It is that time of the year again! It is Naturopathic Medicine Week. This year I am very pleased to see that our American cousins have synchronized their Naturopathic Medicine Week with the Canadian.
Every year I update my post on research in whole person Naturopathic medicine. I deliberately exclude studies on single interventions or products, preferring to focus on Naturopathic medical treatment as a whole.
There was not a great deal of difference from the research review last year, but each year seems to bring new advances, which I am immensely grateful for. To begin with, we should discuss Naturopathic regulation globally, something that the World Naturopathic Federation has done wonderfully in the following paper.
To begin with, two reviews of all clinical trials on Naturopathic medicine have been conducted. The first was done in 2015, and found clinical trials on 13 conditions, finding statistically significant results in 10 of them. A second review conducted in 2019 found 33 trials, with Naturopathic medicine being found effective in pain, cardiovascular illness, type 2 diabetes, PCOS, depression and anxiety. A newer review was also performed, specifically in regard to side effects of Naturopathic medicine and surgical practice. The reviewers found a number of potential benefits naturopathic treatment could have in relation to surgery that demand further study, and no reports of serious side effects present. We will examine the clinical trials in different disease categories below.
Naturopathic Medicine in Metabolic disorders and Diabetes
Numerous clinical trials exist showing the effect of whole person naturopathic care on Diabetes. In this study the types of advice provided to Naturopathic Diabetes patients was examined. As well 31% acheives a HbA1c below 7% ( indicating diabetes was under control) and 61% acheived moderate control (HbA1c 6-10%).
A second study by the same authors examined the course of lab measurements in 37 patients, seen over a mean number of 11 visits. Changes in Lab values were -0.65% for HbA1c (p = 0.046), -45 mg/dL for Triglycerides (p = 0.037), -7 mm Hg in Systolic Blood Pressure (p = 0.02), and -5 mm Hg in Diastolic Blood Pressure (p = 0.003).
Another study examined 40 patients with diabetes given conventional and adjunct naturopathic care, and compared with a matched cohort of 329 patients given standard care alone. In the words of the abstract: “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)” Please note, that insignificant means that a larger sample is needed to determine whether or not those changes are purely due to the intervention, or due to chance. A larger sample size would determine this.
Another study shows the results of 101 patients with Diabetes given a 3 month course of in patient therapy with Yoga and Naturopathy. In this study “A ‘favourable outcome’ was defined as glycaemic control (glycosylated hemoglobin (HbA1c) < 7 % or absolute reduction by 1 %) along with at least 50 % reduction in antidiabetes medication at 3 months relative to baseline”. This study found “Of 101 patients with 3-month follow-up data, 65(65 %) achieved a favourable outcome – with 19(19 %) stopping medication while sustaining glycemic control. Factors associated with favourable outcome were baseline HbA1c and compliance to diet, which showed a significant linear relationship with mean HbA1c reductions of 0.4 %, 1.1 % and 1.7 % in relation to poor, moderate and excellent dietary compliance respectively.”
In this small prospective cohort Study, Naturopathic and Yoga care was observed to reduce postprandial blood glucose, and Hemoglobin A1C.
Another study shows 176 patients with obesity and diabetes randomized to either standard care, or residential naturopathic care. They found, in the words of the study “reduced PPBG levels (P < 0.001), glycated hemoglobin levels (P < 0.001), and reduced requirement for antidiabetic medications (P < 0.008) in the intervention group compared to controls. The effects were more profound immediately following intervention and lasted up to 6 months from the start of the study”
Naturopathic Medicine in Cardiovascular disease
Numerous trials of Naturopathic Medicine in Cardiovascular disease exist. In one trial 104 subjects with mild to moderate hypertension were treated by various Naturopathic therapies on an in patient basis. From the abstract “After starting nonpharmacological approach of naturopathy and yoga, Systolic blood pressure came down from mean of 139.6 to 129.6 where as it came down from 91.2 to 86.1 for diastolic blood pressure. At the same time favorable effect was also seen in other variables like lipid profile and body weight. At the end of one year out of 57 patients who came for follow-up, 14 cases were found to have blood pressure within normal ranges without any medication over the previous 12 months. ”
In a similar trial we see 72 subjects with cardiovascular risk factors receive a three week in patient Naturopathic/yoga treatment, with half receiving treatment, and half not. From the abstract “Compared to waitlist control, subjects in the Intervention group showed significantly (p < 0.05) lower adjusted mean values of systolic blood pressure (140.36 vs. 124.62), diastolic blood pressure (85.28 vs.76.93), fasting blood glucose (142.29 vs. 116.61), postprandial blood glucose (233.2 vs. 172.19), body mass index (33.05 vs. 31.86), total cholesterol(181.61 vs 161.04), LDL cholesterol(107.76 vs 85.72 ),triglycerides (152.8 vs. 131.74), anxiety (6.79 vs 4.98), depression (6.54 vs. 4.45) and somatization symptoms (7.84 vs. 3.56) at 3 weeks following intervention compared to waitlist controls. The intervention group showed significantly higher (p < 0.05) adjusted mean values of current health (29.56 vs 33.31) and prior health (9.67 vs 10.46) on the General Health Perception Questionnaire compared to waitlist controls following intervention.” This trial also found addition beneficial effects on blood glucose, LDL, and trigylcerides.
