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A case report is derived from the detailed reporting of events that take place within the context of treating and observing a single patient (i.e. case). The report is an in-depth longitudinal examination that is essentially qualitative in nature although it may well contain quantitative data. A case report is anecdotal in that it provides informal observations that are uncontrolled, not subject to the scientific method, and cannot be independently confirmed. Although such anecdotal evidence is not regarded as strictly scientific, it is often regarded as an invitation to more rigorous scientific study. For example, in an analysis of 47 case reports detailing side effects of drug therapy, 35 were found to be “clearly correct”. Primarily a case report is a way of communicating information to the medical world through the elucidation of unique and characteristic feature(s) of a condition, complications, and adverse effects and benefits of specific interventions. Case reports may also serve as a valuable research and educational tool. Robert Iles notes that most medical case reports consider one of five topics:

1. An unexpected association between diseases or symptoms

2. An unexpected event in the course of observing or treating a patient

3. Findings that shed new light on the possible pathogenesis of a disease or an adverse effect

4. Unique or rare features of a disease

5. Unique therapeutic approaches

Why write a case report?

The objectives for writing a case report are mainly to 1) inform/educate; 2) share new knowledge/insight; and 3) document processes and procedures. Furthermore, within the naturopathic context, case reports can serve as a method for building evidence for naturopathic healthcare practice and expanding our Materia Medica. Having well-written case reports published in a reputable medical journal adds to the credibility of the naturopathic profession. The goal of a case report is to provide information of value to the audience (i.e. interesting and relevant). Information provided in a report should contain unique features about the condition, the treatment, the outcome, and anything else pertinent to the case. A case report differs from a clinical case intake in that a case report is systematic, and includes a greater depth of detail, in-depth analysis, literature support guidelines and conclusions about the findings. Case reports can also provide findings that are hypothesis generating.

As naturopathic doctors, there will likely be a strong desire to maintain a humanistic and holistic approach to care. While called a ‘case’ report, do not lose sight that we are talking about people. After all, we do not treat cases; we treat patients with presenting symptoms. Case reports provide us with a great tool for learning. Thus, case reports should be written about cases with both positive and negative outcomes, with the emphasis being on learning. In fact, as practitioners, we know that we often learn more from the negative cases. Furthermore, by writing a case report, practitioners will likely add to their own knowledge base.

Case reports play an important role in disseminating information to the medical community. Given the wide variety of naturopathic clinical practice, case reports offer an excellent opportunity to share clinical insights from naturopathic doctors. Typically, unique and rare events or patterns are depicted regarding different aspects of a case, including: symptomatology, pathophysiology, treatment(s), and outcome, including adverse effects. In this paper we elaborate on what a case report is, why one is conducted, and provide a brief set of guidelines on how one is written. We hope to encourage clinicians to write case reports and to submit them for publication. The case report is a well-respected venue for sharing valuable knowledge and generating questions derived from practice. The production of this form of clinically relevant evidence should be actively encouraged within the naturopathic community.

The peer-reviewed medical literature contains articles that cover virtually all topics within medicine including research on therapies used by naturopathic doctors (NDs). The literature is growing at an incredible rate and there is plenty of opportunity for both dedicated researchers and clinicians to participate in this process. Complex studies such as randomized controlled trials, systematic reviews, and large observational trials can be daunting to the practitioner who has little training in research methodology and too little time. The role of the clinician in private practice is critical, however, for the introduction of important clinical information from the ground up. The strength of case reports and case series is primarily in their ability to inject new information into the medical consciousness and to generate hypotheses that can be tested in controlled studies.

Case reports provide a level of evidence that is often a starting point for further research. A classic example is the drastic teratological adverse effect of thalidomide on fetal development. A single case report opened the eyes of the medical community in the late 50s when thalidomide was being touted as an effective treatment for nausea and vomiting of pregnancy. This case report opened a floodgate of responses and the publication of further case reports that quickly led to the drug being pulled from the market (1). Ironically it is through the publication of case reports that thalidomide has been brought back into usage more recently as a treatment for certain dermatological pathologies (2).

