bluuebunny/crossref_metadata_2025_split huggingface dataset:
Transdermal fentanyl for the treatment of pain caused by osteoarthritis of the knee or hip: an open, multicentre study
Authors: Le Loët Xavier , Pavelka Karel , Richarz Ute 
Published: June 2005

Abstract
Background
This study was designed to evaluate the utility of transdermal fentanyl (TDF, Durogesic®) for the treatment of pain due to osteoarthritis (OA) of the knee or hip, which was not adequately controlled by non-opioid analgesics or weak opioids. The second part of the trial, investigating TDF in patients with rheumatoid arthritis (RA) is reported separately.

Methods
Current analgesia was optimised during a 1-week run-in. Patients then received 28 days treatment with TDF starting at 25 μg/hr, with the option to increase the dose until adequate pain control was achieved. Metoclopramide was taken during the first week and then as needed.

Results
Of the 159 patients recruited, 75 with OA knee and 44 with OA hip completed the treatment phase, 30 knee and 18 hip patients entered the one-week taper-off phase. The most frequently used maximum dose of TDF was 25 μg/hr. The number of patients with adequate pain control increased during the run-in period from 4% to 27%, and further increased during TDF treatment to 88% on day 28. From baseline to endpoint, there were significant reductions in pain (p < 0.001) and improvements in functioning (p < 0.001) and physical (p < 0.001) and mental (p < 0.05) health. Scores for 'pain right now' decreased significantly within 24 hours of starting TDF treatment. TDF was assessed favourably and 84% of patients would recommend it for OA-related pain. Nausea and vomiting were the most common adverse events (reported by 32% and 26% of patients respectively), despite prophylaxis with metoclopramide, which showed limited efficacy in this setting.

Conclusion
TDF significantly increased pain control, and improved functioning and quality of life. Metoclopramide appeared to be of limited value in preventing nausea and vomiting; more effective anti-emetic treatment may enable more people to benefit from strong opioids such as TDF. This study suggests that four weeks is a reasonable period to test the benefit of adding TDF to improve pain control in OA patients and that discontinuing therapy in cases of limited benefit creates no major obstacles.
A survey of training and practice patterns of massage therapists in two US states
Authors: Sherman Karen J , Cherkin Daniel C , Kahn Janet , Erro Janet , Hrbek Andrea , Deyo Richard A , Eisenberg David M 
Published: June 2005

Abstract

Background
Despite the growing popularity of therapeutic massage in the US, little is known about the training or practice characteristics of massage therapists. The objective of this study was to describe these characteristics.

Methods
As part of a study of random samples of complementary and alternative medicine (CAM) practitioners, we interviewed 226 massage therapists licensed in Connecticut and Washington state by telephone in 1998 and 1999 (85% of those contacted) and then asked a sample of them to record information on 20 consecutive visits to their practices (total of 2005 consecutive visits).

Results
Most massage therapists were women (85%), white (95%), and had completed some continuing education training (79% in Connecticut and 52% in Washington). They treated a limited number of conditions, most commonly musculoskeletal (59% and 63%) (especially back, neck, and shoulder problems), wellness care (20% and 19%), and psychological complaints (9% and 6%) (especially anxiety and depression). Practitioners commonly used one or more assessment techniques (67% and 74%) and gave a massage emphasizing Swedish (81% and 77%), deep tissue (63% and 65%), and trigger/pressure point techniques (52% and 46%). Self-care recommendations, including increasing water intake, body awareness, and specific forms of movement, were made as part of more than 80% of visits. Although most patients self-referred to massage, more than one-quarter were receiving concomitant care for the same problem from a physician. Massage therapists rarely communicated with these physicians.

Conclusion
This study provides new information about licensed massage therapists that should be useful to physicians and other healthcare providers interested in learning about massage therapy in order to advise their patients about this popular CAM therapy.
Response shift and glycemic control in children with diabetes
Authors: Wagner Julie A 
Published: June 2005

Abstract

Background
The purpose of this study was to investigate the scale recalibration construct of response shift and its relationship to glycemic control in children with diabetes.

