Dietary supplements to reduce symptom severity and duration in people with SARS-CoV-2: a double-blind randomised controlled trial.

BACKGROUND: COVID-19 has caused morbidity, hospitalisation and mortality worldwide. Despite effective vaccines, there is still a need for effective treatments, especially for people in the community. Dietary supplements have long been used to treat respiratory infections, and preliminary evidence indicates some may be effective in people with COVID-19. We sought to evaluate whether a combination of vitamin C, vitamin D3, vitamin K2 and zinc could improve overall health and decrease symptom burden in outpatients diagnosed with COVID-19. METHODS: Participants were randomised to receive either vitamin C (6 g), vitamin D3 (1000 units), vitamin K2 (240 µg) and zinc acetate (75 mg) or placebo daily for 21 days and were followed for 12 weeks. An additional loading dose of 50 000 units vitamin D3 (or placebo) was given on day one. The primary outcome was participant-reported overall health using the EuroQol Visual Assessment Scale summed over 21 days. Secondary outcomes included health status, symptom severity, symptom duration, delayed return to usual health, frequency of hospitalisation and mortality. RESULTS: 90 patients (46 control, 44 treatment) were randomised. The study was stopped prematurely due to insufficient capacity for recruitment. The mean difference (control-treatment) in cumulative overall health was -37.4 (95% CI -157.2 to 82.3), p=0.53 on a scale of 0-2100. No clinically or statistically significant differences were seen in any secondary outcomes. INTERPRETATION: In this double-blind, placebo-controlled, randomised trial of outpatients diagnosed with COVID-19, the dietary supplements vitamin C, vitamin D3, vitamin K2 and zinc acetate showed no clinically or statistically significant effects on the documented measures of health compared with a placebo when given for 21 days. Termination due to feasibility limited our ability to demonstrate the efficacy of these supplements for COVID-19. Further research is needed to determine clinical utility. TRIAL REGISTRATION NUMBER: NCT04780061.

Dietary supplements to reduce symptom severity and duration in people with SARS-CoV-2: study protocol for a randomised, double-blind, placebo controlled clinical trial.

INTRODUCTION: COVID-19 has caused morbidity, hospitalisations and deaths worldwide. Despite four approved vaccines for COVID-19 in Canada, there is still a need for effective treatments, especially for people in the community. Vaccine efficacy is not 100% and long-term efficacy is still unknown. Furthermore, there are challenges to herd immunity including vaccine hesitancy and underlying conditions preventing vaccination. We aim to explore if the nutrients vitamin C, vitamin D, vitamin K2 and zinc are an effective treatment option for outpatients diagnosed with COVID-19. The primary outcome is the difference in participant-reported overall health; secondary outcomes include the effect on health status, symptom severity and duration, frequency and length of hospitalisations and mortality. METHODS AND ANALYSIS: This study is a two-arm, parallel-group, double-blind, placebo-controlled, phase III randomised controlled trial. 200 patients will be recruited remotely from COVID-19 test centres in Ottawa, Canada associated with The Ottawa Hospital. Overall health will be measured using the EuroQol Visual Assessment Scale; health status will be measured using the EuroQol 5-dimension 5-level questionnaire; symptom severity and duration will be measured using an independently developed questionnaire; analyses will use an area under the curve approach and compare mean scores using unadjusted t tests. Study data will be recorded on electronic case report forms using the Research Electronic Data Capture platform. An independent data safety and monitoring board will perform ongoing review of the study for feasibility and safety. ETHICS AND DISSEMINATION: This study has received ethical approval from the research ethics boards of the Canadian College of Naturopathic Medicine and the Ottawa Health Sciences Network, as well as regulatory approval from the Therapeutic Products Directorate and Natural and Non-Prescription Health Products Directorate of Health Canada. Results will be published in a peer-reviewed scientific journal with open access. TRIAL REGISTRATION NUMBER: NCT04780061.

Carnitine in Alcohol Use Disorders: A Scoping Review.

