Adjunctive naturopathic care for type 2 diabetes: patient-reported and clinical outcomes after one year.

BACKGROUND: Several small, uncontrolled studies have found improvements in self-care behaviors and reductions in clinical risk in persons with type 2 diabetes who received care from licensed naturopathic physicians. To extend these findings and determine the feasibility and promise of a randomized clinical trial, we conducted a prospective study to measure the effects of adjunctive naturopathic care (ANC) in primary care patients with inadequately controlled type 2 diabetes. METHODS: Forty patients with type 2 diabetes were invited from a large integrated health care system to receive up to eight ANC visits for up to one year. Participants were required to have hemoglobin A1c (HbA1c) values between 7.5-9.5 % and at least one additional cardiovascular risk factor (i.e., hypertension, hyperlipidemia or overweight). Standardized instruments were administered by telephone to collect outcome data on self-care, self-efficacy, diabetes problem areas, perceived stress, motivation, and mood. Changes from baseline scores were calculated at 6- and 12-months after entry into the study. Six and 12-month changes in clinical risk factors (i.e., HbA1c, lipid and blood pressure) were calculated for the ANC cohort, and compared to changes in a cohort of 329 eligible, non-participating patients constructed using electronic medical records data. Between-cohort comparisons were adjusted for age, gender, baseline HbA1c, and diabetes medications. Six months was pre-specified as the primary endpoint for outcome assessment. RESULTS: Participants made 3.9 ANC visits on average during the year, 78 % of which occurred within six months of entry into the study. At 6-months, significant improvements were found in most patient-reported measures, including glucose testing (P = 0.001), diet (P = 0.001), physical activity (P = 0.02), mood (P = 0.001), self-efficacy (P = 0.0001) and motivation to change lifestyle (P = 0.003). Improvements in glucose testing, mood, self-efficacy and motivation to change lifestyle persisted at 12-months (all P < 0.005). For clinical outcomes, mean HbA1c decreased by -0.90 % (P = 0.02) in the ANC cohort at 6-months, a -0.51 % mean difference compared to usual care (P = 0.07). Reductions at 12-months were not statistically significant (-0.34 % in the ANC cohort, P = 0.14; -0.37 % difference compared to the usual care cohort, P = 0.12). CONCLUSIONS: Improvements were noted in self-monitoring of glucose, diet, self-efficacy, motivation and mood following initiation of ANC for patients with inadequately controlled type 2 diabetes. Study participants also experienced reductions in blood glucose that exceeded those for similar patients who did not receive ANC. Randomized clinical trials will be necessary to determine if ANC was responsible for these benefits.

Observed Changes in Risk during Naturopathic Treatment of Hypertension.

Few outcome assessments are published from complementary and alternative medicine (CAM) practices. We aimed to describe patient and practice characteristics of ND care for hypertension (HTN), quantify changes in blood pressure (BP), and evaluate the proportion achieving control of HTN during care. A retrospective, observational study of ND practice in HTN was performed in an outpatient clinic in WA State. Eighty-five charts were abstracted for the final analysis. At initiation of care, the mean patient age was 61 years, with 51% having stage 2 HTN, despite common use of anti-hypertensive medications (47%). Patients with both stage 1 and stage 2 HTN appeared to improve during care, with stage 2 patients achieving mean reductions of -26 mmHg (P < .0001) and -11 mmHg (P < .0001) in systolic BP (SBP) and diastolic BP (DBP), respectively. The proportion of patients achieving control (<140/90 mmHg) in both SBP and DBP was increased significantly from 14 to 44% (P < .033), although the statistical significance was not maintained upon correction for multiple comparisons. BP appears to improve during ND care for HTN, in a high-risk population. Randomized trials are warranted.

Predictors of Canadian physicians' prevention counseling practices.

