Find out more about Dr. Orest’s original research published in peer-reviewed scientific journals:
Naturopathic medicine for the prevention of cardiovascular disease: a randomized clinical trial
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.
Trial registration: ClinicalTrials.gov, no. NCT0071879.
Canadian College of Naturopathic Medicine, Toronto, Ont. [email protected]
Read more about this study in CMAJ. 2013 Jun 11;185(9):E409-16. doi: 10.1503/cmaj.120567. Epub 2013 Apr 29.
A systematic review of natural health product treatment for vitiligo
Orest Szczurko and Heather S Boon
Background Vitiligo is a hypopigmentation disorder affecting 1 to 4% of the world population. Fifty percent of cases appear before the age of 20 years old, and the disfigurement results in psychiatric morbidity in 16 to 35% of those affected.
Methods Our objective was to complete a comprehensive, systematic review of the published scientific literature to identify natural health products (NHP) such as vitamins, herbs and other supplements that may have efficacy in the treatment of vitiligo. We searched eight databases including MEDLINE and EMBASE for vitiligo, leucoderma, and various NHP terms. Prospective controlled clinical human trials were identified and assessed for quality.
Results Fifteen clinical trials were identified, and organized into four categories based on the NHP used for treatment. 1) L-phenylalanine monotherapy was assessed in one trial, and as an adjuvant to phototherapy in three trials. All reported beneficial effects. 2) Three clinical trials utilized different traditional Chinese medicine products. Although each traditional Chinese medicine trial reported benefit in the active groups, the quality of the trials was poor. 3) Six trials investigated the use of plants in the treatment of vitiligo, four using plants as photosensitizing agents. The studies provide weak evidence that photosensitizing plants can be effective in conjunction with phototherapy, and moderate evidence that Ginkgo biloba monotherapy can be useful for vitiligo. 4) Two clinical trials investigated the use of vitamins in the therapy of vitiligo. One tested oral cobalamin with folic acid, and found no significant improvement over control. Another trial combined vitamin E with phototherapy and reported significantly better repigmentation over phototherapy only. It was not possible to pool the data from any studies for meta-analytic purposes due to the wide difference in outcome measures and poor quality ofreporting.
Conclusion Reports investigating the efficacy of NHPs for vitiligo exist, but are of poor methodological quality and contain significant reporting flaws. L-phenylalanine used with phototherapy, and oral Ginkgo biloba as monotherapy show promise and warrant further investigation.
Ginkgo biloba for the treatment of vitilgo vulgaris: an open label pilot clinical trial
Orest Szczurko (Leslie Dan Faculty of Pharmacy, University of Toronto), Neil Shear (Professor & Chief of Dermatology, University of Toronto), Anna Taddio (Senior Scientist, Dept. of Pharmacy and Child Health Evaluative Sciences, The Hospital for Sick Children), and Heather Boon (Associate Professor, Leslie Dan Faculty of Pharmacy, University of Toronto)
Purpose: To evaluate the feasibility, safety, and trend toward effectiveness of using Ginkgo biloba in the treatment of vitiligo.
Methods: 12 participants 12 to 35 years old were recruited to a prospective non-randomized open-label pilot clinical trial and treated with 60 mg of standardized G. biloba two times per day (BID) for 12 weeks. The primary outcome was the validated Vitiligo European Task Force (VETF). Secondary outcomes included the Vitiligo Area Scoring Index (VASI), photographs, and adverse reactions. Due to Ginkgo biloba’s potential anticoagulant effect, serum coagulation factors (platelets, PTT, INR) were also measured at baseline and week 12.
Results: 11 participants completed the trial with 85% or greater adherence to protocol. VETF total vitiligo lesion size decreased 0.357% (P= 0.102) from 5.91 to 5.55 from baseline to week 12. VETF staging score improved 0.727 (P=0.101) from 6.55 to 5.82, and the VETF progression score improved by 3.9 (P=0.00036) from 2.72 to -1.18. The total VASI score improved by 0.50 (P = 0.021) from 4.97 to 4.46. The progression of vitiligo stopped in all participants; the total VASI indicated an average repigmentation of vitiligo lesions of 15%. A 75% improvement in lesion size and repigmentation is typically considered clinically significant. The platelet count was on average 262 at baseline and increased to 284 at week 12 (range 145-400), PTT decreased from an average of 36.5 to 34.6 (range 26-37seconds), and the INR remained stable at an average of 1.15 (range 0.9-1.3). There were no adverse events.
Conclusions: Ingestion of 60 mg of Ginkgo biloba BID was associated with a trend towards improvement on VETF measures of vitiligo lesion area and staging, and significant improvement in VETF spread and total VASI vitiligo measures. Larger, randomized double-blind clinical studies are warranted.
Naturopathic care for anxiety: a randomized controlled trial (ISRCTN78958974)
Department of Research and Clinical Epidemiology, The Canadian College of Naturopathic Medicine, Toronto, Canada
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.
Read the full trial report.
Naturopathic treatment of rotator cuff tendinitis among Canadian postal workers: a randomized controlled trial.
Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada
OBJECTIVE: To explore the effectiveness of naturopathic care (NC) on rotator cuff tendinitis using a prospective randomized clinical trial design.
