Evaluation of Hilo® Versus Daflon® in Patients Suffering from Hemorrhoids: A Randomized, Controlled, Open-labelled, Multicentric Study

Abstract

Aims: To evaluate and compare the efficacy of Hilo® and Daflon® 500 mg, in the treatment of hemorrhoids. Study Design: It is a multicentric, randomized, comparative clinical trial conducted for the period of 15 days. Place and Duration of Study: Janta Hospital and Maternity Centre, Varanasi; King George Memorial Hospital, Lucknow; Vijan Hospital and Research Centre, Nasik and Santosh Hospital, Bangalore between May 2018 and December 2019. Methodology: 201 patients were screened and 200 patients with hemorrhoids (proctoscopy proven Grade I to III) were randomly assigned to receive either Hilo® capsules (n = 99) or Daflon® 500 mg tablets (n = 101). Assessment of hemorrhoidal symptoms was carried out in all patients on Day 7 and Day 15. Proctoscopic examination was carried out before the start of treatment i.e. on day 0 and at the end of treatment duration i.e. on day 15. Results: The patients treated with Hilo® showed a statistically significant improvement in the clinical symptoms of bleeding, pain, itching, soiling, tenesmus, irritation after defecation and constipation on day 7 and day 15 as compared to baseline. The “mean total symptom score” reduced by 4.55 ± 2.07 vs 3.44 ± 2.00; P < .0001 on day 7 and 7.56 ± 2.40 vs 6.22 ± 2.55; P < .0001 on day 15 in the patients treated with Hilo® and Daflon® respectively. In Hilo® Group, 82.83% of patients assessed that the treatment with Hilo® made them ‘A lot better’ as compared to only 48.51% in Daflon® group. In the Hilo® group 20.2% of patients’ treatment outcome was assessed as ‘Excellent’ by the investigators as compared to only 0.99% of patients in Daflon® group. No major adverse events were reported in the study with the use of either product. Conclusion: Hilo® is found to provide better reduction in clinical symptoms of patients suffering from hemorrhoids as compared to Daflon®.