Biomedical subjects

Joanne Barnes

Publications and source records attributed to Joanne Barnes.

9 recordsLinked to original sources

PubMed2006

Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement.

Herbal medicinal products are widely used, vary greatly in content and quality, and are actively tested in randomized, controlled trials (RCTs). The authors' objective was to develop recommendations for reporting RCTs of herbal medicine interventions, based on the need to elaborate on the 22-item CONSORT (Consolidated Standards of Reporting Trials) checklist. Telephone calls were made and a consensus meeting was held with 16 participants in Toronto, Canada, to develop these recommendations. The group agreed on context-specific elaborations of 9 CONSORT checklist items for RCTs of herbal medicines. Item 4, concerning the herbal medicine intervention, required the most extensive elaboration. These recommendations have been developed to improve the reporting of RCTs using herbal medicine interventions.

Herbal Medicine↗

PubMed2006

Improving the quality of reporting of randomized controlled trials evaluating herbal interventions: implementing the CONSORT statement [corrected].

BACKGROUND: Given that herbal medicinal products are widely used, vary greatly in content and quality, and are actively tested in randomized controlled trials (RCTs), such RCTs must clearly report the specifics of the intervention. OBJECTIVE: Our objective was to develop recommendations for reporting RCTs of herbal medicine interventions. METHODS: We identified and invited potential participants with expertise in clinical trial methodology, clinical trial reporting, pharmacognosy, herbal medicinal products, medical statistics, and/or herbal product manufacturing to participate in phone calls and a consensus meeting. Three phases were conducted: (1) Premeeting item generation via telephone calls, (2) Consensus meeting, and (3) Postmeeting feedback. Sixteen experts participated in premeeting phone calls for item generation, and 14 participants attended a consensus meeting in Toronto, Ontario, Canada, in June of 2004. During the consensus meeting, a modified Delphi technique was used to aid discussion and debate of information required for reporting RCTs of herbal medicines. RESULTS: After extensive discussion, the group decided that context-specific elaborations of nine Consolidated Standards of Reporting Trials (CONSORT) items to RCTs of herbal medicines were necessary: Item 1 (Title and Abstract), 2 (Background), 3 (Participants), 4 (Interventions), 6 (Outcomes), 15 (Baseline data), 20 (Interpretation), 21 (Generalizability), and 22 (Overall evidence). DISCUSSION: The elaboration of item 4 of the CONSORT statement outlines specific information required for complete reporting of the herbal medicine intervention. The reporting suggestions presented will support clinical trialists, editors, and reviewers in reporting and reviewing RCTs of herbal medicines and readers in interpreting the results.

Consensus↗

PubMed2006

Recommendations for reporting randomized controlled trials of herbal interventions: Explanation and elaboration.

Controlled trials that use randomized allocation are the best tool to control for bias and confounding in trials testing clinical interventions. Investigators must be sure to include information that is required by the reader to judge the validity and implications of the findings in the reports of these trials. In part, complete reporting of trials will allow clinicians to modify their clinical practice to reflect current evidence toward the improvement of clinical outcomes. The consolidated standards of reporting trials (CONSORT) statement was developed to assist investigators, authors, reviewers, and editors on the necessary information to be included in reports of controlled clinical trials. The CONSORT statement is applicable to any intervention, including herbal medicinal products. Controlled trials of herbal interventions do not adequately report the information suggested in CONSORT. Recently, reporting recommendations were developed in which several CONSORT items were elaborated to become relevant and complete for randomized controlled trials of herbal medicines. We expect that these recommendations will lead to more complete and accurate reporting of herbal trials. We wrote this explanatory document to outline the rationale for each recommendation and to assist authors in using them by providing the CONSORT items and the associated elaboration, together with examples of good reporting and empirical evidence, where available, for each. These recommendations for the reporting of herbal medicinal products presented here are open to revision as more evidence accumulates and critical comments are collected.

Complementary Therapies↗

PubMed2006

A pilot randomised, open, uncontrolled, clinical study of two dosages of St John's wort (Hypericum perforatum) herb extract (LI-160) as an aid to motivational/behavioural support in smoking cessation.

