Effect of acupuncture and its influence on cerebral activity in patients with persist asthma: study protocol for a randomized controlled clinical trial

Abstract Background Previous studies suggested that acupuncture was a promising adjunct treatment for asthma. However, the underlying mechanism of acupuncture for asthma remains unclear. The present trail aimed to explore whether and how specific meridian acupuncture works in quality of life and symptomatic improvement by modulating brain function in asthma patients. Methods A randomized controlled functional brain imaging trial is currently being conducted in Sichuan, China. In total 48 patients with mild to moderate, persist asthma will be recruited randomly allocated to two acupuncture groups: acupuncturing at Lung Meridian and acupuncturing at Heart Meridian . The treatment period will last for 4 weeks. The Asthma quality of life questionnaire (AQLQ) is the primary outcome. Asthma control test (ACT), the rate of Peak expiratory flow (PEFR), Forced expiratory volume in 1 second (FEV1), Montreal cognitive assessment (MoCA), Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) will also assess the clinical efficacy of different interventions. Functional magnetic resonance imaging (fMRI) scans will be performed to detect cerebral activity changes in each group. The clinical data and fMRI data will be analyzed, respectively. Pearson correlation analysis will be used to assess the association between the changes of cerebral activity features and the improvement of clinical outcomes in each group. DiscussionThe present study has been established on the “meridians-viscera relationship” theory of traditional Chinese medicine and modern central mechanism of acupuncture. The results of this trial would be useful to identify efficiency of the specific meridian acupuncture for asthma. The investigation of its central mechanism would further expand our knowledge of the acupuncture for asthma.

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Effect of acupuncture and its influence on cerebral activity in patients with persistent asthma: study protocol for a randomized controlled clinical trial

10.21203/rs.2.21010/v3 ◽

2020 ◽

Author(s):

Siyi Yu ◽

Xiaohui Dong ◽

Ruirui Sun ◽

Zhaoxuan He ◽

Chuantao Zhang ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Persistent Asthma ◽

Functional Brain Imaging ◽

Central Mechanism ◽

Life Questionnaire ◽

Cerebral Activity ◽

Randomized Controlled ◽

Self Rating

Abstract BackgroundPrevious studies suggested that acupuncture was a promising adjunct treatment for asthma. However, the underlying mechanism of acupuncture for asthma remains unclear. The present trial aimed to explore whether and how specific meridian acupuncture works in quality of life and symptomatic improvement by modulating brain function in asthma patients.Methods: A randomized controlled functional brain imaging trial is currently being conducted in Sichuan, China. In total 48 patients with mild to moderate, persistent asthma will be recruited randomly allocated to two acupuncture groups: acupuncturing at Lung Meridian and acupuncturing at Heart Meridian. The treatment period will last for 4 weeks. The Asthma quality of life questionnaire (AQLQ) is the primary outcome. Asthma control test (ACT), the rate of Peak expiratory flow (PEFR), Forced expiratory volume in 1 second (FEV1), Montreal cognitive assessment (MoCA), Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) will also assess the clinical efficacy of different interventions. Functional magnetic resonance imaging (fMRI) scans will be performed to detect cerebral activity changes in each group. The clinical data and fMRI data will be analyzed, respectively. Pearson correlation analysis will be used to assess the association between the changes of cerebral activity features and the improvement of clinical outcomes in each group.Discussion: The present study has been established on the “meridians-viscera relationship” theory of traditional Chinese medicine and modern central mechanism of acupuncture. The results of this trial would be useful to identify the efficiency of the specific meridian acupuncture for asthma. The investigation of its central mechanism would further expand our knowledge of the acupuncture for asthma. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900027478. Registered on 15 November 2019.

