2022 INCAM Research Symposium

The chiropractic care of children: a survey of chiropractors

Joel Alcantara (1) and Joey D. Alcantara (2)

(1) The International Chiropractic Pediatric Association, Media, Pennsylvania, United States

(2) Alcantara Chiropractic, Canada, Calgary, Alberta, Canada

Background: Of the practitioner-based alternative therapies, chiropractic is highly utilized by parents and their children. To date, six publications have examined aspects of the chiropractic care of children. To provide a more comprehensive update in pediatric care, we performed a survey of chiropractors versed in the care of children.

Methods: We surveyed members of the International Chiropractic Pediatric Association with postgraduate training and actively engaged in the care of children (i.e., age 0–17 years) to characterize them (i.e., age, sex, years in practice), their practices (fee structures), management protocols (i.e., chiropractic techniques and adjunctive therapies) and cross-referrals with other healthcare providers in the care of children.

Results: A convenience sample of 163 chiropractors (115 females; 46 males) with an average age of 37.80 years and practice experience of 10.60 years. The responders attended to a mean of 129.32 patient visits per week with 29.62% this addressing the care of children. The most common chiropractic technique employed in the care of children was Diversified Technique (i.e., defined as “touch and hold” to “a variety of techniques”) along with a number of low force techniques such as Activator Methods and Thompson Technique and Sacro-Occipital Technique. Dietary and nutritional counselling were common adjunctive therapies. Established collaboration were most common with massage therapists followed by medical doctors, naturopaths and acupuncturists. However, their cross-referral patterns did not follow this trend. Younger age groups (i.e., ≤1 year) presented with feeding dysfunctions and gastrointestinal problems while older children (i.e., 6–17 years) commonly presented with musculoskeletal conditions.

Conclusion: Our update provided unique insights on the clinical presentations and the type of chiropractic care (i.e., chiropractic technique and adjunctive therapies) children received and patterns for cross-referral with other providers. We encourage continued efforts to characterize the practitioner, their clinical practice and their patients in pediatric chiropractic.

Hand self-shiatsu to promote sleep among veterans and their family members: a non-randomized, multiple-methods study

Cary Brown (1), Annette Rivard (1), Leisa Bellmore (2), Morgan Kane (1), Mary Roduta Roberts (1), Yuluan Wang (1)

(1) University of Alberta, Department of Occupational Therapy, Edmonton, Alberta, Canada

(2) University Health Network, Family and Community Medicine, Toronto, Ontario, Canada

Background: Sleep deficiency is a growing problem across all populations and is experienced by Veterans, military members and their intimate partners at higher rates than others. Optimal sleep is essential for brain function and overall health and well-being. Current guidelines for sleep deficiency recommend non-pharmacological interventions. Hand self-shiatsu (HSS) may be one such intervention that is easy to learn and which patients actively control, thereby contributing to feelings of self-efficacy.

Methods: This was a non-randomized controlled study. Arm 1 was an active intervention group and arm 2 was a wait-list control group. Objective measures (actigraphy) along with several standardized self-report questionnaires were used to collect data at baseline and at four and eight weeks post-intervention. Additionally, participants completed a detailed sleep log. To identify possible confounding variables participants’ beliefs about sleep, complementary and alternative medicine and holistic health were measured using standardized self-report tools.

Results: Fifty people were recruited, with 30 assigned to the intervention group and 20 to the control group. Sleep dimensions as measured by actigraphy showed no significant differences across measurement periods in either group. Self-report measures showed a statistically significant change in sleep disturbance (X²₂=10 [n=25], p=0.007) for the intervention group and 77% reported they would recommend HSS to others. There was also a significant change in two self-report measures for the control group, possibly an artifact of sub-optimal recruitment to this group due to restrictions imposed by the coronavirus pandemic.

Conclusion: Objective data did not support the hypothesis. However, subjective measures as well as qualitative information from participants’ interviews at study termination demonstrated endorsement of HSS for managing sleep problems and increasing self-efficacy.

