Evaluation of Case Report Publications on Naturopathic Medicine

In the hierarchy of quality in evidence-based medicine, case reports represent information in the lower tier of the pyramid. This contributes to the assumption of their inferior position in science while demonstrating their foundational role in the development of larger studies and reviews.¹ Despite this inherent weakness, journals recognize the value of case reports. The instructions to authors in BMJ Case Reports, a division of the British Medical Journal, state, “We want to publish cases worthy of discussion particularly around aspects of differential diagnosis, decision-making, management, clinical guidelines and pathology. The advantage is that we learn from real cases.”² Another journal editor has stated that case reports by novice authors tend to be focused on the novelty of an unusual or complex case, an unusual presentation of a common problem, or an innovative treatment; however, this person also expressed concern that this de-emphasizes the educational value of case reports presenting pragmatic exemplars.³

In an effort to ensure that case reports are adequately rigorous in design and to provide educational value, the CARE (CAse REport) guidelines were established to provide a productive means of disseminating information.⁴ In their own words, “the CARE guidelines provide a framework that supports transparency and accuracy in the publication of case reports and the reporting of information from patient encounters.”⁵ The CARE guidelines represent an excellent foundation for naturopathic case reports.

Naturopathic medicine is a system of medicine that uses education, natural therapies, and natural products to support and stimulate the patient’s intrinsic self-healing processes, or the vis medicatrix naturae, in order to prevent, diagnose, and treat human illnesses and injuries. The American Association of Naturopathic Physicians (AANP) defines naturopathic medicine as “a distinct primary health care profession emphasizing prevention, treatment and optimal health through the use of therapeutic methods and substances which encourage the person’s inherent self-healing process” (position paper by AANP)⁶. The emphasis on an individual’s self-healing process is a fundamental component of naturopathic medicine.

This paper evaluates a sample of currently published case reports on naturopathic medicine, discusses issues surrounding the content of naturopathic case reports, and argues for the need to provide information supplemental to the CARE guidelines that will better capture naturopathic philosophy and practice.

For clinicians interested in looking up a particular case, a MEDLINE/PubMed search using medical subject headings is probably the single most useful biomedical and life sciences research method. Peer-reviewed case report articles were searched in the National Library of Medicine (NLM) database using the query “naturopathic” and “case report.” The articles were critically evaluated by three licensed naturopathic clinicians independently using the CARE guidelines.⁴ The 13 checklist items of CARE are summarized in Appendix A. Using CARE guidelines as a foundation, the three evaluators synthesized consensus recommendations for case report publications in naturopathic medicine.

A PubMed query “naturopathic” and “case report” was made to identify published case reports in September 2015. The query returned 24 articles. Two were eliminated as non–English-language articles; two were eliminated because they were review articles; and two more were eliminated because they reported aggregate cases. Two types of case reports emerged: (1) the clinical outcome of naturopathic treatment with follow-up report (10 cases) and (2) naturopathic treatment that resulted in adverse events (eight cases with two deaths) (Figure 1).

A total of 18 articles were evaluated by authors JC, HF, and MS. Numerical values of A=3, B=2, C=1, and D=0 are averaged in Table 1. Using 13 evaluation criteria, the mean scores of therapeutic intervention between cases presenting favorable outcomes and cases presenting adverse events were significantly different [F(1,16)=8.984, P=0.009]. It is possible that evaluators were inconsistent about dealing with the description of the original therapeutic naturopathic intervention or subsequent treatments for the adverse event resulting from naturopathic treatment.

Table 1: CARE guidelines checklist of articles found by National Library of Medicine query on “naturopathic” and “case report”.

The patient, diagnosis, treatment, clinical outcome, and average CARE score for each publication are summarized in Table 2. The means of evaluation between cases involving favorable outcomes and cases involving adverse events were significantly different [t(16)=3.835, P=0.001]. Whether this difference is due to the bias of evaluators being naturopathic clinicians is unknown.

Table 2: Summary of 18 case reports.

Of the items evaluated for each case, the patient’s perspective and patient’s consent were the most poorly reported items (16.7% for both types of cases). As stated earlier, all case reports evaluated were retrospective clinical anecdotes; thus, the informed consent was not mandatory, with the exception of the report of Vinchurkar and Arankalle, which was a research project.²¹ The mean CARE scores of the two different types of cases were statistically different (P=0.001); the reliability of the ratings analyzed by the intraclass correlation coefficient (ICC) using IBM SPSS Statistics version 24 software (IBM, Armonk, NY) was borderline inconsistent (P=0.09). For each article, ICC was calculated for the 13 criteria by 3 raters. The ICCs of the type 1 (naturopathic case report) and type 2 (naturopathic case report involving adverse events) were compared. The mean ICC, standard deviation, and number of sample cases (using a single measure, absolute agreement) were (0.733, 0.119, 10) for type 1 and (0.582, 0.250, 8) for type 2. An independent t-test showed that the ICC of the two types of case reports was not statistically different [t(16)=2.143, P=0.09]. The average ICC of 18 articles by 3 raters was 0.669 for single-measure absolute agreement.

Adding information to the standard CARE guidelines may improve their utility in application to naturopathic case reporting. These suggestions include an emphasis on the naturopathic clinician’s evidence- or theory-based practice. Additional questions for writing case reports on naturopathic medicine in addition to those outlined in the CARE guidelines are summarized in Appendix B.

