Buflomedil for intermittent claudication

Background : Intermittent claudication (IC) is pain caused by chronic occlusive arterial disease, that develops in a limb during exercise and is relieved with rest. Buflomedil is a vasoactive agent used to treat peripheral vascular disease. However, its clinical efficacy for IC has not yet been critically examined. This is an update of a Cochrane review first published in 2000, and previously updated in 2007 and 2008. Objectives : To evaluate the available evidence on the efficacy of buflomedil for IC. Search methods : For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched January 2013) and CENTRAL (2012, Issue 12). Selection criteria : Double-blinded, randomized controlled trials (RCTs) in patients with IC (Fontaine stage II) receiving oral buflomedil compared with placebo. Pain-free walking distance (PFWD) and maximum walking distance (MWD) were analysed by standardized exercise test. Data collection and analysis : Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information. Main results : We included two RCTs with 127 participants. Both RCTs showed moderate improvements in PFWD for patients on buflomedil. This improvement was statistically significant for both trials (WMD 75.1 m, 95% confidence interval (CI) 20.6 to 129.6; WMD 80.6 m, 95% CI 3.0 to 158.2), the latter being a wholly diabetic population. For both RCTs, MWD gains were statistically significant with wide confidence intervals (WMD 80.7 m, 95% CI 9.4 to 152; WMD 171.4 m, 95% CI 51.3 to 291.5), respectively. Authors' conclusions : There is little evidence available to evaluate the efficacy of buflomedil for IC. Most trials were excluded due to poor quality. The two included trials showed moderately positive results; these are undermined by publication bias since we know of at least another four unpublished, irretrievable, and inconclusive studies. Buflomedil's benefit is small in relation to safety issues and its narrow therapeutic range

Impact of written drug information in patient package inserts: Acceptance and impact on benefit/risk perception

This thesis discusses the patient package insert (PPI), a folded sheet of paper in the drug package with a text which is supposed to be comprehensible for the general public. The PPI contains information on how the drug must be taken, on the risks of taking the drug, and a limited amount of information on whatthe drug is for. Belgium was the first country in Europe, together with Switzerland, to introduce PPIs. PPIs were first introduced in 1988 and the process was completed in 1992. In Europe, health authorities decided in 1992 that all medicinal product packages should contain a comprehensible insert. This decision is slowly but surely being implemented in all European countries. Similar developments did not take place in the US and other parts of the world, where medicines are distributed in bulk and dispensed without much information, even when dealing with powerful prescription drugs. During the introduction of PPIs in Belgium, a research programme wasconducted to evaluate this change in the way drug information was provided in the drug distribution system. This thesis provides an overview of the studiescarried out during that period. In addition, a number of other descriptive studies of the flow of drug information in specific patients groups is provided. Finally, a number of experimental studies is presented, which evaluate the impact of written drug information on patients? benefit/risk perception. The acceptance of a drug distribution system with mandatory PPIs in all drug packages will be evaluated on the basis of Belgium?s relatively long and welldocumented experience with PPIs. We address the following questions: what is the percentage of patients who read, accept and appreciate PPIs; what happens when a country changes from technical inserts with difficult jargon to comprehensible PPIs; what do we know about the impact of PPIs on patients knowledge and feelings about their drugs? In this thesis, an attempt is made to understand the mental processing of drug information which precedes patients' decisions and coping strategies, necessary for successful drug treatment. The question here is whether the PPI is capable of influencing the benefit/risk perception of patients. A further step is to study the impact of the PPI on behaviour. Here, other questions are at stake. Does the PPI have an impact on patients' reporting of health problems and side-effects, on their ability to carry out a treatment correctly and safely, on their adherence to therapy at the beginning of treatment, and on their motivation to continue crucial therapy? These questions are addressed only to a limited extent in this work, as we have focused on the preceding cognitive process of benefit/risk perception

Geneesmiddelengebruik in RVT's

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Development of a complex intervention to support the initiation of advance care planning by general practitioners in patients at risk of deteriorating or dying: a phase 0-1 study

Background: Most patients with life-limiting illnesses are treated and cared for over a long period of time in primary care and guidelines suggest that ACP discussions should be initiated in primary care. However, a practical model to implement ACP in general practice is lacking. Therefore, the objective of this study is to develop an intervention to support the initiation of ACP in general practice. Methods: We conducted a Phase 0-I study according to the Medical Research Council (MRC) Framework. Phase 0 consisted of a systematic literature review about the barriers and facilitators for GPs to engage in ACP, focus groups with GPs were held about their experiences, attitudes and concerns regarding initiating ACP in general practice and a review of ACP interventions to identify potential components for the development of our intervention. In Phase 1, we developed a complex intervention to support the initiation of ACP in general practice in patients at risk of deteriorating or dying, based on the results of Phase 0. The complex intervention and its components were reviewed and refined by two expert panels. Results: Phase 0 resulted in the identification of the factors inhibiting or enabling GPs' initiation of ACP and important components underpinning existing ACP interventions. Based on these findings, an intervention was developed in Phase 1 consisting of: (1) a training for GPs in initiating and conducting ACP discussions, (2) a register of patients eligible for ACP discussions, (3) an educational booklet on ACP for patients to prepare the ACP discussions that includes general information on ACP, a section on the role of GPs in the process of ACP and a prompt list, (4) a conversation guide to support GPs in the ACP discussions and (5) a structured documentation template to record the outcomes of discussions. Conclusion: Taking into account the barriers and facilitators for GPs to initiate ACP as well as the key factors underpinning successful ACP intervention in other health care settings, a complex intervention for general practice was developed, after gaining feedback from two expert panels. The feasibility and acceptability of the intervention will subsequently be tested in a Phase II study