OBJECTIVE: To understand predictors of Canadian physicians' prevention counseling practices. METHODS: A national mailed survey of a random sample of Canadian physicians conducted November 2007-May 2008. RESULTS: Primary care physicians (n=3213) responded to the survey (41% response rate); those with better personal health habits, female physicians, and physicians aged 45-64 years old were more likely to report "usually/always" counseling patients than did others, but there were no significant differences by province, origin of one's MD degree, or practice location. There was a clear and consistent relationship between personal and clinical prevention practices: non-smokers were significantly more likely to report counseling patients on smoking cessation; those who drank alcohol less frequently, drank lower quantities or binged less often were more likely to counsel on alcohol; those exercising more to counsel patients more about exercise; those eating more fruits and vegetables to counsel patients more often about nutrition; and those with lower weight were more likely to counsel about nutrition, weight or exercise. Physicians who strongly agreed or agreed that "they will perform better counseling if they have healthy habits" averaged higher rates of counseling (p < 0.001). CONCLUSIONS: Personal characteristics of Canadian physicians help predict prevention counseling. These data suggest that by encouraging physicians to be healthy, we can improve healthy habits among their patients--an innovative, beneficent, evidence-based approach to encouraging physicians to counsel patients about prevention.

Secondary prevention of myocardial infarction with nonpharmacologic strategies in a Medicaid cohort.

BACKGROUND: The quality of health care after myocardial infarction (MI) may be lacking; in particular, guidelines for nonpharmacologic interventions (cardiac rehabilitation, smoking cessation) may receive insufficient priority. We identified gaps between secondary prevention guidelines and ambulatory care received by Medicaid enrollees after an MI. METHODS: MI survivors were selected by using 2004 Washington State Medicaid administrative claims. Deidentified data were abstracted for hospitalizations, ambulatory care, and prescriptions for 365 days after the MI. Cox regression analysis compared utilization of guideline-directed secondary prevention strategies with death and recurrent hospitalization. RESULTS: The sample size was 372. Fifty patients died during the year after the MI, and 144 were rehospitalized. Only 2 patients attended a cardiac rehabilitation program. Tobacco cessation counseling was associated with a 66% reduction in death, but only 72.6% of smokers were counseled. Less than half (45.4%) of patients saw a primary care provider within 90 days of their MI, and 7.5% never contacted a health care provider. Receiving regular primary care was associated with a decreased risk for death (hazard ratio, 0.91; 95% confidence interval, 0.84-0.97, P < .01). A protective trend was associated with care by a cardiologist, but only 21.5% received specialist care. CONCLUSION: Analysis of Medicaid claims data suggests rates of secondary prevention are less than optimal. To improve survival and reduce rehospitalization after an MI, policy changes (tobacco cessation benefits, expansion of rehabilitation programs), health care capacity (training, referral patterns, and coordination of care), and improvements to access (removing barriers, increasing facilities, targeting minority populations) could be implemented.

Algorithm for complementary and alternative medicine practice and research in type 2 diabetes.

OBJECTIVE: To develop a model to direct the prescription of nutritional and botanical medicines in the treatment of type 2 diabetes for both clinical and research purposes. METHODS: Available literature on nutritional and botanical medicines was reviewed and categorized as follows: antioxidant/anti-inflammatory; insulin sensitizer; and beta-cell protectant/insulin secretagogue. Literature describing laboratory assessment for glycemic control, insulin resistance, and beta-cell reserve was also reviewed and a clinical decision tree was developed. RESULTS: Clinical algorithms were created to guide the use of nutritional and botanic medicines using validated laboratory measures of glycemic control, insulin sensitivity, and beta-cell reserve. Nutrient and botanic medicines with clinical trial research support include coenzyme Q10, carnitine, alpha-lipoic acid, N-acetylcysteine, vitamin D, vitamin C, vitamin E, chromium, vanadium, omega-3 fatty acids, cinnamon (Cinnamomum cassia), fenugreek (Trigonella foenum-graecum), and gymnema (Gymnema sylvestre). CONCLUSIONS: Clinical algorithms can direct supplementation in clinical practice and provide research models for clinical investigation. Algorithms also provide a framework for integration of future evidence as it becomes available. Research funding to investigate potentially beneficial practices in complementary medicine is critically important for optimal patient care and safety.

Naturopathic medicine and type 2 diabetes: a retrospective analysis from an academic clinic.

