Evaluation of the efficacy and safety of an innovative flavonoid lotion in patients with haemorrhoid: a randomised clinical trial.

Abstract

Objective: Haemorrhoids are one of the most common gastrointestinal and anal diseases. In olive oil and honey propolis, flavonoids have beneficial effects on improving vascular function and decreasing vascular resistance. In this study, we aimed to produce a combination of these two substances in the form of lotions and assess their healing and side effects in comparison with routine treatment, anti-haemorrhoid ointment (containing hydrocortisone and lidocaine).

Design: In this randomised clinical trial study, 86 patients with grade 2 or more haemorrhoid degrees, diagnosed by colonoscopy, were divided into two groups, the case (n=44) and control (n=42). The case group was treated with flavonoid lotion, and the control group was treated with anti-haemorrhoid ointment two times per day for 1 month. Patients were followed weekly with history and physical examination. The data of the two groups were collected before and after the intervention and statistically analysed.

Results: Post-treatment reduction in haemorrhoid grade was significant in the case group (p=0.02). This ratio was insignificant in the control group (p=0.139). Flavonoid lotion (p<0.05) significantly reduced the signs and symptoms of haemorrhoids more than anti-haemorrhoid ointment.

Conclusion: According to the results, flavonoid lotion can be an excellent alternative to topical chemical drugs, such as anti-haemorrhoid ointment, in treating haemorrhoid disease. Besides its effectiveness and safety, it can be easily manufactured and widely available to patien.