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.

Calcium dobesilate in patients suffering from chronic venous insufficiency: a double-blind, placebo-controlled, clinical trial

2011 ◽  
Vol 26 (4) ◽  
pp. 162-168 ◽  
Author(s):  
E Rabe ◽  
K A Jaeger ◽  
M Bulitta ◽  
F Pannier
Keyword(s):  
Treatment Period ◽  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Multicentre Trial ◽  
Controlled Clinical Trial ◽  
Calcium Dobesilate ◽  
Compression Stockings ◽  
Double Blind ◽  
Volume Calculation ◽  
Cone Model

Objective To test the efficacy of calcium dobesilate (CaD) in chronic venous insufficiency (CVI). Method Double-blind, parallel groups, placebo-controlled, multicentre trial in adult patients with symptomatic CVI and pitting oedema. Wearing of compression stockings Class II was admitted. During treatment period of eight weeks, the patients received CaD 3 × 500 mg/day or placebo. The leg volume calculation was based on a truncated cone model. Results A total of 256 patients was randomized to treatment (dobesilate: n = 132, placebo: n = 124); the demographic and anamnestic data at admission were comparable in the two therapeutic groups. The volume of the lower calf diminished in the dobesilate group at the end of the active treatment period by −64.72 ± 111.93 cm3 (mean ± SD), independent of the concomitant usage of compression stockings versus placebo +0.8 ± 152.98 cm3 ( P = 0.0002). The symptoms of pain, discomfort, heavy legs, tired legs, tingling, itching and cramps, as well as the global assessments by investigators and patients, also improved significantly ( P < 0.05) better in the dobesilate group at the end of the treatment. The observed adverse events correspond to the known profile. Conclusion Dobesilate reduces leg oedema and improves the symptoms of objectively diagnosed CVI, independent of the concomitant usage of compression stockings.

scholarly journals A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer’s dementia

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Shifu Xiao ◽  
Piu Chan ◽  
Tao Wang ◽  
Zhen Hong ◽  
Shuzhen Wang ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Controlled Trial ◽  
Drug Effects ◽  
Disease Assessment ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Difference

Abstract Background New therapies are urgently needed for Alzheimer’s disease (AD). Sodium oligomannate (GV-971) is a marine-derived oligosaccharide with a novel proposed mechanism of action. The first phase 3 clinical trial of GV-971 has been completed in China. Methods We conducted a phase 3, double-blind, placebo-controlled trial in participants with mild-to-moderate AD to assess GV-971 efficacy and safety. Participants were randomized to placebo or GV-971 (900 mg) for 36 weeks. The primary outcome was the drug-placebo difference in change from baseline on the 12-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog12). Secondary endpoints were drug-placebo differences on the Clinician’s Interview-Based Impression of Change with caregiver input (CIBIC+), Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, and Neuropsychiatric Inventory (NPI). Safety and tolerability were monitored. Results A total of 818 participants were randomized: 408 to GV-971 and 410 to placebo. A significant drug-placebo difference on the ADAS-Cog12 favoring GV-971 was present at each measurement time point, measurable at the week 4 visit and continuing throughout the trial. The difference between the groups in change from baseline was − 2.15 points (95% confidence interval, − 3.07 to − 1.23; p < 0.0001; effect size 0.531) after 36 weeks of treatment. Treatment-emergent adverse event incidence was comparable between active treatment and placebo (73.9%, 75.4%). Two deaths determined to be unrelated to drug effects occurred in the GV-971 group. Conclusions GV-971 demonstrated significant efficacy in improving cognition with sustained improvement across all observation periods of a 36-week trial. GV-971 was safe and well-tolerated. Trial registration ClinicalTrials.gov, NCT02293915. Registered on November 19, 2014

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.

scholarly journals Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Tsuyoshi Miyaoka ◽  
Motohide Furuya ◽  
Jun Horiguchi ◽  
Rei Wake ◽  
Sadayuki Hashioka ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Treatment Resistant ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Intention To Treat ◽  
The Difference ◽  
The Individual

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted.Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS).Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54:−0.23±0.08; placebo:−0.03±0.08,P<0.018), tension (TJ-54:−0.42±0.09; placebo:−0.18±0.09,P<0.045), and poor impulse control (TJ-54:−0.39±0.10; placebo:−0.07±0.10,P<0.037).Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

scholarly journals A 36-week Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel-group, Phase 3 Clinical Trial of Sodium Oligomannate for Mild-to-Moderate Alzheimer's Dementia

2020 ◽  
Author(s):  
Shifu Xiao ◽  
Piu Chan ◽  
Tao Wang ◽  
Zhen Hong ◽  
Shuzhen Wang ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Controlled Trial ◽  
Drug Effects ◽  
Disease Assessment ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Difference

