence to How to Say No. Book reviews Understand New Approaches. Edward Wang, MD; Andrew page 82 Paul Wallace, MD Golden, MD; Pamela J Butterworth, MA, MHRD 49 Dietary Supplements and Botanical Medicines: A A good clinician-patient rela- Commonsense Approach. tionship is essential in deter- Tieraona Low Dog, MD mining treatment plans and Subscriptions: The Permanente Journal is available by goals. This article discusses the group or individual subscriptions. For information about 54 Integrating CAM Into a Group importance of this relationship subscriptions contact 503-813-2623 or e-mail: Practice: The Experience of The when the clinician must tell the [email protected]. Permanente Medical Group in patient “no,” and offers strate- Submitting Manuscripts: Manuscripts submitted to TPJ Northern California. gies for addressing these un- are reviewed by members of the editorial staff. For more Lee Ballance, MD comfortable situations. information regarding manuscript submissions, read “Instructions for Authors” on our Web site at www.kp.org/ 57 Integrating CAM Into Practice: permanentejournal or contact our editorial office. The KP Northwest Story. Submitting Artwork: Send our editorial office a high-quality Charles Elder, MD color photograph of your art no smaller than 4”x5” and no 60 Complementary and Alternative larger than 8”x10”. Please include a cover letter explaining Medicine: Panel Discussion. Kaiser Permanente association, art background, medium, and a brief statement about the artwork (description, Lee Jacobs, MD, Moderator inspiration, etc). Electronic and e-mail submissions are accepted; 600 dpi resolution is required. Editorial Office: The Permanente Journal 500 NE Multnomah St, Suite 100, Portland, Oregon 97232 Phone: 503-813-4387; Fax: 503-813-2348 E-mail: [email protected] www.kp.org/permanentejournal Calling all Artists Distribution: If you have any questions regarding The Permanente Journal is always interested in considering artwork by KP clinicians distribution of this journal, contact 503-813-2623 or e-mail: [email protected]. and employees. Why not submit a sample of your work today? Where to find The Permanente Journal: A full-text version Send a high-quality sample of your artwork no smaller than 4"x5" and no larger of this journal is available on our Web site: www.kp.org/ than 8"x10" to: Managing Editor, The Permanente Journal, 500 NE Multnomah St, permanentejournal. In addition, copies of The Permanente Journal are available in Kaiser Permanente libraries Suite 100, Portland, OR 97232. E-mail: [email protected]. programwide.

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 1 editorial comments National Institutes of Health “Oregon Center for Complementary and Alternative Medicine”: Value to Permanente Medical Groups and to Kaiser Foundation Health Plan and Hospitals

n 1999, the National Center for Complementary and ties. This group’s expertise would ensure importing the IAlternative Medicine (NCCAM), one of the institutes best scientific thinking and experience in these disci- and centers that make up the National Institutes of plines. This in turn would instruct the development of Health (NIH), approved a proposal from the Kaiser rigorous research in CAM approaches to prevention, Permanente Northwest (KPNW) Center for Health Re- treatment, and mechanisms of action in craniofacial search to be one of 12 national Complementary and disorders. Alex White, DDS, DrPH, as the principal in- Tom Janisse, MD Editor-In-Chief Alternative Medicine (CAM) research centers. This cen- vestigator, brought experience as a research scientist ter would primarily focus on craniofacial disorders. Be- directly from previous work at NIH. Cheryl Ritenbaugh, cause of a growing interest in and use of alternative PhD, MPH, co-investigator and medical anthropologist, therapies by consumers to meet their health care needs, brought 20 years of clinical trials experience and multi- evidence of safety and efficacy was necessary to ensure institutional collaborative research and training experi- the public health. In 1994, the Office of Alternative Medi- ence at the University of Arizona College of Medicine. cine (OAM), the first NIH research and funding arm for As an associate medical director for Northwest alternative therapies, created a taxonomy to define these Permanente, I was working with the KP Regional Ben- therapeutic practices, created research centers, and efits Committee (RBC) designing member benefits in funded research projects. When OAM was expanded the area of alternative therapies in response to con- into NCCAM the budget grew from 19.5 million to 50 sumer and employer demand for these types of health million dollars, with a projected budget for 2003 of 113.2 care products and services. Because of this work and million. Research centers grew in number and scope. my professional interest in innovative approaches to From their inception, the centers were charged with not medical care, I agreed to be a co-investigator on the only conducting rigorous research, but also developing grant and to sit on the OCCAM Executive Committee the capabilities and capacity of a center, such as infra- as the NW Permanente Medical Group representative. structure support, laboratories, biometric functionality, To coincide with this special issue on CAM, I present and a critical mass of researchers, which requires at- a perspective on the value to the medical group, to the tention to development of CAM investigators. RBC, and to the KP health care delivery system of hav- When the KPNW Center for Health Research won ing an association with a CAM research center. I would one of the 12 center grants they established The Or- like to address the following areas: why all Permanente egon Center for CAM (OCCAM). The center was of physicians and clinicians will benefit; physician and interest to NIH because of its location in a metropoli- clinician research opportunities; development of CAM tan area with four CAM colleges—Oregon College of services; continuing medical education opportunities Oriental Medicine, National College of Naturopathic for CAM; patient benefit; benefit to medical practice; Medicine, Western States Chiropractic College, and the and bridging between health care researchers and clini- Oregon School of Massage—in addition to its associa- cal care delivery operations. tion with the Kaiser Permanente (KP) medical care delivery system, the KP Dental Care Program, and the Why All Permanente Physicians Oregon Health Sciences University School of Dentistry. and Clinicians Will Benefit The Oregon Center for CAM compounded this value Regardless of the region of the country in which they by creating an executive committee composed of re- practice, KP physicians and clinicians have always ben- search and clinical representatives from all seven enti- efited from sharing practice information. In the last ten

2 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 editorial comments National Institutes of Health “Oregon Center for Complementary and Alternative Medicine”: Value to Permanente Medical Groups and to Kaiser Foundation Health Plan and Hospitals

years, this cooperation has been enhanced with the sure that their work formulating critical clinical ques- proliferation of interregional groups, national KP edu- tions and study design goes forward. cation and learning conferences, and the work of the Care Management Institute. It is heartening for all to Development of CAM Services know that one of only 12 CAM research centers in the Having an associated research center can be highly country is within our program. In the next year, center beneficial for people designing and developing clinical researchers will begin to publish findings from their stud- services. One new program is an example. Several years ies conducted here, which will become part of a KP ago, John Scott, MD, a Colorado Permanente physician, evidence base to instruct clinical practice. Already CAM developed the Cooperative Health Care Clinic concept, center researchers, physicians, and clinicians have been in which several patients with similar medical condi- teaching others about their research experience and find- tions gathered to have a group visit with their doctor ings. Finally, grant opportunities are available for those and a multidisciplinary team. In the NW, Dr Elder from all regions interested in pursuing CAM research. adapted this model to meet patients’ needs for information and guidance in the area of CAM. In part be- Research Opportunities cause Dr Elder had developed credibility as a serious An essential research center activity is to develop the researcher of CAM through his fellowship with OCCAM, research interest and investigator ability of clinical prac- and because of demand for services by patients and titioners. OCCAM, in addition to its three major CAM physician colleagues alike, his pilot group clinic was projects, developed a research fellowship program. Two recently expanded to better serve the region. Patient KP clinicians were selected as research fellows: Charles satisfaction with the clinic and with the supplemental Elder, MD, a NWP internist, and Jeff Weih, PA, LAc, information and treatment he offered demonstrated their an affiliated clinician in Physiatry. Dr Elder studied need for alternatives to traditional medical care when meditation and Ayurvedic Medicine (an ancient Hindu there wasn’t a conventional alternative. medical system) in “Mind Body Tech- When an innovative clinical phy- niques for Temporomandibular Disorder sician has experimental data, based (TMD),” and Mr Weih studied acupunc- When an on rigorous research design and ture in “Measurement of Nerve Activity innovative clinical methodology, and has presented and Blood Flow During Acupuncture physician has that data at a peer-reviewed na- Treatment.” Other KP clinicians who have experimental data, tional conference, that physician worked on, or are currently working on, based on rigorous has a credible place to start when research projects supported by OCCAM research design discussing new alternatives with include: Mark Rarick, MD, oncologist, and methodology, physician peers. It is no longer studied an ancient Japanese acupuncture … that physician opinion or personal anecdote. This system in “Jin Shin Jyutsu for Mucositis of has a credible place increases the legitimacy of the in- Chemotherapy”; Joe Leben, DDS, Direc- to start when novative effort and infuses the in- tor of the KP TMD Clinic, a co-investiga- discussing new novator with energy to work the tor in the Phase II TMD trials; Susan Kiley, alternatives with research question harder and MSW, a member of the Vohs Award-win- physician peers. longer. Concomitantly, the visibil- ning KPNW Multidisciplinary Chronic ity and credibility of the CAM re- Pain Clinic, for “Evaluation of Healing search center is enhanced. Touch for Headache Patients in the KPNW Pain Clinic”; As a result of my personal involvement on the OCCAM and myself for “Assessing Communication and Rela- Executive Committee, and as an OCCAM researcher, tions Skills of Traditional Chinese Medicine Practitio- I improved my understanding of both CAM practitioners with Patients.” This communication study spe- ners and their therapies, which in turn informed my cifically focuses on using the Art of Medicine patient evaluation of and decisions about CAM benefits de- evaluation survey for acupuncturists working in the KP sign and implementation for KP members. Specifi- CAM network providing services to our members by cally, the improved working relationship built with referral and self-referral. Complementary Health Plans (CHP)—KPNW’s con- Having the assistance and advice of research experts tracted CAM network—through collaboration on so close at hand is extremely valuable for supporting study design, has improved my understanding of the physicians who are new at clinical research and at writ- quality of care that CHP and its practitioners are coming grant proposals. This assistance is necessary to en- mitted to deliver to our members. The KP Art of

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 3 editorial comments National Institutes of Health “Oregon Center for Complementary and Alternative Medicine”: Value to Permanente Medical Groups and to Kaiser Foundation Health Plan and Hospitals

Medicine survey tool, used for several years across cent conference as an opportunity for the research the Permanente Medical Groups, is now being used center to inform clinicians about the center and its re- by acupuncturists at CHP. What will be the effect of search projects and to create an evidence base for CAM. this feedback for these practitioners? Our planned fol- In addition, clinician requests for educational low-up project will study its use in evaluation of pa- preceptorships with CAM practitioners have become tient and practitioner satisfaction for chiropractors, available because the CAM colleges participate in the naturopaths, and massage therapists. To supplement research center planning and clinical studies, and there this anticipated perspective, having an opportunity to is a shared commitment to provide opportunities for bring the voice of KPNW physicians and KPNW pa- interested clinicians. tients to the executive committee’s discussion of CAM The Permanente Journal (TPJ) has featured several has been another benefit for the medical group. articles on CAM topics. Through my work at OCCAM I As an initial response to consumer inter- became aware of other systems of health care and heal- est and demand for CAM, NWP formed an ing. I saw the importance of an article submitted by Ultimately, the Alternative Medicine Journal Club (AMJC) Louis Montour, MD, a Colorado Permanente family phy- most important to create a network of interested physicians sician, who wrote about the Native American “Medi- benefit of and health care practitioners at KP, and to cine Wheel” as a model for understanding patients with OCCAM clinical provide a discussion forum for both clinical chronic pain, and explaining treatments and activities studies is for KP and patient questions, and to review recent patients can use to restore balance in their lives.1 In ad- patients. CAM literature. With the establishment of dition, exploring the healing practice of shamans—an- OCCAM the journal club was infused with cient medicine men who are our professional ances- CAM practitioners from the colleges and investigators—I wrote about the similarities of shamanic healing tors in the study projects. Instead of a forum of un- to the physician-patient interaction and physician treat- informed clinicians seeking understanding from each ment of medical conditions. This editorial was titled, other and from interpretation of the CAM literature, “Healing Physicians, Physicians Healing,”2 OCCAM re- a new level of interaction and understanding occurred searchers have submitted a grant proposal to study when this diverse group of people sat together with shamanic healing of TMD pain. Other CAM articles pub- a common interest and talked about what they knew, lished by TPJ include: “Complementary and Alternative didn’t know, and wondered about. Medicine Comes to KP”3 by Lydia Segal, MD, a Mid-At- The Oregon College of Oriental Medicine (OCOM) is lantic Permanente physician, who authors an update in developing a doctoral program (one of the first in the this current issue; “Use of and Interest in Complementary country). Because of OCOM discussions with NWP phy- and Alternative Therapies Among Clinicians and Adult sicians in the multidisciplinary chronic pain clinic, the Members of the Kaiser Permanente Northern California College plans to have clinical preceptor rotations on Region: Results of a 1996 Survey”4 by Nancy Gordon, PhD, medical services to enhance the integration of western ScD, a Division of Research Investigator, and David Sobel, medicine into the practice of traditional Chinese medi- MD, a Northern California Permanente physician; and cine. This association will enhance the education of NWP “The Herbal Medicine Pharmacy” 5 by Phillip Tuso, MD, a physicians, the integration of acupuncture into the pain Southern California Permanente physician, who authors clinic, and the use of NIH evidence-based indications an update in this issue. for acupuncture in medical practice. Patient Benefit Continuing Medical Education Ultimately, the most important benefit of OCCAM clini- Opportunities for CAM cal studies is for KP patients. Patients who seek treat- Physicians who desire more knowledge about ment for chronic pain often require a multidisciplinary complementary and alternative medicine practices approach utilizing multiple interventions simultaneously have benefited from the expertise now available from or in parallel. These patients become frustrated when the CAM colleges in Portland through the Oregon conventional medical treatments fail to bring desired Center of CAM. At KP Continuing Medical Educa- relief, and there are no other options for them. Across tional conferences, researchers and practitioners pre- the country, they seek alternative therapies. TMD pa- sented information, discussed case studies and re- tients are one such subgroup. They are commonly research findings, answered questions raised by KP ferred to the TMD Clinic, directed by Dr Joe Leben. clinicians, and demonstrated techniques in experi- Here they may enter one of two OCCAM Phase II tri- ential workshops. OCCAM cosponsored this most re- als, and then be randomized to either usual care or

4 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 editorial comments National Institutes of Health “Oregon Center for Complementary and Alternative Medicine”: Value to Permanente Medical Groups and to Kaiser Foundation Health Plan and Hospitals

one of four CAM therapies. In the literature and in my primary and specialty care physicians. OCCAM has ex- conversations with Permanente physicians, some pa- emplified how traditional medical researchers and prac- tients do improve with alternative therapies that titioners from four alternative health disciplines can wouldn’t have if the alternatives weren’t available. It is design and carry out research in the clinical setting, never clear just what the patient needs for improve- benefiting both groups and patients. The Bridge Group’s ment; patients are different, have different belief sys- work is an expression of that model. tems, different experiences, and come from different Because medical anthropologist, Nancy Vuckovic, cultures. For example, Asian patients may view orien- PhD, collaborated with me as co-investigator on my tal medicine as their traditional medicine, and find com- OCCAM developmental study evaluating communi- fort and benefit from this approach. As well, patients cation between acupuncturists and patients, she was routinely express that by participating in a research introduced to, and then became a member of, the KP study they feel good about making a contribution to Interregional Clinician-Patient Communication Lead- improve health care for future patients. ership Group. This bridging activity brought Dr Vuckovic’s professional research and anthropologic Benefit to Clinical Practice perspective to this clinical group, and she found value Physicians have expressed that they too look for al- in participating in and learning from the clinical ap- ternatives and supplements to conventional western plication of our communications research. medical treatment for their patients, especially for chronic conditions, some of which are difficult to treat, Conclusion such as fibromyalgia, headaches, irritable bowel syn- Having a CAM research center associated with a drome, low back pain, dysmenorrhea, and chronic fa- Permanente Medical Group and the Kaiser Founda- tigue syndrome. Physicians can now refer these pa- tion Health Plan and Hospitals has positively impacted tients—or those seeking information, exercise, lifestyle several areas: research opportunities, development of changes, or herbal supplements—to Dr Elder’s CAM CAM services, continuing medical education oppor- group clinic. The collaborative work between CAM tunities for CAM, clinical practice, patient care, and practitioners and physicians can be viewed as founda- bridging research and clinical practice. Rigorous re- tional preparation for future creation of an integrated search, especially multidisciplinary, multihealth sys- medicine clinic. This clinic will likely grow out of our tem collaboration has created the foundation for a multidisciplinary pain clinic. Several other physicians high-quality evidence base for CAM in clinical prac- and clinicians with an interest in CAM are encouraged tice. This continues the integration of conventional by having a CAM research center in our system. In medicine and the best of complementary and alter- conjunction with this, my participation in the research native medicine for the benefit of patients. Imple- center has aided my development of other physician menting research findings improves the delivery of leaders in innovative clinical areas. Having a center health care to meet patients needs, and to produce developing investigational projects allows examination, patient, practitioner, and physician satisfaction and comparison, and reevaluation of traditional medical improved health. ❖ care. This invigorates clinical practice. References: Bridging Research 1. Montour LT. The medicine wheel: understanding and Clinical Practice “problem” patients in primary care. Perm J 2000 Researchers at the KPNW Center for Health Research, Winter;4(1):34-9. who have historically focused on population-based health 2. Janisse T. Healing physicians: physicians healing. Perm J 2000 Spring;4(2):3-7. care studies, have for several years looked for opportu- 3. Segal LS. Complementary and alternative medicine nities to work with physicians in clinical research ad- comes to KP. Perm J 1998 Spring;2(2):33-7. dressing health care issues in the care delivery system. 4. Gordon NP, Sobel DS. Use of and interest in comple- A new group of KPNW physician and research leaders mentary and alternative therapies among clinicians and meet together in a group called the “Bridge Advisory adult members of the Kaiser Permanente Northern Committee” to learn from each other’s perspective and California region: Results of a 1996 survey. Perm J 1999 Summer;3(2):44-55. to encourage and support collaboration between research 5. Tuso PJ. The herbal medicine pharmacy: what Kaiser and clinical practice. Their focus is to conduct rigorous Permanente providers need to know. Perm J 1999 research on the most important clinical issues facing Winter;3(1):33-7.

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 5 soul of the healer

Glade Creek Grist Mill Babcock State Park, West Virginia By Ahmad Abdalla, MD

Impressed by a photograph in a magazine three years earlier, Dr Abdalla’s imagination materialized into reality when, on a cold fall morning, he found himself standing in the middle of this beautiful West Virginia setting. Images that had been formulated in his mind over the years had finally been captured on film. More of Dr Abdalla’s work can be seen on pages 38 and 77.

6 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 letters to the editor From Our Readers …

Dr Janisse, The Permanente Journal,

Having published an article in your very first As I was perusing the latest issue of the Journal, edition of The Permanente Journal, I have I looked at the photos of the authors and noted watched it grow and mature into a fabulous a wide range of ages, including one retired phy- journal. The content of your Summer 2002 is- sician. It reminded me of Hawaii Permanente sue was simply stunning. Great clinical con- Medical Group (HPMG) and the range of ages tent, human interest, art, quotations, and book of its physicians. I joined HPMG in 1968, when reviews. This is absolutely world-class, and it the group was nine years old, and worked with many of the fills me with pride to be part of a group that original members. I learned just how difficult it was to start the can produce this work. Please, if you have a group in a very hostile environment. Years later, after I had retired, spare minute, forward my compliments to all I met with the Executive Committee of the group and learned that who work on this wonderful journal. the present physicians had no idea of the history of HPMG—they had never heard of Phil Chu, who was the first president of the Thanks so much, group and who held it together during the first troubled years— John Davenport, MD, JD and just assumed that history began with their arrival! We then Physician Director, Primary Care Service Line began to interview the early pioneers and put this all together in a Chief, Department of Family Medicine, 37-minute history of the group—not the Health Plan but only of Orange County Market Service Area, SCPMG the group. We had about 4-1/2 hours of tape to edit and now have a permanent record of the first five years of HPMG. The video ◆ was completed by a professional video production company about ten months ago and is (I hope) on file in the HPMG president’s office and (again, I hope) is being used in orientation of physicians who are new to HPMG. The Permanente Journal, The point is: How many young physicians of the other Permanente groups have any idea of the early history of their I just read your article on physician reten- group? It is a shame if they don’t. tion. It is terrific! I have been a health care recruiter for 25 years. The article is one of the Thank you, best I’ve seen. Arg Bacon, MD Honolulu, HI Sue Cejka Senior Client Partner —Reply Healthcare Services Thank you for your letter. Speaking for the Northwest, I want to tell you about a history project to accomplish just what you suggest Permanente physicians should do about their history. Six months ago, the NWP Emeritus Physician Group undertook writing a book about the history of the NW medical group, led by emeritus physicians Ian MacMillan and Harvey Klevitt. This July several of us toured the original Permanente Foundation Hospital built by Dr Ernie Sayward, the first NW Regional Medical Director, and Henry Kaiser in Vancouver, Washington, near the shipyards. The emeritus group will capture from the earliest NWP history up through the eighties for all current and future physicians to learn from. Editor

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 7 commentary Views and Use of Complementary and Alternative Medicine by Mid-Atlantic Permanente Medical Group Health Care Providers

Abstract Context: Knowledge of Kaiser Permanente (KP) health care provider views about and use of many forms of complementary and alternative medicine (CAM) therapy may help KP develop appropriate services for patients and continuing medical education (CME) courses for providers. Objective: To assess provider views and use of CAM therapy in their KP practice. Lydia S Segal, MD, MPH Design: Retrospective survey. Department of Integrated Medicine Main Outcomes Measure: Responses to one questionnaire administered to Mid-Atlantic providers in 2000. Results: Of those surveyed, 26% responded (N = 141). In the 12 months before the survey, 48% of respondents used some form of CAM to treat patients. Respondents expressed strong interest in KP providing (or increasing) CAM services to patients, mainly for acupuncture, acupressure, and biofeedback. Respondents also expressed greatest interest in CME courses about these three types of CAM. Conclusions: Providers appear interested in using and learning more about CAM therapy, particularly those forms having the strongest scientific evidence to support them.

Introduction Harvard.1 His 1993 New England Journal of Medicine The increased use of complementary and alternative article showed that, in 1990, Americans made more medicine (CAM) for medical problems1 means that cli- visits to providers of CAM than to providers of tradi- nicians may need a better understanding of CAM tional medicine and spent about $13.7 billion (out of therapy. The knowledge base of practicing health care pocket) on CAM therapy compared with $12.8 billion providers can be assumed to vary because the field of (out of pocket) for all hospitalization that year. Although alternative medicine is so broad, new, and ever-chang- some researchers define CAM therapy more narrowly, ing and because so many clinicians are referring pa- many use the broad definition which Eisenberg used tients to alternative practitioners.2 Alternative medicine and which we too used for this study. patient services and continuing medical education CAM is generally used for chronic medical condi- (CME) programs for providers need to be tailored to tions such as cancer, arthritis, and HIV/AIDS, as well that varied knowledge base. as for many types of chronic pain, including muscu- We did a pilot study to assess our region’s providers’ loskeletal and headache.4 Patients with these condi- opinions about and use of alternative medicine. This tions tend to use medical facilities frequently, thus in- study was funded by Kaiser Foundation Health Plan creasing total utilization of medical services. and was approved by both the local Mid-Atlantic Providers’ willingness to acknowledge that patients Permanente Medical Group (MAPMG) and national are seeking CAM is often based on their own profes- Kaiser Permanente (KP) Institutional Review Boards. sional and personal experience with CAM.5 Gordon et The pilot study used an abbreviated form of a survey al reported that clinicians are unaware that patients are developed by Drs Nancy Gordon and Diane Sobel at using CAM, because they do not ask patients about it. KP Northern California.3 Patients report hesitancy to disclose use of CAM to Defining unconventional therapy, also known as CAM their clinician because they feel the clinician will be therapy, as that neither widely taught in US medical critical of their nonmainstream choices.3 schools nor generally available in US hospitals was first When alternative modes of care are neutral6 or popularized in a landmark study by Eisenberg at potentially beneficial, broadening the scope of that

8 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 commentary Views and Use of Complementary and Alternative Medicine by Mid-Atlantic Permanente Medical Group Health Care Providers

care benefits the patient and the clinician. However, should increase CAM services, either through in- some alternative forms of therapy can harm patients;7-9 ternal or external offerings. This question sought therefore clinicians need to know when patients are to reveal if providers were receptive to additional seeking alternative care. CAM services. A follow-up question asked providers which forms of therapy they would like to Survey Methods see introduced or increased at KP. The questionnaire developed by Drs Gordon and Interest in attending CME courses Sobel3 was adapted and shortened for this study. The in alternative medicine questions were in Likert format, each offering a range Providers were asked what CAM courses they of one to three or one to five answer choices (eg, “not would like to attend for CME credit. This informa- at all,” “somewhat,” or “great deal”). Several questions tion would help KP target and design CME courses had space for comments. that busy providers would find time to attend. The survey was sent out to all MAPMG primary care and specialty care physicians, nurse practitioners, and physician assistants whose patients might use CAM Table 1. Providers’ use of CAM therapy in practice during preceding 12 months (eg, obstetrics/gynecology, orthopedics, or neurology). Mode of CAM therapy Used Considered using Recommended As an incentive, 20 bookstore gift certificates each Chiropractic 30 23 32 worth $50 were awarded from a random drawing of Acupuncture 15 20 31 completed and returned questionnaires. Twenty-six Biofeedback 3 26 29 percent of the surveys (N = 141) were returned within Massage therapya 81440 four weeks after an interoffice mailing; operational Meditation 16 14 51 issues prohibited a second mailing to increase the Hypnosisa 32411 return rate. Survey results were tabulated. Counseling 30 6 66 Diet 36 4 56 Survey Questions Herbala 20 13 34 a Use of alternative medicine Yoga 61215 a Providers were asked if in the preceding 12 months Prayer 81431 a in their own practice they had used, had consid- Homeopathy 6147 Other 1 3 2 ered using, or had recommended use of any of 12 aAlthough these therapies were neither offered nor covered by KP, providers different modes of CAM therapy for prevention or reported having used them according to their own definition of “used.” treatment of any health problem. Interest in alternative medicine Providers were asked about their general level of Results interest in alternative medicine. Of those providers responding, 48% had used or had Motivation to use alternative medicine recommended use of some form of CAM therapy in Providers were asked about what motivated them their practice during the preceding 12 months. The most to use CAM therapy. Providers often rely on per- common modes of therapy used were chiropractic, sonal and professional experience combined with counseling, diet, and herbal. The most frequently rec- updated scientific information to establish their ommended modes of therapy were counseling, diet, practice styles. The majority of medical school cur- meditation, and massage therapy. When asked which ricula do not include substantial information about modes they had considered using but did not actually CAM,10 so it is unclear where providers get their use or recommend to their patients, providers most motivation and interest to use CAM. frequently listed biofeedback, hypnosis, chiropractic, Concerns about alternative medicine and acupuncture. The basis of provider concerns about using each At the time of the survey, the KP system offered chi- of seven individual types of CAM therapy was ropractic and acupuncture services on a limited basis. asked, and answer choices were the following: Biofeedback, although part of the base benefit, is used “not effective,” “harmful,” “not covered (by insur- by fewer than .01% of members. Counseling was of- ance),” “malpractice,” or “unknown.” fered as part of the standard mental health coverage, Future opportunities for offering CAM at KP and diet recommendations were offered by a KP nu- Providers were asked whether they felt that KP trition department. Meditation training was part of a

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 9 commentary Views and Use of Complementary and Alternative Medicine by Mid-Atlantic Permanente Medical Group Health Care Providers

Table 2. Providers’ motivations for using CAM The driving forces may instead be a combination of Motivator Not at all Somewhat Great Deal belief in the effectiveness of CAM and knowledge about Own experience 79 34 20 CAM gained from medical journals, coupled with de- Experience of others 46 62 26 sire to keep KP competitive. Patient not adequately treated 11 65 56 Table 3 shows that providers’ general concerns about Belief of effectiveness 30 75 39 using CAM therapy in practice stem from lack of knowl- Fewer side effects 41 70 21 edge about CAM therapy, belief that CAM therapy is Media influence 50 70 11 not effective or can do harm, and lack of insurance Medical journal articles 34 88 11 coverage for alternative therapy. Fear of malpractice Keep KP competitive 30 69 33 lawsuits does not appear to be a major concern of Other 1 5 15 providers. Providers’ concerns about lack of information focused number of programs and classes available at KP, and mainly on chiropractic, acupuncture, biofeedback, and the fee (although not directly covered) was about equal herbal therapy. Lack of insurance benefits was the driv- to an office visit copayment. Massage therapy, hyp- ing concern about using massage therapy and medita- nosis, herbs, yoga, prayer, and homeopathy were not tion. Concerns about using diet as CAM therapy fo- offered in the KP system; nor could providers directly cused equally on lack of knowledge about this use of refer a patient for therapy outside the system. diet and on its perceived ineffectiveness. However, some providers reported having used Most providers (85%) responded that at least one or Most of the these modes with patients, perhaps according more forms of CAM therapy should be increased or providers who to their own definition of “used.” incorporated into the organization (Table 4). About 60% used CAM Eighteen percent of respondents stated that of providers believed that use of chiropractic, acupunc- therapy did so they were extremely interested in alternative ture, biofeedback, herbals, meditation, or diet and because they therapy, and 64% stated that they were moder- supplement therapy should be increased or incorpo- doubted that ately or quite a bit interested. Only two respon- rated into the KP system. patients were dents stated they were not interested at all. Interest was strongest for CME courses about acu- being Most of the providers who used CAM therapy puncture, acupressure, or herbal therapy. Providers adequately did so because they doubted that patients were were least interested in massage, yoga, and homeopa- treated with being adequately treated with traditional medi- thy CME courses. traditional cine (Table 2). The next strongest motivator medicine. was the belief that health problems are more Discussion effectively treated by using CAM therapy and The study had a number of limitations, but most im- traditional medicine together. The belief that portant was the low return rate. Because of the small CAM therapy had fewer adverse effects than traditional sample size, we do not know how valid it is to com- therapy was a common motivator. Motivation to use or pare our results with those of similar studies.11 A logi- to consider using CAM therapy also came from the lay cal expectation that the providers who were most in- and professional media and from KP and national pro- terested in and amenable to using CAM therapy would fessional journals. take the time to return the questionnaire was supported A provider’s own experience was not the motivator by the fact that only a few respondents were clearly for using CAM therapy for 59% of the respondents. negative toward CAM therapy. Ardently opposed re-

Table 3. Providers’ concerns about using CAM Mode of CAM therapy Unknown Not effective Harmful Not covered by insurance Malpractice Chiropractic 29 23 25 16 6 Acupuncture 33 10 1 22 2 Biofeedback 28 6 0 23 1 Massage therapy 23 16 1 27 1 Meditation 15 5 0 24 1 Diet and supplements 18 18 15 9 3 Herbals 30 23 25 8 6

10 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 commentary Views and Use of Complementary and Alternative Medicine by Mid-Atlantic Permanente Medical Group Health Care Providers

Table 4. Providers’ opinions about increasing or incorporating CAM into KP organization Question No Probably not Not sure Probably yes Definitely yes Should KP offer alternative 56 15 58 57 medicine therapy? Should the following CAM therapy be increased or instituted at KP? Chiropractic 10 8 23 37 41 Acupuncture 4 3 26 48 40 Biofeedback 1 5 28 43 44 Herbs 12 13 30 33 32 Meditation 6 6 24 39 28 Diet and supplements 8 13 22 39 39 Other 2 0 0 4 8

spondents used the comment space on the survey to population, we believe that patient express their opinions. use of, and views about CAM in the Lack of analysis by provider specialty is another study Mid-Atlantic States Region are simi- In general, when a new limitation.12 Such analysis could have enabled us to de- lar among the Northwest region paradigm is introduced sign separate CME sessions for each providers’ specialty. members. Because of the similar into medicine, physicians The definition of CAM therapy varies, as previously demographics of CAM users in the are greatly reluctancant mentioned. Some providers clearly would not consider two regions, patient demand for to accept the idea biofeedback, counseling, or meditation as alternative CAM information and referrals is without substantial therapy. In this study, no definition was supplied for probably similar, and will probably proof of its efficacy. “diet.” For some providers, diet means nothing more drive providers’ interest in offering exotic than the healthy heart diet-–clearly not an alter- and learning about CAM. In our native therapy—-for others, diet may mean macrobiot- study, providers’ interest was strongest for CME courses ics, which some providers feel has a “fringe” quality. about acupuncture, acupressure, or herbal therapy, For some providers, their lack of basic CAM therapy probably because patients are using and asking ques- knowledge may have affected their viewpoint. For ex- tions about these forms of CAM therapy most often. ample, if they did not know what homeopathy is, they Tailoring future CAM patient services and provider CME probably could not express a view about its effects. courses may in part be based on patient demands in- On the basis of comments written by the respondents, stead of strictly on provider interest. Matching patient we sensed a “mainstreaming” of CAM therapy. In gen- and provider interests may be important for future eral, when a new paradigm is introduced into medicine, implementation of new services. clinicians are greatly reluctant to accept the idea with- CME sessions have been targeted to match provid- out substantial proof of its efficacy. Fifteen years ago, ers’ interests (acupuncture, biofeedback, chiropractic, for example, using antibiotics for ulcers would be considered voodoo medicine, yet is standard care today. Table 5. Likelihood of providers to attend And for some providers in our survey, acupuncture or CME course about modes of CAM therapy meditation were hardly considered alternative at all. CME subject Likely to attend What constitutes efficacy in evidence-based medicine Chiropractic 55 is itself under close scrutiny. For example, the belief Acupuncture 81 that hormone replacement therapy for postmenopausal Acupressure 74 women prevents some forms of cardiovascular disease Biofeedback 68 was medical dogma until recently. From our study, Meditation 51 having scientific evidence about the efficacy of CAM Massage therapy 48 instead of direct experience (personal or professional), Diet and supplements 62 appears to allow providers to feel some level of com- Herbs 71 fort in recommending CAM therapy to patients. Homeopathy 49 On the basis of a pilot study done (as part of a mar- Yoga 46 keting survey) for the KP Northwest Region’s member Other 5

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 11 commentary Views and Use of Complementary and Alternative Medicine by Mid-Atlantic Permanente Medical Group Health Care Providers

and herbal) at KP’s local and regional centers. Med 1998 Nov 23:158(21):2302-10. Addressing which therapy providers believed would 3. Gordon NP, Sobel DS, Tarazona EZ. Use of and interest in be most suitable for KP would help marketing and alternative therapies among adult primary care clinicians and adult members in a large health maintenance program development. In other managed care organi- organization. West J Med 1998 Sep;169(3):153-61. zations, the driver for new services has been market- 4. Gordon JS. Alternative medicine and the family physician. ing.13 The services most likely to be expanded include Am Fam Physician 1996 Nov 15;54(7):2205-12. acupuncture, biofeedback, chiropractic, diet and supple- 5. Hughes EF. Alternative medicine in family practice: it’s ments, herbal, and meditation. already mainstream. Family Practice Recertification 1997 This study, although limited by its low return rate Oct;19(10):24-44. (and other problems), confirms that providers in the 6. MacPherson H, Thomas K, Walters S, Fitter M. A prospective survey of adverse events and treatment MAPMG are using or recommending the use of CAM reactions following 34,000 consultations with professional therapy, most commonly acupuncture, biofeedback, acupuncturists. Acupunct Med 2001 Dec;19(2):93-102. chiropractic, counseling, massage therapy, and medi- 7. Newton KM, Buist DS, Keenan NL, Anderson LA, LaCroix tation. The study also suggests that CAM therapy modes AZ. Use of alternative therapies for menopause symptoms: with the strongest scientific evidence of safety and ef- results of a population-based survey. Obstet Gynecol 2002 Jul;100(1):18-25. ficacy stand the greatest chance of acceptance by pro- ❖ 8. Ernst E. Manipulation of the cervical spine: a systematic viders and, thus, increase in delivery. review of case reports of serious adverse events, 1995– 2001. Med J Aust 2002 April 15;176(8):376-80. Acknowledgements 9. Stevinson C, Ernst E. Risks associated with spinal Bob Dill, MEd, LPC, and Nancy Gordon, PhD, ScD, assisted manipulation. Am J Med 2002 May;112(7):566-71. with application of the project. 10. Wetzel MS, Eisenberg DM, Kaptchuk TJ. Courses involving The Mid-Atlantic Permanente Medical Group funded the complementary and alternative medicine at US medical project. schools. JAMA 1998 Sep 2;280(9):784-7. 11. Drivdahl CE, Miser WF. The use of alternative health care References by a family practice population. J Am Board Fam Pract 1. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins 1998 May-Jun;11(3):193-9. DR, Delbanco TL. Unconventional medicine in the United 12. Berman BM, Singh BB, Hartnoll SM, Singh BK, Reilly D. States. Prevalence, costs and patterns of use. N Engl J Med Primary care physicians and complementary-alternative 1993 Jan 28:328(4):246-52. medicine: training, attitudes and practice patterns. J Am 2. Astin JA, Marie A, Pelletier KR, Hansen E, Haskell WL. A Board Fam Pract 1998 Jul-Aug;11(4):272-81. review of the incorporation of complementary and 13. Montoya ID. Alternative medicine as a carve-out in alternative medicine by mainstream physicians. Arch Intern managed care. Health Mark Q 1998;16(1):11-24.

