Adaptogenic Potential of a Polyherbal Natural Health Product: Report on a Longitudinal Clinical Trial

Stress is a risk factor for a number of diseases and is an important predictor of health in general. Herbal medicines have been used as adaptogens to regulate and improve the stress response and there is evidence to support the use of herbal medicines for this purpose. We conducted an open-label longitudinal study on the natural health product, OCTA©, a compound mixture of eight herbs, to determine its effects on perceptions of stress. Eighteen participants were enrolled in the study and were followed over a period of 3 months. Primary endpoints included scores from four validated questionnaires (SF-36v2, PSS, STAI and BDI-II), serum DHEA, ALT, AST and creatinine all measured at 12 weeks. Seventeen patients completed the study. Except for the physical summary score of the SF36 questionnaire, all the subjective scores indicated a highly significant (P < 0.0001) improvement in the participants' ability to cope with stress. No adverse effects were reported and there was no evidence of damage to the liver or kidney based on serum markers. Initial evidence for this polyherbal compound supports its potential as an effective ‘adaptogenic’ aid in dealing with stress. Further research using a randomized controlled design is necessary to confirm the findings from this pilot study

Whole person integrative cancer care in action - an overview of its implementation and patient related outcomes

Learning Objectives: Explore and understand the implementation and evaluation of an integrative cancer care model based on evidence based care and programming. Goals of care are to improve quality of life for those with cancer and work towards cancer prevention through a combination of approaches including Complementary medicine including nutrition, exercise and lifestyle management.Background and Project Objectives:The Ottawa Integrative Cancer Centre (OICC) provides evidence-informed integrative and preventative cancer care, research, and education across the spectrum of prevention to survivorship. The purpose of this presentation is to describe the population receiving care at the OICC in terms of demographic and disease-related characteristics, in addition to their experience receiving care in terms of therapies received and preliminary outcomes.Methods: All people receiving care at the OICC are invited to complete a registration package that documents demographic and disease-related characteristics in addition to baseline quality of life (EORTC-QLQ C30), cancer-related symptom (ESAS) and patient-identified concerns or problems (MYCaW). Every 3 months, a follow up assessment is completed for continuing patients.Results:The majority of people seek care at the OICC to manage cancer and treatment related side effects. Other people seek supportive care with their prescribed standard care, to control or cure their cancer, or to prevent a recurrence. Approximately one half of people self-identify as under distress for at least one common cancerrelated symptom. Most patients consult a naturopathic doctor, often in combination with a general practitioner, nutritionist, acupuncturist, physiotherapist, or counselor.Results will be presented regarding quality of life, cancer related symptoms and patient-identified concerns, stratified as possible by age, sex, cancer type, stage and types of treatment received.

The head start program for women newly diagnosed with breast cancer

We present the beneficial impact that our Head Start Program for women newly diagnosed with breast cancer has on participants at the Ottawa Integrative Cancer Centre. While beginning a new world of conventional cancer treatments, our program provides support and guidance at a crucial time of flux in a woman’s life, and addresses the spiritual, physical and mental emotional health of women of all ages, from generation Y through to our elders, who are dealing with a cancer diagnosis.This 6 week program is comprised of workshops, support group sessions and experiential mind body techniques, and is led by a group of therapists skilled in cancer’s psychological and physiological effects.Our research outcome measures of the program to date will be touched upon

Vitamin supplementation for prevention of mother-to-child transmission of HIV and pre-term delivery: a systematic review of randomized trial including more than 2800 women

BACKGROUND: Observational studies have suggested that low serum vitamin levels are associated with increased mother-to-child transmission (MTCT) of HIV and increased preterm delivery. We aimed to determine the efficacy of vitamins on the prevention of MTCT and preterm delivery by systematically reviewing the available randomized controlled trials [RCTs]. We conducted systematic searches of 7 electronic databases. We extracted data from the RCTs independently, in duplicate. RESULTS: We included 4 trials in our review. Of the three trials on Vitamin A, two suggested no difference in MTCT, while the third and largest trial (n = 1078) suggested an increased risk of MTCT (Relative Risk 1.35, 95% Confidence Interval [CI], 1.11–1.66, P = 0.009). Two of the vitamin A trials addressed the impact of supplementation on pre-term delivery; one suggested a benefit (RR 0.65, 95% CI, 0.44–0.94) and the other no difference. All three vitamin A trials found no significant effect on infant mortality at 1 year. Of the two trials that looked at multivitamin use, only one addressed the prevention of MTCT, and found a non-significant RR of 1.04 (95% CI, 0.82–1.32). Two of the multivitamin trials found no significant effects on pre-term delivery. The single multivitamin trial examining children's mortality at 1 year yielded a non-significant RR of 0.91 (95% CI, 0.17–1.17). CONCLUSION: Randomized trials of vitamins to prevent MTCT have yielded conflicting results without strong evidence of benefit and have failed to exclude the possibility of harm

