A naturopathic approach to the prevention of cardiovascular disease: cost-effectiveness analysis of a pragmatic multi-worksite randomized clinical trial.
ABSTRACT: To determine the cost-effectiveness of a worksite-based naturopathic (individualized lifestyle counseling and nutritional medicine) approach to primary prevention of cardiovascular disease (CVD).Economic evaluation alongside a pragmatic, multi-worksite, randomized controlled trial comparing enhanced usual care (EUC; usual care plus biometric screening) to the addition of a naturopathic approach to CVD prevention (NC+EUC).After 1 year, NC+EUC resulted in a net decrease of 3.3 (confidence interval: 1.7 to 4.8) percentage points in 10-year CVD event risk (number needed to treat = 30). These risk reductions came with average net study-year savings of $1138 in societal costs and $1187 in employer costs. There was no change in quality-adjusted life years across the study year.A naturopathic approach to CVD primary prevention significantly reduced CVD risk over usual care plus biometric screening and reduced costs to society and employers in this multi-worksite-based study. Trial Registration clinicaltrials.gov Identifier: NCT00718796.
Project description:Although cardiovascular disease may be partially preventable through dietary and lifestyle-based interventions, few individuals at risk receive intensive dietary and lifestyle counselling. We performed a randomized controlled trial to evaluate the effectiveness of naturopathic care in reducing the risk of cardiovascular disease.We performed a multisite randomized controlled trial of enhanced usual care (usual care plus biometric measurement; control) compared with enhanced usual care plus naturopathic care (hereafter called naturopathic care). Postal workers aged 25-65 years in Toronto, Vancouver and Edmonton, Canada, with an increased risk of cardiovascular disease were invited to participate. Participants in both groups received care by their family physicians. Those in the naturopathic group also received individualized care (health promotion counselling, nutritional medicine or dietary supplementation) at 7 preset times in work-site clinics by licensed naturopathic doctors. The body weight, waist circumference, lipid profile, fasting glucose levels and blood pressure of participants in both groups were measured 3 times during a 1-year period. Our primary outcomes were the 10-year risk of having a cardiovascular event (based on the Framingham risk algorithm) and the prevalence of metabolic syndrome (based on the Adult Treatment Panel III diagnostic criteria).Of 246 participants randomly assigned to a study group, 207 completed the study. The characteristics of participants in both groups were similar at baseline. Compared with participants in the control group, at 52 weeks those in the naturopathic group had a reduced adjusted 10-year cardiovascular risk (control: 10.81%; naturopathic group: 7.74%; risk reduction -3.07% [95% confidence interval (CI) -4.35% to -1.78%], p < 0.001) and a lower adjusted frequency of metabolic syndrome (control group: 48.48%; naturopathic care: 31.58%; risk reduction -16.90% [95% CI -29.55% to -4.25%], p = 0.002).Our findings support the hypothesis that the addition of naturopathic care to enhanced usual care may reduce the risk of cardiovascular disease among those at high risk.ClinicalTrials.gov, no. NCT0071879.