Recent studies in alcohol use disorders (AUDs) have demonstrated some connections between carnitine metabolism and the pathophysiology of the disease. In this scoping review, we aimed to collate and examine existing research available on carnitine metabolism and AUDs and develop hypotheses surrounding the role carnitine may play in AUD. A scoping review method was used to search electronic databases in September 2019. The database search terms used included "alcohol, alcoholism, alcohol abuse, alcohol consumption, alcohol drinking patterns, alcohol-induced disorders, alcoholic intoxication, alcohol-related disorders, binge drinking, Wernicke encephalopathy, acylcarnitine, acetyl-l-carnitine, acetylcarnitine, carnitine and palmitoylcarnitine." The inclusion criteria included English language, human-based, AUD diagnosis and measured blood or tissue carnitine or used carnitine as a treatment. Of 586 studies that were identified and screened, 65 underwent abstract review, and 41 were fully reviewed. Eighteen studies were ultimately included for analysis. Data were summarized in an electronic data extraction form. We found that there is limited literature available. Alcohol use appears to impact carnitine metabolism, most clearly in the setting of alcoholic cirrhosis. Six studies found carnitine to be increased in AUD, of which 5 were conducted in patients with alcoholic cirrhosis. Only 3 placebo-controlled trials were identified and provide some support for the use of carnitine in AUD to decrease cravings, anhedonia, and withdrawal and improve cognition. The increase in plasma carnitine in alcoholic cirrhosis may be related to disordered fatty acid metabolism and oxidative stress that occurs in AUD. The multiple possible therapeutic effects carnitine could have on ethanol metabolism and the early evidence available for carnitine supplementation as a treatment for AUD provide a foundation for future randomized control trials of carnitine for treating AUD.

Association between media attention and presentation of vaccination information on Canadian chiropractors' websites: a prospective mixed-methods cohort study.

BACKGROUND: Historically, some chiropractors have been critical of vaccination, and this has been the subject of recent media attention in Canada. We explored the association between media attention and public dissemination of vaccination information on Canadian chiropractors' websites. METHODS: In 2016, we identified all Canadian chiropractors' websites that provided information on vaccination by extracting details from the regulatory college website for each province using the search engine on their "find a chiropractor" page. We assessed the quality of information using the Web Resource Rating Tool (scores range from 0% [worst] to 100% [best]), determined whether vaccination was portrayed in a positive, neutral or negative manner, and conducted thematic analysis of vaccination content. We revisited all identified websites in 2019 to explore for changes to posted vaccination material. RESULTS: In July 2016, of 3733 chiropractic websites identified, 94 unique websites provided information on vaccination: 59 (63%) gave negative messaging, 19 (20%) were neutral and 16 (17%) were positive. The quality of vaccination content on the websites was generally poor, with a median Web Resource Rating Tool score of 19%. We identified 4 main themes: there are alternatives to vaccination, vaccines are harmful, evidence regarding vaccination and health policy regarding vaccination. From 2012 to 2016, there was 1 Canadian newspaper story concerning antivaccination statements by chiropractors, whereas 51 news articles were published on this topic between 2017 and 2019. In April 2019, 45 (48%) of the 94 websites we had identified in 2016 had removed all vaccination content or had been discontinued. INTERPRETATION: In 2016, a minority of Canadian chiropractors provided vaccination information on their websites, the majority of which portrayed vaccination negatively. After substantial national media attention, about half of all vaccination material on chiropractors' websites was removed within several years.

Validation of infant immunization billing codes in administrative data.