Another trial shows the results of yogic exercises, vegetarian diet and education on patients with hypertension. Of 80 patients, 79% acheived target blood pressure, 50% acheived this while reducing hypertensive medication by at least 50%. 10% were actually able to completely discontinue medication. There was also a significant differences in body fat, triglycerides and HbA1C as well.
An observational study was conducted in 2011. From the abstract “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.”
Another trial examined 922 patients recovering from cardiothoracic sugery, 337 of which were given a program of supplements and lifestyle advice, and compared with 585 patients that received standard care. The treatment group required 42% less postoperative inotropic support.
My alma mater, CCNM, recently performed a clinical trial in which 246 postal workers received Naturopathic care (207 completed the study) in addition to normal family medicine from their MD. Lab chemistry was taken before and after Naturopathic care,and their risk of a major cardiovascular even was computed using the Framingham Risk Score method of computing the likelihood of a Cardiovascular event, and the Adult Risk Panel III to compute the prevalence of metabolic syndrome. One group in the study received Naturopathic care plus normal medical care, and another received only normal medical care. In this study a highly significantly reduced risk of a major cardiovascular event (risk reduction in control group of 10.81, risk in Naturopathic group of 7.74% for a reduction of 3.07%) and a reduction of metabolic syndrome (48.48% control group, 31.58% Naturopathic group for a reduction 16.9%).Naturopathic care in Cardiovascular disease was recently examined in a clinical trial. 246 postal workers received Naturopathic care (207 completed the study) in addition to normal family medicine from their MD. Lab chemistry was taken before and after Naturopathic care,and their risk of a major cardiovascular even was computed using the Framingham Risk Score method of computing the likelihood of a Cardiovascular event, and the Adult Risk Panel III to compute the prevalence of metabolic syndrome. One group in the study received Naturopathic care plus normal medical care, and another received only normal medical care. In this study a highly significantly reduced risk of a major cardiovascular event (risk reduction in control group of 10.81, risk in Naturopathic group of 7.74% for a reduction of 3.07%) and a reduction of metabolic syndrome (48.48% control group, 31.58% Naturopathic group for a reduction 16.9%).
This data was further analyzed in another paper for the economic impact of Naturopathic treatment. The above trial resulted in (corresponding to a 3.3% decreased risk of a Cardiovascular event) in a savings of $1138 in costs to society and $1187 in employer costs per year of Naturopathic treatment. The cost savings of livelong Naturopathic care that could be speculated on based on this remain staggering.
In response to this trial, this MD in CMAJ endorsed the idea of delegating some aspects of Cardiovascular care from Medical to Naturopathic Doctors. Many MDs would oppose this, but a significant minority of our Allopathic cousins would gladly cooperate with us in patient management.
Naturopathic Medicine for Musculoskeletal Conditions
Multiple trials have been conducted on the treatment of musculoskeletal pain. One was conducted by CCNM on the Naturopathic treatment of rotator cuff tendonitis was recently published. In it, a group of postal workers with diagnosed rotator cuff tendontis received either a standard set of physiotherapy exercises to do on their own (an approach not unlike that which many MDs in family practice will use before a physiotherapy referral) as well as a matched placebo. Pain was measured using Shoulder pain and disability index scores, visual analogue pain score, Short form 36, and MYMOP. 87% of participants completed 8 weeks of treatment, SPADI scores decreased by 54.5% (p<0.0001) in the Naturopathic care group and 18% (p<0.0241) in the Exercise group. All measures showed significant differences in favor of Naturopathic care, with SPADI showing a difference probability of <0.0001 and no major adverse outcomes reported.
