scholarly journals Effects of daily mindfulness practice on fatigue, kinesiophobia, and quality of life in patients with acute myocardial infarction: a randomized controlled trial

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
C Karadas ◽  
M Oksul ◽  
N Ozer ◽  
L Ozdemir
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Mindfulness Practice ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Quality Of Life Scale ◽  
Tampa Scale For Kinesiophobia

Abstract Funding Acknowledgements Type of funding sources: None. Background and Aim Mindfulness meditation (MM) leads to controlled blood pressure and positive improvements in other symptoms which may trigger acute coronary diseases. The present randomized controlled study was aimed to investigate the effect of the MM on fatigue, kinesiophobia, and the quality of life (QoL) in patients with acute MI. Method The study was carried out with 56 MI patients. Participants were randomly assigned to meditation group (MG; n = 28) or control group (CG; n = 28).  The MG patients received a 15 min MM session comprising sitting and breathing for a total of eight weeks, while the CG patients received only a single-time attention-matched education. Piper Fatigue Intervention, Tampa Scale for Kinesiophobia-Heart and MacNew Quality of Life scales were utilized for data collection. Results After completion of the 8-week MM, any significant difference was not found in the fatigue scores of the patients (p > 0.05). On the other hand, kinesiophobia scores in the MG were significantly lower in the 4th, 8th and 12th weeks (p < 0.05). Similarly, the QoL scores were significantly higher in the MG in 8th week (p < 0.05). Significant change in the emotional function sub-dimension of QoL continued in the follow-up assessment at 12th week (p < 0.05). Conclusion The MM can significantly improve the QoL and decrease kinesiophobia in patients with MI. Beneficial effect of MM is maintained particularly in the emotional aspect. Based on the results of the study, MM may be recommended as a mind-body based complementary approaches within the scope of secondary protection after MI. Comparison of the study groupsGroupBaseline(Mean ± SD)4th week(Mean ± SD)8th week(Mean ± SD)12th week(Mean ± SD)PFSMM2.08 ± 1.870.90 ± 0.990.47 ± 0.780.44 ± 0.76CG1.56 ± 2.011.12 ± 1.590.98 ± 1.520.76 ± 1.33tp1.004 0.32-0.6210.54-1.5840.12-1.0850.28TSK-HMM40.25 ± 5.0436.18 ± 4.4934.39 ± 4.6134.96 ± 4.71CG41.71 ± 7.2841.89 ± 6.7441.82 ± 5.8441.00 ± 5.54tp-0.8750.39-3.7340.001-5.279 0.000-4.3900.00MacNewMM5.04 ± 0.715.53 ± 0.455.76 ± 0.475.77 ± 0.47CG5.17 ± 0.855.32 ± 0.605.37 ± 0.525.53 ± 0.46t; p-0.640; 0.531.436; 0.162.933; 0.0051.964; 0.06(Mean ± SD): Mean ± Standard Deviation; PFS: Piper Fatigue Scores; TSK-H: Tampa Scale for Kinesiophobia-Heart; MacNew: MacNew Quality of life Scale; EFS: emotional functioning sub-dimension; PFS: physical functioning sub-dimension; SFS: social functioning sub-dimension; t= Student T Test value; p< 0.05

scholarly journals Modulation of the human immune status by spinal thermal massage: a non-randomized controlled study

2021 ◽  
Keyword(s):  
Quality Of Life ◽  
Nk Cells ◽  
Nk Cell ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Experimental Group

Thermal and massage therapies have long been used to control pain. Although spinal thermal massage (STM) has been used worldwide, its effectiveness has not been proven in a controlled clinical study. We here conducted a non-randomized controlled trial to assess the pain-relieving and immunomodulatory effects of STM in old-aged patients experiencing pain or disability. The experimental group was treated with STM five times a week for 8 weeks and rehabilitative regular care (RRC). The control group was treated with only RRC. Pain and immunological parameters were tested before treatment and after 4 and 8 weeks of treatment. The scores of three pain parameters were lowered by STM, and the differences between the groups were statistically significant at the two time points (p < 0.01). Quality of life determined using the 3-level EuroQol five-dimensional questionnaire scores was significantly higher in patients in the experimental group than those in the control group. Effect sizes (ES) were in the range of medium to large in the pain-related measures (0.54–1.22). The total leukocyte counts and the proportions of lymphocytes and subsets were not significantly different between the groups, whereas the proportions of monocytes and natural killer (NK) cells were higher in the experimental group than in the control group after 8 weeks (p < 0.05). The production of interleukin (IL)-4 and interferon γ in T cells was not significantly different between the groups, whereas the production of IL-2 was high in the control group. However, there was a significant increase in IFN-γ production by NK cells in the experimental group (at 4 weeks, p < 0.05). ES were medium in the immunological measures (0.53–0.68). No significant difference was observed in the production of proinflammatory cytokines, IL-1β, tumor necrosis factor α, or IL-6 between the groups. In conclusion, STM treatment has a positive effect on subjective pain and quality of life. It also enhanced NK cell proportion and activity, suggesting that STM may be beneficial in the prevention of viral diseases and cancer in old-aged people.

