Abstract
Naturopathic medicine is a “whole systems” form of medicine that emphasizes prevention and individualized treatment of disease with lifestyle changes and natural therapies. This international and multisite naturalistic pilot study aims to evaluate how 12 weeks of individualized naturopathic care affects health-related quality of life (HRQoL) for patients at 2 naturopathic teaching institutions by measuring Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale (GHS) scores. Secondly, this research aims to collect demographic data from 2 naturopathic institutions in the United States and Canada to explore the types of patients seeking naturopathic care in North America. We found that the 2 institutions, Boucher Institute and University of Bridgeport, treat very different populations, yet the main reason for seeking medical treatment remains similar. We also found statistically significant improvements in Global Physical Health (GPH) scores at both institutions (P=0.032) and at Boucher Institute alone (P=0.021) over the 12-week study period.
Introduction
Naturopathic medicine is a form of “whole systems” medicine that emphasizes prevention and treatment of disease with lifestyle changes and natural therapies. This research study has 2 aims. First, this study aims to evaluate the demographics of patients seeking naturopathic care at 2 naturopathic teaching clinics in the United States and Canada. Next, this research aims to study the clinical practice of naturopathic medicine as a whole-system medicine by evaluating patient outcomes. This research is studying naturopathic medicine as a whole system rather than investigating the benefits of standardized protocols. Naturopathic physicians evaluate each patient on an individual basis and use an individual approach, which makes studying naturopathic medicine via randomized controlled trials very challenging.1
Other studies have used this type of whole-systems approach when studying the effects of naturopathic medicine. In one study, 81 patients with anxiety were randomized to receive either comprehensive naturopathic care or standard psychotherapy for 12 weeks. The naturopathic care included a combination of botanical medicine, diet intervention, breathing exercises, and a multivitamin.2
In a study of cardiovascular event risk, 207 patients under usual care with biometric measurement (ie, enhanced usual care) were compared with patients undergoing usual care plus naturopathic medicine. The naturopathic treatment recommendations were individualized to the patient based on risk factors and preferences.3 They found that the naturopathic treatment group had a reduced adjusted 10-year cardiovascular risk and lower adjusted frequency of metabolic syndrome.
Another study analyzed the cost-effectiveness of enhanced usual care vs enhanced usual care plus naturopathic care in postal workers. The researchers evaluated the cost-effectiveness of whole-systems naturopathic care instead of using standardized protocols and found that those with naturopathic care had risk reductions that led to a savings of $1,138 in societal costs and $1,187 in employer costs.4
An observational study in 15 patients with depression and anxiety followed patients through their consults with their naturopathic physician over the course of 6 weeks. The naturopathic physicians were not told how to treat the patients; instead, they were instructed to prescribe individualized naturopathic care as they normally would.5 The results showed a significant reduction in depression, anxiety, and stress along with somatic symptoms, including insomnia. This naturalistic type of observational study allows researchers to assess the effects of naturopathic medicine as a whole system, rather than assigning the same protocol to each patient.
A similar study involved 40 patients with type 2 diabetes mellitus who were assigned to naturopathic care for 1 year. The number of visits, timing of the visits, and treatment plan was determined by the patient’s naturopathic doctor on an individual basis.6 Similar whole-systems approaches to outcome-based studies have been applied to studies in geriatric patients and patients with hypertension, low-back pain, multiple sclerosis, rotator cuff tendinitis, temporomandibular disorders, and HIV.7-13
This pilot study is intended to study the changes in health-related quality of life (HRQoL) in patients undergoing individualized naturopathic care for 12 weeks in 2 naturopathic teaching clinics in the United States and Canada. Self-assessed health status, determined via tools such as the 36-item Short Form Health Survey (SF-36), the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale (GHS), and others, has been shown to be a significant predictor of health outcomes.14,15 Health-related quality of life measures are increasingly being studied to evaluate health status. Studies monitoring HRQoL are being done in diverse fields of medicine, including cardiology, intensive care nursing, and geriatric health.16-18 In addition, interventions for various conditions, such as fibromyalgia and osteoarthritis, are now focusing on changes in HRQoL.19,20
Materials and Methods
This research was granted institutional review board (IRB) approval from the University of Bridgeport IRB on July 11, 2017 (IRB ID 2017-07-01). The research was conducted at 2 naturopathic teaching institutions in the United States and Canada: University of Bridgeport School of Naturopathic Medicine clinic in Bridgeport, Connecticut and Boucher Institute of Naturopathic Medicine clinic in New Westminster, British Columbia.