Lost in PubMed: factors influencing the success of medical information retrieval

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How do general practitioners conceptualise advance care planning in their practice? : a qualitative study

Objectives : To explore how GPs conceptualise advance care planning (ACP), based on their experiences with ACP in their practice. Methods : Five focus groups were held with 36 GPs. Discussions were analysed using a constant comparative method. Results : Four overarching themes in the conceptualisations of ACP were discerned: (1) the organisation of professional care required to meet patients' needs, (2) the process of preparing for death and discussing palliative care options, (3) the discussion of care goals and treatment decisions, (4) the completion of advance directives. Within these themes, ACP was both conceptualised in terms of content of ACP and/or in terms of tasks for the GP. A specific task that was mentioned throughout the discussion of the four different themes was (5) the task of actively initiating ACP by the GP versus passively waiting for patients' initiation. Conclusions : This study illustrates that GPs have varying conceptualisations of ACP, of which some are more limited to specific aspects of ACP. A shared conceptualisation and agreement on the purpose and goals of ACP is needed to ensure successful implementation, as well as a systematic integration of ACP in routine practice that could lead to a better uptake of all the important elements of ACP

Silence of the limbs: pharmacological symptomatic treatment of intermittent claudication

Several oral "vasoactive" drugs claim to increase walking capacity in patients with intermittent claudication (IC). Naftidrofuryl, cilostazol, buflomedil, and pentoxifylline are the most studied molecules. Although spanning several decades, several studies underlying these claims were not properly designed, underpowered or showed clinically doubtful outcomes. The evidence for these "vasoactive" drugs has always been received with scepticism, creating the need for systematic reviews and meta-analyses. This brief review discusses the benefit-risk assessment of vasoactive drugs, by applying a systematic review to evaluate randomized, placebo-controlled trials. Oral naftidrofuryl and cilostazol have an acceptable safety profile as well as sustained evidence (documented by Cochrane analyses) of increased walking capacity. Subsequently, these drugs entered recommendations for peripheral arterial disease (PAD). In contrast, buflomedil and pentoxifylline have limited and/or doubtful evidence to increase walking capacity. Moreover, there were safety concerns about the narrow therapeutic range of buflomedil. Most other "vasoactive" drugs were either inappropriately or insufficiently tested or showed no significant if not negative effects on IC. "Vasoactive" drugs are no substitutes for lifestyle or exercise therapy but are adjuvant treatment to the well-appreciated triad of cardiovascular prevention (antiplatelet agents, statins and ACE-inhibitors), of which statins in their own right have documented claims to significantly increase walking capacity. "Vasoactive" drugs may have a place in the pharmacological management of symptomatic PAD in addition to the basic cardiovascular pharmacotherapy, when revascularization is not indicated, when exercise therapy is not feasible or when there is still insufficient benefit

The use of antidepressants in Belgian nursing homes : focus on indications and dosages in the PHEBE study

Background : Since antidepressants are prescribed for multiple indications, the use of an antidepressant cannot be equated with a diagnosis of depression. Objective : The objective of this study was to examine the quality of antidepressant prescribing in Belgian nursing homes, with a critical evaluation of indications and dosages, to see whether depression was appropriately treated in terms of drug choice, the indications for which antidepressants were being prescribed and whether there was underdosing. Methods : This analysis was based on data obtained in the Prescribing in Homes for the Elderly in Belgium (PHEBE) study, a cross-sectional, descriptive study of a representative, stratified, random sample of 1,730 residents from 76 Belgian nursing homes. The PHEBE study investigated overall drug utilization in Belgian nursing homes in 2006. Clinical and medication data for the present study were obtained from this study. A 28-item checklist of clinical conditions was designed ad hoc for the PHEBE study and sent to the residents' general practitioners (GPs) to collect clinical information. We copied the residents' medication charts, classified the drugs using the Anatomical Therapeutic Chemical (ATC) classification system codes and transferred the drug names and dosages into a database. Information on indications was retrospectively obtained from the GPs, so that we could link the indication to each medication. Minimum effective doses (MEDs) of antidepressants to treat major depression were obtained from the literature to assess underdosing. Results : The overall use of antidepressants in nursing homes was 39.5 % (95 % CI 37.2, 41.8). The physicians classified 34.2 % (95 % CI 32.0, 36.4) of the residents as having depression, and 80.9 To of these patients were treated with an antidepressant. Indications among the single antidepressant users (n = 551) were depression (66.2 %), insomnia (13.4 %), anxiety (6.2 %) and neuropathic pain (1.6 %). In the indication of depression, 74.8 % used a selective serotonin reuptake inhibitor (SSRI), predominantly citalopram, sertraline and escitalopram. Venlafaxine was used by 10.7 % of the residents. Dosages for these antidepressants were equal to or higher than the MED. But when trazodone, amitriptyline or mirtazapine were used to treat depression, respectively, 92.3, 55.5 and 44.5 % of prescribed dosages were below the MED. In the indication of insomnia, most of the time, trazodone (90.5 %) or mirtazapine (5.4 %) were used, and in lower dosages than those required for depression treatment (<MED). Tricyclic antidepressants were predominantly used for the treatment of neuropathic pain and were also used at lower dosages. Of all the residents receiving a medication for anxiety, only 13.9 % received an antidepressant (mostly an SSRI), and the remaining received a benzodiazepine. Conclusions : The number one indication for the use of an antidepressant was depression. Within this indication, mostly the recommended SSRIs were used, in dosages equal to or higher than the MED. Furthermore, we noticed that there was substantial use of sedative antidepressants for insomnia and that the physicians preferred to prescribe benzodiazepines over the recommended SSRIs to treat anxiety chronically