Effects of the introduction of objective criteria for referral and discharge in physical therapy for ischemic stroke in China: a randomized controlled trial

2019 ◽  
Vol 34 (3) ◽  
pp. 345-356
Author(s):  
Nan Xia ◽  
Jan D Reinhardt ◽  
Shouguo Liu ◽  
Juanjuan Fu ◽  
Caili Ren ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Motor Function ◽  
Controlled Trial ◽  
Teaching Hospitals ◽  
Controlled Study ◽  
Control Group ◽  
Tier 2 ◽  
Randomized Controlled ◽  
Tier 3

Objective: To examine the effectiveness of a set of rules for referral and therapy input in a three-tiered physiotherapy program on activities of daily living (ADL), motor function, and quality of life of stroke survivors. Design: Randomized controlled study. Setting: Rehabilitation departments of 11 teaching hospitals. Subjects: A total of 285 participants with stroke. Outcome measures: Primary outcome was ADL independence measured with the Modified Barthel Index (MBI) at weeks 3, 6, 9, 13, and 17. Secondary outcomes were motor function and quality of life measured with Fugel-Meyer Assessment (FMA) and Stroke-Specific Quality-of-Life (SSQOL) scale. Intervention: Two complementary sets of rules governing rehabilitation delivery were introduced: a set of criteria that determined when someone ought to move from tier 1 onto tier 2, and from tier 2 onto tier 3, and a second set of rules that determined the amount and type of physiotherapy input given in each tier. Control group participants received conventional rehabilitation without any specified guidelines. Results: With a difference of 3.97 (95% confidence interval (CI): 1.59–6.36), MBI increased stronger in the study group than in controls between baseline and week 3 ( P = 0.001). This difference could be sustained until study end-point. No significant differences were found for FMA. Differences in increase of SSQOL were higher in the intervention than control at week 9 ( P < 0.05). Conclusion: Introduction of a set of rules for referral and therapy input at different stages of rehabilitation partially improved patients’ ADL and quality of life, but did not improve motor function.

scholarly journals The efficacy of acupressure in managing opioid-induced constipation: Single-blind a randomized controlled study

2021 ◽  
Author(s):  
DİLEK YILDIRIM ◽  
Vildan KOCATEPE ◽  
Gül KÖKNEL TALU
Keyword(s):  
Quality Of Life ◽  
Negative Impact ◽  
Controlled Trial ◽  
Routine Care ◽  
Controlled Study ◽  
Life Questionnaire ◽  
Control Groups ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Purpose Opioid-induced constipation is one of the heath problems with a negative impact on the quality of life. This randomized-controlled trial aimed to investigate the effects of acupressure therapy on the management of opioid-induced constipation. Methods The trial was conducted on 140 patients, who were assigned to the acupressure (n = 70) and the control groups (n = 70). In addition to routine care, patients in the acupressure group received 8-min acupressure from the Zhongwan (CV12), Guanyuan (CV4) and Tianshu (ST25) acupoints once a day for 4 weeks. The outcomes included Defacationa Diary (DD), Visual Analog Scale Questionnaire (VASQ) and Patient assessment of constipation quality of life questionnaire (PAC-QOL). Results DD scores obtained by the acupressure and the control groups. There was a statistically significant difference between the acupressure and control groups in terms of stool consistency (2.22 ± .49 vs 1.80 ± .55) (p = 0.001), straining (1.98 ± .71 vs 2.91 ± .37) (p = 0.001), incomplete evacuation (0.37 ± .29 vs 0.61 ± .43) (p = 0.001), stool amount (0.93 ± .14 vs .95 ± .20) (p = 0.001) and the number of defecations (0.70 ± .22 vs 0.46 ± .29), (p = 0.001) measured at the fifth week. Besides, with the exception of stool amount, there was a statistically significant increase in the DD scores obtained by the acupressure group between the first and the fifth weeks. Inter-group comparison of the pre-test and post-test scores showed that acupressure group obtained statistically significantly higher scores from the PAC-QOL (p = .0001). Conclusions Findings of this trial suggested that 4-week acupressure was an effective way to improve the quality of life and reduce both subjective and objective constipation symptoms in patients with opioid-induced constipations.

scholarly journals Home-based Palliative Intervention to Improve Quality of Life in Children with Cancer: A Randomized Controlled Trial