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12 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 Mary L Durham, PhD, Editor

permanente abstracts Abstracts of Articles Authored or Coauthored by Permanente Clinicians

From Colorado: ticipation in other videodisk programs has been From Southern California: Treatment decisions about low; perhaps physicians should ask patients to A preliminary psychometric lumbar herniated disk in a view these videodisks before their visits. analysis of a computer-assisted shared decision-making program Reprinted with permission. administration of the Barrett PH, Beck A, Schmid K, Fireman B, Telephone Interview of Brown JB. Jt Comm J Qual Improv 2002 From Northern California: Cognitive Status-modified May;28(5):211-9 Quality assurance and risk Buckwalter JG, Crooks VC, Petitti DB. J Clin BACKGROUND: An explicit process of collabo- management in online medical Exp Neuropsychol 2002 Apr;24(2):168-75 rative (shared) decision making involving the discussion groups Most screening tests of cognitive function- patient and physician has been recommended Eshleman AM. Am J Med Qual 2002 May- ing require face-to-face administration by for discretionary surgical procedures in which Jun;17(3):89-93 trained examiners. This limits their utility in small-area analysis demonstrates high varia- There are thousands of sites on the Internet epidemiology and in primary care settings. tion not attributable to differences in the pa- and World Wide Web where health care pro- Further, existing screening tests have not been tient population in the area. One such ex- fessionals and lay people interact to share developed using established psychometric ample is laminectomy for lumbar herniated medical information and health concerns. The principles. We adapted the Telephone Inter- disk (HD). An observational study was un- majority of these sites do not have proce- view of Cognitive Status-modified (TICSm) for dertaken to evaluate the impact of an HD dures in place to assess the quality of the administration as a computer-assisted tele- videodisk program on patient satisfaction, information supplied by the providers or lay phone interview (CATI). We screened 3681 decision making, and treatment preferences. people, nor do they have any formal risk man- elderly women with the CATI version of the METHODS: Enrollment occurred in the out- agement policies to respond to posted mate- TICSm, using lay staff as part of a longitudi- patient offices of surgeons treating Kaiser rial that may reveal a potential risk situation. nal study. A preliminary analysis of the psy- Permanente (Colorado Region) patients with This paper describes the quality assurance chometric properties of the TICSm indicated HD who had indications for surgery. Enroll- and risk management procedures that have good internal consistency. Test-retest reliabil- ment took place from May 1993 to Decem- been developed for KP Online—the Web site ity is needed to confirm reliability. Further ber 1995, and follow-up surveys of patients for members of the Kaiser Foundation Health work remains to adequately judge the valid- were completed by January 1997. Plan, Inc—and shares some preliminary find- ity of the TICSm including comparisons with RESULTS: A 6.0% decrease in the undecided ings based on these procedures. well-standardized tests and assessment of its group and a 1.3% decrease in the group pre- predictive properties in identifying demen- ferring nonsurgical treatment drove a shift of CLINICAL IMPLICATIONS: It’s inevitable that, in tia. However, the CATI version of the TICSm patients toward laminectomy, from 26.7% to time, most physicians will engage in some appears to have potential as a cost-effective 35.8% (Wilcoxon signed rank test = 349.5, form of electronic communication with their means of testing cognitive performance. p = .017). Postviewing preference (74.0%) was patients. This powerful medium presents © Swets Zeitlinger 2002. a better aggregate predictor of the ultimate some unique possibilities for miscommuni- treatment than previewing preference (70.0%) cation. Fortunately, Frankel and Stein’s “Four CLINICAL IMPLICATIONS: The evaluation of for laminectomy. Habits” model for in-person clinician-patient cognitive performance is increasingly rec- DISCUSSION: Viewing the videodisk increased communication maps well to online com- ognized as a crucial part of effective diag- the preference for laminectomy. However, limi- munication. By following a few simple nosis and treatment planning. Given the tations in the data prevented us from determin- guidelines, clinicians can increase the value likelihood that cognitive testing will expand ing whether this change in preference was ac- of online communication, prevent misun- in medical practice, cost effective, yet psy- tually reflected in patients’ ultimate decisions. derstandings, and increase their and their chometrically sound, means of assessing The fact that the strongest predictor of choos- patients’ satisfaction. Data in the article was cognitive performance are needed. We sug- ing surgery was the patient’s valuation of his or obtained through a three-year experience gest computer-assisted telephone inter- her condition supports shared decision mak- moderating members’ message boards on views warrant further development for this ing, with its emphasis on patient’s values. Par- the KP Online Web site. — AE purpose. — JB

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 13 permanente abstracts Abstracts of Articles Authored or Coauthored by Permanente Clinicians

From the Northwest: Clearly new and more intensive approaches From the Northwest: Group cognitive-behavioral are needed for this very at-risk segment of Efficacy and tolerability of treatment for depressed the depressed adolescent population. Can- venlafaxine compared with adolescent offspring of depressed didates for more intensive treatment include selective serotonin reuptake parents in a health maintenance a greater focus on successful treatment for inhibitors and other antidepres- organization the depressed parent(s), more joint parent- sants: a meta-analysis Clarke GN, Hornbrook M, Lynch F, et al. J Am child therapy, and possibly pharmacologi- Smith D, Dempster C, Glanville J, Freemantle Acad Child Adolesc Psychiatry 2002 cal treatments for the adolescents. However, N, Anderson I. Br J Psychiatry 2002 Mar;41(3):305-13 May;180:396-404 the usefulness of any of these approaches is OBJECTIVE: A randomized, controlled ef- not yet known. — GC BACKGROUND: In individual studies and lim- fectiveness trial of group cognitive-behav- ited meta-analyses venlafaxine has been re- ioral therapy (CBT) for depressed adoles- ported to be more effective than comparator cent offspring of depressed parents in a From Northern California: antidepressants, particularly selective seroto- health maintenance organization (HMO) Race, epithelial ovarian cancer nin reuptake inhibitors (SSRIs). was conducted. survival, and membership in a large AIMS: To perform a systematic review of all METHOD: Potential adult cases were found health maintenance organization such studies. by reviewing antidepressant medication pre- McGuire V, Herrinton L, Whittemore AS. METHOD: We conducted a systematic review scriptions, mental health appointments, and Epidemiology 2002 Mar;13(2):231-4 of double-blind, randomised trials comparing medical charts. Introductory study letters BACKGROUND: African-American ovarian can- venlafaxine with alternative antidepressants in signed by each parent’s treating physician cer patients present with more advanced dis- the treatment of depression. The primary out- were mailed to the appropriate adults. Eli- ease and have poorer survival than do white come was the difference in final depression gible offspring aged 13 to 18 who met cur- patients. rating scale value, expressed as a standardised rent DSM-III-R criteria for major depression METHODS: To determine whether these dif- effect size. Secondary outcomes were response and/or dysthymia were randomly assigned ferences occur among African-American and rate, remission rate and tolerability. to either usual HMO care (n = 47) or usual white patients who have equal access to medi- RESULTS: A total of 32 randomised trials were care plus a 16-session group CBT program cal care, we analyzed ovarian cancer patient included. Venlafaxine was more effective than (n = 41). Assessments were conducted at characteristics separately for 1587 members other antidepressants (standardised effect size was baseline, after treatment, and at 12- and 24- of the Kaiser Permanente Medical Plan of -0.14, 95% Cl -0.07 to -0.22). A similar significant month follow-up. Northern California and 5757 non-members. advantage was found against SSRIs (20 studies) RESULTS: Using intent-to-treat analyses, RESULTS: The distributions of disease stage but not tricyclic antidepressants (7 studies). the authors were unable to detect any sig- at diagnosis were similar among African- CONCLUSIONS: Venlafaxine has greater efficacy nificant advantage of the CBT program American and white patients, both in the than SSRIs although there is uncertainty in over usual care, either for depression di- Kaiser plan and elsewhere. However, ova- comparison with other antidepressants. Fur- agnoses, continuous depression measures, rian cancer death rates, adjusted for disease ther studies are required to determine the nonaffective measures, or functioning out- stage and age at diagnosis and for histol- clinical importance of this finding. comes. ogy, were higher for African-American pa- www.rcpsych.ac.uk CONCLUSIONS: Group CBT does not appear tients compared with white patients, regard- to be incrementally beneficial for depressed less of Kaiser membership status. The death CLINICAL IMPLICATIONS: This research, which offspring of depressed parents who are re- rate ratios for African-Americans compared combined data on depression outcomes from ceiving other mental health care. However, with whites were 1.32 (95% CI = 1.02-1.70) 32 randomized trials comparing venlafaxine given that many other studies have found for Kaiser members and 1.20 (95% CI = 1.04- to other antidepressants, suggests that positive effects of CBT for youth depres- 1.40) for Kaiser non-members. venlafaxine offers clinically important ben- sion, this single study should not be viewed CONCLUSION: Further research within an efit over other antidepressants, particularly as evidence that CBT is ineffective overall. equal-access care system is needed to evalu- SSRIs. Overall, patients on venlafaxine had a ate other important factors such as specialty final Hamilton Depression Rating Scale score CLINICAL IMPLICATIONS: The similar outcomes of surgeon, extent of residual tumor after 1.2 points lower than patients on other anti- observed in the usual care and CBT group surgery, chemotherapy treatment, and post- depressants. While further investigation of conditions indicate that usual care was as operative management to determine whether these findings in diverse populations is war- effective as state of the art, research-tested these factors are contributing to the differ- ranted, venlafaxine could be considered in programs. However, both conditions re- ences in survival between African-American patients failing therapy with other antide- sulted in unsatisfactorily low recovery rates. and white ovarian cancer patients. pressants. — DS

14 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 permanente abstracts Abstracts of Articles Authored or Coauthored by Permanente Clinicians

From the Northwest: mendations based on these reviews for spe- CLINICAL IMPLICATIONS: Many clinicians be- Evaluating primary care behavioral cific behaviors. lieve that there is a close relationship be- counseling interventions: an Reprinted by permission of Elsevier Science from Evalu- tween serum ferritin levels and body iron evidence-based approach ating primary care behavioral counseling interventions: an evidence-based approach. American Journal of Pre- stores. While this relationship exists, and Whitlock EP, Orleans CT, Pender N, Allan J. ventive Medicine, Vol 22 No 4, 267-84. Copyright 2002 serum ferritin is the best predictor of total Am J Prev Med 2002 May;22(4):267-84 by American Journal of Preventive Medicine. body iron burden, the correlation is weak, Risky behaviors are a leading cause of pre- especially in patients with iron overload who ventable morbidity and mortality, yet be- From Southern California: have no HFE mutations (the gene implicated havioral counseling interventions to address Relationship of body iron in hereditary hemochromatosis). Other clini- them are underutilized in health care set- stores to levels of serum ferritin, cal measurements such as serum iron or tings. Research on such interventions has serum iron, unsaturated iron transferrin saturation have even less predic- grown steadily, but the systematic review binding capacity and transferrin tive value. There are no robust measurements of this research is complicated by wide saturation in patients with iron that accurately predict the size of increased variations in the organization, content, and storage disease body iron stores. Nonetheless, serum ferritin delivery of behavioral interventions and the Beutler E, Felitti V, Ho NJ, Gelbart T. Acta levels continue to be very useful in the di- lack of a consistent language and frame- Haematol 2002;107(3):145-9 agnosis of iron deficiency. — EB work to describe these differences. The None of the methods for assessing total Counseling and Behavioral Interventions body iron burden in patients with hemochro- Work Group of the United States Preven- matosis is satisfactory. Although it is com- From the Southeast tive Services Task Force (USPSTF) was con- monly believed that a relationship exists be- and Southern California: vened to address adapting existing USPSTF tween serum ferritin levels and total iron Exposure to abuse, neglect, and methods to issues and challenges raised by burden, the extent of this relationship has not household dysfunction among behavioral counseling intervention topical previously been documented. In the present adults who witnessed intimate reviews.The systematic review of behavioral investigation we measured the total body iron partner violence as children: counseling interventions seeks to establish burden of 88 patients with putative hemo- implications for health and whether such interventions addressing in- chromatosis, 54 of whom were homozygotes social services dividual behaviors improve health out- for the 845G—>A (C282Y) mutation. The to- Dube SR, Anda RF, Felitti VJ, Edwards VJ, comes. Few studies directly address this tal body iron stores were estimated from the Williamson DF. Violence Vict 2002 Feb;17(1):3-17 question, so evidence addressing whether volume of red cells removed during thera- Intimate partner violence (IPV) damages a changing individual behavior improves peutic phlebotomy corrected for an estimated woman’s physical and mental well-being, and health outcomes and whether behavioral 2 mg/day dietary iron absorbed during the indicates that her children are likely to expe- counseling interventions in clinical settings phlebotomy period; the amount of storage rience abuse, neglect and other traumatic help people change those behaviors must iron was compared to the serum ferritin, se- experiences. Adult HMO members completed be linked. To illustrate this process, we rum iron, unsaturated iron binding capacity, a questionnaire about adverse childhood ex- present two separate analytic frameworks and transferrin saturation before the begin- periences (ACEs) including childhood abuse, derived from screening topic tools that we ning of phlebotomy. The serum ferritin proved neglect, and household dysfunction. We used developed to guide USPSTF behavioral topic to be the best predictor of body iron stores. their responses to retrospectively assess the reviews. No simple empirically validated The correlation between all of the analytes relationship between witnessing intimate part- model captures the broad range of inter- and the body iron burden was greater in pa- ner violence and experiencing any of the nine vention components across risk behaviors, tients homozygous for the C282Y mutation ACEs and multiple ACEs (ACE score). Com- but the Five As construct—assess, advise, than in those who were not, including the pared to persons who grew up with no do- agree, assist, and arrange—adapted from to- compound heterozygotes for C282Y and mestic violence, the adjusted odds ratio for bacco cessation interventions in clinical care H63D. The body iron burden tended to be any individual ACE was approximately two provides a workable framework to report be- greater in patients homozygous for the C282Y to six times higher if IPV occurred (p < 0.05). havioral counseling intervention review find- mutation than the other patients at any other There was a powerful graded increase in the ings. We illustrate the use of this framework given ferritin level. We conclude that the se- prevalence of every category of ACE as the with general findings from recent behavioral rum ferritin level does provide some infor- frequency of witnessing IPV increased. In counseling intervention studies. Readers are mation regarding total iron burden but even addition, the total number of ACEs was in- referred to the USPSTF (www.ahrq.gov/clinic/ in the case of C282Y homozygotes, the cor- creased dramatically for persons who had prevenix.htm or 1-800-358-9295) for system- relation is not very strong. witnessed IPV during childhood. There was atic evidence reviews and USPSTF recom- Copyright 2002 S Karger AG, Basel a positive graded risk for self-reported alco-

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 15 permanente abstracts Abstracts of Articles Authored or Coauthored by Permanente Clinicians

holism, illicit drug use, iv drug use and de- alternative remedies for premenstrual symptoms. relative to whites. Use of herbal and nutri- pressed affect as the frequency of witnessing METHODS: A total of 1194 women, ages 21-45, tional supplements for premenstrual symp- IPV increased. Identification of victims of IPV selected from members of a large northern Cali- toms steadily increased from 10.8% in the must include screening of their children for fornia health maintenance organization, com- minimal group to 30.4% in the premenstrual abuse, neglect and other types of adverse pleted daily ratings of symptom severity for two dysphoric disorder group (p < .01). exposures, as well as recognition that sub- menstrual cycles. An empirically derived CONCLUSION: The degree of premenstrual stance abuse and depressed affect are likely algorithm defined symptom severity groups as symptom severity varies in the population, is consequences of witnessing IPV. Finally, this minimal (n = 186), moderate (n = 801), severe relatively constant within each woman over data strongly suggest that future studies, which (n = 151), or premenstrual dysphoric disorder two consecutive cycles, particularly for emo- focus on the effect of witnessing IPV on long- (n = 56). Symptom severity as a continuous tional symptoms, and is influenced by age, term health outcomes, may need to take into variable was defined by the two-cycle mean race/ethnicity, and health status. consideration the co-occurrence of multiple symptom ratings in the luteal phase. Demo- Reprinted with permission from the American College ACEs, which can also affect these outcomes. graphic, health status, and behavioral factors of Obstetricians and Gynecologists (Obstetrics and Gynecology 2002 Jun;99(6):1014-24). and use of treatments for premenstrual symp- From Northern California: toms were assessed by self-report. CLINICAL IMPLICATIONS: This study suggests that Severity of premenstrual RESULTS: Luteal phase symptom-specific rat- gynecologists should assess the degree of pre- symptoms in a health mainte- ings were generally significantly greater in menstrual symptom severity in their patients nance organization population the premenstrual dysphoric disorder group since a sizeable proportion of women suffer Sternfeld B, Swindle R, Chawla A, Long S, than in the other groups (p < .001). Symp- Kennedy S. Obstet Gynecol 2002 tom severity score increased with each from moderate to severe symptoms and are Jun;99(6):1014-24 comorbidity and decreased with each year at risk for overall poorer health and more comorbidity. Because symptom severity is rela- OBJECTIVE: To describe severity of emotional of age. Symptom severity was also inversely and physical symptoms in a large diverse associated with oral contraceptive use (emo- tively consistent from one cycle to the next, sample; to examine demographic, health sta- tional symptoms) and better perceived health providers may not need to use prospective tus, and behavioral correlates of symptom se- (physical symptoms). Hispanics reported symptom reporting over two menstrual cycles ❖ verity; and to describe use of medications and greater severity of symptoms, and Asians less, for accurate diagnosis. — BS

Learning Learning is holy, an indispensable form of purification as well as ennoblement. Rabbi Abraham Heschel, 1907-72, activist and Professor of Jewish Ethics and Mysticism

16 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 clinical contributions Immediate Hypersensitivity to Methylparaben Causing False-Positive Results of Local Anesthetic Skin Testing or Provocative Dose Testing

By Eric Macy, MD Michael Schatz, MD, MS Robert S Zeiger, MD, PhD Presented at the 58th annual meeting of the American Academy of Allergy, Introduction Asthma and Immunology, New York, NY, March 3, 2002, and published in Parabens are widely used as pre- abstract form in: J Allergy Clin Immunol 2002 Jan;109(1 Suppl):S149. servatives in cosmetics, foods, and drugs. Parabens have been exten- Abstract sively studied and are safe as cur- 1 Background: Parabens are widely used preservatives in food, cosmetics, rently used. They are commonly en- and drugs, including many amide-type local anesthetic (LA) agents. Al- countered as preservatives in though parabens have been associated with delayed contact sensitivity, multidose vials of amide local anes- immediate hypersensitivity reactions rarely result from parenteral expo- thetic (LA) agents. Parabens sure to parabens and even less commonly result from mucosal or cutane- noncovalently denature proteins through their phenol ous exposure. In addition, immediate hypersensitivity rarely results from Methylparaben, use of amide-based LA agents administered in pure form (ie, prepared with- moiety and haptinate proteins through their benzoic acid one of the most out preservatives). commonly used Objective: Analyze outcome data from LA skin testing (ST) and provoca- moiety. Rarely, patients can become immunologically sen- parabens, is a well- tive dose testing (PDT) administered during a 16-year period; and present documented cause the history in three initially LA ST-positive cases, one of which proved to sitized to parabens. Methylpa- raben, one of the most com- of T-cell-mediated be related to methylparaben. contact sensitivity. Methods: Results of all LA ST or PDT done in a large HMO allergy prac- monly used parabens, is a tice caring for 285,000 to 510,000 people in Southern California from well-documented cause of 2 August 13, 1985 through August 7, 2001 were reviewed. T-cell-mediated contact sensitivity. Results: Of 287 patients who had amide-type LA ST or PDT done initially, One case report documented a ur- 252 received the LA agent preserved with methylparaben. Three patients ticarial maculopapular rash which re- demonstrated a positive ST reaction to lidocaine preserved with meth- sulted 36 hours after ingestion of a ylparaben. All three had a negative ST or PDT reaction to pure LA agents. haloperidol solution containing me- 3 These agents included lidocaine. One patient, who had a history of imme- thylparaben. Methylparaben has diate hypersensitivity reaction when exposed orally to parabens in foods, only rarely been reported to cause had a positive reaction to subsequent ST with pure methylparaben. No immediate hypersensitivity, even af- 4-7 patient had a positive reaction to ST or PDT using amide-type LA agents. ter parenteral exposure. Most of the Conclusions: Local anesthetic ST or PDT is a safe procedure, and immedi- documented cases of immediate hy- ate hypersensitivity to pure amide LA agents is extremely rare. Methylparaben persensitivity to methylparaben have was the only established cause for an immediate hypersensitivity reaction dur- been verified by a positive skin test ing LA ST identified in a large allergy practice during the past 16 years. (ST) result, but positive passive transfer (Prausnitz-Kustner) test reactions

Eric Macy, MD, (top), works in the Department of Allergy in the San Diego Medical Center, as well as being a Partner Physician with the Southern California Permanente Medical Group, and an Assistant Clinical Professor of Medicine at the University of California, San Diego. E-mail: [email protected]. Michael Schatz, MD, MS, (left), has been at Kaiser for 25 years and is currently Chief of the Department of Allergy in San Diego. He is also Clinical Professor in the Department of Medicine, University of California San Diego School of Medicine and currently Vice-President of the American Academy of Allergy Asthma and Immunology. E-mail: [email protected]. Robert S Zeiger, MD, PhD, (right), served for 24 years as Chief of Allergy at the Kaiser Permanente Medical Center in San Diego and recently transitioned to Senior Physician Investigator and Director of Allergy Research. He also is Clinical Professor of Pediatrics at the University of California, San Diego. E-mail: [email protected].

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 17 clinical contributions Immediate Hypersensitivity to Methylparaben Causing False-Positive Results of Local Anesthetic Skin Testing or Provocative Dose Testing

Table 1. Reaction to local anesthetic preparations used for skin testing (ST) and for provocative dose testing (PDT) No. (%) of subjects No. of subjects No. of with adverse reaction with positive test subjects reported despite result Preparation tested negative PDT result ST PDT 1% or 2% lidocaine/0.1% methylparaben 232 19 (8.2) 3a 0 1% mepivacaine/0.1% methylparaben 18 3 (16.6) 0 0 1% bupivacaine/0.1% methylparaben 20 (0) 0 0 Totals for preparations containing methylparaben 252 22 (8.7) 3 (1.2) 0 (0) 1% or 2% lidocaine 22 1 (4.5) 0 0 4% prilocaine 60 (0) 0 0 2% mepivacaine 8 2 (25.0) 00 Totals for local anesthetic agents without preservatives 35 4 (8.6) 0 (0) 0 (0) aThese patients had dose testing using anesthetic preparations without preservatives and include two patients We reviewed with positive result of prick puncture and one patient with positive result of intradermal dose testing. the results of all LA agent PDT done … have also been reported.8 control was considered a positive test ond most commonly used material 85,000 to Reports are rare of well-documented result. If the PP test result was nega- containing methylparaben. A pure 1% 510,000 people positive ST or provocative dose test- tive, the histamine control positive, or 2% solution of lidocaine was the in Southern ing (PDT) results to amide LA agents and the saline control negative, then most commonly used LA agent that California from in patients evaluated for possible clini- an intradermal (ID) test using 0.04 did not contain methylparaben. Other August 7, 2001. cal reactions to LA agents. LA testing mL of a 1:100 dilution of the LA agent LA agents with and without preserva- is routinely done using multidose vi- was placed along with the saline and tives were selected for use on the ba- als of LA agents containing methylpa- 0.01%-histamine controls. These tests sis of the patient’s clinical history or raben as a preservative. Some reported were read at 20 minutes and, if nega- by request of the patient or referring (but poorly documented) positive ST tive, a single-blind placebo, 1-mL physician. Some patients had ST or or PDT reactions to amide LA may in subcutaneous injection of saline was PDT with more than one LA agent or fact be reactions to methylparaben and administered. If the placebo chal- with the same preparation more than not to LA agents. The present report lenge was negative after 20 minutes, once. Some of the additional tests used confirms that methylparaben is re- then a 1-mL subcutaneous injection to further characterize reactivity of the sponsible for at least some of the posi- of an undiluted LA agent was admin- three initially ST-positive patients were tive ST or PDT results in patients tested istered, and the patient was observed limited to puncture and intradermal with amide LA agents. for 20 minutes. ST. Epinephrine-containing materials The placebo or active-drug PDT were not used for any testing. Methods was considered positive if the pa- We reviewed the results of all LA tient had a positive wheal-and-flare Results agent ST and PDT done in a large reaction at the site of undiluted LA Of the 287 patients who had at HMO allergy practice providing all of administration, any acute-onset pru- least one LA ST or PDT, 253 patients the allergy consultative services for ritic rash distant from this site, 15% were exposed to lidocaine. Mean 285,000 to 510,000 people in South- decrease in blood pressure, wheez- age of patients at initial testing was ern California from August 13, 1985 ing, or 15% decrease in FEV1 of pul- 47.8 ± 19.1 years (range, 3.9 to 91.9 through August 7, 2001. This study monary function occurring during years). The cohort included 220 was reviewed and approved by the the 20-minute posttest observation (76.7%) women and 67 (23.3%) Southern California Kaiser Permanente period. Only objectively observed men. Of subjects tested, 252 (87.8%) Institutional Review Board. adverse reactions reported during were also exposed to 0.1% meth- ST with LA agents was done on the performance of the placebo or ylparaben. Table 1 lists the amide the forearm, and PDT was done on active-drug PDT were considered LA agents used for routine ST or the upper lateral arm. A negative positive challenges. PDT and the results of the tests. saline control, a positive 0.1%-his- A 1% or 2% solution of lidocaine Table 2 lists the 25 subjectively per- tamine control, and an initial undi- with 0.1% methylparaben was the ceived adverse reactions reported. luted LA prick puncture (PP) test were material most commonly used for ST Of these reported adverse reactions, placed and read at 20 minutes. A or PDT. A 1% solution of mepivacaine 22 (88%) occurred in women, and wheal 3 mm greater than the saline with 0.1% methylparaben was the sec- 3 (12%) occurred in men. Fourteen

18 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 clinical contributions Immediate Hypersensitivity to Methylparaben Causing False-Positive Results of Local Anesthetic Skin Testing or Provocative Dose Testing

Table 2. Subjectively reported adverse patients had ST or PDT more than visit, and plans were made to give reactions occurring during or after administration of provocative dose tests in 249 once. All patients who had LA ST the patient a skin test with the con- patients who had a negative reaction to local or PDT more than once had a nega- stituents of the implicated ice cream. anestheticagents containing methylparaben a tive result on all tests except as The patient failed to follow up with No. (%) noted in one of the three initially the rest of the evaluation. The pa- Adverse reaction of patients ST-positive patients. All three ini- tient next came to the clinic 51 Anxiety 3 tially ST-positive patients subse- months later with a new complaint Cough, sneeze, or both 2 quently tolerated PDT with pure of severe oral and facial swelling with Headache 2 lidocaine. No objective clinical signs the use of an over-the-counter topi- Itch, no rash 3 of adverse reaction—including pru- cal oral benzocaine preparation. This Lightheadedness 4 Pain at injection site(s) 2 ritic rash at the site of injection, dis- condition became more problematic Nausea 3 tant pruritic rash or urticaria, wheez- when, during the course of dental Sleepiness 2 ing, or hypotension—occurred in work, he was exposed to both topi- Delayed onset of adverse reaction 1 any patient during PDT. cal benzocaine and parenteral (>24 hours) maculopapular rash at Table 3 presents the additional im- lidocaine and had severe immediate- site(s) of methylparaben injection mediate hypersensitivity ST results onset oropharyngeal swelling but no Total 22 (8.8%) a Lightheadedness occurred in three (8.6%) of 35 patients who had for the three patients who initially shock or anaphylaxis. The dental a negative reaction to pure local anesthetic agents administered tested positive to lidocaine with me- work was postponed. The patient had in provocative dose tests. thylparaben. Clinical histories of managed his previous problems from these patients are presented. ice cream and other materials by allergic reaction to either penicillin avoidance. He now needed dental or lidocaine. Fifteen years previ- Case Reports work and needed to know what LA ously, the patient was treated with The patient in Case 1 was a 39- agent he could tolerate. The patient oral amoxicillin or penicillin for one year-old man initially seen in the had tolerated LA agents before 1994 week and with lidocaine spray for allergy department in 1994 with the without any problem. He had no his- a sore throat. Twenty minutes after chief complaint of adult-onset “food tory of hay fever, asthma, or any other receiving a dose of penicillin and allergy” to ice cream. He also had a drug or food allergy or intolerance. an unspecified time after lidocaine four-year history of immediate- He was not taking any medications. was sprayed into her mouth, pal- onset burning, itching, swelling, red- The patient had ST and PDT to a mar itching developed, and she ness, and pain after topical expo- panel of LA agents with and with- fainted. She was aroused with smell- sure to many shampoos and lotions. out preservatives. The patient reacted ing salts and was brought to the The cutaneous symptoms would to all products containing methylpa- emergency department. She had Of these start clearing within ten minutes if raben and not to any of the local cyanotic hands but no rash or res- reported he completely removed the offend- anesthetics without methylparaben, piratory difficulty. She received adverse ing materials from his skin. He had even if they had other nonparaben therapy but could not recall specific reactions, no clinical signs of delayed contact preservatives. The patient was not details of the allergic episode. Her 22 (88%) sensitivity and no fixed eruptions rechallenged with benzocaine (Table symptoms resolved within a couple occurred in or blistering rashes. The most prob- 3). He did not react to the other es- of hours. She had no history of al- women, and lematic food was a particular brand ter forms of local anesthetic: lergic rhinitis, asthma, or allergy to 3 (12%) of “pralines and cream” ice cream. procaine, cocaine, and tetracaine. food or insects, and her family his- occurred in Eating the ice cream caused imme- The patient was given specific in- tory did not include allergic disease. men. diate-onset oropharyngeal swelling, structions on how to identify prod- The patient was well and was not change in tone of his voice, and ucts containing methylparaben and taking medication. The patient was mild shortness of breath. He could obtained a Medic-Alert bracelet in- referred to the allergy department drink milk and eat the other protein- dicating his hypersensitivity to me- for assessment of possible allergy containing materials in the ice thylparaben. He was instructed to to lidocaine. Physical examination cream, such as eggs and nuts, with- avoid cutaneous or mucous mem- results were normal except for evi- out any problem. The patient had brane exposure to benzocaine. dence of pregnancy. The patient no history of physical or idiopathic The patient in Case 2 (initially seen was ST-positive to lidocaine with urticaria. Cold urticaria was ruled in 2000) was a 37-year-old, gravida methylparaben and was ST- and out by negative results of an ice 2, para 1 woman, four months preg- PDT-negative to pure lidocaine cube test administered at the initial nant, who had a history of possible (Table 4). We recommended that

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 19 clinical contributions Immediate Hypersensitivity to Methylparaben Causing False-Positive Results of Local Anesthetic Skin Testing or Provocative Dose Testing

the patient return postpartum for erythema on certain occasions, such methylparaben. She next returned 17 penicillin testing and for further as with heat. She had no history of weeks after the initial test and had testing with methylparaben, but she hay fever, asthma, or eczema. She was negative reactions to ST/PDT with moved from San Diego and did not being treated with verapamil, estro- lidocaine combined with methylpa- return for further evaluation. gen, and nortriptyline. Results of an raben—the same preparation to The patient in Case 3 was a 55- ELISA test to latex were negative. which she initially had a positive ST … the much year-old woman referred to the al- Intradermal ST using a 1:100 di- result (Table 3). more widely lergy clinic for evaluation of local an- lution of lidocaine with methylpa- used, amide esthetic allergy. Fourteen months raben initially produced a positive Discussion group, which before evaluation in the allergy de- reaction manifested by diffuse Depending on their chemical includes partment, the patient did not react to erythema of the arms and trunk with- structure, LA agents are grouped lidocaine, dental injection of lidocaine or to la- out pruritus or any other signs of a into two categories: the ester group, mepivacaine, tex glove exposure. Two months be- systemic IgE-mediated reaction. She which includes benzocaine, co- bupivacaine, fore evaluation in the allergy depart- returned 2-1/2 weeks later to have caine, procaine, chlorprocaine, and prilocaine, ment, similar lidocaine and latex the skin tests repeated, but nonpruritic tetracaine; and the much more etidocaine, and exposure was followed in the evening erythema from sitting in a warm room widely used, amide group, which ropivacaine. by an unusual sensation around her was already apparent, and the test was includes lidocaine, mepivacaine, lips, followed the next day by lip deferred. Four weeks after the initial bupivacaine, prilocaine, etidocaine, swelling. One week later, latex gloves test, the patient had a negative reac- and ropivacaine. The esters are de- and lidocaine were again used and tion to ST with pure prilocaine and rivatives of para-aminobenzoic acid were again followed the next day by with pure lidocaine. She had a nega- and share chemical features with onset of lip swelling. The patient tive reaction to PDT with pure parabens. No epinephrine was used needed further dental work. She had prilocaine. When the patient returned in the testing, because epinephrine a history of postpolio syndrome. She (ten weeks after the initial test), she can mask both vasodilatation and had also noticed nonpruritic skin had a negative reaction to ST with the vascular permeability associated with a positive, immediate-hypersensitivity ST result and may also Table 3. Results of tests (prick puncture, intradermal, and provocative dose tests) using local anesthetic agents, preservatives, or both in patients cause anxiety in some patients. who initially showed positive reaction to methylparaben (mm wheal/mm flare)a In 1984, one patient who appar- Agent Case 1 Case 2 Case 3 ently had an immediate hypersensi- 1% lidocaine/0.1% methylparaben 10/35b 5/20 b 0/0b tivity reaction after mucosal expo- 10/30 b 10/25c sure to methylparaben (delivered by b b 22/50 0/0 barium enema) reportedly had a 0/0 positive methylparaben ST result.9 1% mepivacaine/0.1% methylparaben 20/40 b test not done test not done Despite wide use of methylpara- 0.5% bupivacaine/0.1% methylparaben ben as a preservative in foods, bev- (ester) 15/35b test not done test not done erages, and drugs, no well-defined 1% procaine/0.09% metabisulfitee 0/0b test not done test not done case of immediate hypersensitivity to c 0/0 methylparaben has been reported for negative reactiond patients who had index exposure to 0.1% methylparaben 3/40 b test not done 0/0b 0/0c the preservative via the oral route. 0/0b One report10 described an attempt 0/0c to develop an in vitro test for IgE b 4% cocaine (ester) 0/0 test not done test not done directed against methylparaben, but b 1% tetracaine (ester) 0/0 test not done test not done no positive sera were identified by b 1% etidocaine 0/0 test not done test not done the test. To date, no positive in vitro 4% prilocaine 0/0 b test not done 0/0 b 0/0c test for methylparaben or for amide negative reactiond LA-specific IgE has been reported. 1% lidocaine 0/0b 0/0b 0/0b Little convincing information exists 0/0 c 0/0 c 0/0c that amide LA agents as a class can d d negative reaction negative reaction induce clinically significant IgE pro- a Read at 20 minutes; b prick puncture; c intradermal test positive; d provocative dose test positive; e Metabisulfite is an alternative to methylparaben. All local anesthetic agents are amide unless noted otherwise. duction in humans.

20 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 clinical contributions Immediate Hypersensitivity to Methylparaben Causing False-Positive Results of Local Anesthetic Skin Testing or Provocative Dose Testing

Practice Tips Frequency of adverse reactions at- thylparaben should be the initial ma- The cutaneous symptoms of a topical allergic tributed to LA agents and actually terial used for routine LA ST or PDT. reaction—immediate-onset burning, itching, caused by those agents has been re- Given the infrequency of positive test swelling, redness, and pain—would start clearing duced with widespread use of the results, we would recommend re- within ten minutes if the offending materials were completely removed from the skin. amide type of LA agents throughout peating any positive tests not asso- Cold urticaria can be ruled out by negative 11 the past 30 years. The patient de- ciated with clinically significant sys- results of an ice cube test. scribed in Case 1 had clinical symp- temic reactions. If the test result Epinephrine can mask both vasodilation and the toms of immediate hypersensitivity remains positive, ST or PDT should vascular permeability associated with a positive, after oral and cutaneous exposure both be done using pure lidocaine. The immediate hypersensitivity skin test result. to benzocaine and to methylparaben. person identified by this protocol as Reconfirm initially positive test results, because Fisher and coworkers12 presented having a rare positive reaction to me- transient dermographism may be missed by use of the saline control. data for 208 patients (referred dur- thylparaben can then actively avoid Methylparaben is the preservative most ing a 20-year period) who had a his- parabens and is unlikely to have a commonly used in multidose vials, raising tory of allergy to LA agents. Four of positive reaction to amide LA agents. awareness that methylparaben is a potential these patients had positive PDT test The present study confirms the cause for local reactions previously attributed results, and another four patients had rarity of positive ST or PDT results to the anesthetic agent itself. a delayed cutaneous reaction. Three from exposure to pure amide LA of these eight patients were subse- agents.11 Our experience suggests sensitivity. Report of a case. Oral quently given LA agents and toler- that any positive reaction to ST or Surg Oral Med Oral Pathol 1969 Sep;28(3):439-41. ated them well. The authors con- PDT using LA agents with meth- 6. Nagel JE, Fuscaldo JT, Fireman P. cluded that “a history of allergy to ylparaben is likely either to result Paraben allergy. JAMA 1977 Apr local anesthesia is unlikely to be from exposure to methylparaben or 11;237(15):1594-5. genuine and local anesthetic allergy to represent a false-positive result.12 7. Johnson WT, DeStigter T. Hypersen- is rare. In most instances it can be Data from the present report add sitivity to procaine, tetracaine, excluded from the history and the to the safety database of reactions mepivacaine, and methylparaben: report of a case. J Am Dent Assoc safety of local anesthetic verified by to amide LA agents. Because today 1983 Jan;106(1):53-6. 12:abstract progressive challenge.” Gall methylparaben is the preservative 8. Henry JC, Tschen EH, Becker LE. and coworkers13 described 177 pa- most commonly used in multidose Contact urticaria to parabens. Arch tients with a history of LA intoler- vials, the findings presented here Dermatol 1979 Oct;115(10):1231-2. ance and found five who initially had should raise awareness that meth- 9. Schwartz EE, Glick SN, Foggs MB, a positive reaction to preservatives. ylparaben is a potential cause for Silverstein GS. Hypersensitivity The present reactions after barium enema Of 164 patients tested, the authors local reactions previously attributed examination. AJR Am J Roentgenol study confirms identified two (1.2%) who had a to the anesthetic agent itself. ❖ 1984 Jul;143(1):103-4. the rarity of positive reaction to paraben PP 10. Kokubu M, Oda K, Shinya N. positive ST or and ST,13 virtually the same rate References Detection of serum IgE antibody PDT results identified in the present study. 1. American College of Toxicology. specific for local anesthetics and from exposure Of 252 patients, we identified Final report on the safety assessment methylparaben. Anesth Prog 1989 to pure amide of methylparaben, ethylparaben, Jul-Oct;36(4-5):186-7. only one (0.4%) who had a de- propylparaben, and butylparaben. J 11. Eggleston ST, Lush LW. Understand- LA agents. layed-onset rash at the PDT site of Am Coll Toxicol 1984;3:147-209. ing allergic reactions to local exposure to the lidocaine com- 2. Rietschel RL, Fowler JE Jr. Fisher’s anesthetics. Ann Pharmacother 1996 bined with methylparaben. This recontact dermatitis. 4th edition. Jul-Aug;30(7-8):851-7. sult was compatible with contact Baltimore: Williams and Wilkins; 12. Fisher MM, Bowey CJ. Alleged allergy 1995. p 265-8. sensitivity. This patient was told to to local anaesthetics. Anaesth 3. Kaminer Y, Apter A, Tyano S, Livni E, Intensive Care 1997 Dec;25(6):611-4. avoid methylparaben. Wijsenbeek H. Delayed hypersensi- 13. Gall H, Kaufmann R, Kalveram CM. This study documents the need to tivity reaction to orally administered Adverse reactions to local anesthetics: reconfirm initially positive test results, methylparaben. Clin Pharm 1982 analysis of 197 cases. J Allergy Clin because transient dermographism Sep-Oct;1(5):469-70. Immunol 1996 Apr;97(4):933-7. may be missed by use of the saline 4. Aldrete JA, Johnson DA. Allergy to 14. Schatz M. Skin testing and incremen- local anesthetics. JAMA 1969 Jan control. We now recommend updat- tal challenge in the evaluation of 13;207(2):356-7. adverse reactions to local anesthetics. ing the previous recommendations 5. Latronica RJ, Goldberg AF, J Allergy Clin Immunol 1984 from Schatz14 that lidocaine with me- Wightman JR. Local anesthetic Oct;74(4 Pt 2):606-16.

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 21 clinical contributions The Herbal Medicine Pharmacy Update

By Philip J Tuso, MD, FACP

Introduction Eisenberg5 reported that in the US data suggest that physicians should The continued use of herbal medi- general population, use of over-the- ask all patients, including high-risk cine in the United States and among counter herbal medicine increased patients such as the elderly, about members of Kaiser Permanente from 2.5% in 1990 to 12.1% in 1997, their use of herbal medicine. (KP) makes an updated review of and consultation with alternative this topic timely and important. medicine providers increased from Adverse Effects and Many pharmacies at KP facilities in 10.2% in 1990 to 15.1% in 1997. The Drug-Herb Interaction Southern California now carry tra- estimated total retail cost of herbal Patients taking prescription drugs ditional herbal preparations. These medicine in the United States is and therapeutic herbs may be at risk “dietary supplements” are about $4 to $5 billion per year8 and for adverse drug-herb interactions, over-the-counter therapy is primarily paid by the people seek- including interaction that alters Fifty–five that is not routinely ing herbal medicine treatment.5 bioavailability and efficacy of the percent of screened for drug interac- Little was known about prevalence prescription drugs.12 Drug interac- Alzheimer tion by the pharmacy team. of the use of alternative and herbal tion and adverse effects from herbal patient This article discusses medicine by older adults—the larg- medicines are more likely to occur caregivers herbal medicine with the in- est consumers of health care—until among patients who have chronic reported that terests of the physician in survey results were published by medical conditions, such as liver, they had tried mind by emphasizing the Foster in 2000.9 Thirty percent of the heart, or kidney disease. Older pa- at least one importance of understanding people surveyed who were aged 65 tients have more comorbid illnesses alternative the risks and benefits of years or more reported using alter- and may be more susceptible to therapy to herbal treatment. We use the native medicine, usually chiroprac- complications caused by herbal improve the skills taught to us by Eddy1-4 tic services and herbs. By extrapo- medicines.9,12,13 KP pharmacists rou- patient’s to determine if selected lation, about three million people tinely report potential drug interac- memory … herbal medicines pass the aged 65 or more used herbal tion and adverse affects to patients evidence-based-medicine therapy in 1997, and two million and physicians. However, herbal test. We discuss selected ex- used herbal therapy and prescrip- medicine is not routinely included amples of herbal medicine that have tion medication at the same time.9 in these reports, because this infor- the potential to harm patients. The Physicians are becoming aware of mation is not routinely programmed discussion is not intended to be a the potential benefit of some herbal into our computer data systems. complete review of all aspects of medicines and are using them to herbal remedies. treat conditions common in our eld- Tenuous Position erly population. Fifty–five percent of Herbal Medicines Use of Herbal Therapy of Alzheimer patient caregivers re- in Evidence-Based in the United States ported that they had tried at least Medicine Alternative forms of therapy are one alternative therapy to improve That we practice evidence-based defined as intervention neither taught the patient’s memory,10 and 29% of medicine means that we base our widely in US medical schools nor older patients with arthritis reported decisions on evidence of benefit. If widely available in US hospitals.5,6 A seeing an alternative medicine pro- a therapy has sufficient evidence of 1997 national survey showed that vider for their arthritis.11 However, benefit, we should recommend it to 42% of Americans used some form In 1997, Eisenberg reported that 57% our members; if insufficient evidence of alternative medicine,5,6 but that of those aged 65 years or more did of benefit exists or if evidence indi- figure may be higher for young, af- not disclose use of any alternative cates that the therapy will harm pa- fluent, educated populations.7 medicine to their physician.6 These tients, we should not recommend the

Philip J Tuso, MD, FACP, has been with the Southern California Medical Group since 1993. In 2001, he was appointed Physician Director for the Kaiser Permanente Fresenius Medical Care Unit in Lancaster, California. E-mail: [email protected].

