The Role of Oedema Protective Drugs in the Treatment of Chronic Venous Insufficiency: A Review of Evidence Based on Placebo-Controlled Clinical Trials with Regard to Efficacy and Tolerance

1996 ◽  
Vol 11 (1) ◽  
pp. 23-29 ◽  
Author(s):  
C. Diehm
Keyword(s):  
Clinical Trials ◽  
Chronic Venous Insufficiency ◽  
Therapeutic Efficacy ◽  
Venous Insufficiency ◽  
Combined Treatment ◽  
Compression Therapy ◽  
Horse Chestnut ◽  
Protective Agents ◽  
Venous Ulcers ◽  
Number Of Patients

Objective: To review the therapeutic efficacy and tolerability of oedema protective agents such as diosmin, horse chestnut extract and O-(β-hydroxyethyl)-rutosides in the treatment of chronic venous insufficiency (CVI). Data selection: Relevant clinical studies were selected if they were performed using a double-blind, placebo-controlled design with validated instrument measurement of objective criteria and measurement of subjective criteria by standardized methods. Data synthesis: Judgement of clinical effectiveness of drug treatment with venoprotective/venotropic agents was based on the signs and symptoms of CVI. Measurements; Accepted for consideration included reduction of leg oedema, related subjective symptoms, improvement of haemodynamics and microcirculation, and improved healing of venous ulcers. Tolerability of the compounds in therapeutic use was assessed by comparing the frequency of side-effects in treatment and placebo groups. Conclusion: Oedema protective agents such as diosmin, horse chestnut extract and O-(β-hydroxyethyl)-rutosides are an appropriate option in the management of CVI. The clinical efficacy can be measured objectively and quantified by assessing oedema reduction or in the case of venous ulcers by ulcer healing rates. The extent of oedema reduction in patients with CVI is equivalent to the reduction achieved by compression therapy with elastic stockings as seen in a recent clinical study. Combined treatment of oedema protective agents and compression therapy has a better clinical benefit compared with treatment with either alone. The compounds have a favourable benefit/risk ratio. They combine proven therapeutic efficacy with excellent safety of use confirmed in a large number of patients treated in clinical trials.

Multicomponent compression system use in patients with chronic venous insufficiency: a real-life prospective study

2021 ◽  
Vol 30 (5) ◽  
pp. 400-412
Author(s):  
Markus Stücker ◽  
Karl-Christian Münter ◽  
Cornelia Erfurt-Berge ◽  
Steffen Lützkendorf ◽  
Stephan Eder ◽  
...  
Keyword(s):  
Wound Healing ◽  
Observational Study ◽  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Real Life ◽  
Compression Therapy ◽  
Compression System ◽  
Compression Bandages ◽  
Number Of Patients ◽  
Ankle Mobility

Objective: Compression therapy is the cornerstone of therapeutic management of patients with chronic venous insufficiency (CVI). This study aimed to evaluate the efficacy and safety of a multicomponent compression system in an unselected population of patients with CVI problems under real-life conditions. Method: A prospective, multicentre, observational study with a multicomponent two-bandage compression system (UrgoK2, Laboratoires Urgo, France) was conducted in 103 centres in Germany. Main outcomes included wound healing rate, wound healing progression, assessment of oedema and ankle mobility, local tolerability and acceptance of the compression therapy. Results: A total of 702 patients with venous leg ulcers (VLU) and/or with lower limb oedema due to CVI were treated with the evaluated system for a mean (±standard deviation) duration of 27±17 days. By the last visit, 30.9% of wounds had healed and 61.8% had improved. Limb oedema was resolved in 66.7% of patients and an improvement of ankle mobility was reported in 44.2% of patients. The skin condition under the compression therapy was also considered as improved in 73.9% of patients and a substantial reduction of pain was achieved, both in number of patients reporting pain and in pain intensity. Compression therapy with the evaluated system was ‘very well’ or ‘well’ tolerated and ‘very well’ or ‘well’ accepted by >95% of patients. These positive outcomes were in line with the general opinion of physicians on the evaluated compression bandages, which were judged ‘very useful’ or ‘useful’ for >96.6% of patients. Similar results were reported regardless of the treated condition, VLU and/or limb oedema. Conclusion: Real-life data documented in this large observational study of non-selected patients receiving compression therapy in daily practice confirm the benefits and safety profile of the evaluated compression system. This study also confirms the high-level of performance and acceptability of the system, regardless of the characteristics of the wounds or patients at initiation of the treatment. The data support the use of this multicomponent compression system as one first-line intervention in patients with symptoms caused by CVI.

Changes in Microcirculation in Venous Ulcers with Essaven Gel

Angiology ◽  
2001 ◽  
Vol 52 (3_suppl) ◽  
pp. S23-S27 ◽  
Author(s):  
L. Incandela ◽  
G. Belcaro ◽  
M.R. Cesarone ◽  
M.T. De Sanctis ◽  
M. Griffin
Keyword(s):  
Placebo Group ◽  
Treatment Group ◽  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Local Treatment ◽  
Venous Hypertension ◽  
Controlled Study ◽  
Single Application ◽  
Venous Ulcers

Microcirculatory changes in chronic venous insufficiency (CVI) due to venous hypertension produce venous hypertensive microangiopathy (VHM) and lead to ulceration. VHM is charac terized by enlarged, convoluted capillaries; increase in flux, permeability, and edema; and altered microlymphatics. PO2 is decreased and CO2 increased. Capillary exchanges are altered and nutritional alterations in association with microtrauma may cause venous ulcers. The aim of this pilot, cross-over, randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG) (single acute application) in 10 subjects with VHM and venous ulcers. The study was structured over 3 days: day 1 was used for the control evalua tion for all patients. One group was randomized for the sequence placebo (day 2) and EG the following day; the second group with the sequence EG (day 2) and placebo (day 3). Indepen dently from the sequence, measurements of flux and PO2 in standard conditions showed positive changes (significant decrease of the abnormally increased flux, PO2 increase) in the EG treatment group. Changes in the placebo group were limited and associated with skin manip ulation. In conclusion, EG acutely improves microcirculation in limbs with VHM and ulceration even with a single application.