Methods
At year 1, thirty-eight children with type 1 diabetes attending a diabetes summer camp participated. At baseline and post-camp they completed the Problem Areas in Diabetes (PAID) questionnaire. Post-camp, the PAID was also completed using the 'thentest' method, which requires a retrospective judgment about their baseline functioning. At year 2, fifteen of the original participants reported their HbA1c.

Results
PAID scores significantly decreased from baseline to post-camp. An even larger difference was found between thentest and post-camp scores, suggesting scale recalibration. There was a significant positive correlation between year 1 HbA1c and thentest scores. Partial correlation analysis between PAID thentest scores and year 2 HbA1c, controlling for year 1 HbA1c, showed that higher PAID thentest scores were associated with higher year 2 HbA1c.

Conclusion
Results from this small sample suggest that children with diabetes do show scale recalibration, and that it may be related to glycemic control.
Contribution of anaerobic energy expenditure to whole body thermogenesis
Authors: Scott Christopher B 
Published: June 2005

Abstract
Heat production serves as the standard measurement for the determination of energy expenditure and efficiency in animals. Estimations of metabolic heat production have traditionally focused on gas exchange (oxygen uptake and carbon dioxide production) although direct heat measurements may include an anaerobic component particularly when carbohydrate is oxidized. Stoichiometric interpretations of the ratio of carbon dioxide production to oxygen uptake suggest that both anaerobic and aerobic heat production and, by inference, all energy expenditure – can be accounted for with a measurement of oxygen uptake as 21.1 kJ per liter of oxygen. This manuscript incorporates contemporary bioenergetic interpretations of anaerobic and aerobic ATP turnover to promote the independence of these disparate types of metabolic energy transfer: each has different reactants and products, uses dissimilar enzymes, involves different types of biochemical reactions, takes place in separate cellular compartments, exploits different types of gradients and ultimately each operates with distinct efficiency. The 21.1 kJ per liter of oxygen for carbohydrate oxidation includes a small anaerobic heat component as part of anaerobic energy transfer. Faster rates of ATP turnover that exceed mitochondrial respiration and that are supported by rapid glycolytic phosphorylation with lactate production result in heat production that is independent of oxygen uptake. Simultaneous direct and indirect calorimetry has revealed that this anaerobic heat does not disappear when lactate is later oxidized and so oxygen uptake does not adequately measure anaerobic efficiency or energy expenditure (as was suggested by the "oxygen debt" hypothesis). An estimate of anaerobic energy transfer supplements the measurement of oxygen uptake and may improve the interpretation of whole-body energy expenditure.
Hodgkin's Lymphoma in Elderly Patients: A Comprehensive Retrospective Analysis From the German Hodgkin's Study Group
Authors: Engert Andreas , Ballova Veronika , Haverkamp Heinz , Pfistner Beate , Josting Andreas , Dühmke Eckhart , Müller-Hermelink Konrad , Diehl Volker 
Published: June 2005

Purpose With improved prognosis for patients with Hodgkin's lymphoma (HL), interest increasingly focuses on high-risk groups such as elderly patients. We thus performed a retrospective analysis using the German Hodgkin's Study Group (GHSG) database to determine clinical risk factors, course of treatment, and outcome in elderly HL patients in comparison with younger adults. Patients and Methods A total of 4,251 patients included in the GHSG studies HD5 to HD9 were analyzed, of whom 372 (8.8%) were 60 years or older and 3,879 (91.2%) were younger than 60 years. Patient characteristics, treatment results, toxicity, freedom from treatment failure (FFTF), and overall survival (OS) were compared. Results Elderly patients more often had mixed cellularity subtype, “B” symptoms, elevated erythrocyte sedimentation rate, and poorer performance status. Less frequently observed were nodular sclerosis subtype, large mediastinal mass, and bulky disease. Acute toxicity during chemotherapy was generally higher in elderly patients. This was most obvious for severe infections (grade 3 or 4; 15% v 6%) correlating with more severe leukopenia in elderly patients (grade 4; 38% v 23%). As a result, significantly fewer elderly patients received the intended full chemotherapy dose (75% v 91%). The survival analysis showed a significantly poorer treatment outcome for elderly patients in terms of 5-year OS (65% v 90%), FFTF (60% v 80%), and HL-specific FFTF (73% v 82%). Conclusion Elderly patients have a poorer risk profile compared with younger HL patients and experience more severe treatment-associated toxicity. Higher mortality during treatment as well as lower dose-intensity are the major factors explaining the poorer overall outcome of elderly HL patients.
Phase I Safety, Pharmacokinetics, and Clinical Activity Study of Lapatinib (GW572016), a Reversible Dual Inhibitor of Epidermal Growth Factor Receptor Tyrosine Kinases, in Heavily Pretreated Patients With Metastatic Carcinomas
Authors: Burris Howard A. , Hurwitz Herbert I. , Dees E. Claire , Dowlati Afshin , Blackwell Kimberly L. , O'Neil Bert , Marcom Paul K. , Ellis Matthew J. , Overmoyer Beth , Jones Suzanne F. , Harris Jennifer L. , Smith Deborah A. , Koch Kevin M. , Stead Andrew , Mangum Steve , Spector Neil L. 
Published: June 2005