22 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 clinical contributions The Herbal Medicine Pharmacy Update

Table 1. Herbal medicine forms that have studies supporting treatment. Our goals as physicians help determine whether their use as evidence-based medicine are to provide treatment that makes or not selected catego- Herb Condition treated Reference our patients better and to protect our ries of herbal medicine Ginkgo (Ginkgo biloba) Dementia 20 patients from treatment that may constitute evidence- Intermittent claudication 21 cause harm. In addition, we do not based therapy. Horse chestnut seed extract Chronic venous insufficiency 22 want to waste members’ money. Tables 1 and 2 show Kava (Piper methysticum)Anxiety 23 Because herbal products in the the results of RCTs, St John’s wort Depression 24 (Hypericum perforatum) United States are not approved by the meta-analyses of RCTs, US Food and Drug Administration and case reports for a va- Table 2. Herbal medicine forms that do not have studies (FDA) as drugs used to help treat dis- riety of herbal medi- supporting their use as evidence-based medicine eases, these products do not undergo cines. For a more com- Herb Condition treated Reference premarketing safety and efficacy stud- plete review of this Asian ginseng (Panax ginseng)Decreased mental 27 ies and are not manufactured in a stan- topic, please see the performance Evening primrose Premenstrual syndrome 28 dard way. Herbal medicines are de- Ernst and Pittler article (Oenothera biennis) 15 fined by the Dietary Health and titled “Herbal Medicine.” Feverfew (Tanacetum Prevent migraine 29 Education Act of 1994 as dietary Table 1 lists herbal medi- parthenium) 30 supplements,14 and they are presumed cine that passes the evi- Garlic (Allium sativum)High blood cholesterol 31 safe until new information shows oth- dence-based-medicine levels erwise. Companies manufacturing test. Systematic reviews Ginkgo (Ginkgo biloba) Tinnitus 32 herbal medicine can make structure and meta-analyses of Valerian (Valeriana officinalis) Insomnia 33 and function claims without support RCTs show that some of scientific research, although the herbs may be efficacious for treating scribed in RCTs, meta-analyses of claims must be truthful and not mis- symptoms of certain diseases, such RCTs, and case reports. These herbs leading. Because herbs cannot be pat- as ginkgo for dementia20 and inter- should not be used or should be ented, no incentive exists for pharma- mittent claudication,21 horse chestnut used only with extreme caution. For ceutical companies to invest in extract for chronic venous insuffi- instance, licorice has mineralocor- research. The FDA would have to ciency,22 kava for anxiety,23 and St ticoid properties and has been re- prove that an herb was harmful be- John’s wort for depression.24 How- ported to cause hypokalemia in fore taking it off the market; however, ever, before starting these forms of some patients.44 Hepatitis has been the FDA has no authority to test herbs. herbal medicine, consumers and reported in patients taking comfrey, From a quality control perspective, their physicians should review the chaparral, or celandine and many are concerned about reported consumer report on the herb posted should not be used by patients … these products 25 observations that herbal prepara- on the Internet at consumerlab.com with liver disease or who are do not undergo tions are contaminated with pesti- and other resources for information. taking medication that may af- premarketing 15 16 36,37 cides, heavy metals, microorgan- For example, a recent study pub- fect liver function. safety and 17 isms, and conventional medication lished in the Journal of the Ameri- Other herbal medicine forms, efficacy studies (acetaminophen, hydrochlorothiaz- can Medical Association (JAMA) sug- such as ginger, ginseng, fever- and are not ide, indomethacin, phenobarbital, gests that St John’s wort may lack few, devil’s claw, and donq manufactured in 18 theophylline, and corticosteroids). efficacy for treatment of moderately quai, can interact with warfarin a standard way. This is just one of the reasons that severe depression.26 sodium and may affect plate- pregnant women should not use Table 2 lists herbal medicine forms let function and bleeding herbal medicines. In addition, many that are not supported by RCTs, sys- times. This type of herbal medica- herbal products do not contain what tematic reviews, or meta-analyses of tion should not be taken by patients is written on the label. RCTs as efficacious treatment for already taking anticoagulant medi- The reference standard for testing certain diseases. These medications cation such as aspirin, warfarin so- efficacy of any therapy is the ran- should not be part of our treatment dium, or nonsteroidal anti-inflam- domized clinical trial (RCT). Since regimens. matory agents. Patients scheduled The Permanente Journal last pub- to receive any procedure that may lished a review of herbal medicine,19 Herbs That May cause bleeding should be asked if more RCTs and meta-analyses of Harm Patients they are taking herbal medicine and RCTs on herbal medicine have been Table 3 lists types of herbal medi- should be instructed to stop taking published. We used these data to cine that may be harmful as de- herbs which have anticoagulant

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 23 clinical contributions The Herbal Medicine Pharmacy Update

properties for two weeks before taking Chinese herbs, urinary tract any herbal medicine to patients. receiving the procedure.38-43 carcinomas have developed.50-53 To keep the FDA apprised of the Several recent publications report real risks of using herbs, physicians on renal failure caused by Chinese St John’s Wort and Acute can report adverse effects of any herbal herbs.44-53 Other recent reports indi- Organ Transplant Rejection medicine to FDA MedWatch on the cate that taking St John’s wort can St John’s wort (Hypericum Internet at www.fda.gov/medwatch.14 result in lower cyclosporin levels, perforatum), an herb extract, is an which have been associated with over-the-counter remedy for treating Conclusions transplant rejection.54-59 Both of these depression.54,55 Moschella56 published This article describes selected findings are explained in more de- a case study describing a renal transforms of herbal medication that have tail in the following sections. plant recipient who self-prescribed some evidence that they help to St John’s wort, an action treat certain disease conditions, Table 3. Herbal medicine forms that may harm patients34 which resulted in marked re- some herbs that have no evidence duction in cyclosporin levels. of benefit, and some herbs that are Adverse effect Herb Renal failure Chinese herbs (Aristolochia sp) Acute transplant rejection af- known to cause harm. Most of these Transplant rejection St John’s wort (Hypericum perforatum) ter ingestion of St John’s wort conditions can also be treated with 57 Heart failure Aconite (Aconitum napellus) has been described in heart, conventional medication. Hypertension Ephedra sp kidney,58 and liver59 transplant As a result of the Dietary Supple- Hypertension and Licorice (Glycyrrhiza glabra) recipients. Transplant rejection ment Health and Education Act of hypokalemia35 episodes did not recur when 1994,14 manufacturing of herbal ex- Hyperthyroidism Kelp (Fucus pyriferus) patients stopped taking St tracts is not submitted to the type Hepatitis36,37 Comfrey (Symphytum officinale), Chaparral (Larrea tridentata), John’s wort. of quality control used for manu- Celandine (Chelidonium majus) facturing conventional medication; Bleeding disorders38-43 Ginger (Zingiber officinalis), gingko (Ginkgo Herb Information nor is premarketing safety and effi- biloba), ginseng (Panax ginseng), feverfew Resources cacy research required. Not all (Tanacetum parthenium), devil’s claw (Harpagophytum procumbens), dong quai ConsumerLab.com, LLC herbal preparations are safe, not all (Angelica sinensis) (www.consumerlab.com) herbal products are standardized to Seizures Evening primrose oil (Oenothera biennis) provides independent test re- particular levels of the active ingre- sults to help consumers and dient, and herbal products may con- For a more complete list of herbs health care providers evaluate nu- tain contaminants such as pesticides that may have serious adverse effects, trition products.25 This resource and heavy metals. please refer to the complete German should be reviewed by physicians Commission E Monographs, Thera- as well as by consumers, although peutic Guide to Herbal Medicines (En- the Web site may not be free and ConsumerLab.com, LLC glish translation) published in 1998.34 may require subscription for some (www.consumerlab.com) users. For example, a search of the provides independent Chinese Herbs Nephropathy ConsumerLab.com Web site in prepa- test results to help Chinese herbs nephropathy is ration for this article yielded a report consumers and health characterized by rapidly progressive on ginseng19 which showed that of care providers evaluate fibrosing interstitial nephritis without the 21 ginseng products tested, seven nutrition products. glomerular lesions.44,45 Patients in contained less than the acceptable whom this disease develops are seen amounts of ginsenocide (active ingre- Because of the possibility of adverse initially for subacute renal failure that dient for ginseng), two had levels of effects from herbal medication and progresses rapidly to end-stage re- pesticides 20 times more than allowed of drug-herb interaction, physicians nal disease, even though the patient levels, and two contained more than need to obtain a detailed history about stops taking the herbs immediately the acceptable level of lead. the use of over-the-counter medica- upon diagnosis; ultimately, the pa- Physicians need to be aware of tion in all patients. Herbs should not tient requires dialysis and a renal potential risks of using herbal be used by pregnant women and may transplant.46,47 Aristolochic acid con- medicine and are encouraged to be harmful to high-risk groups, par- tained in these Chinese herbal prepa- visit www.consumerlab.com and ticularly the elderly. Herbal medica- rations is suspected to be the neph- review the information on herbal tion can cause severe adverse effects, rotoxic agent.48,49 In other patients products before recommending such as bleeding complications,

24 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 clinical contributions The Herbal Medicine Pharmacy Update

Practice Tips nephropathy, and transplant rejec- et al. Trends in alternative medicine use in the United States, 1990-97: Manufacturing of herb extracts is not submitted tion. The use of most herbal medi- to the type of quality control used for results of a follow-up national cine is not evidence-based, and the manufacturing conventional medication; nor is survey. JAMA 1998 Nov premarketing safety and efficacy research risk clearly outweighs the benefit. 11;280(18):1569-75. Consumers and clinicians need to required. 6. Eisenberg DM. Advising patients Not all herbal preparations are safe. become familiar with the potential who seek alternative medical Not all herbal products are standardized to risk and benefit of herbal medica- therapies. Ann Intern Med 1997 Jul particular levels of the active ingredient. tion,60 and one good information 1;127(1):61-9. Herbal products may contain contaminants such 7. Delbanco T. A piece of my mind. resource is on the Internet at as pesticides and heavy metals. Leeches, spiders, and astrology: www.consumerlab.com.25 As health Obtain a detailed history about the use of over- predilections and predictions. JAMA the-counter medication in all patients. care providers, we should be lead- 1998 Nov 11;280(18):1560-2. Herbs should not be used by pregnant women. ers in asking our patients about 8. Brevoort P. The booming US herbal medicine use and counseling botanical market: a new overview. patients about any interaction herbal HerbalGram 1998;48:33-40. Pharmacol 1997 Apr;37(4):344-50. 9. Foster DF, Phillips RS, Hamel MB, medicine may have with prescribed 19. Tuso PJ. The herbal medicine Eisenberg DM. Alternative medicine pharmacy: what Kaiser Permanente 61 medication. In addition, physicians use in older Americans. J Am Geriatr providers need to know. Perm J 1999 are encouraged to report adverse Soc 2000 Dec;48(12):1560-5. Winter;3(1):33-5. reactions to herbal medicine to the 10. Coleman LM, Fowler LL, Williams 20. Ernst E, Pittler MH. Ginkgo biloba FDA MedWatch on the Internet at ME. Use of unproven therapies by for dementia: a systematic review of www.fda.gov/medwatch.14 people with Alzheimer’s disease. double-blind, placebo-controlled J Am Geriatr Soc 1995 trials. Clin Drug Invest Sponsoring legislation should be Jul;43(7):747-50. 1999;17(4):301-8. considered in order to require that 11. Kaboli PJ, Doebbeling BN, Saag KG, 21. Pittler MH, Ernst E. Ginkgo biloba herbal medicine be subjected to the Rosenthal GE. Use of complemen- extract for the treatment of same stringent premarketing scrutiny tary and alternative medicine by intermittent claudication: a meta- and controls as conventional drugs. older patients with arthritis: a analysis of randomized trials. Am J population-based study. Arthritis Pharmacist should be aware of herb- Med 2000 Mar;108(4):276-81. Rheum 2001 Aug;45(4):398-403. 22. Pittler MH, Ernst E. Horse-chestnut drug interaction, and our pharmacy 12. Ernst E. Harmless herbs? A review of seed extract for chronic venous and clinical information systems the recent literature. Am J Med 1998 insufficiency. A criteria-based should be programmed to include Feb;104(2):170-8. systematic review. Arch Dermatol information about herbal medicine 13. Gurwitz JH, Avorn J. The ambiguous 1998 Nov;134(11):1356-60. and interaction profile screening. ❖ relation between aging and adverse 23. Pittler MH, Ernst E. Efficacy of kava drug reactions. Ann Intern Med 1991 extract for treating anxiety: Jun 1;114(11):956-66. systematic review and meta-analysis. References 14. United States. Food and Drug J Clin Psychopharmacol 2000 1. Eddy D. Embedding Permanente Administration. Dietary Supplement Feb;20(1):84-9. medicine into the clinical Health and Education Act of 1994, 24. Williams JW Jr, Mulrow CD, information system. National Public Law No. 103-417. Available Chiquette E, Noel PH, Aguilar C, Clinical Content Network, Evidence- at: www.fda.gov/opacom/laws/ Cornell J. A systematic review of based Medicine, March 2001. dshea.html (Accessed October 10, newer pharmacotherapies for Available from: http://pkc.kp.org/ 2002). depression in adults: evidence report national/ikmr/nccn/powerpoint/ 15. Ernst E, Pittler MH. Herbal medicine. summary. Ann Intern Med 2000 May NCCN%20Evidence- Med Clin North Am 2002 2;132(9):743-56. based%20Med%2003_01.ppt. Jan;86(1):149-61. 25. ConsumerLab.com. 2. Eddy DM. Clinical policies and the 16. Cheng TJ, Wong RH, Lin YP, Hwang [Web site] Available from: quality of clinical practice. N Engl J YH, Horng JJ, Wang JD. Chinese www.consumerlab.com. Med 1982 Aug 5;307(6):343-7. herbal medicine, sibship, and blood 26. Effect of Hypericum perforatum (St 3. Eddy DM. Clinical decision making: lead in children. Occup Environ John’s wort) in major depressive from theory to practice. Anatomy of Med 1998 Aug;55(8):573-6. disorder: a randomized controlled a decision. JAMA 1990 Jan 17. Halt M. Moulds and mycotoxins in trial. JAMA 2002 Apr 19;263(3):441-3. herb tea and medicinal plants. Eur J 10;287(14):1807-14. 4. Eddy DM. Clinical decision making: Epidemiol 1998 Apr;14(3):269-74. 27. Vogler BK, Pittler MH, Ernst E. The from theory to practice: a collection 18. Huang WF, Wen KC, Hsiao ML. efficacy of ginseng. A systematic of essays from JAMA. Boston: Jones Adulteration by synthetic therapeutic review of randomised clinical trials. and Bartlett Publishers; 1996. substances of traditional Chinese Eur J Clin Pharmacol 1999 5. Eisenberg DM, David RB, Ettner SL, medicines in Taiwan. J Clin Oct;55(8):567-75.

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 25 clinical contributions The Herbal Medicine Pharmacy Update

28. Budeiri D, Li Wan Po A, Dornan JC. Quarry Press; 1999. 51. Nortier J, Simon J, Petein M, et al. Is evening primrose oil of value in 40. Bordia A, Verma SK, Srivastava KC. Chinese herbs nephropathy and the treatment of premenstrual Effect of ginger (Zingiber officinale urinary tract carcinoma [abstract]. syndrome? Control Clin Trials 1996 Rosc.) and fenugreek (Trigonella J Am Soc Nephrol 1998 Sep;9 Spec Feb;17(1):60-8. foenumgraecum L.) on blood lipids, No:164A. 29. Pittler MH, Vogler BK, Ernst E. blood sugar and platelet aggregation 52. Nortier JL, Martinez MC, Schmeiser As health care Feverfew for preventing migraine. in patients with coronary artery HH, et al. Urothelial carcinoma Cochrane Database Syst Rev disease. Prostaglandins Leukot associated with the use of a Chinese providers, we 2000;(3):CD002286. Essent Fatty Acids 1997 herb (Aristolochia fangchi). N Engl J should be 30. Vogler BK, Pittler MH, Ernst E. May;56(5):379-84. Med 2000 Jun 8;342(23):1686-92. leaders in Feverfew as a preventive treatment 41. Fetrow CW, Avila JR. Professional’s 53. Cosyns JP, Jadoul M, Squifflet JP, asking our for migraine: a systematic review. handbook of complementary & Wese FX, Van Ypersele de Strihou C. patients about Cephalalgia 1998 Dec;18(10):704-8. alternative medicines. Springhouse Urothelial lesions in Chinese-herb (PA): Springhouse Corporation; 1999. nephropathy. Am J Kidney Dis 1999 herbal 31. Stevinson C, Ernst E. Valerian for insomnia: a systematic review of 42. Page RL 2nd, Lawrence JD. Jun;33(6):1011-7. medicine use randomized clinical trials. Sleep Potentiation of warfarin by dong 54. Bisset NG: Hyperici herba (St John’s and counseling Med 2000 Apr 1;1(2):91-9. quai. Pharmacotherapy 1999 wort). In: Bisset NG (translator): patients about 32. Ernst E, Stevinson C. Ginkgo biloba July;19(7):870-6. Herbal drugs and any interaction for tinnitus: a review. Clin 43. Heck AM, DeWitt BA, Lukes AL. phytopharmaceuticals. 2nd ed. herbal Otolaryngol 1999 Jun;24(3):164-7. Potential interactions between Stuttgart: Medpharm Scientific alternative therapies and warfarin. GmbH Publishers. 1994, p 273-5. medicine may 33. Stevinson C, Pittler MH, Ernst E. Garlic for treating hypercholester- Am J Health Syst Pharm 2000 Jul 55. Kessler RC, McGonagle KA, Zhao S, have with olemia. A meta-analysis of 1;57(13):1221-7; quiz 1228-30. et al. Lifetime and 12-month prescribed randomized clinical trials. Ann Intern 44. Vanherweghem JL, Depierreux M, prevalence of DSM-III-R psychiatric medication. Med 2000 Sep 19;133(6):420-9. Tielemans C, et al. Rapidly disorders in the United States. 34. Blumenthal M, Busse WR, Goldberg progressive interstitial renal fibrosis Results from the National A, et al, editors. Klein S, Rister RS, in young women: association with Comorbidity Survey. Arch Gen translators. The complete German slimming regimen including Chinese Psychiatry 1994 Jan;51(1):8-19. Commission E monographs: herbs. Lancet 1993 Feb 56. Moschella C, Jaber BL. Interaction therapeutic guide to herbal 13;341(8842):387-91. between cyclosporine and medicines: developed by a special 45. Depierreux M, Van Damme B, Hypericum perforatum (St John’s expert committee of the German Vanden Houte K, Vanherweghem JL. wort) after organ transplantation. Am Federal Institute for Drugs and Pathologic aspects of a newly J Kidney Dis 2001 Nov;38(5):1105-7. Medical Devices. Austin (TX): described nephropathy related to the 57. Ruschitzka F, Meier PJ, Turina M, American Botanical Council; prolonged use of Chinese herbs. Am Luscher TF, Noll G. Acute heart Boston: Integrative Medicine J Kidney Dis 1994 Aug;24(2):172-80. transplant rejection due to St John’s Communications; 1998. 46. Yang CS, Lin CH, Chang SH, Hsu wort [letter]. Lancet 2000 Feb 35. Cumming AM, Boddy K, Brown JJ, HC. Rapidly progressive fibrosing 12;355(9203):548-9. et al. Severe hypokalaemia with interstitial nephritis associated with 58. Breidenbach T, Hoffmann MW, paralysis induced by small doses of Chinese herbal drugs. Am J Kidney Becker T, Schlitt H, Klempnauer J. liquorice. Postgrad Med J 1980 Dis 2000 Feb;35(2):313-8. Drug interaction of St John’s wort Jul;56(657):526-9. 47. Vanherweghem JL. Nephropathy and with cyclosporin [letter]. Lancet 36. Ernst E. Interactions between herbal medicine. Am J Kidney Dis 2000 May 27;355(9218):1912. synthetic and herbal medicinal 2000 Feb;35(2):330-2. 59. Breidenbach T, Kliem V, Burg M, products: Part 2. A systematic review 48. Vanhaelen M, Vanhaelen-Fastre R, Radermacher J, Hoffmann MW, of the direct evidence. Perfusion But P, Vanherweghem JL. Identifica- Klempnauer J. Profound drop of (Munich, Germany) 2000;13:60-70. tion of aristolochic acid in Chinese cyclosporin A whole blood trough 37. Ernst E. Possible interactions herbs. Lancet 1994 Jan levels caused by St John’s wort between synthetic and herbal 15;343(8890):174. (Hypericum perforatum) [letter]. medicinal products: Part 1. A 49. Schmeiser HH, Bieler CA, Wiessler Transplantation 2000 May systematic review of the indirect M, Van Ypersele de Strihou C, 27;69(10):2229-30. evidence. Perfusion (Munich, Cosyns JP. Detection of DNA 60. Angell M, Kassirer JP. Alternative Germany) 2000;13:4-15. adducts formed by aristolochic acid medicine—the risks of untested and 38. Argento A, Tiraferri E, Marzaloni M. in renal tissue from patients with unregulated remedies. N Engl J Med [Oral anticoagulants and medicinal Chinese herbs nephropathy. Cancer 1998 Sep 17;339(12):839-41. plants. An emerging interaction.] Res 1996 May 1;56(9):2025-8. 61. Bauer BA. Herbal therapy: what a [Article in Italian]. Ann Ital Med Int 50. Vanherweghem JL, Tielemans C, clinician needs to know to counsel 2000 Apr-Jun;15(2):139-43. Simon J, Depierreux M. Chinese patients effectively. Mayo Clinc Proc 39. Boon HS, Smith M. The botanical herbs nephropathy and renal pelvic 2000 Aug;75(8):835-41. pharmacy: the pharmacology of 47 carcinoma. Nephrol Dial Transplant common herbs. Kingston (Ont.): 1995;10(2):270-3.

26 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 clinical contributions The 79-Year Illness

By David Clarke, MD

Abstract time, her stomach first began Physical symptoms caused by psychosocial stress are responsible for most primary care office visits. bothering her. The pains per- Stress capable of producing illness may be in the patient’s life at the moment or may result from past sisted during high school and trauma, depression, or childhood stress. Here is one patient’s story. For more information about stress- college, where she supported related illness, please log on to www.stressillness.com. herself by caring for children. Her career choice: pediatric nursing. She married and had sev- Emma was the sort of patient Was there a source of stress cal resources in rural areas in 1918 eral children of her own. She who drove her doctors to de- in her life? “Since my husband were not abundant. By the time raised them, with great care, to spair. She had been suffering died, I get lonely at times,” she appendicitis was diagnosed, it adulthood. Through all these from bowel problems for nearly replied when asked. But he was too late—the child died. years, her symptoms persisted. eight decades. Just looking at had passed away more than ten Emma went into shock. The She stopped talking and looked her massive medical record was years before. For the most part, emotional self-expression usual again at the landscape painting. discouraging. her days now were pleasant for a young girl temporarily shut After awhile, she turned back. She was 87 years old with and productive. She wasn’t de- down. At the funeral service, an “You know, you’re the first doc- loosely curled, pearl-white hair. pressed or anxious. uncle made a remark that re- tor that ever asked me about my She answered questions thought- Her symptoms had begun mained with her the rest of her sister,” she said. “What do you fully and in great detail. Her eyes when she was a child. Had she life. He pointed out think I should do?” searched your face to see if you experienced any difficulties that she was the only I recommended had the solution to her abdomi- during that time in her life? She person in the church No diagnostic that she visit an el- nal cramps and alternating diar- had grown up on a farm in a who wasn’t crying. test had ever ementary school at rhea and constipation. These valley in the Rocky Mountains. His tone implied that revealed an recess so that she symptoms were not severe, and Her parents loved each other she must not care abnormality. could see the chil- sometimes they even went and their five children. There about her sister’s No treatment dren on the play- away—but never for more than a was no abuse, no alcoholism, death. Her guilt, al- had ever ground. She was week or two. No diagnostic test and no pressure. In many ways, ready intense, went worked for then to pick out a had ever revealed an abnormal- it was a storybook place. Emma off the scale. While very long. girl who reminded ity. No treatment had ever worked was the oldest daughter. When she related this story, her of herself at age for very long. she was six years old, a sister her eyes watered. eight. Emma was All appropriate studies had been was born. With the large num- Her rapidly flowing speech then to ask herself what such a done at least once: lower-GI ber of other children and the slowed to a trickle, and her lively girl could do to save a two-year- series, sigmoidoscopy, upper-GI work of the farm, the mother face softened. She looked away old with a ruptured appendix in series, small-bowel series, ultra- relied on Emma to care for the from me toward the landscape the days before antibiotics. Once sound, CAT scan of the abdomen, baby. Emma took to this task painting on the exam room wall. she had done that, I suggested colonoscopy, gastroduodenoscopy as she would to a favorite doll. Not surprisingly, her sister’s that she return home and write and numerous blood tests. Her She held, fed, dressed, changed, death affected her entire life. a letter to her infant sister, ask- chart also showed a number of played with, sang to, and slept Within two months, she began ing forgiveness. She thanked me different trials of medication: with her sister. They were in- caring for a newborn on a neigh- quietly and has not been to a phy- antispasmodic agents, antide- separable. boring farm. Sometimes, though, sician about her illness since. ❖ pressants, and one prescription for Two and a half years later fe- she couldn’t make the walk to the a tranquilizer. ver developed in the infant. Medi- neighbors because during that

David Clarke, MD, graduated from the University of Connecticut School of Medicine in 1979. His postgraduate training was at Harbor/UCLA Medical Center. He has practiced gastroenterology for Northwest Permanente, PC, since 1984. E-mail: [email protected].

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 27 clinical contributions Jimson Weed Poisoning—A Case Report

By Kit Chan, MD

white flowers in his room and nied any drug use but stated that his Abstract brought them to the ED. friends had given him a blended drink Jimson weed, a plant best known among adolescents and In the ED, the patient was restless, consisting of strawberries, a wild young adults for its hallucinogenic properties, grows as a pacing incessantly, and shaking. He plant, and a small amount of alcohol. wild herb in the United States. Ingestion of jimson weed was awake, alert, and oriented to name In the ED, the patient received sev- produces the toxidrome of anticholinergic intoxication. Un- but not to place or time. Vital signs eral doses of lorazepam intravenously derstanding and recognizing the classic signs and symptoms included oral temperature 99.3oF as treatment for agitation. He was of anticholinergic intoxication can help clinicians evaluate (37.4oC), blood pressure 117/72 admitted to the hospital for observa- persons presenting with jimson weed poisoning. mmHg, heart rate 103 beats/min, and tion and for monitoring. The patient respiratory rate 24 breaths/min. Pu- remained stable, and his mental sta- Introduction pils were dilated to 8 mm, symmet- tus improved. At a subsequent inter- Ingestion of jimson weed (Datura ric, and minimally reactive to light. view, the patient admitted that he and stramonium) is fairly common and Mucous membranes were dry, and his friends had consumed jimson can lead to intoxication and to anti- bowel sounds were decreased. The weed deliberately: They had tried it cholinergic manifestations that are extremities were warm to the touch for the first time after hearing that it potentially dangerous.1 The plant is but were not hot. Neurologic exami- was hallucinogenic. After 36 hours of a wild herb that grows throughout nation showed that the patient was observation, the patient was dis- the United States, usually matures confused and mumbling, cranial charged from the hospital. between May and September, is ac- nerves were intact, and both motor cessible to almost anyone, and is strength and reflexes were within nor- Discussion particularly popular among adoles- mal limits. During the examination, the Jimson weed is a member of the cents curious about the plant’s hal- patient reached into the air as if trying nightshade family. An earlier name lucinogenic effects. Understanding to catch a nonexistent object. for the plant was Jamestown weed, the signs and symptoms of jimson Results of an emergent fingerstick coined after intoxication from the weed toxicity can lead to early diag- blood glucose test, complete blood plant was first recorded in Jamestown, nosis and proper case management. count, chemistry panel, and urinalysis Virginia, in 1676; the name was sub- Anticipatory counseling for teenag- were normal. Results of a toxicology sequently shortened to jimsonweed ers and parents may also prevent ex- screen were negative for alcohol, ben- .2 The same plant is known also as perimentation and resultant harm. zodiazepines, amphetamines, mari- thorn apple, angel’s trumpet, stink- juana, tricyclic antidepressant agents, weed, and green dragon.1,2 The plant Case Report opiate agents, and phencyclidine. An has been used for centuries to treat The mother of a 15-year-old boy electrocardiogram showed sinus tachy- asthma, diarrhea, intestinal cramps, brought him to the emergency de- cardia without other abnormality. Cra- and nocturia because of its anticho- partment (ED) because of his bizarre nial structures appeared normal on linergic effects, and its hallucinogenic behavior, including hallucinating. computed tomography scans admin- effects were mentioned in Homer’s The mother had been advised by a istered without contrast medium. tale, The Odyssey.3,4 neighbor that several neighborhood On the basis of both the clinical Jimson weed reaches a height of youths had been taken to nearby presentation and a history of ingest- five feet and consists of large, hospitals after ingesting wild flowing a wild plant, the ED physician jagged leaves and trumpet-shaped ers and then hallucinating. The suspected jimson weed intoxication, flowers, that may be white or purple. patient’s mother had entered the which was confirmed by comparing At maturity, the plant bears green patient’s room and found him shak- the mother’s plant specimen with a fruit, each containing four compart- ing, mumbling, and trying to pick at picture of jimson weed (obtained ments and holding as many as 100 nonexistent items. She noted several from the Internet). The patient de- seeds.1,5 Although all parts of the plant

Kit Chan, MD, is currently a third-year resident in the Family Medicine residency at Kaiser Permanente, Fontana in Southern California. He grew up in California and graduated from the UCLA Medical School in 2000. E-mail: [email protected].

28 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 clinical contributions Jimson Weed Poisoning—A Case Report

are poisonous, the leaves and seeds breathing, and circulation. Although be induced by using syrup of ipecac contain the highest concentration of rare, some patients with jimson weed if the patient is awake and relatively atropine, hyoscyamine, and scopola- intoxication may be seen for epi- alert. The usual dose of ipecac is 30 mine.6 One hundred seeds contain sodes of seizure or coma. If com- mL for adults and 15 mL for children.3,5 approximately 6 mg of atropine.2,5 A promise of the airway is suspected, After initial assessment and attempts dose of atropine exceeding 10 mg is prompt intubation and mechanical to eliminate the toxin from the gas- regarded as potentially lethal.2 ventilation are indicated. trointestinal tract, most cases of jimson Today, jimson weed poisoning is A detailed history and physical weed poisoning can be managed sim- found primarily among adolescents examination results obtained after ply with observation until symptoms who seek the hallucinogenic effects the patient’s condition is initially sta- resolve. However, cardiac monitor- of the plant.7 In 1998, 152 cases of bilized can often give clues leading ing, serial recording of vital signs, and jimson weed poisoning were re- to diagnosis of anticholinergic serial neurologic assessment are im- ported nationally to the American toxidrome, even if jimson weed poi- portant for detecting occasional oc- Association of Poison Control Cen- soning is not immediately identified. currence of life-threatening events ters, but the true number of cases is A common presenting complaint is and for establishing resolution of undoubtedly far higher.1 altered mental status. The patient symptoms. Serial examinations usu- The anticholinergic effects of jimson may have visual hallucinations, au- ally indicate improvement within 24 weed are attributed to the atropine, ditory hallucinations, or both.9 Physi- hours, and most patients need less hyoscyamine, and scopolamine cal examination may show tachycar- than 48 hours of observation.10 components. Symptoms of jimson dia and elevated blood pressure. Patients with anticholinergic poi- weed toxicity usually occur within Hyperpyrexia is seen in about 20% soning should be observed by using 30 to 60 minutes after ingestion. of the cases.3 Other manifestations a cardiac monitor because of the risk Initial symptoms include hallucina- include mydriasis, blurred vision, for tachyarrhythmia from inhibition tions, dry mucous membranes, decreased bowel sounds, and dry of vagal effect on the sinoatrial node.9 thirst, dilated pupils, blurred vision, mucous membranes. Propanolol may be used for treating and difficulty speaking and swal- A toxicology screen is useful to rule symptomatic tachyarrhythmia; the lowing.2 Subsequent effects may out concomitant use of other drugs. dosage for adults is 1 mg given in- include tachycardia, urinary reten- Most documented lethal cases of travenously for one minute and re- tion, and ileus. Rarely, late symp- jimson weed ingestion occur in per- peated every five minutes (maximum toms may include hyperthermia, res- sons with polysubstance abuse, in- dose, 5 mg); the dosage for children piratory arrest, and episodes of cluding use of jimson weed com- is 0.01 to 0.1 mg/kg, (maximum seizure.6 Slowing of gastrointestinal bined with alcohol, marijuana, or dose, 1 mg).3 motility may prolong elimination of cocaine.7 Drug screens usually do not Patients also need close observa- the toxin, thus causing symptoms to detect pure anticholinergic poisons, tion for hyperpyrexia and convul- persist for 24 to 48 hours. and other laboratory tests are usu- sions, because either condition can One hundred 5 Classic anticholinergic symptoms ally not helpful for identifying jimson be fatal. Cooling measures (eg, seeds contain 3 include mydriasis; dry, flushed skin; weed as the cause of symptoms. sponging or a cooling blanket) may approximately hallucinations; agitation; hyperthermia; Absorption of jimson weed may be be used to treat hyperpyrexia, and 6 mg of urinary retention; delayed intestinal minimized either by using an agent intravenous fluid resuscitation may atropine. A dose motility; tachycardia; and episodes of that binds to the toxins or through prevent this complication. Convul- of atropine 3,5,7,8 seizure. The mnemonic for anti- removal of gastric contents by induc- sions may be treated initially with exceeding 5 cholinergic symptoms—“blind as a bat, ing emesis or administering gastric benzodiazepine therapy. Hyperten- 10 mg is dry as a bone, red as a beet, mad as a lavage. Activated charcoal binds to sion is usually transient and usually regarded as hatter, and hot as a hare”—thus ap- the toxins in jimson weed and de- does not necessitate pharmacologic potentially plies well to jimson weed poisoning. creases overall absorption of these intervention unless hypertensive cri- lethal. Effective treatment of jimson weed toxins.5 The usual oral dose of acti- sis is suspected.9 poisoning requires a primary survey, vated charcoal for adults is 1 g/kg. If In severe cases in which patients clinical evaluation and recognition, medical attention is sought within have symptoms of anticholinergic elimination of the poison, support- several hours after ingestion or if the crisis (eg, dysrhythmia, coma, sei- ive treatment, and continuing obser- patient has been intubated, removal zures, clinically significant hyperten- vation.8 The primary survey includes of the ingested plant by gastric lav- sion, or poorly controlled hyperpyr- assessment of the ABCs—ie, airway, age can be considered. Emesis may exia), the use of physostigmine is

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 29 clinical contributions Jimson Weed Poisoning—A Case Report

5 12 warranted. Physostigmine is an ace- diagnosis of anticholinergic excess. References tylcholinesterase inhibitor and can However, most cases of jimson weed 1. New York State Office of Alcoholism therefore reverse the peripheral and poisoning have a benign outcome and Substance Abuse Services (NYS central manifestations of anticholin- after treatment with only supportive OASAS). OASAS Addiction Medicine. ergic excess.11 The initial dose of phy- care and observation; use of phys- Jimson Weed (Datura Stramonium). Available at: www.oasas.state.ny.us/ sostigmine is 0.5 to 2 mg in adults or ostigmine is therefore not routine and AdMed/FYI-Jimson.htm. Accessed 0.02 mg/kg in children, to whom the should be reserved for patients who September 23, 2002. drug is given slowly by intravenous have clinically significant symptoms 2. Information Packaging Unlimited. route. The maximum dose in adults or complications. Jimson Weed. Available at: should not exceed 4 mg in 30 min- Benzodiazepine therapy is the www.infopackaging.com/IPUweb/ On-Line_Services/adic/jweed.htm. utes.3 Clinicians must remember that main treatment for acute agitation, Accessed September 23, 2002. use of physostigmine carries risks and use of restraints may be neces- 3. Vanderhoff BT, Mosser KH. Jimson and that excess acetylcholine may sary to avoid injury to the patient or weed toxicity: management of induce a cholinergic crisis, symptoms hospital staff. Clinicians must remem- anticholinergic plant ingestion. of which include bradycardia, com- ber that drugs with anticholinergic Am Fam Physician 1992 Clinicians must plete atrioventricular block, asystole, properties (eg, some antipsychotic Aug;46(2):526-30. remember that 4. Do It Now Foundation. Jimson emesis, bronchorrhea, and seizures.5 and sedative drugs) can worsen drugs with Weed: Fast Facts. Catalog no. 525. If overcorrection is suspected (eg, as symptoms of jimson weed poison- anticholinergic Available at: www.doitnow.org/ manifested by cholinergic symp- ing. Agents such as haloperidol or pages/525.html. Accessed properties toms), 0.5 mg of atropine may be chlorpromazine can exacerbate agi- September 23, 2002. (eg, some given intravenously for every 1 mg tation, and psychosis and should 5. Tiongson J, Salen P. Mass ingestion antipsychotic and of physostigmine given.9 therefore be avoided.12 of Jimson Weed by eleven teenagers. sedative drugs) Del Med J 1998 Nov;70(11):471-6. Routine use of physostigmine to can worsen 6. Rodgers GC Jr, Von Kanel RL. treat jimson weed intoxication re- Conclusion symptoms of Conservative treatment of jimson mains controversial. Closely moni- Jimson weed poisoning produces weed ingestion. Vet Hum Toxicol jimson weed tored use of physostigmine in very classic anticholinergic symptoms, is 1993 Feb;35(1):32-3. poisoning. small doses to prevent cholinergic usually self-limiting, and usually re- 7. Jimson weed poisoning—Texas, excess may be safe: When used to quires only supportive measures and New York, and California, 1994. MMWR Morb Mortal Wkly Rep treat a series of 23 patients with hal- observation. Recognizing the signs 1995 Jan 27;44(3):41-4. lucinations from jimson weed intoxi- and symptoms of anticholinergic 8. Haddad LM. Acute poinsoning. In: cation, physostigmine had no ad- poisoning can help clinicians iden- Goldman L, Bennett JC, editors. verse effects.11 Physostigmine can tify the toxidrome early and inter- Cecil textbook of medicine. 21st ed. quickly reverse signs and symptoms vene appropriately in life-threaten- Philadelphia: WB Saunders Company; 2000. p 515-22. of central and peripheral nervous ing cases, which occur rarely. High 9. Klein-Schwartz W, Oderda GM. system dysfunction and can assist levels of jimson weed ingestion may Jimson weed intoxication in produce dangerous medical condi- adolescents and young adults. Am Practice Tips tions, such as cardiac arrhythmia, J Dis Child 1984 Aug;138(8):737-9. Jimson weed is popular among adolescents curious hyperpyrexia, seizures, coma, and 10. Delancy KA. Anticholinergics. In: about the plant’s hallucinogenic effects. respiratory arrest. Physostigmine is Marx JA, Hockberger RS, Walls RM, et al, editors. Rosen’s emergency Anticipatory counseling for teenagers and parents may the preferred treatment for severe medicine: concepts and clinical also prevent experimentation and resultant harm. cases of jimson weed poisoning, and Jimson weed reaches a height of five feet and consists of practice. 5th ed. St Louis: Mosby; large, jagged leaves and trumpet-shaped white or purple benzodiazepine therapy is the pre- 2002. p 2081-7. flowers. ferred treatment for agitation. Antici- 11. Sopchak CA, Stork CM, Cantor RM, Intoxication results in anticholinergic effects. Initial patory counseling, especially around Ohara PE. Central anticholinergic symptoms include restlessness, shaking, hallucinations, summer and early fall (when the syndrome due to jimson weed dry mucous membranes, thirst, dilated pupils, blurred physostigmine: therapy revisited? vision, and difficulty speaking and swallowing. jimson weed plant matures), may [letter]. J Toxicol Clin Toxicol The mnemonic for anticholinergic symptoms—“blind as help deter adolescents from experi- 1998;36(1-2):43-5. a bat, dry as a bone, red as a beet, mad as a hatter, and mental use of this plant. ❖ 12. Shenoy RS. Pitfalls in the treatment hot as a hare.” of jimson weed intoxication [letter]. Treatment may include: activated charcoal, emesis, Acknowledgment Am J Psychiatry 1994 Sep;151(9):1396-7. cardiac monitoring, propanolol, cooling measures, Robert E Sallis, MD, reviewed the benzodiazepine and physostigmine. manuscript.