A randomized, three arm, double blind, placebo controlled study of homeopathic treatment of children and youth with attention deficit hyperactivity disorder

David Brulé (1,2), Beth Landau-Halpern (2), Violeta Nastase (2), Marcia Zemans (3), Nicholas Mitsakakis (4,5), Heather Boon (1,5)

(1) Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada

(2) Riverdale Homeopathic Clinic, Toronto, Ontario, Canada

(3) Centre for Addiction and Mental Health, Toronto, Ontario, Canada

(4) Children’s Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada

(5) Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada

Background: Approximately 30% of children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD), the most prevalent mental health disorder in children worldwide, do not respond to conventional pharmaceutical treatments. Previous studies of homeopathic treatment for ADHD have been inconclusive. The objectives of this study were to determine if there:

1. is an overall effect of homeopathic treatment (homeopathic medicines plus consultation) in the treatment of ADHD;

2. are any specific effects the homeopathic consultation alone in the treatment of ADHD; and

3. are any specific effects of homeopathic medicines in the treatment of ADHD.

Methods: The design was a randomized, double-blind, placebo-controlled clinical trial. Participants were randomized to one of three arms: Arm 1 (Remedy & Consultation); Arm 2 (Placebo & Consultation) or Arm 3 (Usual Care). This trial was registered on ClinicalTrials.gov; NCT02086864 (https://www.clinicaltrials.gov/).

Results: There was an improvement in ADHD symptoms as measured by the Connor Global Index (Parent) T-score in the two groups (Arms 1 and 2) that received consultations with a homeopathic practitioner when compared to the usual care control group (Arm 3). Parents of the children in the study who received homeopathic consultations (Arms 1 and 2) also reported greater coping efficacy compared to those receiving usual care (Arm 3). There was no difference in adverse events among the three study arms.

Conclusion: In this study, homeopathic consultations provided over eight months with the use of homeopathic remedy was associated with a decrease in ADHD symptoms in children aged 6–16 years when compared with usual treatment alone. Children treated with homeopathic consultations and placebo experienced a similar decrease in ADHD symptoms; however, this finding did not reach statistical significance when correcting for multiple comparisons. Homeopathic remedies in and of themselves were not associated with any change in ADHD symptoms.

Current evidence from a systematic review and meta-analysis evaluating the application of mistletoe extracts during the oncological peri-operative period

Elise Cogo (1), Mohamed Elsayed (1,2), Sukriti Bhardwaj (1), Kieran Cooley (1,3,4,5), Christilynn Guerin (1), Vivian Liang (1), Peter Papadogianis (1) Athanasios Psihogios (1,6), Dugald Seely (1,6,7)

(1) Patterson Institute for Integrative Oncology Research, Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada

(2) National Cancer Institute, Radiation Oncology Department, Cairo University, Cairo, Egypt

(3) University of Technology Sydney, Ultimo, Australia

(4) Pacific College of Health Sciences, San Diego, USA

(5) National Centre for Naturopathic Medicine, Southern Cross University, Lismore, Australia

(6) The Centre for Health Innovation, Ottawa, Ontario, Canada

(7) The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

Background: There is uncertainty as to benefit and potential risk from the co-application of mistletoe extract (ME) injections with surgery in the oncology setting among cancer patients, despite the common usage of ME in the integrative oncology setting.

Methods: Detailed methods were registered on the PROSPERO website (CRD42018086168).

Results: This SR and MA included 12 reports: 7 RCTs published in 9 reports and 3 non-RCTs. In 5 RCTs (71%), the control group had no additional intervention, whereas in 2 RCTs (29%), ME was compared to active treatment (i.e., etoposide or bacillus Calmette-Guérin [BCG]. We included 3 RCTs for MA. There was no evidence for a statistical difference between ME and no additional treatment groups for mortality and recurrence (including metastases) (95% CI, 0.79–1.27 and 95% CI, 0.79–1.33, respectively). ME improved the Karnofsky index (p<0.01) in one RCT and provided some positive outcomes to immune cells and inflammatory markers in two RCTs. No additional serious adverse events or surgical complications were reported from the ME use in one RCT. In the comparison of SC ME versus oral etoposide, there was no significant difference between both groups in terms of all-cause mortality or relapse rate in osteosarcoma patients. The rate of local recurrence and stage and grade progression frequency was higher in the ME vs. BCG group, p<0.003 and p<0.01, respectively, with intravesical ME versus BCG. Quality appraisal revealed high or unclear risk-of-bias across the RCTs.

Conclusion: ME may positively impact the immune system and improve the quality of life in cancer patients during the perioperative period. However, the results of the survival are somewhat inconsistent. Further high-quality research is warranted.