2019 ◽  
Author(s):  
Murti Andriastuti ◽  
Pricilia G Halim ◽  
Elnino Tunjungsari ◽  
Dwi P Widodo
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Children With Cancer ◽  
Randomized Controlled ◽  
Home Based ◽  
Significant Difference

Abstract Background: In these last few years, an integrated approach between palliative care (PC) and chronic and/or life-threatening conditions care have been widely used. Home-based PC service is developed to meet the needs of the patients at home, but hasn’t been applied widely. This study is aimed to determine the benefit of integrated home-based PC in the quality of life (QOL) and symtomps intensity of Indonesian children with malignancies. Method: A randomized controlled trial to compare the quality of life between patients who were given PC (a 3-month home visit) and those who were not (intervention vs control group) was conducted, each group containing 30 children with cancer aged 2-18 years old who were consulted to palliative team. Participants were randomly assigned into each group. In the first and twelfth week of the intervention, all patients were assessed with the Pediatric Quality of Life Inventory (PedsQLTM) questionnaire cancer module 3.0 (report by proxy or self-report). Symptoms intensity (pain, anorexia, sleep disturbance) were scored by using Edmonton Symptoms Assessment Scale (ESAS). Mean score and each dimension score of both group were compared and analyzed using bivariate analysis. Results: A total 50 participants were included in analysis. Significant difference was found between two groups with average total score in control group 62.39 and intervention group 81.63 (p<0.001). In the intervention group QoL tends to improve, whereas in the control group, those did not get palliative intervention, quality of life tends to decrease as the disease progress. The most improved aspect in QoL is pain and nausea (p<0.001), followed by procedural anxiety (p=0.002), treatment anxiety (p=0.002), and worry (p=0.014). Palliative intervention was found to be able to reduce sleep disturbances (p=0.003) and anorexia (p<0.001) significantly. Conclusion: Home-based PC improved several aspects of the QOL and provide better symptoms management of children with malignancies. An early intervention concurrent with the underlying treatment is believed to be able to improve their quality of life. Trial Registration: This study has been retrospectively registered in ClinicalTrials.gov ID: NCT04067687 (August, 22nd 2019).

scholarly journals Asthma in Adolescents: A Randomized, Controlled Trial of an Asthma Program for Adolescents and Young Adults with Severe Asthma

2002 ◽  
Vol 9 (4) ◽  
pp. 253-259 ◽  
Author(s):  
Robert L Cowie ◽  
Margot F Underwood ◽  
Cinde B Little ◽  
Ian Mitchell ◽  
Sheldon Spier ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Asthma Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Disease Specific

BACKGROUND: Asthma is common and is often poorly controlled in adolescent subjects.OBJECTIVE: To determine the impact of an age-specific asthma program on asthma control, particularly on exacerbations of asthma requiring emergency department treatment, and on the quality of life of adolescents with asthma.METHODS: The present randomized, controlled trial included patients who were 15 to 20 years of age and had visited emergency departments for management of their asthma. The interventional group attended an age-specific asthma program that included assessment, education and management by a team of asthma educators, respiratory therapists and respiratory physicians. In the control group, spirometry was performed, and the patients continued to receive usual care from their regular physicians. The outcomes were assessed by a questionnaire six months after entry into the study.RESULTS: Ninety-three subjects entered the study and were randomly assigned to the intervention or control group. Of these, only 62 patients were available for review after six months. Subjects in both the control and the intervention groups showed a marked improvement in their level of asthma control, reflected primarily by a 73% reduction in the rate of emergency department attendance for asthma. Other indexes of disease control, including disease-specific quality of life, as assessed by questionnaires, were improved. There was, however, no discernible difference between the subjects in the two groups, with the exception of an improvement in favour of the intervention group in the symptom (actual difference 0.7, P=0.048) and emotional (actual difference 0.8, P=0.028) domains of the asthma quality of life questionnaire. The overall quality of life score favoured the intervention group by a clinically relevant difference of 0.6, but this difference did not reach statistical significance (P=0.06).CONCLUSIONS: Although all subjects demonstrated a significant improvement in asthma control and quality of life, the improvement attributable to this intervention was limited to two domains in disease-specific quality of life.

scholarly journals The Effectiveness of Hope Therapy on Improving the Elderly Quality of Life

2019 ◽  
Author(s):  
Hassan Zareei Mahmoodabadi ◽  
Mansoreh Nourian ◽  
Seyed Reza Reza Javadian ◽  
Elahe Fallah Tafti
Keyword(s):  
Quality Of Life ◽  
Elderly Women ◽  
The Elderly ◽  
Controlled Study ◽  
Daily Care ◽  
Significant Difference ◽  
Quality Of Life Scale ◽  
Hope Therapy ◽  
Experimental Group

