bluuebunny/crossref_metadata_2025_split huggingface dataset:
Palifermin: Role in the Prevention of Chemotherapy- and Radiation-Induced Mucositis
Authors: McDonnell Anne M , Lenz Kristi L 
Published: December 2006

Objective: To assess the efficacy, toxicity, and potential cost benefit of palifermin in the prevention of chemotherapy- and radiation-induced mucositis. Data Sources: MEDLINE and PubMed database searches were conducted (1966–May 2006) using the following search terms: palifermin, human keratinocyte growth factor, fibroblast growth factor, mucositis, and stomatitis. Study Selection And Data Extraction: All published clinical trials and abstracts examining the use of palifermin, as well as information from the manufacturer, were included. Data Synthesis: Severe mucositis resulting from anticancer therapies increases healthcare expenditures and negalively impacts patients' quality-of-life. Radiation therapy to the head and neck, as well as stem cell transplant conditioning regimens, have the highest incidence of severe mucositis. Consequences include prolonged hospitalization, need for parenteral nutrition, increased risk of infection, and severe pain. Palifermin is a recombinant human keratinacyte growth factor indicated in patients with hematologic malignancies who are undergoing stem cell transplant. In a randomized, placebo-controlled, Phase III trial, palifermin significantly reduced the incidence and duration of severe mucositis and days of parenteral nutrition and opioid analgesics in patients undergoing autologous stem cell transplant. The most common adverse effects of palifermin were rash, pruritus, cough, and taste alterations. Data in patients with solid tumors are limited, and there is a theoretical risk of stimulating tumor growth. Conclusions: Treatment with palifermin appears to decrease the severity and duration of severe mucositis following autologous stem cell transplant. Use in these patients appears justified: however, use in non-stem cell transplant patients should bo discouraged until more efficacy and toxicity data are available.
Brand Versus Generic Alendronate: Gastrointestinal Effects Measured by Resource Utilization
Authors: Halkin Hillel , Dushenat Marina , Silverman Barbara , Shalev Varda , Loebstein Ronen , Lomnicky Yosef , Friedman Nurit 
Published: December 2006

Background: Adverse reactions related to the upper gastrointestinal tract (UGIT) that are associated with generic alendronate formulations may differ from those associated with the brand drug. Objective: To test the hypothesis that adverse UGIT effects of alendronate formulations may differ between generic and brand products. Methods: We conducted a database health resource utilization analysis of UGIT outcomes in patients who started treatment with generic or brand alendronate formulations during 2001–2005. We included 6962 patients who were treated continuously for 3 months with 1 of 4 alendronate formulations: brand 10 mg/day (Merck, Sharpe & Dohme, n = 1418), generic A 10 mg/day (Teva, Israel, n = 650), generic B 10 mg/day (Unipharm, Israel, n = 628), and brand 70 mg/wk (n = 4266). In these patients, who had neither filled a prescription for alendronate nor had any gastrointestinal problems in the year preceding the study, we compared incidence rates of new use of gastric medications (H2-blockers, proton-pump inhibitors, or antacids), gastroenterology visits, endoscopies, and hospital admissions. Results: Incident rate ratios (IRR) for treatment discontinuation were higher with both daily generic products (IRR 1.3; 95% CI 1.04 to 1.63). Adherence (medication possession ratio [MPR] >80%) was better with brand 10 mg/day (IRR 1.19; 95% CI 1.11 to 1.27). All comparisons were adjusted for use of concurrent corticosteroids, nonsteroidal antiinflammatory drugs, and potassium supplements. Hospitalization rates (2.7-3.2%) were similar in all groups. New use of gastric medications (3.4–4.9%) was lower with brand 10 mg/day (IRR 0.71; 95% CI 0.53 to 0.95). Rates of UGIT endoscopy (n = 49) in patients receiving 10 mg were 0.6% (brand), 1.1% (generic A), and 1.6% (generic B), with generic B higher (IRR 2.88; 95% CI 1.14 to 7.29) in the entire cohort, but not among new users (n = 273) of gastric drugs (IRR 2.46; 95% CI 0.55 to 11.05). Endoscopic findings were normal in 22 patients, hiatal hernia with no mucosal lesion was present in 10 patients, and there was mild-to-moderate esophagitis or gastritis in 17 patients; there were no significant differences among the formulations. Conclusions: We found insufficient evidence to indicate major differences in UGIT adverse effects related to use of daily generic, as compared with brand, alendronates.
Oral Varenicline for Smoking Cessation
Authors: Zierler-Brown Seena L , Kyle Jeffrey A 
Published: December 2006