Ontario has a single payer provincial health insurance program. Administrative data may provide a potentially robust source of information for post-marketing vaccine studies. Vaccine-specific immunization billing codes were introduced in 2011. Our objective was to validate Ontario's universal health care administrative datasets to assess infant immunization status. Electronic medical record data from the Electronic Medical Record Administrative data Linked Database (EMRALD) was used as the reference standard to calculate performance characteristics of the Ontario Health Insurance Plan (OHIP) database vaccine-specific and general immunization codes for 4 primary infant immunizations: diphtheria, tetanus, acellular pertussis, inactivated polio, Haemophilus influenzae type B (DTaP-IPV-Hib) combination vaccine, pneumococcal conjugate vaccine, measles, mumps, rubella (MMR) vaccine, and meningococcal conjugate serogroup C vaccine. OHIP billing claims had specificity ranging from 81% to 92%, sensitivity 70% to 83%, positive predictive value (PPV) 97% to 99%, and negative predictive value (NPV) 13% to 46% for identifying the various specific vaccines in administrative data. For cohorts vaccinated in the new code introduction phase, using both the vaccine-specific and general codes had higher sensitivity than the vaccine-specific codes alone. In conclusion, immunization billing claims from administrative data in Ontario had high specificity and PPV, moderate sensitivity, and low NPV. This study identifies some of the applications of utilizing administrative data for post-marketing vaccine studies. However, limitations of these data decrease their utility for measuring vaccine coverage and effectiveness. Therefore, the establishment of a comprehensive and linkable immunization registry should be a provincial priority.

The development of vaccination perspectives among chiropractic, naturopathic and medical students: a case study of professional enculturation.

An important influence on parents' decisions about pediatric vaccination (children under 6 years of age) is the attitude of their health care providers, including complementary and alternative medicine (CAM) providers. Very limited qualitative research exists, however, on how attitudes towards vaccination develop among healthcare professionals in-training. We explored perspective development among three groups of students: medical, chiropractic, and naturopathic. We conducted focus group sessions with participants from each year of study at three different healthcare training programs in Ontario, Canada. Semi-structured and open-ended questions were used to elicit dynamic interaction among participants and explore how they constructed their attitudes toward vaccination at the beginning and part way through their professional training. Analyses of verbatim transcripts of audiotaped interviews were conducted both inductively and deductively using questions structured by existing literature on learning, professional socialization and interprofessional relations. We found five major themes and each theme was illustrated with representative quotes. Numerous unexpected insights emerged within these themes, including students' general open-mindedness towards pediatric vaccination at the beginning of their training; the powerful influence of both formal education and informal socialization; uncritical acceptance of the vaccination views of senior or respected professionals; students' preference for multiple perspectives rather than one-sided, didactic instruction; the absence of explicit socio-cultural tensions among professions; and how divergences among professional students' perspectives result from differing emphases with respect to lifestyle, individual choice, public health and epidemiological factors-rather than disagreement concerning the biomedical evidence. This last finding implies that their different perspectives on pediatric vaccination may be complementary rather than irreconcilable. Our findings should be considered by developers of professional and interprofessional educational curricula and public health officials formulating policy on pediatric vaccination.

Vaccine-critical videos on YouTube and their impact on medical students' attitudes about seasonal influenza immunization: a pre and post study.

YouTube is a video-sharing platform that is increasingly utilized to share and disseminate health-related information about immunization. Using a pre-post survey methodology, we compared the impact of two of the most popular YouTube videos discussing seasonal influenza vaccine, both vaccine-critical, on the attitudes towards immunizing of first year medical students attending a Canadian medical school. Forty-one medical students were randomized to view either a scientifically styled, seemingly "evidence-based", vaccine-critical video or a video using anecdotal stories of harms and highly sensationalized imagery. In the pre-intervention survey, medical students frequently used YouTube for all-purposes, while 42% used YouTube for health-related purposes and 12% used YouTube to search for health information. While medical students were generally supportive of immunizing, there was suboptimal uptake of annual influenza vaccine reported, and a subset of our study population expressed vaccine-critical attitudes and behaviors with respect to seasonal influenza. Overall there was no significant difference in pre to post attitudes towards influenza immunization nor were there any differences when comparing the two different vaccine-critical videos. The results of our study are reassuring in that they suggest that medical students are relatively resistant to the predominately inaccurate, vaccine-critical messaging on YouTube, even when the message is framed as scientific reasoning. Further empirical work is required to test the popular notion that information disseminated through social media platforms influences health-related attitudes and behaviors. However, our study suggests that there is an opportunity for public health to leverage YouTube to communicate accurate and credible information regarding influenza to medical students and others.

