Sum Of Symptoms Research Articles

Pathophysiology of Heart Failure.

Heart failure is considered an epidemic disease in the modern world affecting approximately 1% to 2% of adult population. It presents a multifactorial, systemic disease, in which--after cardiac injury--structural, neurohumoral, cellular, and molecular mechanisms are activated and act as a network to maintain physiological functioning. These coordinated, complex processes lead to excessive volume overload, increased sympathetic activity, circulation redistribution, and result in different, parallel developing clinical signs and symptoms. These signs and symptoms sum up to an unspecific clinical picture; thus invasive and noninvasive diagnostic tools are used to get an accurate diagnosis and to specify the underlying cause. The most important, outcome determining factor in heart failure is its constant progression. Constant optimizing of pharmatherapeutical regimes, novel targets, and fine regulation of these processes try to keep these compensatory mechanisms in a physiological range. Beside pharmacological therapy, interventional and surgical therapy options give new chances in the management of heart failure. For the optimization and establishment of these and novel therapeutical approaches, complete and comprehensive understanding of the underlying mechanisms is essentially needed. Besides diagnosis and treatment, efforts should be made for better prevention in heart failure by treatment of risk factors, or identifying and following risk groups. This summary of the pathophysiology of heart failure tries to give a compact overview of basic mechanisms and of the novel unfolding, progressive theory of heart failure to contribute to a more comprehensive knowledge of the disease.

Clinical Significance of Individual GAD Symptoms in Later Life.

There are age-related differences in the manifestation of generalized anxiety disorder (GAD) symptoms and their associated impact on psychosocial and functional status. However, it remains unclear whether specific symptoms (or symptom patterns) are of comparable clinical significance across different functional domains. A sample of 865 self-reported worriers (aged 60 years and older) who endorsed GAD screening questions in the Alcohol Use Disorder and Associated Disabilities Interview Schedule, Diagnostic and Statistical Manual of Mental Disorders, fourth edition, were derived from Wave 1 of the National Epidemiological Survey of Alcohol and Related Conditions. Being easily fatigued was significantly associated with occupational disability and a functional disability variable (restricting usual activity in any way). Irritability was significantly associated with social friction (arguments with friends, family, or colleagues) and a functional disability variable (found was unable to do something wanted to do), and poor self-perceived health was also associated with the same functional disability variable. Excessive worry, despite being among the least reported symptoms, was significantly associated with distress. These findings suggest that individual GAD symptoms are differentially associated with aspects of clinical significance relevant to daily life, such as social, occupational, and functional ability. The differential impact of individual symptoms on functional status may be diluted when using symptom sum scores. A nuanced approach to assessing the clinical significance of individual GAD symptoms in older adults may be fruitful for efforts aimed at early detection and treatment.

The long-term effects of being bullied or a bully in adolescence on externalizing and internalizing mental health problems in adulthood.

BackgroundThe aim is to examine associations between bullying involvement in adolescence and mental health problems in adulthood.MethodsInformation on bullying-involvement (being bullied, bully–victim, aggressive toward others) and non-involved was collected from 2464 adolescents in Mid-Norway at mean age 13.7 and again at mean age 14.9. Information about mental health problems and psychosocial functioning was collected about 12 years later at mean age 27.2 (n = 1266).ResultsAll groups involved in bullying in young adolescence had adverse mental health outcomes in adulthood compared to non-involved. Those being bullied were affected especially regarding increased total sum of depressive symptoms and high levels of total, internalizing and critical symptoms, increased risk of having received help for mental health problems, and reduced functioning because of a psychiatric problem in adulthood. While those being aggressive toward others showed high levels of total and internalizing symptoms. Both those being bullied and bully–victims showed an increased risk of high levels of critical symptoms. Lastly, all groups involved in bullying on adolescence had increased risk of psychiatric hospitalization because of mental health problems.ConclusionInvolvement in bullying in adolescence is associated with later mental health problems, possibly hindering development into independent adulthood.

The relationship between symptoms and functional abnormalities in clinically healthy cigarette smokers.