Objective: To review the pharmacology, pharmacokinetics, efficacy, and safety of varenicline and provide a review of relevant clinical data. Data Sources: A MEDLINE search (2001–December 2006) was conducted using the key words varenicline and nicotine replacement therapy for clinical trials limited to human subjects and published in English. Study Selection And Data Extraction: All available human trials of varenicline were selected for review. References cited in identified articles were used for additional citations. Data Synthesis: Varenicline selectively targets the α4β2 nicotine receptors in the brain that are responsible for cravings and withdrawal associated with nicotine use and dependence. Maximal plasma concentration occurs within 3–4 hours after administration and, after multiple doses, a steady-state concentration is reached within 4 days. Varenicline has a half-life of 24 hours. Oral bioavailability is not affected by food or time of administration. It exhibits linear pharmacokinetics and tow plasma protein binding (≤20%) regardless of a patient's age and renal status. It can be administered once daily. Dosage adjustments are not required in patients with hepatic insufficiency, but adjustments may be necessary in patients with severe renal insufficiency. Clinically significant drug–drug interactions have not been observed with varenicline or co-inhibitors of the human organic cation transporter, which mediates renal secretion of varenicline. Substrates such as warfarin, digoxin, cimetidine, metformin, bupropion, and transdermal nicotine do not alter pharmacokinetic parameters when coadministered with varenicline. In vitro studies have not demonstrated alterations in cytochrome P450 enzyme parameters. Varenicline's safety with coadministration of nicotine replacement products has not been well established. Conclusions: Varenicline is an effective oral agent for smoking cessation.
Botulinum Toxin a in the Treatment of Sialorrhea
Authors: Benson Jennifer , Daugherty Kimberly K 
Published: December 2006

Objective: To review the efficacy and safety of botulinum toxin A (BTX) in the treatment of sialorrhea. Data Sources: A PubMed search and reference list review was performed to find clinical trials on BTX in the treatment of sialorrhea. The search was limited to English-language trials involving human subjects. Articles from 1965 to October 2006 were searched, using key words botulinum, botulinum toxin, Botox, sialorrhea, saliva, salivary gland, and drooling. Study Selection And Data Extraction: Reports of 15 studies were found on BTX in the treatment of sialorrhea in human subjects. Four controlled trials are presented in detail, and 11 uncontrolled studies are summarized. Data Synthesis: One controlled trial found that BTX caused significant reductions in patients' severity and frequency of drooling compared with placebo. Another found significant saliva reductions in the treatment group receiving the highest dose of BTX but found no subjective improvement compared with the placebo group. A third study comparing BTX with placebo found significant improvements in subjective and objective measures of drooling in the treatment group. A fourth controlled trial found significant reductions from baseline levels of drooling after patients received BTX injections. Similar efficacy was found between the BTX and scopolamine treatment groups. Conclusions: Evidence indicates that BTX is a safe and effective treatment for sialorrhea. More research is needed to determine the ideal dose, injection location, and technique of BTX injections.
A Commentary on Psychosocial Interventions and Evidence-Based Practice: Time for Reflection About What an ‘Ideal’ Psychosocial Intervention Would Look Like in Clinical Psychology?
Authors: King Neville J. , Ollendick Thomas H. 
Published: December 2006

AbstractControlled efficacy/effectiveness trials throughout the world have reached a high standard from a methodological stance, but what do we regard as the ideal or elegant intervention in clinical psychology? This article presents six key points as the gold standards of psychosocial interventions by which treatment efficacy/effectiveness research with children, adolescents and adults might be evaluated: (1) theoretical rationale and conceptualisation of clinical dysfunction, (2) clear problem identification and target client group, (3) program features such as realistic goal setting, flexibility, and time-limited interventions, (4) manual-based treatments, (5) research support including clinically significant outcomes, and (6) acceptability/social validation of clients and society. Finally, we discuss the usefulness of such a framework for mental health professionals and clinical researchers.
Rumination and Experiential Avoidance in Depression
Authors: Cribb Gemille , Moulds Michelle L. , Carter Sally 
Published: December 2006