An evaluation of longitudinal quality of life in patients with advanced-stage cancer seeking care at Canadian naturopathic oncology clinics: outcomes from the Canadian/US Integrative oncology study

Ellen Conte (1,2), Mark Legacy (1,2), Julie Ennis (1), Athanasios Psihogios (1,2), Dugald Seely (1,2)

(1) The Centre for Health Innovation, Ottawa, Ontario, Canada

(2) Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada

Background: Quality of life (QOL) is an important outcome for patients with advanced cancer as treatments are usually not curative. Naturopathic medicine is a form of complementary care often used by patients to support QOL; however, data on efficacy is limited. In this study, we evaluated longitudinal QOL and symptom burden in a subset of participants from the Canadian/US Integrative Oncology Study.

Methods: Participants from CUSIOS (stage IV breast/colorectal or stage III/IV ovarian/pancreatic cancer) seen at a Canadian naturopathic clinic were included in this sub-study. QOL and symptom burden were characterized using the European Organization for Research and Treatment of Cancer’s (EORTC) Quality of Life Questionnaire C30, Edmonton Symptom Assessment Scale (ESAS), and Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire. Assessments were completed six times over 36 months. Within person changes were analyzed with unadjusted paired t-tests using the Bonferroni correction for multiple assessments.

Results: 104 participants were enrolled with 97 included in the analyses. Questionnaire completion rates were 91% at baseline, 63–73% between months 3 and 24, and 52% at month 36 (excluding those deceased). Compared to baseline, EORTC global health improved at all timepoints with 3/6 reaching statistical significance; ESAS total symptom score improved at all timepoints with 5/6 reaching statistical significance; MYCAW concerns improved at all timepoints with 5/6 reaching statistical significance. Improvements were above the minimum important difference.

Conclusion: Longitudinal QOL and symptom data in advanced cancer patients receiving naturopathic care was collected, but response rates were suboptimal. QOL and symptom burden generally improved; however, due to the lack of a control group, it is not clear if this was a result of naturopathic medicine. More rigorous and well-controlled research is needed.

What information and services about complementary, alternative, and integrative medicine are provided by world-leading oncology hospital websites?

Melanie N. De Melo (1), Poojitha Pai (1), Michelle O. Y. Lam (1), Sharleen G. Maduranayagam (1), Kundan Ahluwalia (1), Menat Alla Rashad (1), Sahar Popal (1), Janany Gunabalasingam (1), Maiura Muralitharan (1), Anushka Pradhan (1), Jeremy Y. Ng (1)

(1) Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada

Background: With 19.3 million new cases in 2020 alone, cancer remains a leading health concern worldwide. In addition to conventional treatment including chemotherapy and surgery, various complementary, alterative, and integrative medicine (CAIM) therapies are utilized by cancer patients to improve their psychological and functional health.

Methods: The 2021 ranking of world-leading oncology hospitals was obtained from a Newsweek/Statista-administered survey. Hospital websites were reviewed if they provided a complete English translation of their content. Of the eligible websites, we data extracted independently and in triplicate: how each hospital recognized CAIM, which CAIM therapies were described and offered, and whether information on benefits and side effects accompanied CAIM therapy descriptions. Data was analyzed and reported by frequencies.

Results: Of 131 eligible hospital websites, 66 provided a description of CAIM and 63 provided descriptions of one or more CAIM therapies. The most common terms used to describe CAIM were “integrative medicine” (n=27) and “complementary therapy” (n=16). The most common CAIM therapies described were massage (n=53), special foods and diets (n=49), and acupuncture (n=46). Information about CAIM therapy benefits were provided for the vast majority of those described. In contrast, information about CAIM therapy side effects were generally not mentioned. Regarding patient services, 83 hospitals offered one or more CAIM therapies to cancer patients. The most common therapies offered were special foods and diets (n=63), massage (n=55), and creative outlets (n=51).

Conclusion: Given their rankings, these hospitals have the potential to greatly influence the incorporation of CAIM into conventional cancer care, yet CAIM information provided by each varied greatly. There is a need for standardized, accurate, and comprehensive CAIM information on hospital websites to help patients make well-informed decisions about their health.