Project description:BACKGROUND: Anxiety is a serious personal health condition and represents a substantial burden to overall quality of life. Additionally anxiety disorders represent a significant cost to the health care system as well as employers through benefits coverage and days missed due to incapacity. This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a randomized trial. METHODS: Employees with moderate to severe anxiety of longer than 6 weeks duration were randomized based on age and gender to receive naturopathic care (NC) (n = 41) or standardized psychotherapy intervention (PT) (n = 40) over a period of 12 weeks. Blinding of investigators and participants during randomization and allocation was maintained. Participants in the NC group received dietary counseling, deep breathing relaxation techniques, a standard multi-vitamin, and the herbal medicine, ashwagandha (Withania somnifera) (300 mg b.i.d. standardized to 1.5% with anolides, prepared from root). The PT intervention received psychotherapy, and matched deep breathing relaxation techniques, and placebo. The primary outcome measure was the Beck Anxiety Inventory (BAI) and secondary outcome measures included the Short Form 36 (SF-36), Fatigue Symptom Inventory (FSI), and Measure Yourself Medical Outcomes Profile (MY-MOP) to measure anxiety, mental health, and quality of life respectively. Participants were blinded to the placebo-controlled intervention. RESULTS: Seventy-five participants (93%) were followed for 8 or more weeks on the trial. Final BAI scores decreased by 56.5% (p<0.0001) in the NC group and 30.5% (p<0.0001) in the PT group. BAI group scores were significantly decreased in the NC group compared to PT group (p = 0.003). Significant differences between groups were also observed in mental health, concentration, fatigue, social functioning, vitality, and overall quality of life with the NC group exhibiting greater clinical benefit. No serious adverse reactions were observed in either group. RELEVANCE: Many patients seek alternatives and/or complementary care to conventional anxiety treatments. To date, no study has evaluated the potential of a naturopathic treatment protocol to effectively treat anxiety. Knowledge of the efficacy, safety or risk of natural health products, and naturopathic treatments is important for physicians and the public in order to make informed decisions. INTERPRETATION: Both NC and PT led to significant improvements in patients' anxiety. Group comparison demonstrated a significant decrease in anxiety levels in the NC group over the PT group. Significant improvements in secondary quality of life measures were also observed in the NC group as compared to PT. The whole system of naturopathic care for anxiety needs to be investigated further including a closer examination of the individual components within the context of their additive effect. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN78958974.
Project description: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.
Project description:OBJECTIVE: Chronic low back pain represents a substantial cost to employers through benefits coverage and days missed due to incapacity. We sought to explore the effectiveness of Naturopathic care on chronic low back pain. METHODS: This study was a randomized clinical trial. We randomized 75 postal employees with low back pain of longer than six weeks duration to receive Naturopathic care (n = 39) or standardized physiotherapy (n = 36) over a period of 12 weeks. The study was conducted in clinics on-site in postal outlets. Participants in the Naturopathic care group received dietary counseling, deep breathing relaxation techniques and acupuncture. The control intervention received education and instruction on physiotherapy exercises using an approved education booklet. We measured low back pain using the Oswestry disability questionnaire as the primary outcome measure, and quality of life using the SF-36 in addition to low back range of motion, weight loss, and Body Mass Index as secondary outcomes. RESULTS: Sixty-nine participants (92%) completed eight weeks or greater of the trial. Participants in the Naturopathic care group reported significantly lower back pain (-6.89, 95% CI. -9.23 to -3.54, p = <0.0001) as measured by the Oswestry questionnaire. Quality of life was also significantly improved in the group receiving Naturopathic care in all domains except for vitality. Differences for the aggregate physical component of the SF-36 was 8.47 (95% CI, 5.05 to 11.87, p = <0.0001) and for the aggregate mental component was 7.0 (95% CI, 2.25 to 11.75, p = 0.0045). All secondary outcomes were also significantly improved in the group receiving Naturopathic care: spinal flexion (p<0.0001), weight-loss (p = 0.0052) and Body Mass Index (-0.52, 95% CI, -0.96 to -0.08, p = 0.01). CONCLUSIONS: Naturopathic care provided significantly greater improvement than physiotherapy advice for patients with chronic low back pain. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN41920953.
Project description:BACKGROUND AND OBJECTIVES:There is a lack of information on therapies recommended by naturopathic doctors (NDs) for lung and gastroesophageal cancer care. Study objectives were to: (1) identify the most common interventions considered for use by NDs; (2) identify interventions NDs recommend to support key therapeutic goals; and (3) identify potential contraindications between integrative and conventional therapies. METHODS:Oncology Association of Naturopathic Physicians (OncANP) members (n = 351) were invited to complete an electronic survey. Respondents provided information on interventions considered for thoracic cancer pre- and postoperatively across 4 therapeutic domains (supplemental natural health products, physical, mental/emotional, and nutritional), therapeutic goals, and contraindications. This survey was part of the development of the Thoracic Perioperative Integrative Surgical Evaluation trial. RESULTS:Forty-four NDs completed the survey (12.5% response rate), all of whom were trained at accredited colleges in North America and the majority of whom were Fellows of the American Board of Naturopathic Oncology (FABNO) (56.8%). NDs identified significantly more interventions in the postoperative compared to preoperative setting. The most frequently identified interventions included modified citrus pectin, arnica, omega-3 fatty acids, vitamin D, probiotics, exercise, acupuncture, meditation, stress reduction, low glycemic index diet, and Mediterranean diet. Potential contraindications with conventional treatment (surgery, chemotherapy, radiotherapy) differed across natural health products. CONCLUSIONS:These findings highlight naturopathic interventions with a high level of use in thoracic cancer care, describe and characterize therapeutic goals and the interventions used to achieve these goals, and provide insight on how practice changes relative to conventional cancer treatment phase.
