Phiebotonics for venous insufficiency
Por:
Martinez-Zapata, MJ, Vernooij, RWM, Simancas-Racines, D, Tuma, SMU, Steins, AT, Carriles, RMMM, Vargas, E, Cosp, XB
Publicada:
1 ene 2020
Resumen:
Background
Chronic venous insufficiency (CVI) is a condition in which veins are unable to transport blood unidirectionally towards the heart. CVI usually occurs in the lower limbs. It might result in considerable discomfort, with symptoms such as pain, itchiness and tiredness in the Legs. Patients with CVI may also experience swelling and ulcers. Phlebotonics are a class of drugs often used to treat CVI. This is the second update of a review first published in 2005.
Objectives
To assess the efficacy and safety of phlebotonics administered orally or topically for treatment of signs and symptoms of lower extremity CVI.
Search methods
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and Clinicaltrials.gov trials register up to 12 November 2019. We searched the reference lists of the articles retrieved by electronic searches for additional citations. We also contacted authors of unpublished studies.
Selection criteria
We included randomised, double-blind, placebo-controlled trials (RCTs) assessing the efficacy of phlebotonics (rutosides, hidrosmine, diosmine, calcium dobesilate, chromocarbe, Centeila asiatica, disodium flavodate, French maritime pine bark extract, grape seed extract and aminaftone) in patients with CVI at any stage of the disease.
Data collection and analysis
Two review authors independently extracted data and assessed the quality of included RCTs. We estimated the effects of treatment by using risk ratios (RRs), mean differences (MDs) and standardized mean differences (SMDs), according to the outcome assessed. We calculated 95% confidence intervals (as) and percentage of heterogeneity (12). Outcomes of interest were oedema, quality of life (QoL), assessment of CVI and adverse events. We used GRADE criteria to assess the certainty of the evidence.
Main results
We identified three new studies for this update. In total, 69 RCTs of oral phiebotonics were included, but only 56 studies (7690 participants, mean age 50 years) provided quantifiable data for the efficacy analysis. These studies used different phlebotonics (28 on rutosides, 11 on hidrosmine and diosmine, 10 on calcium dobesilate, two on Centella asiatica, two on aminaftone, two on French maritime pine bark extract and one on grape seed extract). No studies evaluating topical phlebotonics, chromocarbe, naftazone or disodium flavodate fulfilled the inclusion criteria.
Moderate-certainty evidence suggests that phlebotonics probably reduce oedema slightly in the lower legs, compared with placebo (RR 0.70, 950/0 CI 0.63 to 0.78; 13 studies; 1245 participants); and probably reduce ankle circumference (MD -4.27 mm, 950/0 CI -5.61 to -2.93 mm; 15 studies; 2010 participants). Moderate -certainty evidence shows that phlebotonics probably make little or no difference in QoL compared with placebo (SMD -0.06, 95% CI -0.22 to 0.10; five studies; 1639 participants); and similarly, may have littEe or no effect on ulcer healing (RR 0.94,95% CI 0.79 to 1.13; six studies; 461 participants; low-certainty evidence). Thirty-seven studies reported on adverse events. Pooled data suggest that phiebotonics probably increase adverse events sEightly, compared to placebo (RR 1.14, 95% CI 1.02 to 1.27; 37 studies; 5789 participants; moderate -certainty evidence). Gastrointestinal disorders were the most frequently reported adverse events. We downgraded our certainty in the evidence from 'high' to 'moderate' because of risk of bias concerns, and further to 'low' because of imprecision.
Authors' conclusions
There is moderate-certainty evidence that phiebotonics probably reduce oedema slightly, compared to placebo; moderate -certainty evidence of little or no difference in QoL; and low-certainty evidence that these drugs do not influence ulcer healing. Moderate -certainty evidence suggests that phlebotonics are probably associated with a higher risk of adverse events than placebo. Studies included in this systematic review provided only short-term safety data; therefore, the medium- and long-term safety of phlebotonics could not be estimated. Findings for specific groups of phlebotonics are limited due to small study numbers and heterogeneous results. Additional high quality RCTs focusing on clinically important outcomes are needed to improve the evidence base.
Filiaciones:
Martinez-Zapata, MJ:
Biomed Res Inst St Pau IIB St Pau, CIBER Epidemiol & Salud Publ CIBERESP, Iberoamer Cochrane Ctr, Barcelona, Spain
Vernooij, RWM:
Univ Med Ctr Utrecht, Dept Nephrol & Hypertens, Utrecht, Netherlands
Univ Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, Utrecht, Netherlands
Simancas-Racines, D:
Univ Tecnol Equinoccial, Ctr Invest Salud Publ & Epidemiol Clin CISPEC, Fac Ciencias Salud Eugenio Espejo, Cochrane Ecuador, Quito, Ecuador
Tuma, SMU:
Vali Hebron Univ Hosp, Prevent Med & Publ Hlth, Barcelona, Spain
Steins, AT:
Univ Fed Ciencias Saude, Dept Publ Hlth, Porto Alegre, RS, Brazil
Carriles, RMMM:
Universitary Hosp La Princesa, Angiol Vasc & Endovasc Surg, Madrid, Spain
Vargas, E:
Univ Complutense Madrid, Hosp Clin San Carlos, Madrid, Spain
Cosp, XB:
Univ Autonoma Barcelona, Iberoamer Cochrane Ctr, Biomed Res Inst St Pau IIB St Pau, CIBER Epidemiol & Salud Publ CIBERESP, Barcelona, Spain
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