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Effect of acupuncture and its influence on cerebral activity in patients with persistent asthma: study protocol for a randomized controlled clinical trial

10.21203/rs.2.21010/v2 ◽

2020 ◽

Author(s):

Siyi Yu ◽

Xiaohui Dong ◽

Ruirui Sun ◽

Zhaoxuan He ◽

Chuantao Zhang ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Persistent Asthma ◽

Functional Brain Imaging ◽

Central Mechanism ◽

Life Questionnaire ◽

Cerebral Activity ◽

Randomized Controlled ◽

Self Rating

Abstract Background Previous studies suggested that acupuncture was a promising adjunct treatment for asthma. However, the underlying mechanism of acupuncture for asthma remains unclear. The present trial aimed to explore whether and how specific meridian acupuncture works in quality of life and symptomatic improvement by modulating brain function in asthma patients. Methods : A randomized controlled functional brain imaging trial is currently being conducted in Sichuan, China. In total 48 patients with mild to moderate, persistent asthma will be recruited randomly allocated to two acupuncture groups: acupuncturing at Lung Meridian and acupuncturing at Heart Meridian . The treatment period will last for 4 weeks. The Asthma quality of life questionnaire (AQLQ) is the primary outcome. Asthma control test (ACT), the rate of Peak expiratory flow (PEFR), Forced expiratory volume in 1 second (FEV1), Montreal cognitive assessment (MoCA), Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) will also assess the clinical efficacy of different interventions. Functional magnetic resonance imaging (fMRI) scans will be performed to detect cerebral activity changes in each group. The clinical data and fMRI data will be analyzed, respectively. Pearson correlation analysis will be used to assess the association between the changes of cerebral activity features and the improvement of clinical outcomes in each group. Discussion : The present study has been established on the “meridians-viscera relationship” theory of traditional Chinese medicine and modern central mechanism of acupuncture. The results of this trial would be useful to identify the efficiency of the specific meridian acupuncture for asthma. The investigation of its central mechanism would further expand our knowledge of the acupuncture for asthma. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900027478. Registered on 15 November 2019.

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Post-Surgical Quality of Life, Psychological State and what Patients Think about the Effectiveness of Heller Myotomy in the Treatment of Achalasia

Acta Médica Portuguesa ◽

10.20344/amp.6758 ◽

2016 ◽

Vol 29 (2) ◽

pp. 107 ◽

Cited By ~ 1

Author(s):

Telma Vale-Fonseca ◽

Luis Ferreira-Pinto ◽

Margarida Figueiredo-Braga ◽

Silvestre Carneiro

Keyword(s):

Quality Of Life ◽

Heller Myotomy ◽

Pearson Correlation ◽

Depression Scale ◽

Laparoscopic Heller Myotomy ◽

Psychological State ◽

Life Questionnaire ◽

Emotional States ◽

Sf 36

Introduction: The disruption of esophageal motility that characterizes achalasia typically provokes dysphagia, pain, loss of weight and malnutrition. Therefore, patients frequently report a reduction in quality of life and negative emotional states. Laparoscopic Heller myotomy proved to be an effective therapy, enabling the resumption of good quality of life. Material and Methods: The authors studied 45 patients previously submitted to laparoscopic Heller myotomy. Postoperative evaluation was performed using a customized version of the achalasia disease-specific quality of life questionnaire. Quality of life and the presence of depressive and anxiety symptoms were assessed using the Portuguese versions of the Medical Outcomes Study SF-36 and the Hospital Anxiety and Depression Scale. Results: Thirty-one patients responded to the survey. Dysphagia was the main clinical symptom before surgery. A clear improvement in dysphagia, regurgitation, pain and weight loss was found after surgery (p < 0.001). The Mental Health domain of SF-36 presented a Pearson correlation coefficient of -0.689 with HADS-D and of -0.557 with HADS-A (p < 0.001 and p = 0.002, respectively). Conclusion: This study demonstrates that the Heller myotomy is associated with a good quality of life in patients with achalasia and strengthens the evidence that this is a safe and reliable procedure.