UNLABELLED: Accurate descriptions of naturopathic medicine as a whole system of medical practice are rare in the literature and non-existent for type 2 diabetes. METHODS: Using retrospective analysis of medical records at an academic naturopathic outpatient clinic, data was abstracted to investigate patterns of patient status, details of treatment recommendations, and levels of evidence. RESULTS: Most naturopathic medical care for type 2 diabetes is adjunctive, although naturopathic physicians are qualified to fill the role of primary care providers. Glycemic control and other vital statistics in patients receiving naturopathic care are comparable to published national averages. Naturopathic physicians prescribe comprehensive therapeutic lifestyle change recommendations supported by a high level of evidence - 100 percent received dietary counseling, 69 percent were taught stress reduction techniques, and 94 percent were prescribed exercise. Patients additionally received prescriptions for botanical and nutritional supplementation, often in combination with conventional medication. Analysis of individual supplement effects was not performed due to inadequate records. Components of treatment recommendations are often evidence-based, with varying evidence quality. CONCLUSION: Naturopathic medicine as a whole medical system supplies evidence-based lifestyle recommendations as suggested in management guidelines for diabetes, hypertension, and hyperlipidemia set forth by the respective national organizations - the American Diabetes Association (ADA), the Joint National Committee on Hypertension (JNC-7), and the National Cholesterol Education Program results of the third Adult Treatment Panel (NCEP ATP-III). Increased research effort to determine the safety and efficacy of combinations of supplements or medications and supplements is warranted. Education of other health care providers, patients, and health policy makers regarding the value of the naturopathic approach in the treatment and prevention of type 2 diabetes is warranted, yet prospective data on efficacy must be collected.

Epigenetics in Clinical Practice: Characterizing Patient and Provider Experiences with MTHFR Polymorphisms and Methylfolate.

BACKGROUND: Observational research associating 5,10-methylenetetrahydrofolate reductase (MTHFR) polymorphisms with risk of autism, depression, cancer, and cardiovascular disease has led to increased diagnoses of MTHFR; however, doctors lack knowledge about safety, effectiveness, and clinical implications of MTHFR treatment. Treatment strategies are hypothetical and mechanistically based, including methylfolate with or without other B vitamins. AIMS: This study was designed to formally describe patient and health care provider experiences with the diagnosis and clinical management of MTHFR. METHODS: Guided by a structured interview guide, a qualitative study queried patients' and providers' observations regarding: testing indications, reaction to results, treatment protocols, and clinical response including adverse effects. RESULTS: Thirty patients and 8 doctors participated. Patient themes included emotionality associated with diagnosis, classification of signs and symptoms, and challenges with treatment. They expressed confusion over their diagnosis, and frustration with the state of knowledge their providers had regarding MTHFR. Testing indications included: fatigue (21%), hormone imbalances (13%), and neurological symptoms (13%) including brain fog (8%). Patients reported improvements in physical (60%) and mental/behavioral symptoms (36%) following treatment. A minority of participants reported side effects, but they occurred in almost every body system and ranged in severity. Doctors relied on trial and error to determine treatment doses, frequency and components. CONCLUSIONS: MTHFR testing results in variable clinical processes in domains related to delivery of diagnosis and prognosis, and therapeutic options. However, patients report largely positive experiences. Clinicians and patients would benefit from therapeutic algorithms based on rigorous research.

Naturopathic practice at north american academic institutions: description of 300,483 visits and comparison to conventional primary care.

This study collected patient visit data to explore similarities and differences between conventional and naturopathic primary care (PC). Administrative data from practice management software systems from the main teaching clinics of four of the eight accredited North American naturopathic academic institutions were abstracted into an integrated database containing five years (2006-2010) of visit, patient, laboratory, and prescribing data. Descriptive analyses of healthcare services were compared to the National Ambulatory Medical Care Survey (NAMCS). Over the five-year period, 300,483 patient visits to naturopathic doctors occurred at clinics, excluding visits at clinics operated by the schools in community settings. Patients were 69% female; mean age was 39 (SE 0.09). Older adults (>65) comprised 9% of the population and children (<16) comprised 8%. Comparing academic naturopathic clinics to national conventional PC (NAMCS), we found more patients paid out of pocket at naturopathic clinics (50 vs. 4%) and naturopathic clinics more frequently offered discounted care (26 vs. 0.3%). There was a 44% overlap in the most frequent 25 diagnoses for PC at conventional community clinics. Overall, these data suggest substantial similarities in care offered by academic naturopathic clinics, at which most Naturopathic Doctor (ND) students are trained, and by conventional PC practices.