Because a number of "early tests" may now be used to measure abnormalities of lung function in cigarette smokers with normal airflow rates, we evaluated the symptoms of cough, sputum, wheezing, and shortness of breath in 60 nonsmokers and 49 smokers to determine whether these symptoms correlated with measurements of lung function that are believed to be altered by mild obstruction. One or more symptoms were present in 5 per cent of the nonsmokers and 90 per cent of the smokers. Individual symptoms, sums of symptoms (symptoms score), and various combinations of symptoms correlated poorly or not at all to measured values for dynamic lung compliance, closing volume, closing capacity, slope of Phase III, and helium flow-volume curves. The symptoms score correlated negatively (P less than 0.05) with forced maximal expiratory flow at 50 per cent of vital capacity. Inasmuch as the serious consequences of chronic airway obstruction are related to abnormalities of lung function, it is likely the function tests will prove more useful than symptoms to reveal smokers at risk to develop chronic obstructive pulmonary disease. Symptoms cannot be used to detect smokers who are liable to have functional abnormalities suggestive of mild peripheral airway obstruction.

Glutamate as a mediating transmitter for auditory hallucinations in schizophrenia: A 1H MRS study

This is a 1H MR spectroscopy (MRS) study of glutamate (Glu), measured as Glx, levels in temporal and frontal lobe regions in patients with schizophrenia compared with a healthy control group with the objective of revealing aspects of the underlying neurochemistry of auditory hallucinations. We further compared and correlated Glu(Glx) levels for the patients-only against frequency and severity of auditory hallucinations and the sum of Positive symptoms, and also for frequency and severity of emotional withdrawal, and sum of Negative symptoms. The sample included 23 patients with an ICD-10 and DSM-IV diagnosis of schizophrenia, and 26 healthy control subjects without any known psychiatric or neurological disorders. Symptom scores were obtained from the Positive and Negative Syndrome Scale (PANSS). 1H MRS data were acquired on a 3T MR scanner from two temporal and two frontal voxels, using standard sequences and analysis parameters. The results showed that schizophrenia patients as a group had reduced Glu(Glx) levels in the voxels of interest compared to the healthy control subjects, while increased levels were found for patients with frequent and severe auditory hallucinations, relative to patients with less frequent and severe hallucination. We further found significant positive correlations between frequency and severity of auditory hallucinations, and for sum Positive symptoms, and Glu(Glx) levels in all regions, not seen when the analysis was done for negative symptoms. It is concluded that the results show for the first time that glutamate may be a mediating factor in auditory hallucinations in schizophrenia.

Health-related quality of life, personality and choice of coping are related in renal cell carcinoma patients

Objective. To investigate whether health-related quality of life (HRQoL) depends on psychosocial factors, rather than on factors related to the cancer treatment, this study explored the associations between HRQoL, personality, choice of coping and clinical parameters in surgically treated renal cell carcinoma (RCC) patients. Materials and methods. After exclusions (e.g. death, dementia), 260 patients were found to be eligible and invited to participate. The response rate was 71%. HRQoL was determined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), personality by the Eysenck Personality Inventory and coping by the COPE Questionnaire. Given tumour treatment, TNM stage and patient-reported comorbidity were also determined. The HRQoL indices were also summarized in general quality of life/health, functional sum and symptom sum scores. Results. EORTC C30 sum scores were negatively associated with the personality trait of neuroticism [common variance (CV) 19–36%]. Avoidant choice of coping inversely accounted for 9–18% of the total HRQoL variance, while reported coping by humour was to some extent negatively associated with HRQoL score (CVmax 4%). Indeed, all of the quality of life indices except for one were significantly negatively correlated with neuroticism and avoidance coping. Patients with low HRQoL due to treatment, secondary to flank or open surgery, reported a closer association between problem-focused choice of coping and HRQoL than the other patients. Moreover, present comorbidities were uniquely associated with a lowered HRQoL. Conclusions. HRQoL is related to treatment-related factors in RCC patients, but shown here to be more strongly associated with psychological factors and present comorbidity. These findings suggest that attention should be paid to supportive treatment of RCC patients.

Characterizing the longitudinal relations between depressive and menstrual symptoms in adolescent girls.

