Abstract
Objective:
To evaluate the efficacy and the tolerability of micronized purified flavonoid fraction (MPFF) on symptoms and signs of acute haemorrhoidal disease (HD).
Research design and methods:
Patients experiencing an acute HD episode for less than 48 h were enrolled in this randomized, double-blind, placebo-controlled study (n = 90 in two hospital-based study centres in Beijing). One group received MPFF, six tablets per day for 4 days followed by four tablets per day for 3 days and the other a placebo. Symptoms and signs of HD were assessed by blinded observers at day (D0), day 4 (D4), and day 7 (D7) on a 4-point severity grading scale (from 1 = absent to 4 = severe). A two-way variance analysis was performed for comparison between groups.
Results:
Forty-nine patients (49) in the MPFF group and 41 in the placebo group (mean age 43.2 years [range 18-76 years]), percentage of male gender 54.4%, mean time from onset of acute episode 45.3 h (range 16-48 h) were included in this analysis. No significant differences between groups were seen at baseline in terms of age, gender, and frequency and intensity of symptoms, except for oedema, whose frequency and severity was significantly greater in the MPFF group (p = 0.024). During the 7-day treatment, there was a significant difference in favour of MPFF in the evolution of pain and oedema (p < or = 0.001 at D7) and in bleeding (p = 0.021 at D4, and p = 0.047 at D7). The appreciation of global efficacy by patients (p = 0.007) or investigators (p = 0.006) also favoured MPFF. Blood pressure, heart rate and laboratory parameters remained within normal ranges and were not modified during the study in either group. No patient had to stop the treatment owing to adverse events and only one patient reported gastrointestinal discomfort.
Conclusion:
MPFF significantly reduced the extent of pain and bleeding in the selected subjects of this study with acute haemorrhoids. The tolerability was similar in patients receiving MPFF to that in patients receiving a placebo during the 7-day duration of the treatment.MPFF can be considered an effective and well-tolerated agent in the treatment of acute episodes of haemorrhoids.
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