Impact of vitamin D3 dietary supplement matrix on clinical response.

CONTEXT: As a result of research suggesting increased health risk with low serum 25-hydroxycholecalciferol (25(OH)D), health care providers are measuring it frequently. Providers and patients are faced with treatment choices when low status is identified. OBJECTIVE: To compare the safety and efficacy of three vitamin D3 dietary supplements with different delivery matrices. SETTING AND DESIGN: A 12-week, parallel group, single-masked, clinical trial was conducted in Seattle, Washington and Kailua Kona, Hawaii. Sixty-six healthy adults with (25(OH)D) <33 ng/mL were randomly assigned to take one of three D3 supplements, ie, a chewable tablet (TAB), an oil-emulsified drop (DROP), or an encapsulated powder (CAP) at a label-claimed dose of 10,000 IU/day. Actual D3 content was assessed by a third party and the results adjusted based on the actual D3 content administered. Mean change in 25(OH)D/mcg D3 administered; difference in the proportion of D3 insufficient participants (ie, 25(OH)D ≤30 ng/mL) reaching sufficiency (ie, 25(OH)D ≥30 ng/mL); and mean change in serum 1, 25-dihydroxycholecalciferol were measured. RESULTS: In two of the three products tested, the measured vitamin D3 content varied considerably from the label-claimed dose. Differences in 25(OH)D/mcg D3 administered were significantly different between groups (P = .04; n = 55). Pairwise comparisons demonstrated DROP resulted in a greater increase than TAB (P < .05) but not than CAP. TAB was not different from CAP. The proportions reaching sufficiency were: 100% (TAB and CAP) and 80% (DROP) (P = .03 between groups; n = 55). 1, 25-Dihydroxycholecalciferol did not change significantly in any group. CONCLUSIONS: Oil-emulsified vitamin D3 supplements resulted in a greater mean change in serum 25(OH)D concentration, but fewer patients reaching vitamin D sufficiency, than chewable or encapsulated supplements.

Older adults' perspectives on naturopathic medicine's impact on healthy aging.

CONTEXT: High rates of complementary and alternative medicine (CAM) utilization among older adults are of interest because studies suggest relationships among CAM, self-care, and healthy lifestyle. These potential relationships are of particular interest because of the contribution of self-care in maintaining physical, emotional, and spiritual health as key strategies to successful aging. Naturopathic medicine (NM) is a type of primary care CAM used by older adults, yet little is known about older adults' use of NM or its role in healthy aging. OBJECTIVES: We sought to examine perceptions about, and utilization of, NM and the experience of addressing health and wellness as part of the aging process. DESIGN: Phenomenology-based qualitative inquiry. SETTING: A total of 13 community-based clinics affiliated with a naturopathic medical school. PARTICIPANTS: A total of 47 adults aged 58-100 years. METHODS: Qualitative analysis of semi-structured focus groups with quantitative analysis of clinical administrative data. RESULTS: Over 2543 older adults used NM services affiliated with a natural academic clinic in Seattle in 2011 for diagnoses consistent with primary care: fatigue, anxiety, diabetes, diarrhea, and depression, in rank order. Participants reported they sought NM because it offered a different system of care aligned with their values. Themes included (1) feeling heard, (2) a focus on health education including prevention and self-care, and (3) feeling supported. Themes further distilled into optimal descriptive characteristics of patient-centered providers that may best support older adults' healthy aging. A final theme described barriers to further utilization.

Self-directed Mindfulness Training and Improvement in Blood Pressure, Migraine Frequency, and Quality of Life.