Naturopathic medicine incorporates an incredibly wide array of modalities often combined in unique ways. The holistic, individualized and eclectic ‘nature’ of naturopathic medicine makes the case report an ideal place to showcase the benefits and also the potential adverse events that can occur within its bounds. The intent of this article is to provide an overview of a case report, the reasons for writing one, and guidelines for writing and publishing such a report. We hope that this paper offers motivation and some of the tools necessary to carry out this process. The clinician who sees patients regularly is intimately aware of what works in practice. This shared knowledge is a resource that can benefit clinicians, the profession and ultimately our patients. The case report is a well-respected medium that should be encouraged so that valuable information is not limited to a few practitioners, but can be widely disseminated amongst colleagues.

Like most colonized countries in the Western world, Australia has a history of natural medicine use that dates back to the first settlement (by the British in 1788). The Government physician on the first fleet was quick to cultivate a physick or medicinal plant garden to provide medicines for all manner of ailments experienced by the government authorities as well as the convicts who established the first settlement. Of course, the original inhabitants of the country, the aborigines, had their own unique natural healing methods that included herbal treatments, food therapy and shamanic practice. Over the first one hundred years of settlement in Australia, herbal medicine, homeopathy and traditional Chinese medicine formed the greater part of early health care for the inhabitants. “Naturopathy” as such, didn’t really become an entity until the late 1960s to early 1970s, although nature cure practitioners did exist during the early part of the 20th century. Today, naturopathic medicine is second only to chiropractic as the most popular form of natural medicine health care in Australia. It is estimated that around 64% of Australians currently use natural medicine health care, whether that is through consultations with natural medicine practitioners or self-medication. They spend over AUS$2 billion annually on natural medicine treatments. This is more than the amount spent on over-the-counter pharmaceutical drugs in Australia each year. Growth of natural medicine usage has been quite significant, increasing from around 22% in 1986 to 50% in 1995, through to more than 60% in 1998. A study conducted in 1997 suggested that there were three main reasons why Australians were turning to natural medicine health care. These were:

Unlike North America, naturopathic practitioners are not registered or licensed by State legislation. Statutory regulation exists for chiropractic and osteopathy and, in one state of Australia, for Chinese medicine. The naturopathic profession is self-regulated, meaning that professional associations monitor the practice and training of practitioners. In reality this means that anyone, regardless of their level of education or training can use the title “naturopath” and practice as a naturopathic physician. As more Australians use natural medicine treatments for the maintenance and improvement of their health (often in conjunction with prescribed or over-thecounter pharmaceutical drugs), there is an increasing level of concern by the medical profession and Government about drug interactions and safety of natural therapies. This has raised the question about the need for closer monitoring and regulation by Government, of natural medicine. Currently an enquiry is underway, in one Australian state (Victoria), into the safety of naturopathy and Western herbal Medicine, and the need for statutory legislation to regulate these practices.

H was given a protocol to follow with goals of alleviating side effects; the modalities included nutrition, hydrotherapy, supplements, and exercise. A whole foods diet was implemented for weight optimization. The diarrhea was treated with eating organic yogurt and kefir as a source of probiotics. L-glutamine powder 7 g/d was recommended for rebuilding the gut as well as treating diarrhea. Zinc gluconate 20 mg/d was added for the restoration of taste. The CIPN was treated with Neurosol at one softgel twice daily.(4) The hydrotherapy consisted of home treatments including warming socks and gloves nightly to increase peripheral circulation and Epsom salt soaking baths twice weekly. The exercise protocol was a daily walk for 20 minutes. When H presented for the 11th cycle of FOLFOX, the peripheral neuropathy had completely resolved as determined by patient interview before administration of the chemotherapy. At this point H had received a cumulative dose of oxaliplatin of approximately 850 mg/m2. The dose-limiting neurotoxicity occurs with a cumulative dose between 780 and 850 mg/m2 in oxaliplatin treatment.(3) At no point during the remaining nine cycles (cycles 12-20) did H present with complaints of CIPN. The CIPN treatment of Neurosol and home hydrotherapy was continued throughout the FOLFOX treatment and discontinued after the last cycle of FOLFOX, October 2004. (Figure 1) H had excellent partial remission and was switched to irinotecan and bevacizumab, and later cetuximab. The partial remission continued through June 2005. Unfortunately, by October 2005 the cancer was found to be progressive as evidenced by CT scan and CEA (carcinoembryonic antigen) levels rising. At this point, a second round of FOLFOX (13 cycles) was started April 2006. The oxaliplatin dose was 85 mg/m2 with a cumulative dose of approximately 1000 mg/ m2. On two of the cycles the oxaliplatin dose was reduced to 75 mg/m2 due to neutropenia, but not reduced due to neurotoxicity or CIPN. H resumed a similar protocol as for the first FOLFOX treatment, including the same diet therapy of whole foods and yogurt, and a meal of organic liver and onions 1-2 times weekly to guard against chemotherapyinduced anemia. Other therapies included Epsom salt baths, Neurosol (one softgel bid), omega-3 fish oil capsules, and one tablet of silymarin 80% bid (equal to 56mg silymarin/tab). The use of silymarin is currently in question with regards to potential interactions from hepatic metabolism of other medications the patient may be on. The specific concern is that silymarin modulates the activity of cytochrome P450 enzymes and may increase the levels of toxic medications in a patient. 5 The silymarin was prescribed for liver health due to the progressive metastatic cancer in the liver. The FOLFOX combination contains three medications, none of which are hepatically cleared,6 so the use of silymarin was not contraindicated in this patient.

