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Biomedical subjects

Edward Mills

Publications and source records attributed to Edward Mills.

At least 19 recordsLinked to original sources
PubMed2007

Mitigation of antiretroviral-induced hyperlipidemia by hepatitis C virus co-infection.

BACKGROUND: Hyperlipidemia is a recognized complication of HIV antiretroviral therapy. The interactions between HIV, hepatitis C virus (HCV), antiretroviral agents and lipids are not well understood. METHODS: We evaluated the lipid data of patients receiving antiretroviral therapy at the Ottawa Hospital Immunodeficiency Clinic between January 1996 and June 2005 using a clinic database. RESULTS: A total of 357 HIV-mono-infected and 115 HIV/HCV-co-infected patients were evaluated. The mean changes in total cholesterol (mmol/l) from baseline to months 6 and 12 were 1.00 and 1.24 in HIV mono-infection, and 0.19 (P < 0.001) and 0.01 (P < 0.001) in HIV/HCV, respectively. Metabolic complications including hypercholesterolemia resulted in the interruption of HAART in HIV mono-infection (8%), but not in those with HIV/HCV (< 1%; P < 0.001). Eight per cent of HIV-mono-infected and no co-infected patients initiated lipid-lowering therapy while on their initial course of HAART (P < 0.001). Total cholesterol increased by 0.85 mmol/l in HIV/HCV-co-infected recipients of interferon-based HCV treatment achieving a sustained virological response (SVR), but did not change in those who did not achieve a SVR. CONCLUSION: HCV co-infection appears to confer a degree of protection from HAART-related lipid complications. The mechanism of this finding deserves evaluation. The implications of this observation for long-term cardiovascular disease risk remains a pressing issue.

Adult↗
PubMed2006

Safety and efficacy of black cohosh (Cimicifuga racemosa) during pregnancy and lactation.

BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines in pregnancy and lactation. This is one article in a series that systematically reviews the evidence for commonly used herbs during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety, and pharmacology of black cohosh focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS: Black cohosh, alone or in combination with other medicinal herbs as "mother's cordial", has a long traditional use and is frequently used by midwives as a uterine stimulant and labour-inducing aid. Low-level evidence based on theory and expert opinion shows the following concerns with respect to black cohosh use during pregnancy: 1) labour-inducing effects, 2) hormonal effects, 3) emmenagogue properties and, 4) anovulatory effects. During lactation, there is low-level evidence from theoretical and expert opinion of black cohosh having hormonal properties. CONCLUSIONS: Black cohosh should be used with caution during pregnancy, particularly during the first trimester where its purported labour-inducing effects could be of concern, and during lactation. Black cohosh should undergo rigorous high quality human studies to determine its safety in pregnancy and lactation.

Cimicifuga↗
PubMed2006

Safety and efficacy of echinacea (Echinacea angustafolia, e. purpurea and e. pallida) during pregnancy and lactation.

BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines used in pregnancy and lactation. This is one article in a series that systematically reviews the evidence for commonly used herbs during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety, and pharmacology of echinacea focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS: There is good scientific evidence from a prospective cohort study that oral consumption of echinacea during the first trimester does not increase the risk for major malformations. Low-level evidence based on expert opinion shows that oral consumption of echinacea in recommended doses is safe for use during pregnancy and lactation. CONCLUSIONS: Echinacea is non-teratogenic when used during pregnancy. Caution with using Echinacea during lactation until further high quality human studies can determine its safety.

Administration, Oral↗
PubMed2006

Safety and efficacy of St. John's wort (hypericum) during pregnancy and lactation.

BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines in pregnancy and lactation. This is one article in a series that systematically reviews the evidence for commonly used herbs during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety, and pharmacology of St. John's wort focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS: There is very weak scientific evidence based on a case report that St Johns wort is of minimal risk when taken during pregnancy. There is in vitro evidence from animal studies that St John's wort during pregnancy does not affect cognitive development nor cause long-term behavioral defects, but may lower offspring birth weight. There is weak scientific evidence that St. John's wort use during lactation does not affect maternal milk production nor affect infant weight, but, in a few cases, may cause colic, drowsiness or lethargy. There is weak scientific evidence that St John's wort induces CYP450 enzymes, which may lower serum medication levels below therapeutic range; this may be of concern when administering medications during pregnancy and lactation. CONCLUSIONS: Caution is warranted with the use of St John's wort during pregnancy until further high quality human research is conducted to determine its safety. St John's wort use during lactation appears to be of minimal risk, but may cause side effects. Caution is warranted when using medications along with St John's wort.