Cost Effectiveness of Natural Health Products: A Systematic Review of Randomized Clinical Trials

Health care spending in North America is consuming an ever-increasing share of Gross Domestic Product (GDP). A large proportion of alternative health care is consumed in the form of natural health products (NHPs). The question of whether or not NHPs may provide a cost-effective choice in the treatment of disease is important for patients, physicians and policy makers. The objective of this study was to conduct a systematic review of the literature in order to find, appraise and summarize high-quality studies that explore the cost effectiveness of NHPs as compared to conventional medicine. The following databases were searched independently in duplicate from inception to January 1, 2006: EMBASE, MEDLINE, CINAHL, BioethicsLine, Wilson General Science abstracts, EconLit, Cochrane Library, ABI/Inform and SciSearch. To be included in the review, trials had to be randomized, assessed for some measure of cost effectiveness and include the use of NHPs as defined by the Natural Health Products Directorate. Studies dealing with diseases due to malnutrition were excluded from appraisal. The pooled searches unveiled nine articles that fit the inclusion/exclusion criteria. The conditions assessed by the studies included three on postoperative complications, two on cardiovascular disease, two on gastrointestinal disorders, one on critically ill patients and one on urinary tract infections. Heterogeneity between the studies was too great to allow for meta-analysis of the results. The use of NHPs shows evidence of cost effectiveness in relation to postoperative surgery but not with respect to the other conditions assessed. In conclusion, NHPs may be of use in preventing complications associated with surgery. The cost effectiveness of some NHPs is encouraging in certain areas but needs confirmation from further research

Personal goals of women recently diagnosed with breast cancer: Protocol for a cohort study

Objectives: This study aims to identify the personal goals of women with breast cancer, to describe the characteristics of partici- pants’ personal goals over four months, and to identify barriers and facilitators to their pursuit. Methods: This protocol outlines plans to conduct a prospective cohort study. We will recruit women participating in the Ottawa In- tegrative Cancer Centre’s Head Start program (an integrative oncology psychoeducational program in Ottawa, Canada), and those on the program’s waiting list if possible. We anticipate a sample size of approximately 18 to 36 women. Prior to the beginning of Head Start, participants will identify their current personal goals and rate them on various dimensions on a questionnaire. At one and three months, participants will re-assess their goals and their goal pursuit. In a one-on-one interview at three months, they will identify barriers and facilitators to the pursuit of their goals. We will analyze quantitative data using descriptive and inferential statistics, and qualitative data using thematic content analysis. Conclusion: Findings from this study will identify important information about the personal goals of women recently diagnosed with breast cancer that can help to support the process of positive goal adjustment and enhance support to these women.  Résumé Objectifs : Cette étude vise à identifier les objectifs personnels des femmes atteintes d’un cancer du sein, à décrire les caractéristiques des objectifs personnels des participantes sur une période de quatre mois, et à identifier les obstacles et les facilitateurs à leur poursuite. Méthodes : Ce protocole décrit les plans pour mener une étude de cohorte prospective. Nous recruterons des femmes qui participeront au programme Head Start du Centre de cancérologie intégrative d’Ottawa (un programme psychopédagogique intégratif en oncologie à Ottawa, au Canada) et celles qui sont sur la liste d’attente du programme, si possible. Nous prévoyons un échantillon d’environ 18 à 36 femmes. Avant le début de Head Start, les participantes identifieront leurs objectifs personnels actuels et les noteront sur différentes dimensions dans un questionnaire. À un et trois mois, les participantes réévalueront leurs objectifs et la poursuite de leur objectif. Dans une entrevue individuelle à trois mois, elles identifieront les obstacles et les facilitateurs à la poursuite de leurs objectifs. Nous analyserons les données quantitatives à l’aide de statistiques descriptives et inférentielles, et les données qualitatives à l’aide d’analyses de contenu thématiques. Conclusion : Les résultats de cette étude permettront d’identifier des informations importantes sur les objectifs personnels des femmes récemment diagnostiquées avec un cancer du sein qui peuvent aider à soutenir le processus d’ajustement positif des objectifs et améliorer le soutien à ces femmes. 