Since H began naturopathic integrative care his weight stabilized and was considered healthy for his height (+/- 5 pounds) for 15 months while undergoing chemotherapy. In addition, the patient experienced a complete elimination of the CIPN. The Neurosol was discontinued after recovery from the neuropathy and this symptom had not returned as of December 2006. H has had regular bowel movements without significant constipation or diarrhea with the exception of chemotherapy days when he experienced one day of diarrhea that affected daily activities. This is a reduction from seven days of diarrhea post chemotherapy before initiating integrative medical care.

In August and September 2006, while undergoing FOLFOX treatments, H enjoyed fishing trips to British Columbia and a vacation to Puerto Vallarta. H has had enough energy to be able to exercise and take pleasure in life. After the 13th cycle of FOLFOX in October 2006, H met with the oncologist and in a review of symptoms had no fevers, unusual anorexia, weight loss, peripheral neuropathy, unusual aches or pains, anxiety, depression, or rashes. There are limitations to this case report. No validated tools were used to objectively evaluate the quality of life, ADLs, and CIPN. The data was retrieved through interview and chart notes from the physicians caring for H. In summary, during the naturopathic care that the patient received, H experienced a reduction in all major side effects from the chemotherapy, increased quality of life as evidenced by the ability to not only leave the house, but also to take vacations and engage in hobbies that were previously difficult.

First line chemotherapy regimens for colon cancer include FOLFOX (leucovorin, 5-fluorouracil, and oxaliplatin). This combination of medications, more significantly oxaliplatin, has been linked to peripheral neuropathy. For patients with previous active lifestyles, peripheral neuropathy can cause a decreased quality of life. In addition, there are many other side effects of FOLFOX including nausea, diarrhea, and weight loss. Significant peripheral neuropathy in patients undergoing FOLFOX therapy may occur spontaneously after oxaliplatin infusions are discontinued. Current literature supports the need to clinically evaluate peripheral neuropathy in patients undergoing FOLFOX chemotherapy, but few studies have shown an effective way to treat the peripheral neuropathy experienced by many patients. Standard of care for chemotherapyinduced peripheral neuropathy (CIPN) includes dose reduction and/or discontinuation of the suspected neurotoxin. Such dose-limiting effects are poor prognostic indicators and often negatively affect a patient’s long-term survival.

Patient H is a 43-year-old male diagnosed with stage IV colon cancer in December 2003. After H was diagnosed he was treated with 20 cycles of FOLFOX (December 2003-October 2004). The FOLFOX was tolerated moderately well. The oxaliplatin dose was 85 mg/ m2 throughout the 20 cycle course. In February 2004, before the fifth cycle of FOLFOX, the oncologist referred H to the Integrative Medicine clinic; the referral was due to H’s desire to continue with the chemotherapy protocol with goals including weight optimization and alleviation of side effects from the medications causing decrease in daily activities and decreased quality of life.

