Randomized clinical trial of micronized flavonoids in the early control ofbleeding from acute internal haemorrhoids

Background: Patients with acute bleeding from internal haemorrhoids often h ave to be referred by the general practitioner to the surgeon for definitiv e treatment with invasive outpatient procedures. At the initial consultatio n, patients frequently seek postponement of immediate surgery to a more con venient time. Effective and rapid non-invasive control of acute bleeding co uld be of practical use in scheduling surgery to a time convenient to both patient and surgeon. Methods: In a 90-day randomized, double-blind study treatment with a micron ized purified flavonoid fraction (MPFF) was compared with placebo, in 100 o utpatients who presented for treatment of acute internal haemorrhoids of le ss than 3 days' duration. The primary endpoint was cessation of bleeding on the third day of treatment. Results: Of 50 patients randomized to each group, acute bleeding ceased by the third day in 40 (80 per cent) who received MPFF compared with 19 (38 pe r cent) who had placebo (P < 0.01). Mean(s.d.) duration of acute bleeding f rom onset to cessation of 4.9(1.6) days was 2.1 (95 per cent confidence int erval 1.2-2.9) days less than that in patients receiving placebo (P < 0.01) . Continued treatment in patients with no bleeding prevented a relapse in 3 0 of 47 patients, compared with 12 of 30 receiving placebo (P < 0.05). Conclusion: Patients with acute internal haemorrhoids treated with MPFF had rapid cessation of bleeding and a reduced risk of relapse. This could be o f value in the more convenient timing of treatment with invasive outpatient procedures.