Project description:Background: The majority of pediatric oncology patients report use of complementary and alternative medicine. Some naturopathic doctors (NDs) provide supportive pediatric oncology care; however, little information exists to formally describe this clinical practice. A survey was conducted with members of the Oncology Association of Naturopathic Physicians (OncANP.org) to describe recommendations across four therapeutic domains: natural health products (NHPs), nutrition, physical medicine, and mental/emotional support. Results: We had 99 respondents with a wide variance of clinical experience and aptitude to treat children with cancer. Of the majority (52.5%) of respondents who choose not to treat these children, the three primary reasons for this are lack of public demand (45.1%), institutional or clinic restrictions (21.6%), and personal reasons/comfort (19.6%). The 10 most frequently considered NHPs by all NDs are fish-derived omega-3 fatty acid (83.3%), vitamin D (83.3%), probiotics (82.1%), melatonin (73.8%), vitamin C (72.6%), homeopathic Arnica (69.0%), turmeric/curcumin (67.9%), glutamine (66.7%), Astragalus membranaceus (64.3%), and Coriolus versicolor/PSK (polysaccharide K) extracts (61.9%). The top 5 nutritional recommendations are anti-inflammatory diets (77.9%), dairy restriction (66.2%), Mediterranean diet (66.2%), gluten restriction (61.8%), and ketogenic diet (57.4%). The top 5 physical modality interventions are exercise (94.1%), acupuncture (77.9%), acupressure (72.1%), craniosacral therapy (69.1%), and yoga (69.1%). The top 5 mental/emotional interventions are meditation (79.4%), art therapy (77.9%), mindfulness-based stress reduction (70.6%), music therapy (70.6%), and visualization therapy (67.6%). Conclusion: The results of our clinical practice survey highlight naturopathic interventions across four domains with a strong rationale for further inquiry in the care of children with cancer.
Project description:Background:Naturopathy is one of seven distinct traditional medical systems acknowledged by the World Health Organization. Naturopathic principles and philosophies encourage a focus on multiple body systems during case-taking and the design of treatments. Little is known about whether such teaching translates into practice. This study aimed to characterise naturopathic practice as it relates to the identification of multiple physiological systems in the diagnosis and treatment of patients. Methods:A cross sectional study was conducted in collaboration with the World Naturopathic Federation. A survey capturing clinical diagnostic and treatment considerations for up to 20 consecutive patients was administered to naturopaths in 14 countries. Results:Naturopaths (n = 56) were mostly female (62.5%), aged between 36 and 45 years (37.5%), in practice for 5-10 years (44.6%), and consulting between 11 and 20 patients per week (35.7%). Participants completed the survey for 851 patient cases. Naturopaths reported a greater number of physiological systems relevant to clinical cases where the patients were working age (18-65 years) (IRR 1.3, p = .042), elderly (65 years and over) (IRR 1.4, p = .046), or considered by the naturopath to have a chronic health condition (IRR 1.2, p = .003). The digestive system was weakly associated with patients based on chronicity of the health complaint (V = .1149, p = .004), or having a musculoskeletal complaint (V = .1067, p = .002) autoimmune pathophysiology (V = .1681, p < .001), and considered relevant in respiratory (V = .1042, p = .002), endocrine (V = .1023, p = .003), female reproductive (V = .1009, p = .003), and integumentary (V = .1382, p < .001) systems. Conclusion:Naturopaths across the world adopt an integrative physiological approach to the diagnosis and treatment of chronic and complex health care complaints..