ScarWork for cancer survivors experiencing pathologic scars as a consequence of surgery and/or radiotherapy: a service evaluation

Beverley de Valois (1), Teresa Young (1), Clare Scarlett (1), Emma Holly (2)

(1) Supportive Oncology Research Team, East and North Hertfordshire NHS Trust incorporating Mount Vernon Cancer Centre, Northwood, Middlesex, United Kingdom

(2) Restore Therapy Ltd, Radstock, Somerset, United Kingdom

Background: In England, 68% percent of early-stage cancer patients undergo surgical resection. Resultant scarring may cause troublesome physiological and psychosocial symptoms; radiotherapy may further damage tissues. We evaluated a 12-month service offering a light-touch manual therapy, ScarWork, to increase understanding of this novel intervention.

Methods: A National Health Service (NHS) cancer centre offered 8 ScarWork treatments to survivors who had undergone surgery and/or radiotherapy for breast, colorectal, gynaecological, head and neck cancers, or melanoma. Validated patient reported outcome measures (PROMs) administered at baseline and end-of-treatment included the Patient Scar Assessment Questionnaire (PSAQ) and Measure Yourself Medical Outcome Profile (MYMOP). Patients could specify one or more scars to be treated. A semi-structured questionnaire administered at end-of-treatment collected patients’ impressions of ScarWork.

Results: Nineteen patients reporting 25 scars received a median of 6 (range: 0–12) treatments during 2019–2020. Mean scar age was 4.2 years (range 0.5–17 years). PSAQ data showed significant (p<0.02) improvements for subscales Appearance, Consciousness, Satisfaction with Appearance, and Satisfaction with Symptoms, with improvements in itching, frequency of discomfort, sensations of numbness and overall troublesomeness. Mean MYMOP profile score showed 1.8 (SE=0.3) points improvement on a 7-point scale, where change of >0.5–1.0 points is clinically significant. Patients reported improved appearance, texture, mobility, wellbeing, and acceptance of scars. No serious adverse events were reported.

Conclusion: This service evaluation suggests ScarWork has potential to help survivors live well after cancer treatment. PSAQ and MYMOP showed trends in improving scar-related symptoms; patients reported physical, emotional, and psychosocial improvements. Experience gained in administering outcome measures contributed to developing a 3-step programme to build the evidence base for ScarWork, including the design of future research.

Real-world data: a service evaluation of a 15-year NADA auricular acupuncture service for breast cancer treatment related hot flushes

Beverley de Valois (1,2), Teresa Young (1), Pam Thorpe (3), Tarsem Degun (3), Karen Corbishley (3)

(1) Supportive Oncology Research Team, East and North Hertfordshire NHS Trust incorporating Mount Vernon Cancer Centre, Northwood, Middlesex, United Kingdom

(2) Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom

(3) Lynda Jackson Macmillan Centre, Mount Vernon Cancer Centre, Northwood, Middlesex United Kingdom

Background: Clinical trials provide valuable data about efficacy of interventions; however, findings often do not translate into clinical settings. We report real-world clinical outcomes of a 15-year service offering breast cancer survivors auricular acupuncture to manage hot flushes and night sweats (HFNS) associated with adjuvant hormonal treatments (tamoxifen and aromatase inhibitors).

Methods: This service evaluation analysed 415 referrals to a service offering women 8 standardised treatments using the National Acupuncture Detoxification Association (NADA) 5-point ear acupuncture protocol. Outcome measures administered at baseline, end of treatment (EOT), and four- and 18- weeks after EOT included Hot Flush Diaries, Hot Flush Rating Scale (HFRS) and Women’s Health Questionnaire (WHQ).

Results: Data from 2285 treatments given to 300 women were analysed; 275 (92.3%) women completed all 8 treatments. Median daily frequency of HFNS reduced from 9.6 (IQR 7.3) to 5.7 (IQR 5.8) at EOT and 6.3 (IQR 6.5) 18 weeks after EOT. HFRS problem rating showed a clinically meaningful reduction of ≥2 points at all measurement points. WHQ showed improvements in menopause-associated symptoms, including anxiety/fears and sleep problems. Two adverse events were reported, neither were serious. Results are comparable to published research.

Conclusion: This to our knowledge is the first analysis of a long-term acupuncture service for breast cancer related HFNS. Clinical results compare favourably with outcomes of published studies of acupuncture and of CBT for reducing HFNS frequency, associated menopausal symptoms, and of HFNS as a problem. In day-to-day clinical practice, NADA appears to be a safe, effective intervention for breast cancer survivors. It has proved a sustainable intervention over the long-term for all parties, including managers, funders, therapists, and breast cancer survivors.