This study examined the association between depressive and menstrual symptoms in adolescent girls in a 3-year longitudinal study. It was hypothesized that menstrual symptoms would increase in early adolescence and decrease in later adolescence, that girls with greater depressive symptoms would report greater menstrual symptoms, and that effects would persist after adjusting for general somatic complaints. A community sample of girls (n = 262) enrolled in an observational study by age cohort (11, 13, 15, 17 years) completed three annual visits. At each time point, girls completed the Menstrual Symptom Questionnaire, Children's Depression Inventory, and the Youth Self Report to assess general somatic complaints. Menstrual symptoms increased significantly across adolescence (p = .006) and began to plateau in later adolescence (p = .020). Depressive symptoms at study entry were significantly associated with menstrual symptoms (p < .001). When general somatic complaints were included in the models, the effect of depressive symptoms on menstrual symptoms remained significant for the sum score (p = .015) and the menstrual somatic symptoms subscale (p = .001). After adjusting for somatic complaints, initial report of depressive symptoms predicted change in menstrual symptoms only for girls with the lowest menstrual symptoms sum score (p = .025). Initial report of somatic complaints predicted change in menstrual symptoms (p = .020). Girls with higher depressive symptoms and higher somatic complaints are at greater risk for experiencing menstrual symptoms and increasing symptoms across adolescence, with a heightened vulnerability for girls with lower baseline menstrual symptoms.

A2: Rapid and Sustained Response in Patients Suffering From Severe Cryopyrin‐Associated Periodic Syndromes Treated With Anakinra (Kineret®)

Background/Purpose:Cryopyrin‐Associated Periodic Syndromes (CAPS) are a group of rare inherited autoinflammatory diseases consisting of a spectrum of three conditions: FCAS, Muckle‐Wells Syndrome and the most severe form, NOMID. Anakinra was recently approved in the US for treatment of NOMID and in the European Union for treatment of CAPS. The objective of the present analysis is to assess the response rate to anakinra treatment and time to changes in symptom severity after initiation, withdrawal and re‐institution of the treatment in patients with severe CAPS.Methods:A prospective, open‐label withdrawal design study of anakinra treatment with long‐term extension including 43 patients was conducted at the National Institutes of Health (Goldbach‐Mansky et al 2006, Sibley et al 2012). The primary efficacy endpoint, the Diary Symptom Sum Score (DSSS) collected daily up to 60 months included 5 symptoms (fever, rash, joint pain, vomiting, headache); each scored from 0 (no symptoms) to 4 (severe symptoms). Earlier data demonstrated that rash and conjunctivitis disappeared in 3 days in all patients, the DSSS was decreased at 3 months and all patients except one met the criteria of a flare during the 7‐day withdrawal phase (Goldbach‐Mansky et al 2006). In the present analysis, we defined the response as at least 50% improvement from baseline in the weekly average DSSS. The mean changes in DSSS were estimated with Mixed Model for Repeated Measures (MMRM).Results:Twenty nine out of the 43 enrolled patients provided valid DSSS data for the analysis. A majority of the patients were children (17% &lt;2 years, 55% 2–11 years, 7% 12–17 years, 21% 18 years or more). All 29 patients responded to the treatment during the first 10 days based on DSSS. The average DSSS decreased from 4.5 to 0.8 in 2 days. This response was maintained throughout the study up to 60 months and at each post‐baseline visit &gt;80% of the patients met the response criteria. Eleven consecutive patients participated in the withdrawal phase at 3 months of treatment. After treatment withdrawal the average DSSS increased from 0.6 to 5.2 (p&lt;0.0001 compared to continuously treated patients). After re‐institution of treatment the DSSS returned to pre‐withdrawal levels within 3 days.Conclusion:All patients experienced a rapid response to the anakinra treatment, both initially and after a flare caused by the withdrawal phase. The response was maintained up to 60 months.

Traumatic grief presented with self-injury and suicide attempt: a case report

Traumatic grief is described as the sum of symptoms and reactions occurred following the sudden and terrific loss of a loved one in who experienced this loss and accepted as a diagnosis distinct from normal grief as well as other psychiatric disorders such as anxiety disorders, major depression and post-traumatic stress disorder. Herein, a 25 year old female case which was hospitalized because of serious self-injurious behavior and suicide attempt, diagnosed as traumatic grief and treated with pharmacotherapy along with hypnotherapy is described and in the context of this case, diagnostic and therapeutic approaches to traumatic grief are discussed.