30 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 C

orridor Consult

clinical contributions How Can We Integrate Alternative Approaches and Mainstream Medicine to Treat Chronic Low Back Pain?

Introduction examination because there may be a new finding and Our patients are using alternative approaches to medi- because patients may expect an examination. Nor- cal problems—both common and rare—-and are spend- mal examination results reassure me that I am going ing more money per year on alternative therapy than in the right direction. For this patient, there are no they do on traditional medicine.1 Unless we ask, we additional findings from the physical examination. often are unaware that our patients are using alternative therapy.2 Alternative approaches, when integrated Treatment By Lydia S Segal, MD, MPH into mainstream medicine, often broaden our treatment I spend most of my time with this patient discussing options, an advantage which is especially true when lifestyle issues—-in this case, the issues are traditional, treating chronic pain.3 although handled slightly differently than in traditional practice—-and I make suggestions about alternative Unless we ask, The Case therapy appropriate to integrate into his care. we often are A 64-year-old man who re- My six-pronged approach to treatment: unaware that ceived disc surgery eight 1. Lifestyle issues: Recommend weight reduction, in- our patients years ago was seen recently creasing exercise, and smoking cessation.4 are using for failed back syndrome 2. Biopsychosocial: Discuss job satisfaction and alternative (impairment and disability workplace ergonomics. therapy. after back surgery). Pain, 3. Cognitive and behavioral program: Address which had worsened six patient’s pain and decreased functional status (abil- months before without an inciting event, limited him ity to work). to light duty at work and prevented him from getting a 4. Supplements: Prescribe glucosamine HCl. sound night’s sleep. Initial diagnostic evaluation included 5. Alternatives: Manual therapy and acupuncture— evaluation by the departments of neurology, rheuma- recommend either. tology, physical medicine, and rehabilitation and physi- 6. Devices: Consider using transcutaneous electrical cal therapy. Examination results were normal, except nerve stimulation (TENS) unit. for musculoskeletal strain and indefinite mild radicular symptoms. No bladder, bowel, or sexual dysfunction Lifestyle issues was noted. X-ray films showed no abnormalities except I spend time probing the patient’s motivation and some age-related arthritis. The patient did not exercise, readiness to change. I explain that patients who change nor had he kept up with the back-strengthening pro- lifestyle behaviors are most often motivated by: gram recommended to him by physical therapy after his 1. fear (example: fear of poor health) disc surgery. The patient was moderately obese and 2. bargaining for rewards (example: If I exercise, I smoked about half a pack of cigarettes a day. will hurt less.) 3. mentor factor (example: If I quit smoking, I will Diagnostic Evaluation be a better role model for my kids.) This patient profile is familiar, as is the frustration of 4. ego (example: If I lose weight, I will be more trying to help these patients. There is little left to add attractive.) to the evaluation at this point. I always do a physical 5. peer pressure

Lydia S Segal MD, MPH, is a family practitioner and Manager of the Alternative Medicine Department for the Mid-Atlantic Permanente Medical Group. She is also the physician lead for the Chronic Pain Program and the Spine Evaluation Service, both in the Northern Virginia service area of MAPMG. E-mail: [email protected].

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 31 clinical contributions How Can We Integrate Alternative Approaches and Mainstream Medicine to Treat Chronic Low Back Pain?

6. relationship to a higher being justing chair height, adding wrist rests (to computer 7. personal or other keyboards) or lumbar supports, or making other ergo- In this case, I ask the patient if he has a sense of nomic changes may improve low back pain. a previous successful style of change–-big or small, fast or slow. For example, did he cut back on his Cognitive and behavioral education program smoking all at once or by one cigarette a day? I Most Kaiser Permanente (KP) regions have these ask him to consider how ready he is to change programs, which may be called chronic pain or now. At the end of the visit, I ask him to go home chronic disease self-management programs or may and spend some time thinking about previous be known as mindful meditation or mindful move- motivators for change. ment programs. Programs consist of two- to three- I will probably not persuade a patient to start doing hour weekly or biweekly sessions held during six to back exercises unless the patient is ready to do them. I ten weeks and are led by a multidisciplinary group rely on the physical therapy department to teach exer- of trained patient leaders, behavioralists, physicians, cises to the patient; I rely on my relationship with the or any combination. Members with a variety of ail- patient to help identify barriers to exercising. My ex- ments participate (mixed disease model). Programs pectation is that the patient will make only limited provide education about chronic conditions and progress on one lifestyle change after this visit. chronic pain and teach patients self-management and I schedule another visit three to six weeks later relaxation response techniques. Numerous studies6 Numerous to discuss the patient’s progress. At that visit, I show that the body’s response to stress and pain studies show reassure the patient that limited progress is not can be changed using the relaxation response, the that the body’s failure and that we just need to figure out the medical term applied to nonreligious meditation. response to next barrier to change. Often, just getting a pa- stress and pain tient to think about changing lifestyle behavior Supplements can be changed is the biggest step. Glucosamine has clinical evidence to support its use using the for treating osteoarthritis.7 Glucosamine is available in relaxation Biopsychosocial a plain formulation or combined with chondroitin sul- response … We know from the literature that job satis- fate. Initially, I prescribe plain glucosamine for three faction is directly related to improving back months at the following dosage: 1000 mg three times pain.5 Therefore, I spend a few minutes reviewing daily (tid) for the first two weeks (loading dose) fol- the patient’s work situation, including job satisfaction lowed by 500 mg tid for ten weeks. Bone remodeling, and autonomy. If the patient is clearly unhappy, we determined on the basis of subjective improvement of spend some time reviewing options. symptoms (not x-ray examination), takes three months We might also review workstation ergonomics: ad- to occur. For some patients, the improvement will be 20%, for others 80%. I have yet to be able to predict who will respond and, if so, by how much. Dr Segal’s favorite Web sites for information Patients whose condition improves by taking glu- on supplements and herbal products cosamine must realize that sustained improvement depends on taking glucosamine for the rest of their • www.consumerlab.com: Independent assessment lives. Because the supplement costs about $30 a of quality of supplements and herbs, nutritional products. month and is not covered by insurance, I check to • www.usp.org: US Pharmacopeia, which sets standards for make sure that my patients are taking a brand of prescription and over-the-counter drugs. glucosamine containing the active ingredient and • www.nsf.org: NSF International, which ensures that labels whose manufacturer guarantees certain standards of reflect bottle contents. product cleanliness and purity. • http://pkc.kp.org/: Within our Permanente Knowledge Because the supplement and herbal product indus- Connection Web page, three excellent databases for try is not well regulated, I ask the patient to use ei- information on supplements and herbals can be accessed: ther the brand we carry at KP or a brand that is ad- - Micromedix equately rated by an independent testing lab and - Natural Standards reviewed in www.consumerlab.com. (See sidebar for - Natural Medicines Comprehensive other reliable Web sites for information on supplements and herbal products.)

32 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 clinical contributions How Can We Integrate Alternative Approaches and Mainstream Medicine to Treat Chronic Low Back Pain?

Manual therapy Summary and Followup I do not believe If a patient has spine-related back For this patient, I recommend weight reduc- that underlying pain but does not have a disc her- tion, smoking cessation, exercise, taking structural niation, fracture, trauma, cancer, or supplements (glucosamine), and attending a abnormalities, other contraindication listed in the cognitive-behavioral mindful meditation move- such as spinal Mid-Atlantic Permanente Medical ment program. About halfway through a six- stenosis, can be Chiropractic Referral Guidelines, I to ten-week program, I recommend starting changed with recommend a trial of manipulative either manual therapy or acupuncture. If the acupuncture, or chiropractic care. If the patient patient is resistant both to starting any lifestyle but the pain has no improvement within four to change and to attending a pain program, I rec- such conditions six visits, I have the patient discon- ommend either acupuncture or manual therapy cause might be tinue the trial therapy and reassess and schedule a follow-up appointment in a alleviated. the choice of manual manipulation. month. I use that appointment as a chance to A variety of massage techniques reassess the patient’s barriers to changing may be beneficial for back pain. Massage therapy is lifestyle behavior that interferes with recovery. ❖ not a member benefit in any KP region except for its Northwest Region, where state governments mandate References: that it be included in benefits. I recommend that pa- 1. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins tients receive deep-tissue or Swedish massage, and I DR, Delbanco TL. Unconventional medicine in the United instruct patients to communicate clearly with the mas- States. Prevalence, costs and patterns of use. N Engl J Med sage therapist (before and during the massage) about 1993 Jan 28;328(4):246-52. the degree of pressure that is comfortable. 2. Gordon NP, Sobel DS, Tarazona EZ. Use of and interest in alternative therapies among adult primary care clinicians and adult members in a large health maintenance Acupuncture organization. West J Med 1998 Sep 1;169(3):153-61. A variety of different types of acupuncture exist, in- 3. Gordon JS. Alternative medicine and the family physician. cluding Chinese traditional, Japanese, Korean, and French Am Fam Physician 1996 Nov 15;54(7):2205-12. Energetics. For a trial of six to eight treatments, I have no 4. Leboeuf-Yde C, Kyvik DO, Bruun NH. Low back pain and preference as to the type of acupuncturist—physician or lifestyle. Part I: Smoking. Information from a population- based sample of 29,424 twins. Spine 1998 Oct nonphysician. Some data suggest that electroacupuncture 15;23(20)2207-13. may provide more benefit than simple acupuncture; 5. Teasell RW, Bombardier C. Employment-related factors in acupressure and shiatsu using the traditional acupunc- chronic pain and chronic pain disability. Clin J Pain 2001 ture ashi points may also be beneficial. I do not believe Dec;17(4 Suppl):S39-45. that underlying structural abnormalities, such as spinal 6. Kabat-Zinn J, Lipworth L, Burney R. The clinical use of stenosis, can be changed with acupuncture, but the pain mindfulness meditation for the self-regulation of chronic pain. J Behav Med 1985 Jun:8(2):163-90. such conditions cause might be alleviated. 7. Ruane R, Griffiths P. Glucosamine therapy compared to ibuprofen for joint pain. Br J Community Nurs 2002 Devices Mar;7(3):148-52. Two devices, a TENS unit and a magnet, have been 8. Milne S, Welch V, Brosseau L, et al. Transcutaneous found useful for a few patients. The evidence in the electrical nerve stimulation (TENS) for chronic low back literature is not strong for efficacy of TENS units, but pain. Cochrane Database Syst Rev 2001; (2):CD003008. 9. Collacott EA, Zimmerman JT, White DW, Rindone JP. some people feel this form of electrotherapy helps.8 Bipolar permanent magnets for the treatment of chronic Magnets, on the other hand, have NOT proved to help low back pain: a pilot study. JAMA 2000 Mar alleviate mechanical back strain.9 8;283(10):1322-5.

Tense Muscles Holding onto anger only gives you tense muscles. Joan Lunden, Television personality and author

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 33 clinical contributions The Macrobiotic Diet as Treatment for Cancer: Review of the Evidence

By Joellyn Horowitz, MD

More recently, macrobiotics has come to mean a di- As a requirement for graduation, all medical students at the University of etary regimen used to prevent and treat many diseases; California, San Diego, must complete an Independent Study Project (ISP). in this sense, its more philosophical aspects are some- Original, independent, creative, and scholarly activities, the ISPs are a cor- what de-emphasized. In addition to the dietary provi- nerstone of UCSD medical education. As an Assistant Clinical Professor on sions of macrobiotics, however, other applications of the faculty of UCSD School of Medicine, Mitsuo Tomita, MD, chaired Joellyn macrobiotic principles—eg, increased emphasis on physi- Horowitz’s ISP Committee. He encouraged and mentored her in writing this cal activity; minimized exposure to pesticides, other paper. Dr Tomita is also the Director of Continuing Medical Education for KP chemicals, and electromagnetic radiation; and stress re- San Diego. He has been actively involved in medical education and points duction—may also be beneficial for cancer prevention.1,2 out that there is ample opportunity for other physicians to get involved in Because the philosophy of macrobiotics promotes the supervising medical students in ISPs at UCSD or in a variety of other ways. concept that phenomena are universal and interrelated, the practice of macrobiotics engenders respect for the This research was done while Dr Horowitz was a spiritual nature of life—a view that bolsters the morale fourth-year medical student at the University of Cali- of cancer patients.1 Patients adhering to this lifestyle nec- fornia School of Medicine, San Diego, California. essarily take an active role in their own treatment, ie, by making necessary lifestyle modifications. Actively par- When I was working at the Veterans Administration ticipating in their own treatment restores a sense of power Medical Center in Mission Valley as part of an outpa- that is sometimes squelched by conventional treatment, tient medicine clerkship, I had an encounter with a very much of which is inherently disempowering because it interesting patient, a 63-year-old man who had recently can cause overwhelming pain and debilitation. Empha- been diagnosed with prostate cancer. His oncologist, who sizing patient spirit and power may be important for had seen him two weeks before my visit with him, had Macrobiotics cancer prevention and patient survival as well as for left a note in his medical chart indicating that the pa- improving the quality of life for people with cancer.3,4 is also a tient should be scheduled for surgical prostatectomy as philosophy soon as possible. Despite several attempts by the oncolo- I found this patient to be a very pleasant gentleman whose and a gist to explain the risks and benefits of various treatment wit and humor were evident from the moment I sat down cultural options, the patient had told the oncologist during that to interview him. I could also see an intelligence behind movement. visit that he was going to try the macrobiotic diet instead his sparkling eyes, so it came as no surprise to find that he of having surgery to cure his cancer. He objected to pos- wished to actively participate in making decisions about sible incontinence of urine after the procedure. his treatment. Immediately after learning of his diagnosis, he began researching his illness on the Internet, in the What is Macrobiotics? library, and in the medical section of his local bookstore. According to Michio Kushi, who is probably the world’s He had decided to try the macrobiotic diet after reading a best-known proponent of macrobiotics, macrobiotics is “the 1982 book titled Recalled by Life: The Story of My Recov- universal way of life with which humanity has developed ery from Cancer, Dr Anthony Sattilaro’s autobiographical biologically, psychologically, and spiritually and with which account of overcoming metastatic prostate cancer.7 we will maintain our health, happiness, and peace.”1:p26 This definition shows how the word “macrobiotics” has Macrobiotic Dietary Guidelines come to mean more than just a way of eating: Macrobiot- The macrobiotic diet first introduced to the United ics is also a philosophy and a cultural movement. States by George Ohsawa consisted of ten progres-

Joellyn Horowitz, MD, (left) graduated from UCSD School of Medicine in June 2002 and is currently applying to residency programs in family medicine. She plans to do a fellowship and specialize in geriatrics. Mitsuo Tomita, MD, (right) is Director of Continuing Medical Education for KP San Diego and an Assistant Clinical Professor at UCSD School of Medicine. He chaired Dr Horowitz’s Independent Study Project Committee.

34 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 clinical contributions The Macrobiotic Diet as Treatment for Cancer: Review of the Evidence

sively restrictive stages; in the final stage, only brown any appropriate treatment minimizes nutritional deficiency, rice and water were permitted.5 Not surprisingly, this many physicians believe that imposition of the dietary version of the diet was associated with reported cases restrictions is potentially dangerous for patients who are of scurvy, anemia, low blood protein, low blood cal- already losing alarming amounts of weight. In contrast, cium levels, emaciation, renal failure, and death.6 these nutritional restrictions have been proposed to help Kushi1 reformulated and popularized macrobiotics in slow progression of cancer by starving the rapidly repro- the United States by emphasizing a high-complex- ducing cells responsible for the disease.20 carbohydrate, low-fat diet that is tailored to meet in- … many Dr Sattilaro was a 49-year-old physician when he was dividual needs, depending on age, sex, activity level, physicians diagnosed with prostate cancer, which had already personal needs, and environment. believe that metastasized to several bones. His prognosis was very The diet consists of five categories of foods (with rec- imposition of poor—he had multiple metastases—so he decided to ommended weight percentage of total food consumed): the dietary treat himself with the macrobiotic diet. After a year of • Whole cereal grains (40%-60%), including brown rice, restrictions is adhering to the diet, results of Dr Sattilaro’s follow-up barley, millet, oats, wheat, corn, rye, and buckwheat; potentially examination showed complete resolution of the bone and other less common grains and products made dangerous metastases. He continued the diet and remained from them, such as noodles, bread, and pasta. for patients cancer-free at followup three years later.7 •Vegetables (20%-30%), including smaller amounts who are of raw or pickled vegetables—preferably locally Even before the patient relayed to me Dr Sattilaro’s already grown and prepared in a variety of ways. story, I was familiar with it, having learned of it while losing • Beans (5%-10%), such as azuki, chickpeas, or len- researching the macrobiotic diet during my second year alarming tils; other bean products, such as tofu, tempeh, of medical school. At that time, I was taking an elective amounts of or natto. class in complementary/alternative medicine (CAM). weight. •Regular consumption of sea vegetables, such as The class exposed me to similar stories of patients who nori, wakame, kombu, and hiziki—cooked either recovered from cancer after using macrobiotic dietary with beans or as separate dishes. therapy. These stories appeared in such books as Dr J • Foods such as fruit, white fish, seeds, and nuts—to Kohler’s (1979) Healing Miracles from Macrobiotics;8 be consumed a few times per week or less often.1,2 M Kushi’s (1983) The Cancer Prevention Diet;2 V Brown The standard macrobiotic diet avoids foods that in- and S Stayman’s (1984) Macrobiotic Miracle: How a clude meat and poultry, animal fats (eg, lard and but- Vermont Family Overcame Cancer;34 H Faulkner’s ter), eggs, dairy products, refined sugar, and foods con- (1993) Physician, Heal Thyself;35 E Nussbaum’s (1992) taining artificial sweeteners or other chemical additives. Recovery from Cancer;36 and Cancer-Free: 30 Who Tri- All recommended foods are preferably organically grown umphed Over Cancer Naturally (1991) by The East West and minimally processed. Consumption of genetically Foundation with A Fawcett and C Smith.37 modified foods is also discouraged.1 For people with cancer, these restrictions may be absolute for a period Does the Macrobiotic Diet Have of time until some recovery has occurred. Several per- Anticancer Properties? sonal accounts7,8 describing individual applications of According to the 1997 report produced by the Ameri- the diet detail the initial period of the diet—in which all can Institute for Cancer Research and the World Can- animal foods and fruit are avoided—followed by peri- cer Research Fund, increasing daily consumption of ods in which these foods are reintroduced into the diet. vegetables and fruit from 250g to 400g may lead to 20% fewer cases of cancer worldwide.21 An increasing Potential Risks of the Macrobiotic Diet collection of evidence suggests that consumption of Cases of infants with symptoms of malnutrition (includ- whole grains can reduce the risk of cancer at various 22,23 ing deficiency of vitamins B12 and D) have been reported anatomic sites. Studies of rats have suggested that in the medical literature.9-11 The possibility of such types consumption of sea vegetables (dietary seaweed) may of nutritional deficiency has been documented in system- decrease the risk of breast cancer.24,25 Given that mac- atic surveys of groups of infants and families who fol- robiotics endorses a diet high in consumption of veg- lowed a macrobiotic lifestyle.12-18 These studies of nutri- etables and whole grains, a logical assumption is that tional status—primarily in infants or in growing the practice of macrobiotics should also reduce the children—have formed the basis for most warnings against risk for cancer. However, few studies specifically sug- use of macrobiotic diets to treat cancer.19 Assuming that gest macrobiotics as an effective cancer prevention

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 35 clinical contributions The Macrobiotic Diet as Treatment for Cancer: Review of the Evidence

method. A few studies26-32 comparing two populations parison of survival times was biased in favor of macro- Given the of women—those who eat a vegetarian or a macrobiotic biotics. Most important, the 23 persons in the anecdotal and diet and those who eat a typical US diet—suggest dif- macrobiotic series must have had to survive at least flawed nature ferences in estrogen metabolism between these two three months to be included. As noted in the SEER of the few populations and, that a vegetarian or macrobiotic diet data, 50% of all people diagnosed with pancreatic can- data currently may affect estrogen metabolisim in ways that reduce cer are dead at three months after diagnosis. Lack of available, the the risk for hormone-dependent forms of cancer, in- information on other factors that may influence sur- efficacy of the cluding breast and prostate cancer. vival in both the macrobiotic and control groups also macrobiotic The data are even more limited regarding macrobiotics limits interpretability of the Tulane study. diet as a as effective treatment for patients who already have can- The prostate cancer component of the Tulane study treatment for cer (ie, the focus of the present literature review). Much was similarly flawed: The nine patients with prostate cancer is of the evidence is purely anecdotal, consisting of indi- cancer who adhered to a macrobiotic diet had a me- impossible to vidual cases reported by those affected. Only one pub- dian survival of 228 months compared with a median determine at lished study attempted to obtain more systematic infor- survival of 72 months in matched control subjects. The this time. mation regarding efficacy of the macrobiotic approach to study did not clearly identify the criteria by which con- cancer, and that study was severely hampered by its ret- trol subjects were matched or how they were selected.33 rospective design.33 No prospective or randomized controlled clinical trials on the subject have been published. I told the patient about the existing data and referred The only published study in the peer-reviewed medical him to the available literature. A month later, the same literature was conducted by Gordon Saxe while a gradu- patient opted to receive the prostatectomy surgery. The ate student at Tulane University under the direction of cancer had not yet spread to local lymph nodes at that James Carter.33 The study had two components: one that time. Although not eating a strictly macrobiotic diet when focused on primary pancreatic cancer and another that I last saw him (four months after the surgery), he was focused on advanced prostate cancer. All study subjects continuing to eat a diet high in vegetables and low in had sought advice about macrobiotics from a certified animal fat because he believed that this regimen gave counselor. Records maintained by macrobiotics counse- him more energy. His postoperative urinary incontinence lors were used to identify 101 people who had seen a was improving with use of Kegel exercises, and his on- counselor for pancreatic cancer during the period ex- cologist was expecting the cancer to resolve completely. tending from 1980 through 1984. Attempts were made to recontact these people, and 28 of them (or their next of Summary kin) were reached. Of these 28 respondents, 23 reported Given the anecdotal and flawed nature of the few data that a macrobiotic diet had been followed for at least currently available, the efficacy of the macrobiotic diet as three months. Median survival of the 23 persons who a treatment for cancer is impossible to determine at this had followed a macrobiotic regimen was 13 months after time. We should also keep in mind (in the case of the 63- diagnosis; in contrast, median survival was three months year-old man described above, for example) that con- for pancreatic cancer patients enrolled in the National ventional screening tools for identifying prostate cancer Cancer Institute’s Surveillance, Epidemiology, and End have not been definitively shown either to enhance or to Results (SEER) program.33 extend life. Moreover, screening for prostate cancer (ie, Unfortunately, the Tulane report was flawed: Com- when and how often to screen, which tools to use) is a contentious topic among medical experts: On the basis of their individual preferences and experience, each phy- Practice Tips sician with whom I have had the opportunity to work has Macrobiotics has come to mean more than just a way offered different advice on the subject. Nonetheless, al- of eating and includes increased emphasis on physical though the medical literature currently available does not activity; minimized exposure to pesticides, other chemicals, show that macrobiotics extends the life of cancer patients, and electromagnetic radiation; and stress reduction. we must keep in mind that few data are available and The diet consists: whole cereal grains, vegetables, ❖ beans, sea vegetables, fruit, white fish, seeds, and nuts. that further investigation is warranted. According to the 1997 report produced by the American Institute for Cancer Research and the World Cancer Acknowledgment Research Fund, increasing daily consumption of vegetables Beatrice Golomb, MD, Department of Geriatrics, University of and fruit from 250g to 400g may lead to 20% fewer California San Diego School of Medicine, reviewed the manuscript. cases of cancer worldwide.

36 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 clinical contributions The Macrobiotic Diet as Treatment for Cancer: Review of the Evidence

20. Weisburger JH. A new nutritional approach in cancer therapy References in light of mechanistic understanding of cancer causation and 1. Kushi M. The book of macrobiotics: the universal way of development. J Am Coll Nutr 1993 Jun;12(3):205-8. health and happiness. Completely revised and enlarged ed. Tokyo: Japan Publications; 1987. 21. World Cancer Research Fund [and] American Institute for Cancer Research. Food, nutrition, and the prevention of 2. Kushi M, Jack A. The cancer prevention diet: Michio Kushi’s cancer: a global perspective. Washington (DC): American nutritional blue print for the prevention and relief of Institute for Cancer Research; 1997. disease. New York: St Martin’s Press; 1993. 22. Jacobs DR Jr, Meyer KA, Kushi LH, Folsom AR. Is whole 3. Fawzy FI, Fawzy NW, Hyun CS, et al. Malignant mela- grain intake associated with reduced total and cause- noma. Effects of an early structured psychiatric interven- specific death rates in older women? The Iowa Women’s tion, coping, and affective state on recurrence and survival Health Study. Am J Public Health 1999 Mar;89(3):322-9. 6 years later. Arch Gen Psychiatry 1993 Sep;50(9):681-9. 23. Slavin JL. Mechanisms for the impact of whole grain foods 4. Classen C, Sephton SE, Diamond S, Spiegel D. Studies of on cancer risk. J Am Coll Nutr 2000 Jun;19(3 Suppl):300-7S. life-extending psychosocial interventions. In: Holland JC, editor. Psycho-oncology. New York: Oxford University 24. Teas J, Harbison ML, Gelman RS. Dietary seaweed Press; 1998. p 730-42. (Laminaria) and mammary carcinogenesis in rats. Cancer Res 1984 Jul;44(7):2758-61. 5. Ohsawa G. Zen macrobiotics: the art of rejuvenation and longevity. Edited by C Ferré. 4th ed. Oroville (CA): George 25. Yamamoto I, Maruyama H, Moriguchi M. The effect of Ohsawa Macrobiotic Foundation; 1995. dietary seaweeds on 7, 12-dimethyl-benz[a]anthracene- induced mammary tumorigenesis in rats. Cancer Lett 1987 6. Dwyer J. The macrobiotic diet: no cancer cure. Nutr Forum May;35(2):109-18. 1990 Mar-Apr;7(2):9-11. 26. Goldin BR, Adlercreutz H, Dwyer JT, Swenson L, Warram 7. Sattilaro AJ, Monte T. Recalled by life. Boston: Houghton JH, Gorbach SL. Effect of diet on excretion of estrogens in Mifflin; 1982. pre- and postmenopausal women. Cancer Res 1981 8. Kohler JC, Kohler MA. Healing miracles from macrobiotics: a Sep;41(9 Pt 2):3771-3. diet for all diseases. West Nyack (NY): Parker Publishing; 1979. 27. Goldin BR, Adlercreutz H, Gorbach SL, et al. Estrogen excretion 9. Robson JR, Konlande JE, Larkin FA, O’Connor PA, Liu HY. patterns and plasma levels in vegetarian and omnivorous Zen macrobiotic dietary problems in infancy. Pediatrics women. N Engl J Med 1982 Dec 16;307(25):1542-7. 1974 Mar;53(3):326-9. 28. Thomas HV, Reeves GK, Key TJ. Endogenous estrogen and 10. Roberts IF, West RJ, Ogilvie D, Dillon MJ. Malnutrition postmenopausal breast cancer: a quantitative review. in infants receiving cult diets: a form of child abuse. Cancer Causes Control 1997 Nov;8(6):922-8. Br Med J 1979 Feb 3;1(6159):296-8. 29. Key TJ, Wang DY, Brown JB, et al. A prospective study of 11. Salmon P, Rees JR, Flanagan M, O’Moore R. Hypocalcae- urinary oestrogen excretion and breast cancer risk. Br J mia in a mother and rickets in an infant associated with a Cancer 1996 Jun;73(12):1615-9. Zen macrobiotic diet. Ir J Med Sci 1981 Jun;150(6):192-3. 30. Adlercreutz H, Fotsis T, Bannwart C, et al. Determination of 12. Dwyer JT, Andrew EM, Berkey C, Valadian I, Reed RB. Growth urinary lignans and phytoestrogen metabolites, potential in “new” vegetarian preschool children using the Jenss-Bayley antiestrogens and anticarcinogens, in urine of women on curve fitting technique. Am J Clin Nutr 1983 May;37(5):815-27. various habitual diets. J Steroid Biochem 1986 Nov;25(5B):791-7. 13. Dwyer JT, Dietz WH Jr, Hass G, Suskind R. Risk of 31. Adlercreutz H, Hockerstedt K, Bannwart C, et al. Effect of nutritional rickets among vegetarian children. Am J Dis dietary components, including lignans and phytoestrogens, Child 1979 Feb;133(2):134-40. on enterohepatic circulation and liver metabolism of 14. Specker BL, Miller D, Norman EJ, Greene H, Hayes KC. Increased estrogens and on sex hormone binding globulin (SHBG). urinary methylmalonic acid excretion in breast-fed infants of J Steroid Biochem 1987;27(4-6):1135-44. vegetarian mothers and identification of an acceptable dietary 32. Ingram D, Sanders K, Kolybaba M, Lopez D. Case-control source of vitamin B-12. Am J Clin Nutr 1988 Jan;47(1):89-92. study of phyto-oestrogens and breast cancer. Lancet 1997 15. Van Staveren WA, Dagnelie PC. Food consumption, growth, Oct 4;350(9083):990-4. and development of Dutch children fed on alternative diets. 33. Carter JP, Saxe GP, Newbold V, Peres CE, Campeau RJ, Am J Clin Nutr 1988 Sep;48(3 Suppl):819-21. Bernal-Green L. Hypothesis: dietary management may 16. Dagnelie PC, Vergote FJ, van Staveren WA, van den Berg H, improve survival from nutritionally linked cancers based Dingjan PG, Hautvast JG. High prevalence of rickets in infants on analysis of representative cases. J Am Coll Nutr 1993 on macrobiotic diets. Am J Clin Nutr 1990 Feb;51(2):202-8. Jun;12(3):209-26. 17. Dagnelie PC, van Staveren WA, Vergote FJ, Dingjan PG, 34. Brown V. Macrobiotic miracle: how a Vermont family van den Berg H, Hautvast JG. Increased risk of vitamin overcame cancer. Tokyo: Japan Publications; 1984. B-12 and iron deficiency in infants on macrobiotic diets. 35. Faulkner H. Physician, heal thyself. Becket. (MA): One Am J Clin Nutr 1989 Oct;50(4):818-24. Peaceful World Press; 1993. 18. Miller DR, Specker BL, Ho ML, Norman EJ. Vitamin B-12 36. Nussbaum E. Recovery from cancer. Garden City Park (NY): status in a macrobiotic community. Am J Clin Nutr 1991 Avery Publishing Group; 1992. Feb;53(2):524-9. 37. East West Foundation, Fawcett A, Smith C, Kushi M. 19. Bowman BB, Kushner RF, Dawson SC, Levin B. Cancer-free: 30 who triumphed over cancer naturally. Macrobiotic diets for cancer treatment and prevention. New York: Japan Publications; 1992. J Clin Oncol 1984 Jun;2(6):702-11.

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 37 soul of the healer

A Gathering of Crabs By Ahmad Abdalla, MD

Walking through a fish market on the Potomac, in Washington, DC, Dr Abdalla was attracted by the orderly arrangement of these crabs. More of Dr Abdalla’s work can be seen on pages 6 and 77.

38 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems Successful Practices in the Physician Work Environment: We Work Together

By Karen Tallman, PhD; Jill Steinbruegge, MD; Michelle Hatzis, PhD

Permanente physicians seek to provide patients with excellent clini- Identification of Successful Practices cal care and an excellent service experience during brief office visits. The Physician Work Environment Workgroup of the Interregional Care However, many patients have heightened expectations for service, Experience Council conducted focus groups in three regions to identify and some have preformed beliefs about their diagnosis and treat- successful practices in the physician work environment. The central fo- ment. There is great variability in how well departments, modules, cus was identification of practices that discriminate “highly rated” teams and teams respond to this and other challenges to achieve high pa- (those with high scores on patient visit satisfaction and physician satis- tient satisfaction while building a positive work environment. This faction surveys) from “medium-rated” or “low-rated” teams (those with research asks what practices distinguish “teams” (departments, mod- medium or low patient and physician satisfaction scores). Physician sat- ules, or teams) that both enjoy a positive work environment and isfaction was defined as the average team rating on five physician survey excel at satisfying patient expectations. items previously shown to be correlated with satisfaction.1 Members of the Physician Work Environment Workgroup are listed in Table 1. Table 1. Care Experience Physician Work Environment Workgroup Member Organizational position The Work Environment Chair: Tom Janisse, MDa NWP: Assistant Regional Medical Director The Care Experience Council is dedicated to identifying ac- Workgroup members: tions leaders can take to improve service. The work is grounded Patty Fahy, MD CPMG: Associate Medical Director of Human in the KP Results model.2 Similar models have been supported Resources by research in service industries.3,4 The KP Results model hy- The Permanente Federation: Director of Leslie Francis, MBA, MPHA Performance Improvement pothesizes causal linkages between leadership actions, the work Geoff Galbraith, MDa HPMG: Vice President for Quality Management environment, patient satisfaction, and outcomes: Dana Gascay, RN, MHA SCPMG: Assistant to Assistant Area Medical Director and to Medical Group Administrator, Los Angeles Medical Center Leadership Work Patient Clinical &

Tom Godfrey, MD SCPMG: Area Medical Director, Los Angeles ▼ ▼ ▼ Actions Environment Satisfaction Business Medical Center Michelle Hatzis, PhD The Permanente Federation: Project Support Outcomes Arthur Huberman, MDa SCPMG: Assistant Area Medical Director, West Los Angeles This model implies that a positive physician work environ- Lee Jacobs, MDa TSPMG: Associate Medical Director, ment is essential for retaining and recruiting physicians, for pa- Professional Development tient satisfaction, and for promoting important outcomes. Kaiser Bob Jako, PhD TPMG: Director, TPMG Human Resources Permanente (KP) research has identified evidence for a link be- Sherilyn Kam, PhD TPMG: Senior Consultant, Leadership 5 Development & Support, California tween the work environment and patient satisfaction. Leslie Koved, LCSW TPMG: Physician Health – Director, Physician Resource Network, California Methods a Dorothy Meder, MFA, MBA KPHI/Program Office: Senior Consultant, Physicians and researchers from the Physician Work Environ- Applied Research/National Market Research Terry Stein, MD TPMG: Director, Clinician-Patient ment Workgroup conducted 20 focus groups in Georgia, Ha- Communication waii, and Colorado. The teams were asked questions related to Jill Steinbruegge, MDa The Permanente Federation: Associate Executive what makes them feel supported to satisfy patients and the role Director for Physician Development; and Co- Chair, Care Experience Council of their local physician-leader in that support them. In Georgia Karen Tallman, PhDa The Permanente Federation: Project Support and Hawaii, the participants were physicians, local physician- aIndicates Workgroup members who conducted successful practices interviews.

Karen Tallman, PhD, (left) is the Project Manager for the Care Experience Physician Work Environment Workgroup. E-mail: [email protected]. Jill Steinbruegge, MD, (middle) is Associate Executive Director, Physician Development for The Permanente Federation in Oakland, CA. E-mail: [email protected]. Michelle Hatzis, PhD, (right) has been with KP since 1997 and currently works as a senior consultant/project manager for The Permanente Federation. E-mail: [email protected].