All adult, noncognitively impaired new patients visiting the clinic between August 2017 and March 2018 were invited to participate. Current doctoral students in the naturopathic medicine program were excluded from participating. Patients were invited to participate by phone before or upon arrival to the clinic appointment. Patients were given a demographics questionnaire and the baseline GHS during their first appointment. At the Boucher clinic, patients were given the 6-week and 12-week GHS assessments during follow-up visits. At the University of Bridgeport clinic, patients were given the 6-week and 12-week GHS assessments either during follow-up visits or electronically via LimeSurvey, a free online survey tool. The research did not interfere with the patients’ naturopathic care. Patients continued to receive their regular, individualized naturopathic care as determined by their naturopathic physician in the clinic.
A total of 67 patients were included in the study and completed demographics questionnaires, with 39 from the University of Bridgeport and 28 from the Boucher Institute. This demographic data was collected at baseline and included the patient’s biological sex, household income level, education level, ethnicity, top 3 reasons for visiting the clinic (ie, “chief complaints”), and age. The PROMIS GHS was collected at baseline, 6 weeks, and 12 weeks. Compliance was monitored by the participants’ naturopathic physician, and participants were excluded from the study if they were found to be noncompliant with the treatment plan after 2 consecutive visits. No participants were excluded from the research for noncompliance. Among the participants from Boucher, 10/28 completed all 3 GHS assessments and 20/28 completed the baseline and 6-week GHS assessments; at the University of Bridgeport, 22/39 participants completed all 3 GHS assessments and 20/39 completed the baseline and 6-week GHS assessments. At both institutions, 6-week data was carried forward to 12 weeks for those who did not complete the 12-week assessment.
The PROMIS GHS includes 10 questions that contribute to a Global Physical Health (GPH) T-score and a Global Mental Health (GMH) T-score. A T-score of 50 is considered an average score for a control population previously sampled by PROMIS.21 According to PROMIS, a T-score over 50 is correlated with better mental/physical health, and a score under 50 is correlated with worse mental/physical health.
Demographic data along with GPH and GMH data was analyzed using IBM SPSS software. Analysis of variants (ANOVA) was used to correlate demographic data with GPH and GMH scores.
Results
Demographics Data
Boucher Institute: The most frequent age range was 25-34 years and the least frequent age range was 18-24 years. Seventy-one percent of participants were female, and 32% held a bachelor’s degree, which was the most frequent education level seen. Thirty-two percent of participants had a household income between $100,000-$149,000, and this was the most frequently seen income level. Seventy-one percent of participants were Caucasian, 14% were Hispanic, and 14% identified as “other.” The most frequent chief complaint was fatigue (43%), followed by depression and anxiety (18%).
University of Bridgeport: The most frequent age range was 50-69 years; 72% were female, and 28% had some college credit with no degree, which was the most frequent education level seen. The most frequent income level was under $29,999 (28%); 10% reported household income level over $100,000. Fifty-one percent of participants were Caucasian, 15% were black or African American, and 8% were Hispanic. Fatigue was the most frequent chief complaint (28%), followed by depression and anxiety (26%).