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A 15 tételes Rövid Geriátriai Depresszió Skála hazai alkalmazásával szerzett tapasztalatok normatív mintán

Mentálhigiéné és Pszichoszomatika ◽

10.1556/0406.22.2021.008 ◽

2021 ◽

Vol 22 (3) ◽

pp. 281-309

Author(s):

Szekeres Tamás ◽

Hargitai Rita

Keyword(s):

Quality Of Life ◽

Depressive Symptoms ◽

Big Five ◽

Geriatric Depression Scale ◽

Depression Scale ◽

World Health ◽

Life Questionnaire ◽

Geriatric Depression ◽

Self Rating

Bevezetés: Az időskori depresszió gyakran aluldiagnosztizált, noha a vezető pszichés problémát jelenti ebben az életkorban. A Rövid Geriátriai Depresszió Skála (GDS-SF) az időskori depresszió tüneteinek felmérésére alkalmas kérdőív, amelyet gyakran alkalmaznak nemzetközi viszonylatban a klinikumban. Célkitűzés: Jelen tanulmány célkitűzése kettős. Elsődleges célja a 15 tételes Rövid Geriátriai Depresszió Skála (GDS-SF) hazai normatív mintán történő tesztelése és az alkalmazásával szerzett tapasztalatok közreadása. Másodsorban arra a kérdésre keressük a választ, hogy az idősek mintáján van-e protektív szerepe az online tér használatának a depresszió vonatkozásában. Módszerek: A keresztmetszeti, kérdőíves kutatásban 65 éves és afeletti életkorú vizsgálati személyek önkéntesen vettek részt, az adatokat anonim módon, papír–ceruza alapon (n = 142) és online (n = 167) formában gyűjtöttük. A kérdőív validálásához az Egészségügyi Világszervezet Rövidített Életminőség Kérdőívét, a Rövidített WHO Jól-Lét Kérdőívet, valamint a Zung Önértékelő Depresszió Skálát használtuk. A válaszmeghamisító tendenciák szűrésére a Caprara-féle Big Five Kérdőív Szociális Kívánatosság alskáláját alkalmaztuk. Eredmények: A parallel-elemzés eredménye egyfaktoros struktúrát jelez, és az egyetlen faktor az összvariancia 64,8%-át magyarázza. A kérdőív megbízhatósága kiváló (Cronbach-α = 0,95). A GDS-SF az elvárásoknak megfelelő irányú és mértékű korrelációt mutatott a validáláshoz alkalmazott mérőeszközökkel: a GDS-SF és az életminőség alfaktorai közötti korrelációs együttható (r) értéke –0,59 és –0,61 közötti (p < 0,001), a jólléttel –0,71 (p < 0,001), míg a Zung Önértékelő Depresszió Skálával 0,74 (p < 0,001). A papíralapú és az online adatgyűjtésben részt vevő vizsgálati személyek körében nem találtunk szignifikáns különbséget a depreszszió előfordulási gyakoriságában, amennyiben kontroll alatt tartjuk az életkor és az iskolai végzettség hatását. Következtetések: A 15 tételes Rövid Geriátriai Depresszió Skála magyar verziója megbízható és érvényes eszköz az időskori depresszió mérésére normatív mintán, miközben a klinikai minta vonatkozásában további vizsgálatok szükségesek. Introduction: Geriatric depression is the leading mental disorder among the older population, although it is often underdiagnosed. The Geriatric Depression Scale (Short Form) (GDS-SF) is a screening tool designed to measure depressive symptoms in older adults and is used by clinicians globally. Objective: The primary objective of the study is the psychometric testing of GDS-SF among pensioners, as well as to present our experiences with using the questionnaire on a Hungarian sample. The secondary objective of the study is to explore whether the use of online space is a protective factor against developing depressive symptoms in this population. Methods: A total of 309 participants took part in this cross-sectional study, all of them above the age of 65, with full anonymity granted to all involved. The questionnaire was available in paper-based (n = 142) and online (n = 167) format as well. For the validation of GDS-SF, the Abbreviated World Health Organization Quality of Life Questionnaire, the Abbreviated WHO Well-Being Questionnaire, and the Zung Self-Rating Depression Scale were used. The Social Desirability Scale of the Caprara Big Five Questionnaire was used to filter out response distortion tendencies. Results: The results of the parallel analysis of the questionnaire supported a one-factor structure design, with 64.8% of the variance explained. According to the validity analysis, GDS-SF showed sufficient direction and degree of correlation with the questionnaires used for comparison and was in accordance with our a priori assumed direction and degree of correlation. Upon examination we discovered that the GDF-SF has a correlation coefficient (r) between –0.59 and –0.61 (p < 0.001) with the quality of life subfactors, –0.71 (p < 0.001) with wellbeing, and 0.74 (p < 0.001) with Zung Self-Rating Depression Scale. The reliability of the survey also proved to be excellent. There was no significant difference between the prevalence of depression between the two groups (paper-based and online), when controlling for the effects of age and level of education. Conclusions: The Hungarian version of the 15-item Geriatric Depression Scale is a reliable and valid tool for measuring depressive symptoms in the older normative adult population. Regarding the clinical sample, further exploration is needed.