Prosthetic joint infections-a clinico-microbiological perspective: Review article

Prosthetic joint infections (PJIs), although not very common, currently pose a very significant threat since they are associated with severe complications, high morbidity rates and substantial costs. PJIs are most commonly caused by Staphylococcus aureus and coagulase-negative staphylococci. The diagnosis of implant-associated infections is very challenging since no single routinely used laboratory or clinical test has been shown to demonstrate adequate results with respect to sensitivity, specificity and accuracy. In most cases, a sum of clinical signs and symptoms, histopathology, blood tests, radiography, bone scans and microbiological testing is considered to arrive at an accurate diagnosis. Treatment of PJIs is also very difficult since most of the infections are caused by biofilm-producing microorganisms which are significantly more resistant to the hosts natural defense mechanisms and antibiotic treatment. For successful management, a combination of both antibiotic and surgical treatment is most often required, and early diagnosis is of the utmost importance. Thus, a multidisciplinary approach is potentially the best option in dealing with PJI, and should include the involvement of microbiologists, orthopedic specialists, clinicians, pathologists and radiologists in order to improve decision-making processes and ensure overall success. The following review aims at briefly outlining the microbiology, diagnostic and treatment options, and preventive measures associated with such infections.

Depression is more than the sum score of its parts: individual DSM symptoms have different risk factors

For diagnostic purposes, the nine symptoms that compose the DSM-5 criteria for major depressive disorder (MDD) are assumed to be interchangeable indicators of one underlying disorder, implying that they should all have similar risk factors. The present study investigates this hypothesis, using a population cohort that shifts from low to elevated depression levels. We assessed the nine DSM-5 MDD criterion symptoms (using the Patient Health Questionnaire; PHQ-9) and seven depression risk factors (personal and family MDD history, sex, childhood stress, neuroticism, work hours, and stressful life events) in a longitudinal study of medical interns prior to and throughout internship (n = 1289). We tested whether risk factors varied across symptoms, and whether a latent disease model could account for heterogeneity between symptoms. All MDD symptoms increased significantly during residency training. Four risk factors predicted increases in unique subsets of PHQ-9 symptoms over time (depression history, childhood stress, sex, and stressful life events), whereas neuroticism and work hours predicted increases in all symptoms, albeit to varying magnitudes. MDD family history did not predict increases in any symptom. The strong heterogeneity of associations persisted after controlling for a latent depression factor. The influence of risk factors varies substantially across DSM depression criterion symptoms. As symptoms are etiologically heterogeneous, considering individual symptoms in addition to depression diagnosis might offer important insights obfuscated by symptom sum scores.

The Effect of PM10 on the Symptoms of Allergic Rhinitis during Spring

Objectives:Clarify the effect of PM10 (particulate matter less than 10 μm), which is the major component of air pollution, on the symptoms of allergic rhinitis patients during spring.Methods:We investigated changes in allergic symptoms (rhinorrhea, sneezing, nasal obstruction and sleep disturbance) and nasal obstruction level as measured using a portable peak nasal inspiratory flowmeter (PNIF) in 108 allergic patients. Forty‐seven control subjects were also included. Spring pollen counts and PM10 concentrations in Incheon city were also evaluated. We conducted long‐term observation of the effect of PM10 on allergic symptoms for 120 days from February to May and compared the changes in symptom scores before and after the 2 days when PM10 concentration was 100μg/m3 (short term).Results:The highest concentration of PM10 during the study period was &lt;150 mg/m3. No significant correlations between PM10 and nasal obstruction (P = 0.0670), rhinorrhea (P = 0.1485), sneezing (P = 0.3991), itching (P = 0.2044), sleep disturbance (P = 0.4413) and the sum of all symptoms (P = 0.0816) were identified. However, the variation in nasal obstruction, as assessed by PNIF, was significantly correlated with the PM10 level (P = 0.0410). There was also a significant correlation between outdoor activity duration and the sum of clinical symptoms (P &lt; 0.001). Neither frequency of drug use nor PNIF values were affected by the short‐term changes in PM10 levels.Conclusions:Our data suggest that PM10 concentration during spring influences nasal obstruction as determined by PNIF; this nasal obstruction was also influenced by the duration of outdoor activity.