Table. Demographics Data
| Boucher Institute | University of Bridgeport | |
| Most frequent age range | 25-34 years | 50-69 years |
| Biological sex | 71% female | 72% female |
| Most frequent household income | $100,000-$149,000 (32%) | Under $29,999 (28%) |
| Most frequent highest level of education | Bachelor's degree (32%) | Some college credit, no degree (28%) |
| Ethnicity | Caucasian (71%), Hispanic (14%), Other (14%) | Caucasian (51%), African American (15%), Hispanic (8%) |
| Most frequent main complaints | Fatigue (43%), depression and anxiety (18%) | Fatigue (28%), depression and anxiety (26%) |
Global Health Scores
Combined data from University of Bridgeport and Boucher Institute showed a statistically significant improvement in GPH scores from baseline to 12 weeks (P=0.032). At the University of Bridgeport, there was a trend for improved GPH and GMH scores, but these were not statistically significant. At the Boucher Institute, there was a statistically significant improvement in the paired samples correlations for GPH scores from baseline to 12 weeks (P=0.021). There were no significant predictors of GMH or GPH outcomes based on demographics.
Discussion
Our research had 2 aims. First, to evaluate the demographics of patients seeking naturopathic care in 2 different naturopathic teaching clinics. Next, to evaluate changes in GHS scores for GPH and GMH in patients receiving individualized naturopathic care for various health complaints over a 12-week period. Overall, we found that the patients visiting the Boucher Institute were younger, had higher income levels, and had a higher education level than patients seen at the University of Bridgeport Naturopathic Clinic. The patients at Boucher were most frequently treated for fatigue, depression, and anxiety. Patients at the University of Bridgeport, who were older and had less income and education, were also primarily seeking care for fatigue, depression, and anxiety. Both institutions saw a high percentage of female and Caucasian patients. We did not find any correlation in GHS scores and demographics, nor did demographics predict survey outcome scores. It seems that depression, fatigue, and anxiety are main concerns for patients seeking naturopathic care even when patients span wide demographic backgrounds.
The GPH scores showed significant improvement when data was compiled from both institutions and at Boucher Institute alone. The PROMIS GPH score is calculated from the GHS by asking patients questions about their physical health. The patients rate their physical health from poor to excellent, and they also are asked about pain levels and their ability to carry out social and everyday activities. Given today’s opioid crisis, our data holds some hope that individualized naturopathic care may improve a patient’s subjective perception of his/her physical health and pain. Future research projects should further investigate further the benefits of individualized naturopathic medicine for physical health and pain.
It seems that depression, fatigue, and anxiety are main concerns for patients seeking naturopathic care even when patients span wide demographic backgrounds.
In addition, future research should be conducted to investigate how fatigue, depression, and anxiety are being managed by naturopathic physicians, since these were the top concerns for patients seeking naturopathic care at each of the clinics. Global mental health scores showed a positive trend at the University of Bridgeport, but they were not significantly changed. If a large number of patients are seeking care for management of these complaints, more research should be done to investigate the effectiveness of naturopathic medicine for these particular complaints.
There were limitations to our study. This study was a naturalistic type of observational study, so we had no control groups or placebo, as we intended to observe naturopathic medicine in the teaching clinics without a research intervention. This means that protocols and methods of treatment were not standardized from patient to patient. Next, we did not include any compliance measures, as compliance was determined solely by the patient’s naturopathic physician. Additional limitations include lack of tracking of number of total clinic visits between groups, which could affect outcomes. Furthermore, the significant outcomes at the Boucher Institute clinic could be related to the higher income level found in those patients. A higher income could mean more frequent clinic visits and better compliance with treatment. Since this data was not tracked in our study, future studies should assess the relationships between income level, frequency of clinic visits, and compliance to treatment, as this would likely affect outcomes.
Conclusion
In summary, our study found that fatigue, depression, and anxiety were the most frequent chief complaints prompting patients to seek naturopathic care at both the Boucher Institute clinic and the University of Bridgeport Naturopathic clinic. We also observed differences in demographics between the 2 clinics, including age range, household income level, ethnicity, and education level. Lastly, the study found that GPH scores significantly improved over 12 weeks when looking at combined data from both clinics, but we did not find that demographics predicted GPH or GMH scores. Further studies of this type are encouraged to validate the utility of a whole-systems approach for studying the benefits of individualized naturopathic care.
