Chronobiology and Clinical Activity of Dation 500 mg in Chronic Venous Insufficiency

1994 ◽  
Vol 9 (1_suppl) ◽  
pp. 15-18 ◽  
Author(s):  
G. Menyhei ◽  
G. Acsady ◽  
A. Hetenyi ◽  
D. Dubeaux ◽  
G. Rado
Keyword(s):  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Controlled Trial ◽  
Clinical Signs ◽  
Vascular Diseases ◽  
Clinical Activity ◽  
Therapeutic Activity ◽  
Double Blind ◽  
Drug Administration Schedule ◽  
Group A

Objective: To assess the chronobiological effect on therapeutic activity of Daflon 500 mg and to determine the optimum method of administration. Design: Multicentre, randomized, double-blind, controlled trial. Setting: Hospital outpatient clinics for vascular diseases in Hungary. Patients: Three hundred and twenty ambulatory patients with symptoms of chronic venous insufficiency randomized to three groups. Interventions: Oral administration daily of 1000 mg of Daflon 500 mg for 2 months in three different ways (morning or evening or morning and evening). Main outcome measures: Symptoms and clinical signs of chronic venous insufficiency. Results: In each group, a statistically significant improve ment was observed between the first (DO) and the last visit (D60) concerning all symptoms. Oedema disappeared in a mean percentage of patients ranging between 26% and 43%, according to the group and the side affected ( p <0.001). For the most affected leg, a significant decrease ( p <0.001) of ankle and calf circumferences was observed in each group. The first significant improvement, in comparison to DO, occurred between D15 and D30 for all symptoms and ankle circumference. The comparison between the groups did not disclose any difference concerning the improvement of symptoms and signs. Conclusion: In this study, Daflon 500 mg demonstrated its therapeutic activity in chronic venous insufficiency, irrespective of the daily drug administration schedule.

Effectiveness and safety of calcium dobesilate in treating chronic venous insufficiency: randomized, double-blind, placebo-controlled trial

2004 ◽  
Vol 19 (3) ◽  
pp. 123-130 ◽  
Author(s):  
K-H Labs ◽  
S Degischer ◽  
G Gamba ◽  
K A Jaeger
Keyword(s):  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Calcium Dobesilate ◽  
Double Blind ◽  
Volume Calculation ◽  
Double Blind Placebo ◽  
Cone Model ◽  
The Difference

Objective: To determine whether calcium dobesilate is effective in reducing chronic venous insufficiency-related peripheral oedema. Methods: Randomized, double-blind, placebo-controlled, multicentre, parallel-group study in 253 consecutive outpatients with chronic venous insufficiency (CEAP C3-C4). The patients were treated for four weeks with either calcium dobesilate (CaD) 500 mg three times a day or matching placebo. The primary outcome measure was the reduction in lower leg volume. The leg volume calculation was based on a truncated cone model Results: Active drug treatment resulted in a median reduction of the leg volume of 25.5 ± 33.6 ml/l tissue. The difference in the median change of the leg volume between the treatment groups at week 4 was -12.2 ml/l tissue (95 % CI -21.6 to -2.8; P =0.01). In contrast with the placebo, the effects of CaD were independent of the duration of CVI and most pronounced in more severely diseased patients. Safety variables did not differ significantly between groups. Conclusions: Calcium dobesilate is an effective and well tolerated treatment for chronic venous insufficiency.

Double-Blind Trial of the Efficacy of Troxerutin in Chronic Venous Insufficiency

1994 ◽  
Vol 9 (2) ◽  
pp. 71-76 ◽  
Author(s):  
F. Vin ◽  
A. Chabanel ◽  
A. Taccoen ◽  
J. Ducros ◽  
J. Gruffaz ◽  
...  
Keyword(s):  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Varicose Veins ◽  
Controlled Trial ◽  
Erythrocyte Aggregation ◽  
Double Blind ◽  
Significant Difference ◽  
Dual Action ◽  
Dissociation Threshold ◽  
Venous Function

Objective: To evaluate the efficacy of troxerutin in chronic venous insufficiency. Design: Randomized, double-blind, multicentre, prospective controlled trial. Setting: Hôtel Dieu Hospital and Notre Dame de Bon Secours Hospital, Paris, France. Patients: Sixty-nine patients with truncal varicose veins. Intervention: After a single-blind 15-day placebo run-in period, one group ( n = 34) received troxerutin 3500 mg daily for 2 months. The other group ( n = 35) received a placebo. Main outcome measures: Subjective symptoms, ankle circumference, venous refilling time with photoplethysmography, erythrocyte aggregation using the SEFAM aggregameter and fibrinogen level. Results: Leg aching ( p < 0.001) and venous function score ( p < 0.001) improvements were significantly higher in the troxerutin group (83% and −3.7) compared with the placebo group (23% and −0.7). A significant difference in favour of troxerutin was found for erythrocyte aggregation kinetic indexes ( p < 0.001) and dissociation threshold ( p < 0.01). Conclusions: This study confirmed the dual action of the drug: a parietal effect and a rheological effect.

