The quality of evidence is downgraded by study limitations (unclear allocation concealment).
A Cochrane review [Abstract] 1 on oral or topical phlebotonics in chronic venous insufficiency (CVI) included 69 studies and analysed data from 56 studies, with a total of 7 690 subjects. Phlebotonics represent a heterogeneous group of venoactive medications, mostly natural flavonoids extracted from plants and synthetic products with flavonoid-like properties. Of the trials included in the efficacy analysis, 28 were of rutosides, 11 of hidrosmine and diosmine, 10 of calcium dobesilate, 2 of centella asiatica, 2 of french maritime pine bark extract, 2 of aminaftone and 1 of grape seed extract. No studies evaluating topical phlebotonics, chromocarbe, naftazone or disodium flavodate fulfilled the inclusion criteria.
Phlebotonics reduced oedema (RR 0.70, 95% CI 0.63 to 0.78; 13 studies, n=1 245) and ankle circumference (MD -4.27 mm, 95% CI -5.61 to -2.93 mm; 15 studies, n=2 010) compared with placebo. There was no difference in the proportion of ulcers cured with phlebotonics compared with placebo (RR 0.94, 95% CI 0.79 to 1.13; 6 studies, n=461), and little or no difference in quality of life compared with placebo (SMD -0.06, 95% CI -0.22 to 0.10; 5 studies, n=1 639). Phlebotonics increased adverse events slightly compared to placebo (RR 1.14, 95% CI 1.02 to 1.27; 37 studies, n=5 789). Gastrointestinal disorders were the most frequently reported adverse events.
Comment: Studies included in this review provided only short-term safety data; therefore, the middle- and long-term safety of phlebotonics could not be estimated.
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