The Integrative Medicine clinic is staffed with an internist, naturopathic doctors, acupuncturists, massage therapists, and a nutritionist. H saw Dr. Ken Weizer, a board certified Naturopathic Doctor (ND). H presented with chief complaints of weight loss over two months totaling 10% of body weight, nausea, diarrhea, and peripheral neuropathy. On exam, chemotherapy-induced peripheral neuropathy (CIPN) presented as paresthesia in the fingertips for 2-3 days post chemotherapy before complete resolution. However, the CIPN by the ninth cycle of FOLFOX was lasting a full week after chemotherapy treatments and the paresthesia progressed to include all fingers and toes. The CIPN subsequently progressed from the tips of the fingers and toes to involving the entire digits with mild to moderate pain and was affecting the patient’s activities of daily living (ADL). The CIPN associated with oxaliplatin is cumulative and dose dependent. The CIPN was graded using a subjective pain scale and through patient interview with specifics determined regarding location, duration, and effects on ADLs. There is controversy regarding the most sensitive scale to evaluate peripheral neuropathy, and many of the scales do not take into account ADLs,3 therefore in H’s case, no objective scale was used to evaluate the neuropathy.

Immune system development in infants is closely tied to gastrointestinal maturation. The immunological factors found in breast milk are key instigators in the maturation of the gastrointestinal tract, as well as the gut-associated and systemic immune systems. Microflora such as Bifidobacterium have been identified in studies of infant fecal composition in association with maternal breast milk composition. Maternal breast milk Bifidobacterial counts dramatically impacted the infants’ fecal Bifidobacterium levels, demonstrating that breast milk is a powerful modifier of infantile gastrointestinal microflora and thus immune status. Breast milk–fed infants showed high levels of fecal calprotectin, indicating a low level of gastrointestinal inflammation. The excessive inflammation seen in NEC is less severe with a lower incidence when infants are given their mothers breast milk, in part due to the influence breast milk has on the intestinal flora. Recent research shows that the mucosal microflora acquired in early infancy determines the production of mucosal inflammation and the consequent development of mucosal disease, autoimmunity, and allergic disorders later in life. The non-absorbed milk oligosaccharides found in breast milk block attachment of microbes to the infant’s gastrointestinal mucosal membranes, thus preventing infections.Although oligosaccharides are major components of breast milk, the milk is also rich in other glycans, including glycoproteins, mucins, glycosaminoglycans, and glycolipids. Glycans protect the infant primarily by inhibiting pathogens’ binding to their host cell’s target ligands. At the same time, human milk oligosaccharides strongly attenuate inflammatory processes in the intestinal mucosa. Undigested glycans stimulate colonization by probiotic organisms through a prebiotic effect, modulating mucosal immunity and protecting against pathogens. Interactions between breast milk glycans, intestinal microflora, and intestinal mucosal surface glycans assist in the development of the innate mucosal immunity, protecting infants from infection and autoimmune inflammatory bowel diseases.

Conclusion
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There is a need for more extensive research into the development of the immune system in infants so that we have a more complete understanding of how to target and prevent immune disorders. Our current understanding points to 4 main areas in the ontogeny of the infant’s immune system as potential early intervention points for the prevention of immune disorders. First, nutritional support that aids in the prevention of immune disorders must be provided for infants. Second, the infant requires Th1 support so that he has protection from infections and the inflammatory damage they can incite. Third, immune tolerance and anti-inflammatory measures must be encouraged so inflammatory reactions and the corresponding immune disorders can be prevented. Fourth, the gastrointestinal health of the infant plays such a foundational role in immune status that it must be supported as well. The research demonstrates how breast milk targets all 4 of these areas and has the potential to be a powerful tool in the prevention of immune disorders. More research is necessary to confirm breast milk as a preventative treatment for asthma, allergies, and autoimmune disorders, but the current evidence is promising.

