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Biomedical subjects

Edward Mills

Publications and source records attributed to Edward Mills.

53 records · Page 3Linked to original sources
PubMed2004

Interaction of St John's wort with conventional drugs: systematic review of clinical trials.

OBJECTIVE: To determine the methodological quality of clinical trials that examined possible interactions of St John's wort with conventional drugs, and to examine the results of these trials. DESIGN: Systematic review. DATA SOURCES: Electronic databases from inception to April 2004, reference lists from published reports, and experts in the field. STUDY SELECTION: Eligible studies were prospective clinical trials evaluating the pharmacokinetic effect of St John's wort on the metabolism of conventional drugs. DATA EXTRACTION: Two reviewers selected studies for inclusion and independently extracted data. DATA SYNTHESIS: 22 pharmacokinetic trials studied an average of 12 (SD 5) participants; 17 trials studied healthy volunteers and five studied patients. Most (17) studies used a "before and after" design; four studies used control groups other than the active group. Three studies randomised the sequence of administration or the participants to study arms or periods; three studies blinded participants or investigators. In 15 trials, investigators independently assayed the herb. Of 19 trials with available plasma data, three found no important interaction (change in area under the curve < 20%) and 17 found a decrease in systemic bioavailability of the conventional drug; in seven studies the 95% confidence interval excluded a decrease of < 20%. CONCLUSION: Clinicians and patients should beware of possible decreases in the systemic bioavailability of conventional drugs when taken concomitantly with St John's wort.

Area Under Curve↗
PubMed2004

n-of-1 randomized controlled trials: an opportunity for complementary and alternative medicine evaluation.

Complementary and alternative medicine (CAM) practice has traditionally relied on expert opinion and case examples to evaluate the outcome of a particular therapeutic treatment. Such trials are subject to bias, leading to the formation of erroneous conclusions about the effectiveness of most treatments. This paper reviews the feasibility of n-of-1 trials to better evaluate the clinical and statistical significance of CAM therapies. In particular: (1) problems arising from the use of standard therapeutic trials; (2) the n-of-1 trial and data analysis; (3) clinical use and advantages of the n-of-1 trial in conventional medicine; (4) potential clinical uses of the n-of-1 trial in CAM; (5) preliminary guidelines for the use of the n-of-1 trial in CAM; (6) constraints on the use of the n-of-1 trial in CAM; and (7) ethical issues in the conduct of the n-of-1 trial.

Bias↗
PubMed2004

Determining the reporting quality of RCTs in clinical pharmacology.

BACKGROUND: The Consolidated Standards for Reporting Trials (CONSORT) are recommendations for improving the quality of reports of randomized controlled trials (RCTs). OBJECTIVE: To determine the extent to which clinical pharmacology journals implement specific CONSORT recommendations. DESIGN AND SETTING: Analysis of RCTs published between May 2002 and May 2003 in four clinical pharmacology journals. MAIN OUTCOME MEASURES: Proportion of RCTs that published a participant flow diagram and that reported on randomization and restriction methods, allocation concealment, blinding, intention-to-treat analysis, ethical considerations, adverse events and source of funding. RESULTS: Of 482 clinical trials, 193 were RCTs. Healthy participants were involved in 129 [66.8%, 95% confidence interval (CI) 59.9, 73.1] trials, patients who required treatment in 61 (31.6%, 95% CI 25.4, 38.4) trials and both in three (1.6%, 95% CI 0.5, 4.4) trials. The following items were infrequently reported: sequence generation (17%), allocation concealment (3%), use of restriction (16%), description of blinding (26%), and flow diagrams of study participants (2%). In contrast, the following areas were often reported: use of intention-to-treat analysis (79%), description of withdrawals (92.2%) and description of adverse events (71%), ethics review (94%) and informed consent (95%). Sources of funding were reported in 56% of studies. CONCLUSION: The use of the selected CONSORT items is limited in these journals, possibly as many items may not be relevant to the types of studies published in clinical pharmacology journals. Further efforts are required to determine the applicability of CONSORT to RCTs in clinical pharmacology.

Humans↗
PubMed2004

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.

Anxiety↗
PubMed2003

Sale of kava extract in some health food stores.

January 2002, Health Canada issued an advisory, followed by a ban in August 2002, on the sale of herbal kava. One month after the advisory, 22 (67%) of 33 health food stores approached were selling kava. Two months after the ban, 17 (57%) of 30 stores continued to sell kava. These findings demonstrate that health food stores may need to be better informed about the sale of restricted natural health products.

Canada↗
PubMed2003

The safety of over-the-counter niacin. A randomized placebo-controlled trial [ISRCTN18054903].

