A double-blind clinical trial of hydroxyethylrutosides in the treatment of the symptoms and signs of chronic venous insufficiency

Objective: To study the safety and efficacy of hydroxyethylrutosides (HR) in patients with chronic venous insufficiency (CVI) (Widmer grade II) and examine any correlation with objective measurements (plethysmography and TcPo2). Design: Double-blind, randomized, placebo-controlled, multicentre trial. Setting: One outpatient university angiology clinic, one outpatient angiology clinic in a military hospital and one private angiological consultation, all in the Paris area. Patients: One hundred and nine patients with grade II Widmer CVI, confirmed by echo-Doppler and plethysmography. Elastic stockings were excluded. After five exclusions, 53 received HR and 51 placebo. Interventions: Patients randomized to one sachet of 1 g HR twice daily (or placebo) for 2 months, after a 1 month placebo run-in period. Examinations on entry to the trial (T--1), after 1 month run-in (T--0) and after 1 (T-+1) and 2 months (T-+2) treatment. Main outcome measures: These were measured at each of the four visits. Primary outcome: minimal ankle and maximal calf circumferences. Secondary outcomes: five individual leg symptoms and total symptom score, pitting oedema. Plethysmography (six calculated variables) and TcPo2. Results: The reduction of both ankle and calf circumferences was significantly greater in the HR group (p<0.0001), as was pitting oedema (p<0.001), the five individual symptoms and the total symptom score (p<0.001). Of the plethysmographic findings, there was a significant reduction in maximum venous outflow (p<0.001 at T-+1 and p<0.05 at T-+2) Overall there was no significant change in TcPo2. Conclusions: HR is an effective and well-tolerated treatment for leg oedema and symptoms of patients with CVI.