Animals↗
PubMed2006

Safety and efficacy of ginkgo (Ginkgo biloba) during pregnancy and lactation.

BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines used in pregnancy and lactation. This is one article in a series that systematically reviews the evidence for commonly used herbs during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety, and pharmacology of ginkgo focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS: There is some very weak scientific evidence from animal and in vitro studies that ginkgo leaf has antiplatelet activity, which may be of concern during labour as ginkgo use could prolong bleeding time. Low-level evidence based on expert opinion shows that ginkgo leaf may be an emmenagogue and have hormonal properties. The safety of ginkgo leaf during lactation is unknown. Patients and clinicians should be aware of past reports of ginkgo products being adulterated with colchicine. CONCLUSIONS: Ginkgo should be used with caution during pregnancy, particularly around labour where its anti-platelet properties could prolong bleeding time. During lactation the safety of ginkgo leaf is unknown and should be avoided until high quality human studies are conducted to prove its safety.

Animals↗
PubMed2006

Barriers to participation in HIV drug trials: a systematic review.

The enrolling of adequate participants into HIV experimental drug trials presents an important challenge. We systematically reviewed the literature to identify barriers and concerns amongst HIV patients to participation in HIV clinical drug trials. We reviewed studies for validity and content, and generated pooled estimates of the frequency with which patients identified particular issues by pooling across studies that presented results as proportions. We included three semi-structured interview studies, two open-ended questionnaires, and nine quantitative studies. Major barriers to participation included fear of side-effects, distrust of researchers, general concerns about research design, interference in everyday life or changes in routine, and social discrimination. Results from the quantitative studies indicated that the most prevalent barriers were as follows: suspicions about the drug itself (53%, 95% CI 24-83%), patients were not informed or believed they were not eligible (38%, 25-50%), and travel or transport obstacles (39%, 21-57%). The findings of this study should aid drug trialists in developing strategies to maximise participation and cooperation in HIV clinical drug trials while adequately informing and protecting prospective participants.

Anti-HIV Agents↗
PubMed2005

Randomized trials stopped early for benefit: a systematic review.

CONTEXT: Randomized clinical trials (RCTs) that stop earlier than planned because of apparent benefit often receive great attention and affect clinical practice. Their prevalence, the magnitude and plausibility of their treatment effects, and the extent to which they report information about how investigators decided to stop early are, however, unknown. OBJECTIVE: To evaluate the epidemiology and reporting quality of RCTs involving interventions stopped early for benefit. DATA SOURCES: Systematic review up to November 2004 of MEDLINE, EMBASE, Current Contents, and full-text journal content databases to identify RCTs stopped early for benefit. STUDY SELECTION: Randomized clinical trials of any intervention reported as having stopped early because of results favoring the intervention. There were no exclusion criteria. DATA EXTRACTION: Twelve reviewers working independently and in duplicate abstracted data on content area and type of intervention tested, reporting of funding, type of end point driving study termination, treatment effect, length of follow-up, estimated sample size and total sample studied, role of a data and safety monitoring board in stopping the study, number of interim analyses planned and conducted, and existence and type of monitoring methods, statistical boundaries, and adjustment procedures for interim analyses and early stopping. DATA SYNTHESIS: Of 143 RCTs stopped early for benefit, the majority (92) were published in 5 high-impact medical journals. Typically, these were industry-funded drug trials in cardiology, cancer, and human immunodeficiency virus/AIDS. The proportion of all RCTs published in high-impact journals that were stopped early for benefit increased from 0.5% in 1990-1994 to 1.2% in 2000-2004 (P<.001 for trend). On average, RCTs recruited 63% (SD, 25%) of the planned sample and stopped after a median of 13 (interquartile range [IQR], 3-25) months of follow-up, 1 interim analysis, and when a median of 66 (IQR, 23-195) patients had experienced the end point driving study termination (event). The median risk ratio among truncated RCTs was 0.53 (IQR, 0.28-0.66). One hundred thirty-five (94%) of the 143 RCTs did not report at least 1 of the following: the planned sample size (n = 28), the interim analysis after which the trial was stopped (n = 45), whether a stopping rule informed the decision (n = 48), or an adjusted analysis accounting for interim monitoring and truncation (n = 129). Trials with fewer events yielded greater treatment effects (odds ratio, 28; 95% confidence interval, 11-73). CONCLUSIONS: RCTs stopped early for benefit are becoming more common, often fail to adequately report relevant information about the decision to stop early, and show implausibly large treatment effects, particularly when the number of events is small. These findings suggest clinicians should view the results of such trials with skepticism.