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 39 health systems Successful Practices in the Physician Work Environment: We Work Together

leaders, associate providers, and staff in teams. In Colorado, physi- Table 2. Five successful practice categories cians and local physician-leaders from departments participated. 1. Connect guiding principles and values to daily work. 2. Demonstrate physician leadership by example. Findings 3. Emphasize team development to create support through Five categories of successful practices that distinguished between interdependence. highly rated teams and medium- or low-rated teams emerged from a 4. Set goals within team’s sphere of influence.

qualitative analysis of the transcripts. Physicians in the highly rated 5. Provide recognition and constructive feedback. teams use these five successful practices (Table 2). The highly rated teams use all five practice categories, whereas the 1. Connect principles and values medium and low-rated teams tended to use fewer practice categories of team and region to daily work or use them less consistently. Contrasting features of highly rated Highly rated teams use the guiding principles and values from teams and medium- and low-rated teams are displayed in Table 3. the region and from the team to guide daily decision making, Quotes from physician team members exemplified each category of align goals, and motivate the team. The most effective principles successful practice (Table 4). and values are simple and easily applied to daily work (eg, The following are descriptions of the five successful team practice “First in quality, first in service,” “Treat patients and team like catagories. family”). At decision points, members of the team deduce what

Table 3. Contrasting practices of highly rated vs medium- or low-rated teams Practices of highly rated Teams Medium- or low-rated teams (medium or low Team practices (high physician and patient satisfaction scores) physician and patient satisfaction scores) Use principles to solve problems, align goals, & unify Connect team (eg, “Treat patients & team like family,” First in Lack connection of principles to daily work Leverage quality, first in service”) principles and principles and values of values Value patients and team (spend time in team and team and individual development, eg, training, meetings, Focus primarily on patient satisfaction region to consultants, and facilitators) daily work Believe clinical and service quality are compatible Service beliefs Believe quality and service goals are mutually exclusive Physicians communicate high standards, exemplify (not Less conscious of effects of modeling Model expected just talk about) what is expected on each other Demonstrate behavior Include staff and Associate Providers (APs) in decisions Lack staff and AP input in decision making physician —“Everyone has a voice” leadership by Address complaints and translate into plans Protect group, try to cope example Dealing with challenge Physician-leader sets clear direction Physician-leader’s direction is less clear Emphasize selection for team fit—they will wait for the Selection Less emphasis on team fit right person Know roles of all team members Role clarity Have less clarity on roles of others (permit interdependency) Emphasize Inclusiveness Be respectful—use input from all team members Have a physician-centered hierarchy team • Support each other so all can finish on time development Interdependence • Feel they are “in this together,“ so they can “give up Have individuals struggling alone in silos the turf” Use team-level data to track performance, including Track performance Tend to track patient satisfaction only team satisfaction Team identity Have meaningful, positive team identities Lack a positive team identity Set goal s Set achievable • Clarify scope of team influence • Set sights too high (eg, regional decisions) within team’s goals • Pursue goals within sphere of influence (start small) • Perceive no team influence sphere of Source of Take responsibility for improvements, but use outside Look outside of team for improvement influence improvement help (training, analytical support, consultants, leaders) • Convey verbal, individualized, 1:1 recognition from members and patients Provide • Have insufficient recognition Recognition • Make staff and associate provider recognition a recognition • Fail to convey patient comments to team and priority constructive • Provide recognition at the team level feedback Constructive • Address interpersonal concerns in a timely manner Tolerate interpersonal problems feedback • Give learning feedback to all (even physicians)

40 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems Successful Practices in the Physician Work Environment: We Work Together

is required from the principles and own their decisions. An the regional leadership team. The physicians appreciated this example of a concept that guides highly rated teams is the practice and were empowered both by board updates in the belief that service and quality are compatible, not mutually facilities and frequent, small group meetings with leadership. exclusive, goals. These meetings were especially valuable because the physicians 2. Demonstrate leadership by example felt free to ask direct questions about tough issues—the “el- Physicians in highly rated teams model expected behaviors. ephants in the room.” They demonstrate—rather than ask for—exemplary behavior. 3. Emphasize team development Physicians and physician-leaders set the tone and direction for to create supportive interdependence the group. Physicians give everyone in the team a true voice in Interdependence is working in a group as though you could decisions and empower nurse-leaders to participate. not work without each other. These teams think as a system and A proactive, positive attitude is present in these teams. The posi- distribute the workload across the team. Pervasive use of the tive physician example reaches the team members, who then re- word “we” is the most definitive sign of a highly rated team. flect the modeling in their interactions with patients. In turn, physi- Functioning in an interdependent manner is associated with cians are cheered by the good examples set by team members. reduced stress, a more predictable workday, and freedom from Positive patient comments to the team complete the feedback cycle. the feeling of having to carry the burden alone. Team mem- In highly rated teams, physicians make timely team alterations. bers “jump in to help others.” They get up and walk around They set expectations for performance and manage to meet them. to determine who needs support. Everyone works together The team addresses interpersonal challenges rather than permitting to provide an excellent experience for patients and have a them to undermine the team’s functioning. The physicians antici- more orderly workday than when they worked more autono- pate and plan for upcoming changes instead of reacting to them. mously. Team members jointly examine and deal with prob- This research was designed to identify practices that discrimi- lems and improve processes together. In time, highly rated nate between the highly rated teams and the medium- and low teams develop a positive team identity, consistent with the rated teams. However, one identified leadership practice ben- team’s principles and values. They are aware of the value and efited all teams in one region: having open communication with uniqueness of their team. Successful team development is associated with an emphasis on at least Table 4. Physician quotes exemplifying the five successful practices five foundational elements, which Successful appear in Table 5. Physician quotes from the teams practices 4. Set goals within the team’s Connect • “We have the perspective that if you’re delivering quality care, then your patient sphere of influence principles and satisfaction should be up there too.” values of • “Years ago, we decided to stop looking at what providers wanted, or what nurses Teams that aspire to change ma- team and or MAs wanted, and went back to the focus of ‘What is the best thing for the jor policies and programs outside region to patient?’ ... How are we going to make the patient’s process smoother, more the team’s sphere of influence are daily work efficient, make them happier with the experience?” • “[The physician lead] comes in happy to be here. He never complains about vulnerable to becoming demoral- Demonstrate too much business.” ized. Highly rated teams do not physician • “He is fair … He wouldn’t ask me to do something he doesn’t do himself.” spend their energy trying to change leadership by example • “Our team lead has a style you want to emulate. You want to be like him … the system; instead, they start with He praises us … and he sets the tone with everybody on the team.” small, realistic goals. They get in- • “We let the nurses run our day. We don’t tell them ‘do this, do that.’ We let the Emphasize nurse decide what to do next. You just want to know what room to go to next.” volved with making improvements team instead of assigning blame and look- development • “When there is an issue, we bring it up as a team, rather than complaining about it, and we solve it together as a team.” ing outside the team for a better • “I spend a lot of time telling people that we have to be clear about what our work environment. By aspiring to influence is, and about what we can expect, and what we can’t expect. I have Set goals no problem with telling people ‘that’s something we can’t control.’” achievable goals, team members in- within the • “We have discussions outside team meetings. We look at our [quality and crease their odds for success and team’s sphere service scorecard] and figure out how we can improve things … to help the of influence build influence and control over their whole team improve quality.” work environment. Success breeds • “We look for small successes. We look for things we can work on and fix.” • “At the end of the day, [the physician lead] says ‘thanks for your hard work. more success. Provide I appreciate it’ … simple comments about the day several times a week.” 5. Provide recognition and timely, recognition • “When I first started, I had a reputation of reducing each nurse to tears at some and constructive feedback point … but I got through all that … they were honest enough to tell me. ” constructive Feeding back information to all feedback • “When a patient says ‘Thanks for saving my life,’ that makes my month. Patients are the most important thing.” work group members is observed

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 41 health systems Successful Practices in the Physician Work Environment: We Work Together

in the highly rated teams. Simple, verbal recognition received strengthening the team and setting a positive example for each other from a patient or team member is the most valued recognition. while caring for patients. In addition, regular recognition and con- The physicians want to know that their effort and time are no- structive feedback is provided to sustain day-to-day team function- ticed. Public recognition given at large events, while valued by ing. Medium-rated and low-rated teams addressed some practice cat- some, is not as helpful as simple comments by leadership and egories but did not consistently address all categories. colleagues. Financial rewards are not consistently motivating. The highly rated teams were not identical to each other. Each highly When interpersonal discord disrupts the work, highly rated teams rated team found its own unique way to use the five categories of suc- deal with the problem in a timely manner, even if a physician is cessful practice. These teams discovered multiple routes to success. ❖ the disruptive team member. References Table 5. Elements associated with strong team 1. Janisse T, Tallman K. Care Experience physician work environment update: functioning physician key drivers [presentation]. Care Experience Council, Oakland, CA, Nov 2001. Selection for team fit and balance 2. Steinbruegge J, Francis L, Stevens S. Understanding the care experience Role clarity (knowledge of the roles of self and others) [presentation]. Permanente Executive Conference, Scottsdale, AZ, Inclusive decision making Nov 2-3, 1999. Interdependency (knowing and working with each other) 3. Rucci AJ, Kim SP, Quinn RT. The employee-customer-profit chain at Sears. Performance tracking using team-level data Harvard Business Review 1998; Jan-Feb: 83-97. 4. Brooks SM, Guth T. When service means more: its impact on customer Conclusions opinions across work environments [presentation]. Wiley JW, chair: Teams with the highest levels of physician and patient satisfaction Practitioner Forum: Relating employee and customer opinion: drilling into are distinguished by rich interdependence, in which all team mem- the business. Society for Industrial and Organizational Psychology, 14th Annual Conference, Atlanta, GA, April 29-May 2, 1999. bers actively support each other on a daily basis. Conceptually, they 5. Kam SM, Brooks SM. Touching the customer by understanding employees: are guided by principles and values and have realistic, attainable preliminary linkage research findings from four regions of Kaiser aspirations. The activities of these team members are focused on Permanente. Perm J 1998 Spring;2(2):47-54.

Leaders and Bosses People ask the difference between a leader and a boss … The leader works in the open, and the boss in covert. The leader leads, and the boss drives. Theodore Roosevelt, 1858-1919, 26th President of the United States

42 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 soul of the healer

Tools of the Trade By John J Kuiper, MD, FACP

Dr Kuiper was an internist and nephrologist with SCPMG in Panorama City for 26 years; since retirement, he has continued teaching and research at the UCLA Medical Center. Upon completion of a drawing class, Dr Kuiper rendered this 16x20-inch graphite on paper drawing of medical equipment that, with the exception of the newer stethoscope, served him for 43 years.

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 43 health systems Special Feature

Excerpts of proceedings from The Southeast Permanente Medical Group’s Spring CME Program held May 2002 in Georgia—edited transcript Symposium on Complementary and Alternative Medicine: In the Era of Evidence-Based Medicine, What’s a Physician to Do?

Introduction Institute (CMI), located in Oakland, California. Dr Wallace Dr Jacobs: I want to welcome you all to this landmark and CMI are doing absolutely cutting-edge work in evi- morning for our [The Southeast Permanente] Medical Group. dence-based medicine and in promoting shared decision This session is noteworthy because this is the first time The making. I continue to be impressed with the quality of Southeast Permanente Medical Group (TSPMG) has made their work, which I believe is now starting to be acknowl- a concerted effort to understand Complementary and Al- edged in the medical community throughout the country. Lee Jacobs, MD Moderator ternative Medicine (CAM) so that a dialogue can begin Dr Wallace will help us discuss CAM in the framework of among the members of our organization. Just what does evidence-based medicine. CAM include? How do we relate to our patients about Next, I would like to introduce Tieraona Low Dog, MD— complementary medicine? How do we integrate CAM into a nationally renowned expert in the field and no stranger our practices and maintain an evidenced-based focus? These to Kaiser Permanente, as she is frequently invited to lec- are the questions that this symposium will address. ture on CAM. Dr Low Dog is from New Mexico and has First, I would like to emphasize that I really do want us been appointed to the White House Commission on to have a dialogue on this subject. Although many of us Complementary and Alternative Medicine Policy. have strong opinions on the subject, I would ask that, to- Named by Time magazine as an Innovator of Alternative day and in the future, we keep an open mind; listen to Medicine in 2001, she has spent the past 20 years work- others so that we have all the facts to formulate opinions; ing to integrate the use of botanical medicines into the and, finally, be ready to change our approach when evi- current health care system. So we’re thrilled to have Dr dence suggests a new direction. Low Dog here this morning to help our dialogue. I think that her national perspective and her understanding of the Why is this Discussion quality and uses of CAM will be extremely helpful. Important to Physicians? Next, I want to welcome and introduce Lee Ballance, Although there are many reasons why we might ben- MD, a Permanente physician from the Kaiser Permanente efit from understanding CAM, in my mind, two reasons Vallejo Medical Center in Northern California and Chief stand above the others. of Alternative Medicine at that facility. Yes, you heard First, we want to maintain an open communication me right: Imagine a medical group taking this subject channel with our patients. We want them to be very seriously enough to have a department dedicated to it! comfortable in telling us what medications they are tak- We are all eager to hear about how CAM has been inte- ing, because what they are taking or doing may have grated into the physicians’ practices in The Permanente real clinical ramifications. However, we must be open Medical Group in Northern California. and listen without prejudice; otherwise, they won’t tell Finally, moving from Northern California to the North- us! If patients don’t feel comfortable, they won’t tell us west, I would like to introduce Charles Elder, MD, a phy- what they are taking and why, in turn, they might not sician from the Department of Internal Medicine in the be taking what we prescribed. Northwest Permanente Medical Group, where he is Di- Second, we may not be offering patients all poten- rector of Quality Assurance at Kaiser Permanente tially beneficial therapeutic options. Both a fully informed Sunnyside Medical Center. Dr Elder is a clinical investiga- physician and a fully informed patient are certainly es- tor at Kaiser Permanente Center for Health Research, where sential if shared decision making is to exist. he does research in mind-body techniques. So, that is our panel of experts. Let’s get started. I will ask the Introducing Panel Experts panel members to present some opening comments, and First, I would like to introduce Paul Wallace, MD, Execu- then the panel will entertain questions from the audience. tive Director of Kaiser Permanente’s Care Management Let’s start with Dr Wallace. ❖

44 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems Complementary & Alternative Medicine Symposium Using Evidence to Understand New Approaches

Background: Making the really must also figure out how to therapy and autologous bone mar- Right Thing Easier To Do actually do it. If we try to implement row transplantation for women with Dr Wallace: Good morning. Dur- something in a way that is actually metastatic breast cancer. As you all ing the next few minutes, I’d like to more complicated than what we’ve recall, this has been quite a conten- think with you about how we go been doing, then I don’t think we tious topic over the past 15 years— about knowing what is “right” for should be surprised that such things even showing up on the cover of Paul Wallace, MD our patients, particularly as we en- often don’t work: the new idea is Time magazine—and has been the Executive Director, Care counter new ideas and interven- not integrated into our practices. subject of innumerable lawsuits. Management Institute tions. First, however, I’d like to pro- But it all starts with rigorously Access to this intervention has ac- vide some brief background so you examining what we know. This con- tually been legislated in several can know where I’m coming from. cept applies directly to thinking states. The dilemma is that after 15 My clinical training is in internal about new and alternative ap- years of performing these trans- medicine, hematology, and medical proaches, because it can be very plants, people got around to actu- oncology, which I practiced over the difficult to figure out the right thing. ally doing the studies in a way that better part of 20 years. I got involved Therefore, I’d like to spend the rest accounted for the biases inherent in producing clinical practice guide- of our time together considering in investigating this approach—only lines for a broad range of condi- some key issues as we try to iden- to learn that it didn’t work! What a tions about a decade ago. Since tify the “right” thing. In particular, shame; it would have really been then, much of my professional fo- how do we manage in a world nice if the approach had worked, cus has moved to aspects of evi- where not everything can be clear, because metastatic breast cancer is dence-based medicine and to mak- where not everything can be cer- a terrible condition for which clini- ing it accessible and applicable both tain, and where there won’t always cians really wanted to offer mean- for clinicians and for health plan be high levels of agreement? ingful treatment while tens of thou- members. I have also had the op- sands of women were led to believe portunity to do what is best called The First Cautionary that they were getting something “administrative work” around popu- Tale: Lessons from the more effective than what they were lation-based care. In short, I get to Metastatic Breast actually receiving. This situation vio- participate with a lot of people Cancer Debacle lates what we talked about before throughout the [KP] Program to think I want to share with you a simple around evidence-based medicine: It about how we can take what we definition for evidence-based medi- is about being clear about what you know about medicine and apply it cine. I think that evidence-based medi- know, what you don’t know, and more effectively. cine is being clear and honest about what you’re going to do about it. It The first slide features the mission • what you know, would be interesting to dig out the statement for the place I now spend • what you don’t know, and dialogue in medical journals and in most of my time and energy, the Care • what you’re going to do about it. Congressional testimony from folks Management Institute (CMI). The mis- It is not a whole lot more than who had strong views about why sion of CMI is at the core of today’s that, and it’s not a whole lot less, women should not be denied this task: to make the right thing easier. either; but those three phrases en- treatment and who aggressively pro- “Making the right thing easier” has tail an awful lot of work. moted this modality as a proven two dimensions: The first is disci- I’d like to begin by sharing with benefit. After randomized trials were plined pursuit of what the right thing you a couple of cautionary tales. reported and failed to demonstrate is. The second is to realize that just The first is the story that was very clear benefit, an editorial in The New figuring out what we should do is close to me as an oncologist. It dealt England Journal of Medicine, stated: only a small part of the journey. We with the role of high-dose chemo- “Advocates of high-dose chemo-

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 45 health systems Special Feature Using Evidence to Understand New Approaches

therapy plus autologous bone mar- story highlights a principle that we ably had a lower overall risk of heart row transplantation for metastatic should consider for any new ap- disease to begin with than the av- breast cancer contend that since this proach: There is a major difference erage female population. The study treatment is unproven, its use is jus- between making observations and subjects had been self-selected, and tified outside of a trial—that actually conducting a controlled the observational design did not is, because they think it might trial. Be particularly cautious of make allowances for that fact. A There is a major be helpful, they should be al- conclusions when existing initial variety of traps weren’t fully con- difference lowed to use it. observational data reinforce what trolled. Although, in all likelihood, between “We should now acknowl- we want to happen. some women can take HRT safely, making edge that, to a reasonable I think we have refined our under- observations degree of probability, this A Second Cautionary standing of who might actually ben- and actually form of treatment for Tale: Hormone efit from it and who would not ben- conducting a women with metastatic Replacement Therapy efit—or worse, who is most likely controlled trial. breast cancer has been The next tale deals with perhaps a to be harmed from it. So, when you proved to be ineffective and more common issue that we deal now have a discussion with a should be abandoned in favor of with in everyday office practice: hor- woman about the risks and benefits well-justified alternative experimen- mone replacement therapy (HRT). of HRT, you can be much clearer tal approaches.”1 How many people ten years ago about what we know, what we don’t An associated aspect to this sad used to be cheerleaders for hormone know, and what we should do. story is that the major study2 cited replacement for most women in their I don’t mean to imply that we as showing that this approach to 50s? I see most of you raising your shouldn’t provide therapy when we metastatic breast cancer had ben- hands. And how many of you re- don’t know all about its approach, efit turned out to be research fraud. main cheerleaders that way today? I but I do mean that we need to be I think this fact reflects the pres- see fewer hands being raised. mindful of the traps if we act as sures that people are under to give What happened to make us ques- though we know more than we the public important new therapeu- tion that approach? actually do. The same lesson applies tic options. The South African in- Well, I think that, first of all, the here as for the breast cancer story: vestigator who produced the study medical community wanted to have There is a major difference between explained why he fudged the data: something that we could do for making observations and actually He thought it so important for women who were having meno- conducting a controlled trial. people to have this therapeutic op- pausal symptoms. This approach tion that he made the data look as was further encouraged by strongly The Physician’s Mindset though the therapy had benefit. If suggestive information that women and Observations that anything violates basic scientific who took HRT had a lower inci- Don’t Make Sense: principles, I think that’s it. dence of heart disease. However, Keeping an Open Mind So, the cautionary tale here is not this observation ended up not be- For many approaches, we neither that we assume research may be ing true when the HERS Study,3 a have randomized control trial data fraudulent but that approaches don’t randomized trial, was published nor are likely to obtain it in the fu- always work—even when they look several years ago. After about four ture. Many other approaches intro- as though they should work and years of rigorously looking at ran- duced go against our intuition. when they intuitively appeal to us domized groups of women, we rec- For example, for me it is still diffi- as beneficial. As physicians, we have ognized that women who had pre- cult to fully reconcile myself with the a responsibility not only to be clear existing heart disease were actually mental maps that I learned in medi- about what we know but to be harmed by taking HRT. cal school about the role of H. py- equally clear about what we don’t What was important about the ob- lori in peptic acid disease. If, during know absolutely. Where I think servational data? Well, one of the my residency 25 years ago, I had people “dropped the ball” on the challenges is that when we look heard that we were going to treat tragic breast cancer story is that we back at the initially promising ob- some gastric problems with antibi- were not mindful of how the data servations made in the 1980s, it turns otics, it would have sounded kind were collected in the early sugges- out that many of these observations of nuts. However, it wasn’t nuts; in- tive (but not definitive) studies. came from groups of women, many stead, somebody was a good scien- In summary, this breast cancer of whom were nurses, who prob- tist and didn’t deny an observation

46 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems Using Evidence to Understand New Approaches Complementary & Alternative Medicine

just because it didn’t fit a precon- an intervention within a timeframe mulation. It’s im portantSymposium for us to un- ceived notion. That scientist pursued too short to fully account for future derstand whether an evidence-based what was observed on some labora- events. Work was recently done on recommendation shared with us by tory slides of ulcers, and, after subse- several drugs that looked safe ini- someone is in fact fully informed by quently conducting good, scientific tially; a variety of problems with all available evidence and reflects studies, the scientist actually changed these drugs were seen after years that information. Does the advocate the way that we think about peptic of use. So, the length of the assess- simply cite a reference to back up ulcer disease. ment period is an important con- what they say, or has the advocate sideration. You might not expect actually cited and systematically re- Interacting with complications years after taking a viewed all that’s known about that Patients Taking CAM: drug if the studies available were particular topic area? Has the advo- Evidence-based conducted for only six months. cate integrated the known Considerations Next, as studies are done and data information rigorously and As we approach CAM, we should are collected, is it clear what prob- then made a recommenda- It’s important for be aware that some approaches just lem formulation the research ad- tion that reflects the whole us to understand won’t fit our current mindset but will dresses? A great deal of challenge and picture? This is an evi- whether an prove true and that other things nuance exists in how you formulate denced-based approach. evidence-based seem to be consistent with our the research problem. For example, Finally, we contemplate recommendation mindset but are wrong. How do we to study cancer chemotherapy, you the analytic approaches and shared with us by find our way through this maze might create a problem formulation then put things through an someone is in fact when interacting with our patients? that includes only people aged un- additional sieve, our clini- fully informed by all First of all, I think that when we der 65 years. If you then see a pa- cal expertise, before drawing available evidence interact with our patients, we can tient who is aged 75 years, you must a conclusion as to whether and reflects that actually be clear with them about be aware of the problem formula- to use a given approach or information. what we know and what we don’t tion that went into creating the data. not. Evidence-based medi- know from an evidence-based Part of clinical judgment is to think: cine is not about minimizing framework. Their mindset and ob- what is there about 75-year-old pa- the importance of clinicial experi- servations may be quite different tients that may not be the same as ence and judgment; instead, evi- from ours, and so our challenge is for 65-year-old patients, and how dence-based medicine supports le- to instill in our patients a degree of should I either discount or transfer veraging those unique dimensions of trust so that we can understand with the observations made with the 65- clinicians’ value. them what we’re getting into with year-old age group? the CAM approaches. Instead of pre- Third, consider whether robust What is the Role senting ourselves in the Marcus evidence exists to support the ap- of the US Food and Welby mode—the all-knowing proach. Individuals and groups Drug Administration oracle—we need to be clear and commonly offer what are promoted (FDA) and Its CAM upfront with our patients about what as “evidence-based” recommenda- Determinations? we know, what we don’t know, and tions when the actual support for Let’s look at what the FDA does, what are we going to do about it. the advocated position is based on so that when you hear that a drug somebody’s favorite article viewed has been approved by the FDA, Evaluating CAM in isolation from other work on the you’ll know what it means. Does it with Evidence: topic. It’s easy to find an article that mean that the drug is effective for Should We Integrate basically supports almost anything all patients? No! The FDA is charged CAM Into Our Practice? you want to support; the dilemma, with answering questions about the In addition to these principles of quite frankly, is that this approach safety and efficacy of the drug. These observation, several areas should is not good enough. Being evi- two words are very important. be considered when evaluating the dence-based requires systematic Some safety rules are limited both efficacy and side effects of CAM review and examination of all the in time and in how the evidence is modalities. literature relevant to a problem and collected; so, although these rules do First, keep in mind the timeframe must include recognition and ac- establish safety to the standards ap- when data are collected. You may counting for variation in study meth- plied, the FDA does not have a “crys- have to decide the effectiveness of odology as well as in problem for- tal ball.” The FDA is inappropriately

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 47 health systems Special Feature Using Evidence to Understand New Approaches

criticized for not being able to antici- a variety of alternative roles—some the work we do; we owe it to them pate future side effects of a drug, even of which are germane to what we to support that eminence by being though the rules the FDA functions will be talking about today. The is- truly evidence based. under do not require investigation into sue is not that the FDA is doing a these side effects. The FDA is asked bad job; the issue here is to be mind- Closing Comments to use a particular timeframe, to ex- ful of what the FDA can contribute In assessing the integration of CAM amine data in a prescribed way, and but also of what they can’t contrib- into our practices, I have given you to determine whether a drug is safe ute. They can give you some help, some thoughts that I hope blend the within those real constraints. The FDA but they can’t tell you everything. If a scientific approach with common does those tasks well. drug isn’t FDA-approved, you should sense. This approach is really about The FDA is also asked to conclude really be cautious; but even if the drug recognizing that, as physicians, we’re if a drug is efficacious: Does it really is FDA-approved, you still don’t nec- bringing to our dialogue with our work? Efficacy means that in a essarily know everything that you patients a certain amount of eminence controlled setting, with limits need to know about the drug’s ap- from our training and from our back- The FDA does placed on that setting, the drug plicability to a specific patient. ground as well as insight from our not demand has discernible benefit. The experience—but that all this must be that a drug be FDA does not demand that a Alternatives to combined with rigorous, complete better than drug be better than—or even Evidence-based consideration of the evidence. Only —or even equivalent to—other drugs that Medicine then will we really accomplish in our equivalent to exist for treating a particular Some folks in New Zealand re- practices what we’ve set out to do. —other drugs medical problem. I’m not sure cently shared a tongue-in-cheek I will stop here. We will have a that exist for that fact is always clear to perspective on alternatives to evi- chance later with the panel discus- treating a people, but it is important to dence-based medicine.4 A few “op- sion to understand how and what particular realize that a drug can be ap- tional” approaches given by the aspects of CAM we might integrate medical proved by the FDA as having authors include: into our practices on the basis of problem. efficacy even if the efficacy is • Eminence-based medicine— available evidence. Thank you. ❖ substantially inferior to other The ability to make the same drugs or interventions. mistake with increasing confi- References So, a dilemma may arise because dence over an impressive num- 1. Lippman ME. High-dose chemo- you want to ensure that your pa- ber of years. therapy plus autologous bone marrow transplantation for tients get the right treatment for • Vehemence-based medicine— metastatic breast cancer. N Engl J them; limitations of FDA approval The substitution of volume for Med 2000 Apr 13;342(15):1119-20. are an important consideration evidence as an effective tech- 2. Bezwoda WR, Seymour L, Dansey when selecting a drug. That’s why nique for browbeating your RD. High-dose chemotherapy with FDA approval is an important first more timorous colleagues and hematopoietic rescue as primary step—but not the final answer—to for convincing relatives of treatment for metastatic breast cancer: a randomized trial [retracted establishing the effectiveness of a your ability. in J Clin Oncol 2001 Jun drug for a large population: We rely • Nervousness-based medicine— 1;19(11):2973]. J Clin Oncol 1995 on appropriately framed and con- Fear of litigation is a powerful Oct;13(10):2483-9. ducted randomized trials to give us stimulus to overinvestigation 3. Schrott HG, Bittner V, Vittinghoff E, this information. Even if these trials and overtreatment. In an atmo- Herrington DM, Hulley S. Adherence to National Cholesterol are conducted, they may lag behind sphere of litigation phobia, the Education Program Treatment goals initial FDA approval. only bad test is the test you in postmenopausal women with Another issue is that FDA-approved didn’t think of ordering.4 heart disease. The Heart and drugs are available for any practice As with most good humor, this Estrogen/Progestin Replacement situation, not only those addressed work has its root some actual real- Study (HERS). The HERS Research Group. JAMA 1997 Apr 23- in the approval documents. Basi- ity and truth. I point these alterna- 30;277(16):1281-6. cally, physicians can prescribe al- tives out to you just so you can rec- 4. Isaacs D, Fitzgerald D. Seven most any FDA-approved drug with- ognize that there are a variety of alternatives to evidence based out being restricted to using it for reasons why we do what we do. medicine. BMJ 1999 Dec the approved purpose. On a serious note, our patients and 18;319(7225):1618. The FDA reviews drugs that have peers have assigned eminence to

48 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems Complementary & Alternative Medicine Symposium Dietary Supplements and Botanical Medicines: A Commonsense Approach

Introduction cans access to dietary supplements. In my opinion, how- Dr Low Dog: That was excellent, Dr Wallace. You pro- ever, the legislation did little to address the issue of pub- vided a great lead-in, because I’m also going to discuss lic safety; what it did was maintain that dietary supple- the FDA. However, I want to focus primarily on two ar- ments will be regulated as food under food regulations. eas that are growing in popularity: dietary supplements The problem with this step is that we accept a cer- and my area of expertise, botanical medicines. tain level of safety regarding food as long as it is pre- Tieraona Low Dog, MD For some cultures in the United States, herbs never pared and handled correctly. By regulating these sub- Clinical Lecturer, went out of style. They remained, especially in cultur- stances as food, we took away the FDA’s ability to Department of Medicine, ally intact communities. I am from New Mexico, where demand safety data before these substances are released Fellowship in Integrative Medicine at the many people use herbal medicines, although they use into the marketplace. Because of this Act, manufactur- University of Arizona them in the context of their own cultural background ers of products introduced into the marketplace after and history. We have done research in those groups 1994 are not required to give the FDA any information and found that they learned about herbal medicines from about their safety. Now, as Dr Wallace stated, the FDA their parents, their grandparents, their aunts and uncles; is asked only to prove that something is unsafe. That and that they use herbs such as chamomile, lavender, sounds easy, but it’s not: Chasing the horse after it has and spearmint—benign herbs that are quite safe. already left the barn is actually quite difficult and very My main concern today is not with these groups of inefficient. people; instead, my concern is primarily directed toward the folks who do not have a culturally intact Foods and Plants are Not Always Safe! memory, if you will, for how to appropriately use herbs. We are the only country in the world that has chosen They’ve read about it in a magazine or book, they’ve to regulate botanicals and dietary supplements as food. heard about it on the news, and, of course, many— Some herbs, such as garlic, oregano, and basil, are foods like my mother, for example—think that if they read it, as well as spices; however, other plants—goldenseal root, then it’s true, especially if it’s in Prevention magazine. poke root, and blood root, for example—are not foods: I will be covering just a couple of topics, including They were never consumed as foods but were used as regulatory status; quality control issues; herb-drug inter- medicine. These plants are pharmacologically active and actions; our current state of science regarding several herbs; really have no place in a “food” category. Categorizing and the issue of selling these products in your office. dietary supplements as foods that do not require any safety data prior to release into the marketplace has led The Saga of Regulatory Oversight to problems such as encountered with combining ephe- Starting around 1991, a government movement—led dra and guarana for weight loss and potential liver toxin part by Dr David Kessler of the FDA—attempted to icity associated with kava. In my opinion, these prob- regulate dietary supplements more strictly. Well, as you lems will continue until this issue has been addressed. know, the American public does not like being told that they’re not going to have access to things that they What’s Really in the Packet? Problems want. Driven in part by a lot of misinformation that in- of Mislabeling and Underlabeling stilled fear, people wrote letters to their representatives Mislabeling and underlabeling are very real problems. in Congress; and the only topic in the history of our I am currently the Chair for the United States Pharma- country that prompted more letters from the public to copoeia (USP) Dietary Supplements/Botanicals Infor- the government was the Vietnam War. That was how mation Expert Panel. The USP is a standard-setting body upset the American public was about losing their poten- for drugs and is now also setting standards for dietary tial right to freely buy herbs and vitamins! All of this led supplements. This situation is interesting because most to enactment of the Dietary Supplement Health Educa- entries in the old US pharmacopoeias from the 1850s tion Act (DSHEA), which basically guaranteed Ameri- and 1870s were botanicals. Why were pharmacopoeias

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 49 health systems Special Feature Dietary Supplements and Botanical Medicines: A Commonsense Approach

created in the first place, and what problems originally substance at the clinic were later diagnosed with pro- necessitated development of standards? Hundreds of gressive interstitial fibrosis of the kidney; in 30 of these years ago, our drugs were botanicals; but even then, women, terminal renal failure developed.5 The FDA consumers had to contend with problems such as adul- has banned products containing aristolochic acid; how- teration, contamination, and substitution of cheaper ever, a number can still be found on the shelves. herbs for more expensive herbs. PC-SPES was a popular botanical product that had A number of products coming from Asia (especially undergone clinical research indicating that the product products used in traditional Chinese medicine) have may be effective for reducing prostate-specific antigen been noted to be contaminated or adulterated. A study (PSA) levels both in androgen-dependent and in andro- in Taiwan1 found that of 2609 traditional Chinese medi- gen-independent prostate cancer. Preliminary data were cine products collected from the pharmacies of eight encouraging; however, questions of safety surfaced about hospitals, 23.7% were adulterated with undeclared phar- men taking PC-SPES who had pulmonary embolism6 and maceutical medication; and more than half of the adul- bleeding diathesis.7 The California Department of Health terated products contained two or more adulterants. tested several batches of the product and found that it The most common additives included nonsteroidal anti- contained warfarin. The FDA then removed the product inflammatory drugs (NSAIDs), diazepam, corticoster- from the market because of adulteration with a pharma- oid agents, and anticonvulsant agents. This problem is ceutical agent. Unfortunately, more investigation indi- real. In addition, concern is growing about presence cates that products sold between 1996 and 1999 were of toxic heavy metals (such as arsenic, lead, and mer- adulterated with indomethacin, diethylstilbestrol, or both.8 cury) in traditional Chinese medicines.2 The “bottom line” is that we have good reason to be Botanicals are not the only problem; other dietary cautious about the products available on our store supplements also have failed to meet their label claims. A shelves. You would have less of a problem if you lived University of California Los Angeles (UCLA) study3 as- in Europe, because these products are more tightly regu- sessed 12 products that were said to contain androstene- lated there. In the United States, we do a good job of dione and concluded that only one of these products giving the public access to dietary supplements, but we contained what it claimed on the label. One product had have done little to ensure that what they’re buying is twice the amount of androstenedione, one product didn’t actually what they think they are getting. contain any, and one product provided 10 mg per day of testosterone—a clinically significant Kava-Related Liver Damage amount, especially given that it was not Kava is an herb with proven anxiolytic declared on the label.3 The point I want properties. This herb has been popular in The “bottom line” to make here is that, of 12 products, only the South Pacific as a mildly intoxicating is that we have one contained what it said it contained! beverage as well as a medicine. I always good reason to be The other area of concern in the mar- enjoyed it while traveling through the is- cautious about ketplace is the widespread use and advertise- lands of Fiji and Samoa and found it useful for occasional the products ment for products containing ephedra and neck and back pain, especially when traveling and not available on our guarana. Now, tell me how much sense it makes sleeping well. Kava is generally sold as a concentrated, store shelves. to market to athletes a product that increases standardized product, mostly from Germany. heart rate, raises blood pressure, and is labeled In November 2000, German health authorities issued with instructions to take the product 30 min- a warning alerting the scientific community that nine utes before heavy exercise! We should not be surprised patients had been diagnosed with what seemed to be when adverse events are reported. kava-related liver damage. The German authorities asked In addition to problems with manufacturing, some for feedback from the industry, requested manufactur- botanicals contain naturally occurring toxic constitu- ers’ safety data, and began networking with the other ents. Aristolochic acid poisoning received a great deal European drug-regulating agencies. By November 2001, of attention after a tragic accident occurred at a Bel- 29 cases of possible kava-related hepatotoxicity were gian weight loss clinic that had ordered the relatively reported in Europe, and the FDA had received reports safe herb Stephania tetandra from an herbal supplier. of as many as 62 adverse events associated with kava. Instead of this herb, the clinic received Aristilochia Germany has removed kava from both the over-the- fangchi, a botanical which contains aristolochic acid, a counter and prescription markets; France, Switzerland, known nephrotoxin.4 Seventy women treated with this and Canada have followed. The United Kingdom and

50 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems Dietary Supplements and Botanical Medicines: A Commonsense Approach Complementary & Alternative Medicine

Ireland also will probably remove kava from the mar- and quality—meaning that it contains Symposium what it claims to ketplace. The FDA is “investigating” the matter, and kava contain and nothing else—certainly that will be a step is still readily available in the United States; however, a forward for the consumer. But although I think it will number of lawsuits against the manufacturers of kava help, the number of companies coming forward products are currently underway. Although people have to participate in this certification process are few. We do not have argued that kava has been safely used for thousands of standardized, years, the substance was used in a very small, geneti- Herb-Drug Interactions validated cally isolated group of people who used a water- Attending a talk yesterday, I listened to an analytic extracted preparation that was not concentrated to con- acupuncturist describe the way in which practi- methods for tain 70% kavalactones! Hepatotoxicity appears to be seen tioners learn the properties of an herb so that evaluating most primarily when kava is taken in highly concentrated herb-drug interactions can be prevented. This de- of these plants, forms. In the United States, I will remind you, some scription was his explanation for why we don’t and developing adolescents use kava as an intoxicant at parties, some- see many herb-drug interactions. Understanding USP standards times taking as much as 20 times the recommended the pharmacologic actions of an herb will cer- is a long, dose. People who take kava in concentrated form, take tainly yield some insight into its potential “class” tedious process. kava for a long period of time, combine kava with alco- interactions; however, without appropriate phar- hol or acetaminophen, or choose more than one of these macodynamic and pharmokinetic studies, we have behaviors may just end up having liver failure.9 no way to accurately predict which herbs might interact with a given drug. Nothing inherent in the known prop- Complexity of Botanicals, erties of St John’s wort would have allowed us to predict Attempts to Verify Quality that it interacts with two metabolic processes within the I want to point out that botanicals are complex and are body: the P450 CYP3A4 system and P2 glycoprotein.10 therefore somewhat difficult to study. We do not have stan- Whether or not St John’s wort interacts with oral con- dardized, validated analytic methods for evaluating most traceptives has not been explored until recently. A study of these plants, and developing USP standards is a long, presented in March 2002 found that more than half of the tedious process. Although typical medicines contain one women receiving birth control pills (norethindrone) who isolated chemical, plants contain hundreds of constitu- then started taking St John’s wort had a decrease in estro- ents in varying amounts. Constituents vary from plant to gen levels and had breakthrough bleeding.11 plant, depending on such factors as when the plant was What about herbal interactions with warfarin? I tell harvested, how it was dried, and how much rain it re- medical residents: If a question on an exam ever asks ceived. Some active constituents in the plant may vary which of the following drugs herb X interacts with and thirtyfold. However, although standards are difficult to de- warfarin is listed as an option, check that one. In general, termine, we are not excused from solving the quality con- patients taking any drug with a narrow therapeutic win- trol problem that currently exists in the United States. dow (eg, anticonvulsants, cardiac glycosides, warfarin) I want to tell you about two initiatives currently be- should be counseled to be cautious about using dietary ing conducted in the United States to address quality supplements. My bottom line with patients in my own control issues by developing quality verification pro- practice is that the more necessary that a drug is for life grams. Existing in addition to the USP is another group, and the more narrow the therapeutic window, the fewer the National Sanitation Foundation (NSF), which certi- choices they have for exploring the use of dietary supple- fies water filtration systems. If a company is willing to ments and herbal medicines. We try to choose more submit to a Good Manufacturing Practice (GMP) audit noninvasive types of alternative therapy—including mas- by having its manufacturing facility inspected and then sage, meditation, biofeedback, and yoga—if that’s what having their products randomly tested four times a year, the patient is looking for. That way, at least the patients then the company may place a certification seal on the are not ingesting problematic substances and may im- front of their product’s label. This seal is not an en- prove their health without using substances that may al- dorsement of the efficacy of the product, but it does ter the mechanism of response to necessary medications. indicate that the bottle contains what is stated on the label. This certification will go a long way toward as- The Danger of Observation suring American consumers that they are getting a qual- Alone in Evaluating Efficacy ity product. For example, if one of the 20 ginkgo prod- A growing body of research about plants supports what ucts on the market receives a certification seal for purity Dr Wallace said about the need to be very cautious about

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 51 health systems Special Feature Dietary Supplements and Botanical Medicines: A Commonsense Approach

observation. For instance, I love reading the stories about one of the alpha blockers was a three-week study—and, digitalis. A book written in the 1860s or 1870s presented of course, you should know that saw palmetto doesn’t 32 diseases that should be treated with foxglove, a plant work in three weeks. If you’re looking for a rapid effect, containing cardiac glycosides (digitalis). The list of dis- you’re not going to find it in saw palmetto: It really doesn’t eases included typhoid, dysentery, and a range of other begin to take effect for six to eight weeks, and the effects ailments. When viewed from a purely observational are maximized at about three or four months—so a regi- perspective, treating these ailments with foxglove made men of this substance must be started early. The USP has sense to early practitioners, as digitalis slows the heart recognized the once-per-day (320 mg/day) and twice- rate. Because digitalis was observed to slow the rapid per-day (160 mg twice daily) dose for saw palmetto. pulse that normally accompanies a high fever, digitalis Glucosamine is another dietary supplement that really was used commonly as a treatment for fever and infec- prompts the question of whether it should be consid- tious disease; however, it also killed people. ered alternative or complementary medicine. I don’t re- If you look back through history, you’ll find that many ally like either term, because every treatment modality, of these plants in fact had some effect on the vast array dietary supplement, and botanical gets included in it. It of conditions we treated but that we had no explana- doesn’t matter if you’re talking about homeopathy, mas- tion for these effects. There were probably a few ail- sage, energy medicine, iridology, or botanicals; we just ments for which an herb was truly efficacious, but it is throw everything under this umbrella of “CAM.” Sixteen unlikely that a single herb could treat the hundreds of trials on glucosamine now exist; however, all but one problems that were sometimes claimed. have shown benefit.14 The Cochrane Review issued a positive recommendation, finding that glucosamine was Dietary Supplements Proven more effective than placebo.14 Actually, several studies Effective: Saw Palmetto showed that glucosamine was as effective as NSAIDs,14 and Glucosamine, but and the Lancet study15 may have actually shown joint not Chondroitin preservation by glucosamine in osteoarthritic patients. Because preparations of saw palmetto, glu- Patients obtained tremendous relief with glucosamine cosamine, or chondroitin cannot be pat- compared with placebo, and radiographic imaging ented, pharmaceutical companies have no showed greater joint preservation (in the knee) in pa- incentive to produce them or to do the research needed tients who received glucosamine;15 however, follow-up to ensure their safety and efficacy. This lack of patent studies are needed to determine if glucosamine is actu- protection hinders research on botanicals and other ally our first disease-modifying agent for osteoarthritis. dietary supplements in this country by preventing manu- When I spoke recently to a group of rheumatologists, I facturers from collecting a sufficient return on their re- asked how many of them would recommend glu- search investment. cosamine in an older patient who may not be a great Despite this fact, some success stories have been re- candidate for treatment with NSAIDs. Most of them felt ported. We are now able to state with some certainty comfortable recommending glucosamine—a response that saw palmetto is more effective than placebo for very different from responses given three and four years treatment of mild benign prostatic hypertrophy (BPH). ago. So, now I need to ask, why isn’t glucosamine more In addition to one meta-analysis12 that was done, the available on a formulary? You still have to buy it from Cochrane Review also has issued a favorable position.13 Sam’s Club or Wal-Mart or the health food store, not Saw palmetto is indicated for patients who have mild with a copayment at the hospital pharmacy. symptoms, no sign of clinically significant obstruction, Although studies show that glucosamine is effica- and normal creatinine level. I have to question why saw cious, studies on chondroitin are less impressive: The palmetto isn’t available on more hospital formularies. bioavailability of chondroitin taken orally is still un- It’s not really a choice for many patients because a $2.00 clear. Because chondroitin costs about twice as much copayment is required for terazosin as compared with as glucosamine and has unproven effectiveness, pa- $28.00 for saw palmetto at the local health food store. tients are probably better off in the long term to use However, if I have an elderly, normotensive man with glucosamine without chondroitin. very mild symptoms of BPH and don’t want to give him something that might make him orthostatic, recommend- A Few Closing Comments ing saw palmetto as initial therapy may be wiser. In conclusion, I just want to comment again that I think The only good study that compared saw palmetto with this terminology of “complementary” and “alternative” is