Juvenile fibromyalgia: Guidance for management

Juvenile fibromyalgia (JFM) is a disease in which patients complain of acute and chronic severe pain, an overt primary cause for which cannot be found or surmised. Although patients with JFM mainly complain of systemic pain or allodynia in the medical interview and physical examination, the concept of the disease is the total sum of painful illness, chronic fatigue, hypothermia and many other autonomic symptoms and signs. Many issues are interacting including individual traits (personality, temperament, sensitivity, memory of pain; age: early adolescence), individual states (self-esteem, anxiety, developmental level), and external stressors (parent especially mother, school environment). JFM is diagnosed on the combination of disease history, physical examination to determine the 18 tender points and allodynia, pain from gently touching their hair, and negative results of blood tests (inflammatory markers, thyroid function, myogenic enzymes). The goals of treatment are the following: restoration of function and relief of pain. Psychological support is advocated. Although the exact number of patients with JFM is still to be elucidated, it seems to be growing because pediatric rheumatologists in Japan encounter children with a wide variety of musculoskeletal pains. This guideline describes how to diagnose JFM in children and how to treat them appropriately.

Congestive heart failure and decongestion ability of two diff erent treatments: continuous renal replacement and diuretic therapy: experience of a cardiac step down unit

Introduction The rehospitalization rate for decompensated heart failure (HF) is high and can be ascribed also to a suboptimal decongestion before discharge. Congestion can be treated with diuretics or continuous renal replacement therapy (CRRT). Aim of this study was to evaluate if diuretics and CRRT, used in agreement to international guidelines, may have a dissimilar decongestion ability in patients with decompensated HF with diff erent baseline characteristics.Methods In 88 patients with HF (NYHA class III-IV) we evaluated the eff ect of CRRT (n = 46) and intravenous diuretics (n = 42) on clinical and instrumental signs of congestion. A clinical score was obtained as the sum of signs and symptoms of HF to estimate the severity of each patient’s clinical condition. The choice of diuretics or CRRT was guided by renal impairment or diuretics’ resistance.Results A signifi cant reduction in clinical HF score was observed in the CRRT group at discharge vs admission (1.3 ± 1.9 vs 5.7 ± 2.3, P < 0.001) and in the diuretic group (1.8 ± 1.4 vs 3.7 ± 1.6, P < 0.001), while a signifi cant reduction in radiographic signs of pulmonary congestion, pleural eff usion, echocardiographic systolic arterial pulmonary pressure (43.4 ± 13.6 vs 50.5 ± 20.2 mmHg, P < 0.005) and NT-proBNP (6,676 vs 15,492 pg/ml, P < 0.05) were observed only in CRRT patients. Moreover, also urine output signifi cantly increased only in CRRT patients (1.8 ± 0.8 vs 0.9 ± 0.6 ml/h/kg, P < 0.001).Conclusions CRRT and diuretics showed an equivalent ability in relieving clinical signs and symptoms of HF but only CRRT was able to signifi cantly improve several instrumental and biohumoral indicators of congestion.

Optimizing EEMCO guidance for the assessment of dry skin (xerosis) for pharmacies

People with dry skin (xerosis) are common in community pharmacies, but there is no consistent guidance for community pharmacists to evaluate and alleviate dry skin. Through evaluating any difference of the clinical scoring systems of EEMCO guidance between a dermatologist and pharmacists and the efficacy of moisturizers for the treatment of dry skin recommended by community pharmacists, we aim to validate a dry skin guidance through the help of community pharmacists. These results provide insight into how community pharmacists can help patients with dry skin. The clinical scoring systems of EEMCO guidance used in this study comprised analog scales, the overall dry skin score (ODS), and the specific symptom sum score (SRRC) system. All pictures of the dry skin scored by pharmacists were visually evaluated by a dermatologist. The efficacy of the moisturizers was determined by the difference of the scales on day 0 and on day 28. In this study, 387 patients with dry skin from 157 community pharmacies were evaluated by pharmacists. Visual scale with divisions, ODS and SRRC that were evaluated by pharmacists on day 0 and day 28 were moderately reliable by a dermatologist. All parameters of dry skin were significantly improved by the moisturizers which were recommended by community pharmacists on day 28. Visual scale, ODS and SRRC can be generally measured to evaluate dry skin in community pharmacies with moderate degree of reliability. This finding has possible applications for investigating the assessment of the community pharmacists on clinical scoring system of dry skin and moisturizers.