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The Relationship Between Depression and Quality of Life in Elderly Patients with Glaucoma

Progress in Health Sciences ◽

10.5604/01.3001.0014.6589 ◽

2020 ◽

Vol 10 (2) ◽

pp. 55-64

Author(s):

R.N. Çavdar ◽

S. Türkleş

Keyword(s):

Quality Of Life ◽

Elderly Patients ◽

Pearson Correlation ◽

Geriatric Depression Scale ◽

Depression Scale ◽

Life Questionnaire ◽

Geriatric Depression ◽

The Mean ◽

The Relationship

Purpose: To examine the relationship between depression and quality of life in elderly patients with glaucoma. Materials and methods: The study was conducted as a descriptive and cross-sectional research. The sample of the work consists of 130 patients aged 60 years and over who were followed up at Mersin University Hospital Ophtalmology Department between 01 October 2016 and 31 March 2017. The data were gathered with Personal Information Form, Geriatric Depression Scale and Modifiye GLAU-QOL 17 Glaucoma Quality of life. Number, percentage, mean, Pearson Correlation, Student`s t test, ANOVA test, Tukey and Games-Howell statistic were used in the evaluation of the data. Results: The mean age of the patients was 67.9±7.27. The mean score of geriatric depression scale of the patients was 15,23±5,52. It was determined that 16,2% of the patiens had possible depression and 62,3% had definite depression. The median Glau–QOL-17 Glaucoma Quality of Life Questionnaire subcale scores of the patients were as follows: daily living (3,58±3,25), driving (3,23±2,53), worry (5,26±3,47), self-assesment (6,4±3,07), psychology (4,08±2,74), feeling oppressed (4,39±2,35) and taking responsibility (3,56±1,86). The mean total score was 34.44±15.29. There was a negative and statistically significant relationship between the age of the patients and the scores of geriatric depression and the scores of age and quality of life. Conclusions: Elderly patients with glaucoma are at a major risk for depression and their quality of life is negatively affected.

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QUALIDADE DE VIDA NO TRABALHO DA EQUIPE DE ENFERMAGEM DO CENTRO CIRÚRGICO

Enfermagem em Foco ◽

10.21675/2357-707x.2018.v9.n3.1159 ◽

2018 ◽

Vol 9 (3) ◽

Author(s):

Arethuza De Melo Brito Carvalho ◽

Juliana Araújo Cardoso ◽

Francisca Aline Amaral Da Silva ◽

Jefferson Abraão Caetano Lira ◽

Samuel Moura Carvalho

Keyword(s):