BACKGROUND: Interest in case studies has undergone a resurgence concurrent with increasing prioritization of illustrations of patient-centered care. However, substantial inclusion of the patient in these reports remains limited. Here, a doctor and patient collaborate to present her case report of self-directed mindfulness training and the subsequent changes in blood pressure, migraine frequency, and quality of life. METHODS: After receiving encouragement from her naturopathic doctor, the patient initiated an 8-week program in mindfulness training following the Kabat-Zinn protocol and logged her daily blood pressure and symptoms before and after meditation sessions over an 11-week period. RESULTS: Patient-reported outcomes included decreased perceived stress, increased focus, and a newfound sense of centeredness and calm. Changes in objective outcomes were clinically and statistically significant, including reductions in mean systolic and diastolic blood pressure between week 1 and week 11 (P = .0001 and P = .0004 for systolic and diastolic, respectively, by paired, 2-sided t-tests). Self-reported frequency of chronic migraine was also reduced. Critical to the patient's success was that mindfulness training was first approached in a simple, accessible manner prior to embarking on a deeper, extended experience. DISCUSSION AND CONCLUSION: Self-directed mindfulness training can have a meaningful impact on both subjective and objective health outcomes. It may take years of encouragement from a healthcare provider before a patient is ready to adopt a mind-body practice; it is important to recognize and counsel patients with messages appropriate to their stage of change and self-efficacy. Additionally, case studies that combine the voice of the clinician and the patient can provide useful illustrations of truly patient-centered care.

Patient-reported experiences with first-time naturopathic care for type 2 diabetes.

Differences in the effectiveness of diverse healthcare providers to promote health behavior change and successful diabetes self-care have received little attention. Because training in naturopathic medicine (NM) emphasizes a patient-centered approach, health promotion, and routine use of clinical counseling on wellness and prevention, naturopathic physicians (NDs) may be particularly well-prepared for promoting behavior change. However, patients' experiences with NM have not been well studied. This study provides the first report of the perceptions of persons with type 2 diabetes of their first experiences with naturopathic care for their diabetes. Following their participation in a one-year prospective cohort study of adjunctive naturopathic care for diabetes, twenty-two patients were interviewed about their experiences working with a naturopathic physician. Using a content analysis approach, nine dominant themes were identified. Three themes characterized the nature of the ND-patient interaction: 1) patient-centered, 2) holistic health rather than diabetes focused, and 3) collaborative. Five themes characterized the content of the clinical encounter: 1) individualized and detailed health promotion, 2) counseling that promoted self-efficacy, 3) pragmatic and practical self-care recommendations, 4) novel treatment options that fostered hopefulness, and 5) patient education that addressed both diabetes self-care and general health. A ninth theme was cross-cutting: the contrast between ND care and conventional medical care. Results indicate that the routine clinical approach used by NDs is consistent with behavior change theory and clinical strategies found most effective in promoting self-efficacy and improving clinical outcomes.

The intersecting paradigms of naturopathic medicine and public health: opportunities for naturopathic medicine.

Complementary medicine research, including naturopathic medicine research, is plagued with many methodological challenges. Many of these challenges have also been experienced in public health research. Public health research has met these challenges with a long history of multidisciplinary, multimethod, and whole systems approaches to research that may better resonate with the ?real world? clinical settings of naturopathic medicine. Additionally, many of the underlying principles of naturopathic medicine are analogous to the underlying principles and activities of public health, specifically in such areas as health promotion, prevention, patient education, and proactive rather than reactive approaches to disease management and treatment. Future research in the field of naturopathic medicine may benefit from adopting public health research models rather than focusing exclusively on biomedical models. A complementary and collaborative relationship between these fields may provide an opportunity to deliver research that more accurately reflects naturopathic medicine practice, as well as providing the opportunity to improve health outcomes more generally.

CAM: naturopathic dietary interventions for patients with type 2 diabetes.

OBJECTIVE: To test feasibility, acceptability, and preliminary effectiveness of a naturopathic dietary intervention in patients with Type 2 diabetes. METHODS: Prospective observational pilot study evaluating the change in clinical and patient-centered outcome measures following a 12-week individualized and group dietary education program delivered in naturopathic primary care. RESULTS: HbA1c improved in all participants (n = 12); mean - 0.4% +/- 0.49% SD, (p = 0.02). Adherence to healthful eating increased from 3.5 d/wk to 5.3 d/wk (p = 0.05). Specific nutritional behavior modification included: days/week consuming ≥5 servings of fruit/vegetables (p = 0.01), attention to fat intake (p = 0.05), and -11.3% carbohydrate reduction. Measures of physical activity, self-efficacy and self-management also improved significantly. CONCLUSION: A naturopathic dietary approach to diabetes appears to be feasible to implement among Type 2 diabetes patients. The intervention may also improve self-management, glycemic control, and have influences in other domains of self-care behaviors. Clinical trials evaluating naturopathic approaches to Type 2 diabetes are warranted.

