Micronized Purified Flavonoid Fraction in Hemorrhoid Disease: A Systematic Review and Meta-Analysis

Parvez Sheikh, Varut Lohsiriwat, Yury Shelygin, Parvez Sheikh, Varut Lohsiriwat, Yury Shelygin

Abstract

Introduction: Hemorrhoidal disease (HD) is a common and recurrent problem for many adults worldwide. Venoactive drugs, such as micronized purified flavonoid fraction (MPFF; Daflon®), have been used to treat HD and their clinical benefits have been demonstrated in previous meta-analyses of clinical trials. The aim of this study was to evaluate the efficacy of MPFF across the broader spectrum of signs and symptoms following treatment of patients with HD.

Methods: We performed a systematic review of the literature to identify randomized clinical trials in which MPFF treatment was compared to placebo or no treatment for acute HD or for relief of symptoms after patients had undergone medical management or a surgical procedure to remove hemorrhoids. The main endpoints investigated were bleeding, pain, pruritus, discharge or leakage, and overall improvement. There was no limit on treatment duration.

Results: From 351 unique records retrieved, 11 studies reported in 13 articles were included. On the basis of findings from qualitative analysis, MPFF was reported in most studies to be beneficial in treating bleeding, pain, pruritus, anal discharge/leakage, and tenesmus, and in overall improvement. Quantitative meta-analysis of four studies indicated that MPFF treatment provided significant benefits for bleeding (odds ratio [OR] 0.082, 95% confidence interval [CI] 0.027-0.250; P < 0.001), discharge/leakage (OR 0.12, 95% CI 0.04-0.42; P < 0.001), and overall improvement according to patients (OR 5.25, 95% CI 2.58-10.68; P < 0.001) and investigators (OR 5.51, 95% CI 2.76-11.0; P < 0.001). MPFF also tended to decrease pain (OR 0.11, 95% CI 0.01-1.11; P = 0.06).

Conclusion: Taken together, these results suggest that MPFF treatment can improve the most important signs and symptoms of HD.

Keywords: Hemorrhoidal disease; Hemorrhoidectomy; Hemorrhoids; MPFF; Micronized purified flavonoid fraction; Venoactive drugs.

Figures

Fig. 1
Fig. 1
PRISMA flow diagram. HD hemorrhoidal disease, MPFF micronized purified flavonoid fraction RCT randomized controlled trial
Fig. 2
Fig. 2
Forest plot comparisons of MPFF versus placebo for bleeding in acute HD after 7 days of treatment. In a pooled analysis of two studies using the fixed-effect (Mantel–Haenszel) method, micronized purified flavonoid fraction (MPFF) treatment was associated with a beneficial and statistically significant effect for bleeding in acute hemorrhoidal disease (odds ratio [OR] 0.08, 95% confidence interval [CI] 0.03–0.25; P < 0.001) with no statistical heterogeneity (I2 = 0%) (a). Results were similar in a sensitivity analysis that included a third study (Jiang 2006) in which the bleeding endpoint was heterogeneous (OR 0.10, 95% CI 0.04–0.27; P < 0.001) (b)
Fig. 3
Fig. 3
Forest plot comparison of MPFF versus placebo for pain in acute hemorrhoidal disease after 7 days of treatment. In a pooled analysis of two studies, micronized purified flavonoid fraction (MPFF) treatment was associated with a beneficial but not statistically significant effect for pain in acute hemorrhoidal disease (odds ratio [OR] 0.11 95% confidence interval [CI] 0.01–1.11, P = 0.06) with high statistical heterogeneity (I2 = 84.6%)
Fig. 4
Fig. 4
Forest plot comparison of MPFF versus placebo for discharge or leakage after 7 days of treatment. In a pooled analysis of two studies using the fixed-effect (Mantel–Haenszel) method, micronized purified flavonoid fraction (MPFF) treatment was associated with a beneficial and statistically significant effect for discharge or leakage in acute hemorrhoidal disease (odds ratio [OR] 0.12, 95% confidence interval [CI] 0.04–0.42; P < 0.001) with no statistical heterogeneity (I2 = 0%)
Fig. 5
Fig. 5
Forest plot comparisons of MPFF versus placebo for overall improvement according to patient and to investigator after 7 days of treatment. In a pooled analysis of three studies using the fixed-effect (Mantel–Haenszel) method, micronized purified flavonoid fraction (MPFF) treatment was associated with a beneficial and statistically significant effect for overall improvement according to patients (odds ratio [OR] 5.25, 95% confidence interval [CI] 2.58–10.68; P < 0.001) with no statistical heterogeneity (I2 = 0%) (a). In a pooled analysis of two studies using the fixed-effect (Mantel–Haenszel) method, MPFF treatment was associated with a beneficial and statistically significant effect for overall improvement according to investigators (OR 5.51, 95% CI 2.76–11.00; P < 0.001) with no statistical heterogeneity (I2 = 0%) (b)

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