In a similar trial 75 postal employees with back pain greater than 6 weeks duration were given either Naturopathic medicine or standardized exercises ( again similar to what they might recieve at an MD practice) for 12 weeks. Progress was measured using the Oswestry disability questionaire, as well as the SF-36, lower back range of motion, weight loss and BMI. 92% completed at least 8 weeks of treatment. Back pain reduced significantly in the Naturopathic group (-6.92 on Oswestry, p<0.0001) and all other measure improved significantly as well.
The above trial was analyzed for economic impact. In the analysis, employees experienced 9.4 more perfect health days and reduced societal ( read employer) costs of $1212 per participant over the course of the study. The intervention cost $154 per day, compared with lost productivity costs of $178 per day, representing a return on investment of7.9%. Individuals participating saved $1096 each. Again this was from a single course of treatment. Imagine the cost savings applied society wide, particularly in countries like Canada with socialized medicine.
Another trial was performed comparing conventional and naturopathic treatment of back pain, using the Oswestry score. Very little difference was noted overall, but a superior outcome for naturopathic care was noted in women.
One poster presented an observational study of 221 patients treated with naturopathic therapies across a wide range of diagnoses such as fibromyalgia, rheumatoid arthritis, low back pain and chronic neck pain. According to the abstract “Mean VAS decreased by 15.1 from 60.7+23.0 (T1) to 45.6+26.2 (T5) (p<0.0001, two-sided t-test), with highest improvement for low back pain (decrease of 17.5) and no differentiation for multi-morbidity (n=46 with, n=55 without). SF-36 physical and mental component scores improved significantly from 40.0+12.2 to 44.3+12.5 and from 29.6+8.2 to 32.9+10.5, respectively (p<0.0001 for each).
Another pilot study compared 160 women comparing conventional care, naturopathic medicine and chinese medicine in the treatment of TMJ disorders. From the abstract “CM and NM demonstrated significantly greater in-treatment reductions for worst facial pain compared to SC (adjusted regression analysis; higher negative values indicate greater improvement, = -1.11 +/- 0.43, p = 0.010 and -1.02 +/- 0.45, p = 0.025 for TCM and NM, respectively, compared to SC) and at 3 months post-treatment (-1.07 +/- 0.51, p = 0.037 and -1.27 +/- 0.54, p = 0.019 for TCM and NM versus SC, respectively). Additionally, TCM provided significantly greater decreases in average pain than SC; NM provided significantly greater decreases than SC or TCM in TMD-related psychosocial interference”.
One final study was conducted on chiropractice, acupuncture and naturopathic medicine on pain, showing significant reductions in all groups.
Naturopathic Medicine for Mood Disorders
Several trials have examined the efficacy in Naturopathic medicine for mental health conditions. One trial, conducted my my alma mater CCNM, compared Naturopathic care or standardized psychotherapy for the treatment of generalized anxiety, finding a significant difference in favor of Naturopathic medicine.
Another study was conducted on patients with anxiety and depression using Naturopathic medicine as primary therapy. In the words of the abstract “The overall improvement in symptoms of depression and anxiety was highly significant (p < 0.0001) when comparing the group’s average initial screener scores to their average final screener scores for both depression (16.4 vs. 8.6) and anxiety (12.4 vs. 7.2). The response rate, as measured by a 50% decrease in scores, for those with initial scores ≥10 was 58.6% for depression (PHQ-9) and 50% for anxiety (GAD-7). ”
A small Australian trial shows some preliminary results in improving mood and decreasing anxiety though small sample size prevented definite conclusions. A second small case series found a number of bipolar patients who were, with naturopathic therapy, able to reduce or eliminat medication, with mood stability continuing.
Naturopathic medicine for Asthma
Another small Indian study showed significant improvements in PEFR, VC, FVC, FEV1, FEV/FEC%, MVV< ESR and Absolute Eosinophil count in Asthma patients undergoing a Naturopathic and Yogic treatment regimen.
Another Indian study we see the results of a one month in patient regimen on 159 bronchial asthma patients. From the abstract “The paired sample t test results showed significant increase in the Forced Vital Capacity and Forced Expiratory Volume from the date of admission up to 6th month (P < 0.0035) post Bonferroni correction. Maximum Voluntary Ventilation significantly increased from admission till the date of discharge (P < 0.0035) and Peak Expiratory Flow Rate significantly increased from admission till the 36th month of follow-up (P < 0.0035), post Bonferroni correction.”
In another study, patient outcomes from Naturopathic and Allopathic medical practices were compared in the treatment of menopausal symptoms. Consistent with other research, Naturopathic patients reported higher income, lower rates of smoking, higher rates of exercise, but interestingly, greater rates of fatigue, insomnia and hot flashes. Both patient groups resulted in improvements in anxiety, hot flashes, vaginal dryness and menstrual changes. Significantly better results were found in insomnia and fatigue.