METHODS: Canadian postal workers with rotator cuff tendinitis for a duration of >6 weeks were randomized to receive NC (n = 43) or standardized physical exercises (PEs; n = 42) over 12 weeks. Participants in the NC group received dietary counseling, acupuncture, and Phlogenzym (2 tablets 3 times/day). The PE intervention group received passive, active-assisted, and active range of motion exercises and matched placebo. The primary outcome measure was the Shoulder Pain and Disability Index (SPADI), and secondary outcomes were the pain visual analog scale (VAS), Short Form 36 (SF-36), Measure Yourself Medical Outcomes Profile (MYMOP), and shoulder maximal range of motion. Participants and assessors were blinded to group and placebo allocation.
RESULTS: Seventy-seven participants (87%) completed >or=8 weeks of the trial. Final total SPADI scores decreased by 54.5% (P < 0.0001) in the NC group and by 18% (P = 0.0241) in the PE group. Between-group differences in changes to SPADI scores showed statistically significant decreases in shoulder pain and disability in the NC group compared with the PE group (P < 0.0001). Significant differences between groups were also observed in the pain VAS, MYMOP, SF-36, and shoulder extension, flexion, and abduction, with the NC group showing superiority in each outcome. No serious adverse reactions were observed.
CONCLUSION: NC and PE provided significant improvements, with greater improvement in shoulder function in the NC group compared with the PE group. Statistically significant improvements in quality of life measures were observed in the NC group as compared with the PE group.
PMID: 19644905 [PubMed – indexed for MEDLINE]
Read the free full trial report.
Cost-effectiveness of naturopathic care for chronic low back pain.
Herman PM, Szczurko O, Cooley K, Mills EJ
OBJECTIVE: To determine the cost-effectiveness of naturopathic care (acupuncture, relaxation exercises, exercise and dietary advice, and a back care booklet) compared to standardized physiotherapy education and a back care booklet (control treatment) for low back pain in a sample (N = 70) of warehouse workers.
DESIGN: Economic evaluation based upon the results of a pragmatic randomized controlled trial to determine the cost-effectiveness of naturopathic care to society as a whole, to the employer, and to participants.
RESULTS: Naturopathic care (as compared to the control treatment) significantly improved quality-adjusted life-years over the 6-month study period (3-month intervention period and 3-month follow-up period) by 0.0256 (95% CI: 0.0075, 0.0437)–roughly equivalent to 9.4 “perfect health” days. Naturopathic care also significantly reduced societal costs by $1212 per participant. From the perspective of the employer, the intervention cost $154 per absentee day avoided (compared to employer costs of lost productivity of $172 per day) and had a return on investment of 7.9% under the healthcare coverage limits set by this employer and assuming the employer paid the full cost of naturopathic care. Participants experienced savings in adjunctive care of $1096 per participant.
CONCLUSIONS: This economic evaluation alongside a pragmatic randomized control trial shows naturopathic care to be more cost-effective than a standardized physiotherapy education regimen in the treatment of chronic low back pain. Further studies of the economic impact of naturopathic medicine are warranted.
Please visit PubMed for the complete article.
Naturopathic Care for Chronic Low Back Pain: A Randomized Trial
Orest Szczurko, Kieran Cooley, Jason W. Busse, Dugald Seely, Bob Bernhardt, Gordon H. Guyatt, Qi Zhou, Edward J. Mills
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 (26.89, 95% CI. 29.23 to 23.54, 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 (20.52, 95% CI, 20.96 to 20.08, p = 0.01). Conclusions. Naturopathic care provided significantly greater improvement than physiotherapy advice for patients with chronic low back pain.
Induction of antitumor immunity through xenoplacental immunization.
Zhong Z, Kusznieruk KP, Popov IA, Riordan NH, Izadi H, Yijian L, Sher S, Szczurko OM, Agadjanyan MG, Tullis RH, Harandi A, Reznik BN, Mamikonyan GV, Ichim TE.
Historically cancer vaccines have yielded suboptimal clinical results. We have developed a novel strategy for eliciting antitumor immunity based upon homology between neoplastic tissue and the developing placenta. Placenta formation shares several key processes with neoplasia, namely: angiogenesis, activation of matrix metalloproteases, and active suppression of immune function. Immune responses against xenoantigens are well known to break self-tolerance. Utilizing xenogeneic placental protein extracts as a vaccine, we have successfully induced anti-tumor immunity against B16 melanoma in C57/BL6 mice, whereas control xenogeneic extracts and B16 tumor extracts where ineffective, or actually promoted tumor growth, respectively. Furthermore, dendritic cells were able to prime tumor immunity when pulsed with the placental xenoantigens. While vaccination-induced tumor regression was abolished in mice depleted of CD4 T cells, both CD4 and CD8 cells were needed to adoptively transfer immunity to naïve mice. Supporting the role of CD8 cells in controlling tumor growth are findings that only freshly isolated CD8 cells from immunized mice were capable of inducing tumor cell caspases-3 activation ex vivo. These data suggest feasibility of using xenogeneic placental preparations as a multivalent vaccine potently targeting not just tumor antigens, but processes that are essential for tumor maintenance of malignant potential.
Please visit PubMed for the complete article.