Abstract Background: New therapies are urgently needed for Alzheimer’s disease (AD). Sodium oligomannate (GV-971) is a marine-derived oligosaccharide which reconstitutes gut microbiota, reduces neuroinflammation, decreases amyloid deposition, and improves cognition in AD animal models. The first phase 3 clinical trial of GV-971 has been completed in China. Methods: We conducted a phase 3, double-blind, placebo-controlled trial in participants with mild-to-moderate AD to assess GV-971 efficacy and safety. Participants were randomized to placebo or GV-971 (900 mg) for 36 weeks. The primary outcome was the drug-placebo difference in change from baseline on the 12-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog12). Secondary endpoints were drug-placebo differences on the Clinician’s Interview-Based Impression of Change with caregiver input (CIBIC+), Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, and Neuropsychiatric Inventory (NPI). Safety and tolerability were monitored. Results: 818 participants were randomized: 408 to GV-971 and 410 to placebo. A significant drug-placebo difference on the ADAS-Cog12 favoring GV-971 was present at each measurement time-point, measurable at the week 4 visit and continuing throughout the trial. The difference between groups in change from baseline was −2.15 points (95% confidence interval, −3.07 to −1.23; P<0.0001; effect size 0.531) after 36 weeks treatment. Treatment-emergent adverse event incidence was comparable between active treatment and placebo (73.9%, 75.4%). Two deaths determined to be unrelated to drug effects occurred in the GV-971 group.Conclusions: GV-971 demonstrated significant efficacy in improving cognition with sustained improvement across all observation periods of a 36-week trial. GV-971 was safe and well tolerated. Trial registration: ClinicalTrials.gov, NCT02293915. Registered on November 19, 2014.

scholarly journals Effect of oligofructose supplementation on body weight in overweight and obese children: a randomised, double-blind, placebo-controlled trial

2014 ◽  
Vol 112 (12) ◽  
pp. 2068-2074 ◽  
Author(s):  
Anna Liber ◽  
Hania Szajewska
Keyword(s):  
Body Weight ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Obese Children ◽  
Double Blind ◽  
Body Weight Reduction ◽  
Score Difference ◽  
The Difference ◽  
Total Body ◽  
And Control

Limited evidence suggests that the dietary inclusion of oligofructose, an inulin-type fructan with prebiotic properties, may increase satiety and, thus, reduce energy intake and body weight in overweight and obese adults. The aim of the present study was to assess the effect of oligofructose supplementation for 12 weeks on the BMI of overweight and obese children. A total of ninety-seven children aged 7–18 years who were overweight and obese (BMI >85th percentile) were randomly assigned to receive placebo (maltodextrin) or oligofructose (both at an age-dependent dose: 8 g/d for children aged 7–11 years and 15 g/d for children aged 12–18 years) for 12 weeks. Before the intervention, all children received dietetic advice and they were encouraged to engage in physical activity. The primary outcome measure was the BMI-for-age z-score difference between the groups at the end of the intervention. Data from seventy-nine (81 %) children were available for analysis. At 12 weeks, the BMI-for-age z-score difference did not differ between the experimental (n 40) and control (n 39) groups (mean difference 0·002, 95 % CI − 0·11, 0·1). There were also no significant differences between the groups with regard to any of the secondary outcomes, such as the mean BMI-for-age z-score, percentage of body weight reduction and the difference in total body fat. Adverse effects were similar in both groups. In conclusion, oligofructose supplementation for 12 weeks has no effect on body weight in overweight and obese children.

scholarly journals Treatment of acute bronchitis in adults with extract of Pelargonium Sidoides: a randomised, double-blind, placebo controlled trial

2007 ◽  
pp. 49-55
Author(s):  
A. G. Chuchalin ◽  
B. Berman ◽  
V. Lemakher
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Controlled Trial ◽  
Alternative Therapy ◽  
Acute Bronchitis ◽  
Complete Recovery ◽  
Primary Outcome Measure ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Pelargonium Sidoides

Acute bronchitis is a wide-spread disease. Although it is generally caused by viruses, antibiotics are used for its treatment too much often. So it is very important to evaluate alternative therapy of acute bronchitis. The aim of the trial was to assess efficacy and safety of Pelargonium Sidoides (EPs 7630 is a registered trademark of Dr. Willmar Schwabe GmbH & Co, Karlsruhe, Germany) compared to placebo in patients with acute bronchitis. Study design: randomised, double-blind, placebo controlled trial with planned interim analysis. The trial centres: 6 outpatient medical centres. Patients: 124 adult patients with acute bronchitis, onset of the disease ≤ 48 h, and severity of symptoms ≥ 5 according to BSS scale gave written informed concert. EPs 7630 or placebo were administered in the dose of 30 drops t.i.d. during 7 days. The primary outcome measure was BSS scoring at the 7th day of the treatment. BSS scoring decreased by 7.2 ± 3.1 in the EPs 7630 group (n = 64) vs 4.9 ± 2.7 in the placebo group (n = 60). 95 % confidence interval (CI, 1.21, 3.56) for difference of the effects between two groups demonstrated significant improvement in the EPs 7630 in 7 days of the treatment compared to the placebo group (p < 0.0001). The EPs 7630 patients had parameters of complete recovery for every of 5 individual symptoms reliably higher compared to placebo patients. During the first 4 days of the treatment therapeutic effect was noted in 68.8 % of the EPs 7630 group vs 33.3 % of the placebo group (p < 0.0001). Health-related quality of life improved better in the EPs 7630 patients compared to the placebo group. Adverse events were found in 25 of 124 patients: 15 / 64 in the EPs 7630 group and 10 / 60 in the placebo group. All the adverse events were considered as non-serious. The efficacy of EPs 7630 in treatment of adults with acute bronchitis was higher compared to placebo. It could be an efficient alternative drug in therapy of acute bronchitis at the absence of indications for antibiotics administration.

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