52 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems Dietary Supplements and Botanical Medicines: A Commonsense Approach Complementary & Alternative Medicine

problematic. Medicine should really be about what works—the best choices Symposium that can be made from what we know at the time, and remedies and treatments that present the least harm. We need to be careful not to place something in the category of complementary and alternative and then add to it a lot of mysticism and pseudoscientific information and present it as something that it isn’t. We do want to offer people choices and options for therapy—but only for options that are proven or that offer some reasonable hope of benefit. I believe that further research will help us learn a lot more about the potential benefits and pitfalls of botanicals and dietary supplements. The Natural Medicines Comprehensive Database (www.NaturalDatabase.com) is a good resource for health care professionals. People argue that it’s a little conservative, but I think we should err on the side of conservatism, especially when we are not familiar with the subject. All right, I think I’ll stop there. I look forward to your questions during the panel question-and-answer session. Thank you. ❖ New Alternative Medicine References Database— http://pkc.kp.org/ 1. Huang WF, Wen KC, Hsiao ML. Adulteration by synthetic therapeutic substances of PKC (Permanente Knowledge Connection) has just traditional Chinese medicines in Taiwan. J Clin Pharmacol 1997 Apr;37(4):344-50. added a new alternative medicine database called 2. Cheng TJ, Wong RH, Lin YP, Hwang YH, Horng JJ, Wang JD. Chinese herbal medicine, “Natural Standard” to its suite of products. To access sibship, and blood lead in children. Occup Environ Med 1998 Aug;55(8):573-6. this site, click on the URL: http://pkc.kp.org/, and you 3. Green GA, Catlin DH, Starcevic B. Analysis of over-the-counter dietary supple- will find “Natural Standard” listed under the Drug, Lab ments. Clin J Sports Med 2001 Oct;11(4):254-9. 4. Vanherweghem LJ. Misuse of herbal remedies: the case of an outbreak of terminal & Formulary category. renal failure in Belgium (Chinese herbs nephropathy). J Altern Complement Med Natural Standard is an international research collabo- 1998 Spring;4(1):9-13. ration that aggregates and synthesizes data on comple- 5. Lee TV, Wu ML, Deng JF, Hwang DF. High-performance liquid chromatographic mentary and alternative therapies. Using a comprehen- determination for aristolochic acid in medicinal plants and slimming products. sive methodology and reproducible grading scales, J Chromatogr B Analyt Technol Biomed Life Sci 2002 Jan 5;766(1):169-74. information is created that is evidence-based, consen- 6. Schiff JD, Ziecheck WS, Choi B. Pulmonary embolus related to PC-SPES use in a patient with PSA recurrence after radical prostatectomy. Urology 2002 Mar;59(3):444. sus-based, and peer-reviewed, tapping into the collec- 7. Weinrobe MC, Montgomery B. Acquired bleeding diathesis in a patient taking tive expertise of a multidisciplinary Editorial Board. The PC-SPES. N Engl J Med 2001 Oct 18;345(16):1213-4. aim of this collaboration is to provide objective, reli- 8. Sovak M, Seligson AL, Konas M, et al. Herbal composition PC-SPES for manage- able information that aids clinicians, patients, and ment of prostrate cancer: identification of active principles. J Natl Cancer Inst health care institutions to make more informed and 2002 Sep 4;94(17):1275-81. safer therapeutic decisions. 9. American Academy of Ambulatory Care. American Board of Ambulatory Medicine. For each therapy covered by Natural Standard, a re- What’s New. Kava and Serious Hepatoxicity [Web site]. Available from: www.ambulatorymedicine.org/news.asp?whichHeadline=3 (accessed search team systematically gathers scientific data and September 26, 2002). expert opinions. Validated rating scales are used to 10. Durr D, Stieger B, Kullak-Ublick GA, et al. St John’s Wort induces intestinal P- evaluate the quality of available evidence. Information glycoprotein/MDRI and intestinal and hepatic CYP3A4. Clin Pharmacol Ther is incorporated into comprehensive monographs which 2000 Dec;68(6):598-604. are designed to facilitate clinical decision making. All 11. Gorski JC, Hamman MA, Wang Z, Vasavada N, Huang S, Hall SD. The effect of St monographs undergo blinded editorial and peer review John’s Wort on the efficacy of oral contraception [abstract]. Clin Parmacol Ther 2002 Feb;71(2):P25. prior to inclusion in Natural Standard databases. 12. Wilt TJ, Ishani A, Stark G, MacDonald R, Lau J, Mulrow C. Saw palmetto extracts for You may look up information either by the name of treatment of benign prostatic hyperplasia: a systematic review [published erratum the herb or supplement or by using the “Condition Cen- appears in JAMA 1999 Feb 10;281(6):515). JAMA 1998 Nov 11;280(18):1604-9. ter,” where you can focus your search on a specific dis- 13. Wilt T, Ishani A, MacDonald R. Serenoa repens for benign prostatic hyperplasia. ease or condition and find strong scientific evidence, Cochrane Database Syst Rev 2002;(3):CD001423. unclear or conflicting scientific evidence, or traditional 14. Towheed TE, Anastassiades TP, Shea B, Houpt J, Welch V, Hochberg MC. Glucosamine therapy for treating osteoarthritis. Cochrane Database Syst Rev 2001;(1):CD002946. or theoretical uses that lack sufficient evidence. No pass- 15. Reginster JY, Deroisy R, Rovati LC, et al. Long-term effects of glucosamine sulphate on word is needed for the site if you are connecting from osteoarthritis progression: a randomized, placebo-controlled clinical trial. Lancet 2001 an in-house terminal. For further questions or comments, Jan 27;357(9252):251-6. please call Drug Information at 404-364-7076.

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 53 health systems Special Feature

Integrating CAM Into a Group Practice: The Experience of The Permanente Medical Group in Northern California

Introduction service was already in place. I am of Alternative Medicine position and Dr Ballance: One day, a patient told that in 1976, an emergency appointed Dr Harley Goldberg to it. came in and told me, “I don’t take department doctor from Walnut medicine.” Before I moved on, I Creek, Forrest Cioppa, returned from Early Alternative asked, “Do you take anything else?” a two-year study in England with Medicine Activities She said, “Oh yeah,” and pulled out Felix Mann and taught 35 of The Permanente Lee Ballance, MD Northern California a large bag of supplements—to which Permanente physicians how to do Medical Group Chief of Alternative I replied, “Well, so I see: If the FDA acupuncture. Two of them that I We needed to respond to several Medicine, TPMG will approve it, you won’t take it; but know of adopted the skill in their problems developing regionally. if they don’t approve it, you will.” practices. One was Russ Erickson, a First, we had to respond to the man- Then she laughed and said “Well pediatrician at the KP Richmond fa- date for chiropractic coverage for yeah, something like that.” What I cility; he is still very active in the Medicare patients. And how would considered medicine, she didn’t. American Academy of Medical Acu- we manage the issue of acupunc- Terminology has been a real chal- puncture. The other was Howard ture, which was being provided for lenge for our organization, just as it Liebgold, Director of the KP Vallejo almost anybody with any diagnosis? is for patients. Our CAM Advisory Rehabilitation Unit, which is the KP Very important, if we did acupunc- Group wanted to use the phrase “in- rehabilitation unit for all of North- ture at KP Vallejo, were we going to tegrative medicine,” but we decided ern California. When I arrived in provide it also at KP Walnut Creek? not to do that because it might con- 1980, it was mainly Dr Liebgold who At KP Redwood City? We knew that fuse the issue with the principle of was using acupuncture. A Chinese- many patients and members were Kaiser Permanente (KP) being an in- trained radiologist also had a small acu- coming to us for advice about nutri- tegrated model of medicine. Because puncture practice within the facility. tional supplements and about other we didn’t think we would get the When Dr Liebgold retired, his suc- treatment modalities. How should term “integrative medicine” accepted cessor expanded the acupuncture we respond to that need? in our integrated medical group, we practice in the Rehabilitation Depart- A 1996 survey of Northern Cali- had to continue with “complemen- ment and created an Alternative fornia Health Plan members and tary and alternative medicine.” Medicine Clinic at KP Vallejo. This clinicians by Nancy Gordon of our I’m going to talk about complemen- event created something of an up- Department of Research and David tary and alternative medicine within roar because it attracted publicity Sobel of Regional Health Education The Permanente Medical Group through the local press and in at least revealed that a large number of both (TPMG) in Northern California. You one national magazine. We started members and clinicians were using should know that we have about to get letters from all over the coun- alternative modalities and wanted three million patients and about 4000 try wanting to know if people could their health care system to incorpo- physicians. A major challenge for us come and use the service; if we rate such modalities.1 is to manage CAM in such a large had housing facilities so they The State of California Department patient population and with such a could stay with us; and if we of Managed Care required that if we diverse practitioner population. treated all sorts of maladies. This provided a service at one location, was the reason we decided to cre- we would have to provide this ser- The History of CAM ate the position of KP Vallejo Chief vice consistently to our three million in TPMG of Alternative Medicine. Soon there- health plan members in Northern Cali- When I came to KP Vallejo in after, the KP Northern California Re- fornia. This was one of our earliest 1980, I found that an acupuncture gion created the Regional Director challenges. We developed method-

54 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems Integrating CAM Into a Group Practice: The Experience of The Permanente Medical Group in Northern Complementary California & Alternative Medicine

ology based on safety, effectiveness, Early Challenges as CAM encourage people Symposium to consider—the and quality before we considered is Extended Regionwide use of glucosamine. It appears to be practical issues of implementation. For us, the major challenge was to very safe and seems to be about as Workgroups evaluated the evidence provide CAM services in a consis- effective as NSAIDs. The quality is- for acupuncture, manual medicine, tent, high-quality way across all KP sues have been addressed by our herbs, and mind-body interventions, facilities. For example, after the pharmacy and by national organiza- and this was a major task. The herbal therapy workgroup approved tions such as Consumer Reports and workgroups collected relevant lit- six herbal and supplement products, ConsumerLab.com. Glu- erature, reviewed the evidence, and the next question was how we cosamine is an over-the- If we’re created evidence tables. In our re- should manage availability of the counter product, so it’s not going to do views, we first considered safety products: Should they be placed on on our formulary. People are acupuncture at because if something was unsafe, the formulary? Where should they be going to pay a dollar a day if KP Vallejo, then why go further and assess effective- made available? Most important— they buy it from a warehouse we must have ness? Opportunity always exists to and this reflects the issue Dr Low store or a little more than that comparable disagree about efficacy, because re- Dog raised—how do we recommend if they buy it from us (be- services with sults are not always clear. something if we don’t know the qual- cause we don’t stock the vol- comparable If we believed that something was ity of the product? ume that the warehouse standards at all safe and probably effective, we then We asked the pharmacy services stores have). But to me, non- the major KP considered whether The Permanente department to evaluate several steroidal anti-inflammatories facilities … Medical Group could provide it to manufacturers so that we could be are inherently risky when members and patients in a high-qual- assured that the products were of used by older people, espe- ity way. This project did result in sev- good quality. Pharmacy Services con- cially to treat chronic conditions; and eral recommendations to the medi- ducted site visits to review manufac- even the safest NSAIDS carry a fairly cal group. We then created two turing quality and developed a short high risk of gastrointestinal bleeding. additional committees: an education list of products from which we pur- So, I often find myself encouraging committee and a research committee. chased specific products. The USP patients to give glucosamine a trial. Expanding from the original commit- Verification Program (USP-VP) now For intermediate categories, tees, we have identified a CAM rep- is available and has been presented Eisenberg talks about condoning or resentative at each major KP North- in Northern California. We have accepting CAM use. Many CAM op- ern California facility. The CAM agreed to use the USP-VP standard tions seem pretty safe but do not representatives meet regularly to in the future for products we pur- show evidence of efficacy or qual- guide implementation of CAM pro- chase. However, USP standards did ity—for example, use of valerian for grams and are the on-site contacts at not exist for herbs and supplements sleep or chiropractic for “tennis el- their home facilities. when we began this project. bow.” You might say to somebody We have developed several guiding who wants to try these, “I have no principles for our medical group as Framing the Clinical evidence that they will work, but I we considered alternative medicine. Discussion of think it probably wouldn’t hurt, so it Probably the most important is that Alternative Treatments sounds reasonable to try it; come we must be consistent across the KP A recent series of articles in the back and tell me what happens.” This Northern California Region: If we’re Annals of Internal Medicine has approach assumes that you have going to do acupuncture at KP Vallejo, been edited by Eisenberg and evaluated the problem and have of- then we must have comparable ser- Kaptchuk and is well worth your fered the patient the standard op- vices with comparable standards at all attention.2-13 The articles address tions that you have available. the major KP facilities—whether the basic questions: What is alternative An example of something that I service is offered internally or referred medicine? What are its major treat- would discourage today would be out of plan. This rule is intended to ment modalities? How should we ad- the use of kava for anxiety. Al- prevent a patient being offered acu- dress the questions of malpractice and though this use has shown pretty puncture for an indication at one fa- integration? Eisenberg has ingeniously good efficacy, recent European re- cility and then hearing that their defined three categories of use: To ports of liver failure make me hesi- cousin or neighbor was refused the approve, to accept, and to discour- tant to condone use of kava until same request at another facility. We age. Working in musculoskeletal more is known. Eisenberg talks needed to have consistency. medicine, I often accept—or even about accepting, condoning, and

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 55 health systems Special Feature Integrating CAM Into a Group Practice: The Experience of The Permanente Medical Group in Northern California

discouraging use, and I think that have been prepared for acupuncture 7;135(3):196-204. that is a very good framework for and chiropractic. Where possible, 5. Kessler RC, Davis RB, Foster DF, et al. clinical discussion. CAM modalities have been included Long-term trends in the use of in patient educational material such complementary and alternative medical therapies in the United 14 Future CAM as the menopause guidelines. States. Ann Intern Med 2001 Aug Research at TPMG Classes in such practices as yoga, tai 21;135(4):262-8. We believe that anything we bring chi, qigong, and Feldenkrais move- 6. Eisenberg DM, Kessler RC, Van in must be evidence-based. We have ment have been instituted at most Rompay MI, et al. Perceptions about to agree at some level that the sub- of our facilities. complementary therapies relative to conventional therapies among adults stance is effective or safe, or else we who use both: results from a national have to make it a research project. If Conclusions survey. Ann Intern Med 2001 Sep one of our staff comes to us believ- We believe that CAM options that 4;135(5):344-51. ing that an alternative modality of- have been proven safe and effec- 7. Vandenbroucke JP, de Craen AJ. We believe fers great benefit, we ask them to set tive should not be distinguished Alternative medicine: a “mirror up a clinical study to see if they can from mainstream methods of care. image” for scientific reasoning in that we have conventional medicine. Ann Intern the population prove that to be the case. We are mov- I shouldn’t have my own practice Med 2001 Oct 2;135(7):507-13. of patients and ing to create an infrastructure that will where people come and talk about 8. Goldman P. Herbal medicines today interested support reasonable pilot studies for herbs while other physicians tell pa- and the roots of modern pharmacol- physicians to research projects that people want to tients that they don’t know anything ogy. Ann Intern Med 2001 Oct be in an do. We believe that we have the popu- about those things and that they 16;135(8 Pt 1):594-600. lation of patients and interested phy- should go and talk to Dr Ballance! 9. Ernst E. The risk-benefit profile of excellent commonly used herbal therapies: position to do sicians to be in an excellent position The solution to this problem is best Ginkgo, St John’s wort, ginseng, cutting-edge to do cutting-edge research. We have stated in a quote from my Chief of echinacea, saw palmetto, and kava. research. a standing CAM Research Committee Medicine, who recently retired after Ann Intern Med 2002 Jan in association with our Division of 25 years. He said, “What’s all the fuss 1;136(1):42-53. Research and have a growing num- about? If it works, everybody should 10. Meeker WC, Haldeman S. Chiropractic: a profession at the ber of research projects underway. Our do it; if it doesn’t, no one should.” crossroads of mainstream and Research Committee coordinator is The spirit of this quote probably best alternative medicine. Ann Intern available to consult with clinicians in- characterizes integration of CAM into Med 2002 Feb 5;136(3):216-27. terested in developing research trials. the practices of TPMG physicians. 11. Kaptchuk TJ. Acupuncture: theory, I will stop here and answer any efficacy, and practice. Ann Intern Education and CAM questions during the panel discus- Med 2002 Mar 5;136(5):374-83. 12. Cohen MH, Eisenberg DM. Another guiding principle has sion. Thank you. ❖ Potential physician malpractice been the importance of educating liability associated with comple- ourselves and our fellow practitio- References mentary and integrative medical ners as well as our healtlh plan 1. Gordon NP, Sobel DS, Tarazona EZ. therapies. Ann Intern Med 2002 Apr members and patients about the Use of and interest in alternative 16;136(8):596-603. therapies among adult primary care safety, efficacy, and quality of CAM 13. Kaptchuk TJ. The placebo effect in clinicians in a large health alternative medicine: can the interventions. We have sponsored maintenance organization. West J performance of a healing ritual have a series of regional teleconferences Med 1998 Sep;169(3)153-61. clinical significance? Ann Intern on various CAM issues. We have 2. Eisenberg DM, Kaptchuk TJ, Laine C, Med 2002 Jun 4;136(11):817-25. worked to make CAM resources Davidoff F. Complementary and 14. Kaiser Permanente of California. alternative medicine—an Annals available in the Clinical Library and Regional Health Education, series. Ann Intern Med 2001 Aug Northern California. Menopause: a in the Permanente Knowledge Con- 7;135(3):208. Kaiser Permanente guidebook for nection (PKC) so that our clinicians 3. Kaptchuk TJ, Eisenberg DM. Varieties women. [Oakland (CA)]: The can now access the most up-to-date of healing. 1: Medical pluralism in Permanente Medical Group; 2002. information from the desktop. Patient the United States. Ann Intern Med Available from: URL: http://clinical- tipsheets have been developed for 2001 Aug 7;135(3):189-95. library.ca.kp.org/clib/ 4. Kaptchuk TJ, Eisenberg DM. Varieties health_education/core/kaiser/ the herbs and supplements that have of healing. 2: A taxonomy of menopause_booklet/ been approved for use, and Fre- unconventional healing practices. menopause_full_text.pdf (accessed quently Asked Questions (FAQs) Ann Intern Med 2001 Aug September 26, 2002).

56 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems Complementary & Alternative Medicine Symposium Integrating CAM Into Practice: The KP Northwest Story

Introduction modality during the preceding 12 months.1 When the As a general internist with an interest in CAM, I find survey was repeated four years later, in 1997 (with the it exciting to be at Kaiser Permanente (KP), because data published in JAMA in 1998),2 the 34% figure had our group is at the cutting edge of integrating CAM increased to 42%! The data suggest that CAM use is with conventional care. We have a great story to tell! In widely prevalent among patients and that, far from rep- this discussion, I will paint a broad picture for you of resenting a fad, this use is increasing. Charles Elder, MD what we are doing in the KP Northwest Region (KPNW) Another figure illustrates the competitive pressures Clinical Investigator at in the area of complementary and alternative medicine which this use of CAM generates. In 1998, Landmark Kaiser Permanente (CAM). As we go along, you should be thinking, as an Health Care Corporation conducted a national tele- Center for Health Research, NWP individual practitioner, about how you can begin to phone survey of consumers to ask them how much actively integrate evidence-based CAM into your prac- importance they attach to CAM coverage when se- tice. As we, both as individuals and as an organization, lecting a health plan.3 Thirty-one percent of respon- gain increasing proficiency at doing this, the care ex- dents answered that CAM coverage is very important, perience for patients as well as for practitioners will 36% responded that it is somewhat important, and proportionally improve. 33% said that it is not important.3 We thus conclude First, I will talk about why we are interested in CAM that CAM use among patients is high and that for about in the first place. Then, against that backdrop, we will two thirds of patients, CAM coverage is a consider- look at what is happening in the Pacific Northwest. I ation when purchasing health insurance. These two will describe the networks of CAM providers to whom phenomena play an important role in propelling CAM we refer our patients, how we make those referrals, onto the health care agenda. and under what circumstances. Next, I will review sev- Physician practice patterns represent another impor- eral ongoing projects that introduce CAM practice within tant consideration. In a study by Gordon and Sobel our own medical offices. Finally, we will talk about the published in The Permanente Journal in 1999,4 the in- Oregon Center for Complementary and Alternative vestigators mailed a survey to all primary care clini- Medicine Research, an NIH-funded CAM research cen- cians and a subset of the obstetrics and gynecology ter based at the KP Center for Health Research (in Port- clinicians in the KP Northern California Region (KPNC) land, OR). When we have concluded, I think you will and received approximately 800 responses. Approxi- all clearly understand that we have a great story to tell. mately 70% of clinicians who responded were some- You should also gain at least a few practical ideas for what or very interested in having better CAM avail- integrating CAM that you can then take right back to ability for their practices. These clinicians were then your practice. asked to explain why they wanted this improved access to CAM. Although “growing patient demand” and Background of the CAM Movement the need for KP to “remain competitive” were cited as What is behind the CAM movement? Why do we even important reasons, these were not the most popular care about CAM in the first place? I’ll describe four answers; the two main reasons given by KPNC clini- forces that are propelling this phenomenon forward: cians for wanting improved CAM access were that 1) medical utilization, competitive pressures, physician patients are seen for problems that cannot be ad- practice patterns, and legislative mandates. Regarding equately treated with more conventional methods and medical utilization, I refer to a study published by that 2) the clinicians believed that many health prob- Eisenberg and colleagues in the New England Journal lems can be more effectively treated by using a mind/ of Medicine in 1993.1 The authors of that paper con- body or holistic approach than with a more conven- ducted a national telephone survey of 1539 adults to tional, Western approach.4 ask about details of their CAM use. Approximately one That most of the KP clinicians responding to the sur- third of respondents reported use of at least one CAM vey wanted better CAM access is important—but not

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 57 health systems Special Feature Integrating CAM Into Practice: The KP Northwest Story

surprising. What is fascinating, however, is that the main Accepted indications for referral are acute nonradicular reasons relate not to patient demand or to competitive back or neck pain only, for which most patient refer- pressures but to self-perceived shortcomings in our own rals are approved for a total of approximately six visits. conventional clinical paradigm. A pressing need to KPNW is using this Chironet referral mechanism with expand the armamentarium of the primary care clini- sufficient frequency that the possibility of providing cian thus represents another major force driving the limited chiropractic services as an internal service is CAM phenomenon forward. being considered. For naturopathic services, we simi- In addition to patient demand, competitive pressures, larly contract with a network called Naturenet. Histori- and physician practice patterns, legislative mandates cally, referral has been indicated for women with represent a fourth important factor in the equation. In perimenopausal symptoms in whom hormone replace- the state of Washington, the “any category ment therapy has failed or is contraindi- of provider” statute was enacted in 1995. cated; currently, these guidelines are un- … the group With approximately one third of our health der review. In practice, KPNW approves clinic is open to plan membership residing in Washington approximately two or three referrals per any member state, efforts to comply with this law have month for naturopathic care. who is had a substantial impact on operations in In addition to referral-generated con- interested in a the KPNW. Succinctly stated, the law man- sultations, some of our members’ em- holistic model dates that health insurance companies do- ployers purchase a product that allows of care and who ing business in the state of Washington the patient to self-refer to CAM provid- is referred by must provide coverage for clinically indi- ers. Substantial copayments and other another clinician cated health care services provided by any limitations apply, and patients who se- for treatment of category of provider for which there is a lect this plan are obligated to select from a subacute or licensing body in the state. In other words, among the network providers. chronic medical because Washington awards licenses to Although most of the CAM care pro- condition. acupuncturists, chiropractors, and vided by KPNW to our members is de- naturopaths, KP’s health plan must cover livered through these affiliated networks, those services when clinically indicated. Along with several efforts through the KP primary care, pharmacy, patient demand, competitive pressures, and physician health education, and other departments offer mem- practice patterns, the “any category of provider” stat- bers access to CAM services at our own medical of- ute has played a substantial role in shaping our ap- fices. As one example, KPNW offers an internal, refer- proach to CAM at KPNW. ral-based group integrative medicine clinic. The rationale inspiring the clinic stems from well-known What KPNW is Doing to Meet improvements in communication, quality, and cost, the Challenges of CAM which can be achieved by maintaining an internal re- Having a clear sense of why we are interested in ferral service (ie, versus an outside referral service). In CAM, we can now discuss efforts underway at KPNW addition, the clinic introduces further efficiency by us- to meet this challenge. First, we have established rela- ing the cooperative health care clinic model.6 Staffed tionships with local networks of CAM providers to pro- by a primary care physician and a nurse, the group vide services on a referral basis for our patients when clinic is open to any member who is interested in a these services are clinically indicated. For acupuncture, holistic model of care and who is referred by another referrals to an Acumed network provider can be ap- clinician for treatment of a subacute or chronic medi- proved only for Washington members in the setting of cal condition. The two-hour group session is mostly chronic pain or for nausea and vomiting associated didactic and encompasses dietary, behavioral, herbal, with either cancer chemotherapy or pregnancy. These and other modalities that are based on a Vedic medi- referral guidelines are based in large part on the NIH cine paradigm.7 After attending the group session, most consensus statement on acupuncture, which, though patients follow up with an individual return visit. Mem- released in 1997, nonetheless represents an excellent ber survey data suggest excellent patient satisfaction synopsis of the evidence base.5 Currently, we approve as well as excellent self-reported outcomes for patients one or two acupuncture referrals a week. attending this clinic.8 Chiropractic care is similarly available to most mem- The KPNW Regional Pharmacy Committee has ap- bers on a referral basis through the Chironet network. pointed a natural products subcommittee charged with

58 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems Integrating CAM Into Practice: The KP Northwest Story Complementary & Alternative Medicine

educating members and clinicians about herbal supple- practitioners, CAM providers, clini- Symposium ments and with evaluating supplements for potential cal investigators, pharmacists, nurses, inclusion in the over-the-counter shelves of KP phar- and others. Both patient macies. The committee conducts evidence reviews of and clinician popular herbal extracts and is responsible for identify- Conclusions satisfaction ing appropriate suppliers with good manufacturing prac- This impressive array of activities with the care tices. We expect that some supplements, such as glu- shows that KP is in a leading posi- experience cosamine sulfate, saw palmetto, ginkgo, and St John’s tion to support, at both practitioner stand to wort may be available to members at KPNW pharma- and system levels, integration of evi- dramatically cies in the near future. dence-based CAM into routine prac- improve as we The KPNW Health Education Department has sev- tice. The history of our group is one move forward eral CAM-related offerings for members. These offer- of bold and farsighted innovation, and with this work. ings include a women’s health education series (with it is incumbent upon us to provide some lectures led by naturopathic physicians) and a strong leadership on this issue. Individual clinicians class on managing stress and anxiety that teaches breath- can educate themselves to provide accurate informa- ing, visualization, and relaxation techniques as well as tion about CAM to patients, to refer patients to CAM a number of other stress management tools. In addi- providers when this is indicated, and to recommend tion to these programs, numerous individual KPNW herbal extracts for appropriate purposes. In addition, clinicians provide integrated care in a number of ways. some KP clinicians have received CME training in CAM For example, both hypnosis and healing touch are of- systems and modalities. Both patient and clinician sat- fered by trained clinicians at our regional pain clinic. isfaction with the care experience stand to dramati- Several osteopathic physicians in KPNW do spinal ma- cally improve as we move forward with this work. ❖ nipulation, and a dentist at our Temporomandibular Disorders (TMD) Clinic offers neurofeedback. References In addition to these clinical activities, KPNW is ac- 1. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins tive in the areas of both CAM education and research. DR, Delbanco TL. Unconventional medicine in the United States. Prevalence, costs, and patterns of use. N Engl J Med The KP Center for Health Research has been desig- 1993 Jan 28;328(4):246-52. nated one of about 16 NIH-funded CAM research cen- 2. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in ters in the country. Known as the Oregon Center for alternative medicine use in the United States, 1990-1997: Complementary and Alternative Medicine Research results of a follow-up national survey. JAMA 1998 Nov (OCCAM), the consortium includes investigators and 11;280(18):1569-75. clinicians from KP, from the Oregon Health & Science 3. Landmark Healthcare. The Landmark report on public perceptions of alternative care: selected findings [Web site]. University, and from four CAM colleges located in the Available from: www.landmarkhealthcare.com/98tlrI.htm Portland metropolitan area. OCCAM is currently con- (accessed September 26, 2002). ducting three large phase II clinical trials and also 4. Gordon NP, Sobel DS. Use of and interest in complemen- provides funds for smaller developmental projects, all tary and alternative therapies among clinicians and adult focusing on evaluating CAM interventions in the set- members of the Kaiser Permanente Northern California ting of craniofacial disease. In addition to these re- Region: results of a 1996 survey. Perm J 1999 Sum- mer;3(2):44-55. search projects, OCCAM offers research fellowships 5. Acupuncture. NIH Consens Statement 1997 Nov 3- to help train clinicians as CAM clinical researchers. 5;15(5):1-34. Several KPNW clinicians have been awarded funding 6. Beck A, Scott J, Williams P, et al. A randomized trial of by OCCAM, both for fellowship training and for de- group outpatient visits for chronically ill older HMO velopmental research. members: the Cooperative Health Care Clinic. J Am Geriatr In cooperation with OCCAM, KPNW sponsors a Soc 1997 May;45(5)543-9. 7. Sharma HM, Clark C. Contemporary Ayurveda: medicine quarterly CAM journal club that provides a forum and research in Maharishi Ayur-Veda. New York: Churchill for continuing education in the area of CAM research Livingston; 1998. as well as opportunities for discussion and network- 8. Elder C. Application of group outpatient visit model for the ing among members of the KP community interested delivery of integrative medicine at a health maintenance in CAM. These dinner meetings generally last about organization. Presented at the 2nd International Confer- two hours and are attended by a broad range of ence on Complementary, Alternative and Integrative Medicine, Boston, MA, April 12-14, 2002. health care professionals, including physicians, nurse

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 59 health systems Special Feature

Complementary and Alternative Medicine: Panel Discussion

Lee Jacbos, MD, Moderator

Moderator: I want to thank all selves to think about value. If we buy their herbs from any one com- dibular disease (TMD). Being in four of our experts recognize that value has two pany. Are there certain manu- an otolaryngology practice, I see for their highly infor- components—cost and quality— facturers that we can trust to this problem regularly. Our mative presentations. then we will clearly see that it is produce safe preparations? guidelines recommend a prosthe- It is valuable to have artificial to think about the cost of Dr Low Dog: You can go to sis and maybe physical therapy, experienced people addressing something without also thinking Consumerlab.com but I have patients who come back the issue from different perspec- about its quality. Our obligation, for I believe about to me very frustrated with our ap- tives. Now let me open it up for both as clinicians and as decision- $15.00 a year and you proach and not noting improve- comments or questions for our makers in administrative roles, is can see where they ment. I know of a dentist in the expert panel. to maximize the value of the ser- list all the companies that have community who sounded as Question from the Audience: vices that we provide to purchas- passed and failed testing. You will though he was into biofeedback Dr Ballance, do you have any ers as well as to members. I think find that the same companies and other alternative approaches, data on the cost-effectiveness and the way we should look at ques- nearly always pass or always fail and his patients have told me that utilization of your acupuncture tions like this is to ask, “Does this the tests. I will say that some of their problems have improved. service? actually improve the quality of the companies that always pass Are you finding that the mind- Dr Ballance: I am glad you what we are doing?” and “Is this the tests include Nature’s Way, body approach is much more asked that question. the way that we can best manage Twinlab, and Solgar, and that a important for a large number of The short answer is costs for our patients while maxi- number of other large companies these patients? no; we don’t yet have mizing value?” So, my caution have good quality. Dr Elder: As you point out, that data. We decided would be that whenever we start Consumerlab.com is a great TMD can be a diffi- to implement the program on the thinking, “What does this cost?” we group to support, because this cult condition to treat basis of our review of the litera- should also ask how it actually Web site provides information that using conventional ture. We believe that offering acu- works for our medical group and will help you know where the modalities. A mind- puncture is a good care option for for our patients in terms of add- problems are. body approach would seem like this population [patients with ing value. Question from the Audience: an appealing alternative. An in- chronic pain] and that it may be Dr Ballance: I want to make A quick follow-up: After you pay teresting finding in our pilot study more cost-effective than some of one other point. You should be your $15.00, do they give biblio- of mind-body techniques for our traditional approaches. At the aware that acupuncture is a very graphic references to your pa- TMD was that from a clinical same time, we realize that the bur- protean field. Acupuncture is tients, or do you send the patients standpoint, there was surprisingly den is on us over the next few years probably taught in several to the Web site? good compliance with these in- to prove that hypothesis with stud- schools—some that use Chinese Dr Low Dog: We tell them terventions. We offered patients ies, and we are beginning to put herbs and some that don’t. Our about the Web site and give them one of three mind-body interven- the infrastructure in place to do acupuncturists do not use these a handout that clearly states prob- tions: transcendental meditation, those studies. We are now in the herbs, because we do not have lems with certain medications and qi gong, or neurofeedback and process of collecting data on cost an adequate understanding of all the fact that a lot of quality issues found that, of those who presented and outcomes. The preliminary the issues of Chinese herbal exist. We also give them a list of for initial treatment and instruction, data are provocative, but, as I said, preparations. six companies that have repeatedly about 70-80% of patients regularly they are preliminary. Question from the Audience: met GMP standards as well as a practiced the techniques at home Dr Wallace: I just wanted to Dr Low Dog, you mentioned that list of the herbs that have been clini- and stuck with the relatively de- comment that when- you admonish us to be concerned cally tested in clinical trials. manding follow-up schedules. In ever we raise the is- about the safety of herbal prepa- Question from the Audience: addition, within-group improve- sue of cost, we need rations that people use. Patients Dr Elder, I noticed that you are ment in pain intensity scores for to discipline our- ask me all the time if they should doing research on temporoman- the treatment group was statisti-

60 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems Complementary and Alternative Medicine: Panel Discussion Complementary & Alternative Medicine

cally significant. So the short an- not “Anglo”; they are either Na- ity, we must redu ce defeSymposiumcts and these products. swer is yes. There are two other tive American or Hispanic. Know- errors. I would argue that a re- Dr Low Dog: Just a quick com- larger CAM TMD trials at our Cen- ing the culture and how to ask ferral to a gastroenterologist is a ment: With the botanicals, gas- ter for Health Research that are questions is essential. In addition defect if it is made without fully trointestinal symptoms are some still ongoing. In these trials, TMD to asking the usual questions— ascertaining that the person is of the most common side effects patients are being randomized to “Do you take any prescription taking a potentially liver-toxic because herbs can contain gas- treatment with a range of CAM drugs prescribed by the doctor?” substance. The best way to ap- tric irritants. Pharmacologically interventions, including acupunc- or “Do you take any over-the- proach defects is often system- active plants are rich in these ir- ture, massage, chiropractic care, counter remedies, like Tylenol or atically. That way, we can better ritants—alkaloids in particular— and naturopathy. I think the rel- Pepto-Bismol?”—you should use understand the defects in our and may contain substances that evant question for clinicians is, specific language: “Do you use system so that we can improve cause vomiting and that are toxic “Can we identify subsets of these any herbal remedies? Do you use the quality of the service we of- in larger doses. So, gastric upset patients who will be most likely any ginkgo? Do you use any fer. To do this, I think I would try is not uncommon. to benefit from particular CAM in- alhucema [Spanish for lavender]?” to identify early opportunities to Question from the Audience: terventions?” Most of my patients will respond, reduce defects and errors—for Dr Low Dog, is there a registry of Question from the Audience: “Oh, yes.” It is amazing: When example, by educating patients neonatal side effects and syn- I am a gastroenterologist, and I we first started doing this in the and clinicians. dromes resulting from botanical see a lot of patients who have emergency department, we just products? symptoms of irritable bowel syn- asked, “Are you taking any di- My own philosophy Dr Low Dog: That’s a good drome as well as abnormal liver etary supplements?” The answer … is that if the question. We don’t know the ef- test results. The patients typically was always, “No, no.” When you substance is not fects of many of these plants on have had a battery of tests (such start asking, “Do you use any something we would organogenesis or the implications as serologic testing or CT or MRI herbal products, such as ginkgo commonly consume for fetal outcomes. Data on scans before they even see me. The or echinacea?” people say, “Oh, in our diet … then whole-animal reproductive toxi- cause of these symptoms turns out yes.” My point is that you have they are really best cology exist for the top botani- to be that the patients were tak- to ask for specifics or else patients avoided. cals, such as echinacea and ing herbs. You just ask a simple will not tell you that they are tak- ginkgo. Many have been studied question—basic communica- ing botanicals. extensively in Germany. No mation—about what they have been Remember, patients have their Dr Ballance: I just wanted to jor problems have been identi- taking, and they pull out their bag beliefs and the culture of their add that I heard a story in the fied on the basis of this limited of herbs. At least 80% of my pa- community, and our beliefs and hallway a month or two ago information. My own philosophy tients are taking some sort of bo- our culture may be different. So, about someone who was admit- with patients is that if the sub- tanical tea or other herbs. being aware of their community ted for nausea and loss of appe- stance is not something we would Two questions: First, have you and what people are using is, I tite. When the dust settled, the cli- commonly consume in our diet— seen this side effect? I also was think, very important. To answer nician found that the symptoms foods such as chamomile, pep- wondering whether, in your future your question, I believe that this began when the patient started tak- permint, garlic, and oregano— studies of cost-effectiveness, you awareness will definitely decrease ing herbs and supplements. I agree then they are really best avoided. might consider measuring not unnecessary tests. I do think that with Dr Low Dog’s comments: We Question from the Audience: only the cost impact of the pain or if primary care providers can be need to ask patients about their Dr Low Dog, could you comment the disease process but also how a little more diligent, we can re- intake of herbs and supplements on the effectiveness of progester- awareness of these herbal agents duce costs and decrease the num- by using the most specific ques- one creams? might lower the cost of inappro- ber of referrals. tions we can. A recent study by Dr Low Dog: Sure. As long as priate referrals or the inappropri- Regarding the abnormal liver Nancy Gordon of our Division of the cream contains USP proges- ate use of imaging technology. test results and gastrointestinal Research showed that the yield is terone (usually 3%), there is Dr Low Dog: I think that part upset, slimming teas and diet teas substantially increased when pa- some evidence that it does help of the communication with pa- are loaded with diuretics, alka- tients are asked about specific with hot flashes and other symp- tients is about normalizing behav- loids, and glycosides that can supplements as opposed to being toms of menopause—especially ior and communicating so that the cause blips in their liver function asked more global questions about perimenopause. patient clearly understands the test results. “herb” or “supplement” or “alter- Obstetrics & Gynecology in 1999 questions. I live in New Mexico, Dr Wallace: My response native medicine” use. There is no published a year-long study1 of where 51% of the population is would be that to improve qual- universal name out there for all the effects of progesterone cream