There is an association between smoking and depression, yet the herbal antidepressant St John's wort (Hypericum perforatum L.; SJW) herb extract has not previously been investigated as an aid in smoking cessation. In this open, uncontrolled, pilot study, 28 smokers of 10 or more cigarettes per day for at least one year were randomised to receive SJW herb extract (LI-160) 300 mg once or twice daily taken for one week before and continued for 3 months after a target quit date. In addition, all participants received motivational/behavioural support from a trained pharmacist. At 3 months, the point prevalence and continuous abstinence rates were both 18%, and at 12 months were 0%. Fifteen participants (54%) reported 23 adverse events up to the end of the 3-month follow-up period. There was no statistically significant difference in the frequency of adverse events for participants taking SJW once or twice daily (p > 0.05). Most adverse events were mild, transient and non-serious. This preliminary study has not provided convincing evidence that a SJW herb extract plus individual motivational/behavioural support is likely to be effective as an aid in smoking cessation. However, it may be premature to rule out a possible effect on the basis of a single, uncontrolled pilot study, and other approaches involving SJW extract may warrant investigation.

Adolescent↗

PubMed2005

Echinacea species (Echinacea angustifolia (DC.) Hell., Echinacea pallida (Nutt.) Nutt.,Echinacea purpurea (L.) Moench): a review of their chemistry, pharmacology and clinical properties.

This paper reviews the chemistry, pharmacology and clinical properties of Echinacea species used medicinally. The Echinacea species Echinacea angustifolia, Echinacea pallida and Echinacea purpurea have a long history of medicinal use for a variety of conditions, particularly infections, and today echinacea products are among the best-selling herbal preparations in several developed countries. Modern interest in echinacea is focused on its immunomodulatory effects, particularly in the prevention and treatment of upper respiratory tract infections. The chemistry of Echinacea species is well documented, and several groups of constituents, including alkamides and caffeic acid derivatives, are considered important for activity. There are, however, differences in the constituent profile of the three species. Commercial echinacea samples and marketed echinacea products may contain one or more of the three species, and analysis of samples of raw material and products has shown that some do not meet recognized standards for pharmaceutical quality. Evidence from preclinical studies supports some of the traditional and modern uses for echinacea, particularly the reputed immunostimulant (or immunomodulatory) properties. Several, but not all, clinical trials of echinacea preparations have reported effects superior to those of placebo in the prevention and treatment of upper respiratory tract infections. However, evidence of efficacy is not definitive as studies have included different patient groups and tested various different preparations and dosage regimens of echinacea. On the basis of the available limited safety data, echinacea appears to be well tolerated. However, further investigation and surveillance are required to establish the safety profiles of different echinacea preparations. Safety issues include the possibility of allergic reactions, the use of echinacea by patients with autoimmune diseases and the potential for echinacea preparations to interact with conventional medicines.

Adjuvants, Immunologic↗

PubMed2003

Quality, efficacy and safety of complementary medicines: fashions, facts and the future. Part I. Regulation and quality.

This is the first of two papers which review issues concerning complementary medicines. The first reviews the extent of use of complementary medicines, and issues related to the regulation and pharmaceutical quality of these products; the second considers evidence for the efficacy of several well-known complementary medicines, and discusses complementary-medicines pharmacovigilance. The term complementary medicines describes a range of pharmaceutical-type preparations, including herbal medicines, homoeopathic remedies, essential oils and dietary supplements, which mainly sit outside conventional medicine. The use of complementary medicines is a popular healthcare approach in the UK, and there are signs that the use of such products is continuing to increase. Patients and the public use complementary medicines for health maintenance, for the treatment or prevention of minor ailments, and also for serious, chronic illnesses. The pervasive use of complementary medicines raises several concerns. Many of these arise because most complementary medicines are not licensed as medicines, and therefore evidence of quality, efficacy and safety is not required before marketing. The regulatory framework for herbal medicines and dietary supplements is currently under review. A new system for registration of traditional herbal medicines will ensure that marketed products meet standards for quality and safety. At present, the pharmaceutical quality of many complementary medicines is a cause for concern.

