Objective: To observe the efficacy and safety of diosmin administration for patients with lower-limb chronic venous diseases (CVD) of different CEAP grades.
Methods: Two hundred and forty patients with CEAP class C0-C3 CVD and reflux of the lower limb without prior surgical treatment, and 240 patients with CEAP class C4-C6 CVD and reflux of the lower limb after long saphenous vein (LSV) stripping were enrolled, and were randomly assigned to respective study group (oral administration plus compression stocking therapy) and control group (compression stocking therapy alone). The calf circumference and subjective symptoms of the patients were examined before and after treatment, and the safety variables such as blood routine, liver function, renal function and blood glucose were determined, and the adverse events were also recorded.
Results: In the 480 patients, 24-week study was completed in 438 cases and 42 cases (8.75%) dropped out from the study. In patients with C0-C3 CVD without prior surgical treatment, the ankle circumferences of the affected leg at 4, 12 and 24 weeks after treatment were all significantly decreased in both study group and control group compared with their values before treatment, but the decreasing amplitudes were significantly greater in study group than those in control group at 12 and 24 weeks after treatment (all P<0.05); the subjective symptoms were all improved in both groups, but study group was superior to control group in terms of improving sensation of heaviness and swelling of the leg at 24 weeks after treatment (both P<0.05). In patients with C4-C6 CVD having prior surgical treatment, the ankle circumferences of the affected leg in study group at 4, 12 and 24 weeks after treatment and in control group at 12 and 24 weeks after treatment were all significantly decreased compared with their values before treatment, but the decreasing amplitudes were significantly greater in study group than those in control group at 12 and 24 weeks after treatment (all P<0.05); the subjective symptoms were all improved in both groups, but study group was superior to control group in terms of improving sensation of heaviness and swelling of the leg at 24 weeks after treatment (both P<0.05). During the study, gastrointestinal reactions occurred in 7 patients (1.60%), and those were all tolerable without causing discontinuation of medication; the observed biochemical parameters were all normal in all of the patients. 
Conclusion: Diosmin can effectively alleviate the edema and symptoms of lower-limb CVD patients of different severities, and with good safety. Therefore, it is recommended to be used as a basic medication for lower-limb CVD during the entire treatment course, with an administration time of at least 3 to 6 months.