The effect of external ventricular drain tunneling length on CSF infection rate in pediatric patients: a randomized, double-blind, 3-arm controlled trial

2021 ◽  
pp. 1-8
Author(s):  
Esmaeil Mohammadi ◽  
Sara Hanaei ◽  
Sina Azadnajafabad ◽  
Keyvan Tayebi Meybodi ◽  
Zohreh Habibi ◽  
...  
Keyword(s):  
Infection Rate ◽  
Pediatric Patients ◽  
Controlled Trial ◽  
External Ventricular Drain ◽  
Hazard Ratio ◽  
Spontaneous Discharge ◽  
Standard Group ◽  
Double Blind ◽  
Group A ◽  
Group B

OBJECTIVE The role of tunneling an external ventricular drain (EVD) more than the standard 5 cm for controlling device-related infections remains controversial. METHODS This is a randomized, double-blind, 3-arm controlled trial done in the Children’s Medical Center in Tehran, Iran. Pediatric patients (< 18 years old) with temporary hydrocephalus requiring an EVD and no evidence of CSF infection or prior EVD insertion were enrolled. Patients were randomly assigned (1:1:1) into the following arms: 5-cm (standard; group A); 10-cm (group B); or 15-cm (group C) EVD tunnel lengths. The investigators, parents, and person performing the analysis were masked. The surgeon was informed of the length of the EVD by the monitoring board just before operation. Patients were followed until the EVD’s fate was established. Infection rate and other complications related to EVDs were assessed. RESULTS A total of 105 patients were enrolled in three random groups (group A = 36, group B = 35, and group C = 34). The EVD was removed because there was no further need in most cases (67.6%), followed by conversion to a new EVD or ventriculoperitoneal shunt (15.2%), infection (11.4%), and spontaneous discharge without further CSF diversion requirement (5.7%). No statistical difference was found in infection rate (p = 0.47) or EVD duration (p = 0.81) between the three groups. No group reached the efficacy point sooner than the standard group (group B: hazard ratio 1.21, 95% CI 0.75–1.94, p = 0.429; group C: hazard ratio 1.03, 95% CI 0.64–1.65, p = 0.91). CONCLUSIONS EVD tunnel lengths of 5 cm and longer did not show a difference in the infection rate in pediatric patients. Indeed, tunneling lengths of 5 cm and greater seem to be equally effective in preventing EVD infection. Clinical trial registration no.: IRCT20160430027680N2 (IRCT.ir)

Comparative Effectiveness of Amoxicillin and Amoxicillin-Clavulanate Potassium in Acute Paranasal Sinus Infections in Children: A Double-Blind, Placebo-Controlled Trial

PEDIATRICS ◽  
1986 ◽  
Vol 77 (6) ◽  
pp. 795-800 ◽  
Author(s):  
Ellen R. Wald ◽  
Darleen Chiponis ◽  
Jocyline Ledesma-Medina
Keyword(s):  
Group A Streptococcus ◽  
Maxillary Sinusitis ◽  
Controlled Trial ◽  
Relative Effectiveness ◽  
Nasal Discharge ◽  
Cure Rate ◽  
Double Blind ◽  
Amoxicillin Clavulanate ◽  
Group A ◽  
To Receive

This study compared the relative effectiveness of two antimicrobial preparations, amoxicillin and amoxicillin-clavulanate potassium (Augmentin), in the treatment of acute maxillary sinusitis in children 2 to 16 years of age. Of 171 children with persistent (ten to 30 days' duration) nasal discharge or daytime cough or both, 136 (80%) had abnormal maxillary sinus radiographs. These children were stratified by age and severity of symptoms and randomly assigned to receive either amoxicillin, amoxicillin-clavulanate potassium, or placebo. After the exclusion of 28 children with throat cultures positive for group A Streptococcus and 15 who did not complete their medication, the remaining 93 children were evaluated: 30 received amoxicillin, 28 received amoxicillin-clavulanate potassium, and 35 received placebo. Clinical assessment was performed at three and ten days. On each occasion, children treated with an antibiotic were more likely to be cured than children receiving placebo (P &lt; .01 at three days, P &lt; .05 at ten days). The overall cure rate was 67% for amoxicillin, 64% for amoxicillin-clavulanate potassium, and 43% for placebo.

Chronic Venous Insufficiency of the Upper Limb Due to Outflow Obstruction of Venous Access

1988 ◽  
Vol 3 (4) ◽  
pp. 265-270
Author(s):  
A. Halevy ◽  
A. Zelikovski ◽  
D. Modai ◽  
Y. Swissgarten ◽  
R. Orda
Keyword(s):  
Upper Limb ◽  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Clinical Signs ◽  
Venous Access ◽  
Lower Limbs ◽  
Vein Thrombosis ◽  
Short Period ◽  
Cubital Fossa ◽  
Deep Vein

Two patients with angio-access for haemodialysis in whom the main venous outflow tract was thrombosed, developed severe chronic venous insufficiency (CVI) of the upper limb after a short period; one case developing a stasis ulcer of the cubital fossa. The angio-accesses were still functioning when the diagnosis was made. Treatment by surgery resulted in a dramatic regression of clinical signs of chronic venous insufficiency. CVI of the upper limb has not previously been described. CVI is a frequent and known complication after deep vein thrombosis (DVT) of the lower limbs, but never appears after DVT of the upper limbs. We describe two cases of upper limb CVI which developed as a complication of angio-access for haemodialysis treatment, and their successful treatment by surgery.