AbstractRecent investigations have demonstrated a renewed interest in the role of avoidance in depression; however, little is known of which specific forms of avoidance — cognitive, behavioural or experiential — are important in this context. This study examined (a) the relationship between depression, rumination and these subtypes of avoidance, and (b) the proposal that the abstract/analytical nature of ruminative thought is linked to experiential avoidance. A nonclinical sample (N = 101) of undergraduate students completed self-report measures of depression, rumination, avoidance and mood state and viewed a low mood emotion-eliciting video stimulus. Participants' written summary of the film clip was independently rated for the degree to which it was abstract or concrete. Rumination, depression and cognitive, behavioural and experiential avoidance were all significantly correlated and remained so when anxiety was controlled. Further, reduced concreteness of description of the film clip was associated with experiential avoidance and rumination. Taken together, the findings underscore the value of clinicians being attentive to experiential avoidance in the assessment and treatment of depression.
The Effects of Diagnostic Labelling on the Implicit Theories of Attention-Deficit/Hyperactivity Disorder Held by Health Professionals
Authors: Dryer Rachel , Kiernan Michael J. , Tyson Graham A. 
Published: December 2006

AbstractAttention-deficit/hyperactivity disorder (ADHD) is the most recent diagnostic label used to describe a behavioural condition of which the essential features are developmentally inappropriate levels of inattention, impulsivity and overactivity. ADHD has attracted both controversy and attention from the professional and scientific community. However, little is known regarding the explanatory models (implicit theories) of health professionals or of their beliefs regarding the treatment of this condition, specifically the impact of diagnostic labelling on their decisions concerning treatment. This study manipulated the presence versus absence of the diagnostic label ‘ADHD’ in a vignette study describing the symptoms of this condition. The vignette was presented to professionals in the educational, mental health and allied health fields. After reading the vignette, participants were required to complete a questionnaire examining implicit beliefs concerning ADHD. The results confirmed that the presence of the diagnostic label (ADHD) changed the causal explanations by professional groups. However, the presence of the diagnostic label did not significantly change the beliefs about the optimal treatment strategy for this condition.
Deliberate Self-Harm: Have We Scratched the Surface?
Authors: Cumming Steve , Covic Tanya , Murrell Elizabeth 
Published: December 2006

AbstractThis article presents the current state of knowledge in deliberate-self harm (DSH). DSH presents as a comorbidity with a number of personality disorders and psychopathologies, but is also relatively common in the psychologically healthy population. Over the past 10 years, attention has shifted from the investigation of DSH as a cardinal or comorbid symptom of psychopathology to an attempt to understand the behaviour itself, without reference to other psychopathological processes. It is argued that this development in understanding the aetiology of DSH has not been matched by developments in treatment or management of DSH, with the majority of treatment programs targeting larger syndromes of which DSH is a symptom. Treatment regimes aimed at reducing DSH appear to be either untested or demonstrably unsuccessful.
Manualised Cognitive–Behavioural Therapy in the Intensive Treatment of Adolescent Obsessive–Compulsive Disorder
Authors: Savva Danay , Rees Clare 
Published: December 2006

AbstractThis article offers a preliminary investigation of the delivery of an intensive version of manualised cognitive–behavioural therapy for adolescent obsessive–compulsive disorder (OCD). The aim was to address issues of treatment accessibility within the area, including a shortage of therapists who feel competent and possess the expertise to successfully deliver these protocols. Two male adolescents, with a principal diagnosis of OCD, participated in eight weekly 150-minute sessions. A series of diagnostic, symptom severity, global functioning, and self-report measures were completed at pretreatment, across treatment weeks, at posttreatment, and at 6-week follow-up. Further, monitoring of multiple baselines across behaviours for each adolescent across treatment weeks served to extend results beyond mere end points. Process issues specific to each adolescent, his family, and the therapeutic relationship were considered. Along with the overall outcome results, such information aimed to provide useful data for clinicians interested in implementing the program. Reductions in OCD symptomology and symptom severity for both participants at posttreatment and at 6-week follow-up suggest that an intensive format of treatment delivery might benefit some adolescents.
Effect of Orlistat on Weight Regain and Cardiovascular Risk Factors Following a Very-Low-Energy Diet in Abdominally Obese Patients
Authors: Richelsen Bjørn , Tonstad Serena , Rössner Stephan , Toubro Søren , Niskanen Leo , Madsbad Steen , Mustajoki Pertti , Rissanen Aila 
Published: December 2006