Surgical Treatment of the Superficial and Perforating Veins

2000 ◽  
Vol 15 (3-4) ◽  
pp. 131-136 ◽  
Author(s):  
P. Gloviczki
Keyword(s):  
Surgical Treatment ◽  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Varicose Veins ◽  
High Ligation ◽  
Ulcer Recurrence ◽  
Perforating Veins ◽  
Post Thrombotic Syndrome ◽  
Venous Ulcers ◽  
Ulcer Surgery

Objective: To review the techniques and results of surgical treatment of the superficial and perforating veins in patients with chronic venous insufficiency. Methods: The current techniques used at the Mayo Clinic for treatment of simple varicose veins and venous ulcers are presented. Results of subfascial endoscopic perforator vein surgery (SEPS) are discussed and data from large centres are tabulated. Results are compared with those reported following non-operative management. Synthesis: High ligation and invagination stripping of the incompetent segment of the saphenous vein, with stab avulsion of branch varicosities, is the optimal surgical technique to ablate superficial venous incompetence. SEPS is safer than open perforator vein ligation and is the technique of choice to interrupt incompetent perforating veins. A review of 12 series on SEPS, that included 361 limbs, found an ulcer recurrence rate of 10% in those 211 patients who underwent ablation of superficial reflux together with SEPS. One hundred and fifty limbs had SEPS alone, without saphenous stripping: ulcer recurrence in this group at a mean of 23 months was 12%. Results in primary valvular incompetence were significantly better than in post-thrombotic syndrome. Conclusions: Ablation of superficial reflux remains the main surgical treatment of all forms of chronic venous insufficiency. SEPS is safe and effective to interrupt medial calf perforators and results in rapid ulcer healing and low recurrence in patients with primary valvular incompetence. The treatment of post-thrombotic syndrome remains a challenge. Results of the North American Venous Ulcer Surgery (NAVUS) trial, a prospective, randomised, multicentre study, will be required to provide level 1 evidence of the effectiveness of surgical treatment over medical therapy in the treatment of venous ulcers.

The Chymopapain Clinical Trials

Neurosurgery ◽  
1985 ◽  
Vol 17 (1) ◽  
pp. 107-110 ◽  
Author(s):  
Stephen J. Haines
Keyword(s):  
Clinical Trials ◽  
Outcome Assessment ◽  
Therapeutic Efficacy ◽  
Selection Criteria ◽  
Randomized Clinical Trials ◽  
Successful Outcome ◽  
Relative Efficacy ◽  
Number Of Patients ◽  
Current Controversy ◽  
Probability Of Success

Abstract The three published randomized clinical trials of chymopapain injection vs. placebo injection for the treatment of herniated lumbar discs are reviewed. Despite some differences, the similarities in selection criteria, technique, and outcome assessment are great enough to justify pooling the results to obtain an overall assessment of chymopapain efficacy. These pooled results suggest that the odds of successful outcome (at least some improvement in symptoms after injection) are 2.6 times as great with chymopapain injection as those after placebo injection. This corresponds to a 50% greater probability of success with chymopapain than with placebo or a 23% increase in the number of patients successfully treated with chemonucleolysis over those successfully treated with placebo. The fact that data from 234 patients evaluated in randomized clinical trials could resolve a controversy over therapeutic efficacy that the uncontrolled evaluation of over 20,000 patients could not answer suggests that the current controversy over the relative efficacy of chymopapain and discectomy should be studied in the same way. The difficulties of such a study are discussed. (Neurosurgery 17:107-110, 1985)

Adherence to and efficacy of different compression methods for treating chronic venous insufficiency in the elderly

2016 ◽  
Vol 31 (10) ◽  
pp. 723-728 ◽  
Author(s):  
Kotaro Suehiro ◽  
Noriyasu Morikage ◽  
Osamu Yamashita ◽  
Takasuke Harada ◽  
Koshiro Ueda ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Retrospective Review ◽  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Compression Therapy ◽  
The Elderly ◽  
Compression Method

Objectives To investigate the adherence to and efficacy of different compression methods in elderly patients. Methods A retrospective review of compression therapy in 120 elderly patients (≥65 years) with chronic venous insufficiency was performed to study the initially preferred compression method, adherence to each method, and its efficacy. Results Initially, an oversize strong stocking (24%), an appropriate size moderate stocking (19%), and bandages (37%) were equally preferred. Adherence at 1 month was 69%, 96%, and 91%, respectively, and they reduced ankle circumferences in C3 patients by 1.8 ± 1.9 cm, 0.3 ± 1.7 cm, and 2.9 ± 1.7 cm, respectively. The improvement rates of C4 symptoms were 79%, 60%, and 91%, respectively. Only three patients (2%) preferred an appropriate size strong stocking. Conclusions In elderly patients, an appropriate size strong stocking was not preferred. The best adherence was achieved by using a moderate stocking, while the best efficacy was achieved by using bandages.

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