Naturopathic medicine in other Chronic Conditions
Naturopathic medicine has been studied in a wide variety of other conditions. One German study on in patient treatment showed significant improvement in quality of life, though with rheumatic patients showing a different improvement profile. Another feasibility trial examined one housing complex. The results showed “After 12 months, effect sizes ≥0.3 were observed for activities of daily living on the NOSGER-Activities of Daily Living subscale (0.53), Barthel Index (0.30), Qualidem total sum score (0.39), Profile of Wellbeing (0.36), NOSGER-Impaired Social Behavior (0.47), and NOSGER-Depressed Mood subscales (0.40). Smaller or no effects were observed for all other outcomes. The intervention itself was found to be feasible, but elaborate and time consuming. ”
An observational study on 5278 patients with a wide variety of concerns for 12 months. From the abstract”Complaints had persisted for 6 years (median). The intensity of the main complaint decreased from 59+/-25 by an average of 25 points at discharge (19 points at 6-month follow-up) corresponding to an effect size of 0.86 (0.62 at 6-month follow-up). At 6-month follow-up about half of the patients showed a clinically relevant improvement of quality of life (SF-36 sum scores increased by >or=5 points). Intake of drugs was reduced,the number of days off work had decreased after rehabilitation. ”
Another small observational trial showed 49 patients with an average of 57.14% improvement in presenting symptoms and 34.69 percent improvement in overall wellbeing over three years.
An observational trial was conducted in menopausal patients. From the results ” In univariate analyses, patients treated with naturopathy for menopausal symptoms reported higher monthly incomes ($1848.00 versus $853.60), were less likely to be smokers (11.4% versus 41.9%), exercised more frequently, and reported higher frequencies of decreased energy (41.8% versus 24.4%), insomnia (57.0% versus 33.1%), and hot flashes (69.6% versus 55.6%) at baseline than those who received conventional treatment. In multivariate analyses, patients treated with naturopathy were approximately seven times more likely than conventionally treated patients to report improvement for insomnia (odds ratio [OR], 6.77; 95% confidence interval [CI], 1.71, 26.63) and decreased energy (OR, 6.55; 95% CI, 0.96, 44.74). Naturopathy patients reported improvement for anxiety (OR, 1.27; 95% CI, 0.63, 2.56), hot flashes (OR, 1.40; 95% CI, 0.68, 2.88), menstrual changes (OR, 0.98; 95% CI, 0.43, 2.24), and vaginal dryness (OR, 0.91; 95% CI, 0.21, 3.96) about as frequently as patients who were treated conventionally. ”
In a retrospective review of patients with Hepatitis C who were treated with a comprehensive naturopathic protocol. Of 14 patients that had not undergone interferon therapy, 7 had a greater than 25% decrease in ALT, a measure of liver inflammation. The average reduction in ALT was 35 U/L (p=0.026)
Another trial on 20 patients with HIV on standard antiretroviral medications treated with Naturopathic interventions (IG) and compared with 20 matched patients (CG) from the results “: After the end of 6 month, the IG showed significant changes CD4 cell count (p=3.96E-05). The CG also showed a significant improvement in CD4 cell counts (p= 0.024) but not of the same magnitude as of IG. An independent t-test between the groups has shown that the IG was more significant (p=0.047). ”
One study was done on patients with Autism, 67 patients ranging from 3-58 years were given supplementation, with additional naturopathic treatments, such as enzymes, carnitine, epsom salts baths and a diet free of gluten, casein and soy. Lab results show a significant improvement of blood nutrient levels, and nonverbal IQ and autism symptoms also significantly improved.
Another study examines Polycystic ovarian syndrome patients who had undergone a Naturopathic and Yogic regimen for 12 weeks. 25 patients were given the intervention, while 25 others were placed on a wait list. Significant changes were observed in ovarian morphology and body measurements.A second trial of PCOs was also conducted on 101 women who were given either lifetyle advice, or lifestyle advice plus herbal therapy. “At 3 months, women in the combination group recorded a reduction in oligomenorrhoea of 32.9% (95% confidence interval 23.3-42.6, p < 0.01) compared with controls, estimated as a large effect (ηp2 = 0.11). Other significant improvements were found for body mass index (p < 0.01); insulin (p = 0.02) and luteinizing hormone (p = 0.04); blood pressure (p = 0.01); quality of life (p < 0.01); depression, anxiety and stress (p < 0.01); and pregnancy rates (p = 0.01).”