OBJECTIVE—To investigate the efficacy of orlistat on the maintenance of weight loss over 3 years following a major weight loss induced by very-low-energy diet (VLED) in obese patients with metabolic risk factors such as dyslipidemia, impaired fasting glucose, and diet-treated type 2 diabetes.
RESEARCH DESIGN AND METHODS—Initially, weight loss was induced by an 8-week VLED (600–800 kcal/day) in 383 patients with a mean BMI of 37.5 kg/m2 (range 30.0–45.2). Those who lost ≥5% of their body weight (309 of 383 patients) were then randomized to receive lifestyle counseling for 3 years together with either orlistat 120 mg t.i.d. or matching placebo capsules. Primary end points were the maintenance of ≥5% weight loss after 3 years. Additionally, differences in the development of type 2 diabetes between orlistat and placebo were analyzed.
RESULTS—The VLED induced a mean weight loss of 14.4 ± 2..0 kg among the subsequently randomized patients. The mean weight gain after 3 years was lower with orlistat than with placebo (4.6 ± 8.6 vs. 7.0 ± 7.1 kg; P &lt; 0.02). The number of participants who achieved ≥5% weight loss also favored orlistat (67 vs. 56%; P = 0.037). Waist circumference was significantly more reduced in the orlistat group (P &lt; 0.05), but no other differences in the risk factors were observed between the two groups. The incidences of new cases of type 2 diabetes were significantly reduced in the orlistat group (8 cases out of 153 subjects) versus placebo (17 cases out of 156 subjects) (P = 0.041).
CONCLUSIONS—The addition of orlistat to lifestyle intervention was associated with maintenance of an extra 2.4 kg weight loss after VLED for up to 3 years in obese subjects. The combination of orlistat and lifestyle intervention was associated with a reduced occurrence of type 2 diabetes.
Minimum Waist and Visceral Fat Values for Identifying Japanese Americans at Risk for the Metabolic Syndrome
Authors: Hayashi Tomoshige , Boyko Edward J. , McNeely Marguerite J. , Leonetti Donna L. , Kahn Steven E. , Fujimoto Wilfred Y. 
Published: December 2006

OBJECTIVE—Japanese American is an ethnic group with a high risk for type 2 diabetes, which is linked to the metabolic syndrome. Central adiposity is considered to play a key role in the metabolic syndrome. Not known are the optimal cut point values for central and visceral adiposity to identify Japanese Americans at risk for the metabolic syndrome.
RESEARCH DESIGN AND METHODS—Study subjects included 639 Japanese Americans. The nonadipose variables of the metabolic syndrome were defined using modified International Diabetes Federation criteria, and the accuracy of identifying at least two of these by intra-abdominal fat area (IAFA) as measured by computed tomography and waist circumference was cross-sectionally assessed using area under receiver operating characteristic (ROC) curves. The values for IAFA and waist circumference that resulted in maximizing the Youden index were defined as “optimal.”
RESULTS—The area under the ROC curve for IAFA exceeded that for waist circumference (men 0.787 vs. 0.686; women 0.792 vs. 0.721). For women, the optimal cut points for IAFA and waist circumference were 51.5 cm2 and 80.8 cm (age ≤56 years) and 86.3 cm2 and 89.0 cm (age &gt;56 years). For men, the optimal cut points for IAFA and waist circumference were 88.6 cm2 and 90.0 cm (age ≤57 years) and 96.1 cm2 and 87.1 cm (age &gt;57 years).
CONCLUSIONS—These results argue that current Japanese waist circumference cut points for the metabolic syndrome need to be revised. Moreover, the waist circumference and IAFA cut points should be age specific, especially in women. Appropriate waist circumference cut points are from 80 to 90 cm in women and from 87 to 90 cm in men.
Autonomic Nerve Testing Predicts the Development of Complications
Authors: Maguire Ann M. , Craig Maria E. , Craighead Anne , Chan Albert K.F. , Cusumano Janine M. , Hing Stephen J. , Silink Martin , Howard Neville J. , Donaghue Kim C. 
Published: December 2006