Assessment of long-term rectal function in patients who received pelvic radiotherapy: a pooled North Central Cancer Treatment Group trial analysis, N09C1

Pelvic radiotherapy (PRT) is known to adversely affect bowel function (BF) and patient well-being. This study characterized long-term BF and evaluated quality of life (QOL) in patients receiving PRT. Data from 252 patients were compiled from two North Central Cancer Treatment Group prospective studies, which included assessment of BF and QOL by the BF questionnaire (BFQ) and Uniscale QOL at baseline and 12 and 24 months after completion of radiotherapy. BFQ scores (sum of symptoms), Uniscale results, adverse-event incidence, and baseline demographic data were compared via t test, χ (2), Fisher exact, Wilcoxon, and correlation methodologies. The total BFQ score was higher than baseline at 12 and 24 months (P < 0.001). More patients had five or more symptoms at 12 months (13 %) and 24 months (10 %) than at baseline (2 %). Symptoms occurring in greater than 20 % of patients at 12 and 24 months were clustering, stool-gas confusion, and urgency. Factors associated with worse BF were female sex, rectal or gynecologic primary tumors, prior anterior resection of the rectum, and 5-fluorouracil chemotherapy. Patients experiencing grade 2 or higher acute toxicity had worse 24-month BF (P values, <.001-.02). Uniscale QOL was not significantly different from baseline at 12 or 24 months, despite worse BFQ scores. PRT was associated with worse long-term BF. Worse BFQ score was not associated with poorer QOL. Further research to characterize the subset of patients at risk of significant decline in BF is warranted.

Is Fibromyalgia Syndrome Common in the Patients with Primary Dysmenorrhea?

AbstractObjective: To determine the association between fibromyalgia syndrome [FMS] and primary dysmenorrhea [PD].Methods: Patients with PD formed the PD group and age-matched healthy normal controls were included in the HNC group. The new American College of Rheumatology FMS criteria were used in all patients and depression was assessed with the Beck Depression Inventory [BDI].Results: There were 45 patients in the PD group and 45 patients in the HNC group. We found FMS in 15.6% of the PD patients and 0.0% of the HNCs. The mean sum of the somatic symptoms was higher in the PD patients with FMS than without FMS. The mean sore of BDI was higher in the PD group than the HNC group, but the mean depression score of the PD patients with FMS was not significantly higher than PD patients without FMS.Conclusions: The frequency of FMS was increased in PD patients, especially in the PD patients who exhibited many somatic symptoms.

Clinically Relevant Effect of a New Intranasal Therapy (MP29-02) in Allergic Rhinitis Assessed by Responder Analysis

Background: It is unclear what constitutes a clinically meaningful response for allergic rhinitis (AR) outcomes. The objectives of these post hoc analyses were (1) to define a clinically meaningful response using novel efficacy analyses (including a responder analysis), and (2) to compare the efficacy of MP29-02 [a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP)] with commercially available FP, AZE and placebo in seasonal AR (SAR) patients, using these novel analyses. Methods: 610 moderate-to-severe SAR patients (≥12 years old) were randomized into a double-blind, placebo-controlled, 14-day, parallel-group trial. Change from baseline in the reflective total nasal symptom score (rTNSS) over 14 days was the primary outcome. Post hoc endpoints included the sum of nasal and ocular symptoms (rT7SS), efficacy by disease severity and by predominant nasal symptom, and a set of responder analyses. Results: MP29-02 most effectively reduced rT7SS (relative greater improvement: 52% to FP; 56% to AZE) and both nasal and ocular symptoms irrespective of severity. More MP29-02 patients achieved a ≥30, ≥50, ≥60, ≥75 and ≥90% rTNSS reduction, which occurred days faster than with either active comparator; MP29-02 alone was superior to placebo at the ≥60% (or higher) threshold. One in 2 MP29-02 patients achieved a ≥50% rTNSS reduction and 1 in 6 achieved complete/near-to-complete response. Only MP29-02 was consistently superior to placebo for all patients, whatever their predominant symptom. Conclusions: MP29-02 provided faster and more complete symptom control than first-line therapies. It was consistently superior irrespective of severity, response criteria or patient-type, and may be considered the drug of choice for moderate-to-severe AR. These measures define a new standard for assessing relevance in AR.