Variability in the clinical management of fatty acid oxidation disorders: results of a survey of Canadian metabolic physicians.

INTRODUCTION: There is little robust empirical evidence on which to base treatment recommendations for fatty acid oxidation disorders. While consensus guidelines are important, understanding areas where there is a lack of consensus is also critical to inform priorities for future evaluative research. METHODS: We surveyed Canadian metabolic physicians on the treatment of medium-chain acyl-CoA dehydrogenase (MCAD) deficiency, very long-chain acyl-CoA dehydrogenase (VLCAD) deficiency, long-chain 3-hydroxyacyl-CoA dehydrogenase (LCHAD) deficiency, and mitochondrial trifunctional protein (MTP) deficiency. We ascertained physicians' opinions on the use of different interventions for the long-term management of patients as well as for the management of acute illness, focusing on identifying interventions characterized by high variability in opinions. We also investigated factors influencing treatment decisions. RESULTS: We received 18 responses (response rate 45%). Participants focused on avoidance of fasting and increased meal frequency as interventions for the management of MCAD deficiency. For the long-chain disorders, avoidance of fasting remained the most consistently endorsed intervention, with additional highly endorsed treatments differing for VLCAD versus LCHAD/MTP deficiency. L-carnitine supplementation and restriction of dietary fat were characterized by high variability in physicians' opinions, as were several interventions specific to long-chain disorders. Social factors and patient characteristics were important influences on treatment decisions. CONCLUSIONS: Based on our findings we suggest that high priority treatments for rigorous effectiveness studies could include L-carnitine supplementation (MCAD and LCHAD/MTP deficiencies), restriction of dietary fat, and, for the long-chain disorders, feeding practices for breastfed infants and the use of various supplements (essential fatty acids, carbohydrates, cornstarch, multivitamins).

Parents' experiences discussing pediatric vaccination with healthcare providers: a survey of Canadian naturopathic patients.

BACKGROUND: Parents who choose to selectively vaccinate or avoid vaccination for their children may do so at risk of compromising relations with their family physician or pediatrician. Groups that are associated with reduced rates of pedicatic vaccination, such as parents who access naturopathic care, may be particularly vulnerable to this issue. METHODOLOGY/PRINCIPAL FINDINGS: In March through September 2010, we administered a 26-item cross-sectional survey to 129 adult patients, all of whom were parents with children ≤ 16 years of age, presenting for naturopathic care in Ontario, Canada. Ninety-five parents completed the survey (response rate 74%), and only 50.5% (48 of 95) reported that their children had received all recommended vaccines. Most parents (50.5%; 48 of 95) reported feeling pressure to vaccinate from their allopathic physician and, of those who discussed vaccination with their physician, 25.9% (21 of 81) were less comfortable continuing care as a result. Five percent (4 of 81) of respondents were advised by their physician that their children would be refused care if they decided against vaccination. In our adjusted generalized linear model, feeling pressure to vaccinate (odds ratio [OR] = 3.07; 95% confidence interval [CI] = 1.14 to 8.26) or endorsing a naturopathic physician as their most trusted source of information regarding vaccination (OR = 3.57; 95% CI = 1.22 to 10.44) were associated with greater odds of having a partially vaccinated or unvaccinated child. The majority (69.6%; 32 of 46) of parent's with partially vaccinated or unvaccinated children reported a willingness to re-consider this decision. CONCLUSIONS/SIGNIFICANCE: Use of naturopathic care should be explored among parents in order to identify this high-risk group and engage them in discussion regarding pediatric vaccination to encourage evidence-based, shared decision making. Physicians should ensure that discussions regarding vaccination are respectful, even if parents are determined not to vaccinate their children.

Attitudes towards vaccination among chiropractic and naturopathic students.