Background: Elderly is an era of life, which affects quality of life; aging changes the thinking ways and reduces the self-confidence. The present study was conducted to evaluate the effect of hope therapy on the elderly quality of life in Mehriz, Yazd in 2016 - 2017. Methods: In this controlled study with pre-test post-test design, the study population consisted of all elderly people who referred to daily care centers of Mehriz. The sample consisted of 24 elderly women in the daily care centers, who were divided into two groups of experimental (n = 12) and awaiting (n = 12).Hope therapy was provided in eight sessions for the experimental group. The instrument used in this research was Quality of Life Scale for the Elderly. Results: The MANOVA results showed a significant difference between the experimental and awaiting groups. In the experimental group, physical function, depression, anxiety, mental performance, and life satisfaction improved, but education did not affect the sex dimension. Hope therapy, was effective on improving the elderly quality of life. Conclusion: The studied training can be used as an effective treatment to improve the elderly quality of life.

Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Kathleen P. O'Hora ◽  
Raquel A. Osorno ◽  
Dena Sadeghi-Bahmani ◽  
Mateo Lopez ◽  
Allison Morehouse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Early Treatment ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact ◽  
Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

scholarly journals M51. EFFICACY OF “PRAGMACOM TRAINING” IN SCHIZOPHRENIA: A RCT ON A NOVEL PRAGMATIC INTERVENTION

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S153-S153
Author(s):  
Giulia Agostoni ◽  
Elisabetta Tonini ◽  
Mariachiara Buonocore ◽  
Margherita Bechi ◽  
Maria Paola Silvestri ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Executive Functions ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Daily Functioning ◽  
Control Group ◽  
Abstract Thinking ◽  
Metaphor Comprehension ◽  
Quality Of Life Scale

Abstract Background A pragmatic disruption is observed in several clinical conditions and especially in schizophrenia. It is estimated that over 75% of patients affected by schizophrenia present a pervasive and wide impairment of pragmatic abilities, encompassing both comprehension and production abilities, thus confirming the hypothesis of a wide Pragmatic Language Disorder in schizophrenia. More specifically, the comprehension of figurative languages, such as metaphors, idioms, and irony, is the most compromised domain in schizophrenia. Poor pragmatics has a relevant impact on daily functioning, by contributing to social isolation and lower quality of life. Only few pragmatic treatments have been developed and tested in schizophrenia, focusing only on specific pragmatic features and without using a Randomized Controlled Trial (RCT) design. This study aimed at investigating the efficacy of PragmaCom Training (PT), a novel 12-weeks intervention specifically developed to enhance pragmatics in schizophrenia. Methods 30 patients with schizophrenia, according to DSM 5, were randomly assigned to PT to an active control group (ACG). All patients were assessed for global pragmatics with the Assessment of Pragmatic Abilities and Cognitive Substrates test, APACS), metaphor comprehension (Physical and Mental Metaphors task, PMM), executive functions (Brief Assessment of Cognition in Schizophrenia, Tower of London score, BACS), abstract thinking (Positive and Negative Syndrome Scale for Schizophrenia, N5 score, PANSS), and daily functioning (Quality of Life Scale, QLS). To quantify the magnitude of changes after the PT, effect sizes were estimated using Cohen’s d (Cohen, 1988) for APACS, PMM, PANSS N5 Score, and QLS only in PT Group. The effect of PT in enhancing pragmatic abilities, the abstract thinking and daily functioning was tested between groups by means of several ANCOVA, entering post-training measures as dependent variables, measures at the baseline and executive functions as covariates, and treatment (PT vs ACG) as grouping variables. Results Patients treated with PT showed small to medium-large effect-sizes in global pragmatics (0.25), metaphors comprehension (0.72), functioning (0.23), and abstract thinking (-0.18). ANCOVAs revealed a significant effect of PT in enhancing global pragmatic abilities (F=5.4, p=.03), metaphor comprehension (F=8.94, p=.007) and abstract thinking (F=8.1, p=.01). No significant effect was found for functioning. Discussion This is the first study using a RCT design to test the efficacy of a pragmatic training. PT is a novel training specifically developed to target the pragmatic impairments that characterize schizophrenia. This study confirms the efficacy of PT in improving multiple domains, encompassing global pragmatics, the comprehension of figurative language, and abstract thinking in schizophrenia. Impact on functioning is also expected. However, in line with literature, it is likely to occur at later time points, since it requires the chance to apply the enhanced abilities in ecological contexts.

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

2012 ◽  
Vol 27 (2) ◽  
pp. 133-141 ◽  
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.

Daflon 500 mg: Symptoms and Edema

Angiology ◽  
2005 ◽  
Vol 56 (6_suppl) ◽  
pp. S25-S32 ◽  
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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