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 61 health systems Special Feature Complementary and Alternative Medicine: Panel Discussion

on bone loss comparing proges- our case, the herb would make the were not compatible with the hy- do a randomized controlled trial terone cream against a placebo patient vomit. That substance is pothesis that the clinical effects of the impact of anesthesia on cream. Women in both groups then diluted into minuscule con- of homeopathy are completely surgery: Observation is absolutely were also given calcium and vi- centrations, which are then given due to placebo. Given that the adequate to make a valid conclu- tamin D. Both groups of women to the patient. The idea is that by homeopathic product is certainly sion in that context. But when had exactly the same bone loss, administering the substance in van- harmless—although not for the you begin to work with smaller and the authors concluded that ishingly small concentrations, it will pocketbook—it is probably fine effect sizes—things such as the progesterone cream does not pro- actually treat the patient’s symp- as long as patients don’t forego impact of hormone replacement tect bone. However, an interest- toms. An American Homeopathic regular medical treatment for an therapy on women who have caring finding was that the women Pharmacopeia [Homœopathic important problem. diovascular disease—the actual who received progesterone Pharmacopœia of Dr Low Dog: Well, impact is really pretty modest 2 cream had a strongly statistically the United States ] … you need just to conclude that compared with the whole popu- significant reduction in meno- sets the standards to use thought, let me em- lation, so you need to use meth- pausal symptoms within the first for homeopathic methodology phasize that the 1997 odology appropriate for the ef- six weeks after the study began. medicines. appropriate for study was a meta- fect you are evaluating. By the So, I think that if women want to In a sense, that is the effect you analysis for which the time you get to arguing whether use this cream, fine; but it should what we do in al- are evaluating. investigators lumped the analysis shows a marginal ef- not be relied on when oral estro- lopathic medicine together all homeo- fect, you have to take a step back gen is being taken—it should not when we immu- pathic trials, gathering and ask whether you are look- be used to complement the es- nize our patients or when we give everything on which a homeo- ing at something clinically and trogen in protecting the uterine allergy immunotherapy. pathic trial could be done. Apples biologically significant and endometrium. There is no doubt that home- weren’t compared with apples; the whether the only way to find the Question from the Audience: opathy is safe, but no evidence researchers rejected many studies effect is to torture the data over I have a question about patients shows that it is effective. A per- but included ones that compared centuries. And you have to re- who take little drops of some sub- son might have to consume 7587 different doses and different dilu- mind yourself of the problem that stance that they get in bottles gallons of an herbal preparation tions for different conditions. The you are trying to solve and con- from homeopaths. What are to get one molecule of the active conclusion was that the test sub- sider whether it is really worth these patients taking? substance, so I’m not surprised stances marginally edged out the it. You have to consider whether Dr Low Dog: The founder of that the herbal preparation is safe. placebo when the results were con- there are better ways to focus homeopathy was Christian I am also not surprised at the lack sidered as a whole. But how can your effort and whether to rely [Friedrich Samuel] Hahnemann, of evidence showing that it works. this result mean anything? How can on other things. an Austrian trained physician, Dr Elder: A couple of com- you compare a 6× dilution with a I think that is how I would fil- who developed the system of ments: Hahnemann and his fol- 100× dilution? So, the meta-analy- ter my skepticism about home- homeopathy in the early 1800s, lowers are said to have been pio- sis has been heavily hammered, opathy; I would ask whether we a time when physicians in the neers in random controlled testing and the conclusions were correctly have to look under that many United States treated many dis- of drugs and medications. So, he challenged. rocks to find something that sug- eases with bloodletting and ad- did us a great service in that area, Dr Wallace: When we look at gests benefit. If so, then we might ministration of arsenic, mercury, and you can see that his approach types of studies, we see sort of a want to look in other places— and toxic botanicals. was probably in hierarchy between observational places where I think there might Generally speaking, There is no some ways more studies and randomized con- be more direct kinds of evidence. homoeopathy is, in doubt that scientific than the trolled trials. I think meta-analy- Question from the Audience: essence, the opposite homeopathy observational and sis is really one step further up I am discouraged by some of the of allopathic medi- is safe, but no evidence-based ap- that hierarchy: observational tri- information today about the herb- cine. Let me use a evidence shows proach in place in als are at the bottom, then ran- als—especially the large amount case of a nauseated that it is the 1800s. domized controlled trials, and of money patients spend on these patient to demon- effective. Some limited then meta-analyses at the top. products, the poor quality stan- strate what home- evidence shows You may also consider that the dards for the ingredients, and the opathy is. The approach is to take that homeopathic products are ef- magnitude of the effect must be lack of evidence of their efficacy. an herb which, if administered in fective. Findings from a meta- taken into account when you are It seems to me it is the lucrative a reasonable concentration, would analysis by Linde and colleagues3 deciding what kind of trial to use. business that drives the marketing, actually trigger the symptoms. In published in the Lancet in 1997 For example, you don’t need to not an honest attempt to provide

62 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems Complementary and Alternative Medicine: Panel Discussion Complementary & Alternative Medicine

necessary medical care to patients. organization such as the Institute colonic therapy is Symposiumaimed at should stop here. I do want to Has the medical community of Medicine should implement a people who feel like they are thank the panel for their involve- failed? If the FDA can’t fix it, can review on the subject. unclean if their bowels are not ment. You four have presented a the medical community? Dr Ballance: I think Kaiser regularly moving. This marketing wonderful symposium that will Dr Low Dog: First, let’s talk Permanente can assume some of approach capitalizes on a long- help our medical group here in about just how widespread CAM these tasks ourselves. For ex- standing belief existing through- Georgia as we begin the journey is. I think it is important to recog- ample, today we have heard that out the history of medicine that to better understand the oppor- nize that the growth of CAM is true efforts on the West Coast are be- if the colon is not cleansed, tunities and challenges presented in some respects, but the statistics ing taken to identify evidence- people become ill. So I listen to by these alternative approaches. are actually inflated, and involve- based activities and then to iden- patients and then try to steer them I suspect that the readers of these ment in CAM may not be as wide- tify suppliers which achieve good toward foods that are actually proceedings in The Permanente spread as you think. If you look manufacturing standards. healthy additions to their diet, and Journal will also derive real ben- at David Eisenberg’s study,4 the Dr Elder: I agree. Kaiser I tell them to avoid things such efit from this dialogue regardless largest percentage of what folks Permanente can have a major im- as colonic therapy or laxatives. of where they are in the integra- were doing that we call “CAM” pact as the organization leverages Dr Elder: I would agree. When tion of complementary and alter- consisted of exercise, prayer, and its size and generates interest on the patient asks me about native medicine. ❖ weight management programs, the part of manufacturers to be- colonics, I generally discourage such as Weight Watchers. come involved in standardization their use. It is true that in some References There certainly is concern over initiatives so that our members CAM systems, such as western 1. Leonetti HB, Longo S, Anasti JN. the marketing of CAM. At the can be assured of product purity naturopathy and ayurveda, there Transdermal progesterone cream for vasomotor symptoms and White House Commission, we and accurate label claims. is a strong emphasis on maintain- postmenopausal bone loss. heard extensive testimony from Question from the Audience: ing strong digestion and keeping Obstet Gynecol 1999 Hispanic physicians who are very My question is for Dr Low Dog: the body free of toxins. As Dr Low Aug;94(2):225-8. concerned about the growing use Have you found any particular Dog points out, however, the best 2. Homœopathic Pharmacopœia of CAM among exclusively Span- botanicals efficacious for treating way to achieve this goal is simply Convention of the United States. ish-speaking people because they premenstrual syndrome (PMS)? through a healthy diet. In the Homœopathic Pharmacopœia of the United States. Southeastern are being specifically targeted. Dr Low Dog: With regard to bo- ayurvedic system, there is a pro- (PA): Homœopathic With regard to the quality of CAM tanicals for PMS, the Shellenberg cedure called “Pancha Karma,” Pharmacopœia Convention of the promotions, the Federal Trade trial on Vitex, or chaste tree berry, which is a seasonally administered United States; 1988. Commisstion (FTC) told the White was published in the British Jour- multimodality intervention, includ- 3. Linde K, Clausius N, Ramirez G, House Commission that in one af- nal of Obstetrics and Gynaecology ing therapeutic massage, inhala- et al. Are the clinical effects of homeopathy placebo effects? A ternoon—four hours—of going in 2001.5 The study showed good tion of herbalized steam, applica- meta-analysis of placebo- through Web sites looking for efficacy for all parameters of PMS, tion of heat, and administration of controlled trials [published fraudulent medical information, so I will often recommend chaste herbalized enema preparations. erratum appears in Lancet 1998 they found 400 such sites. These tree berry along with calcium. There is clinical trial data6 suggest- Jan 17;351(9097):220]. Lancet sites were blatantly fraudulent, mis- Vitex is its botanical name, chaste ing improvements in serum lipid 1997 Sep 20;350(9081):834-43. leading, and misrepresentative, es- tree berry is its common name. It values, lipid peroxide levels, and 4. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative pecially about conditions such as usually takes a couple of cycles, other cardiovascular risk factors medicine use in the United States, HIV and cancer. This is the kind of but most women do quite well on in patients who have undergone 1990-1997: results of a follow-up misinformation the public is ex- it, so I think is a reasonable ap- this multimodality procedure.6 So, national survey. JAMA 1998 Nov posed to. We have to figure out a proach for PMS. although the concept of detoxi- 11;280(18):1569-75. way to balance public access with Question from the Audience: fication is something that I think 5. Schellenberg R. Treatment for the premenstrual syndrome with public safety. Consumers want to We have talked a lot about ingest- we should not completely dis- agnus castus fruit extract: know that what they are buying is ing things and about using topi- miss intellectually, as a practical prospective, randomized, placebo safe and that it is actually what the cal medications. Practically matter—with the problems re- controlled study. BMJ 2001 Jan label says it is. We have an obliga- speaking, what do you tell the lated to quality control and the 20;322(7279):134-7. tion as a medical community to healthy young lady who comes to many unorthodox issues here—I 6. Sharma HM, Nidich SI, Sands D, provide them with this assurance. your office and wants your opin- suggest that we advise our Kaiser Smith DE. Improvement in cardiovascular risk factors In terms of taking action, the ion about colon cleansing? Permanente patients to avoid through Panchakarma purification White House Commission’s report Dr Low Dog: This comes up a colonic therapy. procedures. J Res Edu Ind Med recommended to Congress that an lot. A strong marketing effort for Moderator: Well, I think we 1993 Oct-Dec;12(4):2-13.

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 63 soul of the healer

Spider Web By Suzanne Ackley, MD

Dr Suzanne Ackley is an orthopedic hand surgeon with SCPMG in Orange County, California since 1986. She lives in Newport Beach, CA.

64 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems Clinical Information System (CIS) Baselets Help Standardize Evaluation of ADHD in the KP Colorado Region

By Mark Groshek, MD

Introduction Organizational Context for time is allotted to complete the evaluation. For more than three years, nearly all pa- Creating an ADHD Baselet •Provide tools that allow health care tient charting in the Kaiser Permanente (KP) In KP Colorado during the past two years, practitioners to adequately assess pa- Colorado Region (KP Colorado) has been the departments of pediatrics, family prac- tients both for signs of ADHD and for done in an electronic medical record called tice, mental health, health education, and signs of other disorders that may coex- the Clinical Information System (CIS), a na- pharmacy have formed the ADHD Task ist with or masquerade as ADHD. tional version of which is currently being Force (Table 1) to develop tools for stan- •Provide suggestions for appropriate treat- introduced to several KP Regions. One dardizing the telephone intake, clinical evalu- ment of ADHD when the condition is powerful tool in CIS is the baselet, a mod- ation, and treatment of health plan mem- diagnosed. ule containing a set of prewritten items that bers with ADHD. In developing its approach, •Provide tools to support close follow- can be inserted into a clinical progress the ADHD Task Force has drawn from re- up of patients diagnosed with ADHD. note. The purpose of this article is to de- cent guidelines published by the American • Ensure a cooperative relationship be- scribe a baselet instituted in KP Colorado Academy of Pediatrics (AAP),1,2 the Agency tween participating departments so that to help streamline telephone intake of for Health Care Policy and Research patients can make a smooth transition pediatric health plan members whose par- (AHCPR),3 the National Institutes of Mental between them when interdepartmental ents call to schedule an evaluation for at- Health (NIMH),4 and national experts5 as well referral is needed to provide proper care. tention deficit and hyperactivity disorder as from Best Practices guidelines developed (ADHD), often because the child is hav- in the KP Northern California Region.6 Description of the ADHD ing problems at school. To improve the quality of care to our mem- Baselet: Structure and bers, the task force has de- Processes veloped seven major goals: Baselets are among the most powerful tools Table 1. Attention Deficit and Hyperactivity Disorder •Assure that patients are in CIS and are conceptually similar to the (ADHD) Task Force members—KP Colorado properly screened for macro feature of word processing programs. Co-Chairs: Mark Groshek, MD Pediatrics signs of ADHD as well Both tools are designed to allow users to in- Bruce Doenecke, MD Pediatrics as for other mental sert prewritten items into a document by us- Carol Annibella, MSN, FNP Mental Health health disorders so ing only a few keystrokes instead of typing Thomas E Boschen, MD Pediatrics that they are seen in the item completely, letter by letter. In CIS Elizabeth A Chester, PharmD Clinical Pharmacy Services the department best baselets, prewritten items may include medi- R Edward Gibson, MD Mental Health equipped to do the ini- cal history, results of physical examination, Jeanne Habib, MD Behavioral Health/Diagnostics; tial evaluation. other types of assessment, physician orders, Clinical Management Consulting Richard E Koken, MD Pediatrics •Assure that information and other plans. Items can be inserted as Katherine T Morrison, MD Family Practice needed to assist in this full text or as coded terms. Any of these items Kathy Noll, MSN, CPNP Health Education evaluation is obtained may be selected (“turned on”) or deselected Nancy Rogers, LCSW Mental Health by clinical staff and (“turned off”) by the person who is chart- Annette Rothman, RN, CPNP CS Perinatal Home Care practitioners before the ing. Selecting an item causes the item to Michael S Seller, MD Pediatrics initial visit. become part of the patient’s permanent Wendy S Zerin, MD Pediatrics • Assure that adequate medical record; deselected items do not be-

Mark Groshek, MD, practices Pediatrics at the Arapahoe Medical Office in the Colorado Region, and is the Lead Physician for KP Online in Colorado. He is also an avid rower. Email: [email protected].

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 65 health systems Clinical Information System (CIS) Baselets help Standardize Evaluation of ADHD in the KP Colorado Region

Quotes From Nurses Using the ADHD Baselet

Caroline Koehler, RN, from the KP Colorado Region’s East Medical Facility, says, “The ADHD baselet is clear, concise, and easy to use. It’s an effective tool to accurately telephone triage these children. It gives the RNs a clear baselet to direct the patient to the appropriate department for continued care. Over- all, it’s a very helpful telephone triage tool.” “This has really streamlined the triage process for complicated behavioral concerns,” said one nurse of the KP Colorado Region’s Westminster Medical Facility. Another said, “It is a great prompting tool for guiding our phone interview for behavioral and emotional issues.” A third added “It really has helped me make appropriate triage decisions about whether to send the member to mental health or to pediatrics” for initial evaluation. “It’s very thorough and quite user-friendly,” said a fourth nurse.

come part of the permanent record. These features enable clinicians to edit items so that charting is done accurately for each patient. Because the clinician need not type everything by hand, a baselet can increase the speed and completeness of charting. In addition, blocks of text can be added to a baselet to provide instruction and guidance to users of the baselet. In the baselet for ADHD, such blocks include information about diagnostic criteria and treatment ap- Figure 1 of 2. Captured screen image, shown here in black and white, as seen when using the ADHD Triage Baselet, currently used in the KP Colorado Region. Sections shown with a light gray back- proaches for ADHD and for other related ground, which appear as yellow onscreen, have been selected to become part of the permanent disorders. As long as these blocks remain note in CIS. Sections shown with a dark gray background, gray onscreen, have been deselected— deselected, they do not become part of the either because they are instructional or optional—and do not become part of the permanent note in CIS. They can be selected with a single keystroke, in which case they do become part of the patient’s permanent chart. permanent note. Once a section has been committed, it has a white background. After the clinician has edited the informa- (Reproduced by license from IBM, joint developer of CIS with Kaiser Permanente of Colorado.) tion to accurately reflect the patient’s medical history and results of physical examination, this information is committed to the In addition, each department has one or more ing to be taken will be taken. Each depart- chart. At this point, the information becomes departmental in-baskets. When a clinician or ment specifically assigns persons to manage a permanent part of the medical record, and other staff member electronically signs a note the departmental in-baskets. blocks that were not selected are deleted in CIS, a copy of the note can be sent elec- Most appointments in the primary care de- from the chart. tronically to another person’s in-basket. All partments in KP Colorado are made by ap- Every clinician and other staff member who clinical staff may look at any in-basket, thus pointment clerks in the KP Colorado call cen- provides patient care using CIS has an in-basket. helping to assure that needed actions remain- ter. Because these clerks do not provide direct

66 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems Clinical Information System (CIS) Baselets help Standardize Evaluation of ADHD in the KP Colorado Region

patient care, they might not understand the time issues involved. Consequently, in the past, appointments for ADHD evaluation were frequently made in slots reserved for short appointments; this practice left inadequate time for complete evaluation. In addition, although packets containing forms used to assist evaluation were provided to the call center, these forms often were not sent to members—an omission that further hampered initial evaluation. Now, all calls regarding evaluation for ADHD or for behavioral problems (at home or at school) are sent directly to the primary care clinic for triage and appointment scheduling. The nurse who responds to the phone call opens the ADHD Triage Baselet (Figures 1 and 2). This baselet includes some explanatory text for the nurse in addition to a series of questions designed to assist in screening patients for clinically significant mental health problems. These questions are followed by a series of questions designed to assist in screening patients for signs of ADHD. The baselet includes instructions for the nurse in how to proceed on the basis of information provided by the health plan member. If the screen suggests presence of a clinically significant mental health problem, the nurse informs the caller that his or her needs are most likely to be served by scheduling an appointment with the mental health department. The completed note is routinely sent to the appropriate mental health facility, which then contacts the patient to schedule an evaluation. If the screen suggests that ADHD is the primary issue of concern, the nurse mails a packet of evaluation questionnaires to the patient’s family. An appointment is scheduled only after the completed forms are received; this procedure ensures that full information will be available to the clinician at the time of evaluation. If the problem seems to be neither ADHD nor a clinically significant mental health problem, the nurse schedules a general appointment for the patient. The baselet is designed so that the nurse making the telephone call can complete the baselet either while making the call or immediately afterward. Each yes/no screening ques-

Figure 2 of 2. Captured screen image. (Reproduced by license from IBM, joint developer of CIS with Kaiser Permanente of Colorado.)

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 67 health systems Clinical Information System (CIS) Baselets help Standardize Evaluation of ADHD in the KP Colorado Region

tion is followed by two text blocks, one say- simplifies charting of the intake encounter. Pediatrics. Subcommittee on Attention-Deficit/ ing “no” and one saying “yes.” This design The ADHD Task Force developed three Hyperactivity Disorder and Committee on allows the nurse to select the patient’s answer additional baselet groups in CIS to help Quality Improvement. Pediatrics 2001 Oct;108(4):1033-44. to the question quickly and easily—often streamline and standardize the approach to 3. United States. Agency for Health Care Policy using as few as two keystrokes—before pro- ADHD at KP Colorado. We plan to intro- and Research. Diagnosis of attention-deficit/ ceeding to the next question. The baselet duce those baselets in future Permanente hyperacticity disorder. Rockville (MD): Agency design also allows the nurse the flexibility Journal articles. ❖ for Health Care Policy and Research; 1999. of adding explanatory text if necessary to (AHCPR publication No. 99-0050) 4. Elia J, Ambrosini PJ, Rapoport JL. Treatment of explain the member’s answer to the ques- Acknowledgments attention-deficit-hyperactivity disorder. N Engl J Marcia E Howard-Odnert, RN, produced the CIS tion, thus ensuring that important informa- Med 1999 Mar 11;340(10):780-8. baselet screen shots. tion is not lost. 5. Barkley RA. Attention-deficit hyperactivity disorder: a handbook for diagnosis and treatment. Conclusion References 2nd ed. New York: Guilford Press; 1998. Feedback from nursing staff that use the 1. Clinical practice guideline: diagnosis and 6. Kaiser Permanente Northern California. ADHD ADHD baselet has been positive. These staff evaluation of the child with attention-deficit/ Best Practices Committee. Evaluation and hyperactivity disorder. American Academy of treatment of attention deficit hyperactivity members have found that the baselet helps Pediatrics. Pediatrics 2000 May;105(5):1158-70. disorder (ADHD): regional interdepartmental to explain the process of the evaluation thor- 2. Clinical practice guideline: treatment of the best practice model. [Oakland (CA): ADHD Best oughly to health plan members, helps en- school-aged child with attention-deficit/ Practices Committee; 1997]. sure completeness of intake screening, and hyperactivity disorder. American Academy of

The Reality of Tomorrow It is difficult to say what is impossible, for the dream of yesterday is the hope of today and the reality of tomorrow. Robert H Goddard, 1882-1945, physicist and rocket scientist

68 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 soul of the healer

You Can’t Go Home

By Calvin Weisberger, MD

hey say you can’t go home. Well, I tried. To be precise, really short. The property I grew up on was tiny. Where TI went back to what was my home for the first 16 home was now sits a low-slung bar populated by deni- years of my life to see what was there. I suppose I was zens straight out of Deliverance. The dirt I played in is still somewhat shocked—but then, perhaps I shouldn’t have there, the dirt where I fell learning to ride a bike is still been. When I grew up in Kingston/Edwardsville, in Penn- there. I don’t know about any of the people. The busi- sylvania, my neighborhood was decidedly the wrong side ness establishments are gone; most of the storefronts of the tracks. I never thought anything of it, because my are empty. The schools are closed. The streets throng street was home. The people seemed to be right out of with memories but few people are visible. Those who Damon Runyon or Jack London. There was Pidgy, Donald eyed the stranger with a camera, a sport coat and tie Duck, Gunshi, and a host of and stood next to a non- characters that would have descript white Oldsmobile spiced up Guys and Dolls. probably thought he was a Our grocery store was set federal agent photographing between two beer gardens. the bar/pharmaceutical es- Across the street were sev- tablishment. Well, I suppose eral pool halls, gambling home is gone, home has establishments, and a bowl- changed; or perhaps it’s me ing alley. While the coal who has changed. Perhaps mines were still in operation, Home is where the bar is? the essence of the place has people had worked and remained, and my reference lived there. Schools were full points have changed so of children; the standard much that I no longer can small business establish- appreciate what is there. If ments for a neighborhood there are children in that were operating. When I left neighborhood, it still is home at 16 or 17 to return home to them. It probably few times until medical still seems like a significant school and then not after, part of their world and not Main Street, Edwardsville, Pennsylvania I carried a pleasant image the depressed area it seems in my mind. That was 40 years ago and the pleasent to me. Instead of gray dirt and dingy buildings in disrepair, image remained in my engrams. Somehow I knew the Santa Monica is now my reference point. To my children, area had gone downhill with the demise of anthracite now adults, a wide tree-lined street with well-manicured coal mining. While I was in medical school, our store/ lawns and a thriving city around them is their “home” home burned down, and my mother moved away from memory. What will their home look like in 40 years? Will the street. I never returned to the area after the late 1960s. they be able to return and see the same neighborhood, or My first recent view of the street came on the detour will degeneration strike their roots? We all carry a compo- through it that I took following my mother’s funeral. The nent of where we came from in our personalities. We all image was so fleeting that nothing really stuck in my have behavior that is shaped by our early life experiences. mind. But last May, I returned to the street for the first Wherever we come from, whatever our home is like, we time in all those years to see what had become of my old carry it with us. As we carry fond memories of beloved neighborhood. After I got over the initial shock of being people, we can carry fond memories of home, whatever it there, all kinds of impressions flooded in. First was the has become. Perhaps in the end, home is not so much a impression of size. The Main Street I grew up on would place as an idea. Mine is still there—its corporeal reality just be an alley in Santa Monica. The block I grew up on was belies its spiritual existence. ❖

Calvin Weisberger, MD, is Regional Coordinating Chief of Cardiology for Southern California. He is co-author of the book Practical Nuclear Cardiology. He has written other pieces in various venues.

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 69 health systems How to Say No

Introduction that the patient has been waiting in the examination When patients demand medication, tests, or some- room, the clinician may say to the patient, “I am sorry thing not medically indicated, several things may go about the wait.” CPC Corner CPC through your mind: By Edward Wang, MD • Why is this happening to me? Elicit the Patient’s Perspective Andrew Golden, MD • Until now, I thought I was having a good day. A patient’s own explanation of his or her illness is Pamela J Butterworth, • Who does the patient think I am, their medical called the Explanatory Model1 and is an important con- MA, MHRD waiter? sideration in delivering effective medical care. The ability • No. No. No! to discover the patient’s perspective regarding his or The usual scenario might find you repeating phrases her medical condition is a crucial skill for clinicians such as the following: because it may prevent or defuse potential conflict with •“No, you don’t really need this, because …” the patient, who usually has a personal reason for re- •“There is no reason to order this [test, procedure] questing a particular drug or medical procedure. The or to either prescribe or take this [medication].” reason may seem illogical to the clinician, but it always As most clinicians know, taking this approach does deserves to be heard. A patient may, for example, be not always work. Well trained as we are in the medical afraid of catching pneumonia or being diagnosed with sciences, practiced as we are in the art of healing, and incurable cancer if a symptom is left unattended for wanting as we do to please our patients, we are often too long. A patient may be reluctant or unable to ex- unready to say no to patients when they want a par- press his or her theory and fear about the symptom. ticular prescription or test, even if it is unwarranted. Most of the time, the patient wants (and expects) the What strategies can we use to address these frequently clinician to relieve symptoms or address the patient’s uncomfortable situations? fear. This expectation must be met before the patient can obtain satisfaction; indeed, the emotional needs of Establishing Rapport the patient must be addressed before any treatment is Before a patient listens to your advice, a good clini- given. You must listen carefully for the psychological cian-patient relationship must be established. The trust reason why the patient has come to see you. Only then placed by patients in their clinicians must be estab- can effective reassurance be given. Questions such as lished up front. Often, however, this relationship must “What do you think is going on?” or “Are you afraid of be established in unfamiliar surroundings, such as the anything in particular?” may allow the patient to reflect emergency department or urgent care department. In and express his or her own perspective. these busy areas, where each patient-clinician interaction is very brief, establishing rapport—the first of the Empathy Four Habits of Highly Effective Clinicians1—is particu- Empathy is a skill that allows a clinician not only to larly important because it sets the tone of the interac- understand patients (ie, by identifying their emotions) tion, during which the patient must develop the trust but to effectively reassure them (ie, by verbalizing this essential for hearing (and accepting) medical informa- understanding). By expressing this understanding ver- tion and adhering to therapeutic regimens. To estab- bally, clinicians can show that they care for their pa- lish rapport with the patient, the clinician may say some- tients’ well-being and thus promote patients’ trust. For thing personal or use “small talk” upon entering the example, a clinician may say, “This cold must have been examination room. For example, if the clinician knows terrible for you!” or “Your headaches must have scared

Edward C Wang, MD, (left) is an Internal Medicine physician at Woodland Hills Kaiser Permanente Medical Center in Southern California. He is the chair of the Southern California Clinician-Patient Communication Committee and is very involved in the wellness of physicians in the region. E-mail: [email protected]. Andrew Golden, MD, is the Chief of Family Practice, SCPMG. E-mail: [email protected]. Pamela J Butterworth, MA, MHRD, is a Senior Consultant for the San Diego Member Service Area of SCPMG. E-mail: [email protected].

70 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems How to Say No

you! Since your dad had a brain tumor, you must be being caused by a brain tumor). These initial reasons thinking that maybe you have the same illness.” should be addressed, and the treatment goals formulated by the end of the visit should be consistent with Acknowledging Difficulties, Being the reason that initially prompted the patient to visit Flexible, and Setting Boundaries the clinic. Technical language should be When disagreement or dissatisfaction—expressed used only sparingly, if at all, and words Often, if you verbally or nonverbally—develops while interviewing should be chosen to address directly the acknowledge the patient or while administering treatment, clinicians patient’s initial concerns. For example, the the difficulty sense this difficulty but often do not address it. A clini- clinician might say, “You don’t have a brain internally to cian may have many reasons for refusing to acknowl- tumor” instead of saying, “There is only a yourself and edge conflicts. “I don’t have enough time” or “I don’t 2% chance that the MRI result would be verbally to the want to get into an argument” are examples of these positive.” Other important tasks are to in- patient, that reasons. However, the conflicts will probably resur- volve the patient in making the final deci- patient will take face later: The patient may initiate another office visit sion about treatment and to check for ad- the first step or develop distrust of the clinician or medical care sys- herence to prescribed therapeutic regimens. toward tem. Often, if you acknowledge the difficulty internally negotiating to yourself and verbally to the patient, that patient will Conclusion a helpful take the first step toward negotiating a helpful com- The Four Habits Model1 serves as a use- compromise. promise.2 One such statement acknowledging a diffi- ful communication template for enabling cult situation could be, “I can see that we are having clinicians to say no to patients who demand some difficulty here in agreeing on the treatment plan.” inappropriate drugs or medical procedures. Clinician- In saying no, your flexibility is at issue. Therefore, when patient conflict—and the nonadherence that frequently a conflict occurs, be conscious of whether you want more results from this conflict—can often be avoided if the flexibility or whether you must set firm boundaries.2 clinician uses empathetic, clear communication; nego- tiation based on acknowledgment; the ability to set Invest in the End boundaries; and flexibility. ❖ Clinicians are generally more able to identify problems than to communicate findings. Patients who re- References quest antibiotic drugs or diagnostic tests are usually 1. Frankel RM, Stein T. Getting the most out of the clinical asking for symptom relief: They may request medica- encounter: the Four Habits Model. Perm J 1999 Fall;3(3):79-88. tion to cure a cold or may seek reassurance in the form 2. White MK, Keller VF. Difficult clinician-patient relation- of negative test results (eg, requesting magnetic reso- ships. Journal of Clinical Outcomes Management 1998 nance imaging [MRI] to prove that a headache is not Sep-Oct;5(5):32-36.

Understanding One should aim not at being possible to understand, but at being impossible to misunderstand. Quintillian, 35-96 AD, Roman teacher of Rhetoric

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 71 soul of the healer

In Memory of Carol Abramowski, RN, NP, MS December 14, 1945—April 26, 2002

IT WAKES YOU UP TO LIFE WHEN SOMEONE CLOSE TO YOU DIES MOMENTS IN SMALL ELEVATORS IN UNION WITH PERFECT STRANGERS BECOME SIMPLE RAPTURE

CLIMBING EIGHT FLIGHTS OF STAIRS ON ANY GIVEN DAY A STRUGGLE BECOMES EFFORTLESS WHEN YOU THINK OF WHAT YOUR FRIEND WENT THROUGH Carol Abramowski (left) and Winnie TO LOSE HER LIFE Star (right). MORNING COFFEE AT THE LOCAL LINE TRANSFORMS INTO GESTURES RICH WITH KNOWING THAT YESTERDAY WAS ALL IT WAS AND TODAY IS ALL THERE IS

WHEN YOUR FRIEND DIES THE WORLD CHANGES AND THE SIGNS WITH ARROWS POINTING RIGHT OR LEFT DIRECT YOU TO THE NEXT STOP AND AS YOU LOOK TO FIND THE TRUE DIRECTION YOU ALREADY KNOW WHERE TO TURN WHEN THEY DIE, THESE FRIENDS YOU STOP LOOKING FOR A TREND AND THE SIMPLE MOMENT THAT LASTS A LIFETIME IN SILENCE WITH GLAZED FACE CONVEYS WHAT LOVE AND LIFE REALLY MEAN

By Winnie Star May 10, 2002

Carol Abramowski was a women’s health nurse practitioner in the Department of OB/GYN at Kaiser Permanente Medical Center, San Francisco for nearly 20 years. She fought bravely after her diagnosis of cancer and was a source of inspiration for her family, friends, colleagues, and patients in the ways in which she coped with, prepared for, and accepted the inevitability of her untimely death. She will be dearly missed.

Winnie Star, RNP, has been a nurse practitioner in OB/GYN for 20 years at Kaiser Permanente Medical Center in San Francisco, CA. She has coauthored and edited several textbooks in women’s health. Her hobbies include writing poetry and short stories, and playing drums.

72 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 P

hysicians as Leaders

health systems Roundtable Discussion – Human Resource Leaders from the Permanente Medical Groups

is the physician who determines the In support of the belief that all Permanente physicians are leaders, pace of the workflow. That then The Permanente Journal, in the Summer 2002 issue, created the new causes the staff who support that column: Physicians as Leaders. Sharon Levine, MD, from The Permanente physician to act or react in certain Medical Group wrote a commentary introducing this new section, and ways. It is by default a leadership Debra Mipos from The Permanente Federation presented the findings of function. Because medical decision a focus group on the subject.1 Both authors supported the premise that making is clearly in the physician’s whether or not a physician has an administrative title, he or she is viewed realm, that drives what the rest of by the surrounding health care team staff as a leader for the work group. the team does and again, by de- The following conversations have been edited from a recent roundtable fault puts the physician in the lead- discussion. The participants included: Lee Jacobs, MD, Associate Medi- ership position. By Lee Jacobs, MD, cal Director for Professional Development, TSPMG, as Moderator; Mike Moderator Dr Green: When I raised this McCabe, Manager, Permanente Human Resources, SCPMG; Craig Green, topic with our human resource lead- MD, Physician In Chief, Administration, SCPMG; Jill Steinbruegge, MD, ers, they were very pleased to hear Associate Executive Director for Physician Development, The Permanente that this discussion was occurring, Federation; Patty Fahy, MD, Associate Medical Director of Human Re- because they have seen the fallout sources, CPMG; Marci K Clark, Director of Professional Resources, NWP; from physicians who are unaware Tom Janisse, MD, Assistant Regional Medical Director, NWP; and Karen of the influence that they exert ev- Tallman, Senior Analyst, The Permanente Federation. ery day. What comes to the attention of human resource leaders are Are Physicians Dr Craig Green: It is important examples of how problems are com- Really Viewed by to acknowledge that in our society, pounded when a physician leads Staff to be Leaders? there is a hierarchy of people, and poorly and the people around him Moderator: Probably the best like it or not, physicians occupy a or her emulate that behavior. way to open this discus- place that is fairly high up in this Ms Clark: That all physicians are sion is to make certain hierarchy. For that reason, people leaders is important because it that all of us are on the tend to defer to us. I believe that places medical leadership at the same page. So let me physicians should accept that they forefront of the patient’s Kaiser start by asking: Do you all support are on stage and should act accord- Permanente medical care experi- the premise that regardless of ingly. Emmanuel Chabrier wrote an ence, right where it belongs. whether or not they have a formal opera entitled The King in Spite of Dr Patty Fahy: I agree. It is posi- leadership position, all physicians Himself, and I think that is the way tional authority by na- are viewed by the staff as leaders? it is with physicians as leaders. Phy- ture of the fact that the Marci Clark: I definitely support sicians are leaders whether they physicians’ credentials the premise. Certainly want to be or not. put them into that lead- from the work group Dr Jill Steinbruegge: In addition ership role. The contract between the perspective, physicians to the hierarchical piece, Health Plan and the Medical Group are seen as leaders. They there are some other also puts the physician in the posi- set the tone for the work group. It very practical issues that tion of authority and makes physi- is also true that not all physicians put the physician into a cians responsible for the delivery of believe they are leaders. leadership position. For example, it medical services. So, it is not only

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 73 health systems Roundtable Discussion – Human Resource Leaders from the Permanente Medical Groups

through informal leadership and po- ues and ethics of the partnership of Dr Fahy: An article published in sitional authority but also by our Southern California. Although these the Annals of Internal Medicine2 medical services agreement with the characteristics may not always be mentions that the best physician Health Plan that the physician has au- obvious during the interview pro- leaders behave as if they have a thority for making decisions. cess, in our experience, these are patient at their elbow. Although the “… in successful Dr Green: The problem the physicians who make good authors are talking about formal teams, physicians for many physicians is that leaders. physician-leaders, it is also true of take responsibility they feel powerless—that Ms Clark: Although we haven’t informal leaders. They bring the for constructively what they do doesn’t make had a specific recruitment strategy patient’s perspective into every con- addressing problems any difference and that no- to address leadership skills, we do versation. Excellent physicians are and engaging others body listens to them anyway. screen for quality of communication strong patient advocates, and they to help solve them.” They don’t realize that and interaction skills—both very im- bring this perspective into their de- —Dr Jill Steinbruegge people are watching and are portant considerations regardless of partment or clinic and balance the going to change how they the level of leadership we are talking needs of their staff and the patient. do business on the basis of about. In our recruiting process, we Dr Steinbruegge: In addition, what they see the physician do. are now beginning to focus more our recent research suggests that Moderator: In our team devel- overtly on fit with organizational and in successful teams, physicians take opment activities in KP Georgia, we medical group goals. responsibility for constructively ad- are starting to appreciate the impor- dressing problems and for engag- tance of all the physicians on the What Does Informal ing others to help solve them. As teams understanding and demon- Physician Leadership they say in the KP Colorado Medi- strating good leadership. In our Look Like? cal Group, these physicians lead by model for team development, we Moderator: It might be helpful initiating courageous conversa- have learned over the years that cer- for our readers to hear your descriptions. They give both recognition tain states of readiness must be ad- tion of what it looks like when a for good work and constructive dressed before embarking on the physician is a good informal leader feedback about what can be im- journey of developing strong, inter- in a workgroup. proved. That’s strong leadership. dependent teams. In addition to hav- Mr McCabe: Two things come to ing adequate staffing and a strong mind: First, a significant reflection Informal Physician physician team leader (the formal of the level of leadership is the way Leadership in Action leader), getting the other physicians a physician approaches the care and Moderator: Can any of you give on board as informal leaders is a criti- the service level given to members. some examples of when a physical step in having a successful team. The manner in which they treat cian, without a formal leadership members demonstrates the essence title, demonstrated leadership skills? Considerations of Permanente Medicine. Second, Dr Tom Janisse: Recently, I pre- During Physician the way physicians treat their peers sented worklife survey Recruitment and staff is important. If they treat data at our All-Physi- Moderator: Do any of your medi- people with respect and dignity, it cians meeting. After- cal groups have a strategy to select is infectious. ward, one of the physi- physicians who demonstrate lead- Dr Green: I agree with Mike and cians and I were talking about ership competency skills during the would add another aspect: self- interactions with staff and about ex- recruitment process? awareness. Physicians who are pectations and roles. He said, “You Mr McCabe: In Southern Califor- strong informal leaders know as they know, I actually have a clear state- nia, I would have to say go through their day—and as they ment of my expectations for my that we have not had go through life—they are not in a medical assistant posted right on such a strategy as part vacuum. They realize that what they my door.” I said, “That’s terrific; at of the overall interview do has an effect on people, either least you are being explicit about process. However, in the forefront positively or negatively, and so they it. Most people don’t do that. If of the process for some area associ- take steps to channel each hour in a people would share their expecta- ate medical directors is the search way that has a positive effect on oth- tions, that would be great.” He for physicians who buy into the val- ers throughout the organization. looked up in the air, thinking, and

74 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 health systems Roundtable Discussion – Human Resource Leaders from the Permanente Medical Groups

then back at me and said, “You know ues, which strongly influence the The Influential Physician what, I never asked my medical as- team’s culture. People Want to Follow sistant her expectations of me.” Moderator: Let’s say I’m a physi- Moderator: It is important to em- That is an example of a physician cian reading this dialogue, and you phasize for our readers that we are “taking the lead.” have convinced me that how I re- talking about physicians having in- Dr Green: Although I don’t have spond to situations will strongly influence over the staff, not heavy- a specific example, there is a situa- fluence how the team responds in handed control over them. We prob- tion that happens hundreds of times the future. Can you help this physi- ably need to clarify that we are not a day: how a physician deals with cian? Are there leadership skills that talking about creating authoritarian patients who are late. The physi- a physician can learn? “little Napoleons” on our teams. We cian can set an example by dealing Ms Clark: In KP Northwest, we are talking about encouraging with the late patient in a low-key, have consultants from our CME Permanente physicians to be strong understanding, and positive way, and Professional Development leaders so people want to follow instead of grousing or “flying off the groups who will work one-on-one them. Any thoughts to add? handle.” It’s amazing how quickly with physicians to provide feed- Dr Fahy: It is a baseline under- the staff picks up on the behavior back on how their communication standing that the physicians we are the physician models and then al- style and body language is com- recruiting are collegial and collabo- most immediately behaves in ex- ing across to others. Effective com- rative. We hope that would immu- actly that same way to the patient munication, both verbal and non- nize us against giving the impres- and, I am sure, to other late patients verbal, is critical to successful sion that we are encouraging a throughout the week. In searching leadership modeling. dictatorial style when we empha- for an example of how physicians’ Mr McCabe: Although in South- size the importance of physician behavior models and affects the ern California we may not do as leadership. tenor in the clinic, their reaction to good a job at identifying the role the late patient is one that really of the physician in the medical “Effective jumps out at me. group, we are now looking at our communication, Moderator: Craig, that’s an orientation program to make cer- both verbal and excellent example, because every tain it is clear to new physicians nonverbal, is critical Permanente physician reading this that they are leaders with certain to successful discussion can identify with the expected behavior. This is some- leadership late patient and with the various thing that is on our radar screen in modeling.” emotional responses the situation Southern California. —Marci Clark provokes. Team members observe Dr Fahy: In Colorado, we are en- the physician’s response. Other couraging our informal physician thoughts? leaders to attend our Introduction Dr Steinbruegge: Leadership Dr Steinbruegge: Craig’s ex- to Management training class. It is means different things to different ample brings to mind another situ- a two-and-a-half-day class with people, and the most common idea ation—namely, how the physician about 20 physicians in attendance. about leadership is a general who handles adding another patient to The physicians’ leadership experi- tells everyone to “go up that hill.” an already very busy schedule. Al- ence falls into three groups: those That isn’t the kind of leadership we though medically the problem with new administrative roles, ex- are talking about. In the Advanced could be handled on the phone, perienced physician-managers, and Leadership Program, we ask the the advice nurse may be caught in physicians who have no adminis- question, “What does every leader the middle between the patient trative role. They have an oppor- need?” The answer is: “followers.” who wants to come in and the tunity to talk about things like re- So how does a physician without a physician who says “they don’t cruiting, performance management, formal title get followers? You don’t need to come in. Find some way and working in the union environ- get them by bossing them around to take care of them.” How a phy- ment. That dialogue goes quite a and telling them what to do. sician supports the nurse and other long way toward helping some- Dr Janisse: Some of what we are team members in these situations body improve his or her informal talking about might be titled The is a reflection of their personal val- leadership skills. Subtle Leaders.