Purpose This study ( EGF10004 ) assessed the safety/tolerability, pharmacokinetics, and clinical activity of daily oral dosing with lapatinib ( GW572016 ) in patients with ErbB1-expressing and/or ErbB2-overexpressing advanced-stage refractory solid tumors. Patients and Methods Heavily pretreated patients with ErbB1-expressing and/or ErbB2-overexpressing metastatic cancers were randomly assigned to one of five dose cohorts of lapatinib administered once daily. Pharmacokinetic samples were obtained on days 1 and 20. Clinical response was assessed every 8 weeks. Results Sixty-seven patients with metastatic solid tumors were treated with lapatinib. The most frequently reported drug-related adverse events were diarrhea (42%) and rash (31%). No grade 4 drug-related adverse events were reported. Five grade 3 drug-related toxicities (gastrointestinal events and rash) were experienced by four patients. Drug-related interstitial pneumonitis or cardiac dysfunction associated with other ErbB-targeted therapies was not reported. Four patients with trastuzumab-resistant metastatic breast cancer—two of whom were classified as having inflammatory breast cancer—had partial responses (PRs). Twenty-four patients with various other carcinomas experienced stable disease, of whom 10 received lapatinib for ≥ 6 months. The relationships between lapatinib dose or serum concentration and clinical response could not be adequately characterized due to the limited response data. The incidence of diarrhea increased with increasing dose, whereas the incidence of rash was not related to dose. Conclusion Lapatinib was well tolerated at doses ranging from 500 to 1,600 mg once daily. Clinical activity was observed in heavily pretreated patients with ErbB1-expressing and/or ErbB2-overexpressing metastatic cancers, including four PRs in patients with trastuzumab-resistant breast cancers and prolonged stable disease in 10 patients.
FDA Policy on Unapproved Drug Products: Past, Present, and Future
Authors: Chhabra Renu , Kremzner Mary E , Kiliany Brenda J 
Published: June 2005

OBJECTIVE To review the history of drug regulation by the Food and Drug Administration (FDA) as it relates to unapproved drugs and FDA policy, along with the FDA's efforts to avoid future incidents by amending and enforcing those policies that are already in place. DATA SOURCES Data from FDA history documents, FDA guidances, Code of Federal Regulations Title 21, and presentations by the FDA's Office of Compliance were gathered. STUDY SELECTION AND DATA EXTRACTION All information identified from the data sources was evaluated, and all information deemed relevant was included for this review. DATA SYNTHESIS Contrary to popular belief, there are drugs on the market that have not been evaluated for safety or efficacy by the FDA. For almost a century, the FDA has taken action against public health threats posed by unapproved drug products, and today's drugs and vaccines are required to demonstrate both safety and efficacy prior to marketing. The FDA has taken great strides to ensure the welfare of Americans by reacting to disasters that have occurred in the past and being proactive by setting regulations that will prevent such catastrophes from occurring in the future. CONCLUSIONS The FDA recognizes that drug regulation is an ongoing process and that, although we have come a long way, there is still much to be done.
Intentional and Unintentional Nonadherence to Antihypertensive Medication
Authors: Lowry Kathryn P , Dudley Tara K , Oddone Eugene Z , Bosworth Hayden B 
Published: June 2005