We have investigated the attitudes towards vaccination of undergraduate chiropractic and naturopathic students in the two major complementary and alternative medicine colleges in Canada. While the majority of the students were not averse to vaccination, we found in both colleges that anti-vaccination attitudes were more prevalent in the later years of the programs. Reasons for this are discussed, and we provide suggestions for strategies to address the situation.

Disclosure of natural product use to primary care physicians: a cross-sectional survey of naturopathic clinic attendees.

OBJECTIVE: To determine factors that predict disclosure of natural product use by patients to their primary care physicians. METHODS: An 18-item survey about health care use and communication was distributed to patients who presented to the Canadian College of Naturopathic Medicine in March 2003. We examined correlations between responses and created a multivariable logistic regression model to explore which factors were associated with patients' discussion of natural product use with their primary care physicians. RESULTS: The survey was given to 198 patients, 174 of whom responded (response rate, 87.9%). Most respondents (161 [92.5%] of 174) made use of natural products, and many (61 [41.5%] of 147) reported that they did not discuss natural product use with their primary care physician. The most significant factor predictive of patients having discussed natural product use with their primary care physician was having their primary care physician ask about natural product use (odds ratio, 18.77; 95% confidence interval, 5.06-69.62). Most respondents (107 [69.9%] of 153) indicated that their primary care physician did not ask about natural product use. CONCLUSIONS: An important number of patients who visit a naturopathic clinic do not disclose natural product use to their primary care physicians. Our findings suggest that disclosure rates could be improved by physicians taking a more active role in asking their patients about natural product use.

Changing attitudes towards polio vaccination: a randomized trial of an evidence-based presentation versus a presentation from a polio survivor.

We compared the impact of epidemiological evidence and anecdotal evidence on changing vaccination attitudes amongst alternative medical students. Ninety-seven students were randomized to either an evidence-based lecture on the benefits of the polio vaccine on population health or a presentation from a visibly affected victim of polio. We compared change in responses to a survey measuring vaccination attitudes between the two groups. The follow-up rate was 73%. There was no statistically significant difference between the two groups in change in response to any of the survey questions. In a post hoc analysis we found that 25% of students were less likely to recommend the vaccine after being provided with evidence supporting vaccination. These findings suggest that confronting deeply held beliefs regarding vaccination may paradoxically strengthen these belief systems.

Characteristics of pediatric and adolescent patients attending a naturopathic college clinic in Canada.

OBJECTIVES: The use of complementary and alternative medicine (CAM) has grown substantially in North America and has drawn the attention of conventional-medicine practitioners. Conventional-medicine practitioners have expressed concern about the potential for unregulated CAM therapies to cause harm, the sometimes-uncertain cost-benefit ratios associated with these therapies, and the possibility that some CAM providers might advise against established conventional therapies, such as vaccination. These concerns are heightened with respect to the pediatric use of CAM products. To address this issue, we conducted a systematic audit of pediatric and adolescent case files at a large, college-based, Canadian naturopathic teaching clinic. We specifically sought to describe the demographic characteristics, reasons for presentation, use of CAM products, and vaccinations status of children presenting for naturopathic assessment. We also determined factors associated with the use of CAM products and vaccination status. METHODS: We identified all charts for children (<18 years of age) who presented to the Robert Schad Naturopathic Clinic, the teaching clinic of the Canadian College of Naturopathic Medicine, between February 1 and May 31, 2002. Data were abstracted directly from the standardized patient intake forms and from clinical notes recorded during the patient's initial visit to the clinic. The following data were obtained: age, gender, chief presenting complaints reported by parents, CAM product use at presentation, vaccination status, and reactions to vaccination. We conducted logistic regression analyses to identify factors associated with both CAM product use and vaccination status. RESULTS: A total of 482 charts were identified. The mean age of patients was 6.5 years (95% confidence interval [CI]: 1.6-11.4 years). The ratio of female subjects to male subjects was 1.09:1 (248:227). The most common reasons for presentation were skin disorders (23%), gastrointestinal complaints (17%), and psychiatric/behavioral disorders (15%). Thirty-five percent of children were using CAM products at presentation (21.2% when both vitamins and minerals were excluded). Vitamins were the most commonly used products (34.6%), followed by herbal remedies (14.9%), oil blends/fats (7.2%), minerals (5.6%), probiotics (4.5%), and homeopathic remedies (3.7%). Of charts with vaccination information, 8.9% indicated that children had not been vaccinated; possible vaccine-associated adverse events were reported for 27% of those who had been vaccinated. Partial or unvaccinated status was associated with younger age, attending the Canadian College of Naturopathic Medicine for advice regarding vaccination, and greater use of CAM products. CAM product use was associated with unvaccinated or partially vaccinated status (odds ratio [OR]: 2.86; 95% CI: 1.46-5.63), presenting with poor energy or fatigue (OR: 3.36; 95% CI: 1.00-11.26), or presenting with throat or sinus infections (OR: 4.06; 95% CI: 1.23-13.04). CONCLUSIONS: Children present for naturopathic assessment for diverse reasons, are high-level consumers of CAM products, and have lower rates of vaccination than population averages. The conventional-medicine community should work with naturopaths to address public health concerns in this population.

