Phlebotonics for venous insufficiency

Abstract

Analysis 2.1. Comparison 2: Sensitivity analysis excluding studies that allowed the use of elastic stockings, Outcome 1: Oedema in the lower legs (dichotomous variable

Is There a Difference in the Clinical Efficacy of Diosmin and Micronized Purified Flavonoid Fraction for the Treatment of Chronic Venous Disorders? Review of Available Evidence

“…A Cochrane review and meta-analysis of phlebotonics for venous insufficiency, published in 2020, analyzed 56 randomized, double-blind, placebo-controlled trials involving 7690 participants. 24 Ten trials with MPFF out of forty using flavonoids were included. 24 The meta-analysis suggests that oral venoactive drugs considered as a whole reduce lower leg oedema (risk ratio (RR) 0.70, 95% confidence interval (CI) 0.63 to 0.78) and ankle circumference (mean difference −4.27 mm, 95% CI −5.61 to −2.93 mm) compared with placebo.…”

“…24 Ten trials with MPFF out of forty using flavonoids were included. 24 The meta-analysis suggests that oral venoactive drugs considered as a whole reduce lower leg oedema (risk ratio (RR) 0.70, 95% confidence interval (CI) 0.63 to 0.78) and ankle circumference (mean difference −4.27 mm, 95% CI −5.61 to −2.93 mm) compared with placebo. Little or no effect was evidenced for ulcer healing (RR 0.94, 95% CI 0.79 to 1.13).…”

“…21 This latter study has never been included in a systematic review or meta-analysis. 22 In 1995, Henriet et al conducted a Phase III clinical study to compare the efficacy of non-micronized diosmin 600 mg (Diovenor ® 600 mg) once a day vs MPFF 500 mg (Daflon ® 500 mg) twice a day in CVD. 17 It was a prospective, comparative, randomized, double-blind, double-dummy study performed in nine French centers in women aged 18 to 45 years old suffering from pain and/or heaviness in the two lower limbs for at least 6 months.…”

P-valor e dimensão do efeito em estudos clínicos e experimentais

“…Furthermore, particularly when dealing with larger samples, detection of low p -values may not indicate a clinically sensitive effect that leads to changes to medical paradigms. In an important systematic review conducted by Martinez-Zapata et al 27 on the subject of phlebotonics for venous insufficiency, it was suggested that phlebotonics are superior, on the basis of their statistical significance (p < 0.05), but the effect size observed was the result of a mean reduction of just 4.27 mm (95%CI 2.93–5.61 mm) in ankle circumference in 2,010 participants (15 studies), which, although true, does not indicate an evident benefit for patients with edema of the lower limbs.…”

“…Por outro lado, especialmente, em amostragens mais vultosas, o encontro de p-valores reduzidos pode não representar em um efeito clinicamente sensível que leve à mudança de paradigmas médicos. Na importante revisão sistemática de Martinez-Zapata et al 27 sobre ventonônicos em insuficiência venosa, foi sugerida a superioridade de drogas venotônicas devido a sua significância estatística (p < 0,05), porém, a dimensão do efeito encontrada resultou em uma redução média de apenas 4,27 mm (IC95% 2,93–5,61 mm) na circunferência do tornozelo de 2.010 participantes (15 estudos), o que, apesar de verdadeiro, não representa um benefício evidente para o paciente com edema dos membros inferiores.…”