Quality Of Life ◽

Family Income ◽

Pearson Correlation ◽

Working Life ◽

Life Questionnaire ◽

Cross Sectional ◽

Calidad De Vida ◽

Kolmogorov Smirnov ◽

Room Nursing

Objetivo: avaliar a qualidade de vida no trabalho da equipe de enfermagem do centro cirúrgico. Metodologia: estudo descritivo, de corte transversal e com abordagem quantitativa, desenvolvido com 70 profissionais de enfermagem do centro cirúrgico em um hospital de referência em Teresina (PI), com a aplicação dos questionários sociodemográfico e Quality Working Life Questionnaire-bref. A análise foi realizada com o SPSS versão 21.0, utilizando a correlação de Pearson e os testes alfa de Cronbach, Kolmogorov-Smirnov, Qui-quadrado e regressão linear múltipla, com intervalo de confiança de 95%. Resultados: a maioria dos participantes (62,9%) tiveram menor impacto na qualidade de vida no trabalho, entretanto a renda familiar e a formação acadêmica foram bastante significativas. Conclusão: apesar do trabalho no centro cirúrgico apresentar baixo impacto na qualidade de vida, o domínio psicológico demonstrou impacto considerável, destacando que a preocupação com a saúde do trabalhador e a valorização da equipe de enfermagem ainda precisam avançar.Descritores: Qualidade de vida; Enfermagem de centro cirúrgico; Saúde do trabalhador.QUALITY OF LIFE IN THE WORK OF THE SURGI CAL CENTER NURSING TEAMObjective: to evaluate the quality of life in the work of the nursing staff of the surgical center. Methodology: a descriptive, cross-sectional study with a quantitative approach developed with 70 nursing professionals from a surgical center at a reference hospital in Teresina (PI), with the application of the sociodemographic and Quality Working Life Questionnairebref questionnaires. The analysis was performed with the SPSS version 21.0, using the Pearson correlation and the Cronbach, Kolmogorov-Smirnov, Chi-square and multiple linear regression alpha tests with a 95% confidence interval. Results: the majority of the participants (62.9%) had a lower impact on the quality of life at work, however the family income and academic training were quite significant. Conclusion: Although the work in the surgical center has a low impact on the quality of life, the psychological domain has shown considerable impact, emphasizing that the concern with the health of the worker and the appreciation of the nursing team still need to move forward.Descriptors: Quality of life; Operating Room Nursing; Occupational Health.CALIDAD DE VIDA EN ENFERMERÍA DEL CENTRO DE TRABA JO DE EQUIPO QUIRÚRGICOObjetivo: Evaluar la calidad de vida del personal de enfermería que trabaja en la sala de operaciones. Metodología: enfoque descriptivo, transversal y cuantitativo desarrollado con 70 enfermeras en el quirófano de un hospital de referencia en Teresina (PI), con la aplicación de un cuestionario sociodemográfico y Calidad de Vida Cuestionario de Trabajo-BREF. El análisis se realizó con el programa SPSS versión 21.0 mediante la prueba de correlación de Pearson y alfa de Cronbach, prueba de Kolmogorov-Smirnov, regresión lineal chi-cuadrado y múltiple con un intervalo de confianza del 95%. Resultados: La mayoría de los participantes (62,9%) tenían un menor impacto en la calidad de la vida laboral, aunque el ingreso familiar y la formación académica eran bastante significativa. Conclusión: Aunque el trabajo en la sala de operaciones tiene un bajo impacto en la calidad de vida, el dominio psicológico mostró un impacto considerable, teniendo en cuenta que la preocupación por la salud de los trabajadores y la apreciación del equipo de enfermería todavía tienen que seguir adelante.Descriptores: Calidad de vida; Enfermería de quirófano; Salud laboral.