What is the impact of knowledge and attitudes on the recommendation of probiotics among physicians, nurses and pharmacists? A systematic review

Yi Yang Fei (1), Emma Tutt (2), Jeremy Steen (3), Jeremy Y. Ng (4,5), Maureen Dobbins (6,7)

(1) Bachelor of Health Sciences (Honours) Program, McMaster University, Hamilton, Ontario, Canada

(2) Integrated Science Program, Faculty of Science, McMaster University, Hamilton, Ontario, Canada

(3) Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada

(4) Centre for Journalology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

(5) Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada

(6) McMaster University School of Nursing, Hamilton, Ontario, Canada

(7) National Collaborating Centre for Methods and Tools, McMaster University, Hamilton, Ontario, Canada

Background: Patient interest/use in probiotics has surged in recent decades. Probiotic use is not without risk, however, and patients may increase their risk of harm when they fail to consult their primary healthcare provider(s) about safe use. Healthcare providers should be knowledgeable about when and how to recommend probiotics.

Methods: A systematic review with narrative synthesis was conducted (PROSPERO: CRD42022311784). MEDLINE, EMBASE, Web of Science, CINAHL and PsycINFO were searched from database inception until December 17, 2021. Title/abstract and full-text screening, along with quality assessment using the JBI’s Critical Appraisal Checklist for Analytical Cross-Sectional Studies, were each conducted independently and in duplicate.

Results: Seventeen studies were included; all were cross-sectional surveys. PNPs were generally knowledgeable about probiotics’ definition and mechanism of action. Pharmacists were the most knowledgeable. Physicians and pharmacists expressed positive attitudes about the safety, efficacy, and clinical role of probiotics; nurses’ attitudes were not reported. Most PNPs indicated they lacked experience and/or would not consider recommending probiotics. Among PNPs who made recommendations, probiotics were commonly recommended for less severe and non-life-threatening conditions such as diarrhea, bloating, and irritable bowel syndrome. The most common barrier to recommending probiotics was a perceived lack of knowledge or evidence on the topic.

Conclusion: We found that PNPs made limited probiotic recommendations. Our preliminary searches identified minimal evidence on how knowledge of probiotics is learned or applied. Future research should investigate the inclusion of probiotics in PNP curricula and scope of practice. Availability of and accessibility to probiotics-related continuing education opportunities should also be studied.

Supporting behavioral change in integrative medicine: insights from a patient survey and systematic scoping review

Christopher Knee (1), Ross Bailey (2), Jaslyn English (3), Alex Keller (4)

(1) Medical Education & Research Manager, Integrative Medical Advisory Team, Fullscript, Ottawa, Ontario, Canada

(2) Medical Education Lead, Integrative Medical Advisory Team, Fullscript, Ottawa, Ontario, Canada

(3) Insights Analyst, Data & Insights Team, Fullscript, Ottawa, Ontario, Canada

(4) Medical Director, Integrative Medical Advisory Team, Fullscript, Ottawa, Ontario, Canada

Background: A major challenge faced by medical practitioners is understanding how to best support patients in making sustainable, health-promoting behavioral changes (BC). Lifestyle factors are known to impact health outcomes and chronic disease risk, but long-term BC and treatment adherence rates are low, and there is limited guidance on optimizing BC support, especially in the context of integrative medicine (IM).

Methods: We conducted a systematic scoping review of identified concepts in BC literature (e.g., theories, assessments, techniques, etc.). Findings guided the development of a 27-question survey that was emailed to 30,000 patient users of the Fullscript platform, who had received a treatment plan containing dietary supplements from their practitioner within the last 12 months. The invitation was skewed 70% toward patients of naturopathic doctors, medical doctors, osteopaths, chiropractors, and nurse practitioners.

Results: There were 605 responses. Patients reported the most success with BC and adherence to recommendations for taking supplements, medications, and lab testing, and the least success with recommendations for diet/nutrition, physical activity, stress management, and sleep hygiene. Commonly reported barriers included financial cost (of supplements/goods or visits/treatments), lack of time, and lack of motivation, positive attitudes or beliefs. Patients sought additional support with education, treatment plan simplification, goal-setting, and practitioner monitoring/feedback.