Integrative Treatments to Reduce Risk for Cardiovascular Disease.

Recognizing the contribution and interrelatedness of lipoprotein risk factors is critical to prioritizing treatment strategies for cardiovascular risk reduction. Lipoprotein factors still dominate risk for developing cardiovascular disease, including myocardial infarction. Some emerging risk factors such as C-reactive protein are gaining acceptance due to recent prospective clinical trials demonstrating clinical benefit in reducing these markers. Other emerging risk factors, including lipoprotein particle size, remain to be validated.In this second article of a 2-part series, we will begin with a review of formal risk assessment, discussing the contribution of multiple "risky" and "healthy" components that play a part in overall cardiovascular health. Following risk assessment, we will discuss evidence-based integrative therapies that can be used to modify any risky lipoprotein and inflammatory patient profiles, including medications, functional foods, supplements, and lifestyle approaches. The focus is on low-density lipoproteins, high-density lipoproteins, triglycerides, and C-reactive protein.Understanding the interrelatedness of lipoprotein risk factors, and finding efficient methods of treating multiple risk factors simultaneously, will not only improve the long-term health of patients but will also save on the expenditure of healthcare dollars for unnecessary testing and ineffective treatments. Integrative practitioners who understand the contribution of lifestyle factors, and who have numerous effective treatment options at their disposal, are well positioned to counsel patients on cardiovascular disease prevention.

Are Additional Lipid Measures Useful?

Total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) are the well-established standards by which clinicians identify individuals at risk for coronary artery disease (CAD), yet nearly 50% of people who have a myocardial infarction have normal cholesterol levels. Measurement of additional biomarkers may be useful to more fully stratify patients according to disease risk. The typical lipid panel includes TC, LDL-C, high-density lipoprotein cholesterol (HDL-C), and triglycerides (TGs). Emerging biomarkers for cardiovascular risk include measures of LDL-C pattern, size, and density; LDL particle number; lipoprotein(a); apolipoproteins (apoA1 and apoB100 being the most useful); C-reactive protein; and lipoprotein-associated phospholipase A(2). Some of these emerging biomarkers have been proven to add to, or be more accurate than, traditional risk factors in predicting coronary artery disease and, thus, may be useful for clinical decision-making in high-risk patients and in patients with borderline traditional risk factors. However, we still believe that until treatment strategies can uniquely address these added risk factors-ie, until protocols to rectify unhealthy findings are shown to improve cardiovascular outcomes-healthcare providers should continue to focus primarily on helping patients reach optimal LDL-C, HDL-C, and TG levels.

Medication Management Among Medicaid Myocardial Infarction Survivors.

Despite guidelines to direct appropriate medical management, the quality of care following acute myocardial infarction (AMI) may be lacking. This study characterizes medication utilization by Medicaid enrollees in the year following AMI, compares it to guidelines for secondary prevention and investigates associations with rehospitalization and survival. Using DSHS administrative claims data from Washington State, Medicaid enrollees who had an AMI in 2004 were selected. Data were de-identified and details of demographics, hospitalizations, ambulatory care, and prescriptions over the following 365 days were abstracted. Utilization of guideline-directed secondary prevention strategies was measured and associations with death and recurrent hospitalization were tested. The mortality rate was 13.4% and 38.7% were rehospitalized. Mean time to first rehospitalization was 188.6 days (SD 102.3). Prescriptions for angiotensin enzyme inhibitors or receptor blockers were initially filled by 54.0%, but year-long adherence declined to 33.3%. Beta blockers, aspirin and statins followed the same trend: 65.1% to 39.5%, 37.9% to 16.7% and 58.1% to 41.9% respectively. Twenty-two percent received all medications; 8.2% were adherent. Only the initial prescription of aspirin was significantly associated with a survival benefit (HR = 0.35, p=0.003). If the results suggested by the claims data are representative of care delivered to Medicaid enrollees, rates of application of guideline-directed medication are less than optimal. To improve survival and reduce re-hospitalization following AMI, changes in the access and delivery of healthcare could be implemented to improve medication management, both at time of discharge and over the year following AMI.