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Psychological well-being, marital adjustment and quality of life after hysterectomy: a comparative study

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20184948 ◽

2018 ◽

Vol 7 (12) ◽

pp. 4960

Author(s):

Kusum Lata Mathur ◽

Manu Sharma ◽

Mohua Mazumdar ◽

Shikha Talati ◽

Siddharth Srivastav

Keyword(s):

Quality Of Life ◽

Marital Adjustment ◽

Comparison Group ◽

Psychiatric Morbidity ◽

Depression Scale ◽

Well Being ◽

Study Groups ◽

Life Questionnaire ◽

Gynecological Surgery

Background: Hysterectomy is the most common major gynecological surgery often performed for benign lesions. Many studies have reported adverse psychosocial outcomes post-hysterectomy. There is a paucity of studies from India addressing psychiatric morbidity after hysterectomy. To evaluate psychological wellbeing, marital adjustment and quality of life in patients undergoing hysterectomy for non-malignant conditions, in comparison with patients undergoing surgery other than hysterectomy.Methods: A cross-sectional study was conducted on 100 consecutive out-patients who underwent hysterectomy for non-malignant indications at least 6 months ago. The comparison group comprised of 50 consecutive out-patients who underwent gynecological surgery other than hysterectomy at least 6 months ago formed the comparison group. The study participants were evaluated on Hospital Anxiety and Depression Scale (HADS), Psychological General Well-being Index (PGWBI), Marital Adjustment Test (MAT) and Women’s Quality of Life Questionnaire (WOMQOL).Results: The indications for hysterectomy were: uterine leiomyoma (69%), uterovaginal prolapse (18%), dysfunctional uterine bleeding (12%), and endometriosis (1%). Abdominal hysterectomy was performed in 92 patients while 8 patients underwent vaginal hysterectomy. There were no significant differences in the study groups on scores of HADS, PGWBI, MAT and WOMQOL (p>0.05). Both the study groups had good marital adjustment and majority reported no depression and anxiety.Conclusions: There is no major psychiatric morbidity, decline in marital adjustment and quality of life after hysterectomy for benign conditions among Indian women. Future research on the ethno-cultural implications and effect of hysterectomy on mental health will be a significant addition to the available evidence in India.

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Comparison of the effects of Buteyko and pranayama breathing techniques on quality of life in patients with asthma – a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215512450521 ◽

2012 ◽

Vol 27 (2) ◽

pp. 133-141 ◽

Cited By ~ 27

Author(s):

Venkatesan Prem ◽

Ramesh Chandra Sahoo ◽

Prabha Adhikari

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Control Group ◽

Life Questionnaire ◽

Control Groups ◽

Quality Of Life Questionnaire ◽

Randomized Controlled ◽

Questionnaire Score ◽

And Control

Objective: To compare two breathing exercises (Buteyko and pranayama) with a control group in patients with asthma. Design: Randomized controlled trial. Subjects: One hundred and twenty subjects were randomized to three groups through block randomization. Subjects with an Asthma Quality of Life Questionnaire score <5.5 participated in the study. Setting: Outpatient pulmonary medicine department. Interventions: Subjects in the Buteyko and pranayama groups were trained for 3–5 days and instructed to practise the exercises for 15 minutes twice daily, and for three months duration. The control group underwent routine pharmacological management during the study period. Outcome measures: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire and pulmonary function test. Results: The baseline characteristics were similar in all three groups. Post intervention, the Buteyko group showed better trends of improvement (mean (95% confidence interval), P-value) in total Asthma Quality of Life Questionnaire score than the pranayama (0.47 (–0.008–0.95), P = 0.056) and control groups (0.97 (0.48–1.46), P = 0.0001). In comparison between the pranayama and control groups, pranayama showed significant improvement (0.50 (0.01–0.98), P = 0.042) in total Asthma Quality of Life Questionnaire score. Conclusion: The Buteyko group showed better trends of improvement in quality of life and asthma control than the group performing the pranayama breathing exercise.