Conclusion: Supporting BC is challenging, yet evidence-based strategies are likely underutilized by practitioners. Results of our survey provide insightful strategies for practitioners that may enhance the quality of BC support needed to improve long-term treatment adherence and health outcomes.

A longitudinal comparison of effectiveness of integrative medical care to standard care on adult depression scores

Anne Leis (1), Wendy Verity (1), Marcus Ilesanmi (1), Amanjot Kaur (1), Chrys Henry (1), Vicky Holmes (2), Shirley (DeeDee) Maltman (3)

(1) Department of Community Health & Epidemiology, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada

(2) Retired family physician and volunteer

(3) Family Physician Practice, Saskatoon, Saskatchewan, Canada

Background: Depression is a contributing factor of global disability. Conventional treatment of depression has relied on antidepressants and cognitive behavioral therapy. Although these treatments generally work in the short term, the long-term management of depression is still challenging. The purpose of this study was to compare the effectiveness of integrative medical care and standard care on adult depression scores reduction over one year.

Methods: After screening for depression, 130 adults aged 17–73 years who were referred from family physician practices or self-referred were non-randomly allocated into two arms of conventional standard (66) and integrative medical care (64). After the baseline visit, they were subsequently followed every 3 months for 4 additional visits. We measured the severity of depression (Beck Depression Inventory (BDI)) at every visit. Analysis included change in mean depression scores and treatment effect with regression.

Results: Eighty-eight percent of conventional standard care participants and 76% of the integrative medical participants completed the BDI tool at least four of the required five times. After an initial reduction of depression in both groups, patients in the integrative care showed on average, a more beneficial effect than the standard group. The relative reduction in the Beck depression scores at the 2nd and 5th visit were 20% and 37.7% in the integrative care group compared with 26.7% and 25.6% in the conventional standard care. Treatment effect analysis revealed that at visit 4, the average BDI scores were significantly reduced by an additional 4.84 points compared to those in the conventional standard care (p=0.038).

Conclusion: This study revealed that the integrative medical care was as effective as the standard care after 3 months. A more substantial long-term depression reduction effect was found after one year of follow-up with the integrative medical approach which suggests it can be an effective long-term treatment modality.

How do naturopathic doctors define the quality of natural health products? An inductive approach to establish North American standards

Daniella Remy (1), Adam Gratton (1), Kieran Cooley (1,2,3,4)

(1) Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada

(2) University of Technology Sydney, Ultimo, Australia

(3) Pacific College of Health Sciences, San Diego, United States

(4) National Centre for Naturopathic Medicine, Southern Cross University, Lismore, Australia

Background: Healthcare professionals have the responsibility to educate their patients on natural health products (NHPs), yet the assessment of NHP quality throughout North America remains relatively subjective and prone to personal biases, marketing exposure and convenience. For single-ingredient products, third-party laboratories can independently examine the purity and chemical quality of products, but an objective quality assessment for multi-ingredient NHPs is lacking. With the aim of developing a user-friendly quality scoring system, the identification of subjective and empirical attributes that define a quality product Naturopathic Doctors (NDs) would want to prescribe must be determined.

Methods: This study was divided into two phases. Phase 1 involved one-hour virtual interviews with eight NDs across Canada and the United States who have been licensed and practicing for a minimum of five years. Interviews used open-ended questions to garner common themes defining quality evaluation of complex natural health products. Phase 2 was an online survey to licensed and practicing NDs across Canada and the United States that was entirely based on the key themes extracted from Phase 1. Survey participants were asked to rank-order the themes and sub-themes and could comment on additional items to include in an NHP assessment.

Results: Using an inductive approach to qualitative analysis in Phase 1, four key themes were extracted: sourcing, labeling, monographs, and third party testing; with each one having several sub-themes. Phase 2 revealed that sourcing was the most important theme, specifically from manufacturing companies that adhere to good manufacturing practices, followed by products on which labels provide specific details of the active compounds. Third party testing ranked third, especially if used to verify that ingredients match the label, and monographs should include referenced evidence on the therapeutic efficacy specific to the recommended dose of the product.

Conclusion: The strongest measure of NHP quality is the manufacturing company’s ability to adhere to GMP and high caliber extraction processes. Third party testing could be used to verify standards of quality with product details included in labels and ample referenced evidence in monographs.

