This report suggests that clinically important risk factors reductions are achieved during N.D. care for T2DM. Health-promotion counseling, including dietary change, exercise, and stress reduction, appear to be fundamental elements of N.D. practice. These high rates of health-promotion counseling contrast with those estimates reported from conventional, allopathic primary care.2–5
It is possible that this self-selecting patient cohort is more receptive to individual health-promotion counseling, yet it is also likely that the N.D. standard is to recommend lifestyle modification in practice in an effort to affect the patient's readiness to change. As lifestyle change has a considerable impact on mortality in patients with cardiovascular disease (CVD), and because T2DM is considered a CVD equivalent, optimizing delivery and receptivity of health-promotion messages in clinical practice remains a critical and fundamental challenge to reducing chronic disease risk.16
N.D. practice appears to be an existing model of health-promotion counseling in physician practice, though controlled evaluation is necessary.
Nutritional and botanical supplementation is also recommended commonly. Numerous nutritional supplements were prescribed, and many have clinical trial evidence for effect in T2DM17
; a review of the level of evidence of nutritional supplementation used in naturopathic practice has been reported elsewhere.14,18
Unfortunately, the relative contribution of each supplement or combination of supplements to the observed changes in clinical risk factors cannot be determined from this study design due to its limited statistical power; logistic regression analyses in larger, controlled samples would be necessary to determine promising supplements and/or supplement combinations.
Objective clinical risk factors were moderately well controlled for most patients at baseline; however, additional improvements were observed during the course of N.D. care. Observed changes in clinical risk factors in this cohort are clinically meaningful. An additional average reduction in HbA1c of 0.65% corresponds to an approximate 14% risk reduction for microvascular complications.19
In addition, the observed SBP and DBP reductions are clinically meaningful; a 5 mm Hg reduction in SBP and DBP are comparable to estimates of blood pressure reduction achieved through lifestyle modification and correspond to approximately 25% and 50% reductions in relative risk for cardiovascular event, respectively.7
Although changes in the distribution of cholesterol measures did not meet statistical significance, 25%–28% of patients had at least 10% improvements in HDL and LDL, respectively. A near perfect linear relationship exists between LDL reduction and risk reduction for coronary event; a 1% reduction in LDL corresponding to a 1% reduction in risk.20,21
Additive risk reduction is achieved through HDL elevations, with a 1% increase in HDL corresponding to a 1% reduction in risk.20,22
Although this report suggests that clinical risk factor improvements occur during the course of N.D. care for T2DM, this study has several important limitations. Most notably, since many patients are utilizing naturopathic services as adjunctive care, and patients self-select N.D. services, the generalizability of these findings in more diverse populations is unknown. As evidenced by the mean levels of clinical risk factors at the beginning of care, patients continuing with N.D. care for T2DM appear to be moderately well controlled (i.e., a relatively healthy cohort despite diabetes). This observation, plus the lack of a natural history control or conventional care control, suggests the possibility of bias in the reported estimates of clinical change. These findings are biased, by design, in favor of those patients who continue with N.D. care for at least 6 months, who may be exceptionally motivated regardless of their exposure to N.D. care. In addition, the risk factor reductions reported here are unadjusted estimates of change over the course of care, comparing baseline values to the most recent values in the medical chart. Therefore, they do not describe the longitudinal time course of change. Also, we performed analyses on limited risk factors understanding that additional risk factors may be altered throughout the course of N.D. care and remain unquantifiable by this analysis; similarly, this description does not include any measures of patient experience with N.D. care.
A further limitation is that the contributions of medication modifications to the observed changes cannot be determined using these descriptive analyses. A high prevalence of use of pharmaceutical medications for glucose (54%) and blood pressure (70%) was observed at baseline. Medication change, including either new medications or increases in medication dosage, was evident for 10/37 (27%) and 7/27 (26%) of observed cases for glucose and blood pressure medications, respectively. Evidence of medication discontinuation or dosage reduction was available for 4/37 (11%) of patients. Interestingly, in several circumstances, a recommendation to improve adherence to already prescribed medications, or a recommendation for the patient to return to their primary care physician for medication management, was recommended in the N.D. treatment plan, suggesting a recognition of a need for additional, or optimal, medication management. It is nearly impossible to quantify the effect of this type of naturopathic advice on patient self-management.
Ongoing studies are in progress to evaluate risk factor changes longitudinally over time to determine the relationship, if any, between duration of care and the observed changes in risk factors and to determine the average rate of change. In addition, controlled, observational studies have just begun to evaluate the promise of N.D. care in a more generalized, managed care patient population.