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 75 health systems Roundtable Discussion – Human Resource Leaders from the Permanente Medical Groups

Dr Steinbruegge: Or leadership with medium or low ratings on issues within their sphere of influ- by influence, rather than by fiat or these measures. We observed the ence. They started with smaller by formal titles. importance of physician modeling. projects. They succeeded with most Dr Fahy: You might also consider Providers and staff form an inter- of these projects and were able to it “the new leader.” It is evidence- dependent system. In strong expand their control over the work based leadership that really works. groups, the physicians set a posi- environment. It is not coercive leadership or Na- tive tone for the group. They give Moderator: Thanks, Karen. poleonic leadership, but leadership recognition and corrective feed- I would encourage our readers by influence. back. In high-scoring work units, to review your research on page Dr Green: There is one other physicians are inclusive in the de- 39 of this edition of The Journal. I thing that leaders need cision-making process. By bringing agree with you: Today’s discussion besides followers: They all members of the team into the on the importance of all physicians need a clear goal where process, these physicians use the as leaders mirrors the major find- both the leader and fol- experience of the entire group to ings of your work. lowers are heading. One of the gain cooperation. Most importantly, I do want to thank the panel for things all physicians can do is to we learned that when there are contributing to this dialogue. In set a goal for their local unit to do rich, positive interdependencies, many ways, this is just the begin- X, Y, and Z for all our patients. This there is less stress in the team and ning as we all continue to learn activity is very powerful. the workday is more predictable. about this subject. Along with our Moderator: Karen, I know that Moderator: Any areas that you readers, I look forward to your con- you interviewed physicians on adult identified in your team research that tributions to this topic in future edi- medicine teams all around the coun- we did not cover in this discussion? tions of The Permanente Journal. try, and I think some of these com- Karen Tallman: We found that a Thanks again. ❖ ments on being an influential leader physician’s management of aspira- are consistent with key observations tions affected morale. In some of the References of your work. teams with low patient and physi- 1. Mipos D. Are all physicians leaders? Karen Tallman: Yes. The discus- cian satisfaction ratings, people as- The opinions of Permanente physician-leaders. Perm J 2002 sion today reaffirms our findings. pired to change things that were Summer;6(3):55-56. The Care Experience Project outside of their control. This had a 2. Reinertsen JL. Physicians as leaders looked at work units with high rat- demoralizing effect on the work unit. in the improvement of health care ings on patient satisfaction surveys In contrast, the physicians in strong systems. Ann Intern Med 1998 May and physician surveys (the People work units were focused on things 15;128(10):833-8. Pulse) in contrast with work units they realistically could change—

The Greatest Good The greatest good you can do for another is not just to share your riches but to reveal to him his own. Benjamin Disraeli, 1804-81, British statesman and Prime Minister

76 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 soul of the healer

Portland Head Light Portland, Maine By Ahmad Abdalla, MD

Born and raised in Alexandria, the city that housed the Pharos lighthouse, Dr Abdalla says that he has always been attached to lighthouse photography. He has traveled extensively to add to his lighthouse photographic collection. Portland Head lighthouse is one of the most beautiful settings he has come across. More of Dr Abdalla’s work can be seen on pages 6 and 38.

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 77 medical ethics To Be or Not to Be— Preimplantation Genetic Diagnosis

The case and commentary are re- some genetic defects by amniocen- been harvested from a dead man.

edical Ethics printed from Ethics Rounds, 10(4), tesis. During the next decade, abor- With each major developmental 2001. KFHP Inc, and TPMG Inc. tion was legalized and the first test- milestone, we encountered fresh The development of reproductive tube baby was born. The abortion dilemmas unique to the new inno- M technologies throughout the last drug, RU-486, became available in vation while simultaneously revis- By Kate Scannell, MD, four decades has given birth at a the 80s. In the last decade, Dolly iting older, fundamental arguments Editor daunting pace to a host of formi- the sheep was cloned, and a child about the definition of life itself. dable questions for ethical reflec- was birthed by a 63-year-old post- New reproductive technologies Commentary by Jeffrey R Botkin, MD, MPH tion. The 60s ushered in the birth menopausal woman and another aiming to foster the creation of life control pill and prenatal testing for conceived from sperm that had always brought with them addi-

Commentary Preimplantation Genetic Diagnosis and the Biologic Selection of Children By Jeffrey R Botkin, MD, MPH, Professor of Pediatrics and Medical Ethics, University of Utah

This case is by no means science fiction, as the ability to gressions than does abortion, since a number of embryos select future children for their genetic traits is now available. are created and discarded in the process. For the past 30 years, prenatal diagnostic technology has of- But the ethical complexity of PGD goes well beyond right- fered the ability to perform a negative selection—that is, the to-life issues for embryos. The complexity arises from this ability to detect an abnormal fetus and terminate the preg- ability to perform positive selections. We can imagine a day nancy prior to fetal viability. Now, as this case illustrates, pre- in the not-too-distant future in which a woman would un- implantation genetic diagnosis (PGD) offers the ability to per- dergo an ovarian biopsy via endoscopy to provide tissue form positive selections—that is, the ability to select an embryo with hundreds of immature eggs. Maturation of the eggs in for desirable traits, as well as to discard those embryos with the lab would be performed, followed by fertilization from genetic flaws. her partner and then PGD. Emerging technology will per- PGD is offered in over 50 centers around the world, and it mit the analysis of hundreds or thousands of genetic loci. is estimated that more than 500 children have been born The couple then would have, say, 75 genetic profiles of po- following this procedure.1 PGD has been used primarily by tential children from which to choose. They might choose couples who are at increased risk of bearing a child with a #32 for this first pregnancy and #59, along with some other genetic disease or chromosome abnormality. The obvious ad- contenders, could be frozen for their next pregnancy. Per- vantage of PGD for some couples is the ability to initiate fect babies and a family of their dreams. pregnancy with what is considered a healthy embryo rather If something seems less than perfect in this scenario, then we than take a chance with traditional reproductive means need to unpack our sense of unease. Are we just queasy about and face the prospects of a termination decision four to new things, or is there a coherent logic to these concerns? five months into the pregnancy. Of course, for those who The Patterson case offers the opportunity to think through believe human life should be afforded full moral status at the some of these issues. A similar case received wide publicity moment of fertilization, PGD involves greater ethical trans- last year in which parents used PGD to select an embryo that

Kate Scannell, MD, is an internist, rheumatologist, and geriatrician at Kaiser Permanente Oakland, CA. She is author of the book, “Death of the Good Doctor” and a columnist for the Oakland Tribune/ANG Newspapers. She also edits Ethics Rounds for Kaiser Permanente. Email: [email protected]. Jeffrey R Botkin, MD, MPH, Professor of Pediatrics and Medical Ethics, University of Utah. Co-Editor, Genetics and Criminality: The Potential Misuse of Scientific Information in Court; American Psychological Association 1999.

78 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 medical ethics To Be or Not to Be —Preimplantation Genetic Diagnosis

tional concerns about their poten- has been difficult to reflect on mat- CASE: The Biologic tial to end life as well. ters of life and death without some Construction of a Child In this article, we will explore fun- degree of refraction through the Oscar and Nadine Patterson damental ethical issues raised by re- lens of war. Speaking to this, one present Nadine’s gynecologist, Dr productive technologies through a could remark about broad concep- Quatrain, with their request for pre- specific focus on preimplantation tual similarities between them; of implantation genetic diagnosis genetic diagnosis (PGD), a new tech- using value judgments—about a (PGD) in order to create a healthy nology that allows biologic selection particular nationalism, religion, ge- baby harboring the exact type of of children according to their genetic netic makeup—to determine the cells needed by their desperately profiles. Bioethicist Dr Jeffrey R appropriateness of another’s con- ill five-year-old daughter, Randy, for Botkin, Professor of Pediatrics and tinued potential to live; of attempt- an organ transplant. The procedure Medical Ethics at the University of ing to control or minimize the na- involves hormonal stimulation and Utah, provides the commentary. tive biologic and socioethnic egg harvest from Nadine, followed The theme for this article reso- diversity of the human population; by in-vitro fertilization of the eggs nates with the recent first anniver- or even of asking in each circum- with Oscar’s sperm. The subse- sary of the September 11 terrorist stance by what agency and author- quently formed test-tube embryos attacks on New York and Wash- ity each of us decides how life be- would then undergo genetic screen- ington, DC. Since that violence, it gins and how it should end. ing tests, and those embryos not

was both free of a mutation for Fanconi anemia and a tissue larly, the investment society makes in the health of indi- match for their six-year-old daughter who suffered with the viduals with heritable or congenital conditions affords them disease. Stem cells from her new brother’s umbilical cord great benefit with many secondary benefits extending were transfused into the little girl and, remarkably, the proce- through society. It is difficult to claim that these investments dure worked.2 In that case, a new life was created to save a do not produce a substantial net benefit to society. There- life in jeopardy. fore, of the potential justifications for prenatal diagnosis, If we accept the use of PGD for, say, Tay-Sachs disease or the most compelling, if not the only real justification, is to cystic fibrosis or muscular dystrophy, must we accept its assist prospective parents in their desire to avoid the diffi- use for gender selection or for the right HLA type, or, some culties of an impaired child. day, intelligence or perfect musical pitch? While professional Note that this justification is not founded on a simple societies discourage the use of PGD for gender selection philosophy of parental autonomy. Prospective parents have (other than for sex-linked genetic conditions), there are no strong negative rights to be left alone with their reproduc- articulated standards for the use of PGD that delineate its tive decisions, but they do not have positive rights to obtain ethical applications.3 any or all prenatal diagnostic services for any purpose they To work through these issues, we must start with the most wish. This is simply because these diagnostic services are basic question: What justifies preimplantation genetic di- provided by moral agents—such as doctors, nurses, and agnosis or any form of prenatal diagnosis? Potential justifi- counselors. As moral agents, professionals have the preroga- cations focus on the welfare of the fetus/child through pre- tive of deciding the scope of their services based on per- venting a burdensome existence—the parents through sonal and professional values. As providers undertake an preventing the burdens of an impaired child, or on social ethical analysis of the issues, they must balance the poten- welfare by avoiding the social costs of ill or disabled indi- tial welfare of the prospective parents with the potential viduals. While these issues deserve more exploration than harms to others. In the case at hand, Dr Quatrain has every can be provided here, it strains logic and common experi- right to analyze the Pattersons’ request in terms of his per- ence to claim that the vast majority of individuals with sonal values and in terms of values that he would promote heritable conditions do not benefit from their lives. Simi- for his profession. Continued on next page.

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 79 medical ethics To Be or Not to Be —Preimplantation Genetic Diagnosis

matching Randy’s cell type or those her job to provide for Randy’s care. when he tries to separate out a carrying the gene for her immuno- But the Pattersons stumbled across medical decision from his religious logic disease would be discarded. a newspaper account of a “test tube beliefs, he still concludes that it is Embryos passing the tests would be baby” engineered by PGD in order wrong to create “designer babies” implanted in Nadine’s womb. Once to save his sick sister’s life. They and to generate one life in order a baby was born, some of his or also read that the involved proce- to sustain another’s. her bone marrow would be re- dures cost approximately $30,000 Mr Patterson is annoyed by Dr moved and transplanted to Randy and were not covered benefits of Quatrain’s hesitation. He even sug- in hopes of establishing a healthy insurance policies. Instantly, they gests that the $30,000 fee should immune system for her. envisioned a potential for their be paid by the health plan because The Pattersons had not planned daughter to be made well and sur- Randy is a plan member and en- to have another child. The work of vive her otherwise fatal illness. titled to treatment to save her life. raising Randy through multiple in- Dr Quatrain is uncomfortable What should be done? What ethi- fectious complications had stressed with the Pattersons’ request. A de- cal issues are raised by this case? ❖ their relationship, and the family fi- vout Catholic, he views embryo nances suffered after Nadine quit discard as a form of abortion. Even

Continued from previous page.

So what should Dr Quatrain decide in this situation? If, for cells, but would become a loved and welcomed mem- as a devout Catholic, he is opposed to the whole enterprise ber of the family. The Pattersons’ need for this help is com- of PGD, then the discussion need not go any further. How- pelling, and no harm to others is apparent (the discarded ever, if he is willing to consider assisting with PGD for this embryos aside). purpose, he will need to think through the pros and cons So the deep problems inherent in the positive selection more carefully. Beyond the harm of embryo destruction with of children do not pertain to this case. PGD for the PGD, the other potential harm with positive selections is to Pattersons looks like a win-win scenario—a new life is the children who would be created. Selection of children created and a threatened life can be saved. Would this by parents for their purposes in life poses a threat to the selection place our society on a “slippery slope” to other child’s autonomy as s/he grows to chart his/her own course kinds of unacceptable selections? Possibly, but only if we in life. Selection for traits that normally would be beneficial continue to use this powerful technology without a thor- could be seen as a curse by the child, as parents bear down ough analysis of its ethical justification and without a to achieve their goals and to make their investment worth- professional standard that clearly articulates a strong set while. Uninhibited selection of children may threaten the of moral values.4 ❖ very foundation of the parent-child relationship that must embody a strong element of unconditional love. References But note that this risk to the future child hinges on the 1. Lewis R. Preimplantation genetic diagnosis: the next big parents’ desire to use the child as the instrument for their thing? The Scientist 2000; 14(22) 16. goals. In this case, the Pattersons want to select a child, 2. Weiss R. Test-tube baby born to save ill sister. Washington Post, Oct 3, 2000, p A01. not for the qualities s/he would have as a person, but sim- 3. Botkin JR. Ethical issues and practical problems in ply for his/her HLA matched cells. Once the cells were preimplantation genetic diagnosis. Am J Law, Med and harvested from [the infant], any special expectations for Ethics 1998; 26:17-28. him/her would cease. Certainly the child is being used for 4. Botkin J. Fetal privacy and confidentiality. Hastings Center his/her cells; but, presumably, s/he would not be used only Report 1995; 25(5): 32-40.

80 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 announcements

Now Available: CME Mindfulness in Medicine Videotape Training for Busy Doctors Primary Care 2003 and Health Care Professionals Jon Kabat-Zinn, PhD, featured in this user-friendly practical video, instructs beginners and advanced practitioners in The 14th National mindfulness meditation. Dr Kabat-Zinn and physician faculty discuss and Primary Care Conference demonstrate tools for integrating mindfulness in treating patients, staff, and oneself with greater moment-to-moment awareness. Dr Kabat-Zinn April 18th–23rd, 2003 is the founder and former director of the University of Massachusetts Memorial Health Care Stress Reduction Clinic and is Professor of Medi- The Orchid at Mauna Lani cine in the Division of Preventive and Behavioral Medicine at the Uni- Kohala Coast versity of Massachusetts Medical School. He is the author of two best- The Big Island of Hawaii selling books: Full Catastrophe Living: Using the Wisdom of Your Body and Mind to Face Stress Pain, and Illness; and Wherever You, Go There For a brochure or registration, visit: You Are: Mindfulness Meditation in Everyday Life. www.kpprimarycareconference.org Tapes are available at a cost of $10 for KP employees; $20 for others. To or call 1-510-625-6374. order, contact Gus Gaona 323-259-4776, E-mail: [email protected].

the lighter side of medicine

THE HUMERUS ZONE

Cartoon submitted by Don Wissusik, MA, MS, a Clinical Supervisor in the Department of Addiction Medicine at Cascade Park Medical Center, Vancouver, WA.

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 81 book reviews

Ophelia Speaks: Adolescent Girls Write About Their Search for Self by Sara Shandler

Review by Vincent J Felitti, MD

he editor of this book is a teenaged girl who Eating disorders are common, although we generally Tconceived the idea of publishing a book of brief do not recognize them in our medical practice. These essays written by adolescent girls. She asked hun- disorders are described clearly in the book, some- New York: dreds of girls from around the country and from a times along with other distressing techniques, such HarperPerennial; 1999. ISBN: 006-0952970 wide range of backgrounds to write about the most as self-cutting: “When blood starts to gush out of the Paperback $12.95. important of their life experiences. The result is an newly opened veins, all the bad feelings fly out with impressive piece of psychosocial journalism that will it and I find release. I find my heaven. If only they be important and useful to anyone wanting firsthand would ever let me bleed long enough. They believe descriptions of the life-shaping experiences faced by they are saving me, but only I know how to save teenage girls. Some of those experiences reflect con- myself.”1:p93 The remarkable editor observes, “Sadly, temporary issues; some go back to biblical times. tragically, three abusive themes—incest, violence, and Ophelia Speaks is thus relevant for physicians, both alcoholism–-were mentioned more often than all oth- in their practices and in their homes; for parents who ers when girls wrote about their fathers.”1:p105 cannot understand what is happening to their daugh- Touched by Desire contains details, often ters; and for adolescents themselves. counterintuitive, of adolescent love and affection. The book is divided into five sections: The Body Some of the stories may induce personal remembrance Under Assault; Family Matters; The Best and Worst of of anguish and confusion or perhaps memories of emo- Friends; Touched by Desire; and Overcoming Obstacles tional support and understanding. “No one wrote about and Coming Into Our Own. Each section begins with a feeling satisfied by first-time sexual relationships. In- few pages of the author’s remarkably frank descrip- stead of feeling love and commitment, girls consistently tions of her own feelings and experiences in that area, reported disappointment and disillusionment.”1:p184-5 One followed by those of her contributors. Of the process girl writes, “I thought by having sex together we would of creating the book, she writes,“… most girls, but not become closer; instead it tore us apart.”1:p185 The book all, opened the door on dark and disturbing times. Still contains meaningful descriptions of manipulative and others allowed light, instead of darkness, to glitter in destructive relationships. their contributions.”1:p.xvi Its concept and firsthand descriptions make this a Section One discusses sexual abuse, something we remarkable book. Its thematic material makes it an all tend to deny but which current news articles force important book because it affects us all: as humans, as us to acknowledge. The editor writes, “… I was asked, parents, and as physicians. We might wonder how these ‘Would you use the [Wesleyan College] escort service?’ girls’ emotions will later manifest in our offices de- I sighed, ‘I don’t want to recognize the possibility of cades later. Adolescence is not an easy time; we will my being raped at my new home. If I call the escort remember that Shakespeare’s Ophelia escapes into service, I’m admitting to myself I can’t be safe here madness. Some of these girls will escape into illness. walking alone.’ … Yet the mere existence of sexual Will we be aware of its causality? Or will we merely Vincent J Felitti, MD, violence shapes me.”1:p54 respond to its physical symptoms while knowing noth- has been with the Family Matters addresses loss, especially the ongoing of our patients’ unexpressed feelings? ❖ Southern California Permanente Medical ing effects of divorce, but also death. “I can remember Group since its opening nights that I would yell and scream at my mother–-but Reference in San Diego in the only in my head: Why did you abandon us? Do you 1. Shandler S. Ophelia speaks: adolescent girls write about late 1960s. know what you did when you left us?”1:p100 their search for self. New York: HarperPerennial; 1999.

82 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 book reviews

Pregnancy, Birth, and the Early Months: The Thinking Woman’s Guide by Richard I Feinbloom, MD

Review by Luz Garcia, PA

he goal of Pregnancy, Birth, and the Early Months: Pregnancy, Birth, and the Early Months is particu- TThe Thinking Woman’s Guide is written to educate larly well suited for women who want to know all they pregnant women, and I, as a woman, certainly did feel can about pregnancy. The book will be a wonderful re- very well informed after reading this book. source for mothers who have at least a high school edu- 3rd ed. Cambridge (MA): Now in its third edition, the book is written clearly, cation and an interest in learning. A full range of topics is Perseus; 2000. 345 pages. concisely, and comprehensively. The author, an experi- covered, ranging from prenatal visits and genetics to labo- ISBN: 0-7382-0181-2. enced physician, starts with an unusual, interesting dis- ratory tests and the reasons for them. Probably of great- cussion of the decision-making process and provides est interest to mothers will be the section that discusses information that people can use throughout their lives common problems in pregnancy, how to choose a healthy when facing complex choices. The first piece of advice diet, and how to care for a baby. Useful information is given is for women to become widely informed about provided about special situations and complications so all aspects of pregnancy and reproduction so that they that if problems do occur, readers are equipped in ad- Luz Garcia, PA, is with the can evaluate the pros and cons of any pregnancy-re- vance with the knowledge provided by this book. Department of Preventive lated choices to be made. The book takes an intellectual Pregnancy, Birth, and the Early Months is a helpful Medicine in San Diego, approach to its subject (appropriate for most—but per- resource containing valuable information that most CA. She also works in community clinics haps not all—of the intended audience), and relevant mothers will read, appreciate, and understand. The providing prenatal care. supporting data are provided freely. The book will be multiple editions of this book speak to its success in of interest not only to mothers but also to fathers. accomplishing its goal. ❖

Helping Your Child Lose Weight the Healthy Way: A Family Approach to Weight Control by Judith Levine, RD, MS, and Linda Bine

Review by Kathleen H Jones, MD

e’ve all seen the headlines: Obesity and type II sity. Braver yet are the clinician and health writer who Wdiabetes in children are now reaching epidemic would create a guide for such parents. proportions. Indeed, surveys by the National Center Judith Levine (a registered dietician and consultant for Health Statistics indicate that about one in five chil- for the American Heart Association) and Linda Bine (a New York: Citadel Press; 1 dren in the United States is now overweight. But obe- health and medical writer as well as senior editor for 2001. ISBN: 0-8065-2283- sity in children is not just a frightening headline: Obe- Kaiser Permanente in Northern California) have done 6. 302 pages, paper, sity is an important chronic disorder associated with just that by creating the revised and updated edition of $14.95. many possible long-term complications as well as com- Helping Your Child Lose Weight the Healthy Way. plex family, social, and psychological issues. Brave is The authors use a sensitive, well-organized, practi- the parent or clinician who dares to assume the task of cal, family-oriented approach to outline a concise plan attempting to rescue a child from the clutches of obe- for helping a child lose weight. More important, they

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 83 book reviews

do not address weight loss as the goal but rather de- sensitively avoid singling out one child as needing to scribe ways to make slow, incremental changes in lose weight or be more active. This approach not only food choice and activity. Developing a healthy lifestyle respects the self-esteem of the child but also recog- is the goal: “Positive changes in food and fitness should nizes that long-term success can be achieved only if be your goal–-not changes on the bathroom scale.”2:p69 the whole family is involved and if changes are gradual, This book is not about putting your child “on a diet.” small, and ongoing. The authors also recognize that The authors present a stepwise plan. First, assess children learn best by example. the child: Does the child think he (or she) is over- The last section teaches parents how to facilitate change weight? Are you the only one who detects a problem? and how to recognize their own attitudes that might You should select an approach on the basis of an- hinder change. The book also contains a section of “kid- swers to these questions. friendly” recipes, followed by excellent bibliographic Next they guide us gently through the process of references. The book’s recommendations closely follow gathering data. Growth charts for height and weight recommendations of the Expert Committee on Pediatric and calculation of body mass index (BMI) are presented Obesity convened by the Maternal and Child Health clearly and simply, as are instructions in how to com- Bureau, Health Resources and Services Administration, plete a food diary and eating behavior survey as well as US Department of Health and Human Services.3 how to assess your child’s (and your family’s) exercise As a parent and as a pediatrician who is truly frus- attitudes and behaviors. Having acquired assessment trated by inadequate skills in treating obesity, I see this tools, readers are presented with eight substantial chap- book as a ray of light in a dark room. The book uses ters on basic principles of nutrition. Among the topics an excellent stepwise approach that treats obesity sim- discussed are the food pyramid, how to understand ply and logically as a chronic problem and warns against nutrition labels, savvy grocery shopping and planning, short-term, quick weight loss. The book is helpful not how to eat healthfully away from home, and calorie- only for parents but also for any clinician who pro- lowering strategies designed especially for kids. This vides medical care to overweight children. ❖ section of the book serves as great reference material. The third major section of the book, “Focus on Fit- References ness,” starts appropriately with a chapter titled “Off the 1. Troiano RP, Flegal KM, Kuczmarski RJ, Campbell SM, Couch!”: “The widespread use of two modern inven- Johnson CL. Overweight prevalence and trends for children and adolescents. The National Health and Nutrition tions–-the television and the automobile–-have con- Examination Surveys, 1963 to 1991. Arch Pediatr Adolesc tributed significantly to the decrease in physical activ- Med 1995 Oct;149(10):1085-91. 2:p177 ity among adults and children.” In terms of causing 2. Levine J, Bine L. Helping your child lose weight the healthy epidemic obesity, this decrease in activity is at least as way: a family approach to weight control. Rev. and important as overeating. As in the section on making updated ed. New York: Citadel Press; 2001. Kathleen H Jones, MD, healthy food choices, the “Off the Couch!” section em- 3. Barlow SE, Dietz WH. Obesity evaluation and treatment: is a general pediatrician Expert Committee recommendations. The Maternal and phasizes ways to make slow, incremental changes in at the Otay Mesa Medical Child Health Bureau, Health Resources and Services Offices in San Diego, CA. family activity lifestyle. Emphasis is placed on the fam- Administration and the Department of Health and Human Her special interests are ily being active together—not on the child joining or- Services. Pediatrics 1998 Sep;102(3):E29. Available on the adolescent medicine and World Wide Web (accessed September 5, 2002): adolescent and pediatric ganized sports or exercise regimens. All of the recom- gynecology. mendations given in the book meticulously and www.pediatrics.org/cgi/reprint/102/3/e29.pdf.

The World of Letters The world of letters is the true world of bliss. Abraham Abulafia (1240 - 1292), Jewish mystic

84 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 book reviews

Why Our Drug Laws Have Failed and What We Can Do About It: A Judicial Indictment of the War on Drugs by Judge James P Gray

Review by Jill Waalen, MD, MPH

f there’s any doubt that the country is awash in dictions, serving a full sentence is not mandatory for illegal drugs, Americans need look no further than many violent crimes (eg, bank robbery and kidnapping). Philadelphia: Temple Itheir wallets: 79% of US paper currency circulating in In fact, according to Judge Gray, one of the only University Press; 2001. ISBN: 1566398606. this country carries detectable amounts of cocaine.1 And laws that has functioned as expected in the War on headlines heralding seizure of tons of marijuana, heroin, Drugs is the law of supply and demand: Largely due to cocaine, or other drugs are not signs of successfully drug prohibition, the driving force in the increasing fighting the “War on Drugs”; instead, such drug seizure drug problem is the huge profit which accompanies is a sign of failure—proof that illegal drugs are being drug trafficking. found in ever-increasing amounts within our borders. Why Our Drug Laws Have Failed is intellectually A lively narrative filled with similarly provocative in- stimulating and rivals the 2000 film Traffic in illustrat- sight, Judge James P Gray’s book details how current US ing the pervasiveness of the drug problem in America. drug laws have created a wonderland of unintended con- After reading the book, one finds it difficult to identify sequences. The book also pleads for acute change in the any aspect of American life that has not been corrupted direction of these laws. As a 20-year veteran of the Supe- by both our country’s drug problem and our chosen rior Court in Orange County, CA, Judge Gray writes from method of combating it. The enormous profits to be the front line in the War on Drugs—a futile battle, which, reaped from drug trafficking have encouraged creation he maintains, has to date mostly been prosecuted against of youth gangs, corruption of law enforcement offi- drug users instead of suppliers. As a result, the laws have cials, and a dramatic increase in crime rates. At the successfully filled ever-growing numbers of prisons across same time, the ever-escalating War on Drugs also has the country with nonviolent drug offenders while both had negative effects: Channeling resources away from availability of drugs and the criminal activity surround- prosecution of other crimes; threatening the environ- ing them continue to escalate. mental health of developing countries by using toxic Gray’s account of the endless stream of drug offend- herbicides to eradicate drug-producing plants; and, in ers into the nation’s prisons yields some astounding the name of drug interdiction, stripping civil rights from statistics. For example, the incarceration rate in the United many US citizens in a way unlike any other pre-Sep- States is higher than in any other country except Russia. tember 11 law enforcement initiative. This statistic is largely a result of jailing drug users: 58% Judge Gray’s book presents an insider’s view backed of federal prisoners are serving time for drug offenses. by quotes from many other judges across the country One of every 150 Americans is in jail at any one time— who echo his desperation in the fight against illegal and this number is growing. As a result, one in 20 white drugs. The book goes beyond the standard call for Americans and one in four black Americans will be jailed blanket legalization of all drugs, a call based solely on sometime during their lifetime. comparison with the failed prohibition on alcohol. The One of Judge Gray’s examples of unintended conse- author digs deeper, tracing historical idiosyncrasies that quences is that our main method of getting tough on have created the current situation. According to Judge drugs—trying to “incarcerate ourselves out of the prob- Gray, original drug laws were “ … fundamentally racist lem”—has resulted in leniency for more violent crimi- laws aimed at perceived threats to white women … [from Jill Waalen, MD, MPH, nals: The combination of overcrowded prisons and laws the use of cocaine, marijuana, and opium ] by black, is board certified in 2:p20 Preventive Medicine. She that specifically require drug offenders to serve full Mexican, and Chinese men, respectively;” and in the conducts epidemiologic sentences has allowed criminals serving time for vio- decades since, US Presidents and the US Congress have research at The Scripps lent offenses to be granted early release to make room continued to pass stringent laws—and when these laws Research Institute in La Jolla, CA. for more drug offenders. This result occurs because, fail, to pass more of the same—so as to gain the political unlike the rule governing drug offenses in many juris- benefits of “getting tough on drugs.” Judge Gray also

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 85 book reviews

describes “the Prison-Industrial complex”—prison-build- cessful comprehensive model exists; and, as the second ing industries combined with the bureaucracies running section of the book makes clear, changing our approach the prisons-—as a self-interested force that practices po- to the drug problem will ultimately require “a leap of litical opportunism in perpetuating the status quo. faith,” ie, a willingness to try creative new strategies. Dividing the book into two roughly equal parts (as Although included in Judge Gray’s list of options, suggested by the title), Gray performs best in the first continuing to escalate the current War on Drugs is one part: How the War on Drugs is failing. Probably be- option that, as the book clearly shows, is not viable. If cause it lacks concrete examples of success, the sec- the book attracts enough readers, its well-reasoned and ond half of the book—the part that discusses what we convincing arguments may help increase the ranks of can do about drug abuse—is less satisfying. Judge Gray drug antiprohibitionists beyond the libertarian fringe outlines specific strategies for education, mandatory and could draw a coalition of drug law reformists from drug treatment, needle exchange, and drug decrimi- all political quarters. Judging from the wide spectrum nalization as steps toward a solution. In particular, he of support for the book—represented on the jacket by emphasizes education—but not the “Just Say No” vari- endorsements—from people ranging from political com- ety. Instead, he argues for a more realistic, truthful ap- mentator Arianna Huffington to broadcast journalist proach that recognizes drug use as part of the culture Walter Cronkite to economist Milton Friedman—Judge and that portrays drug use as risky, harmful, and unat- Gray’s effort to assemble such a coalition is off to a tractive—an educational approach similar to that taken good start. ❖ in current antitobacco campaigns. For Judge Gray, drug decriminalization—a big step References toward removing the profit from drug trafficking—would 1. Oyler J, Darwin WD, Cone EJ. Cocaine contamination of restrict and regulate drug sales instead of prohibiting United States paper currency [Published erratum appears in them outright. Here his argument is buttressed by the J Anal Toxicol 1998 Jul-Aug;22(4):15]. J Anal Toxicol 1996 Jul-Aug;20(4):213-6. apparently arbitrary line between some legally prescribed 2. Gray JP. Why our drug laws have failed and what we can drugs (eg, tranquilizers) and illicit, “street” drugs. Al- do about it: a judicial indictment of the War on Drugs. though Judge Gray cites some successful examples of Philadelphia: Temple University Press; 2001. these approaches in other countries, no currently suc-

Two Freedoms There are two freedoms—the false, where a man is free to do what he likes; the true, where a man is free to do what he ought. Charles Kingsley, 1819-75, English clergyman and novelist

86 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 Earn your CME credits online Fill out this form on our Web site: CME Evaluation Form www.kp.org/permanentejournal

All PMG physicians and those clinicians eligible to do so may earn up to two hours of Category 1 credit for reading and analyzing the four designated CME articles, by selecting the most appropriate answer to the questions below, and by successfully completing the evaluation form. This form must be returned (fax or mail to the address listed on the back of this form) to The Permanente Journal by December 20, 2002 in order to receive credit. You will receive an acknowledgment by January 6, 2002. You must complete all sections to receive credit. The Permanente Journal has been approved by the American Academy of Family Physicians as having educational content acceptable for prescribed credit hours. Term of approval covers issues published within one year from the distribution date of November 2002. This Fall 2002 issue has been reviewed and is acceptable for one prescribed credit hour and one elective credit hour. Credit may be claimed for one year from the date of this issue.

Section A. page 8 page 28 Article 1. Views and Use of Complementary Article 2. Jimson Weed Poisoning and Alternative Medicine by Mid-Atlantic —A Case Report Permanente Medical Group Health Care The following statements are true EXCEPT: Providers a. The leaves and seeds of jimson weed contain Physicians are most likely to use an alternative the highest concentrations of potent chemicals form of therapy when: b. Symptoms of jimson weed toxicity take longer a. They use it personally with success than two hours after ingestion to occur b. Patients demand it c. Hallucinations, dry mucus membranes, thirst, c. Evidence-based information supports its use blurred vision, and difficulty speaking and d. They believe that alternative medication has swallowing are presenting symptoms fewer side effects d. Elimination of toxin and symptoms persist Providers’ concerns about alternative therapies for up to two days focus mainly on: Treatment of jimson weed poisoning is limited to: a. Their lack of knowledge about complementary a. Activated charcoal and observation and alternative medicine therapy b. Gastric lavage and induced vomiting b. Their lack of personal experience with these c. Cardiac monitoring and serial neurological forms of therapy measurements c. Malpractice issues d. Use of physostigmine in severe cases d. What their patients will think if they suggest e. All of the above alternative therapy f. A and b Completed forms must be (Continued on next page) returned by December 20, 2002 in order to receive credit.

The Kaiser Permanente National Continuing Medical Education Program (KPNCMEP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The KPNCMEP takes responsibility for the content, quality, and scientific integrity of this CME activity. The KPNCMEP designates this educational activity for up to two hours of Category 1 CME credit for each TPJ issue applicable to the AMA Physician Recognition award and/or physicians award. Each physician should claim credit for only those hours that were actually spent in this educational activity. Author disclaimer forms are on file with any conflicts of interest listed or necessary disclaimers.

The Permanente Journal/ Fall 2002/ Volume 6 No. 4 87 (Continued from previous page)

page 31 page 39 Article 3. How Can We Integrate Alterna- Article 4. Successful Practices in the Physician Work tive Approaches and Mainstream Medicine Environment: We Work Together to Treat Chronic Low Back Pain? Practice teams which have high physician satisfaction show the following Which of the following is NOT an appropriate characteristics EXCEPT: choice for the treatment of chronic mechanical a. Physicians and support staff are all included in decision making back pain: b. Physicians set the tone for the team by modeling expected behavior, rather a. Cognitive-behavorial mindful meditation than asking for exemplary behavior from others movement program c. Physicians and support staff give each other recognition and constructive feedback b. Acupuncture d. Members of the team handle interpersonal discord in a timely manner c. Lifestyle changes: weight reduction, e. Teams try to solve problems outside their sphere of influence to improve the smoking cessation work environment d. Magnets Which of the following statements are true: The biopsychosocial predictor most likely to be a. Use of values and guiding principles to guide daily decision making related to improved outcome for back pain is: characterizes work units with a positive physician work environment a. Well-balanced family life b. A strong team environment where everyone works together to provide an b. Job satisfaction excellent experience for patients which creates high physician satisfaction ratings c. Status in the community c. Research has demonstrated a link between the work enviornment at KP and d. Number of children patient satisfaction d. B only e. A and b only f. A, b, and c

Section B. Referring to the CME articles and the stated objectives, please check the box next to each statement as appropriate.

Article 1 Article 2 Article 3 Article 4 Strongly Strongly Strongly Strongly Strongly Strongly Strongly Strongly Agree Disagree Agree Disagree Agree Disagree Agree Disagree 543 2 1 543 2 1 543 2 1 543 2 1 The article covered the stated objectives. I learned something new that was important. I plan to use this information as appropriate. I plan to seek more information on this topic. I understood what the author was trying to say.

Section C. Section D. (Please print) What change(s), if any, do you plan to make in Name: ______your practice as a result of reading these articles? E-mail: ______Address: ______Signature: ______Date: ______Mail or fax completed form to: The Permanente Journal ______500 NE Multnomah Street, Suite 100, Portland, OR 97232 Phone: 503-813-2623 • Fax: 503-813-2348

88 The Permanente Journal/ Fall 2002/ Volume 6 No. 4 PermanenteThe Journal

Administrative Team Advisory Board Editors Richard Abrohams, MD; Internist and Geriatrician, Georgia ...... TSPMG Dan Cherkin, PhD; Senior Scientific Investigator ...... GHCHS Tom Janisse, MD Editor-In-Chief & Publisher Linda Fahey, NP; Regional Coordinator of Advanced Practice ...... SCPMG Mary Durham, PhD Research & Abstracts Carol Havens, MD; Director, Department of Continuing Medical Education ...... TPMG Vincent J Felitti, MD Book Reviews Arthur Hayward, MD; Internist and Geriatrician, Continuing Care Services ...... NWP Lee Jacobs, MD Health Systems Tom Janisse, MD; Chairperson, Assistant Regional Medical Director, Health Plan Liaison ...... NWP Arthur Klatsky, MD Clinical Contributions Laura Marshall; Public Affairs and Communications, Program Offices ...... KFHP Helen Pettay Care Management Institute Michael Mustille, MD; Associate Executive Director, External Relations ...... TPF David Price, MD Clinical Vignettes Eric Schuman, PA; Family Practice Clinician, Northwest ...... 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