Mediterranean diet adaptations to traditional cultural eating paradigms: a realist synthesis

Nana-Adjoa Bourne (1), Gursharan Mangat (1), Prabhjot Chohan (1), Yumna Farooq (1), Herpreet Singh (1), Kieran Cooley (1,2,3,4)

(1) Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada

(2) Australian Research Centre in Complementary & Integrative Medicine, University of Technology Sydney, Sydney, New South Wales, Australia

(3) Pacific College of Health Sciences, San Diego, California, United States of America

(4) National Centre for Naturopathic Medicine, Southern Cross University, Lismore, New South Wales, Australia

Background: The Mediterranean Diet (MD) has been studied for its benefits in metabolic risk factors since the 1950s. In recent years, debates around barriers to access within cultural, socioeconomic, and environmental fields have arisen within non-Eurocentric cultural backgrounds. Using data on the effects of dietary components with health benefits, this realist synthesis will produce a map of the evidence for modifications to the MD that match various cultural eating patterns.

Methods: Foods and constituents of the MD were compared and analyzed to assess benefits for both healthy and metabolic disease states using both empirical and theoretical approaches. Databases (PubMed and Cochrane) were searched using terms for cultural diets (eg. “standard American diet,” “Mediterranean diet,” “Japanese diet”) and metabolic disease outcomes associated with the MD (eg. HbA1C, cholesterol, waist circumference, weight, AST and ALT). A cultural affinity diet database was used to identify culturally-specific foods that match components of the MD (eg. Foods with high soluble fiber that have been shown to have impact on HbA1C).

Results: Cultural alternatives to foods and components of the MD exist, however there is modest research on the specific health effects of most culturally-adapted diets as alternatives. Five major cultural regions are identified in research with traditional diets and foods that promote similar effects to the MD​. Cooking methods, food storage/preservation may vary for same food in different regions/cultures​, and some sociological factors appear influence adherence to traditional diet (religion; socioeconomic status/ access to; involvement in community; physical activity). ​Some limitations to this research exist including that research done on specific tribes/regions/ethnic group may not be applicable across the country. There is also a paucity of specific evidence relative to other culturally competent diets eaten in North America and their metabolic health benefits.​

Conclusion: Whilst some evidence-gaps exist, it is feasible to translate most components of the MD to various diets of cultural affinity based on evidence that supports the effects of dietary constituents. Future study is needed to examine the overall effects of cultural adaptations to the MD, the design and effectiveness of healthcare practitioner training and resources for implementation, and the barriers and facilitators to cultural inclusion or health access for a broader range of dietary behaviours.

Promising effect of acupuncture to reverse chemotherapy induced leukopenia

Katayoon Keyhanian (1), Maryam Yavari (2)

(1) Imohe (Instituto de Medicina I Oncologia Holistica Eres), Barcelona, Spain

(2) Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada

Background: Leukopenia is one of the most important side effects of some types of cancer treatments that interfere with the cycle of chemotherapy. Colony-stimulating factors (CSFs) injection) is not always a fast-acting effective intervention for this condition so some researchers propose acupuncture as an alternative or integrative therapy to restore the neutrophil count during chemotherapy.

Methods: 5 patients with white blood cell count less than 1000 (range 400–1000 WBC per microliter) received two rounds of acupuncture each. Kid 3 and Kid 10 (to tonify the kidney organ which is responsible for erythropoiesis), GB39 (which has recovering effect on the medulla) were used in the protocol in conjunction with some other points that were selected based on the pattern differentiation of each patient.

Results: All patients showed improvement in their WBCs after each round of acupuncture. Almost all patients’ WBC reached to more than 1000 level after each round of acupuncture except the patient who had the lowest initial WBC of 400 who reached 900 after acupuncture therapy in the first round and reached >1000 after the second round.

Conclusion: All the patients who participated in this study were able to receive the chemotherapy treatment as scheduled. Although this study does not benefit from randomization and blindness and there is no control group for comparison present, the current result might shed some light on the possible effective adjunct therapy of acupuncture treatment for patients undergoing chemotherapy.

