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Evidence summaries

Phlebotonics for Venous Insufficiency

Phlebotonics appear to have limited efficacy for oedema and for some signs and symptoms related to chronic venous insufficiency with more adverse events compared to placebo. They may not influence ulcer healing. Level of evidence: "B"

The quality of evidence is downgraded by study limitations (unclear allocation concealment).

Summary

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.

References

  • Martinez-Zapata MJ, Vernooij RW, Simancas-Racines D et al. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev 2020;(11):CD003229. [PubMed].

Primary/Secondary Keywords