Attitude to Health↗

PubMed2003

Quality, efficacy and safety of complementary medicines: fashions, facts and the future. Part II: Efficacy and safety.

This is the second of two papers which review issues concerning complementary medicines. The first reviewed the extent of use of complementary medicines, and issues related to the regulation and pharmaceutical quality of these products; the second considers evidence for the efficacy of several well-known complementary medicines, and discusses complementary-medicines pharmacovigilance. The term complementary medicines describes a range of pharmaceutical-type preparations, including herbal medicines, homoeopathic remedies, essential oils and dietary supplements, which mainly sit outside conventional medicine. The use of complementary medicines is a popular healthcare approach in the UK, and there are signs that the use of such products is continuing to increase. Patients and the public use complementary medicines for health maintenance, for the treatment or prevention of minor ailments, and also for serious, chronic illnesses. There is a growing body of evidence from randomized controlled trials and systematic reviews to support the efficacy of certain herbal extracts and dietary supplements in particular conditions. However, many other preparations remain untested. Strictly speaking, evidence of efficacy (and safety) for herbal medicines should be considered to be extract specific. Pharmacovigilance for complementary medicines is in its infancy. Data are lacking in several areas relevant to safety. Standard pharmacovigilance tools have additional limitations when applied to investigating safety concerns with complementary medicines.

Complementary Therapies↗

PubMed2003

Pharmacovigilance of herbal medicines : a UK perspective.

There is an increasing awareness at several levels of the need to develop pharmacovigilance practices for herbal medicines. The current model of pharmacovigilance and its associated tools have been developed in relation to synthetic drugs, and applying these methods to monitoring the safety of herbal medicines presents unique challenges in addition to those described for conventional medicines. Several problems relate to the ways in which herbal medicines are named, perceived, sourced, and utilised. Other important challenges arise from the current regulatory framework for herbal medicines in the UK. In the UK at present, the Committee on Safety of Medicines/Medicines and Healthcare products Regulatory Agency's (CSM/MHRA) 'yellow card' scheme for adverse drug reaction (ADR) reporting is the main method of monitoring the safety of herbal medicines. Despite recent initiatives to stimulate reporting of suspected ADRs associated with herbal medicines, such as extending the scheme to unlicensed herbal products, and including community pharmacists as recognised reporters, numbers of herbal ADR reports received by the CSM/MHRA remain relatively low. Under-reporting, an inevitable and important limitation of spontaneous reporting schemes, is likely to be significant for herbal medicines, since users typically do not seek professional advice about their use of such products, or report if they experience adverse effects. The herbal sector in the UK has initiated various spontaneous reporting schemes, based on the yellow card scheme, but targeted mainly at herbal-medicine practitioners. It is important that these schemes have a link with the CSM/MHRA so that potential signals are not missed. Several other tools used in pharmacovigilance of conventional medicines, such as prescription-event monitoring, and the use of computerised health-record databases, currently are of no use for evaluating the safety of herbal and other non-prescription medicines. Proposed European Union legislation for traditional herbal medicinal products will require manufacturers of products registered under new national schemes to comply with regulatory provisions on pharmacovigilance. In the longer term, other improvements in safety monitoring of herbal medicines may include modifications to existing methodology, patient reporting and greater consideration of pharmacogenetics and pharmacogenomics in optimising the safety of herbal medicines.

Herbal Medicine↗

PubMedDate not supplied

Implementing a perinatal clinical information system: a work in progress.

Implementation of a clinical information system is a work in progress. There are many factors to consider, including (a) clearly defining the scope of the project and associated goals, (b) identifying background, skills, and beliefs of the key players, (c) assessing the unit's strengths and weaknesses, (d) assessing the current documentation's strengths and weaknesses, (e) assessing the clinical information system's strengths and weaknesses, (f) determining the project's constraints, and (g) discussing different implementation strategies. This article describes how these factors were considered during implementation of a clinical information system in a labor and delivery unit.

Attitude of Health Personnel↗