Project description:Background:Functional gastrointestinal disorders (FGID) affect more than one-third of the general population and contribute a considerable burden on the health and wellbeing of the community and the economy. This study aims to examine the treatment approaches and outcomes of naturopathic management of individuals presenting with a non-specific FGID. Methods:We report a comparison of two clinical case studies of patients being treated by a naturopath for a functional gastrointestinal disorder. The care was provided by two different student practitioners under the supervision of an industry qualified mentor within a multidisciplinary academic clinic at the Endeavour College of Natural Health. A student practitioner and student observer conduct consultations under the supervision of an industry qualified mentor. The outcomes of care were measured by the Gastrointestinal Symptom Rating Scale. Results:Clinical notations partially correlate to Jane's outcomes measured by gastrointestinal rating scale scores, which remain stable. Significant changes in Rona's gastrointestinal rating scale scores equate to only generalizable minimal clinical notations. Conclusions:The holistic and individualised approach core to naturopathic medicine practice is also informed by traditional methods, research evidence and the pragmatic needs of the patient. The emphasis within naturopathic treatment approaches on dietary changes and lifestyle prescription alongside other ingestive therapies such as herbal and nutritional medicine underscores the need for clinical research designs which support evaluation of complex interventions in real-world settings.
Project description:Working adults spend much time at the workplace, an ideal setting for wellness programs targeting weight loss and disease prevention. Few randomized trials have evaluated the efficacy of worksite diabetes prevention programs. This study evaluated the efficacy of a worksite lifestyle intervention on metabolic and behavioral risk factors compared with usual care.A pretest-posttest control group design with 3-month follow-up was used. Participants with prediabetes were recruited from a university worksite and randomized to receive a 16-week lifestyle intervention (n = 35) or usual care (n = 34). Participants were evaluated at baseline, postintervention, and 3-month follow-up. Dietary intake was measured by a food frequency questionnaire and level of physical activity by accelerometers. Repeated measures analysis of variance compared the change in outcomes between and within groups.Mean (standard error [SE]) weight loss was greater in the intervention (-5.5% [0.6%]) than in the control (-0.4% [0.5%]) group (P < .001) postintervention and was sustained at 3-month follow-up (P < .001). Mean (SE) reductions in fasting glucose were greater in the intervention (-8.6 [1.6] mg/dL) than in the control (-3.7 [1.6] mg/dL) group (P = .02) postintervention; both groups had significant glucose reductions at 3-month follow-up (P < .001). In the intervention group, the intake of total energy and the percentage of energy from all fats, saturated fats, and trans fats decreased, and the intake of dietary fiber increased (all P < .01) postintervention.The worksite intervention improved metabolic and behavioral risk factors among employees with prediabetes. The long-term impact on diabetes prevention and program sustainability warrant further investigation.
Project description:In a follow-up study overweight and obese patients fasting according to Buchinger (modified) and a control group treated by a weight reduction diet in the context of an inpatient naturopathic complex treatment were compared using a questionnaire developed for a standardized phone interview 6.8 ± 1.1 years after inpatient treatment. During the inpatient treatment the fasting patients significantly more body weight, but at the time of the interview significantly more weight was gained again. 10.7% of the fasting patients and 31.9% of the control group lowered their weight at least 5% of their initial weight up to the interview. 42% of the fasting and 74% of the control group persistently changed their diet. The control group followed a significantly higher number of trained nutritional aspects. 21% of the fasting and 40% of the control group increased their leisure activity permanently. Continued improvement in quality of life was achieved by 16% of the fasting patients and 28% of the control group. The fasting therapy, carried out as part of the inpatient naturopathic complex treatment, turned out to be less suitable for the treatment of overweight and obesity compared to standard therapy. One likely determinant is the minor poststationary lifestyle modification.