A randomised controlled trial of micronised purified flavonoid fraction vs placebo in patients with chronic venous disease.

OBJECTIVE: to evaluate the efficacy of a micronised purified flavonoid fraction (MPFF) in the treatment of chronic venous disease (CVD). DESIGN: prospective double blind, randomised, control study. PATIENTS and METHODS: one hundred and one patients with symptomatic CVD were randomly allocated to treatment for 60 days with either MPFF (51 patients) or placebo (50 patients) 500 mg twice daily. There were 28 men and 73 women, aged 22-65 years (mean age 48 years). No difference regarding age, gender, clinical class or duration of symptoms was recorded between the treatment and placebo groups. A global score for evaluation of symptoms was used. Patients were investigated with plethysmography (foot-volumetry) and duplex-ultrasonography before and after the treatment period. For statistical comparison Cochran-Mantel-Haenszel test, two-sided Student t-test and covariance analysis were used and p<0.05 was regarded significant. RESULTS: improvement of the global score of symptoms was reported by 21 patients in the MPFF group and by 16 in the placebo group (N.S.). For the whole groups, no significant differences were recorded before and after treatment regarding foot-volumetric or ultrasonographic parameters. On the other hand, in patients with edema (20 in the MPFF group, 23 in the placebo group) ultrasonographic reflux time was significantly reduced for those in the treatment group (p=0.03). This finding did not correlate to clinical symptoms. CONCLUSION: in this study, MPFF did not change the symptoms of CVD, except night cramps. A secondary finding was reduced reflux times in patients with oedema, although no ultrasonographic or foot-volumetric parameters changed significantly for the whole group. The role of MPFF in treatment of patients with CVD needs to be further analysed in a large population.