BACKGROUND Hypertension is poorly controlled in the US due to medication nonadherence. Recent evidence suggests that nonadherence can be classified as intentional or unintentional and different patient characteristics, such as the experience of adverse effects, may be associated with each. OBJECTIVE To examine associations between patient characteristics, including reported adverse effects, and both intentional and unintentional nonadherence among 588 hypertensive patients. METHODS Baseline data from a clinical trial, the Veterans' Study To Improve the Control of Hypertension, were examined. Intentional and unintentional nonadherence were assessed using a self-report measure. Participants were presented with a list of adverse effects commonly associated with antihypertensive medication and asked to indicate which symptoms they had experienced. Logistic regression analyses were used to examine adjusted associations between patient characteristics and type of nonadherence. RESULTS Approximately 31% of patients reported unintentional nonadherence and 9% reported intentional nonadherence. Non-white participants, individuals without diabetes mellitus, and individuals reporting ≥5 adverse effects were more likely to report intentional nonadherence than their counterparts. Individuals with less than a 10th-grade education and non-white participants were more likely to report unintentional nonadherence than their counterparts. When symptoms of increased urination and wheezing/shortness of breath were reported, patients were more likely to report intentional and unintentional nonadherence compared with those who were adherent. Unintentional nonadherence was also associated with reports of dizziness and rapid pulse. CONCLUSIONS Both intentional and unintentional nonadherence are common and related to perceived adverse effects. Furthermore, different interventions may be necessary to improve adherence in unintentionally and intentionally nonadherent patients.
Effect of Cyclobenzaprine on Tricyclic Antidepressant Assays
Authors: Van Hoey Nicole M 
Published: June 2005

OBJECTIVE To evaluate cyclobenzaprine interference on tricyclic antidepressant assays. DATA SOURCES Literature was identified through a MEDLINE search (1966–August 2004) using the search terms cyclobenzaprine, tricyclic antidepressant, toxicology, and assay. DATA SYNTHESIS Cyclobenzaprine is structurally similar to tricyclic antidepressants and is often identified as a tricyclic antidepressant on toxicology assays. Older chromatographic assays demonstrate retention time differences of only seconds and nearly identical color stains between cyclobenzaprine and individual tricyclic antidepressants. In comparison, ultraviolet absorption ratios of 4.18 for amitriptyline and 1.85 for cyclobenzaprine are easily distinguished. Spectroscopy also consistently identifies cyclobenzaprine's unique mass-to-charge ratio peaks of 275 and 215 compared with those of amitriptyline. Available bioanalytic techniques are reviewed for their ability to correctly identify cyclobenzaprine and differentiate the drug from tricyclic antidepressants. CONCLUSIONS When assays are positive for tricyclic antidepressants without a history of their use, an attempt should be made to identify confounders, such as cyclobenzaprine. Newer bioanalytic techniques, such as ultraviolet absorption and mass spectroscopy, accurately identify cyclobenzaprine in such instances.
Relative Thromboembolic Risks Associated with COX-2 Inhibitors
Authors: Jones S Christopher 
Published: June 2005

