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.

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 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.

Comparison of the effect of Myrtus communis herbal and anti-hemorrhoid ointments on the hemorrhoid symptoms and quality of life in postpartum women with grade I and II internal hemorrhoid: A triple-blinded randomized controlled clinical trial

2019 ◽  
Vol 16 (4) ◽  
Author(s):  
Jamileh Malekuti ◽  
Mojgan Mirghafourvand ◽  
Khadijeh Samadi ◽  
Fatemeh Abbasalizadeh ◽  
Laleh Khodaei
Keyword(s):  
Quality Of Life ◽  
Intervention Group ◽  
World Health ◽  
Control Group ◽  
Life Questionnaire ◽  
Myrtus Communis ◽  
World Health Organization Quality ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Introduction Due to the effects of hemorrhoids on physical and mental health, this study aimed to compare the effect of Myrtus communis herbal and anti-hemorrhoid ointments on symptoms of hemorrhoid and quality of life (primary outcomes) and satisfaction of the treatment and side effects (secondary outcomes). Methods This triple-blind randomized controlled trial was performed on women with grade I and II hemorrhoid referring to health centers in Tehran, Iran, in 2017. Individuals were randomly assigned to two groups of 67 people through block randomization method. The intervention group received the Myrtus communis herbal ointment and the control group received anti-hemorrhoid ointment twice a day, every 12 ± 2 h, an applicator of the drug through the rectum for 4 weeks. The Colorectal Evaluation of a Clinical Therapeutics Scale (CORECTS) was used to assess the severity of symptoms of hemorrhoid. To assess the quality of life, the World Health Organization Quality of Life questionnaire (WHOQOL-BREF) was used to measure the general quality of life of participants. This questionnaire was completed once before the start of the study, then on the fourth and the eighth week after the start of the intervention. Repeated measure ANOVA, Chi-square, Mann–Whitney U and independent t-test were used for data analysis. Results The severity of all symptoms of hemorrhoid decreased in both two group and there was no statistically significant difference between the two groups (p>0.05). However, the mean of anal itching at 4 and 8 weeks after the intervention was significantly lower in the Myrtus communis ointment group (p<0.05). There was no significant difference between groups in terms of quality of life at 4 and 8 weeks after the intervention (p>0.05). There was a significant difference between the two groups in terms of satisfaction with the drug (p=0.019) and the participants in the Myrtus communis ointment group were more satisfied with their drug use. Conclusions Myrtus communis herbal ointment was able to reduce the symptoms of hemorrhoid in the affected women. Therefore, it is likely that the use of this drug will promote the health of mothers with hemorrhoid.

scholarly journals Effectiveness of acupuncture, ozonio therapy and low-intensity laser in the treatment of temporomandibular dysfunction of muscle origin: a randomized controlled trial

2019 ◽  
Vol 48 ◽  
Author(s):  
Síglia Adriana Campos TORTELLI ◽  
Leonardo SARAIVA ◽  
Daniela Cristina MIYAGAKI
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Laser Therapy ◽  
Controlled Trial ◽  
Mouth Opening ◽  
Life Questionnaire ◽  
Ozone Therapy ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Introduction One of the most common causes of orofacial pain is temporomandibular disorder (TMD). Objective The aim of this study was to compare the effectiveness of acupuncture, ozone therapy and laser therapy in the treatment of muscle TMD patients through a randomized controlled trial. Material and method Twelve professors and postgraduate students from the University of Passo Fundo, diagnosed with TMD, aged between 23 and 50 years old, of both sexes, were evaluated. Individuals were randomly divided into 3 groups: G1: laser therapy, G2: acupuncture, and G3: ozone therapy. TMD diagnostic questionnaires (RDC / TMD), Quality of Life Questionnaire (OHIP-14), Pain Scale (VAS) and maximum mouth opening were applied. Descriptive statistics and percentage were used for sample characterization, which were presented using absolute and relative frequency distributions. Qualitative variables were analyzed with Wilcoxon tests p≤0.05. Result There was no statistically significant difference between treatments. Regarding pain and maximum mouth opening, the groups showed no statistical difference when individually analyzed, but when compared in general, they did (p=0.002 and p=0.003). Conclusion It can be considered that all treatments were able to decrease pain and improve maximal opening capacity related to muscle TMD. It can also be concluded that the TMD-related quality of life, in relation to the pain variable, was generally effective when compared before and after the interventions.

scholarly journals Randomised, Double-Blind, Placebo-Controlled Study of Iguratimod in the Treatment of Active Spondyloarthritis

2021 ◽  
Vol 8 ◽  
Author(s):  
Yan Li ◽  
Kunpeng Li ◽  
Zheng Zhao ◽  
Yanyan Wang ◽  
Jingyu Jin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Physical Function ◽  
Combined Treatment ◽  
Final Analysis ◽  
Spinal Mobility ◽  
Controlled Study ◽  
Double Blind ◽  
Significant Difference