BACKGROUND: Niacin is widely available over the counter (OTC). We sought to determine the safety of 500 mg immediate release niacin, when healthy individuals use them as directed. METHODS: 51 female and 17 male healthy volunteers (mean age 27 years SD 4.4) participated in a randomized placebo-controlled blinded trial of a single dose of an OTC, immediate-release niacin 500 mg (n = 33), or a single dose of placebo (n = 35) on an empty stomach. The outcomes measured were self-reported incidence of flushing and other adverse effects. RESULTS: 33 volunteers on niacin (100%) and 1 volunteer on placebo (3%) flushed (relative risk 35, 95% confidence interval (CI) 6.8-194.7). Mean time to flushing on niacin was 18.2 min (95% CI: 12.7-23.6); mean duration of flushing was 75.4 min (95% CI: 62.5-88.2). Other adverse effects occurred commonly in the niacin group: chills (51.5% vs. 0%, P <.0001), generalized pruritus (75% vs. 0%, P = <.001), gastrointestinal upset (30% vs. 3%, P =.005), and cutaneous tingling (30% vs. 0%, P = <.001). Six participants did not tolerate the adverse effects of niacin and 3 required medical attention. CONCLUSION: Clinicians counseling patients about niacin should alert patients not only about flushing but also about gastrointestinal symptoms, the most severe in this study. They should not trust that patients would receive information about these side effects or their prevention (with aspirin) from the OTC packet insert.

Adult↗
PubMed2003

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.

Breast Neoplasms↗
PubMed2003

Adverse effects of acupuncture. Which are clinically significant?

OBJECTIVE: To review potentially serious adverse events associated with acupuncture. QUALITY OF EVIDENCE: Studies in the medical literature primarily provide level II evidence from retrospective reviews, case reports, and prospective surveys of practitioners. MAIN MESSAGE: Both the general public and physicians are becoming more interested in the ancient Chinese medical practice of acupuncture. This paper discusses the basic philosophy of acupuncture and describes adverse events that might be associated with acupuncture treatment. Some events, such as nausea and syncope, can be mild and transient, but rare events, such as septicemia and hepatitis C infection, can be fatal. As the role of acupuncture in today's multidisciplinary clinics increases, the complications of acupuncture, although infrequent, cannot be overlooked. CONCLUSION: Responsible clinicians practising acupuncture and seeing patients who use acupuncture should be aware of the adverse events associated with it.

Acupuncture↗
PubMed2002

Teaching Evidence-Based Complementary and Alternative Medicine (EBCAM); changing behaviours in the face of reticence: a cross-over trial.

BACKGROUND: The effectiveness of teaching critical appraisal to students of Complementary and Alternative Medicine (CAM) has not been studied. In this study we attempt to determine if a workshop for final year students at a naturopathic college improved their ability to utilize critical appraisal concepts. METHODS: We assigned 83 Naturopathic Interns to two groups: Group A (n = 47) or Group B (n = 36). We conducted a baseline assessment of all subjects' critical appraisal skills. Group A was assigned to receive a 3(1/2) hour workshop on Evidence Based Medicine (EBM) and Group B received a workshop on bioethics (control intervention). The groups critical appraisal skills were re-evaluated at this time. We then crossed over the intervention so that Group B received the EBM workshop while Group A received the bioethics workshop. Assessment of critical appraisal skills of the two groups was again performed. RESULTS: The students mean scores were similar in Group A (14.8) and Group B (15.0) after Group A had received the intervention and Group B had received the control (p = 0.75). Group scores were not significantly improved at the end of the trial compared to at the beginning of the study (Group A: 15.1 to 16.1) (Group B 15.6 to 15.9). Student's confidence in reading research papers also did not improve throughout the course of the study. CONCLUSION: The final year is a difficult but important time to teach critical appraisal and evidence skills. Single, short intervention programs will likely yield negligible results. A multi-factorial approach may be better suited to implementing EBCAM than single short interventions.

Biomedical Research↗
PubMed2002

Isolated myocardial revascularization with intermittent aortic cross-clamping: experience with 800 cases.