OBJECTIVE To evaluate the clinical literature on cyclooxygenase-2 (COX-2) inhibitors to determine whether a greater incidence of thromboembolic events is universal within the drug class. DATA SOURCES A MEDLINE search was conducted (1996–March 2005) for key articles in the English language assessing the efficacy or safety of these agents. STUDY SELECTION AND DATA EXTRACTION Randomized, double-blind, and controlled trials, as well as case–control and retrospective cohort studies, that assessed the cardiovascular safety of COX-2 inhibitors were reviewed. DATA SYNTHESIS Seventeen published studies were reviewed, and the cardiovascular safety data were extracted from each trial. The mechanism by which COX-2 inhibitors may induce a thromboembolic event is likely multifactorial involving (1) COX-2–specific isoform binding affinity, (2) drug dose, (3) duration of therapy, and (4) cardiovascular risk profile of the patient. Evidence supports an association between cardiovascular adverse events and the use of rofecoxib, valdecoxib, and celecoxib. However, this risk is not equally distributed among the drugs. Given the relative paucity of data, lumiracoxib and etoricoxib cardiovascular effects remain uncertain. CONCLUSIONS Each COX-2 inhibitor has a unique cardiovascular risk profile. Based on the current evidence, celecoxib is the safest COX-2 inhibitor when prescribed appropriately in the lowest possible dose for the shortest duration in the ideal target population.
Evidence-Based Practice by Pharmacists: Utilization and Barriers
Authors: Burkiewicz Jill S , Zgarrick David P 
Published: June 2005

BACKGROUND Evidence-based medicine (EBM) is the use of the current best evidence from research to make practice and policy decisions. Little is known regarding the attitudes of pharmacists toward EBM. OBJECTIVE To determine the attitudes of pharmacists toward EBM, the extent that pharmacists use evidence to make decisions, and identify barriers to the use of evidence. METHODS A self-administered questionnaire was mailed to 2000 randomly selected Illinois licensed pharmacists. The questionnaire assessed the pharmacists' attitudes toward EBM, the extent to which recommendations are based on primary and tertiary literature, and perceived barriers to the use of EBM. RESULTS Completed responses were received from 323 pharmacists (17.2% response rate). Overall, respondents had positive attitudes toward EBM (58% positive, 32% somewhat positive). Respondents thought research findings were useful (42%) or very useful (42%) to daily practice. Nearly one-half (49.8%) of respondents had conducted a primary literature search within the past year. Hospital pharmacists and pharmacists in other practice settings were more likely than community pharmacists to conduct a literature search in the past year (75%, 61%, and 30%, respectively; p < 0.001). Although 86% of respondents reported having Internet access at home, only 42% of all respondents identified that they had PubMed access at home. Common barriers to the use of EBM include lack of time (45%), physician attitudes toward pharmacist recommendations (19%), and access to resources (11%). CONCLUSIONS Pharmacist respondents have positive attitudes toward EBM and the application of research findings to practice.
Acute Liver Failure with Renal Impairment Related to the Abuse of Senna Anthraquinone Glycosides
Authors: Vanderperren Bénédicte , Rizzo Michela , Angenot Luc , Haufroid Vincent , Jadoul Michel , Hantson Philippe 
Published: June 2005

OBJECTIVE To report a case of chronic ingestion of very large amounts of senna fruits as an herbal tea, possibly leading to severe hepatotoxicity. CASE SUMMARY A 52-year-old woman who had ingested, for >3 years, one liter of an herbal tea each day made from a bag containing 70 g of dry senna fruits, developed acute hepatic failure and renal impairment requiring intensive care therapy. The severity of the hepatic failure was reflected by the increase in prothrombin time (international normalized ratio >7) and the development of encephalopathy. Liver transplantation was discussed, but the patient ultimately recovered with supportive therapy. Renal impairment was consistent with proximal tubular acidosis, also with marked polyuria refractory to vasopressin administration. Suprisingly, large amounts of cadmium were transiently recovered in the urine. DISCUSSION Cassia acutifolia and angustifolia plants are widely used as laxatives. Their chronic abuse may be associated with serious manifestations, including fluid and electrolyte loss, with chronic diarrhea. Severe hepatotoxicity is unusual, but could be explained by the exposure of the liver to unusual amounts of toxic metabolites of anthraquinone glycosides (sennosides). An objective causality assessment suggests that hepatotoxicity was possibly related to senna laxative abuse. Regarding nephrotoxicity, there are no available human data on sennosides, while experimental models suggest that anthraquinone derivatives may also accumulate in the kidneys. The finding of high urinary concentrations of cadmium would suggest contamination of the herbal tea by metals, but this hypothesis could not be verified. CONCLUSIONS Ingestion of large doses of senna laxatives may expose people to the risk of hepatotoxicity.