Background and Purpose: The effect of Iguratimod in the treatment of rheumatoid arthritis was confirmed in past studies. In terms of the mechanism of the effect and clinical application experience, Iguratimod has a potential value in the treatment of spondyloarthritis (SpA). This study evaluated the efficacy and safety of Iguratimod on active SpA.Methods: Subjects with active SpA were enrolled and randomly divided into two groups at a ratio of 1:2 (placebo vs. Iguratimod). On the basis of non-steroidal anti-inflammatory drugs, combined treatment with Iguratimod or placebo, followed by follow-up every 4 weeks for 24 weeks. The primary efficacy endpoint was to evaluate the alleviation rate of ASAS20; the important improvement of ASDAS and the efficacy of spinal mobility, physical function and quality of life at the 24th week.Results: A total of 48 cases in the Iguratimod group and 25 cases in the placebo group were included in the final analysis. On the 24th week, the percentage of responders to ASAS20 (80 vs. 44%) and ASAS40 (56 vs. 20%) treated with Iguratimod were significantly higher than that in the placebo group (P &lt; 0.05). Twelve cases had gastrointestinal discomfort, of which eight were in the Iguratimod group (16.7%, one case withdrew from the study due to diarrhoea) and four were in the placebo group (16.0%). No significant difference was found between the two groups (P &lt; 0.05). Three cases of elevated transaminase were observed in the Iguratimod group and none in the placebo group, with no significant difference (P &lt; 0.05).Conclusion: Iguratimod could significantly reduce the symptoms and signs of patients with active SpA. It could improve the physical function and quality of life of these patients and the overall safety and tolerance are good.

An Open, Pilot Study to Evaluate the Potential Benefits of Coenzyme Q10 Combined with Ginkgo Biloba Extract in Fibromyalgia Syndrome

2002 ◽  
Vol 30 (2) ◽  
pp. 195-199 ◽  
Author(s):  
RE Lister
Keyword(s):  
Quality Of Life ◽  
Coenzyme Q10 ◽  
Ginkgo Biloba ◽  
Fibromyalgia Syndrome ◽  
Ginkgo Biloba Extract ◽  
Controlled Study ◽  
Life Questionnaire ◽  
Self Rating ◽  
Significant Difference

An open, uncontrolled study was undertaken to measure the subjective effects of coenzyme Q10 combined with a Ginkgo biloba extract in volunteer subjects with clinically diagnosed fibromyalgia syndrome. Anecdotal reports from patients with fibromyalgia syndrome have claimed benefits from the use of these supplements. The aim of this study was to determine if these reports could be substantiated in a pilot clinical trial. Patient questioning had determined that poor quality of life was a major factor in the condition and a quality-of-life questionnaire was used to measure potential benefit. Subjects were given oral doses of 200 mg coenzyme Q10 and 200 mg Ginkgo biloba extract daily for 84 days. Quality of life was measured, using the well-validated Dartmouth Primary Care Cooperative Information Project/World Organization of Family Doctors (COOP/WONCA) questionnaire that measures seven different subjective responses, at 0-, 4-, 8- and 12-week intervals. The subjects were asked for an overall self-rating at the end of the study. A progressive improvement in the quality-of-life scores was observed over the study period and at the end, the scores showed a significant difference from those at the start. This was matched by an improvement in self-rating with 64% claiming to be better and only 9% claiming to feel worse. Adverse effects were minor. A controlled study is now planned.

scholarly journals An External CAM Therapy (Tian Jiu) versus Placebo in Treatment of Allergic Rhinitis: A Pilot Single-Blinded, Three-Arm, Randomized Controlled Study

2019 ◽  
Vol 2019 ◽  
pp. 1-11 ◽  
Author(s):  
Liang Dai ◽  
Linda L. D. Zhong ◽  
Wai Kun ◽  
Wai Ching Lam ◽  
Zhen Yang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Placebo Group ◽  
Nasal Obstruction ◽  
Nasal Symptom ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Life Questionnaire ◽  
Randomized Controlled