Clinical practice guidelines on the evidenceâ based use of integrative therapies during and after breast cancer treatment

Answer questions and earn CME/CNEPatients with breast cancer commonly use complementary and integrative therapies as supportive care during cancer treatment and to manage treatmentâ related side effects. However, evidence supporting the use of such therapies in the oncology setting is limited. This report provides updated clinical practice guidelines from the Society for Integrative Oncology on the use of integrative therapies for specific clinical indications during and after breast cancer treatment, including anxiety/stress, depression/mood disorders, fatigue, quality of life/physical functioning, chemotherapyâ induced nausea and vomiting, lymphedema, chemotherapyâ induced peripheral neuropathy, pain, and sleep disturbance. Clinical practice guidelines are based on a systematic literature review from 1990 through 2015. Music therapy, meditation, stress management, and yoga are recommended for anxiety/stress reduction. Meditation, relaxation, yoga, massage, and music therapy are recommended for depression/mood disorders. Meditation and yoga are recommended to improve quality of life. Acupressure and acupuncture are recommended for reducing chemotherapyâ induced nausea and vomiting. Acetylâ Lâ carnitine is not recommended to prevent chemotherapyâ induced peripheral neuropathy due to a possibility of harm. No strong evidence supports the use of ingested dietary supplements to manage breast cancer treatmentâ related side effects. In summary, there is a growing body of evidence supporting the use of integrative therapies, especially mindâ body therapies, as effective supportive care strategies during breast cancer treatment. Many integrative practices, however, remain understudied, with insufficient evidence to be definitively recommended or avoided. CA Cancer J Clin 2017;67:194â 232. © 2017 American Cancer Society.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/136746/1/caac21397_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/136746/2/caac21397.pd

Effect of selenium supplementation on CD4 T-cell recovery, viral suppression, morbidity and quality of life of HIV-infected patients in Rwanda: study protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Low levels of serum selenium are associated with increased risk of mortality among HIV+ patients in East Africa. We aim to assess the effect of selenium supplementation on CD4 cell count, HIV viral load, opportunistic infections, and quality of life in HIV-infected patients in Rwanda.</p> <p>Methods and Design</p> <p>A 24-month, multi-centre, patient and provider-blinded, randomized, placebo-controlled clinical trial involving 300 pre-antiretroviral therapy (ART) HIV-infected patients will be carried out at two sites in Rwanda. Patients ≥ 21 years of age with documented HIV infection, CD4 cell count of 400-650 cells/mm³, and not yet on ART will be recruited. Patients will be randomized at each study site using a randomized block design to receive either the selenium micronutrient supplement or an identically appearing placebo taken once daily. The primary outcome is a composite of time from baseline to reduction of CD4 T lymphocyte count below 350 cells/mm³ (confirmed by two measures at least one week apart), or start of ART, or the emergence of a documented CDC-defined AIDS-defining illness. An intention-to-treat analysis will be conducted using stepwise regression and structural equation modeling.</p> <p>Discussion</p> <p>Micronutrient interventions that aim to improve CD4 cell count, decrease opportunistic infections, decrease HIV viral load, and ultimately delay initiation of more costly ART may be beneficial, particularly in resource-constrained settings, such as sub-Saharan Africa. Additional trials are needed to determine if micro-supplementation can delay the need for more costly ART among HIV-infected patients. If shown to be effective, selenium supplementation may be of public health importance to HIV-infected populations, particularly in sub-Saharan Africa and other resource-constrained settings.</p> <p>Trial Registration</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT01327755">NCT01327755</a></p

Naturopathic Care for Chronic Low Back Pain: A Randomized Trial

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 (-6.89, 95% CI. -9.23 to -3.54, 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 (-0.52, 95% CI, -0.96 to -0.08, p = 0.01). CONCLUSIONS: Naturopathic care provided significantly greater improvement than physiotherapy advice for patients with chronic low back pain. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN41920953

EDTA chelation therapy for cardiovascular disease: a systematic review

BACKGROUND: Numerous practitioners of both conventional and complementary and alternative medicine throughout North America and Europe claim that chelation therapy with EDTA is an effective means to both control and treat cardiovascular disease. These claims are controversial, and several randomized controlled trials have been completed dealing with this topic. To address this issue we conducted a systematic review to evaluate the best available evidence for the use of EDTA chelation therapy in the treatment of cardiovascular disease. METHODS: We conducted a systematic review of 7 databases from inception to May 2005. Hand searches were conducted in review articles and in any of the trials found. Experts in the field were contacted and registries of clinical trials were searched for unpublished data. To be included in the final systematic review, the studies had to be randomized controlled clinical trials. RESULTS: A total of seven articles were found assessing EDTA chelation for the treatment of cardiovascular disease. Two of these articles were subgroup analyses of one RCT that looked at different clinical outcomes. Of the remaining five studies, two smaller studies found a beneficial effect whereas the other three exhibited no benefit for cardiovascular disease from the use of EDTA chelation therapy. Adverse effects were rare but those of note included a few cases of hypocalcemia and a single case of increased creatinine in a patient on the EDTA intervention. CONCLUSION: The best available evidence does not support the therapeutic use of EDTA chelation therapy in the treatment of cardiovascular disease. Although not considered to be a highly invasive or harmful therapy, it is possible that the use of EDTA chelation therapy in lieu of proven therapy may result in causing indirect harm to the patient