OBJECTIVE—Cardiac autonomic nerve tests have predicted increased mortality in adults with diabetes, predominantly due to nephropathy, cardiac disease, and hypoglycemia. The significance of subclinical autonomic nerve test abnormalities has not been systematically studied in adolescents. We aimed to reassess an adolescent cohort, whose autonomic nervous system had been tested 12 years earlier by both pupillometry and cardiovascular tests.
RESEARCH DESIGN AND METHODS—From 1990 to 1993, adolescents with type 1 diabetes (n = 335) were assessed for autonomic neuropathy (median age 14.7 years [interquartile range 13.0–16.8], duration of diabetes 6.3 years [4.0–9.6], and A1C 8.3% [7.5–9.4]). Between 2003 and 2005, contact was made with 59% of the original group. Individual assessment 12 years later included completion of a validated hypoglycemia unawareness questionnaire (n = 123) and urinary albumin-to-creatinine ratio (n = 99) and retinal (n = 102) screening, as well as analysis of reports from external doctors (n = 35).
RESULTS—At baseline, there was no difference in age, duration of diabetes, or complications between those who participated in the follow-up phase (n = 137) and those who did not participate (n = 196). However, baseline A1C was lower in the follow-up participants (8.2 vs. 8.5% for participants vs. nonparticipants, respectively, P = 0.031). At 12 years of follow-up, 93% were aware and 7% were unaware that they had hypoglycemia; 32 (31%) had no retinopathy, but 10% required laser therapy, and 80 (81%) had no microalbuminuria. Small pupil size at baseline was independently associated with the development of microalbuminuria (odds ratio 4.36 [95% CI 1.32–14.42], P = 0.016) and retinopathy (4.83 [1.3–17.98], P = 0.019) but not with the development of hypoglycemia unawareness. There was no association with baseline cardiovascular tests and the development of complications 12 years later.
CONCLUSIONS—In this study, we found an association between baseline pupillometry tests and the presence of microalbuminuria and retinopathy at 12 years of follow-up. This suggests that pupillometry abnormalities may be early indicators of patients who are at high risk of future microvascular disease.
Rosiglitazone in Diabetes Control in Hemodialysis Patients With and Without Viral Hepatitis Infection
Authors: Chiang Chih-Kang , Ho Tai-I. , Peng Yu-Sen , Hsu Shih-Ping , Pai Mei-Fen , Yang Shao-Yu , Hung Kuan-Yu , Wu Kwan-Dun 
Published: December 2006

OBJECTIVE— Thiazolidinedione (TZD) may provide an additional benefit of cardiovascular protection in diabetic patients through targeting of insulin resistance. However, use of a TZD is hampered by possible effects of fluid retention and hepatotoxicity. In this study we aimed to determine whether the risk of TZD-induced fluid retention or hepatic injury is higher in hemodialysis patients with persistent viral hepatitis infection.
RESEARCH DESIGN AND METHODS—This was a prospective, cohort study on hemodialysis patients. Type 2 diabetic patients with A1C levels of &gt;8% were followed for at least 12 months. Rosiglitazone was initiated at 2–4 mg/day. The primary outcome was the target A1C (&lt;7%) achieved and dosages of rosiglitazone. Secondary outcomes included changes in lipid profile and inflammatory biomarkers. Safety evaluations were number of hypoglycemic episodes, changes in liver transaminase levels, cardiothoracic ratio (CTR), fluid status control during dialysis, and events of symptomatic heart failure.
RESULTS—A total of 78 patients, including 15.4% (n = 12) hepatitis B surface antigen–positive and 16.7% (n = 13) anti–hepatis C virus (HCV)-positive patients, were enrolled. The mean follow-up period was 15.4 ± 3.8 months. The diabetic response rate (A1C &lt;7%) to rosiglitazone was 86.1%. The serum triglyceride level was reduced (194 ± 112.5 to 168 ± 88 mg/dl, P = 0.037) more significantly than the total cholesterol level (178 ± 42.1 to 174 ± 46.5 mg/dl, P = 0.13). High-dose rosiglitazone (8 mg/day) reduced the serum level of C-reactive protein and increased the serum adiponectin level significantly. After rosiglitazone, interdialysis weight gain (2.07 ± 1.6 to 3.2 ± 1.2 kg, P &lt; 0.01) and mean CTR (48.2 ± 5.6 to 50.4 ± 6.2%, P = 0.0213) of individuals increased significantly. Nevertheless, liver aminotransferase (aspartate aminotransferase and alanine aminotransferase) levels did not show a tendency to increase in patients (n = 25) with viral hepatitis B or C infections.
CONCLUSIONS—Among regular hemodialysis patients with chronic viral hepatitis infections, rosiglitazone may be safely used for diabetes control. However, one must be aware that a possible effect of its use is a deterioration in cardiovascular reserve.