Clinical Trials Data Monitoring Committees↗
PubMed2005

Media reporting of tenofovir trials in Cambodia and Cameroon.

BACKGROUND: Two planned trials of pre-exposure prophylaxis tenofovir in Cambodia and Cameroon to prevent HIV infection in high-risk populations were closed due to activist pressure on host country governments. The international news media contributed substantially as the primary source of knowledge transfer regarding the trials. We aimed to characterize the nature of reporting, specifically focusing on the issues identified by media reports regarding each trial. METHODS: With the aid of an information specialist, we searched 3 electronic media databases, 5 electronic medical databases and extensively searched the Internet. In addition we contacted stakeholder groups. We included media reports addressing the trial closures, the reasons for the trial closures, and who was interviewed. We extracted data using content analysis independently, in duplicate. RESULTS: We included 24 reports on the Cambodian trial closure and 13 reports on the Cameroon trial closure. One academic news account incorrectly reported that it was an HIV vaccine trial that closed early. The primary reasons cited for the Cambodian trial closure were: a lack of medical insurance for trial related injuries (71%); human rights considerations (71%); study protocol concerns (46%); general suspicions regarding trial location (37%) and inadequate prevention counseling (29%). The primary reasons cited for the Cameroon trial closure were: inadequate access to care for seroconverters (69%); participants not sufficiently informed of risks (69%); inadequate number of staff (46%); participants being exploited (46%) and an unethical study design (38%). Only 3/23 (13%) reports acknowledged interviewing research personnel regarding the Cambodian trial, while 4/13 (30.8%) reports interviewed researchers involved in the Cameroon trial. CONCLUSION: Our review indicates that the issues addressed and validity of the media reports of these trials is highly variable. Given the potential impact of the media in formulation of health policy related to HIV, efforts are needed to effectively engage the media during periods of controversy in the HIV/AIDS epidemic.

Journal Article↗
PubMed2005

Nepal's war on human rights: a summit higher than Everest.

Nepal has witnessed serious human rights violations including arbitrary arrests, detentions, "disappearances", extra judicial executions, abductions and torture carried out by both the Royal Nepalese Army and the Maoist rebels in the 10 years of the "peoples war". Women and children have borne the brunt of the conflict. Massive displacement has led to adverse social and psychological consequences. While the reasons for the conflict are mainly indigenous and rooted in the social and economic inequities, remedies for health inequities must come not only from the health sector but also from broad social policies and adopting a participatory and conflict-sensitive approach to development. Meanwhile the international community needs to use its leverage to urge both sides to accept a human rights accord and honor international human rights and humanitarian laws, while investigating allegations of abuse and prosecute those responsible.

Journal Article↗
PubMed2005

African herbal medicines in the treatment of HIV: Hypoxis and Sutherlandia. An overview of evidence and pharmacology.

In Africa, herbal medicines are often used as primary treatment for HIV/AIDS and for HIV-related problems. In general, traditional medicines are not well researched, and are poorly regulated. We review the evidence and safety concerns related to the use of two specific African herbals, which are currently recommended by the Ministry of Health in South Africa and member states for use in HIV: African Potato and Sutherlandia. We review the pharmacology, toxicology and pharmacokinetics of these herbal medicines. Despite the popularity of their use and the support of Ministries of Health and NGOs in some African countries, no clinical trials of efficacy exist, and low-level evidence of harm identifies the potential for drug interactions with antiretroviral drugs. Efforts should be made by mainstream health professionals to provide validated information to traditional healers and patients on the judicious use of herbal remedies. This may reduce harm through failed expectations, pharmacologic adverse events including possible drug/herb interactions and unnecessary added therapeutic costs. Efforts should also be directed at evaluating the possible benefits of natural products in HIV/AIDS treatment.

Alkynes↗