Traditional Acupuncture for Reflex Sympathetic Dystrophy: A Randomised, Sham-Controlled, Double-Blind Trial

1995 ◽  
Vol 13 (2) ◽  
pp. 78-80 ◽  
Author(s):  
E Ernst ◽  
KL Resch ◽  
V Fialka ◽  
D Ritter-Dittrich ◽  
Y Alcamioglu ◽  
...  
Keyword(s):  
Reflex Sympathetic Dystrophy ◽  
Rating Scale ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Outcome Variable ◽  
Controlled Study ◽  
Double Blind ◽  
Subjective Success ◽  
Group A

Acupuncture has been suggested as helpful in reflex sympathetic dystrophy (RSD), but no controlled study has yet been published. The hypothesis of this randomised, double-blind, sham-controlled trial, therefore, was that traditional Chinese acupuncture improves subjective as well as objective signs in this condition. Patients were included when suffering from clinically and scintigraphically confirmed acute RSD of the upper or lower limb, with a history between one and four months. They were randomly assigned to either traditional acupuncture (group A) or sham acupuncture (group S). Treatments were applied five times a week for three weeks, each session lasting for 30 minutes. Both groups received identical standard treatments in addition. The primary outcome variable had been pre-defined to be pain, as measured by visual analogue scale assessed before each treatment. Subjective success was also recorded by the patients on a rating scale. Due to force of circumstances, only 14 patients were entered into the study, therefore no test statistics could be performed and the data was evaluated descriptively. At baseline, pain was almost identical in both groups. During the course of the study, patients in group A demonstrated a more pronounced reduction of pain: 28.6% ± 1.9 vs 17.9% ± 2.4 (Mean ± SEM). Similarly, subjective success was rated to favour traditional acupuncture. It is concluded that acupuncture may be useful in the management of pain in patients with acute RSD, but that the present results are not conclusive. Larger, rigorous studies are required to answer the question.

scholarly journals Acute dose-response effect of coffee-derived chlorogenic acids on the human vasculature in healthy volunteers: a randomized controlled trial

2020 ◽  
Author(s):  
Louise H Naylor ◽  
Diane Zimmermann ◽  
Marjorie Guitard-Uldry ◽  
Laure Poquet ◽  
Antoine Lévêques ◽  
...  
Keyword(s):  
Endothelial Function ◽  
Controlled Trial ◽  
Coffee Consumption ◽  
Epidemiological Studies ◽  
Internal Diameter ◽  
Chlorogenic Acids ◽  
Double Blind ◽  
Positive Tendency ◽  
Group A ◽  
Dose Response Effect

ABSTRACT Background Epidemiological studies have reported lower risk of cardiovascular disease with moderate coffee consumption. In addition, emerging evidence indicates that consumption of coffee beverages enriched in chlorogenic acids (CGAs) may influence blood pressure and endothelial function, suggesting that the beneficial cardiovascular effect of coffee may relate to its CGA content. Objectives We conducted a double-blind randomized crossover trial to test the effect of acute consumption of a decaffeinated green coffee extract (DGCE), rich in CGAs, on endothelial function in healthy subjects. Methods We compared 3 different doses of DGCE (302, 604, and 906 mg, respectively) with a placebo. Endothelial function was defined as the percentage change in the internal diameter of the brachial artery in response to flow-mediated dilation (%FMD). In addition, we followed the plasma concentration-time profiles of 25 systemic CGA metabolites over 24 h after DGCE consumption and we explored the relation between systemic concentrations of CGAs and the effect on %FMD. Results The DGCE formulations containing different amounts of CGAs resulted in dose-proportional increases in overall total polyphenol concentrations. The systemic appearance of total CGAs was biphasic, in agreement with previous results suggesting 2 sites of absorption in the gastrointestinal tract. Compared with the placebo group, a significant FMD increase (&gt;1%) was observed 8.5, 10, and 24 h after consumption of 302 mg DGCE (∼156.4 mg CGAs). The differences with placebo observed in the other 2 groups were not statistically significant. Evaluation of the relation between phenolic exposure and %FMD showed a positive tendency toward a larger effect at higher concentrations and different behavior of CGA metabolites depending on the conjugated chemical position. Conclusions We demonstrated an acute improvement in %FMD over time after ingestion of a DGCE, explained at least partly by the presence in the blood circulation of CGAs and their metabolites. This trial was registered at clinicaltrials.gov as NCT03520452.

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