BACKGROUND: We investigated the clinical outcome of elective and nonelective myocardial revascularization performed with intermittent aortic cross-clamping. METHODS: Prospective data on 800 consecutive patients (from May 1996 to July 2000), who underwent isolated myocardial revascularization with intermittent aortic cross-clamping, were analyzed. A subgroup analysis was performed on the elective (n = 520), urgent (n = 226), and emergency (n = 54) procedures. RESULTS: The elective group of patients had a mean age of 61.5 +/- 9.46 years, mean Parsonnet score of 5.23 +/- 5.1, and mean number of distal anastomoses of 3.22 +/- 1.04. The hospital mortality was 0.57%. The urgent group of patients had a mean age of 63.06 +/- 10.43 years, mean Parsonnet score of 6.73 +/- 6.22, and mean number of distal anastomoses of 3.21 +/- 1.04. The hospital mortality was 3.09%. The emergency group of patients had a mean age of 63.75 +/- 9.63 years, mean Parsonnet score of 11.24 +/- 11, and mean number of distal anastomoses of 2.87 +/- 0.86. Hospital mortality was 5.55%. Postoperative hospital stay was 7.11 +/- 5.47 days for the elective group, 7.59 +/- 5.07 days for the urgent group, and 7.40 +/- 4.01 days for the emergency group. CONCLUSIONS: Intermittent aortic cross-clamping is a safe technique both in elective and nonelective patients. The mortality and morbidity in the three subgroups analyzed reflects patients' distribution against Parsonnet score.

Aged↗
PubMedDate not supplied

Randomized trials stopped early for harm in HIV/AIDS: a systematic survey.

PURPOSE: The decision to stop trials early because of the harmful effects of the intervention is complex and requires weighing statistical, logistical, and ethical considerations. We assessed the prevalence of randomized clinical trials (RCTs) stopped early for harm in HIV/AIDS and determined the quality of reporting of methods to inform the decision to stop the trial. METHOD: We searched 11 electronic databases and major conference abstract databases, contacted trialist and advocacy groups, and searched the Internet. We selected RCTs stopped early for harm. We extracted data on journal and year of publication, reporting of methods and funding, planned sample size, number and planning of interim analyses, stopping rules, and effect size of the harm outcomes. RESULTS: We found 10 RCTs stopped early for harm (median, n = 85; range, 7-1227). Most interventions (n = 9) were antiviral drugs; one trial studied vitamins to prevent vertical transmission of HIV. Five studies reported a priori defined adverse events, and only 1 trial reported planned stopping guidelines. The primary harm outcomes reported across trials included toxicity, death, and increased mother-to-child transmission. Two trials were stopped due to sudden unanticipated adverse events (Stevens-Johnson syndrome, death, and encephalopathy). Relative risk point estimates for harm ranged from 1 to 6.18. Six studies reported the presence of a data safety and monitoring board. CONCLUSION: The reporting of methods to inform the decision to stop trials for harm in this population is deficient in a variety of ways, including lack of stopping guidelines. Clinicians should interpret RCTs stopped early for harm with caution and interpret the results in light of related evidence. Trialists should improve the transparency of their decision-making regarding early stopping for harmful effects.

Anti-HIV Agents↗
PubMedDate not supplied

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.

Canada↗
PubMedDate not supplied

Addressing the emergence of pediatric vaccination concerns: recommendations from a Canadian policy analysis.

Ever since the advent of pediatric vaccination, individuals have expressed concerns about both its risks and benefits. These concerns have once again resurfaced among some segments of the population and could potentially undermine national vaccination programs. The views of the public, however, must be considered and respected in the formulation of vaccination policy. We have conducted an analysis of the pediatric vaccination "debate" in the Canadian context. We believe that there is common ground between those who support pediatric vaccination and those who are concerned about these programs. Based on our findings, we believe that the goal of public health authorities should be to maintain trust in vaccines by continuing to meet certain reciprocal responsibilities. To do so, we recommend the following: 1) increased investment in adverse event reporting systems; 2) request for proposals for consideration of a no-fault compensation program; 3) developing pre-emptive strategies to deal with potential vaccine risks; 4) further examination of mechanisms to improve communication between physicians and parents concerned about vaccination. All of these approaches would require additional investment in pediatric vaccination. However, such an investment is easy to justify given the benefits offered by pediatric vaccination and the ramifications of failing to maintain confidence in vaccination programs or missing a vaccine-related adverse event.

Adverse Drug Reaction Reporting Systems↗
PubMedDate not supplied

An in vivo analysis of the herbal compound essiac.

BACKGROUND: Essiac is a herbal compound that has been in common use with cancer patients in North America for over 80 years. Despite its relatively widespread use, there are no peer-reviewed published reports of in vivo studies regarding the use of this compound. MATERIALS AND METHODS: Essiac was administered orally to test animals prior to all experiments. Standard assays to test protection from ethanol-induced gastric ulceration and carbon tetrachloride-induced hepatic injury were performed on Wistar rats. Assays of postglucose-load serum glucose and cellular and humoral immune modulation were conducted on ICR and BALB/C mice, respectively. RESULTS: Essiac demonstrated a modest gastric protective effect via reduction of ethanol-induced gastric ulceration. However, Essiac did not demonstrate significant hepatoprotective, hypoglycemic or immunomodulatory properties. CONCLUSION: Essiac, administered in established in vivo experimental models, did not significantly demonstrate its purported physiological modifying effects.

Animals↗