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Predictors of Change in Quality of Life in Patients With End-Stage Disease During Hospitalization

Journal of Palliative Care ◽

10.1177/0825859717724687 ◽

2017 ◽

Vol 32 (2) ◽

pp. 69-76

Author(s):

Radka Bužgová ◽

Lucie Sikorová ◽

Radka Kozáková ◽

Darja Jarošová

Keyword(s):

Quality Of Life ◽

Functional Status ◽

Karnofsky Performance Status ◽

Depression Scale ◽

Life Questionnaire ◽

European Organization ◽

Stage Disease ◽

End Stage ◽

Predictors Of Change

Background: Currently, there are no studies aimed at evaluating the quality of life (QoL) of patients with end-stage disease during hospitalization and the factors that influence it. Aim: The aim of the research was to identify predictors of change in the QoL of patients hospitalized due to advanced stage of disease. Methods: The sample consisted of 140 patients with end-stage disease who were hospitalized on this account. For evaluation of QoL, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was used. The Hospital Anxiety and Depression Scale and Karnofsky Performance Status questionnaires were used for the assessment of mental and functional status. For the evaluation of predictors of negative change in QoL, a logistic regression analysis was used. Results: During hospitalization, there was a significant deterioration in the scores given for all domains of the functional QLQ-C30 scale, but not the symptomatic scale. Predictors of change in overall QoL detected were marital status, improved functional status, and depression detected on admission to hospital. Gender and age were found to be protective factors against deterioration in overall QoL. Conclusion: Sociodemographic characteristics and mental and functional status may be associated with change in QoL of patients with end-stage disease during hospitalization.

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Daflon 500 mg: Symptoms and Edema

Angiology ◽

10.1177/00033197050560i105 ◽

2005 ◽

Vol 56 (6_suppl) ◽

pp. S25-S32 ◽

Cited By ~ 11

Author(s):

Albert-Adrien Ramelet

Keyword(s):

Quality Of Life ◽

Controlled Study ◽

Venous Disease ◽

Double Blind Study ◽

Life Questionnaire ◽

Double Blind ◽

Randomized Controlled ◽

Randomized Controlled Studies ◽

Significant Difference

Patients suffering from any class of the Clinical, Etiological, Anatomical, Pathophysiological (CEAP) classification of chronic venous disease (CVD) may be symptomatic (C0s-C6s). Leg heaviness, discomfort, itching, cramps, pain, paresthesia, and edema (C3) are the most frequent manifestations of CVD and a major reason for medical consultation. Daflon 500 mg (micronized purified flavonoid fraction [MPFF]) is an effective treatment for symptoms and edema in CVD as demonstrated in several randomized controlled studies. A 2-month, double-blind study in 40 patients established the superiority of Daflon 500 mg over placebo with regard to symptoms and objective signs. This was confirmed in another double-blind, placebo-controlled trial (2 months’ treatment, 160 patients), and in the Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids (RELIEF) study. The latter included 5,052 patients in 23 countries, using a visual analog scale for evaluating pain, leg heaviness, cramps, and a sensation of swelling. All symptoms showed significant and progressive improvement. The quality-of-life results (scores on the ChronIc Venous Insufficiency quality of life Questionnaire [CIVIQ]) paralleled those of symptoms. The decrease in the ankle and calf circumferences was significantly greater (p<0.001) in the group of patients treated with Daflon 500 mg in two studies, and correlated well with the improvement in the sensation of swelling (p<0.001). This was confirmed with more sophisticated measurement techniques as in the RELIEF study or in a trial assessing edema with an optoelectronic volumeter in 20 patients. A further double-blind, randomized, controlled study established a statistically significant difference in favor of Daflon 500 mg in comparison with diosmin, both on symptoms and edema. The therapeutic efficacy of Daflon 500 mg on CVD symptoms and edema has been demonstrated in double-blind, randomized, controlled studies. Further studies using a new approach may define the most precise and validated methodology for application in future research in phlebology.

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