Milk thistle and indinavir: a randomized controlled pharmacokinetics study and meta-analysis.

OBJECTIVES: To determine whether ingestion of milk thistle affects the pharmacokinetics of indinavir. METHODS: We conducted a three-period, randomized controlled trial with 16 healthy participants. We randomized participants to milk thistle or control. All participants received initial dosing of indinavir, and baseline indinavir levels were obtained (AUC(0-8)) (phase I). The active group were then given 450 mg milk-thistle extract capsules to be taken t.i.d. from day 2 to day 30. The control group received no plant extract. On day 29 and day 30, indinavir dosing and sampling was repeated in both groups as before (phase II). After a wash-out period of 7 days, indinavir dosing and sampling were repeated as before (phase III). RESULTS: All participants completed the trial, but two were excluded from analysis due to protocol violation. There were no significant between-group differences. Active group mean AUC(0-8) indinavir decreased by 4.4% (90% CI, -27.5% to -26%, P=0.78) from phase I to phase II in the active group, and by 17.3% (90% CI, -37.3% to +9%, P=0.25) in phase III. Control group mean AUC(0-8) decreased by 21.5% (90% CI, -43% to +8%, P=0.2) from phase I to phase II and by 38.5% (90% CI, -55.3% to -15.3%, P=0.01) of baseline at phase III. To place our findings in context, milk thistle-indinavir trials were identified through systematic searches of the literature. A meta-analysis of three milk thistle-indinavir trials revealed a non-significant pooled mean difference of 1% in AUC(0-8) (95% CI, -53% to 55%, P=0.97). CONCLUSIONS: Indinavir levels were not reduced significantly in the presence of milk thistle.

Impact of African herbal medicines on antiretroviral metabolism.

We examined the effects of two African herbal medicines recommended for HIV/AIDS patients on antiretroviral metabolism. Extracts from Hypoxis and Sutherlandia showed significant effects on cytochrome P450 3A4 metabolism and activated the pregnane X receptor approximately twofold. P-glycoprotein expression was inhibited, with Hypoxis showing 42-51% and Sutherlandia showing 19-31% of activity compared with verapamil. Initiating policies to provide herbal medicines with antiretroviral agents may put patients at risk of treatment failure, viral resistance or drug toxicity.

Impact of federal safety advisories on health food store advice.

In early 2002, the FDA and Health Canada issued federal advisories that people should discontinue taking the herbal antianxiolitic kava kava, until further information regarding safety and potential for liver damage were determined. We conducted a field study 2 months following the advisories in Toronto, Canada to determine whether kava kava continued to be recommended to consumers at retail health food stores. Eight participants asked employees at all stores what was recommended for anxiety and whether the products were safe. Twenty-two of 34 stores recommended kava kava, 9 of which mentioned safety concerns. Physicians should be aware that federal advisories may not affect sales of unsafe products.

A survey of attitudes towards paediatric vaccinations amongst Canadian naturopathic students.