Helfgott employs experienced faculty in the fields of nutrition, psychology, immunology, whole systems research, and acupuncture, among other natural medicine research faculty, to carry out natural medicine clinical trials. Further, Helfgott faculty work with conventional biomedical researchers, using groundbreaking technology to study ancient traditions. A donation from Don Helfgott has helped fund the state-of-the-art basic science laboratory, as well as the resources to carry out clinical research.
Dedicated to the advancement of natural medicine, Helfgott was founded with the goals of training students and faculty interested in conducting research, collaborating with other research institutes and organizations, and conducting research specifically on naturopathic and Chinese medicine. At Helfgott, scientists from the fields of naturopathic medicine, Chinese medicine, acupuncture, immunology, and nutrition work together to apply their expertise to the study of natural medicine. “Our philosophy is that every study is a collaboration,” notes Zwickey, emphasizing the importance of collaborative research at Helfgott. Studies at Helfgott almost always involve external organizations, which “not only strengthens the study, but those relationships are what ultimately get natural medicine accepted in some of these more mainstream places.” Current faculty research projects at Helfgott include grants directly funded by the National Institutes of Health’s National Center for Complementary and Alternative Medicine.
In addition, Helfgott participates in several collaborative grants with Oregon Health & Sciences University as well as with other Western biomedical and naturopathic schools. In addition to working with external health organizations nationwide, Helfgott is largely involved in the local community as well. “One of the things that we’ve been doing is being the conduit for people in Portland to learn about who’s in their community and what type of research they’re doing,” says Zwickey. Helfgott is active not only at the local level, but at national and international levels as well.
“We envision Helfgott as the premier natural medicine research institute. Our vision includes a consortium of researchers from naturopathic medicine, Chinese medicine, Ayurvedic medicine, physical medicine, energy medicine, and other natural medicine disciplines. We envision an institute based on health rather than disease. We see a think tank that develops new innovative approaches to healthcare, and clinical floors where these approaches can be piloted. We see the development of research moving away from treating symptoms, and moving toward promoting health.” —From Helfgott Research Institute’s vision

Chronic diseases like heart disease, stroke, cancer,respiratory disease, and diabetes are the leading cause of mortality in the world, causing 60% of all deaths, according to the World Health Organization. Of the 35 million people who died worldwide from chronic disease in 2005, half were under age 70. These numbers emphasize the intense need for research related to chronic disease. In America, chronic disease is replacing infectious disease as the primary health concern, further highlighting the need for research related to its complex nature. At the Helfgott Research Institute in Portland, Ore., healing chronic disease is one of the manygoals of researchers. Established in 2003 at the National College of Natural Medicine (NCNM), Helfgott is a professionally independent, nonprofit research institute whose mission is to conduct rigorous, high-quality research on the art and science of healing, specifically working to understand natural forms of medicine. Although chronic illness can sometimes be effectively treated by pharmaceutical medicine alone, it often requires a more comprehensive approach due to its complex nature.

Lifestyle, nutrition, and behavioral changes all affect chronic disease, so Helfgott employs traditional approaches combined with natural medicine such as herbs, homeopathy, hydrotherapy, and acupuncture in order to prevention and treatment. One of the unique aspects of Helfgott’s research is the way clinical trials are conducted. “We are committed to studying natural medicine the way that it’s practiced,” says Heather Zwickey, PhD, director of research at Helfgott and dean of research at NCNM. “When a naturopath sees a patient, they don’t ever give just one thing. They always address the diet, and the lifestyle, and may provide some herbs, and maybe a homeopathic; it’s never one thing. If that’s what naturopaths are doing in practice, then that’s what we ought to be studying.” Instead of studying medicines individually or in a manner that would reduce an herb to its constituent components, Helfgott researchers look at a combination of herbs being administered. Zwickey continues, “Part of our mission is to study whole systems of medicine; we try to do as little with isolated components as possible.” The need for evidence-based research and clinical studies to evaluate and confirm the safety and effectiveness of natural medicine continues to grow.

Just as pharmaceutical medicine undergoes clinical trials, natural medicine is researched and studied through clinical trials. Helfgott employs experienced faculty in the fields of nutrition, psychology, immunology, whole systems research, and acupuncture, among other natural medicine research faculty, to carry out natural medicine clinical trials. Further, Helfgott faculty work with conventional biomedical researchers, using groundbreaking technology to study ancient traditions. A donation from Don Helfgott has helped fund the state-of-the-art basic science laboratory, as well as the resources to carry out clinical research.