Appropriate reporting of diagnostic assessment is crucial for naturopathic cases because algorithms of treatment are not standardized to a symptoms-based approach. The clinical thinking of the physician must be reproducible and succinct. Naturopathic doctors often encounter patients with extensive treatment histories compiled by different practitioners unable to provide the desired outcome to the patient. As such, these patients have already undergone significant workup to identify the etiology of the disease to which the naturopathic doctor is privy and that the reader of the case report should be as well. In addition to previous diagnosticians’ treatment approaches, imaging, laboratory values, and other advanced diagnostic information needs to be included.

Obtaining information about a patient’s motivation and knowledge of naturopathic medicine will help to define the role of naturopathic medicine in the overall healthcare system. This includes but is not limited to (1) fee structure, (2) insurance coverage, (3) ethnic or religious compatibilities with the clinician, and (4) feelings about past treatment experiences in conventional medical settings. Naturopathic patients tend to be self-selected, affluent individuals who are likely educated about self-care and highly motivated to help themselves.²⁵ This disparity in who seeks out naturopathic care may stem from variability in insurance coverage due to a geopolitical environment that may be for or against naturopathic medicine. Patient motivation in seeking naturopathic care could help direct its utility in the current healthcare paradigm.

Reductionist approaches tend to be focused on the function of individual components, but they often miss how the components operate in relation to each other as a functional system. Specialization in medicine is an example of a reductionist approach that enhances greater understanding of individual components. Naturopathic medicine uses a systems-based or nonreductionist approach. It is defined not by a single treatment modality but by the philosophy and therapeutic intent as it pertains to the individual patient, encompassing their totality of parts. Considering each individual as a whole and using a systems-based approach means examining an individual not only from a physical standpoint but also from a mental, emotional, and spiritual standpoint. What is clear is that these holistic views are not generally captured in the electronic medical record (EMR), and thus case reports may be the only existing scientific methodology that can capture the benefit of the therapeutic effect of this systems-based, whole person–centered, patient-empowering approach to medicine.

The concept of the “therapeutic alliance” has evolved as a usable skill taught to therapists with a premise that includes agreeing on treatment goals and establishing a bond based on reciprocal positive feelings of regard. The ability to develop mutual goals with patients is paramount.²⁶ In placing the emphasis on a trainable skill, however, one might risk losing the authenticity of a fundamental human interaction. Naturopathic medical training includes collaborative goal setting, participatory decision making, and motivational interviewing as tools to encourage the formation of a therapeutic alliance, combined with 30–90 minutes of face-to-face time with the patient.²⁷ Currently, there is very little scientific research that addresses the importance of time, authenticity, or skill in forming a therapeutic alliance. Documentation of the patient’s experience and a definition of the therapeutic alliance from the patient’s perspective could contribute to the knowledge base and inspire trials to understand how to make patient outcome–oriented medicine more effective.

Meza and Fahoome define healing as “the human experience of self-discovery and transformation that results in a sense of being whole and connected.”²⁸ Developing a therapeutic relationship with a person who has socially constructed power, a healer or doctor, can initiate the healing process and can facilitate discovering and naming emotions that can contribute to repairing and improving relationships with oneself, others, and one’s spirituality. The idea of providing optimal healing environments by using the relationship between healer and patient, as well as among healers themselves, is an important component of integrative medicine.²⁹ The Self-Integration Scale is a tool used to measure the process of healing.²⁸ Naturopathic medicine is considered integrative medicine,³⁰ and the process of healing may be captured through using such an instrument.

The transtheoretical model is a robust theory that conceptualizes stages of change pertinent to addictive behaviors (precontemplation, contemplation, preparation/determination, action, relapse, and maintenance).³¹ Numerous sets of short questions have been published for assessing the stage of different types of behavior change, including smoking,³² exercise,³³ opioid drug use,³⁴ and oral self-care.³⁵ Naturopathic doctors prescribe an individualized treatment plan that is based on and targets these stages of change. The stage must continually be reassessed and treatment plans reevaluated in order to consistently meet the patient at the patient’s level of change and to optimize the therapeutic effect and progression. Emphasis is placed on the practitioner identifying and meeting a patient where the patient is rather than drawing a line of expectation that may not be realistic or achievable by the patient. When publishing a case report, sharing the individualized assessment questions serves two purposes: (1) It describes key components of health-related ­behavior change in this particular patient, and (2) it adds ­credibility to the case for further study.

We chose to use the CARE guidelines for evaluation because we found them to be the most robust and concise set of guidelines. Other limitations include the search criteria used (NLM only) and the fact that acupuncture, physical medicine, and other eclectic modalities were not captured.

List of abbreviations: AANP, The American Association of Naturopathic Physician; BMJ, British Medical Journal; CARE, CAse REport; CIH, Complementary and Integrative Health; EBM, Evidence-based Medicine; EHR, Electronic Health Record; ICC, Intraclass Correlation Coefficient; IRB, Institutional Review Board; NCCIH, National Center for Complementary and Integrative Health; NLM, National Library of Medicine

The authors acknowledge librarians Jane Saxton and Linda Tally for their support in the literature search.