Aromatherapy and sleep hygiene as therapeutic approaches for postmenopausal women with insomnia: a randomized clinical trial

Leandro Lucena (1), Jair Guilherme Santos-Junior (2), Sergio Tufik (1), Helena Hachul (1)

(1) Universidade Federal de Sao Paulo, Sao Paulo, Brazil

(2) Faculdade de Ciencias Medicas da Santa Casa de Sao Paulo, Sao Paulo, Brazil

Background: Insomnia is one of the most common sleep disorders experienced during the menopausal transition and in the postmenopause, in addition to vasomotor symptoms that tend to worse the sleep maintenance and quality of life.

Methods: Experimental, double-blind, randomized controlled trial composed by 35 women clinically identified in postmenopause and with diagnosis of insomnia were distributed in two groups: Placebo Group (sunflower oil) and Aroma Group (Lavandula angustifolia essential oil), both inhaled before bedtime for 29 days. The groups received sleep hygiene guidelines and were followed weekly to clarify doubts about them. To assess the effect of the intervention, the Menopause-Specific Quality-of-Life Questionnaire, intervention version (MENQOL-I), and Epworth Sleepiness Scale (ESS) were used. Furthermore, with the sleep diary was possible to assess Sleep Latency Onset (SLO), Total Sleep Time (TST), and Sleep efficiency (SE) daily. Regarding the vasomotor symptoms, only participants who identified this complaint were invited to fill a record about the hot flashes, reporting the presence or absence of these symptoms, daily amount, and its intensity.

Results: All participants benefited in almost all domains of quality of life and in the self-assessed sleep pattern, such as TST and SE. Specifically, the Aroma group achieved a significant improvement in the overall quality of life score over time. No differences were observed considering the hot flashes record and sleepiness.

Conclusion: The aromatherapy intervention was effective to improve the overall quality of life in the Aroma group. Moreover, we suggest that the sleep diary and sleep hygiene instructions helped the participants to self-assess their sleep pattern and improve it.

Adjunctive intravenous ascorbic acid for advanced non-small cell lung cancer: protocol for a double blind, placebo controlled, phase II randomized controlled trial

Dugald Seely (1,2,3), Legacy Mark (1,2,3), Ellen Conte (1,3), Garth Nicholas (2,4), Scott Laurie (2,4), Stephanie Brule (2,4), David Stewart (2,4), Tim Ramsay (2), Gillian Flower (1,3), Paul Wheatley-Price (2,4)

(1) Ottawa Hospital Research Institute, Ottawa Ontario, Canada

(2) The Centre for Health Innovation, Ottawa, Ontario, Canada

(3) Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada

(4) University of Ottawa Division of Medical Oncology, Ottawa Ontario, Canada

Background: Lung cancer is the leading cause of cancer-related mortality in Canada. For patients with metastatic disease, first line treatment is typically a platinum-based chemotherapy doublet wherein toxicity can be high. Innovations that improve outcomes and reduce toxicity are needed. In this study, we will evaluate the effectiveness of intravenous vitamin C (IVC) in advanced lung cancer.

Methods: This is a two-arm, parallel group, double-blind, placebo-controlled, phase II randomized controlled trial. 90 patients with stage IIIB or IV non-small cell lung cancer receiving first line platinum doublet chemotherapy (with or without concurrent immunotherapy) will be recruited from The Ottawa Hospital. Treatments will be administered twice weekly for 6 months at the Centre for Health Innovation. IVC will be dosed at 1 g/kg; normal saline will be used as placebo. Outcome measures include Functional Assessment of Cancer Therapy – Lung questionnaire for QOL, Edmonton Symptom Assessment Scale and the Patient Reported Outcomes – Common Terminology Criteria for Adverse Events for chemotherapy-related toxicities, C-reactive protein for inflammation, and Response Evaluation Criteria in Solid Tumours version 1.1 for tumor progression. Continuous variables will be analyzed using unadjusted t tests; dichotomous outcomes will be analyzed using the chi-squared test or Fisher’s exact test; tumour progression and survival outcomes will be graphically depicted with Kaplan-Meier curves and compared using the log-rank test. Questionnaires and blood draws will be administered over a period of 1 year; follow-up for progression and survival will take place for up to 3 years.

Conclusion: To date, no double-blind, randomized, placebo-controlled trial has investigated the effect of IVC alongside chemotherapy in patients with lung cancer. With public usage of IVC and the promise of early research, well-controlled clinical research on this therapy is essential.