Allergic rhinitis (AR) is one of the common allergic diseases in clinical practice and significantly impairs the quality of life (QoL) of patients. The conventional treatments are not satisfactory because of various reasons. Tian Jiu (TJ) therapy is a characteristic external intervention of complementary and alternative medicine (CAM) and has been widely utilized in the management of AR. However, the evidences resulted from current studies were generally poor due to high risk of bias. Therefore, we conducted this rigorous designed, single-blinded, three-arm, randomized controlled study to evaluate the efficacy and safety of TJ therapy on AR. Totally 138 AR patients were enrolled. The TJ group and placebo group received 4-week treatment with either TJ or placebo patches for 2 hours each time applied to Dazhui (GV 14), bilateral Feishu (UB 13), and bilateral Shenshu (UB 23) one session per week and then underwent a 4-week follow-up. The waitlist group received no treatment during the corresponding treatment period, but would be given compensatory TJ treatment in the next 4 weeks. The primary outcome was the change of the Total Nasal Symptom Score (TNSS) after treatment. The secondary outcomes included the changes of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and rescue medication score (RMS). After treatment, the total TNSS in TJ group was significantly reduced compared with baseline, but showed no statistical meaning compared with placebo. Among the four domains of TNSS, the change of nasal obstruction exhibited statistical difference compared with placebo group. The total RQLQ score in TJ group was significantly reduced compared with both placebo and waitlist groups. The needs of rescue medications were no distinct difference between two groups. In summary, this study showed potential effectiveness of TJ therapy in improving nasal obstruction symptoms and QoL of AR patients.

scholarly journals The Effect of Mulligan Mobilization Technique in Older Adults with Neck Pain: A Randomized Controlled, Double-Blind Study

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Oznur Buyukturan ◽  
Buket Buyukturan ◽  
Senem Sas ◽  
Caner Karartı ◽  
İsmail Ceylan
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Neck Pain ◽  
Group Treatment ◽  
Treatment Programs ◽  
Double Blind Study ◽  
Functional Level ◽  
Double Blind ◽  
Randomized Controlled

Background. The purpose of this study was to examine the effect of Mulligan mobilization technique (MMT) on pain, range of motion (ROM), functional level, kinesiophobia, depression, and quality of life (QoL) in older adults with neck pain (NP).Methods. Forty-two older adults with NP were included in the study, and they were randomly divided into two groups: traditional physiotherapy (TP) group and traditional physiotherapy-Mulligan mobilization (TPMM) group. Treatment program was scheduled for 10 sessions. Participants were assessed in terms of pain, ROM, functional level, kinesiophobia, depression, and QoL both pre- and posttreatment.Results. Pain, ROM, functional level, kinesiophobia, depression, and QoL improved in both groups following treatment (p<0.05). When comparing effects of these two treatment programs, it was observed that the TPMM group had a better outcome (p<0.05) in terms of ROM, kinesiophobia, depression, and QoL.Conclusion. In older adults with NP, MMT has been found to have significant effects on pain, ROM, functional level, kinesiophobia, depression, and QoL as long as it is performed by a specialist. “This trial is registered withNCT03507907”.

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 &gt; 0.05). On the other hand, kinesiophobia scores in the MG were significantly lower in the 4th, 8th and 12th weeks (p &lt; 0.05). Similarly, the QoL scores were significantly higher in the MG in 8th week (p &lt; 0.05). Significant change in the emotional function sub-dimension of QoL continued in the follow-up assessment at 12th week (p &lt; 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&lt; 0.05

scholarly journals OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine over one year of treatment: Pooled results from the PREEMPT randomized clinical trial program

Cephalalgia ◽  
2016 ◽  
Vol 36 (9) ◽  
pp. 899-908 ◽  
Author(s):  
Richard B Lipton ◽  
Noah L Rosen ◽  
Jessica Ailani ◽  
Ronald E DeGryse ◽  
Patrick J Gillard ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Migraine ◽  
Life Questionnaire ◽  
Open Label ◽  
Double Blind ◽  
Significant Difference ◽  
Related Quality ◽  
Prophylaxis Therapy ◽  
Clinical Trial Program

Background Chronic migraine (CM) is associated with high impact and reduced health-related quality of life (HRQoL). Methods Patients with CM from PREEMPT (Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy) were randomized (1:1) to receive onabotulinumtoxinA or placebo for two 12-week cycles in the double-blind (DB) phase, followed by three 12-week cycles of open-label (OL) onabotulinumtoxinA (onabotulinumtoxinA/onabotulinumtoxinA (O/O) and placebo/onabotulinumtoxinA (P/O) groups, respectively). HRQoL endpoints were assessed over 56 weeks using the Headache Impact Test (HIT-6) and the Migraine-Specific Quality of Life Questionnaire (MSQ). HIT-6 score reductions ≥2.3 and ≥5 denoted between-group minimally important difference and within-patient clinically meaningful response, respectively. Results A total of 1236 participants (O/O, n = 607; P/O, n = 629) participated in both phases. The DB phase showed significantly reduced HIT-6 and MSQ for onabotulinumtoxinA versus placebo (all p < 0.001). The OL phase showed significantly reduced HIT-6 for O/O versus P/O at weeks 28, 36, and 48, but not 56. All three MSQ domains showed improved HRQoL relative to baseline, but only the role restrictive domain showed a significant difference between O/O and P/O at week 56. Conclusions Benefits of onabotulinumtoxinA on HRQoL versus baseline persisted throughout the OL phase. Statistical superiority in favor of O/O was demonstrated for HIT-6 through 48 weeks and for MSQ (role restrictive) at 56 weeks.

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