Previous studies have suggested that providers of alternative medicine may harbour anti-vaccination attitudes and that these attitudes may develop at an early stage in their careers. We further explored this question by conducting a survey to determine the attitudes of students of naturopathic medicine, a growing alternative medicine discipline, towards recommended paediatric vaccines. We sampled all 4 years of students at the Canadian College of Naturopathic Medicine (CCNM) and obtained a response rate of 59.4% (312 of 525). We found that only 12.8% (40 of 312) of the respondents would advise full vaccination; however, 74.4% (232 of 312) of the respondents would advise partial vaccination. Importantly, both willingness to advise full vaccination and trust in public health and conventional medicine decreased in students in the later years of the programme. Our findings suggest that public health and conventional medical supporters of vaccination need to identify mechanisms for engaging in discussion with this population of complementary/alternative medical professionals at an early stage in their careers.

Emerging issues associated with HIV patients seeking advice from health food stores.

OBJECTIVES: To ascertain the recommendations, training and education of health food store employees and determine how they communicate the costs, benefits and risks associated with natural health products for the HIV/AIDS community. METHODS: Four male research assistants, posing as asymptomatic HIV-positive individuals, inquired of employees of all retail health food stores in a major Canadian city as to what is recommended for their condition. The research assistants asked about product costs, side effects, potential drug interactions and efficacy. They also inquired as to employee education related to Complementary and Alternative Medicine (CAM) and noted whether employees asked about which conventional medications they were taking and whether they recommended that the subjects seek physician or CAM provider advice. RESULTS: A total of 32 stores were included. Eight store employees (25%) offered no advice; eight (25%) inquired whether the subjects were currently taking medications; six (19%) suggested visiting a physician; and eight (25%) suggested visiting a CAM provider. A total of 36 different products (mean 2.3 per employee) were recommended with considerable variability in product evidence and cost. The education of the employees varied from postgraduate education (n=3), to undergraduate degree (n=3), college level (n=5) in CAM, or no formal education in CAM (n=21). CONCLUSION: There was considerable heterogeneity in advice on natural food products provided by employees of natural food stores and, in general, these individuals had limited formal training in CAM. The products they recommended had limited evidence supporting their efficacy and in some instances were potentially harmful and had considerable costs. The findings of this study support the need to further examine how best to regulate this growing component of the health care system.

Health food store recommendations: implications for breast cancer patients.

BACKGROUND: Many breast cancer patients use complementary and alternative medicine (CAM). We aimed to determine what advice health food store employees present to individuals seeking treatment options for breast cancer. METHODS: Eight data gatherers asked employees of all retail health food stores in a major Canadian city, what they recommended for a patient with breast cancer. The data gatherers inquired about product safety, potential drug interactions, costs and efficacy. They also enquired about employee training related to the products. RESULTS: Thirty-four stores were examined. A total of 33 different products were recommended, none of which are supported by sufficient evidence of efficacy. The average cost of the products they recommended was 58.09 dollars (CAD) (minimum 5.28 dollars, median 32.99 dollars, maximum 600 dollars) per month. Twenty-three employees (68%) did not ask whether the patient took prescription medications. Fifteen employees (44%) recommended visiting a healthcare professional (naturopaths (9), physicians (5), nutritionists (1). Three employees (8.8%) discussed potential adverse effects of the products. Eight employees (23.5%) discussed the potential for drug interactions. Two employees (5.9%) suggested a possible cure with the products and one employee (2.9%) suggested discontinuing Tamoxifen. Four employees (11.8%) recommended lifestyle changes and three employees (8.8%) recommended books for further reading on the products. CONCLUSION: This study draws attention to the heterogeneity of advice provided by natural health food stores to individuals seeking treatments for breast cancer, and the safety and cost implications of some of the products recommended. Physicians should enquire carefully about the use of natural health food products by patients with breast cancer. Regulators need to consider regulations to protect vulnerable patients from incurring significant costs in their purchasing of natural health food products lacking evidence of benefit and of questionable safety.