A direct comparison of efficacy between desloratadine and rupatadine in seasonal allergic rhinoconjunctivitis: a randomized, double-blind, placebo-controlled study

BackgroundH1-antihistamines are recommended as the first-line symptomatic treatment of allergic rhinitis. The objective of this study was to evaluate the effects of rupatadine (RUP) versus desloratadine (DES) in subjects with seasonal allergic rhinitis (SAR).MethodTo assess the efficacy and safety of RUP in SAR in comparison with placebo (PL) and DES. A randomized, double-blind, multicenter, international, and PL-controlled study was carried out. The main selection criteria included SAR patients over 12 years old with a positive prick test to a relevant seasonal allergen for the geographic area. Symptomatic patients at screening with a nasal symptom sum score of ≥6 points (nasal discharge, nasal obstruction, sneezing, and nasal pruritus), a non-nasal score of ≥3 points (ocular pruritus, ocular redness, and tearing eyes), and a rhinorrhea score of ≥2 points with laboratory test results and electrocardiography within acceptable limits were included in the study. Change from baseline in the total symptom-score (T7SS) over the 4-week treatment period (reflective evaluation) was considered the primary efficacy variable. Secondary efficacy measures included total nasal symptom score (T4NSS) and conjunctival symptom score (T3NNSS), both of which are reflective and instantaneous evaluations. Furthermore questions related to quality of life (eg, sleep disturbances or impairment of daily activities) have also been evaluated. Safety was assessed according to adverse events reported, as well as laboratory and electrocardiography controls.ResultsA total of 379 patients were randomized, of which 356 were included and allocated to PL (n = 122), RUP (n = 117), or DES (n = 117). Mean change of T7SS over the 4-week treatment period was significantly reduced in the RUP (–46.1%, P = 0.03) and DES (–48.9%, P = 0.01) groups, compared with PL. Similarly, RUP and DES were comparable and significantly superior to PL for all secondary endpoints, including nasal and conjunctival symptoms and patients’ and investigator’s overall clinical opinions. Symptom score evaluation (both reflective and instantaneous evaluations) throughout the treatment period showed a progressive and maintained significant improvement with both treatments at day 7 (P = 0.01), day 14 (P = 0.007), and day 21 (P = 0.01) in comparison with PL. Adverse events were scarce and were similar in both treatment groups. Electrocardiography (QTc) and lab test results did not show any relevant findingsConclusionRUP is a very good choice for SAR due to its contribution to the improvement of nasal (including obstruction) and non-nasal symptoms to a similar degree as DES.

Prediction of Survival by Pretreatment Health-Related Quality-of-Life Scores in a Prospective Cohort of Patients With Head and Neck Squamous Cell Carcinoma

To evaluate the association between pretreatment health-related quality-of-life (HRQOL) scores and survival in a heterogeneous cohort of patients with newly diagnosed head and neck squamous cell carcinoma (HNSCC). Prospective cohort study. University hospital and referral center in Western Norway. A total of 106 patients with intact cognitive functioning who were younger than 78 years, were diagnosed as having HNSCC, and underwent treatment with curative intent from November 1, 2002, through June 30, 2005. Overall survival and HRQOL scores obtained at the time of diagnosis. All dichotomized HRQOL sum scores except the functional score (P = .20) were significantly predictive of survival in univariate analyses. The hazard ratios of the dichotomized general symptom, global quality-of-life, and head and neck sum score were 3.66, 0.31, and 2.28, respectively. All sum scores except the dichotomized functional score remained predictive of survival after sequential adjustment for sociodemographic and clinical characteristics, neuroticism, choice of psychological coping, current smoking and alcohol consumption, and comorbidities. Similar findings were found for specific HRQOL indices of physical functioning, dyspnea, sleep disturbance, appetite loss, swallowing, and social eating from the European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire, version 3.0, and the Quality of Life-Head and Neck Cancer Module. Moreover, patients in the highest scoring quartiles for the symptom sum scores and/or the lowest scoring quartile for the global score had overall mortality rates of 50% to 64% compared with 23% to 26% among the other patients. The HRQOL sum scores and specific indices among HNSCC patients predict survival independently of established known prognostic factors.