A pilot study was with MS patients. 45 patients were randomized to either usual care, usual care plus MS education, or usual care plus naturopathic care. There were no significant differences between the groups, but a nonsignificant trend in favor of naturopathic medicine in general health, timed walk and neurological impairment. These results would likely have been significant in a slightly larger trial.
Naturopathic Medicine and Cancer
This study shows a trial of 116 patients with stage II and stage III adenocarcinoma of the colon, randomized to standard treatment (counselling and chemotherapy) and to Standard therapy plus natuorpathic medicine, yoga, and dietary management. The trial found statistical improvements in Carcinoembryonic antigen and hemoglobin and psychological attributes such as anxiety, depression, symptom severity, and Functional Living Index: Cancer (FLIC) were found to be significantly improved.
Another trial of 101 individuals focused on the survival of patients diagnosed with hepatocellular carcinoma treated with any number of 12 naturopathic agents. From the abstract ” Initial treatment was with 2.6 ± 0.8 agents (range 2-4). Overall, patients were treated with 3.7 ± 1.2 agents (range 2-7). There was a significant correlation between number of agents administered and survival (P < .0001). Patients treated with ≥4 agents survived significantly longer than patients treated with ≤3 agents (40.2 vs 6.4 months, P < .0001). This difference could not be attributed to statistically significant differences in severity of liver disease or tumor stage, delay in treatment, previous treatment, concurrent nondrug treatment, or censoring effects. The greatest effect was seen in patients treated with at least 4 agents that included Cordyceps sinensis. This prolonged survival was without toxic side effects and appeared to potentiate the survival benefit of conventional therapy. ”
Recent Indian research has focused on a number of areas of integration of Naturopathic medicine and conventional care. This paper reviews the multiple ways many Naturopathic agents can aid in modulating cell signalling pathways in cancer. Another paper shows a similar conclusion, with Natural compounds showing great promise in decreasing resistance to one method of cell self destruction in cancers.
Demographics and Morbidity of Naturopathic Patients
Much recent research has focused on the types of patients Naturopathic Doctors see. In one recent study a survey of 300483 visits to a Naturopathic teaching clinic was examined. It was found that Naturopathic clinics saw a similar range of problems to other primary care practices, that patients paid out of pocket more (unsurprisingly) and that Naturopathic clinics offered discounted care far more often.
Another recent study discussed characteristics of Pediatric patients coming to CCNM, a Naturopathic college in Toronto. Furthermore, a cross section of Naturopathic patients as a whole at CCNM was done, showing the incredibly wide variety of issues people come to Naturopathic Doctors with.
Another study was done on the morbidity profiles of patients for Naturopaths in India, showing a very wide variety of ages attending. The diseases presenting tended to be chronic and multisystematic “followed by Obesity, Diabetes Mellitus, Hypertension, Arthritis, and Back pain”.
Naturopathic Medicine in Public Health
Another fascinating direction of research has emerged in the applications of Public health models of research to Naturopathic care, rather than more allopathic models a potential research enterprise with much potential. Another study measured the characteristics of rural Naturopathic practice in Australia, showing the important role played by naturopaths in the provision of underserved rural populations. Another study showed a high level of patient and staff satisfaction resulting from integration of Naturopathic medicine into an acute care hospital.
Perhaps most intriguingly in our survey of research is this paper, published in the Indian Journal of Medical Ethics. India is in the slow process of constructing a healthcare system of Universal coverage (often jokingly termed Modicare after the Indian Prime Minister Narendera Modi). Unlike in Countries such as Canada which have long traditions of public medicine that were built during the low point of Holistic medicine, in the 1960s, India likely will be including all systems of medicine in it’s public scheme, along with allopathic care. AYUSH is the term in India used for such systems, including Ayurveda, Therapeutic Yoga, Unani, Sidda, Homeopathy and Naturopathy. The above mentioned paper examined the AYUSH systems in light of a report on the Principles of Universal Care produced by the Planning Commission of India. In that paper, the authors conclude that not only does AYUSH meet the standards the India government wishes to see in it’s Universal system, they would actually further it’s goals more effectively in many cases than Allopathic care alone would be able to.
A newer paper has also been published advocating for the inclusion of Naturopathy and Yoga for it’s expertise in treating the burden of non communicable disease.
Finally, there is a free documentary showing Naturopathic medicine being practiced in India, to fully scope, in in-patient facilities. I encourage you to watch it. It is my hope that the example of India in medical equality and non discrimination will be followed by Canada and other Western countries, giving all citizens the potential for access to the benefits of Naturopathic Treatment.